Astrotech Corp. (NASDAQ: ASTC)

The QualityStocks Daily Newsletter would like to spotlight Astrotech Corp. (NASDAQ: ASTC).

Hemp was federally legalized under the 2018 Farm Bill, permitting its cultivation and production. Last week, the U.S. agriculture department published a roadmap for hemp that focused on the crop's research needs. The roadmap is divided into the following areas: best production practices, genetics and breeding, consistency and transparency, and biomanufacturing for end uses. The department explained that these areas were important in strengthening research on the hemp industry and focused on the entire hemp supply chain. In other news, a new federally funded study identified new techniques for differentiating marijuana and hemp. The FDA is also looking over a proposal to permit the use of hemp seed meal as feed for hens. The analytics instruments which enterprises such as Astrotech Corp. (NASDAQ: ASTC) make can make a valuable contribution toward facilitating the growth of the hemp industry, especially at this time when it is vital to conduct definitive tests that differentiate hemp from marijuana products.

Astrotech Corp. (NASDAQ: ASTC) is an instrumentation company that designs, manufactures and commercializes solutions. Its solutions include mass spectrometry, process controls, chemical detectors and medical disease detection.

The company was established in 1984 and, prior to 2009, was known as SPACEHAB Inc., a NASA contractor offering technology originally developed for NASA to monitor air quality on the International Space Station. When the Space Shuttle program ended, the company focused on its satellite processing and mass spectrometer instrumentation units and adopted the Astrotech name.

In 2014, Astrotech sold its satellite subsidiary to focus on its Astrotech Technology Inc. (ATi) mass spectrometry solutions, which offer a number of advantages over competing platforms. Notably, Astrotech’s ATi technology is ruggedized, rapid, simple to use and customizable, with hands-free calibration and tuning.

Between 2016 and 2019, the company secured U.S. patents for its technology and achieved European Union (ECAC) certification for the TRACER 1000™, the world’s first mass-spec Explosives Trace Detector (ETD) used in airports worldwide. Astrotech continues to innovate and add to its suite of products, including AgLAB-1000, a process control system, and the BreathTest 1000, a disease detection solution.

Astrotech is headquartered in Austin, Texas.

Subsidiaries

Astrotech Technologies Inc.

Astrotech Technologies Inc. (ATi) owns and licenses the platform mass spectrometry technology originally developed by 1st Detect. This technology is designed to be less expensive, smaller and easier to use than traditional mass spectrometers.

Unlike other technologies, ATi works under high vacuum, which eliminates competing molecules, yielding higher resolution and fewer false alarms. The company’s intellectual property includes 18 granted patents, along with extensive trade secrets.

ATi exclusively licenses the Astrotech Mass Spectrometer Technology to the three wholly owned subsidiaries of Astrotech.

1st Detect Corp.

1st Detect Corp. developed the TRACER 1000, the world’s first mass spectrometry-based explosives and narcotics trace detector. 1st Detect ETDs were developed for use at airports, cargo facilities and other secured locations and borders worldwide.

1st Detect’s commercial sales of the TRACER 1000 ETD, consumables and recurring maintenance services brought in $750,000 in total revenue during the fiscal year ended June 30, 2023. The Astrotech subsidiary recently secured two orders for a total of 24 Tracer 1000 units from two Romanian security and telecommunications companies, to be delivered during calendar 2023.

AgLAB Inc.

AgLAB Inc. is developing a series of mass spectrometers for use in the hemp and cannabis market, with an initial focus on optimizing yields in the distillation processes.

AgLAB, which uses the company’s proprietary AgLAB 1000-D2™ mass spectrometer, has been proven to improve distillation oil yields and bottom-line profits for hemp and cannabis producers. During field trials, AgLAB was able to improve ending-weight yields by an average of 24%.

BreathTech Corp.

BreathTech is developing the BreathTest-1000™, a breath analysis tool to screen for volatile organic compound (“VOC”) metabolites found in a person’s breath that could indicate they may have a compromised condition including but not limited to a bacterial or viral infection. The company believes that new tools to aid in the battle against COVID-19 and other diseases remain of the utmost importance to help more quickly identify that an infection may be present.

Market Opportunity

A report by Mordor Intelligence, a research and advisory firm, put the global mass spectrometry market at $6.37 billion in 2023. The market is forecast to grow to $8.63 billion by 2028, achieving a CAGR of 6.25% during the forecast period.

One of the major driving factors for the growth of the mass spectrometry market is technological advancements in mass spectrometer devices, the report states. Key market players are continuously working toward advancing their existing products and launching innovative and advanced mass spectrometer devices.

Another major factor that is expected to boost market growth is increasing research and development expenditure by both government and private entities, according to the report. Mass spectrometry devices are also being used in the detection and analysis of COVID-19 and other disease samples, which may have a positive impact on the market.

Management Team

The Astrotech leadership team includes management executives, as well as industry and technology experts. The company continues to actively expand its talent pool to meet evolving demands.

Thomas B. Pickens III is Chairman, CEO and Chief Technology Officer of Astrotech Corp. He also serves as CEO of Astrotech subsidiaries ATi, 1st Detect, AgLAB Inc. and BreathTech Corp. Previously, he was the founder and president of Beta Computer Systems Inc. and T.B. Pickens & Co. He was founder and general partner of Grace Pickens Acquisition Partners L.P and managing partner of Sumpter Partners. He also served as CEO of Catalyst Energy Corporation and United Thermal Corporation and as president of Golden Bear Corp., United Hydro Inc. and Slate Creek Corp. He received a B.A. in Economics, Computer Science and Engineering from Southern Methodist University.

Jaime Hinojosa, CPA, is CFO at Astrotech Corp. He joined the company in 2015 and has served as its Corporate Controller since 2019. His previous roles with the company include Director of Finance, from 2017 to 2019, and Assistant Controller, from 2015 to 2017. Prior to joining Astrotech, Mr. Hinojosa worked as an Accounting Manager for O’Reilly Auto Parts and gained public accounting experience as an Audit Manager at Burton McCumber & Cortez LLP.

Astrotech Corp. (NASDAQ: ASTC), closed Tuesday's trading session at $8.75, off by 0.22805%, on 1,533 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $7.00/$15.11.

Recent News

• Astrotech Corp. (NASDAQ: ASTC) - USDA Publishes Roadmap for Hemp Highlighting Research Needs
• New AI Model Can Detect Diseases by Analyzing Visual Maps
• TechMediaBreaks - Astrotech Corporation's (NASDAQ: ASTC) Subsidiary Tapping into Fast-Growing Opportunity

Genprex Inc. (NASDAQ: GNPX)

The QualityStocks Daily Newsletter would like to spotlight Genprex Inc. (NASDAQ: GNPX).

