Software Effective Solutions Corp. (OTC: SFWJ)

The QualityStocks Daily Newsletter would like to spotlight Software Effective Solutions Corp. (OTC: SFWJ).

Hemp advocates in the state of California may sue the governor over the recently proposed emergency rules because they may negatively impact vulnerable individuals. During a press conference held earlier this month, Governor Gavin Newsom announced that he would be clamping down on intoxicating hemp products that were often marketed to minors. The governor explained that because drug peddlers are targeting children with unregulated and dangerous hemp products containing THC, it was important to increase enforcement to prevent minors from accessing these products, while also closing loopholes. Newsom proposed these regulations after AB 2223, which targeted hemp, failed to get approved in the Senate. Newsom signaled that the rules would take effect as soon as the Office of Administrative Law approved them. Public comment on the proposed rules ended on Sept. 18, 2024. An ideal path for the hemp industry and companies that make CBD products, such as Software Effective Solutions Corp. (d/b/a MedCana) (OTC: SFWJ), would be for the federal government to pass comprehensive regulations for cannabinoids so that states can derive their own iterations from these clear rules.

Software Effective Solutions Corp. (d/b/a MedCana) (OTC: SFWJ) is a global infrastructure and holding company in the cannabis industry. MedCana currently has five companies focused on pharmaceutical cannabis production, as well a software company focused on managing processes for plant-to-patient operations. The recent acquisition of an irrigation and greenhouse technology company has rounded out MedCana’s portfolio of holdings.

MedCana’s focus is on developing clients and companies in Latin America, initially in Colombia, and partnerships with laboratories, research facilities and hospitals throughout the world. MedCana is building the technology, laboratories, growing facilities and scientific teams to provide premium pharmaceutical-grade cannabis extracts to the world.

MedCana’s goal is to be the world’s premier resource for pharmaceutical cannabis products. The company believes its advantage is its global view and reach. From initial cultivation to final product, MedCana aims to help partners produce pharmaceutical CBD and other extracts that will have no equal.

The company’s mission is to utilize its technology to partner with and develop companies that provide premium pharmaceutical-grade cannabis extracts with absolute integrity, sustainability and social responsibility. MedCana’s team of pharmaceutical scientists includes some of the most respected chemists in the world. They aim to ensure that the company’s customers and partners create premium cannabis extracts that meet the growing worldwide demand. MedCana’s software is designed to ensure traceability and quality from seed to finished product.

MedCana is headquartered in Austin, Texas, with offices in Colombia.

Production

MedCana announced in May 2023 the beginning of full-scale production of non-THC cannabis for export to Europe in response to high demand in that market. This expansion comes after the successful completion of full crop cycle testing and infrastructure development at production sites in Columbia.

The recent acquisition of the assets of Tokan Corp., a software company focused on creating an enterprise resource planning (ERP) platform for the cannabis industry, and Eko2O S.A.S., a greenhouse and irrigation engineering company, has positioned MedCana for explosive growth in the region.

As a MedCana subsidiary, Eko2O SA will increase the company’s revenue potential in Central and South America. The subsidiary specializes in the construction and distribution of greenhouses and sophisticated irrigation platforms. A positive outlook has resulted from the company’s expansion as it investigates new opportunities for greenhouse and irrigation system installations in Panama and Uruguay. These opportunities are expected to accelerate Eko2O’s development and strengthen its position as a top supplier of innovative agricultural solutions in cannabis and other sectors that are quickly moving to high technology agricultural production.

In addition, MedCana has started talks with the government in Argentina about possible incentives for beginning operations in that country as part of its ongoing worldwide development strategy. Support from the Argentinean government and the start of new operations there would greatly increase MedCana’s market share in Latin America and solidify the company’s position as the market leader in the cannabis industry.

Market Opportunity

According to a report by Grand View Research, a San Francisco-based market research and consulting company, the global cannabis extract market was valued at $3.5 billion in 2022 and is expected to expand at a CAGR of 20% from 2023 to 2030 to be worth more than $15 billion.

Growing demand for cannabis extracts, including oils and tinctures, and the increased legalization of marijuana for the treatment of different chronic ailments like arthritis, Alzheimer’s, anxiety and cancer are driving the expansion of the industry. The marijuana derivative industry is flourishing due to a greater understanding of its various medical benefits.

Management Team

Jose Gabriel Diaz is CEO of MedCana. He has successfully built, grown and sold multiple telecom companies. He was senior vice president of sales at IP Communications, a national high-speed data provider. He also founded Reallinx, a national data carrier later sold to GTT Communications. Additionally, he is currently president of the A.E.M. Business and Entrepreneurship Association in Austin, Texas.

