Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF)

The QualityStocks Daily Newsletter would like to spotlight Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF).

Imagin Medical (CSE: IME) (OTCQB: IMEXF), a surgical imaging company, is at the forefront of change in its focus to establish a new standard of care in visualizing cancer. Minimally invasive surgery (“MIS”) using white light to illuminate tumor growth is the current standard of care for bladder cancer. This method is highly effective for visualizing cancerous tumors that protrude above the bladder’s wall. However, due to the difficulty in distinguishing flat tumors from normal tissue, it is nearly impossible to visualize the margins of the tumor under current standards. To view the full article, visit: https://ibn.fm/n1dIM

Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF) is a surgical imaging company focused on establishing a new standard of care in visualizing cancer during minimally invasive procedures. Its initial focus is on bladder cancer.

The company’s first product is the i/Blue Imaging™ System, based on advanced optics and light sensors and employing patented ultrasensitive imaging technology. Imagin Medical believes the system can significantly improve surgeons’ ability to visualize and remove cancer cells.

Founded in 2016 and headquartered in Boston, Massachusetts, the company works to enhance its market potential by expanding its technology to multiple endoscopic indications, such as laparoscopic, colorectal and thoracic procedures, accommodating multiple contrast agents and illumination sources.

i/Blue Imaging™ System

The conventional method used for visualizing bladder cancer during surgery is an endoscopic procedure called a cystoscopy. This procedure uses white light to illuminate the bladder. White light has been used for decades and is the standard for more than 90% of the market. Blue light cystoscopy uses blue-filtered white light, which addresses the limitations of white light (such as detecting flat tumors and the fine edges that may result in cancerous cells being left behind during removal).

Blue light uses a contrast agent that causes cancer cells to fluoresce when illuminated. Surgeons are then able to more effectively visualize and resect the margins of bladder tumors to reduce the risk of recurrence. Notably, the use of the white light is still necessary during a blue-light procedure so that the surgeon can orient their position within the bladder.

Imagin Medical’s i/Blue Imaging System addresses the limitations of both white and blue light cystoscopies. The i/Blue System combines the white and blue light with an FDA-approved imaging agent and simultaneously displays side-by-side images in real-time, without the necessity to switch back and forth between the two images.

The i/Blue Imaging System is unlike other methods available on the market today. It is external to the body and can attach to almost any endoscope model currently in use. This way, hospitals adopting Imagin Medical’s technology have the ability to use their current endoscopes without the need to purchase new equipment.

Bladder Cancer Prevalence

The company’s initial focus is bladder cancer, which is the sixth most prevalent form of cancer in the United States. In 2020, the number of new bladder cancer cases is expected to total 81,400, accounting for 4.5 percent of all new cancers diagnosed. The death rate in 2020 for cancer deaths associated with the bladder is forecast at 17,980, or 3% of all cancer-related deaths (https://ibn.fm/qLi3l).

Bladder cancer also has one of the highest recurrence rates among all forms of cancer, leaving about 600,000 people in fear that their cancer will return, according to Imagin Medical. The company is committed to addressing this issue, and i/Blue demonstrations have indicated that the use of both white and blue light can enhance accuracy of detection and removal of cancer cells, potentially lowering recurrence rates.

Based on Verified Market Research, the global bladder cancer research market was valued at $3.43 billion in 2018. It is estimated to grow with a CAGR of 4.03% through 2026, resulting in a projected $4.71 billion market (https://ibn.fm/rI7G6).

Management Team

E. James Hutchens is the Chief Executive Officer of Imagin Medical Inc. He is a proven entrepreneur with over 30 years of experience in management in the medical technology industry. Hutchens served as a managing partner with Origin Partners, a $55 million early-stage venture capital fund. He was also the founder and CEO of both Microsurge Inc. (a venture-backed minimally invasive surgical company) and Choice Therapeutics (an advanced wound-care company). He is a former member of the Board of Directors of the Brigham and Women’s and Faulkner hospitals. Hutchins holds a BS in Business Administration from Boston University.

John Vacha is the company’s Chief Financial Officer. He has 20 years of experience in the health care industry. Prior to Medtronic’s acquisition of Intact Medical Corp. in 2017, Vacha was the company’s President, CEO and a board member for seven years. He is a licensed CPA in Massachusetts. Vacha has an MBA and an MS in Accounting from Northeastern University in Boston. He is also a serving member of the Board of Directors at the South Boston Health Center. He currently has two patents in electrosurgical instrumentation.

Michael G. Vergano is the Director of Operations of Imagin Medical. He has been the President of The Harvest Group Inc. since 1998, where he has provided consultant services for startups and major corporations. Vergano has over 30 years of experience in the medical device industry. He has held management positions at Microsurge Inc., Ciba Corning Diagnostics and Boston Scientific Corp. He is currently the holder of 11 medical device patents and holds a BS in Mechanical Engineering from Tufts University.

Pam Papineau is the company’s Director of Regulatory Affairs. She has over 30 years of experience in quality and regulatory affairs with Boston Scientific, Baxter and Cogentix. She has served as a consultant on various devices including imaging, endoscopy, orthopedic, GI/GU and cardiovascular applications. Papineau has successfully prepared dozens of FDA pre-market and EU submissions to support CE marking of a broad spectrum of medical devices. She is an ASQ Certified Quality Engineer, a Certified Biomedical Auditor, a Certified Quality Auditor and an ISO 13485:2016 Lead Auditor, and she is certified by the Regulatory Affairs Professional Society – U.S., EU and Canada. Papineau works with the company’s legal counsel to prepare pre-submission meetings with the FDA and activities through the regulatory approval process.

Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF), closed Tuesday’s trading session at $0.2839, up 10.596%, on 2,698 volume. The average volume for the last 3 months is 10,650 and the stock's 52-week low/high is $0.200000002/$1.55599999.

Recent News

• BioMedNewsBreaks - Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF) Takes Game-Changing Visualization Method to the Next Level
• BioMedNewsBreaks - Why Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF) Is 'One to Watch'
• Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF) Technology Makes it Easier to See the Invisible in Cancer Surgery

SRAX Inc. (NASDAQ: SRAX)

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

SRAX (NASDAQ: SRAX), focused on unlocking data and insights through its software-as-a-service (“Saas”) platform, Sequire, is emerging as a leader within the investor intelligence field. Launched as a stand-alone platform in early 2020, Sequire has amassed over 1 million investors and traders and has attracted over 91 publicly listed companies as subscribers. To view the full article, visit https://ibn.fm/ZVeSp

SRAX Inc.'s (NASDAQ: SRAX) is a digital marketing and consumer data management technology company. SRAX’s technology unlocks data to reveal brands’ core consumers and their characteristics across marketing channels.

Through its BIGtoken platform, SRAX has developed a consumer-managed data marketplace where people can own and earn from their data, thereby providing everyone in the internet ecosystem choice, transparency and compensation.

SRAX’s tools deliver a digital competitive advantage for brands in the CPG, automotive, investor relations, luxury and lifestyle verticals by integrating all aspects of the advertising experience, including verified consumer participation, into one platform.

SRAX Verticals

• SRAX Core: SRAX Core is a custom digital media management platform that enables brands and agencies to surpass the challenges of omnichannel marketing campaigns. It offers one comprehensive dashboard to manage digital media campaigns, inventory and reporting.
• SRAX Social: SRAX Social is a free social media management tool that makes it easy for brands, agencies and individuals to grow their digital presence. It offers free and unlimited users, Facebook auto boosting, and a custom analytics dashboard. Its managed services team can also build and execute marketing plans for your unique specific needs.
• SRAX IR: SRAX IR unlocks stock buyers’ behaviors and trends for issuers of publicly traded companies. The platform provides insights on shareholders and market makers, investor relations management, shareholder outreach tools and data-driven marketing.
• SRAX Auto: SRAX Auto unlocks auto intenders’ data to create measurable connected experiences on the road to purchase. It offers proprietary auto intender profiles, multi touchpoint communication and custom location-based ads.
• SRAX Shopper: SRAX Shopper delivers a cross channel, premium digital experience at scale to high value shopper audiences. It offers proprietary shopper profiles, cost per click pricing, and custom text and add to cart ad units.
• SRAX Lux: Launched in June 2019, the SRAX Lux platform targets and reaches luxury consumers at luxury retail stores, high-end art, music, film, fashion and sports events, across all consumer devices.

BIGtoken

BIGtoken, available for download on the App Store and Google Play, revolutionizes data collection. BIGtoken is a platform that creates a secure and transparent environment for consumers to own and earn from their data. To date, there are 15.9 million BIGtoken registered users worldwide.

The optimization and monetization of data is a multibillion-dollar business. Worldwide spending on big data and business analytics solutions reached $166 billion in 2018 and is projected to surge to $260 billion by 2022. BIGtoken’s consumer vision is committed to delivering choice, transparency and compensation to the individual.

Through BIGtoken, consumers earn rewards when they opt into sharing their data and when that data is purchased. Consumers decide what data is shared, who can buy it and how it’s used, and advertisers reach real, responsive audiences. The benefit of this is two-fold: consumers know how their data is used and advertisers gain verified consumer data for targeting.

Users of the BIGtoken app can officially be paid in cash or gift cards in exchange for giving brands access to their anonymized data, answering questions, checking into locations, recruiting new members, and more. Users can deposit their earnings directly into PayPal accounts or be paid through gift cards from favorite retailers such as Walmart.

SRAX has also partnered with several high-profile, nonprofit associations to provide BIGtoken users the ability to donate their earnings. Partnerships include the American Heart Association, dedicated to fighting heart disease and stroke; HealthCorps, which helps high school students make better choices about health and physical fitness; and the ALS Association, which recently launched its Challenge Me campaign.

International Expansion

BIGtoken is formally launching into several international markets and partnering to foster local support. SRAX recently signed a joint venture with the Yash Birla Group to launch BIGtoken in India. Based in Mumbai, the Yash Birla Group, one of India’s largest conglomerates, has diversified interests in consumer and industrial products.