Genprex (NASDAQ: GNPX) is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. The company today announced its entry into definitive agreements for the sale and issuance of 1,542,112 shares of its common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to 1,542,112 shares of common stock at a combined offering price of $4.215 per share of common stock (or per prefunded warrant in lieu thereof) and accompanying warrant, in a registered direct offering priced at-the-market under the Nasdaq rules. The warrants have an exercise price of $4.09 per share, exercisable on the date of issuance and expiring five years following the date of issuance. Subject to customary conditions, the closing of the offering is expected to occur on or about March 21, 2024. The gross proceeds to Genprex are expected to be approximately $6.5 million, of which the company intends to use the net proceeds for working capital and general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

To view the full press release, visit https://ibn.fm/1k17U

Genprex Inc. (GNPX) is a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients based upon a unique proprietary technology platform, including Genprex’s initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex’s platform technologies are designed to administer cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.

Research and Development

Genprex holds a portfolio of 30 issued and two pending patents covering its technologies and targeted molecular therapies. The company’s research and development program is focused on identifying and developing leading-edge gene therapies that can be used alone or in combination with other therapies for treatment of cancer.

Genprex’s initial product candidate is Oncoprex™, an immunogene therapy for the treatment of non-small cell lung cancer (NSCLC). Oncoprex works by interrupting cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (or programmed cell death) in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.

Preclinical research is being conducted with the goal of developing Oncoprex to be administered with targeted therapies in other solid tumors, and with immunotherapies in NSCLC and other solid tumors. In addition, Genprex has conducted and plans to continue research into other tumor suppressor genes associated with chromosome 3p21.3, as well as other potential applications of the company’s immunogene therapy platform.

Clinical Trials

Genprex is currently conducting the second phase of a phase I/II clinical trial at the University of Texas MD Anderson Cancer Center in Houston. The company plans to expand its clinical program by adding a new clinical study evaluating Oncoprex™ in combination with a checkpoint inhibitor for treatment of Stage IV or recurrent NSCLC. In research presented at the 2017 Annual Meeting of the American Association of Cancer Research in Washington, D.C., Genprex’s collaborators showed that TUSC2 in combination with PD-1 checkpoint inhibition has a significantly greater anti-tumor effect in lung cancer than either agent alone. The research also shows that TUSC2 in combination with PD-1 blockade has synergistic activity in upregulating natural killer (NK) cells, correlating with prolonged survival in mice.

TUSC2 (Tumor Suppressor Candidate 2) is a tumor suppressor gene that is absent or deficient in cancer cells of many different cancer types.

The Market

Genprex technologies seek to bridge a critical gap by combining with targeted therapies and immunotherapies to provide treatments to large patient populations who would otherwise not be candidates for those therapies or who have become resistant to them. Genprex technologies are being developed to overcome genomic limitations which are inherent in targeted therapies and immunotherapies in order to provide new treatment solutions to large cancer populations, such as those with lung cancer.

Each year, more people die of lung cancer than of colon, breast and prostate cancers combined. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all lung cancers, according to the American Cancer Society (“ACS”). Despite radical advances in drug development and novel therapeutic standards, survival for late stage lung cancer has not improved significantly in the past 25 years.

Senior Management

Chairman and Chief Executive Officer J. Rodney Varner, JD, is a co-founder of Genprex and has served in these roles since August 2012. He has more than 35 years of legal experience with large and small law firms and as outside general counsel of a Nasdaq-listed company. Varner has served as counsel in company formation, mergers and acquisitions, capital raising, other business transactions, protection of trade secrets and other intellectual property, real estate, and business litigation. He is a member of the State Bar of Texas and has been admitted to practice before the U.S. Court of Appeals for the Fifth Court and the U.S. Tax Court.

Julien L. Pham, M.D., MPH, is president and chief operating officer of Genprex. In March 2013, Dr. Pham co-founded RubiconMD, a healthcare IT company that connects primary care providers to specialists for additional guidance and opinions on medical cases and served as its chief medical officer. He has served on the faculty at Harvard Medical School’s Brigham and Women’s Hospital and is a board-certified internal medicine doctor and nephrologist.

Ryan M. Confer, MS, has served as Genprex chief financial officer since September 2016. Confer has more than 10 years of executive experience in planning, launching, developing, and growing emerging technology companies and has served in the chief operating and chief financial roles for non-profit and for-profit entities since 2008. Confer has also served as an international business development consultant for the University of Texas at Austin’s IC2 Institute, where he focused on evaluating the commercialization potential of nascent technologies in domestic and international markets applicable to technology incubator programs associated with the University. Confer holds a BS in finance and legal studies from Bloomsburg University of Pennsylvania and an MS in technology commercialization from the McCombs School of Business at the University of Texas at Austin.

Jan Stevens, RN, is vice president of Clinical Operations. Stevens has nearly 20 years of comprehensive clinical operations experience in the biopharma industry and a specialization in early-to-late stage oncology companies. Stevens joined the company to help support the various clinical development programs for Oncoprex™.

Genprex Inc. (NASDAQ: GNPX), closed Tuesday's trading session at $3.38, off by 17.3594%, on 204,021 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $3.23/$46.00.

Recent News

• Genprex Inc. (NASDAQ: GNPX) - InvestorNewsBreaks - Genprex Inc. (NASDAQ: GNPX) Announces $6.5M Registered Direct Offering
• InvestorNewsBreaks - Genprex Inc. (NASDAQ: GNPX) Adds Korean Patent for Leading Drug Candidate to Growing International Patent Portfolio
• InvestorNewsBreaks - Genprex Inc. (NASDAQ: GNPX) Preclinical Data to be Presented at Upcoming AACR Annual Meeting

NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW)

The QualityStocks Daily Newsletter would like to spotlight NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW).

Earlier this week, cryptocurrency platform Binance announced that it would conduct a Web3 workshop for law enforcement officers from the Keelung District Prosecutors Office in Taiwan. The virtual assets workshop is meant to boost trust and strengthen ties with law enforcement tasked with handling cryptocurrency-related offenses. The move underscores the cryptocurrency platform's commitment to boosting safety in the nascent Web3 ecosystem and creating a safe and secure environment for users. In March 2024, Taiwan's government announced plans to introduce a measure that would create a regulatory framework for cryptos later this year. The measure would implement strict controls over international and local cryptocurrency entities to control criminal activity within the blockchain ecosystem and provide financial markets with the security and stability they need to thrive. Such interactions between industry actors and law enforcement agencies are crucial in spreading awareness about the benefits and risks of Web3 technologies. Through those interactions, law enforcement personnel can be equipped to identify legitimate Web3 use as companies such as NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW) exemplify.

NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW), a next generation e-commerce platform, was created with vision and purpose to capitalize on high growth sectors and global markets. The company collaborates with businesses – large and small – to simplify and accelerate online commerce and uniquely enables customers and partners to optimize their e-commerce reach, presence and revenue. NextPlat recently launched a new e-commerce development program to provide American businesses with easy access to the massive Chinese consumer market.

Current Initiatives

NextPlat provides cutting edge technology in an advanced e-commerce ecosystem. The company is actively expanding its global network of online storefronts serving thousands of consumers, enterprises and governments. The company also has developed a next generation platform built for Web3 that enables the creation and sale of digital assets, as well as optimizing e-commerce transactions and business building activities. The company’s current initiatives include:

• E-Commerce Development Program – In April 2023, NextPlat announced it had entered into a merchant sourcing agreement with Alibaba.com Singapore E-Commerce Private Limited (“Alibaba”) and its Tmall Global e-commerce platform whereby the two companies will collaborate to increase the sale of products produced and sold by American companies to the multi-trillion-dollar Chinese consumer market. Alibaba’s Tmall Global e-commerce platform will provide NextPlat customers a turn-key solution through which products can be sold to the Chinese consumer market. The launch of the Florida E-Commerce Development Program is the first in a series of new NextPlat programs designed to assist U.S. businesses in expanding their online sales capabilities to reach new international customers in the Chinese market. NextPlat intends to rapidly expand this unique e-commerce development opportunity to businesses throughout the United States and all of North America, as well as Central and South America. The new development program features NextPlat’s turnkey global e-commerce solution for customers and leverages NextPlat’s relationships with key partners, including Tmall Global, China’s largest cross-border B2C online marketplace.
• Progressive Care Inc. – In August 2022, NextPlat completed a strategic $7 million investment in Progressive Care Inc. (OTCQB: RXMD), a personalized health care services and technology company. In a news release announcing the investment, NextPlat CEO Charles M. Fernandez noted that the company is “committed to harnessing the power of digital technologies to capitalize on the ongoing digital transformation of Progressive Care and the entire health care industry.” NextPlat intends to accelerate Progressive Care’s digital health care transformation with the launch of a new e-commerce platform for health care products later this year.
• NextPlat NFT Platform – Building on its existing e-commerce initiatives, NextPlat is working to bridge the gap between tangible and digital e-commerce marketplaces by incorporating burgeoning Web3 technologies. The company intends to launch a fully integrated NFT platform in the coming months that will enable brands to create, manage and authenticate digital assets while serving as a new source of revenue for NextPlat. Through this model, the company will receive a portion of the revenue generated from branded NFT drops, as well as subsequent secondary market transactions.
• Global Telesat Communications and Orbital SatCom Corp. – Targeting both domestic and international markets, NextPlat’s subsidiaries leverage partnerships with major e-commerce platforms such as Amazon, Alibaba, eBay and Walmart to serve a growing base that includes more than 50,000 corporate, governmental and individual customers. In total, the brands market more than 10,000 individual products, with a focus on satellite-based connectivity solutions. In addition to exploring accretive M&A opportunities, NextPlat aims to diversify its range of products and broaden its geographic footprint moving forward in an effort to better capitalize on the tremendous growth potential in the United States, Europe and Asia.

“Our goal for 2023 and beyond is to leverage our improved operational capabilities and enhanced leadership team as we expand our offerings in communications and connectivity into the high-growth health care market where we intend to launch an array of innovative new offerings,” Fernandez said in a March 2023 news release detailing the company’s record top-line performance. “Although there remain supply chain headwinds and the challenge of global inflation, we are confident that we have the right combination of market-tested expertise, technology and partnerships that will enable us to bring the power of e-commerce to more customers, brands and industries in the United States and abroad.”

Market Opportunity

The rapid growth of e-commerce over the last decade is expected to continue for the foreseeable future. According to data published by Forbes, roughly 20.8% of all retail purchases are expected to take place online in 2023, accounting for total sales of $6.31 trillion worldwide. It total, e-commerce sales are expected to grow by 10.4% YoY in 2023, accounting for a whopping 24% of all retail purchases by 2026.

For NextPlat, existing partnerships in the industry could be key to capitalizing on this growth. The Forbes report indicates that Amazon accounts for roughly 38.7% of e-commerce sales, while sites like Walmart, eBay and Alibaba round out the list of most visited e-commerce websites. Alibaba is especially interesting due to NextPlat’s recent strategic merchant sourcing agreement with Tmall Global. The Chinese market is “mammoth,” as a recent Alizila report noted. The country’s annual online retail sales of physical goods have nearly doubled in the last five years, reaching approximately 13.8 trillion yuan in 2022, which is nearly $2 trillion USD.

The health care portion of the e-commerce market is generating particularly bullish forecasts, bolstered by the continued adoption of the 340B Drug Pricing Program in the U.S., which requires most drug manufacturers to provide outpatient drugs to covered entities at significantly reduced prices. Industry reports suggest that the global health care e-commerce market will expand at a compound annual growth rate of 16.8% from 2022 to 2030, climbing to a value of more than $1.37 trillion by the end of the forecast period.

Management Team

Charles M. Fernandez, CEO, Executive Chairman and Director of NextPlat, has over three decades of experience in identifying profitable start-up and dislocation opportunities, building significant value and executing exit strategies as an entrepreneur and global investor. Successful across multiple sectors, Fortune Magazine actually labeled Fernandez ‘a restructuring whiz’. As President of Fairholme Capital Management, which he joined in 2008, Mr. Fernandez co-managed all three Fairholme funds and brought in a $2 billion gain for shareholders. Throughout his impressive career, he has participated in more than 100 significant mergers, acquisitions and product development projects across multiple industries. Mr. Fernandez was the founder, Chairman and CEO of eApeiron Solutions LLC, a brand protection and e-commerce company in partnership with Alibaba (NYSE: BABA) and Eastman Kodak (NYSE: KODK), which was successfully sold to Smartrac, a unit of Avery Dennison Corp. (NYSE: AVY).