Claudio Jiménez Cartagena, QF, Ph.D. is Chief Scientific Officer at MedCana. He joined MedCana after working with Sosteli Pharma as Technical Director and serving as a director consultant for the Corporation for Agricultural Industrial Development at the University of Antioquia in Colombia. Before that, he worked as the scientific director at the Institute of Food Science & Technology. He holds a bachelor’s degree in pharmaceutical chemistry, a master’s degree in basic biomedical sciences and a doctoral degree in Environmental Engineering from the University of Antioquia.

Julián Alberto Londoño Londoño, Ph.D., is Senior Vice President of Operations at MedCana. He previously served as general manager for the Corporation for Agricultural Industrial Development, and as Chief Scientific Officer at Sosteli Pharma in the Resource Management Department. He has developed multiple U.S. patents, and recently served as senior advisor to the Secretariat of Agriculture Development for the Government of Antioquia. He holds a doctorate in Chemical Sciences from the University of Antioquia.

Software Effective Solutions Corp. (OTC: SFWJ), closed Tuesday's trading session at $0.015, up 42.8571%, on 4,002 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.000001/$0.09.

Recent News

• Software Effective Solutions Corp. (OTC: SFWJ) - Missouri Authorities Raid Shops Searching for Hemp Edibles Containing Intoxicants
• California Governor Announces Emergency Regulations Banning THC-Infused Hemp Products
• Proposed Georgia CBD Law Seeks to Cap Delta-9 THC

Horizon Fintex | Upstream

The QualityStocks Daily Newsletter would like to spotlight Horizon Fintex | Upstream

As the world of Web3 gaming keeps evolving, it is becoming clear that Pixels, the blockchain-based farm simulator, is at the forefront in more ways than one. With more than a million daily active users, Pixels has officially become the largest Web3 game out there since its launch in 2021. But this is not all — the game has made a bold move: clickable in-game ads, which are already generating impressive results. On July 24, 2024, Pixels launched its first intrinsic in-game advertising feature, strategically placing ads on virtual billboards and banners. Picture this: Take a stroll through your virtual land, casually spotting a clickable ad for a crypto token. More than 50 out of the 237 people who clicked the ad made a purchase. That's a conversion rate of more than 20% in only two weeks! That's a win-win for both gamers and advertisers. Despite the risks, Pixels' ad strategy isn't only benefiting advertisers. The players, especially those who own virtual land, are raking in some sweet rewards too. Thanks to in-game ads, landowners are earning revenue from billboards placed on their digital plots, and some are reportedly seeing returns of up to 33% annual yield on their NFTs, according to Quinn Campbell, founder of ad tech company PTAL. In-game adverts could find some utility among enterprises such as Horizon Fintex as they drum up awareness about their different solutions needed by the public.

Horizon Fintex is a software business specializing in compliant securities solutions. The company aims to facilitate the future of capital markets by leveraging the regulatory experience of Wall Street bankers and the proven track record of technology veterans to bring focus to compliance, efficiency, security and transparency.

Horizon’s flagship product is the revolutionary trading app ‘Upstream’, a MERJ Exchange Market, and the first regulated market powered by a blockchain to offer both digital securities and NFT trading. Upstream traders experience T+0 settlement, best bids and offers displayed on a transparent public orderbook that prevents predatory market practices – all from a user-friendly trading app.

Products

Horizon Fintex offers a full suite of end-to-end blockchain-enhanced software solutions to create a seamless experience for both issuers and investors. Its product suite includes:

• Securitization & Issuance – ETSware is an end-to-end Electronic Trading System streamlining capital raising from primary issuance through compliant secondary trading.
• KYC Compliance Onboarding – KYCware is a white label Know Your Customer (KYC) and Anti-Money Laundering (AML) compliance software solution offering best-in-class cryptographic security to compliantly onboard and verify user identity through a smartphone application.
• AML Screening Software – AMLCop offers advanced Anti-Money Laundering (AML) software to streamline the verification of user details against a proprietary database of global sanctions, politically exposed persons (PEPs) and watchlists.
• Cap. Table Management Tools – CustodyWare equips registered U.S. transfer agents with next-generation cap. table management software to manage securities on behalf of their clients pursuant to an SEC-registered or exempt securities offering.
• Exchange & Trading App Technology – Open Order Book offers Ethereum blockchain securities exchange software to power the next generation of trading venues for digital assets.

Upstream – The Horizon-Powered Trading App

Upstream is a joint venture with MERJ Exchange (merj.exchange), an affiliate of the World Federation of Exchanges.