The partnership will bring BIGtoken’s platform to India, which has a digital population of 627 million. The India digital advertising market is $3.6 billion and is set to grow at a compound annual growth rate of 32%, making it one of the largest growing digital ad markets in the world.

SRAX Mexico is led by Moe Avitia, who has more than 18 years of experience in business development and building high-tech teams. SRAX Mexico includes a team of 90 employees, including 70 engineers.

BIGtoken Europe is currently evaluating data centers in individual countries for privacy laws.

Leadership

Christopher Miglino is CEO and founder of SRAX. He has spent the past 20 years working in the digital advertising space and has successfully launched and sold two internet companies. Both of these companies were sold to publicly traded companies on the NASDAQ. He has a detailed understanding of how technology interacts with brands.

Kristoffer Nelson is COO of SRAX and a founding member of BIGtoken. With over 15 years of technology and creative business experience, Nelson has been a guest speaker for Loyola Marymount University among other academic institutions, the National Association of Broadcasters, the IAB and numerous other professional and media organizations.

SRAX Inc. (NASDAQ: SRAX), closed Tuesday’s trading session at $2.76, up 6.9767%, on 230,748 volume. The average volume for the last 3 months is 78,559 and the stock's 52-week low/high is $1.28999996/$3.35739994.

Recent News

• InvestorNewsBreaks - SRAX Inc. (NASDAQ: SRAX) Poised in Convergence of Digital Technologies, Engagement
• SRAX Inc.'s (NASDAQ: SRAX) Sequire Helps Companies Gather Investor Insights, Harness Big Data to Improve Investor Interactions
• InvestorNewsBreaks - SRAX Inc. (NASDAQ: SRAX) to Host Prominent LD Micro Main Event via the Sequire Platform

Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR)

The QualityStocks Daily Newsletter would like to spotlight Energy Fuels Inc. (UUUU).

Energy Fuels (NYSE American: UUUU) (TSX: EFR), the largest uranium miner in the U.S., applauds the bipartisan, bicameral launch of the U.S. uranium reserve, as $75 million of funding was included in the omnibus appropriation bill. The bill, passed last night by both houses of Congress, is expected to be sent to the President for signature in the coming days. One of the main recommendations of the U.S. Nuclear Fuel Working Group, directed to make recommendations on securing the domestic capacity to produce uranium and nuclear fuel, was to appropriate funding for a U.S. uranium reserve. This key funding opens the door for the U.S. government to purchase domestically-produced uranium to guard against potential commercial and national security risks presented by the country's near-total reliance on foreign imports of uranium. To view the full press release, visit http://ibn.fm/q2cZy

Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR),based in Lakewood, Colorado, is the country’s largest producer of uranium and the leading conventional producer of vanadium, both designated by the U.S. government as critical minerals.

As the leading U.S. diversified uranium miner, Energy Fuels’ uranium production portfolio stands apart in the world. Energy Fuels has more uranium production facilities, more production capacity, and more in-ground resources than any other company in the United States. In fact, the company’s assets have produced over one-third of all U.S. uranium over the past 15 years and is uniquely positioned to increase production to meet new demand.

Energy Fuels utilizes both conventional and in-situ recovery (“ISR”) technology to produce uranium from three strategic facilities:

• White Mesa Mill in Utah (conventional) has a licensed capacity of over 8 million pounds of U3O8 per year. The highly strategic White Mesa Mill is the only conventional uranium mill in the country and is proximate to some of the largest and highest-grade uranium mines and projects in the U.S., including the Company’s Canyon mine, La Sal Complex, Henry Mountains Complex and Roca Honda Project. White Mesa Mill provides Energy Fuels with significant production scalability as uranium demand increases. The White Mesa Mill also has other diverse businesses, including vanadium, rare earth elements (REE’s), alternate feed materials recycling and land cleanup, all described below.
• Nichols Ranch Plant (ISR) is located in the productive Powder River Basin district of Wyoming and has a total licensed capacity of 2 million pounds of U3O8 per year. Nichols Ranch has produced 1.2 million pounds of U3O8 since commissioning in 2014, and it has significant future expansion potential from 34 fully licensed wellfields containing significant in-ground uranium resources.
• Alta Mesa Plant (ISR) is located on over 200,000 acres of private land in Texas. The fully licensed and constructed ISR project has a total operating capacity of 1.5 million pounds of uranium per year and produced nearly 5 million pounds of U3O8 between 2005 and 2013. This low-cost production facility is currently on standby, maintained in a state of readiness to respond to expected increases in demand.

In addition to being the largest uranium miner in the U.S., Energy Fuels’ overall portfolio also includes a pipeline of high-quality, large-scale exploration and development projects that are permitted or are in advanced stages of permitting, as well as an industry-leading U.S. NI 43-101 Mineral Resource portfolio.

FACTOID: Energy Fuels has led industry efforts over the past two-plus years to get the U.S. government to recognize the importance of domestically produced uranium, including the 2018 – 2019 Uranium Section 232, the ongoing Nuclear Fuel Working Group and the recently announced creation of the U.S. strategic uranium reserve. The U.S. is by far the largest consumer of uranium in the world, yet we import almost all of our requirements; Energy Fuels aims to change that.

Nuclear Market Potential

Multiple studies in top scientific journals have shown that nuclear power is cleanest and most economical way to produce reliable electricity as worldwide demand continues to soar. Nuclear power is presently the only available and affordable low-carbon power source that can meet both current and future baseload electricity demands while simultaneously reducing air pollution and mitigating climate change. U.S. nuclear power plants currently generate nearly 20% of the nation’s electricity overall and 55% of its carbon‐free electricity and even a modest increase in electricity demand would require significant new nuclear capacity by 2025. According to the World Nuclear Association (WNA), there are currently 441 operable reactors, with another 54 units under construction and 439 in various stages of planning; in addition, the WNA has identified a potentially massive supply/demand gap through 2040 of 1 billion pounds. These factors among others are expected to significantly drive increased demand for uranium.

Reasons Nuclear is Gaining Traction

• Nuclear reactors emit no greenhouse gases during operation. Over their full lifetimes, they result in comparable emissions to renewable forms of energy such as wind and solar.
• Unlike any other form of energy, the waste from nuclear energy is contained and managed securely. Used fuel is currently being safely stored for ultimate disposal or future reprocessing, and 96% of this waste can potentially be recycled.
• Greater demand for clean electricity to power everything from homes to automobiles, reducing dependence on fossil fuels.

No. 1 U.S. Producer of Vanadium in 2019

Energy Fuels also produces vanadium as a byproduct of uranium production. Vanadium is designated a critical mineral, essential to the economic and national security of the United States. Energy Fuels was the largest producer of vanadium in the U.S. in 2019, and has significant high-grade, in-ground vanadium resources, as well as a separate high-purity vanadium production circuit at their White Mesa Mill, which is also the only conventional vanadium mill in the country. Crucial for use in the steel, aerospace, and chemical industries, vanadium plays a critical role in the production of high-strength and light-weight metallic alloys and demand is expected to increase across the globe.

Energy Fuels has several fully permitted and developed standby mines containing large quantities of high-grade vanadium, along with uranium, including:

• La Sal Complex (Utah)
• Whirlwind Mine (Colorado/Utah)
• Rim Mine (Colorado)

Vanadium has also gained increased attention as a catalyst in next-generation high-capacity, “community-scale” batteries used for energy storage generated from renewable sources. Demand is only expected to grow as this market expands. With recent upgrades in its vanadium production operations, in 2019 Energy Fuels produced commercial levels of the highest purity (99.7%) vanadium in the mill’s history and can rapidly adjust production to meet volatile market conditions. Energy Fuels is one of the very few known avenues that provides investors access the vanadium market.

Rare Earth Element (REE) Production, Alternate Feed Material Recycling, and Land Cleanup

The White Mesa Mill also provides the company with diverse cashflow generating opportunities. Security of supply for Rare Earth Elements (REEs) supporting U.S. military and defense requirements is a major issue today. Energy Fuels has been approached by a number of entities, including the U.S. government, inquiring about the potential to process certain REEs at the mill. The White Mesa Mill is currently licensed to process certain REEs, including tantalum and niobium. And, early indications are that the mill can be utilized to produce several other REEs. The White Mesa Mill is also the only facility in North America licensed and capable of recycling alternate feed materials (AFMs). AFMs are essentially low-level waste materials that contain recoverable quantities of natural (or unenriched) uranium. The Company typically generates between $5 and $15 million per year from AFM recycling. Finally, Energy Fuels is seeking to become involved in the cleanup of legacy Cold War era uranium mines in the Four Corners region of the U.S., including on the Navajo Nation. The U.S. Environmental Protection Agency (EPA) has access to over $1.5 billion for the cleanup of just a fraction of the sites on the Navajo Nation. The White Mesa Mill is fully licensed to receive much of this material, we are one of the government’s lowest cost options, and we have the ability to recycle the material and produce usable uranium from it.

Management Team

Mark S. Chalmers, President and CEO
Mark S. Chalmers is the president and chief executive officer of Energy Fuels, a position he has held since Feb. 1, 2018, following his role as chief operating officer of Energy Fuels from July 1, 2016 – Jan. 31, 2018. From 2011 to 2015, Chalmers served as executive general manager of Production for Paladin Energy Ltd., a uranium producer with assets in Australia and Africa, including the Langer Heinrich and Kayelekera mines where, as head of operations, he oversaw sustained, significant increases in production while reducing operating costs. He also possesses extensive experience in in situ recovery (“ISR”) uranium production, including management of the Beverley Uranium Mine owned by General Atomics (Australia), and the Highland mine owned by Cameco Corporation (USA). Chalmers has also consulted to several of the largest players in the uranium supply sector, including BHP Billiton, Rio Tinto, and Marubeni, and until recently served as the chair of the Australian Uranium Council, a position he held for 10 years. Chalmers is a registered professional engineer and holds a Bachelor of Science in Mining Engineering from the University of Arizona.