Rodney Barreto is Chairman and CEO of the Barreto Group and Director of Nextplat. Mr. Barreto’s business career spans over 35 years, including his role at the Barreto Group and, earlier, as the founding partner of Floridian Partners LLC, a corporate and public affairs consulting firm recognized by policy makers as one of the top in its industry in Florida. He chaired the Super Bowl Host Committee in 2007, 2010 and 2020, helping to raise more than $100 million for the success of Miami Super Bowls. As a philanthropist and conservationist, Mr. Barreto is also a three-time appointee to the Florida Fish and Wildlife Conservation Commission, where he has served for over 10 years including holding the title of Chairman eight times. He has twice chaired the Annual U.S. Conference of Mayors, was Chairman of the 1999 Breeder’s Cup Championship held in South Florida and was the Chairman of the 1999 Sister Cities International Convention in Miami. Currently, Mr. Barreto is the Membership Chairman of the Florida Council of 100, and a member of the Boards of Fairchild Tropical Botanic Garden, the Baptist Health South Florida Giving Society, the Bonefish and Tarpon Trust, the Guy Harvey Ocean Foundation, and a member of Miami Dade County Schools Superintendent Carvalho’s Business Advisory Council. Prior to his career in public affairs and real estate, Mr. Barreto was a City of Miami police officer and is a member of the Florida Highway Patrol Advisory Council.

NextPlat Corp. (NXPL), closed Tuesday's trading session at $1.36, off by 1.4493%, on 9,141 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $1.2101/$4.26.

Recent News

• NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW) - Binance Organizes Web3 Workshop for Law Enforcement to Boost Trust
• Web3 Researcher Says Blockchain Could Be Instrumental in Taking AI Forward
• Despite Slowing Growth, eCommerce Sales Reach Record Level in US

Clene Inc. (NASDAQ: CLNN)

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

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, was featured in a recent episode of First in Human, a biotech-focused podcast featuring interviews with industry leaders and investors to learn about their journeys to in-human clinical trials. Hosted by Vial EVP Rich McCormick, the podcast is available for on-demand listening on First in Human by Vial. Rob Etherington, president, director and CEO of Clene joined the program to highlight information about the company's work in the field of nanotechnology. "For decades…the idea of a therapeutic elemental metal having some medicinal efficacy has been well understood. We at Clene had the idea to combine this with the mechanism of a nanotherapeutic, providing, at the atomic level, the ability to drive energy into the failing mitochondria that powers your and my brain," Etherington said during the interview.

"We first completed some translational medicine work, whereby we were able to show that our drug taken orally got into the stomach then into the bloodstream and then across the blood brain barrier to drive the key bio energetic metabolites that you and I rely upon for energy… we were able to reverse the clock potentially by decades, in terms of key bioenergetic metabolites. We then proceeded into two amyotrophic lateral sclerosis (‘ALS') studies and one multiple sclerosis study, all of which have concluded in the past 18 months. These studies have shown the ability of CNM-Au8(R) to improve function, which can be translated as how to improve the way patients move and walk and talk and eat and chew and breathe."

To view the full press release, visit https://ibn.fm/zoLH8

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 $0.4011, off by 1.4012%, on 202,346 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.25/$1.27.

Recent News

• Clene Inc. (NASDAQ: CLNN) - InvestorNewsBreaks - Clene Inc.'s (NASDAQ: CLNN) Work in Nanotechnology Highlighted in 'First in Human' Podcast
• InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Announces Publication of Peer-Reviewed Research for Investigational Drug CNM-Au8(R)
• InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Announces FY 2023 Results, Recent Operating Highlights

SOBRsafe Inc. (NASDAQ: SOBR)

The QualityStocks Daily Newsletter would like to spotlightFathom SOBRsafe Inc. (NASDAQ: SOBR).

SOBR Safe (NASDAQ: SOBR) ("SOBRsafe") has developed a patent-pending alcohol detection device to detect alcohol in humans with just a single touch of the finger. "SOBRsafe's alcohol detection technology can improve workplace safety and provide advanced screening and monitoring solutions for the behavioral health industry… SOBRsafe's next-generation transdermal technology detects and instantaneously reports the presence of alcohol through the user's skin. No breath, blood or urine samples are required – making it a hygienic alternative to traditional breathalyzers," a recent article reads. "SOBRsafe's technology is integrated within the company's robust and scalable platform, producing statistical and measurable user and business data. The company's products include: SOBRsafe(TM), SOBRcheck(TM), and SOBRsure(TM)." According to the article, SOBRsafe is the company's patent-pending platform for non-invasive alcohol detection, with real-time reporting and historical data aggregation. SOBRcheck is the company's stationary identification and alcohol detection product that provides quick, specific, point-of-care screening. Lastly, SOBRsure is the company's transdermal, alcohol-detecting wearable band that provides continuous monitoring, discreetly detecting and instantaneously reporting the presence or absence of alcohol by the band wearer.

To view the full article, visit https://ibn.fm/p0mm5

SOBRsafe Inc. (NASDAQ: SOBR) is a provider of a game-changing transdermal (touch-based) alcohol detection technology that can improve workplace safety and provides advanced screening and monitoring solutions for the behavioral health industry.

Alcohol misuse is the fourth leading cause of preventable death in the U.S., and the seventh worldwide. Nearly half of all industrial accidents with injuries are alcohol-related, and 1-in-10 U.S. commercial drivers tests positive for alcohol – the highest rate in the world. Despite these statistics, prevention and monitoring solutions have not kept pace with this epidemic. Legacy detection technologies are invasive and inefficient, unhygienic and unconnected. SOBRsafe believes there is a better way.

The company has developed a patent-pending alcohol detection device called SOBRcheck™ for use in detecting alcohol in humans, with just the touch of a finger. SOBRsafe’s next-generation transdermal technology detects and instantaneously reports the presence of alcohol as emitted through a user’s skin. No breath, blood or urine sample is required. SOBRsafe believes its technology is a superior, hygienic alternative to traditional breathalyzers for frontline, preventative applications.

With a powerful backend data platform, SOBRsafe provides humane, passive and connected alcohol detection for the behavioral health, transportation, oil and gas, judicial and consumer markets.

A preventative solution in historically reactive industries, SOBRsafe technology is being deployed for commercial fleets, workplaces, alcohol rehabilitation, probation management and teen drivers. This monitoring technology helps prevent intoxicated workers from taking the factory floor or drivers from receiving the keys to a truck, bus or family car. An offender is immediately flagged, and an administrator is empowered to take the appropriate corrective actions.

SOBRsafe technology is commercially available for access control (SOBRcheck), wearable use (SOBRsure™) and licensing or white labeling.

The company is headquartered in the Denver (CO) Technology Center.

Products

The SOBRsafe technology is integrated within the company’s robust and scalable data platform, producing statistical and measurable user and business data.

SOBRsafe™

With a mission is to save lives, increase productivity, create significant economic benefits and positively impact behavior, SOBRsafe developed the scalable, patent-pending SOBRsafe™ platform for non-invasive alcohol detection, real-time reporting and historical data aggregation.

SOBRsafe is a solution that has broad applications in behavioral health, fleet and facility safety, youth drivers and judicial markets.