Upstream aims to be the premiere global trading hub offering issuers around the world exposure to a digital-first investor base that can trade using USDC digital currency along with credit, debit, PayPal, and USD (fiat) to increase liquidity and enhance price discovery; while also offering investors access to dual-listed companies, IPOs, crowdfunded companies, U.S. & Int’l. equities, digital coupons and NFTs directly from a user-friendly trading app.

Upstream aims to unlock liquidity for investors of all levels while offering industry-leading levels of transparency, accessibility and investor protections enforced using Ethereum blockchain technology.

Management Team

Brian Collins is the CEO of Horizon Fintex. He founded the company in 2010. From 1999-2010, Mr. Collins was CEO of Abbey Technology in Switzerland, specializing in the design of trading software for Swiss banks. Prior to this, he worked for Credit Suisse in Zürich, designing and building proprietary equity trading solutions. Mr. Collins graduated in 1990 with a BS in Computer Systems from the University of Limerick, Ireland.

Mark Elenowitz is the company’s President. He is a Wall Street veteran with over 29 years of experience. Mr. Elenowitz was the co-founder of a U.S. broker dealer and is Managing Director of two U.S. broker dealers, responsible for advising clients on compliance, capital structure and capital market navigation. He was responsible for leading the first successful Reg A+ IPO of a company to list on the NYSE and others which listed directly onto Nasdaq. He is a noted speaker at Small Cap and Reg A events, including the SEC Small Business Forum, and has been profiled in BusinessWeek and CNBC, as well as several other publications. Mr. Elenowitz is a graduate of the University of Maryland School of Business and Management with a BS in Finance and holds Series 24, 62, 63, 79, 82 and 99 licenses.

Dr. Andrew Le Gear is the CTO of Horizon Fintex. Prior to joining the company in 2013, he worked as a software engineer with Dell Inc. (2012-2013) and Lehman Brothers and Nomura Plc. (2007-2012). Dr. Le Gear was a co-founder of Juneberi Ltd., a research-driven software tech start-up (2004-2007). He graduated in 2006 with a Ph.D. in Computer Science from the University of Limerick, Ireland.

Peter Hall is the company’s CIO. Prior to joining Horizon Fintex in 2011, he worked at Microsoft (2008-2011), Atos Origin (2004-2008) and AIT Group Plc. (1998-2002). Mr. Hall has held CISSP certification since 2010. He graduated from the University of Sheffield, UK in 1995 and earned an MS from the University College London in 2006.

Mike Boswell is the CFO of Horizon Fintex. A Wall Street veteran, he co-founded a U.S. broker dealer and served as Chief Compliance Officer. Mr. Boswell was also Managing Director of TriPoint Capital Advisors, a merchant banking and financial consulting company, and CFO of Mission Solutions Group, a privately held defense sector firm. He earned an MBA from John Hopkins University and a BS in Mechanical Engineering from the University of Maryland. Mr. Boswell holds Series 24, 62, 63, 79, 82 and 99 licenses.

Recent News

• Horizon Fintex | Upstream - Web3 Game Publisher Views In-Game Adverts as a Unique Opportunity
• Web3 Professionals Confident about Cryptocurrencies’ Future Despite Uncertain Regulations
• InvestorNewsBreaks – Upstream Spotlighted in Security Token Magazine Article

Nutriband Inc. (NASDAQ: NTRB)

The QualityStocks Daily Newsletter would like to spotlightFathom Nutriband Inc. (NASDAQ: NTRB) .

Nutriband (NASDAQ: NTRB), a pharmaceutical company with a special focus on transdermal technologies, is announcing that its patent application, which protects its AVERSA(TM) abuse deterrent transdermal technology, has been allowed in China. This follows the receipt of a Notice of Allowance from the Chinese National Intellectual Property Administration ("CNIPA") for the application entitled "Abuse and Misuse Deterrent Transdermal Systems." The latest allowance expands the company's international intellectual property portfolio, which now includes patents issued in 46 countries: Australia, Canada, China, Europe, Japan, Korea, Mexico, Russia, the U.S., and more.

To view the full press release, visit https://ibn.fm/oxL2p

Nutriband Inc. (NASDAQ: NTRB) is engaged in the development of a portfolio of transdermal pharmaceutical products. The company’s AVERSA™ technology can be incorporated into any transdermal patch and includes aversive agents to prevent abuse, diversion, misuse and accidental exposure to drugs with abuse potential, specifically opioids.

AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to patients who need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico and Australia.

The company’s business model is to apply its transdermal technology to existing FDA-approved drugs with a goal of improving safety, efficacy and patient comfort while qualifying for a limited-development regulatory pathway that reduces the number of clinical trials required for approval of new drugs.