W. Paul Goranson, COO
W. Paul Goranson is the chief operating officer for Energy Fuels. Goranson has 30 years of mining, processing and regulatory experience in the uranium extraction industry that includes both conventional and in-situ recovery (“ISR”) mining, and he is a registered professional engineer. Prior to the acquisition by Energy Fuels of Uranerz Energy Corporation, Goranson served as president, chief operating officer and director for Uranerz, where he was responsible for operations of the Nichols Ranch ISR Uranium Project. In addition to those duties, he also managed uranium marketing, regulatory and government affairs, exploration and land. Prior to joining Uranerz, Goranson served as president of Cameco Resources, where he led the operations at the Smith Ranch-Highland, Crow Butte and North Butte ISR uranium recovery facilities. Goranson also served as vice president of Mesteña Uranium LLC, and he has served in senior positions with Rio Algom Mining, (a subsidiary of BHP Billiton), and Uranium Resource Inc. Goranson has a Bachelor of Science in Natural Gas Engineering from Texas A&I University, and a Master of Science in Environmental Engineering from Texas A&M University-Kingsville.

David C. Frydenlund, CFO, General Counsel, Corporate Secretary
David C. Frydenlund is chief financial officer, general counsel, and corporate secretary of Energy Fuels. His responsibilities include oversight of all legal matters relating to the company’s activities. His expertise extends to NRC, EPA, state and federal regulatory and environmental laws and regulations. From 1997 to 2012, Frydenlund was vice president of regulatory affairs, general counsel and corporate secretary of Denison Mines Corp., and its predecessor International Uranium Corporation (“IUC”). He also served as a director of IUC from 1997 to 2006 and CFO of IUC from 2000 to 2005. From 1996 to 1997, Frydenlund was vice president of the Lundin Group of international public mining and oil and gas companies, and prior thereto was a partner with the Vancouver law firm of Ladner Downs (now Borden Ladner Gervais) where his practice focused on corporate, securities and international mining transactions law. Frydenlund holds a bachelor’s degree in business and economics from Simon Fraser University, a master’s degree in economics and finance from the University of Chicago and a law degree from the University of Toronto.

Curtis H. Moore, Vice President of Marketing and Corporate Development
Curtis H. Moore is the vice president of Marketing and Corporate Development for Energy Fuels. He oversees product marketing for Energy Fuels, and is closely involved in mergers & acquisitions, investor relations, public relations, and corporate legal. He has been with Energy Fuels for over 12 years, holding various roles of increasing responsibility. Prior to joining Energy Fuels, Moore worked in multi-family real estate development, government relations and public affairs, production homebuilding, and private law practice. Moore is a licensed attorney in the State of Colorado. He holds Juris Doctor and MBA degrees from the University of Colorado at Boulder, and a Bachelor of Arts dual degree in Economics-Government from Claremont McKenna College in Claremont, California.

Energy Fuels Inc. (UUUU), closed Tuesday’s trading session at $3.63, up 5.8309%, on 3,405,623 volume with 1 trade. The average volume for the last 3 months is 2,359,646 and the stock's 52-week low/high is $0.779999971/$3.68000006.

Recent News

• MiningNewsBreaks - Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) Applauds Bipartisan Appropriation of Funds for US Uranium Reserve
• MiningNewsBreaks - Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) Announces Publication of Sustainability Report, Policy Updates
• Expected Shortage of Lithium in Mining Industry Prompts New Exploration

DarioHealth Corp. (NASDAQ: DRIO)

The QualityStocks Daily Newsletter would like to spotlight DarioHealth Corp. (DRIO).

DarioHealth (NASDAQ: DRIO), a pioneer in the global digital therapeutics market, has inked an agreement with one of the largest integrated healthcare systems in the state of New Mexico to provide remote patient monitoring (“RPM”). The partnership with Presbyterian Medical Services begins Jan. 1, 2021. The agreement, which followed a rigorous request for proposal (“RFP”) process, reflects DRIO’s shift in focus to B2B2C and outlines the company’s commitment to provide access to Dario's next-generation, AI-powered digital therapeutics tools and quality care to patients living with chronic conditions, such as diabetes and hypertension. To view the full press release, visit http://ibn.fm/JOGwD

New York and Israel-based DarioHealth Corp. (NASDAQ: DRIO) leads global digital therapeutics (DTx) with its popular, smartphone-centered personalized chronic illness management software-as-a-service (SaaS). The company’s strategic advantages include:

• AI-powered digital solutions that drive durable behavior change in chronic disease patients, and
• Personalized user experience at scale to make behavior change the path of least resistance.

Approximately $3 trillion in annual U.S. costs associated with chronic illnesses like diabetes, hypertension and obesity are largely preventable with behavioral therapies. Formerly limited to periodic office visits, these therapies can now scale to millions with tech-enabled, continual and remote health monitoring, as well as AI-driven digital and live coaching. This is all possible while still maintaining the personalization required for success in reducing illness and its related effects and costs.

Roughly 51,000 active, paying users manage their health with Dario’s platform that combines smartphone-connected vitals measurement, remote patient monitoring (RPM), lifestyle management tools, and AI-driven and human coaching to deliver improved clinical outcomes.

Among the most downloaded medical apps, the Dario platform is rated at 4.9 stars on the Apple App Store and features 11,000 reviews, along with a Net Promoter Score (a measurement of consumers’ willingness to recommend the product to others) that’s the highest in its field.

Company Strategy

Clinical studies demonstrate Dario’s direct improvement on users’ health measures like H1AC scores (diabetes) and blood pressure (hypertension).

Patient engagement in therapies leads to health success. Dario’s platform centers on continual maximization of patient engagement through personalization, including ‘nudges’ and live, AI-generated responses to health measures provided by Dario’s smartphone-connected medical devices.

Proprietary data analysis provides valuable insights that not only improve health care providers’ medical capabilities but, through artificial intelligence, encourage patients to take evidence-based and highly personalized preventative measures that reduce risk, emergency room visits and preventable hospitalization.

Dario is now deploying its successful B2C platform in B2B2C, targeting employers and health plans with competitive advantages in cost, software and hardware.

The company estimates an annual addressable U.S. market of $72 billion, only 1% of which has been penetrated with digital therapeutics.

The strategic transition to B2B2C (from exclusively B2B) is intended to accelerate revenue growth by reducing Dario’s cost per acquisition per user and expanding margins.

Dario’s commitment to aggressive growth is also shown by its appointment of a new president, chief medical officer and head of sales for North America, all from a highflyer behavioral health company.

Key growth drivers planned include expansion of the company’s paying B2C subscriber base; lateral expansion into other chronic conditions that overlap with its core diabetes populations, such as hypertension, obesity and depression; and increased B2B2C penetration.

Financial Highlights

The company plans to leverage a massive opportunity for growth, with a global addressable market for digital therapeutics of roughly $108 billion. In the U.S. alone, that number is estimated at $72 billion, and only about 1% of that market has been penetrated.

Dario’s strategic transition to an SaaS membership business model increased gross profit by 87% in Q1 2020, as compared to the prior year. Membership revenue increased from 27.1% to 46.7% in the same period. The company is seeing improved operating efficiencies as it shifts focus to the B2B2C business model, and it expects average revenue per user per month (ARPU), which was $6 and $25 in 2019 and 2020, respectively, to reach $70.

Value to Consumers and Businesses

Dario continually evaluates and optimizes the value and return its platform delivers to consumers and businesses.

Consumers seeking to understand how their everyday behavior impacts their personal health and chronic conditions benefit from actionable feedback on how to improve health and better collaborate with health care providers.

Businesses looking to increase employee satisfaction, loyalty and productivity with fewer health-related absences take advantage of Dario’s services for employers.

Health care providers improve patient compliance using the platform’s interactive services that allow for greater monitoring, which improve engagement with patients at the right times and with the right treatments.

Health plans can leverage DarioHealth’s solutions to improve patient outcomes and lower costs.

Recent Studies

The company recently presented the results of two new studies at the American Diabetes Association’s 80th Scientific Sessions, which showed sustained improvements in blood glucose levels and blood pressure among users of its digital therapeutic platform for chronic diseases. The results of these two studies demonstrate that the use of Dario’s therapeutic platform promotes behavioral modification, enhanced individual engagement and improved clinical outcomes.

Remote Patient Monitoring (RPM) Agreements

The Centers for Medicare & Medicaid Services recently approved RPM codes for Medicare patients, which enables physicians to bill for between-visit patient care.

This simplifies implementation of the company’s open and scalable AI-driven platform and further supports transition to the company’s high-margin, recurring SaaS model targeting B2B2C revenue channels.

Emergency COVID-19 FDA Guidelines Allow Self-Test Blood Glucose Meters

In an effort to preserve personal protective equipment (PPE) and reduce contact between health care providers and patients in hospital settings due to COVID-19, the U.S. Food and Drug Administration (FDA) has recognized that home-use blood glucose meters, including Dario’s smartphone-connected metering device, may be used by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose levels and provide the readings to the health care personnel caring for them.

As a result, hospitals can now allow patients to self-test using their Dario blood glucose testing strips and smartphone-connected devices, or hospitals can issue patients Dario devices upon admission for COVID-19-related conditions.

Irregularities in blood glucose levels are suspected as a factor in the increased severity of potentially deadly COVID-19 complications. As such, a high priority is being placed on stabilization of patients’ blood glucose levels.

Awards and Recognition

DarioHealth’s Blood Glucose Monitoring System was voted as the ‘Best Glucometer for Data Management’ by Top Ten Reviews. Jeph Preece, senior editor at Top Ten Reviews, said, “The Dario app is the best data management system that I’ve seen. Compared to apps by popular brands, Dario’s system looks and feels like it’s years ahead of the curve.”

‘The Global Digital Health 100’, an annual award sponsored by the reputable Journal of Health, recognized DarioHealth as a leader among health technology companies demonstrating the greatest potential to change the way that health care is delivered.