SOBRcheck™

SOBRcheck is the company’s stationary identification and alcohol monitoring product, providing a quick, specific-point-in-time test for the presence of alcohol. In hygienic, real-time fashion, SOBRcheck verifies user identity and determines the absence or presence of alcohol.

SOBRcheck provides an administrator immediate results – delivered securely – to aid in the efficient management of an existing substance abuse policy.

SOBRsure™

SOBRsure is the company’s transdermal, alcohol-detecting wearable. SOBRsure provides continuous, mobile alcohol monitoring. The band’s advanced alcohol safety technology discreetly detects and instantaneously reports the presence of alcohol in the body. Additionally, SOBRsure provides app-based alcohol detection alerts, pinpoint location tracking and band-removal notifications.

The SOBRcheck and SOBRsure revenue models consist of two components: (1) a hardware device purchase and (2) a recurring monthly SaaS subscription fee.

Design, manufacturing, quality testing and distribution for all SOBRsafe devices takes place in the U.S.

 

Market Opportunity

A report from Data Bridge Market Research, an international market research and consulting firm, estimated the global alcohol sensor market at $2.3 billion in 2022. The market is forecast to reach a value of $6.3 billion by 2030, recording a CAGR of 13.7% over the forecast period.

Market growth drivers, as cited by the report, include rising alcohol consumption rates, more stringent laws pertaining to alcohol consumption and new, more effective technologies that facilitate detection and enforcement.

Greater awareness of alcohol consumption as a potential threat to public and workplace safety has led to increased emphasis on preventing operation of motor vehicles and machinery by those under the influence of alcohol and promoting responsible alcohol consumption, as the report details.

Management Team

David Gandini is Chairman and CEO of SOBRsafe. He most recently served as president of IPS Denver, a bank card personalization company. Prior to that, Dave was the COO at First World Communications, a U.S. internet and data center provider, and participated in its successful IPO. He previously founded Pace Network Services and facilitated a successful exit to ICG Communications. Dave also co-founded Detroit-based Digital Signal in the fiber optic long haul market sector, where he executed a successful exit to SP Telecom.

Chris Whitaker, CPA, is CFO of SOBRsafe. Previously, Chris had served as the Company’s Vice President of Finance and Accounting. He has held various executive finance positions with large public multi-national corporations and small entrepreneurial companies throughout a progressive 30-year career that began with KPMG. Chris was formerly President – Americas and Vice President of Finance and Administration for public, multinational corporation Elixinol. He also served as the Managing Director of AEGIS Financial Consulting, leading a team of consultants in providing fractional CFO and financial consulting services to a wide variety of businesses in the public and private sectors.

Scott Bennett is EVP, Business Operations at SOBRsafe. He has more than 20 years of experience as a senior executive in technology-driven enterprises. Prior to joining SOBRsafe, he co-founded cybersecurity firm GBprotect and served as its COO until its successful sale to Nuspire. He previously served as Chief Technical Officer/Chief Information Security Officer of fintech businesses Catalyst Card Company and Integrated Printing Solutions.

SOBRsafe Inc. (NASDAQ: SOBR), closed Tuesday's trading session at $0.4, off by 9.2971%, on 161,901 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.2004/$2.53.

Recent News

• SOBRsafe Inc. (NASDAQ: SOBR) - InvestorNewsBreaks - SOBR Safe Inc. (NASDAQ: SOBR) Announces Webinar Series Focused on Behavioral Health, First Segment Scheduled for March 27
• InvestorNewsBreaks - SOBR Safe Inc. (NASDAQ: SOBR) Announces New Customer in Sober Living Space
• InvestorNewsBreaks - SOBR Safe Inc. (NASDAQ: SOBR) Reports 'Dual Adoption' of Proprietary Technology as Existing Behavioral Health Customer Expands Use

Longeveron Inc. (NASDAQ: LGVN)

The QualityStocks Daily Newsletter would like to spotlight Longeveron Inc. (NASDAQ: LGVN) .

Longeveron Inc. (NASDAQ: LGVN) is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions. The Company’s research and therapies are aimed at improving the outcome of infants born with a life-threatening heart condition, as well as improving the healthspan for the aging population – the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging, with function and ability to perform activities of daily living.

Longeveron is involved in clinical trials in the following indications: Hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty.

The Company’s philosophy revolves around the idea that regenerative medicine may hold the potential to improve certain rare medical conditions and contribute to healthy aging. While there has been a remarkable rise in life expectancy over the last century due to medical and public health advancements, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging.

Longeveron’s lead investigational product is Lomecel-B™, an allogeneic Medicinal Signaling Cell therapy product isolated from the bone marrow of young, healthy adult donors. As humans age, they experience a decrease in immune system function, a decline in blood vessel functioning, chronic inflammation, and other issues. Clinical data has suggested that Lomecel-B™ may address these conditions through multiple mechanisms of action (MOA) that simultaneously target key aging-related processes.

The Company is headquartered in Miami, Florida.

Lomecel-B™

Lomecel-B™ is being evaluated in multiple clinical trials for aging-related chronic diseases and other life-threatening conditions under U.S. FDA-approved Investigational New Drug applications. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas.

The drug is made from special living cells called Medicinal Signaling Cells (MSCs) that are isolated from fresh bone marrow tissue that has been donated by adult donors aged 18 to 45. Once the MSCs have been isolated from the fresh bone marrow through a careful selection process, the cells are culture-expanded (allowed to replicate under controlled laboratory conditions) into the billions using specialized techniques and processes. After a specific number of expansion cycles, called “passages,” the cells are harvested, separated into specific doses (e.g., 50 million cells), and cryopreserved until future use.

These cells have been shown to have characteristics that allow them to be transplanted from a donor to host without triggering a harmful immune response in the recipient, and they can be administered on an outpatient basis in as little as 40 minutes after thawing. Because of these characteristics, Lomecel-B™ is considered an “off-the-shelf” product.

In some trials, such as for Alzheimer’s disease and Aging-related Frailty, Lomecel-B™ is administered via peripheral intravenous infusion, while, in the Company’s HLHS trial, Lomecel-B™ is administered via direct injection into the heart tissue.

Market Opportunity

Longeveron estimates the potential market size for Lomecel-B™ in the treatment of HLHS to be up to $1 billion annually, globally.

U.S. patients suffering from Aging-related Frailty are estimated using U.S. Census Bureau statistics to be approximately 8.1 million. That population potentially represents a market for Lomecel-B™ of between $4 billion and $8 billion globally per year, according to Company estimates.

Additionally, the Alzheimer’s Association puts the number of Americans with that disease at 5.1 million, highlighting another potentially addressable market for Lomecel-B™, that’s worth $5 billion to $10 billion annually.