Nutriband has three subsidiaries, including 4P Therapeutics, its clinical and regulatory subsidiary; Pocono Pharmaceutical, a contract manufacturer for a wide range of clients; and Active Intelligence, a developer of sports recovery products. This ownership of manufacturing and clinical development capabilities drastically reduces costs for AVERSA and other technologies.

In April 2024, Nutriband announced that the company had been engaged by and received a first order from Fit For Life Group, a major brand license holder. A fully executed supplier agreement is expected to follow. Nutriband’s wholly owned Active Intelligence subsidiary will act as manufacturer.

The company is headquartered in Orlando, Florida.

Products

Nutriband’s lead product candidate is AVERSA Fentanyl, an abuse-deterrent fentanyl transdermal patch. The company announced in March 2024 that it will submit a New Drug Application to the U.S. Food and Drug Administration seeking approval to market AVERSA Fentanyl.

Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband’s AVERSA abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system. Because Nutriband’s abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate from and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation would not be required.

AVERSA Fentanyl has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The company plans to seek an expedited review by the FDA, as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs.

Nutriband’s AVERSA product development pipeline also includes abuse deterrent versions of currently approved and marketed transdermal patches containing buprenorphine, an opioid used to treat opioid use disorder, and methylphenidate, a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD). Both are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure.

Market Opportunity

Nutriband cites a market analysis report from Boston-based Health Advances, a healthcare and life sciences consulting firm. According to the report, upon FDA approval, AVERSA Fentanyl has the potential to reach peak annual sales of $200 million in the U.S.

The company further states that, should non-abuse-deterrent transdermal fentanyl products lose FDA marketing approval, AVERSA Fentanyl would have greater pricing flexibility and would have the potential to generate more than $500 million in annual revenue.

Management Team

Gareth Sheridan is Co-Founder and CEO of Nutriband. He was Ireland’s ‘Young Entrepreneur of the Year’ in 2014 for establishing Nutriband. He has worked as a Business Mentor with 100 Minds, a social enterprise that brings together some of Ireland’s top college students and connects them with a cause to achieve large charitable goals. He received a B.Sc. in Business and Management from Dublin Institute of Technology.

Serguei Melnik is Co-Founder and President of Nutriband. He has been involved in general business consulting for companies in the U.S. financial markets and setting up legal and financial frameworks for operations of foreign companies in the U.S. He previously was the COO of Florida-based Asconi Corporation. He also was a lawyer in the Department of Foreign Affairs, JSC Bank “Inteprinzbanca,” in Chisinau, Moldova, and prior to that practiced law in Moldova. He is fluent in four languages.

Jeff Patrick, Pharm.D., is Chief Scientific Officer of Nutriband. He currently serves as Director of the Drug Development Institute at the Ohio State University Comprehensive Cancer Center. His prior roles included Global Vice President at Mallinckrodt Pharmaceuticals Inc.; and roles at Dyax, Myogen/Gilead, Actelion and Sanofi-Synthelabo Inc. He was a clinical pharmacist at the University of Tennessee Medical Center and a clinical assistant professor of pharmacy at the University of Tennessee College of Pharmacy.

Gerald Goodman is CFO of Nutriband. He is a certified public accountant with his own firm, Gerald Goodman CPA. He also practiced with Madsen & Associates, CPAs, and was a partner in the accounting firm of Wiener, Goodman & Company. He is also a director of Lifestyle Medical Network Inc., which provides management services to healthcare providers. He is a graduate of Pennsylvania State University, where he received a bachelor’s degree in accounting.

Nutriband Inc. (NASDAQ: NTRB), closed Tuesday's trading session at $6.7, off by 0.297619%, on 75,544 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $1.53/$9.595.

Recent News

• Nutriband Inc. (NASDAQ: NTRB) - InvestorNewsBreaks - Nutriband Inc. (NASDAQ: NTRB) Announces Receipt of Notice of Allowance for China Patent Application Covering AVERSA(TM) Technology
• InvestorNewsBreaks - Nutriband Inc. (NASDAQ: NTRB) Reports on Share Repurchase Program
• BioMedNewsBreaks - Nutriband Inc. (NASDAQ: NTRB) Releases Q2 Report, AVERSA Fentanyl Update

Mullen Automotive Inc. (NASDAQ: MULN)

The QualityStocks Daily Newsletter would like to spotlight Mullen Automotive Inc. (MULN).

Mullen Automotive (NASDAQ: MULN), an emerging electric vehicle ("EV") manufacturer, today shared a video update to shareholders provided by CEO and Chairman David Michery. In the video, Michery provides a detailed overview of the company's recent progress, including sales and distribution expansion and financial performance. According to the update, the company's sales activities with existing and new companies have resulted in new sales opportunities and vehicle orders received and or completed. Additionally, Mullen has secured financing to support sales growth through a $100 million preferred instrument and a $150 million fully available equity line. The update also highlighted Bollinger Motors' progress, including regulatory and sales approvals, its partnership with Roush Industries, and the commencement of production on the first customer-ready B4 electric trucks.