DarioHealth Corp. (DRIO), closed Tuesday’s trading session at $13.97, up 1.2319%, on 143,704 volume. The average volume for the last 3 months is 92,853 and the stock's 52-week low/high is $3.01999998/$22.4899005.

Recent News

• BioMedNewsBreaks - DarioHealth Corp. (NASDAQ: DRIO) Finalizes Agreement to Provide RPM Solution to Presbyterian Medical Services
• Human Evolution May Be Responsible for Increased Risk of Developing Cancer
• President Putin Orders Coronavirus Vaccination to Begin

VistaGen Therapeutics Inc. (NASDAQ: VTGN)

The QualityStocks Daily Newsletter would like to spotlight VistaGen Therapeutics Inc. (NASDAQ: VTGN).

VistaGen Therapeutics, Inc. (NASDAQ: VTGN) (“VistaGen”), a biopharmaceutical company committed to developing a new generation of medicines with potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, today announced the closing of its $100 million underwritten public offering consisting of 63,000,000 shares of its common stock at an offering price of $0.92 per share, par value $0.001 per share (the “Common Stock”), and 2,000,000 shares of its Series D convertible preferred stock (“Series D Preferred Stock”) at a public offering price of $21.16 per share. All of the securities in the offering were sold by VistaGen.

VistaGen Therapeutics Inc. (NASDAQ: VTGN) is a biopharmaceutical company committed to developing and commercializing a new generation of medications that go beyond the standard of care for anxiety, depression and other central nervous system (CNS) disorders.

The company is headquartered in South San Francisco, California, the “Birthplace of Biotechnology,” among the largest cluster of biotechnology companies in the world.

New Generation Medications

VistaGen currently has three innovative CNS drug candidates in its pipeline: PH94B, PH10 and AV-101. With a differentiated mechanism of action and an exceptional safety profile in all clinical studies to date, each of VistaGen’s three drug candidates offers significant commercialization potential in multiple large CNS markets.

PH94B

Fast-acting (10-15 minutes), non-systemic and non-sedating in Phase 2 clinical studies, PH94B is a first-in-class neuroactive nasal spray that, administered in microgram doses, binds to chemosensory receptors in the nasal passage that trigger neural circuits responsible for suppressing fear and anxiety caused by stressful social or performance situations.

PH94B is currently being developed as an acute treatment of anxiety in adults with Social Anxiety Disorder (SAD). In December 2019, PH94B became the first drug candidate to be granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for development of a treatment for SAD, positioning it to potentially become the first FDA-approved fast-acting acute treatment for adults with the anxiety disorder, if planned Phase 3 studies are successful.

A successful Phase 2 program has been completed, and, after achieving consensus with the FDA in mid-2020 that the design of its Phase 3 studies of PH94B in SAD may mirror the design of the highly statistically significant (p=0.002) Phase 2 public speaking study of PH94B in SAD, the company’s preparations for pivotal Phase 3 clinical development of PH94B are underway.

To support Phase 3 development and commercialization of PH94B for anxiety disorders in large anxiety disorder markets in Asia, VistaGen recently entered into a strategic licensing and collaboration agreement with EverInsight Therapeutics, a company formed and currently funded by a large global venture capital firm, CBC Group. The company received a $5 million non-dilutive upfront license payment from EverInsight in August 2020. If Phase 3 development is successful, VistaGen is eligible to receive additional development and commercial milestone payments of up to $172 million, plus tiered royalties on sales of PH94B in Greater China, South Korea and Southeast Asia. VistaGen retains exclusive rights to develop and commercialize PH94B in all other markets.

VistaGen is also assessing potential Phase 2A clinical development opportunities to evaluate PH94B in a range of other anxiety disorders, including:

• Adjustment Disorder with Anxiety
• Generalized Anxiety Disorder
• Postpartum Anxiety
• Perioperative Anxiety
• Panic Disorder
• PTSD

PH10

PH10 is an investigational fast-acting synthetic neuroactive nasal spray with therapeutic potential in a wide range of neuropsychiatric indications involving depression and suicidal ideation. VistaGen is initially developing PH10 as a potential fast-acting, non-sedating, non-addictive new generation treatment of major depressive disorder (MDD).

Upon self-administration, a microgram-level dose of PH10 sprayed into the nose binds to nasal chemosensory receptors that, in turn, activate neural circuits in the brain that lead to rapid-onset antidepressant effects, without side effects, systemic exposure or safety concerns that may be caused by FDA-approved drug treatments for MDD, including oral antidepressants and intranasal esketamine.

In a published exploratory Phase 2A MDD study, PH10 demonstrated rapid-onset and sustained antidepressant effects without the serious psychological side effects and safety concerns of ketamine-based therapy.

Following successfully completed Phase 2A development of PH10 for MDD, the company is currently preparing for a Phase 2B program in MDD.

VistaGen is also assessing the potential for Phase 2A clinical development of PH10 in a range of other depression-related indications, including:

• Postpartum Depression
• Treatment-resistant Depression
• Suicidal Ideation

AV-101

Part of a class of new generation investigational medicine in neurology and neuropsychiatry known as N-methyl-D-aspartate receptor (NMDAR) modulators, AV-101 is an oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA), a potent and selective NMDAR glycine site antagonist. This drug candidate has the potential to serve as an innovative treatment for MDD and multiple neurological indications where current therapies are unsatisfactory.

VistaGen is currently evaluating AV-101, in combination with FDA-approved probenecid, in a range of neuropsychiatric and neurological indications, with both MDD and Neuropathic Pain already granted Fast Track designation by the FDA. The company is assessing the combination for a potential Phase 1B study to support a potential Phase 2A program in one or more of the following indications:

• Major Depressive Disorder
• Neuropathic Pain
• Levodopa-induced dyskinesia associated with Parkinson’s disease therapy
• Epilepsy
• Suicidal Ideation

CNS Therapeutics Market Outlook

The global CNS therapeutics market is estimated to reach $130 billion by 2025. The market was valued at approximately $82.3 billion in 2017 and is anticipated to grow at a healthy CAGR of more than 5.93% from 2018 to 2025. Even before the onset of the anxiety- and depression-provoking stressors from the COVID-19 pandemic, this growth was expected to be driven by a rise in mental illnesses and increased awareness of psychiatric disorders (https://nnw.fm/K2m0s) – all likely to be amplified by the diverse impacts of the pandemic.

The two most common mental health conditions – anxiety and depression – cost the global economy an estimated $1 trillion each year. The impact of these conditions is particularly devastating among the young. Industry data suggest that approximately 20% of the world’s children and teens are affected by mental health conditions, and suicide is the leading cause of death among 15- to 29-year-olds (https://nnw.fm/oftNb).

VistaGen’s mission is to help address the unmet needs of patients suffering from CNS disorders whose current treatments are either inadequate or generate debilitating side effects and serious safety concerns, including risk of abuse and death.

“Now more than ever, the new generation anti-anxiety and antidepressant medications we are developing at VistaGen – PH94B, PH10 and AV-101 – are relevant, necessary and demand the highly-focused and passionate efforts of our team and partners, with the support of our stockholders, to advance them to patients whose lives are disrupted by anxiety and depression disorders,” VistaGen CEO and Director Shawn K. Singh said in his closing remarks at the company’s 2020 Annual Meeting of stockholders.

Management Team

Shawn K. Singh, J.D. is the Chief Executive Officer and a Director of VistaGen. He has served on the company’s board of directors since 2000. He has nearly 30 years of experience serving in numerous senior management roles across multiple industries, including private and public biotechnology, pharmaceuticals, medical devices, venture capital, contract research and development, and law. Singh has a B.A. with honors from the University of California – Berkley. He has a J.D. degree from the University of Maryland Carey School of Law. He is also a member of the State Bar of California.

H. Ralph Snodgrass, Ph.D., is the Founder, Chief Scientific Officer and Director of the company. Snodgrass has more than 20 years of experience in the biotechnology field as a senior manager. He is recognized as an expert in stem cell biology, with over 28 years of experience using stem cells as biological research tools to promote development and drug discovery. He received a Ph.D. in immunology from the University of Pennsylvania. Snodgrass has published over 50 scientific papers with more than 17 patents and a number of patent applications.

Mark A. Smith, M.D., Ph.D., is VistaGen’s Chief Medical Officer He has over 20 years of pharmaceutical industry experience, primarily with CNS drug development. Smith has been a successful leader in the discovery and development of approximately 20 investigational new drugs. He has been a part of numerous CNS-related clinical trials. Smith received a bachelor’s and Master of Science from Yale University and a Doctor of Medicine and Doctor of Philosophy in Physiology and Pharmacology from the University of California – San Diego. He completed his residency in the psychiatry department at Duke University Medical Center.

Jerrold D. Dotson, CPA, is the Vice President, Chief Financial Officer and Secretary of VistaGen. He has over 25 years of experience in senior management positions in finance and administration at both public and private companies. Dotson is a licensed CPA in California and received his B.S. degree (Cum Laude) in business administration with a concentration in accounting from Abilene Christian College.

Mark A. McPartland is the company’s Vice President of Corporate Development and Investor Relations. He has over 20 years of experience in senior management roles in corporate development and investor relations at both public and private companies. McPartland received his Bachelor’s in business administration and marketing from Coastal Carolina University.

VistaGen Therapeutics Inc. (NASDAQ: VTGN), closed Tuesday’s trading session at $1.42, up 2.8986%, on 5,592,271 volume with 3 trades. The average volume for the last 3 months is 1,342,945 and the stock's 52-week low/high is $0.300000011/$1.54999995.

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AzurRx BioPharma Inc. (NASDAQ: AZRX)

The QualityStocks Daily Newsletter would like to spotlight AzurRx BioPharma Inc. (NASDAQ: AZRX).

AzurRx BioPharma Inc. (AZRX) is a clinical-stage biopharmaceutical company focused on developing treatments for gastrointestinal diseases using recombinant proteins.