Management Team

Wa’el Hashad is CEO of Longeveron. He has more than 35 years of experience in the pharmaceutical and biotech industries. He has launched several successful brands in the U.S. and worldwide markets. Prior to joining Longeveron, he was president and CEO of Avanir Pharmaceuticals. Before Avanir, he was the chief commercial officer of Seres Therapeutics. He also has held senior leadership positions at Amgen, Boehringer Ingelheim, and Eli Lilly and Company. He holds a bachelor’s degree in pharmacy from Cairo University and an MBA from the University of Akron.

Joshua M. Hare, M.D., FACC, FAHA, is Co-Founder, Chief Science Officer and Chairman of Longeveron. He is a double board-certified cardiologist and is the founding director of the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine. He is a recipient of the Paul Beeson Physician Faculty Scholar in Aging Research Award and is an elected member of the American Association of Physicians and The American Society for Clinical Investigation. He is also an elected Fellow of the American Heart Association. He received a bachelor’s degree from the University of Pennsylvania and his M.D. from The Johns Hopkins University School of Medicine.

Lisa Locklear is CFO at Longeveron. She previously served as the senior vice president and CFO for Avanir Pharmaceuticals. Prior to Avanir, she held senior financial roles at GSN Games, CoreLogic, Ingram Micro, the Walt Disney Company, and Price Waterhouse, with assignments in Paris and London. She holds a bachelor’s degree in plant science from the University of California, Davis, and an MBA from the University of California, Irvine. She is a licensed CPA (inactive) and is a member of the American Institute of Certified Public Accountants, the California Society of CPAs, and Financial Executives International.

Dr. Nataliya Agafonova, M.D., is the Chief Medical Officer at Longeveron. She previously served as clinical development lead, senior medical director, and product development chair at Otsuka Pharmaceuticals. Before that, she was the clinical development lead and senior medical director at Bristol-Myers Squibb. She previously held senior leadership positions at Ardea Bioscience, Biogen, Amgen, and Genzyme Corporation. She earned an M.D. from the Ukrainian National Medical University and completed her internal medicine residency at Kharkov State University Hospital in Ukraine.

Certain statements in this corporate profile that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this corporate profile are made as of the date of this corporate profile, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com

Date prepared: August 31, 2023

Longeveron Inc. (NASDAQ: LGVN), closed Tuesday's trading session at $0.4516, up 2.3804%, on 175,168 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.4175/$4.40.

Recent News

• Longeveron Inc. (NASDAQ: LGVN) - Study Links Parkinson's Onset in Rocky Mountain Area to Agricultural Pesticides
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• InvestorNewsBreaks — Longeveron Inc. (NASDAQ: LGVN) Announces Plans to Release Year-End 2023 Financial Results, Corporate Update

Sigyn Therapeutics Inc. (OTCQB: SIGY)

The QualityStocks Daily Newsletter would like to spotlightFathom Sigyn Therapeutics Inc. (OTCQB: SIGY).

Sigyn Therapeutics Inc. (OTCQB: SIGY) is a development-stage medical technology company headquartered in San Diego, California. The company’s therapeutic candidates include Sigyn Therapy™ to address pathogen-associated inflammatory disorders, the ImmunePrep™ platform to enhance the performance of immunotherapeutic antibodies, ChemoPrep™ to improve the delivery of cancer chemotherapy and ChemoPure™ to reduce the toxicity of chemotherapy.

Sigyn created each of these technologies with two prerequisites in mind: 1) they must offer to overcome a clearly defined limitation in healthcare, and 2) their successful clinical advancement would offer a potential competitive advantage to established therapeutic organizations.

Sigyn Therapy™

The company is advancing Sigyn Therapy™ to treat pathogen-associated inflammatory disorders that are not addressed with FDA approved drugs. Candidate treatment indications include community-acquired pneumonia, drug-resistant virus and bacterial infections, endotoxemia and sepsis, which is the leading cause of hospital deaths in the United States.

The technology has the following attributes and capabilities.

• Sigyn Therapy™ incorporates a formulation of adsorbent components that have more than 200,000 square meters (~50 acres) of surface area on which to adsorb and remove therapeutic targets from the bloodstream.
• In vitro studies have demonstrated the ability of Sigyn Therapy™ to eliminate life-threatening pathogen and inflammatory disease targets from human blood plasma. In these studies, 12 relevant targets, including viral pathogens, bacterial toxins and inflammatory cytokines, were validated. Subsequent animal studies were completed at the University of Michigan.
• Sigyn Therapy™ is highly efficient, as the entire circulatory system of a patient can pass through the device ~15-times during a four-hour treatment.
• To allow for broad deployment, Sigyn Therapy™ is designed for use on the established infrastructure of dialysis and continuous renal replacement machines already located in hospitals and clinics around the world.

First-in-human studies of Sigyn Therapy™ plan to enroll dialysis dependent end-stage renal disease (ESRD) patients with endotoxemia and concurrent inflammation, which are highly prevalent and associated with increased mortality in the ESRD population. There are more than 550,000 individuals with ESRD in the United States, which result in approximately 85 million dialysis treatments being administered each year.

The ImmunePrep™ Platform

Immunotherapeutic antibodies to treat cancer are among the most valued assets in global medicine. However, these drugs suffer from a severe limitation: they are poorly delivered to cancer cell targets, and, as a result, a majority of patients do not respond to therapy.

The Sigyn team recognized that just a small fraction of an antibody dose reaches its cancer cell target, yet a significant portion of the same dose can be sequestered by circulating decoys that display the target (antigen) binding site of the antibody. In response, Sigyn designed the ImmunePrep™ platform to leverage the use of therapeutic antibodies to create extracorporeal blood purification devices that sweep antibody decoys from the bloodstream prior to the subsequent infusion (normal delivery) of the same therapeutic antibody.

The company believes its reverse decoy mechanism will increase the availability of antibodies to interact with their intended disease targets, and, simultaneously, the devices will also extract disease targets from the bloodstream to further improve patient benefit.

The opportunity to enhance the performance of therapeutic antibodies is significant. Consider that Pfizer’s $43 billion acquisition of Seagen Inc. and Amgen’s $27.8 billion acquisition of Horizon Therapeutics were the highest valued M&A deals of 2023. In both cases, transaction values were driven by market-cleared antibody assets.

Perhaps more revealing were the values placed on clinical-stage (pre-revenue) therapeutic antibody candidates. In this regard, consider Merck’s $10.8 billion acquisition of Prometheus Biosciences and Roche’s $7 billion acquisition of a clinical-stage antibody from Roivant Sciences.