"Our group of companies, including Bollinger Motors and Mullen Advanced Energy Operations, continue to work towards meeting milestones and growing sales and I remain optimistic that the company success will continue despite the challenges associated with our stock price," commented Michery.

To view the video update, visit https://ibn.fm/3ywdM

To view the full press release, visit https://ibn.fm/wTgwe

Mullen Automotive Inc. (NASDAQ: MULN) is a Southern California-based automotive company that owns and partners with several synergistic businesses working toward the unified goal of creating clean and scalable energy solutions. Mullen has evolved over the past decade in sync with consumers and technology trends. Today, the company is working diligently to provide exciting EV options built entirely in the United States and made to fit perfectly into the American consumer’s life. Mullen strives to make EVs more accessible than ever by building an end-to-end ecosystem that takes care of all aspects of EV ownership.

Commencement of Trading on Nasdaq

On November 5, 2021, Mullen announced its commencement of trading on the Nasdaq Capital Market.

“Today is a monumental day for Mullen Automotive. I am especially proud of our team, investors and all who have believed in Mullen and taken us to this point as a publicly traded company on the Nasdaq Capital Market,” David Michery, CEO and Chairman of Mullen Automotive, stated in the news release. “Trading on Nasdaq now opens us up to new investors, both institutional and retail shareholders, and broadens our awareness and company profile, while increasing awareness of Mullen and our technology platform and opening new opportunities in EV and beyond. The road ahead has never been brighter for Mullen, and I am proud to lead us into the future.”

The milestone came in the wake of the company’s stock-for-stock merger with Net Element Inc.

The Mullen FIVE

The Mullen FIVE EV Crossover, debuting at the Los Angeles International Auto Show (LAIAS) on November 17, 2021, embodies Mullen’s Southern California roots with an inspired design focused on two complementary Golden State themes – California landscape and California urban.

The FIVE is built on an EV Crossover skateboard platform that offers multiple powertrain configurations and trim levels in a svelte design that is Strikingly Different™ and exciting to experience in person.

Prior to the start of LAIAS, the Mullen FIVE was selected as a finalist by the LA Auto Show for Top EV SUV in the ZEVA “People’s Choice” Awards.

LAIAS provides Mullen an opportunity to display multiple variants of the FIVE model while also showcasing its powertrain, battery and charging technology. The company intends to bring the FIVE to market in 2024, and reservations are currently open here.

Mullen’s development portfolio also includes EV Fleet Vans, which it intends to bring to market in Q2 2022, and the pure electric, high performance Mullen DragonFLY.

Expansion of Manufacturing Capacity

On November 2, 2021, Mullen announced plans to expand its facility in Robinsonville, Mississippi.

Mullen’s Advanced Manufacturing and Engineering Facility (AMEC) currently occupies 124,000 square feet of manufacturing space. The total available land on the property is over 100 acres, and Mullen is moving ahead with plans to build out another 1.2 million square feet of manufacturing space to support class 1 and class 2 EV cargo vans and the Mullen FIVE EV Crossover.

On the expanded site, Mullen plans to build a body shop, a fully automated paint shop and a general assembly shop.

EV Market Outlook

The global EV market was reported to consist of 3,269,671 units in 2019, a figure that is expected to grow at a CAGR of 21.1% through 2030 to a total of 26,951,318 units worldwide. This market’s monetary value was estimated at $162.34 billion in 2019 and is expected to grow at a CAGR of 22.6%, resulting in an approximate value of $802.81 billion by 2027. The primary driver for this exponential growth is a worldwide increase in vehicle emissions regulations.

Management Team

David Michery is the CEO and Founder of Mullen and has been leading the company and its divisions since inception in 2014. With over 25 years of executive management, marketing, distressed assets, and business restructuring experience, Mr. Michery brings a wealth of relevant knowledge and expertise to the Mullen brand. He has notably created 12 trademarks so far to develop the company brand and vision.

Mr. Michery is working toward a sustainable future accessible to all by creating a suite of clean-energy electric vehicles at varied price points. With entirely U.S.-based manufacturing and operations, he is also determined to have Mullen Technologies play a role in shaping a self-sustaining local economy by creating more jobs in America.