The company’s lead drug candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients suffering from cystic fibrosis and chronic pancreatitis.

AzurRx has already completed two Phase 2 clinical trials for MS1819 and is currently pursuing approval through parallel monotherapy and combination therapy pathways.

The company was founded in 2014 and is headquartered in New York City, with scientific operations in Langlade, France, and clinical operations in Hayward, California.

MS1819 Clinical Trials

The two current ongoing clinical trials for MS1819 in cystic fibrosis (CF) are the Phase 2b Option 2 monotherapy trial and the Phase 2 combination therapy trial, using MS1819 together with porcine pancreatic enzyme replacement therapy (PERT), the current standard of care. Pending the Phase 2b trial outcome, the company intends to initiate a Phase 3 trial in cystic fibrosis.

• Phase 2b CF Option 2 Trial – The study was initiated in Q3 2020, using MS1819 doses in enteric capsule form (2240mg and 4480mg). Topline data for the trial is anticipated in Q1 2021.
• Phase 2 CF Combination Trial – The study was initiated in Q4 2019, using daily dose levels of PERT in combination with MS1819 dosages (700mg, 1120mg and 2240mg). Topline data is anticipated in Q2 2021.

These trials are currently addressing the treatment of EPI in patients with cystic fibrosis and chronic pancreatitis – an established global market with an estimated value in excess of $2 billion that has been growing at a CAGR greater than 20% over the past five years.

Results from AzurRx’s Phase 2b Option 2 trial of MS1819 in cystic fibrosis patients demonstrate that the non-porcine MS1819 lipase is well-tolerated by patients, with no significant safety signals observed at the 2240mg daily dose level.

“[W]e have evaluated four different enteric capsules and identified the best suitable formulation for MS1819 that provides gastroprotection of enzyme content and delayed release into the duodenum,” James Sapirstein, President & CEO of AzurRx, stated in a September 2020 news release (https://ibn.fm/27t4W). “Our clinical program continues to advance, and we are determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy, significantly reducing the pill burden of cystic fibrosis patients.”

Financial Highlights

As of July 2020, AzurRx had raised gross cash capital of $22.1 million, including $15.2 million from Series B convertible preferred stock and warrants in July 2020 and $6.9 million from convertible promissory notes and warrants in December 2019 and January 2020. Notably, AzurRx solidified its financial position and created an effectively debt-free balance sheet by exchanging substantially all of its outstanding convertible notes into the Series B convertible preferred stock financing.

The company secured an additional $2.5 million in French Research Tax Credits, received in 2020, for the years 2017-2019 (https://ibn.fm/Qxk7O).

In a letter to shareholder, Sapirstein noted that ensuring the company maintains sufficient capital to support its business operations has been a key focus. He further stated that the company is in “a financially secure position” to complete its two Phase 2 MS1819 clinical trial programs and to begin preparations in 2021 for a pivotal Phase 3 study.

The company has no current plans to access additional financing, as it believes it has enough cash to fund existing operational and clinical objectives through Q3 2021.

Management Team

James Sapirstein is the President and CEO of AzurRx BioPharma. He was previously the CEO and a board member for ContraVir Pharmaceuticals Inc., which is now known as Hepion Pharmaceuticals Inc. (NASDAQ: HEPA). Mr. Sapirstein has almost 36 years of experience in the pharmaceutical industry, with expertise in drug development and commercialization. He currently serves on the Emerging Companies and Health Section boards of the BIO (Biotechnology Innovation Organization) and is Chairman Emeritus of BioNJ. He earned his Bachelor’s degree in Pharmacy from Rutgers University and has an MBA in management from Fairleigh Dickinson University.

Daniel Schneiderman is the Chief Financial Officer of AzurRx. He previously served as the CFO of Biophytis SA and its U.S. subsidiary, Biophytis, Inc., clinical-stage biotechnology companies focused on the development of pharmaceutical candidates for age-related diseases. He was appointed to the AzurRx position in January 2020, bringing to the team over 18 years of experience in capital markets and finance operations. Mr. Schneiderman holds a degree in economics from Tulane University.

James Pennington, M.D., is the Chief Medical Officer of AzurRx. Before joining the team, he was the Chief Medical Officer and Senior Clinical Fellow for 11 years at Anthera Pharmaceuticals. Before becoming a part of the biotech industry, Dr. Pennington was on the Medical Faculty of Harvard Medical School for 10 years. He received his medical degree from Oregon Health & Science University.

Martin Krusin is the Senior Vice President for Corporate Development at AzurRx. He has 20 years of experience in business development, strategic marketing, financing and operations in the health care, financial services and consulting sectors. Before joining AzurRx, he was the VP for Business Development at FluoroPharma Medical Inc. Mr. Krusin received his MBA from Columbia Business School in finance and marketing, an MPhil. in political economy from Oxford University and a BA in international relations from Swarthmore College.

Dinesh Srinivasan, Ph.D., is the Vice President for Translational Research at AzurRx. He has over 15 years of experience leading drug discovery and development in the pharmaceutical industry. He began his career as a post-doctorate fellow at Roche Palo Alto. Dr. Srinivasan received his MSc in Biotechnology from the University of Mumbai, India, and a Ph.D. in Pharmacology and Toxicology from the University of Arizona – Tucson.

Ted Stover is the Product Development Director at AzurRx. He joined the company in 2020 to oversee CMC and Project Management. Before joining AzurRx, he spent 20 years focused on manufacturing operations and analytical method development for all stages of pharmaceutical drug development. Mr. Stover earned his MBA from the University of Florida.

AzurRx BioPharma Inc. (AZRX), closed Tuesday’s trading session at $0.7801, up 1.2985%, on 204,748 volume. The average volume for the last 3 months is 158,392 and the stock's 52-week low/high is $0.370867997/$1.93830001.

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Grey Cloak Tech Inc. (GRCK)

The QualityStocks Daily Newsletter would like to spotlight Grey Cloak Tech Inc. (GRCK).

Grey Cloak Tech (OTCQB: GRCK) (soon to be Healthy Extracts Inc.), a company engaged in proprietary development of natural plant-based formulations and sales and distribution of cardiovascular and neuro products, today announced that its subsidiary, Ultimate Brain Nutrients(TM) (“UBN”) has reported the successful completion of a pilot study for its proprietary Fuel4Thought(TM) (F4T(TM)) formulation to help with migraines. To view the full press release, visit https://ibn.fm/d09dF

Grey Cloak Tech Inc. (GRCK), through its growing portfolio of wholly owned subsidiaries, is engaged in the proprietary research and development of natural plant-based formulations, sales, and distribution of cardiovascular and neuro products. The company’s focus is to advance its market positions in the broader health industry through the unique assets and operations of its science-based BergaMet North America and Ultimate Brain Nutrients (“UBN”) subsidiaries and to offer better lifestyles through superior health technology.

BergaMet North America

BergaMet NA is engaged in the sale and distribution of a full line of proprietary product formulations derived from the rare Citrus Bergamot SuperFruit™ called “bergamot.” Bergamot is native to Southern Italy and is naturally sourced and uniquely loaded with various antioxidant polyphenols. Thanks to this composition, bergamot supports and promotes overall wellness specific to cholesterol, cardiovascular and metabolic health with no known side effects.

BergaMet NA is the only Citrus Bergamot SuperFruit™ heart health supplement backed by 17 clinical studies. The BergaMet brand supplement boasts the highest quality and concentration of polyphenols and flavonoids available anywhere in the world. It is also the only bergamot supplement approved by the prestigious Accademia del Bergamotto of Italy. BergaMet NA is the only company authorized to manufacture, distribute and sell these products in the United States, Canada and Mexico.

Consumers are including the Citrus Bergamot SuperFruit™ in their everyday personal health programs. The clinically proven antioxidant provides benefits to tens of thousands of people daily.

The company’s line of products can be found at www.bergametna.com, through Amazon, other online retailers and in doctors’ offices throughout the United States.

The BergaMet Advantage

BergaMet has been studied in 17 published clinical trials which reported results of lower LDL cholesterol, higher HDL cholesterol, lower triglycerides, lower blood pressure, lower blood glucose, increased arterial function, improved liver function and is effective as a complement to statin use.

Cardiovascular disease is the number one cause of death in the U.S. and worldwide, claiming nearly 18 million lives each year accounting for 31% of all global deaths. In the U.S., statins are one of the most commonly prescribed medicines for cardiovascular disease. The Centers for Disease Control estimates that 28% of American women and men over the age of 40 take a statin to lower the amount of cholesterol in the blood.

Taking aim at this market for cardiovascular care, BergaMet NA continues to advance the awareness of its medical-grade supplements and separate its formulation from competitors.

BergaMet NA products contain 47% BPF (bergamot polyphenolic fraction), while its closest competitors have only 38%. The company’s increased dosages (600-675mg vs 500mg) and 47% BPF are clinically proven to be more effective in improving heart health and metabolic syndrome.

BergaMet Citrus Bergamot SuperFruit™ supplements:

• Support healthy immune systems with powerful antioxidants and proprietary formulations.
• Reduce cholesterol and support healthy glucose and blood pressure levels.
• Are fully organic, vegan-friendly and dairy, gluten, soy and GMO-free.
• Contain five key unique flavonoids that make up the most powerful 47% BPF (bergamot polyphenolic fraction) in the world, providing superior results compared to their competitors.
• Have been clinically shown to increase arterial elasticity while reducing arterial and muscle inflammation.

Ultimate Brain Nutrients

Grey Cloak’s Ultimate Brain Nutrients (“UBN”) subsidiary is a science-based company that develops unique, plant-based superior health technology neuro-products that improve brain health, including memory, cognition, focus and neuro-energy.

UBN’s KETONOMICS® proprietary formulations — targeting brain activity, focus, headache and cognitive behavior — provide multiple intellectual property license opportunities for monetizing the company’s portfolio.

License opportunities include multiple beverage formats, individual products, proprietary mixtures and other food platforms.