In the backdrop of these M&A transactions, the immune checkpoint antibody Keytruda (Merck) became the world’s best-selling (non-vaccine) drug in 2023, with anticipated revenues of ~$24 billion.

ChemoPrep™ and ChemoPure™

Recent scientific publications have reported that only 1% of chemotherapy is delivered to the tumor cell targets of cancer patients. In response, the Sigyn team designed ChemoPrep™ to overcome a delivery limitation of the most commonly administered drug to treat cancer.

The company is developing ChemoPrep™ to reduce the circulating presence of tumor-derived exosomes (tumor exosomes), which interfere with chemotherapy delivery. High concentrations of tumor exosomes in the bloodstream correspond with poor treatment outcomes, whereas low concentrations of tumor exosomes correspond with more favorable outcomes. As compared to non-cancer subjects, exosome populations are reported to be 10x to 500x higher in the bloodstream of cancer patients. Based on these factors, the company believes there is a compelling scientific rationale to reduce the circulating presence of tumor exosomes prior to chemotherapy administration.

Inversely, the Sigyn team recognized that if 99% of chemotherapy was missing its target, then there was a need to eliminate off-target chemotherapy from the bloodstream to reduce toxicity and limit organ damage. This factor led to the design of ChemoPure™ to reduce treatment toxicity by reducing the presence of off-target chemotherapy from the bloodstream. The company believes that a reduction in chemotoxicity may also alleviate treatment-related fatigue and potentially temper the long-term health consequences associated with chemotherapy administration.

Management Team

James A. Joyce is Co-Founder, Chairman and CEO of Sigyn Therapeutics. He has more than two decades of public company CEO and corporate board leadership experience and is an inventor or co-inventor of 20 pending or issued patents, including those underlying ImmunePrep, ChemoPrep, ChemoPure and Sigyn Therapy. Previously, he was founder and CEO of Aethlon Medical, a therapeutic technology company that he built from a start-up to a Nasdaq-traded company. Under his leadership, Aethlon developed the first medical device to receive two breakthrough device designations from the FDA. Mr. Joyce graduated from the University of Maryland.

Annette Marleau, Ph.D., is Chief Scientific Officer at Sigyn Therapeutics. Prior to joining the company, she was Chief Technology Officer at Immunicom Inc. and Director of Research at Aethlon Medical Inc. Additionally, she is an inventor on pending and issued patents underlying blood purification therapies targeting cancer, inflammatory disorders and life-threatening infectious diseases. She holds a Ph.D. from Western University, an M.S. from the University of Guelph and a B.S. from the University of Waterloo in Canada.

Jerry DeCiccio, CPA, is CFO at Sigyn Therapeutics. He has more than 40 years of financial industry experience. Previously, he was CFO/COO at Intech Electromechanical, CFO/COO at GTC Telecom, CFO at Incomnet Communications and President at Cerebain Biotech Corp. He also served in senior financial roles at Parker Hannifin Corp., Waste Management Inc. and Newport Corp. He earned a bachelor’s degree in accounting and business administration from Loma Linda University and an MBA in finance and systems technology from the University of Southern California.

Sigyn Therapeutics Inc. (OTCQB: SIGY), closed Tuesday's trading session at $5, even for the day. The average volume for the last 3 months is and the stock's 52-week low/high is $2.08/$12.80.

Recent News

• Sigyn Therapeutics Inc. (OTCQB: SIGY) - BioMedNewsBreaks - Sigyn Therapeutics Inc. (SIGY) Filling Gap in Therapeutic Antibody Treatment Space
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• InvestorNewsBreaks - Sigyn Therapeutics Inc. (SIGY) Announces CEO Presentation at Upcoming Emerging Growth Conference

Vision Marine Technologies Inc. (NASDAQ: VMAR)

The QualityStocks Daily Newsletter would like to spotlight Vision Marine Technologies Inc. (NASDAQ: VMAR).

Vision Marine Technologies Inc. (NASDAQ: VMAR) is a global leader and innovator within the performance electric recreational boating industry. The company is engaged in designing and manufacturing electric outboard powertrain systems and related technology. It strives to be a guiding force for change and an ongoing driving factor in fighting the problems associated with waterway pollution by disrupting the traditional boating industry with electric power, in turn directly contributing to zero pollution, zero emission and a noiseless environment.

Vision Marine manufactures hand-crafted, highly durable, low maintenance, environmentally friendly electric recreational powerboats. The company’s business segments include the sale and rental of electric boats, with the majority of its revenue attributable to electric boat sales.

The designs and technology applied to Vision Marine’s boats result in enhanced performance, higher speeds and longer range. Put simply, Vision Marine boats offer a smoother ride than a traditional internal combustion engine motorboat.

The company is headquartered in Montreal.

Products

Vision Marine’s flagship E-Motion™ 180E electric marine powertrain is the first fully electric outboard powertrain combining advanced battery pack, inverter and high efficiency motor with proprietary union assembly between the transmission and motor. Vision Marine’s E-Motion and related technologies in this system utilize extensive control software and are uniquely designed to improve the efficiency of the outboard powertrain. As a result, both range and performance are enhanced.

More than a powerful electric outboard motor, the 180E is a complete powertrain package. The high-tech, marine-specific motor is equipped with multi-sensor captors and independent cooling, providing 180 horsepower.

An onboard charging system allows for quick and easy charging from any shore outlet, whether the vessel is in or out of the water. It implements cutting-edge marine battery packs that are IP67 certified and built to withstand the harshest marine environments. The system is glycol cooled with a controlled heat exchanger, ensuring optimal performance and longevity. A stainless-steel casing protects the battery from corrosion and physical damage over time.

The 180E is built to be integrated with many boat models produced by other marine manufacturers. Since boat manufacturers rarely build their own engines, instead choosing to source them from engine manufacturers, Vision Marine believes the 180E propulsion system can in the future end up powering nearly every recreational boat.

Market Opportunity

According to a report from Future Market Insights, a certified market research organization, the global electric boats market is expected to grow from a value of $5.6 billion in 2023 to $15.1 billion by 2033, achieving a CAGR of 10.4% during the forecast period.

Factors driving growth include rising seaborne commerce activities, a flourishing marine tourism industry and stringent emissions regulations aimed at reducing pollution. In addition, government support for electric speedboat adoption, advances in technological development and research and forecast expansion of needed charging infrastructure are credited as growth drivers.

An emphasis on reducing carbon emissions and encouraging consumer adoption of eco-friendly boats is also likely to drive expansion of the market, the report states.

Management Team

Alexandre Mongeon is Co-Founder and CEO of Vision Marine Technologies. He has served as CEO since 2014. Prior to that, he imported high-performance boats from the United States to Canada for more than 15 years. During much of that time, he also worked as a designer and contractor and managed several new construction projects on the waterfront in and around Montreal. He is a graduate of the School of Construction in Laval, Quebec, with a specialization in electrical systems.