Mr. Michery manages risks and company expectations as a pathway to success and has personally overseen several businesses that totaled over $1 billion in transactions. His key strength is the ability to be fiscally responsible and lead teams to complete projects on time and within budget. As a seasoned professional in this space, Mr. Michery has demonstrated skill in building businesses from the ground up and into successful entities that subsequently sold for hundreds of millions of dollars.

Mullen Automotive Inc. (MULN), closed Tuesday's trading session at $5.07, off by 13.4812%, on 2,235,400 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $4.9001/$5700.00.

Recent News

• Mullen Automotive Inc. (NASDAQ: MULN) - InvestorNewsBreaks - Mullen Automotive Inc. (NASDAQ: MULN) Shares Video Update from CEO
• InvestorNewsBreaks - Mullen Automotive Inc. (NASDAQ: MULN), Subsidiary Celebrate Production of B4 Electric Truck, CEO to Release Shareholder Update Video
• InvestorNewsBreaks - Mullen Automotive Inc. (NASDAQ: MULN) Officials in UAE to Support Volt Mobility $210M Order

Clene Inc. (NASDAQ: CLNN)

The QualityStocks Daily Newsletter would like to spotlight Clene Inc. (NASDAQ: CLNN).

The company is seeking an accelerated approval regulatory pathway for CNM-Au8® for ALS.

The FDA agreed to an in-person meeting to reevaluate Clene's submission.

Lead drug candidate CNM-Au8 has been shown to restore and protect neurological function, offering hope for patients with neurodegenerative conditions.

The FDA meeting will be held before the end of November and will be attended by top FDA officials and key opinion leaders in ALS, biostatistics and biomarkers.

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis ("ALS") and multiple sclerosis ("MS"), announced an upcoming meeting with the U.S. Food and Drug Administration ("FDA") leadership to discuss lead candidate CNM-Au8^®.

Clene Inc. (NASDAQ: CLNN) is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).

Its lead drug candidate is CNM-Au8®, an oral suspension developed to restore neuronal health and function by increasing energy production and utilization by driving critical cellular energy producing reactions that enable neuroprotection and remyelination to increase neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is being studied in various clinical trials, including the Harvard/MGH Healey ALS Platform clinical trial for patients with ALS; RESCUE-ALS, a completed proof-of-concept clinical trial in patients with early symptomatic ALS; the REPAIR trials, completed target engagement clinical trials showing brain energy metabolite change with CNM-Au8; and a completed MS clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing MS. The company also has a nanotherapeutic platform of drug discovery.

CNM-Au8

CNM-Au8, Clene’s lead asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Multiple pathogenic insults contribute to neuronal death. Mitochondrial dysfunction and NAD+ decline is a common final pathway in neurodegeneration, with NAD+ as a critical determinant of cell survival and function. CNM-Au8’s catalytic mechanisms target the energetic deficits, oxidative stress and accumulation of misfolded proteins that are common to many neurodegenerative diseases.

The unique catalytic mechanism of action of CNM-Au8 is hypothesized to act as a neuroprotective and remyelinating therapy in neurodegenerative disease states in order to: (1) drive, support and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed and/or damaged cells, (2) directly catalyze the reduction of harmful, reactive oxygen species (“ROS”) and (3) promote protein homeostasis via activation of the heat shock factor-1 pathway, recognized to dampen the cytotoxicity caused by misfolded and denatured proteins, which are known to occur ubiquitously in neurodegenerative diseases.

CNM-Au8 is used in combination with other agents, has no known drug-drug interactions, and is designed to improve function and survival. The clinical effects of both function and survival were seen in its clinical ALS trials, as earlier announced.

More than 500 estimated years of collective exposure across ALS, MS, and Parkinson’s disease participants in CNM-Au8 clinical trials and Expanded Access Protocol (compassionate use) programs have been recorded without any observed safety signals.

CNM-Au8 is a federally registered trademark of Clene Inc. Clene, based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland, began in 2013.

Market Opportunity

ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide, with a life expectancy of typically three to five years. Clene estimates that global ALS treatment sales will be greater than $1 billion annually within the coming few years. Additional treatments affecting daily function and survival remain the market need.

Additionally, there are more than 2 million MS patients globally, and Clene estimates the market size to be worth more than $23 billion annually. While the MS community has been successful at limiting relapses, non-relapsing MS patients continue to clinically deteriorate even while receiving effective immunomodulatory disease-modifying therapies (“DMTs”). A critical unmet medical need remains for therapeutic interventions that protect neuronal function and myelin health independent of immunomodulation to address progression independent of relapse activity.