UBN has five unique formulation patents — one issued and four pending — targeting brain activity, focus, headache and cognitive behavior.

The UBN Advantage

UBN’s all-natural, sugar-free and caffeine-free proprietary formulations are the result of 20 years of scientific research and are positioned to provide consumer neuro-products that are natural brain solutions. UBN has filed for approval to the U.S. Food and Drug Administration (FDA) to make a Qualified Health Claim for its migraine formulation, tapping into consumer demands for healthy beverages that contribute to brain health, overall well-being and performance.

Over 50 million Americans consume unhealthy energy shots and drinks each day, while the neuro/energy market generates over $10 billion per year in revenue. Within this growing market, UBN is advancing its position to meet rising consumer demand for healthy, science-based options. The company’s KETONOMICS® proprietary formulations have been proven to naturally elevate brain energy and function, including memory, cognition and focus.

UBN’s KETONOMICS® supplementation has also been studied in sports physiology, with specific regard to its potential benefits for competitive performance and endurance.

Grey Cloak Executive Team

Kevin “Duke” Pitts, Director, President and Chief Operating Officer

• Started and built from the ground up two multi-million-dollar businesses, one of which grew into a Top 100 retailers in the U.S.
• Unique management skills led to the development of successful teams for 35 years
• Pioneered direct marketing for a Fortune 200 company, creating a 20% increase in targeted incremental sales
• Founded Einstein’s Hemp, which developed and brought to market one of the only odorless and tasteless water-soluble CBD products in the world
• Developed and implemented digital/guerrilla marketing strategies for public and private companies focused on long-term brand position and acquisition efforts
• Specialized in customer relationship management (CRM) tools for creating the best customer experiences
• Worked in publicly traded industries for 10 years, overseeing up to $20 million in annual marketing budgets

William “Bill” Bossung, Director, Chief Financial Officer

• 35 years of diverse experience in corporate finance, insurance and accounting
• 20 years of experience with IPOs focusing on audits, FINRA and SEC regulations
• Specializes in the formation of capital raising over $100 million, recently raising $12 million for Splash Beverage
• Specializes in upgrading penny stocks companies to the NYSE or Nasdaq
• Involved in 30+ companies transitioning from private to public identities
• Founded several companies, including BCF Technology Inc., which sold to Vertafore; managing partner at Bishop Equity Partners LLC; director at Splash Beverage Group; and director of finance at Chadmoore Wireless, where he licensed channels to Nextel for $162 million

Bill Croyle, Director, Private Investor and Accomplished Senior Executive

• More than 40 years of success in the IT, energy, manufacturing, telecommunications, venture capital and finance industries
• Broad expertise includes negotiating mergers and acquisitions, as well as service and delivery contracts
• Formerly was a founder, owner or executive of EnTX Group; Impact Legacy Partners; FB Oilfield Special Tools; and Western Energy Advisors

Dr. Gerald Haase, Chief Medical Officer

• Clinical professor of surgery at the University of Colorado, School of Medicine
• Actively involved in medical research and clinical trials for 35 years
• Received U-10 grant funding from the National Institutes of Health cooperative group clinical trials program, as well as U.S. Congressional funding for Cooperative Research and Development Agreements with the Department of Defense and NASA
• Was chairman of the Department of Pediatric Surgery at Children’s Hospital Colorado; consultant surgeon to the Department of the Army; vice-chairman of the Children’s Cancer Group, a cooperative research consortium of the National Cancer Institute; on the National Board of Directors of the American Cancer Society; a senior member of the Commission on Cancer of the American College of Surgeons; and a member of the editorial board of The Annals of Surgical Oncology
• Has published 180 scientific papers and is the inventor or co-inventor of 12 issued U.S. patents for micronutrient and phytonutrient therapy, with five pending patents
• Recipient of clinical research grants and contracts funded at a several million-dollar cumulative level
• Is an editorial reviewer for medical journals and a member of numerous professional societies, including the American Association for Cancer Research, International College of Surgeons, American Academy of Pediatrics, New York Academy of Sciences and American College of Physician Executives

Grey Cloak Tech Inc. (GRCK), closed Tuesday’s trading session at $0.08, even for the day, on 18,957 volume. The average volume for the last 3 months is 23,040 and the stock's 52-week low/high is $0.019999999/$0.109999999.

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Rritual Superfoods Inc.

The QualityStocks Daily Newsletter would like to spotlight Rritual Superfoods Inc..

Rritual, a plant-based consumer brand, is set to take advantage of opportunity as functional mushrooms move mainstream. Within the rapidly emerging functional foods industry, the functional mushrooms sector is projected to increase at a CAGR of 5.6% during 2021–2026 and reach $24.85 billion by the end of the forecast period. To view the full article, visit https://ibn.fm/kv8Z7

Rritual Superfoods Inc. is a private company founded in 2019, whose declared purpose is to help people meet the demands of modern life with style and ease by incorporating functional mushrooms, adaptogens and superfoods into their diets.

The company manufactures premium plant-based products such as small-batch elixir powders, and each product features mindfully selected medicinal mushrooms and adaptogenic herbs. Pursuing customers with various need-states, Rritual offers products that fit every lifestyle.

Suite of Premium Rritual(TM) Products

Rritual recently announced the launch of its suite of premium functional mushroom and adaptogenic elixirs. These elixirs were developed by a leading team of scientists, doctors and experts across the wellness industry, under the guidance of Rritual President Dr. Mike Hart.

The initial product line includes:

• Chaga (immune booster) – Full of bioactive polysaccharides, Rritual’s Chaga blend combines the Chaga mushroom with Eleuthero root for optimal immune system benefits.
• Lion’s Mane (brain booster) – Designed to support cognitive function and brain health, Lion’s Mane is paired with Rhodiola root. The elixir can also help the body manage stress.
• Reishi (stress support) – Rich in polysaccharides, triterpenes, amino acids and fatty acids, the Reishi blend is infused with Ashwagandha root. This combination aims to help the body and mind fight anxiety, with long term effects that may improve quality of sleep for those with restless minds.

“The health and wellness benefits of mushrooms and plant-based therapies are backed by decades of scientific research. Rritual’s new line of elixirs embraces that research and provides consumers with an easy way to get a daily dose of the powerful effects,” Hart said in a news release.

Rritual CEO David Kerbel noted that the company is proud to bring together age-old mushroom consumption practices and data-backed research to create new formulas that meet the needs of modern consumers. “Whether to relieve stress, increase mental output or boost immunity, we want to be a trusted and effective component of a consumer’s daily health and wellness routine,” he added.

Rritual Timeline

According to its investor presentation, Rritual has already fulfilled most of the milestones it set for Q1 and Q2 2020 as part of its growth and development timeline. So far, the company has completed formulation R&D, product line development, test marketing, brand development, logistics partnerships and agreements, initial distributor partnerships, seed financing and the phase one launch of its product suite.

Rritual E-Commerce Rollout Strategy

The company’s strategy for e-commerce rollout success consists of direct-to-consumer (D2C) sales through the use of multiple online platforms and through team connections to facilitate rapid expansion within the market.

In the first stage, Rritual will use its own website and Amazon to facilitate its D2C initiative, followed by leveraging its team connections to sell products through planned specialty e-commerce channels such as Costco, CVS, Walmart, and Vitacost using preexisting relationships.

Brick-and-Mortar Rollout Strategy

Using partnerships already in place with The Jet Collective and leveraging the preexisting connections of its team for direct discussions with global retail brands, Rritual’s brick-and-mortar strategy features a two-stage rollout that targets 15 leading retailers.

In the first stage, Rritual aims to launch with four non-competing chains, while utilizing best practice agreements (320 Sprouts stores, 330 H-E-B stores, 240 Meijer stores and 1,600 Publix stores). In stage 2, distribution is expected to advance to additional retail establishments (100 Wegmans stores, 77 Fresh Thyme stores, 440 Whole Foods stores, 120 Shaw’s stores, 400 Stop & Shop stores, 300 Wakefern/Shoprite stores, 610 Vitamin Shoppe stores, 90 Bartell Drug stores, 40 Giant Eagle market district stores and 1,800 Target stores), while collaboration with Kroger will take place within two sub-markets (300 Ralphs stores and 120 Harris Teeter stores).

Market Growth Outlook

As it is yet in its early stages, the functional mushrooms market is rife with opportunities for growth. At this time, no dominant brand is in place, and there remains an absence of a premium brand to lead the category.

The entire functional food market is currently valued at more than $275 billion, with global shifts supporting wellness and a 7.9% CAGR forecast through 2025. Demand for functional mushrooms is also growing, with a forecast rise from $23 billion to $34 billion by 2024 as a result of growing popularity due to the superfood’s unique properties that have been shown to boost immunity, cognitive function and more. The worldwide functional mushroom market is projected to exceed $50 billion by 2025, with recent data indicating an increase in demand for key mushroom varieties of up to 800%.

Management Team

David Kerbel, CPC, is CEO of Rritual and has over 30 years of senior experience in retail, brokerage and CPG industries. From 2008 to 2011, Kerbel served as Senior Vice President of Sales for Celsius Holdings Inc., helping that company achieve a number of important milestones. During his tenure, Celsius grew its retail sales from $400,000 to a multimillion-dollar figure, developed nationwide representation with CROSSMARK Inc. and established distribution with industry giants such as 7-Eleven, Ralph’s, C&S, Costco, BJ’s Wholesale, CVS, Walgreens, Walmart, Rite Aid, Target, Duane Reade and Stop & Shop. In total, Celsius’ new distribution stemming from Kerbel’s direct efforts led to $36 million in incremental sales in 2010 alone. He also implemented new procedures that led to a 10 percent reduction in operating expenses. Kerbel brings tremendous experience to the Rritual team, as well as vital relationships with industry leaders such as Walmart, Costco, Kroger, Walgreens, CVS, 7-Eleven, Safeway, Publix, Sprouts and more.