Xavier Montagne is Chief Technical Officer at Vision Marine. Prior to joining the company, he was the CEO of Mac Engineering for six years. While there, he was the electric powerline architect of the Renault Trezor concept car (awarded 2016 Best Concept Car), technical designer of the Zoe E-sport race car driven in Formula-E races from 2016-2019 and senior battery designer for Forsee Power, SAFT, Renault and Peugeot in Europe, to mention a few of the many projects he headed. He received an electronic engineer diploma from IFITEP Paris Polytech in France.

Kulwant Sandher is CFO at Vision Marine. He is a Chartered Professional Accountant with more than 25 years of experience in business and finance. He has served as CFO of multiple public and private companies, including ElectraMeccanica Vehicles Corp., MineSense Technologies Inc., Alba Mineral Ltd., Delta Oil & Gas, Astorius Resources Ltd., Norsemont Mining Inc. and Intigold Mines Ltd. He graduated from Queen Mary College, University of London.

Vision Marine Technologies Inc. (NASDAQ: VMAR), closed Tuesday's trading session at $0.5904, off by 0.789783%, on 32,958 volume. The average volume for the last 3 months is 111,885 and the stock's 52-week low/high is $0.57/$5.60.

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Software Effective Solutions Corp. (OTC: SFWJ)

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

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 $0.034, even for the day. The average volume for the last 3 months is 1,740 and the stock's 52-week low/high is $0.000001/$0.09.

Recent News

• Software Effective Solutions Corp. (OTC: SFWJ) - Reports Suggest DEA Resisting Pressure from White House to Reclassify Marijuana
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Turbo Energy S.A. (NASDAQ: TURB)

The QualityStocks Daily Newsletter would like to spotlight Turbo Energy S.A. (NASDAQ: TURB).

Turbo Energy S.A. (NASDAQ: TURB) designs, develops and distributes equipment for the generation, management and storage of photovoltaic energy in Spain, Europe and internationally.

Turbo Energy’s products include lithium-ion batteries and inverters. Additionally, the company recently launched its flagship product, the Sunbox, an all-in-one device that integrates most of the equipment required for a residential photovoltaic installation. The Sunbox is powered by AI and features a software system that monitors the generation, use and management of photovoltaic energy by analyzing large amounts of data related to energy generation, consumption, market prices and weather forecasts. This AI system optimizes battery usage, reducing electricity bills and providing peak-use reduction and uninterruptible power supply functions.

Turbo Energy currently sells its photovoltaic energy equipment primarily through distributors for residential consumers in Spain, but it possesses the expertise and international perspective to expand its product portfolio into industrial and commercial scale and markets, as well as advancing the internationalization process it has already started. The company plans to expand into the industrial photovoltaic sector with its new Sunbox, launched in 2023, in higher power and capacity variants. Its goal is to become a significant player in this sector and contribute to the growth of renewable energy solutions.

The company was incorporated in 2013 and is based in Valencia, Spain. It operates as a subsidiary of Umbrella Solar Investment S.A.

Products

Lithium-Ion Batteries

Turbo Energy is one of the leading companies that introduced lithium-ion batteries for photovoltaic energy storage in Spain. Primarily for the home energy storage market, the company’s batteries have capacities from 2.24 kWh to 5.1 kWh in 24 and 48 volts. In addition, its 48V / 5.1 kWh units are available in a dual battery system.

Inverters

The inverter converts the direct current produced by the photovoltaic panels into alternating current that can be used by household appliances. It also regulates battery charging and discharging based on energy needs and optimizes utilization of generated renewable energy. Turbo Energy currently offers multiple models that cover most household installations.

All-in-One Sunbox

This product incorporates inverters, batteries and the rest of the components necessary to operate and protect the photovoltaic installation. This saves installation cost and assembly and configuration time while preventing errors. Notably, the latest Sunbox models also offer an EV charging option.

Software System

In communication with the inverter, the company’s software monitors energy flows between the photovoltaic panels, household consumption, storage and an optional electric vehicle charging station. The software allows users to customize an automatic backup mode based on weather forecasts, or manually select which part of the battery will be reserved for possible power outages. It also allows the battery to be used in a peak shaving mode, which leverages AI to trigger battery power when grid energy is most expensive, effectively reducing the amount of high-cost power drawn from the grid.

Market Opportunity

According to a report by Fortune Business Insights, a global research and reporting firm, the solar energy storage battery market was estimated to be worth $3.33 billion in 2022 and is projected to reach a value of more than $20 billion by 2030, marking a CAGR of 24.2% over the forecast period.

These batteries are crucial components of renewable energy systems, allowing for the storage of excess electricity generated by solar panels, so it can be used during times of no or low sunlight. By storing energy and supplying it when needed, these batteries reduce reliance on the power grid and maximize self-consumption while helping users avoid peak electricity rates. They also contribute to the transition toward a cleaner and more sustainable energy future by enabling residential consumers and businesses to use solar power even when the sun is not shining.

Management Team

Enrique Selva Bellvís is the CEO and founder of the Umbrella Group. In addition, he serves as vice-president of the Valencian Association of Energy Sector Companies industry group. Before his career in the solar energy sector, he was the founder and CEO of Innova Ingenieros Consultores. He holds a degree in industrial engineering with a specialization in energy from the Polytechnic University of Valencia and completed the Management Development Programme at the IESE Business School.

Mariano Soria is the Chief Innovation Officer for the Umbrella Group and serves as General Manager of Turbo Energy. He was CEO of Punt Moble XXI S.L. and continues to serve on that company’s board. Before that, he was the General Manager of REJMAR S.A., a land development company. He received his degree in industrial engineering and industrial organization from the Polytechnic University of Valencia, and his MBA from the European University of Madrid.

Alejandro Moragues is CFO of Turbo Energy. Previously, he held the position of Senior Corporate Auditor for U.S. company Euronet Worldwide Inc. and was an external auditor for PricewaterhouseCoopers. He holds a bachelor’s degree in business administration and management from the Polytechnic University of Valencia.

Manuel Cercos is Chief Commercial Officer at Turbo Energy. Previously, he held positions at Técnicas Aplicadas en Baterías S.L., where he served as Sales Director and Sales Manager. Before that, he worked as a Sales Technician at DAISA.

Turbo Energy S.A. (NASDAQ: TURB), closed Tuesday's trading session at $1.21, even for the day, on 4,653 volume. The average volume for the last 3 months is 36,920 and the stock's 52-week low/high is $0.855/$7.90.

Recent News

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