Management Team

Robert Etherington is President, Director and CEO of Clene. He has more than 30 years of sales, marketing and leadership experience in the pharmaceutical industry. Prior to joining Clene, he worked at Actelion Pharmaceuticals, the largest biopharma company in the European Union prior to its acquisition by Johnson & Johnson in 2017, where he led that company’s U.S. commercial operations. He began his pharmaceutical sales and marketing career at Parke-Davis, a division of Pfizer, where he rose to the position of Team Leader overseeing the drug Lipitor.

Mark Mortenson is Chief Science Officer at Clene. He is co-inventor of the technology platform developed to produce the company’s therapeutics. He is the inventor or co-inventor on 32 other U.S. patents and hundreds of corresponding international patents. He is a former chief patent counsel responsible for 5,500 U.S. and international patents and patent applications. He holds bachelor’s degrees in physics and ceramic engineering from Alfred University, a master’s degree in materials science from Penn State University and a J.D. from George Washington University.

Benjamin Greenberg, M.D., MHS, FAAN, is Head of Medical at Clene. He is an internationally recognized expert in disorders of the central nervous system. He is currently professor of neurology and Vice Chair of Clinical and Translational Research in the department of Neurology at University of Texas Southwestern Medical Center in Dallas. He holds a bachelor’s degree from Johns Hopkins, a master’s degree in molecular microbiology and immunology from the Johns Hopkins School of Public Health and graduated from Baylor College of Medicine. He served residency in neurology at The Johns Hopkins Hospital.

Morgan R. Brown is CFO at Clene. He has more than 30 years of finance and accounting experience, with 23 years at biotech, pharmaceutical and medical device companies. He has served in similar roles at Lipocine Inc., Innovus Pharmaceuticals, World Heart Corp., Lifetree Clinical Research and NPS Pharmaceuticals Inc. He previously worked at accounting firm KPMG. He is a CPA with a bachelor’s degree in accounting from Utah State University and an M.S. in business administration from the University of Utah.

Clene Inc. (NASDAQ: CLNN), closed Tuesday's trading session at $4.41, off by 1.5625%, on 46,027 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $3.8181/$13.20.

Recent News

• Clene Inc. (NASDAQ: CLNN) - Clene Inc. (NASDAQ: CLNN) to Discuss Lead Candidate CNM-Au8(R) Biomarker, Clinical Data for ALS with Food and Drug Administration Leadership
• InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Announces Upcoming In-Person FDA Meeting to Discuss CNM-Au8
• Does Multiple Sclerosis Reduce Risk of Developing Dementia?

SuperCom Ltd. (NASDAQ: SPCB)

The QualityStocks Daily Newsletter would like to spotlight SuperCom Ltd. (NASDAQ: SPCB) .

SuperCom (NASDAQ: SPCB), a global provider of secured solutions for the e-government, Internet of Things ("IoT") and cybersecurity sectors, has secured a three-year national contract with the government of a European country. The contract calls for SuperCom deploy its PureSecurity domestic violence ("DV") monitoring solution. Since entering the market, SuperCom has become a leader in Europe's national domestic violence monitoring sector, deploying a substantial number of units and outpacing its competitors. This new contract further solidifies the company's continued expansion in the region as it works to enhancing domestic violence prevention and intervention capabilities.

"We are honored to collaborate with this EU country to support their initiatives in addressing domestic violence through advanced monitoring solutions," said SuperCom president and CEO Ordan Trabelsi in the press release. "Winning our fifth national domestic violence contract in Europe is a testament to the trust governments place in our technology and our commitment to enhancing public safety. Our DV monitoring solution offers real-time tracking, communication and security, providing authorities with a powerful tool to improve the protection of vulnerable individuals and promote offender accountability."

To view the full press release, visit https://ibn.fm/axedM

SuperCom Ltd. (NASDAQ: SPCB) provides secured solutions for the e-government, IoT and cybersecurity sectors. Since 1988, the company has been a trusted global provider of traditional and digital identity offerings, providing cutting-edge electronic and digital security solutions to governments and organizations, both private and public, around the world.

SuperCom’s mission is to revolutionize the public safety sector worldwide through proprietary electronic monitoring technology, data intelligence, and complementary services.

The company is headquartered in Tel Aviv, Israel, with offices in California and other regions in the U.S.

Business Units

IoT and Connectivity

SuperCom IoT products and solutions provide advanced electronic monitoring solutions and services to criminal justice agencies, enabling customers to detect unauthorized movement of people, vehicles, and other monitored objects. The company provides an all-in-one, field-proven PureSecurity offender monitoring suite, accompanied by services such as GPS monitoring, home detention, domestic violence prevention, and more. The company’s services are specifically tailored to meet each client’s needs.