Warren Spence is the COO and a Director of Rritual. He has over 25 years in the food and beverage industry. His roles within the industry have included senior positions with brands like Red Bull and Olivieri. His specialization is in supply chain and operations systems. He was appointed Head of Supply Chain for Nude Beverages in 2019.

Dr. Mike Hart, MD, is the President of Rritual. His work has been published in peer-review journals about therapies involving cannabis and ketamine. His outspoken stance on these subjects landed him an appearance on the Joe Rogan Experience Podcast in 2019. On-air, he discussed the use of psychedelic medicines as a treatment for mental health conditions, including PTSD.

Stacie Gillespie is CCO and Director of Formulations for Rritual. She has over 25 years of leadership in the branding and product strategies used by wellness companies. She has leveraged this expertise for companies such as Aura Cacia, MegaFood and Gaia Herbs. She is the creator of multiple award-winning consumer health products.

Sarton Molnar-Fenton is Vice President of Sales-USA for Rritual. She started her career with Vitamin Water, with other large companies under her belt, including Danone, as a District Manager. She worked with Nestle on its Tribe Hummus brand and played an integral part in relaunching the brand, gaining category share and establishing product development partnerships with companies like Trader Joe’s. She also played a key role in launching the Hydralyte brand in the United States.

Scott Naccarrato is the company’s Vice President of Sales-Canada. He is experienced in sales with a deep connection in retail. Recently, he worked with Nutiva, assisting in the pioneering of Organic MCT oil, healthy fats and the plant-based protein categories. He is data-oriented in his approach, which has resulted in over $100 million in sales and double-digit year-over-year growth for the brands of which he has been a part.

Investment Considerations

• Rritual’s suite of premium functional mushroom and adaptogenic elixirs is designed to offer various health benefits, such as increased immunity, cognitive function, stress management and more.
• The company’s products are expected to be available online through Rritual’s site and Amazon by fall 2020.
• The Rritual team has extensive ties and influential relationships with leading retail businesses, providing a wide market for growth.
• The functional mushroom industry has no clear and dominant leader, allowing Rritual to target this role with its premium products. Rritual is currently the only premium brand on the market.
• The global functional mushroom market is expected to exceed $50 billion by 2025, putting Rritual in the position for success.
• Functional mushroom demand is expected to rise from $23 billion to $34 billion by 2024.

Recent News

• QualityStocksNewsBreaks – Rritual Superfoods Inc. Eyes Growing Opportunity in Nascent Functional Mushrooms Market
• Traditional Chinese Medicine Takes Root in Western Culture with Rritual Superfoods Product Line
• QualityStocksNewsBreaks – Rritual Superfoods Inc. Holds Key Certification in Emerging Market

RYAH Group Inc.

The QualityStocks Daily Newsletter would like to spotlight RYAH Group Inc..

RYAH Group is a leading digital health care analytics and technology company with a mission to advance the world’s transition to remote-health solutions and data analytics in patient treatments. Through its IoT dose-measuring devices and AI analytics, RYAH is focused on expanding understanding of the value of devices combined with data to positively impact the future treatment of patients for various medical conditions. To view the full article, visit https://ibn.fm/PWPVG

RYAH Group is a leading digital health care analytics and technology company with a mission to advance the world’s transition to remote-health solutions and data analytics in patient treatments. Through the company’s IoT dose-measuring devices and AI analytics, RYAH is reshaping understanding of the value of devices combined with data, to positively impact the future treatment of patients for various medical conditions.

RYAH Group Inc. is a leading digital health care analytics and technology company with a mission to advance the world’s transition to remote-health solutions and data analytics in patient treatments. Through the company’s IoT dose-measuring devices and AI analytics, RYAH is reshaping understanding of the value of devices combined with data, to positively impact the future treatment of patients for various medical conditions.

The company is a leading developer of dose-measuring IoT devices connected with its turn-key platform designed to aggregate and correlate HIPPA-compliant data, suitable to all participants in the patient treatment cycle. The company also specializes in customized, fully integrated, mobile applications and APIs, specifically designed to meet the needs of clinics, clinical trials, government and university research centers, for experimentation and treatment validation – significantly reducing variations in patient-related trials. RYAH unlocks data in the complete therapeutic plant lifecycle – from seed to consumption.

Since it began developing and commercializing its smart inhaler solution in 2018, the company has evolved a complete IoT device and data analytics platform that includes multiple delivery mechanisms, designed to capture anonymous patient dosing and feedback, combined with detailed strain analytics, enabling customized dosing regiments. The company has secured numerous partnerships across the globe, including establishing a footprint in the UK, USA, Australia and Canada, and it has closed several deals in the European Union, as well. The company’s Smart-Inhaler has been selected as the dose-measurement, dose-control and data analytics platform for a UK pain management study and one of the world’s most ambitious and largest clinical trials ever to be conducted in cannabis.

Product Portfolio

The company’s current portfolio incorporates an ecosystem of IoT products, each consisting of three elements: the device, the medicine-carrying component and the mobile application. The product line currently includes a Smart Dry-Herb Dose-Measuring Inhaler in the commercial stage, a Smart Transdermal Patch in the production stage and a Smart Liquid Dispensing Pen in the prototype stage.

RYAH Smart-Inhaler

The RYAH Inhaler is the first dry-herb inhaler that allows users to track and control how much is inhaled, providing consistent and predictable results. This inhaler connects with the RYAH Health App, which features stat-tracking and presets for temperatures and dosages, all of which can be customized to individual needs and doctor recommendations, as well as a post-session review mechanism that allows the collection of session data and feedback for further efficacy analysis for customized dosing capabilities.

RYAH’s proprietary stainless-steel cartridges for the inhaler use QR technology that contains lab testing and grower information pertaining to the specific strain, thereby mitigating elicit product use and enabling completely transparent remote medicinal analytics, from seed to consumption.

In addition, the RYAH Cartridges provide a unique closed-loop recurring revenue opportunity for the company, as the RYAH Inhaler only works with this type of proprietary cartridges that licensed partners fill with medicine. The partners benefit from all the back-end data, providing them access to consumption habits, statistics and other data on patient preferences.

RYAH Smart-Patch

The RYAH Smart Transdermal Patch is a lightweight, reusable, mobile-controlled patch used for site-specific therapies. The Patch is an Electronic Topical Delivery Patch system intended for recommendation and administration by pain relief professionals and physical and occupational therapists. The patch data and the heating element is completely IoT and controlled by RYAH’s proprietary smartphone applications, which allows scheduling and ‘boosting’ medicine release, on-demand.

RYAH Smart-Pen

The RYAH Pen is an app-controlled liquid dispenser designed to provide a precise mix of up to three medicine components to create an ‘entourage effect’, enabling customized, wide-spectrum recommendation opportunities by licensed clinicians. The Smart-Pen will feature cartridges that contain CBD, THC and other isolates such as flavonoids or vitamins, or other solutions. There is a built-in mechanism designed to control usage based on recommended dosing schedules.

RYAH MD

RYAH MD serves as a remote and interactive patient-doctor collaboration and dosing administration platform. Doctors can remotely set dosage amounts for their patients, creating digital prescriptions for the RYAH IoT devices and tracking patient usage in real-time. RYAH MD offers features that include real-time monitoring, appointment booking, doctor-patient video calls and science-based strain recommendations, as well as promoting a better understanding of the effects and benefits of those recommendations among patients. Information is gathered from all of the RYAH devices.

PotBot App

The PotBot App is a medical cannabis education mobile application that leverages patented AI technology to capture structured and unstructured data to assist patients in learning about various treatments in plant-medicine based on their efficacy goals. The PotBot App is currently one of the top-rated medical cannabis educational mobile applications on the Apple App Store in the United States, with over 300,000 downloads.

Through the combination of peer-reviewed and empirical data, the PotBot App provides detailed information on the targeted and tested cannabinoid levels and associated strains from cannabis patients. The result is personalized and driven by data to inform patients of potential product matches associated with similar ailments and efficacy goals.

Market Outlook

RYAH holds a unique position in the $100.3 billion medical plant market, with the potential to capture and capitalize on growth opportunities made available by both the IoT and Data Intelligence sectors.

In 2018, the global IoT market was valued at $212.1 billion, and it is expected to grow exponentially to $1.3 trillion by 2026, registering a CAGR of 25.68%, according to Verified Market Research (https://ibn.fm/XtkPZ).

Management Team

Dr. Boris Goldstein, Ph.D., is the founder and Chairman of RYAH Group. He is a seasoned entrepreneur, investment banker and venture capitalist. He started his career as the founder of Software House HT, which grew into a worldwide corporation with over 40 offices in 17 countries. Since then, Goldstein has founded and served on the boards of directors and advisory boards for numerous companies in Silicon Valley and Silicon Alley. Goldstein brings experience in fundamental research, investment and technology, authoring multiple patents and books.

Gregory Wagner, MBA, is Chief Executive Officer and Director of RYAH Group. He has over 20 years of experience in global financial markets and entrepreneurship. Wagner has held executive roles in the United States and London. He has co-founded and built several startups from the ground up. His current licensures and degrees include FINRA Series 7, 63, 24 and 55, as well as an MBA from Fordham University. Wagner received a Certification in Innovation and Strategy from Harvard University.

Investment Considerations

• RYAH Group is a technological leader in the plant-based treatment market with its unique combination of proprietary IoT devices and data analytics, supported by patented AI technology.
• The company’s products pair a growing ecosystem of therapeutic plants with top-rated apps, devices and services.
• RYAH offers a complete remote dosage delivery and dose-monitoring platform based on data-driven analytics supported by prescribing doctors and their patients.
• The company is finalizing its anticipated listing on the Canadian Securities Exchange.
• RYAH holds a unique position on the $100.3 billion medical plant market, with the potential to capture footholds in both the IoT and Data Intelligence industries.

Recent News

• QualityStocksNewsBreaks – Why RYAH Group Inc. Is ‘One to Watch’
• RYAH Group Inc. Is ‘One to Watch’
• RYAH Enters into Merger Agreement with Prime Blockchain in respect of Previously Announced Proposed Reverse Takeover

Net Element (NASDAQ: NETE)

The QualityStocks Daily Newsletter would like to spotlight Net Element (NETE).