SuperCom’s proprietary Puresecurity suite of hardware, connectivity, and software components is the foundation for its criminal justice services and offerings. SuperCom is leveraging its extensive technology expertise to implement groundbreaking artificial intelligence (AI) technologies into various parts of its core offerings. By leveraging the power of AI, SuperCom’s PureSecurity platform can offer new abilities, such as amplified data analysis, predictive modeling, and streamlined automation – all geared toward optimizing decision-making and operational efficiency.

Competitive advantages of SuperCom’s technology include:

• Long Battery Life (No Tag Charging Required)
• Ultra Lightweight Form Factor
• Next-Gen Location Tech
• Protection of Domestic Violence Victims
• And More

Cybersecurity

In 2015, SuperCom identified the cybersecurity market as a fast-growing space with significant advantages due to synergistic technologies and a shared customer base with its e-Gov and IoT business units. Consequently, SuperCom strategically acquired Prevision Ltd., a company with a strong presence in the market and a broad range of competitive cybersecurity services.

During the first quarter of 2016, SuperCom acquired Safend Ltd., an international provider of cutting-edge endpoint data protection guarding against corporate data loss and theft through content discovery and inspection, encryption methodologies, and comprehensive device and port control.

Both acquisitions significantly expanded the breadth of the company’s global cybersecurity capabilities.

e-Gov

Through proprietary e-government platforms and innovative solutions for traditional and biometrics enrollment, personalization, issuance, and border control services, SuperCom has helped governments, and national agencies design and issue secured multi-identification, or Multi-ID, documents and robust digital identity solutions to their citizens, visitors, and lands.

The company has focused on expanding its activities in the traditional identification, or ID, and electronic identification, or e-Gov, markets, including the design, development, and marketing of identification technologies and solutions to governments in Europe, Asia, America, and Africa using SuperCom’s e-Government platforms.

Market Opportunity

Data from Berg Insight estimates the market for electronic monitoring solutions will grow from $1.2 billion in 2021 to $2.1 billion in 2026, marking a CAGR of 10.8% for the forecast period.

High recidivism rates, prison overcrowding, and soaring incarceration costs are some factors that are driving the electronic monitoring of offenders’ market growth.

An analysis by ReportLinker forecasts that the global cybersecurity market will grow from an estimated value of $173.5 billion in 2022 to $266.2 billion by 2027, achieving a CAGR of 8.9% for the period.

The increased number of data breaches worldwide, the ability of malicious actors to operate from anywhere in the world, the links between cyberspace and physical systems, and the difficulty of reducing vulnerabilities and consequences in complex cyber networks are some factors driving the cybersecurity market growth.

Management Team

Ordan Trabelsi is President and CEO of SuperCom. He has over 15 years of experience as CEO, growing high-tech companies globally. He also has experience in research and development and product innovation, as well as hands-on experience in cybersecurity, encryption, advanced mathematics, and mobile and internet network technologies. Prior to joining SuperCom, he served as co-founder and CEO of Klikot Inc., a global social networking company. He holds an MBA from Columbia University and a B.Sc. in Computer Engineering from The Technion: Israel Institute of Technology.

Barak Trabelsi is COO of SuperCom. He has expertise in big data, cyber, mobile, and internet network technologies, as well as extensive experience in product development and strategies. Prior to joining SuperCom, he served as Senior Product Manager at Equinox Ltd. Before that, he served for four years as VP of R&D at Sigma Wave, a wireless, security, and internet-focused company. He holds a B.Sc. in Computer Science and Business, as well as an MBA from Tel Aviv University.

Gil Alfi is VP of Sales at Safend Ltd., SuperCom’s cybersecurity subsidiary. He joined SuperCom in 2016 as VP of Business Development for Safend. He has more than 18 years of experience in technology companies. He served as an R&D team technology lead for more than seven years and as Director of Product Management for various telecom and wireless companies for more than 10 years. Prior to joining SuperCom, he served as Regional Sales Director at Safend, managing sales regions in Europe and Africa. He holds a B.Sc. in Computer Science and Mathematics and an M.Sc. in Computer Science from Bar-Ilan University.

SuperCom Ltd. (NASDAQ: SPCB), closed Tuesday's trading session at $3.75, off by 1.1962%, on 95,329 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $2.55/$22.60.

Recent News

• SuperCom Ltd. (NASDAQ: SPCB) - InvestorNewsBreaks - SuperCom Ltd. (NASDAQ: SPCB) Awarded DV Electronic Monitoring Contract by Government of European Country
• Domestic Violence Victim Data Breach is a Case Example Showing Critical Need for Monitoring Technology of SuperCom Ltd. (NASDAQ: SPCB)
• InvestorNewsBreaks - SuperCom Ltd. (NASDAQ: SPCB) Continues to Expand Footprint in the US with New Competitive Contract in New York State