Net Element (NASDAQ: NETE) was featured today in a publication from Green Car Stocks, examining how electric vehicles (“EVs”) are poised to replace internal-combustion-engine vehicles over the next couple of decades. EVs run on clean, renewable energy and produce minimal emissions at the tailpipe, but there’s one caveat: they are too expensive for most consumers. Unlike internal-combustion-engine vehicles, EVs are powered by rechargeable lithium-ion batteries that require minerals such as cobalt, nickel, lithium, and manganese to function. These minerals need to be mined, processed and converted into pure chemical compounds before use in batteries — a process that can cost a pretty penny.

On June 15, 2020, Net Element announced its entry into a binding letter of intent to merge with privately-held Mullen Technologies Inc., a Southern California-based electric vehicle company, in a stock-for-stock reverse merger in which Mullen’s stockholders will receive the majority of the outstanding stock in the post-merger company. The proposed merger is currently pending the execution of a definitive agreement, shareholder vote and regulatory approval.

Net Element Inc. (NASDAQ: NETE) is a global financial technology and value-added solutions group that supports electronic payments acceptance in an omni-channel environment spanning across point-of-sale, e-commerce and mobile devices. The company operates a payments-as-a-service transactional model and value-added services platform for small to medium enterprises in the U.S. and selected emerging markets.

Net Element believes the future of global commerce is being revolutionized as consumers quickly migrate toward omni-channel shopping utilizing mobile devices, desktop, and online services. The company’s all-in-one payment solutions support and unify a whole range of applications through a single, robust platform, allowing global onboarding and support for multiple payment methods.

Net Element has also launched a blockchain-focused business unit that will develop and deploy blockchain technology-based solutions. Net Element expects the new division to create a decentralized crypto-based ecosystem that will act as a framework for an unlimited number of value-added services, connecting merchants and consumers in a seamless, economically efficient transaction. This new business unit intends to also identify and invest in unique projects that decentralize and disrupt the payment processing industry by combining blockchain technology and real-world applications with talented development teams, strong fundamentals and addressable markets large in size.

“We believe that we’re at the dawn of a new evolution where additional digital payment methods are being introduced,” Net Element chairman and CEO Oleg Firer, says. “Introduction of our division focused on blockchain as part of the NASDAQ-listed entity will add transparency and compliance assurance to our investors as well as provide access to deploy value-added services to over 20 million electronic commerce clients that are currently part of Net Element’s growing network.”

Net Element clients are treated to customized solutions that provide the flexibility needed to keep up with customers. Among the services offered are mobile payment apps that accept payments anywhere, anytime; cloud-based solutions built to increase productivity and enhance revenue for clients and partners; marketing solutions that turn lookers into buyers; and business analytics that make it easy for clients to monitor business metrics, engage with customers and compare the competition. Its multi-channel platform combines e-commerce, offline, point-of-sale, comprehensive back office tools, mobile point-of-sale, credit scoring and customer interaction in one powerful platform-as-a-service technology.

Net Element owns and operates a global mobile payments and transactional processing provider, TOT Group, Inc., with the following subsidiaries:

• Unified Payments – An award-winning, customized mobile billing and payments solution, recognized by Inc. Magazine as the No. 1 Fastest Growing Company in America in 2012.
• Aptito – A next-generation, all-in-one, cloud-based restaurant management and point-of-sale payments platform using wireless technology.
• Payonline – A fully integrated, processor agnostic electronic commerce platform.

Net Element is ranked on Deloitte’s Technology Fast 500™ list of North America’s 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in both 2017 and 2018, during which the company grew 190 percent and 183 percent, respectively. The company credits its progression to organic growth in its North America Transactions Segment, specifically the success of its Unified Payments brand, which focuses on value-added payment acceptance solutions for small to medium enterprises in the United States.

Net Element was also listed among South Florida Business Journal’s 2016 fastest growing technology companies.

Leveraging its suite of application performing interfaces (APIs) and connectors, Net Element powers commerce for businesses of all sizes through multi-channel platforms, all-in-one digital solutions, and end-to-end encryption of cardholder data utilizing tamper resistant hardware that ensures integrity and simplifies security.

Leading this innovation is chairman and CEO Oleg Firer, who is responsible for the overall vision, strategy and execution of the company’s mission of powering global commerce. He is joined by CFO Jeffrey Ginsburg, CPA, and Steven Wolberg, the company’s chief legal officer and secretary. Each corporate officer brings a unique blend of leadership, vision, experience and creative energy to the company.

From mobile payments and value-added transactional innovations like Aptito to e-commerce and retail payment transaction processing brands like Payonline and Unified Payments, Net Element is transforming the online and mobile experience.

Net Element (NETE), closed Tuesday’s trading session at $12.50, off by 3.5494%, on 832,262 volume with 2 trades. The average volume for the last 3 months is 2,164,870 and the stock's 52-week low/high is $1.472/$20.0783996.

Recent News

• Are EV Makers Assuming Too Much Regarding Battery Prices?
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CNS Pharmaceuticals Inc. (NASDAQ: CNSP)

The QualityStocks Daily Newsletter would like to spotlight CNS Pharmaceuticals Inc. (NASDAQ: CNSP).

CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announced that it obtained the Food and Drug Administration’s Investigational New Drug (“IND”) approval for its lead drug candidate Berubicin, according to a company press release on December 17, 2020 (https://ibn.fm/2Tin7). The press release was followed a day later by a public conference call during which the company’s CEO John Climaco and CMO Sandra Silberman, M.D., Ph.D. discussed the IND approval, as well as what that means for CNS Pharmaceuticals.

CNS Pharmaceuticals Inc. (NASDAQ: CNSP) is a clinical stage biotechnology company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system.

The company was founded in 2017 and is headquartered in Houston, Texas.

Organ Targeted Therapeutics

The company’s lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer. Berubicin also has potential to treat other central nervous system malignancies. Based on limited clinical data, Berubicin appears to be the first anthracycline to cross the blood brain barrier in the adult brain, and it was the subject of a successful Phase 1 study which found the MDT and produced efficacy data as well.

CNS holds a worldwide exclusive license to the Berubicin chemical compound. The company has acquired all requisite data and know-how from Reata Pharmaceuticals Inc. related to a completed Phase I clinical trial of Berubicin in malignant brain tumors. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. In 2017, CNS entered into a collaboration and asset purchase agreement with Reata.

CNS intends to explore the potential of Berubicin to treat other diseases, including pancreatic and ovarian cancers and lymphoma. The company is also examining plans to develop combination therapies that include Berubicin.

CNS estimates that more than $25 million in private capital and grants were invested in Berubicin prior to the company’s $9.8 million IPO in November 2019.

CNS intends to submit an IND for Berubicin during the fourth quarter of 2020 and expects to commence a Phase II clinical trial of Berubicin for the treatment of GBM in the U.S. in Q1 2021. A sub-licensee partner was awarded a $6 million EU/Polish National Center for Research and Development grant to undertake a Phase II trial of Berubicin in adults and a first-ever Phase I trial in pediatric GBM patients in Poland in 2021.

The company’s second drug candidate, WP1244, is a novel DNA binding agent licensed from the MD Anderson Cancer Center. In preclinical studies, WP1244 proved to be 500-times more potent than the chemotherapeutic agent, daunorubicin, in inhibiting tumor cell proliferation. The company has entered into a sponsored research agreement with the MD Anderson Cancer Center to further the development of WP1244.

CNS Pharmaceuticals recently engaged U.S.-based Pharmaceutics International Inc. and Italian BSP Pharmaceuticals SpA for the production of the Berubicin drug product. The company has implemented a dual-track manufacturing strategy to mitigate COVID-19-related risks, diversify its supply chain and provide for localized availability of Berubicin. CNS has already completed synthesis of Berubicin’s active pharmaceutical ingredient (API) and has shipped the API to both manufacturers in order to prepare an injectable form of Berubicin for clinical use.

Global Brain Tumor Therapeutics Market

The high recurrence rate of malignant brain tumors is due to reappearance of focal masses, indicating that a sub-population of tumor cells in these cancers may be insensitive to current therapies and may be responsible for reinitiating tumor growth. This necessitates the development of newer drugs in the market that demonstrate greater efficacy in treating such aggressive cancers.

A global increase in neurological disorders has placed increased attention on cancers of the brain over the past decade. Neurological disorders are becoming one of the most prevalent types of disorders, due to longer life expectancy, greater exposure to infection and an increasingly sedentary lifestyle. Because few treatments for primary and metastatic cancers of the brain exist, costs are high and have acted as a restraint for the brain tumor therapeutics market.

Despite progress in surgery, radiotherapy and chemotherapeutic strategies, effective treatments for brain cancer are limited by a lack of specific therapies for the brain and the difficulty in transporting therapeutic compounds across the blood brain barrier. Therefore, there is a significant need for novel and effective therapeutic drugs and strategies that prolong survival and improve quality of life for brain tumor patients.

Several companies are making significant investments into R&D, which is expected to bring more treatment options to the market in the near future. Industry reports consistently project continued growth in the market.

One report estimates that the global brain tumor therapeutics market will reach a valuation of $2.74 billion in 2023, with the market expected to register a CAGR of 11% during the forecast period from 2018 to 2023. Another report projects that the global brain tumor therapeutics market will reach $3.4 billion by 2025, up from $2.25 billion in 2019 (http://nnw.fm/eDUjp).

Management Team

John M. Climaco is the CEO of CNS Pharmaceuticals. For 15 years, Climaco has served in leadership roles for a variety of health care companies. Recently, Climaco served as the Executive Vice President of Perma-Fix Medical S.A, where he managed the development of a novel method to produce Technitium-99. Climaco also served as President and CEO of Axial Biotech Inc., a DNA diagnostics company. In the process of taking Axial from inception to product development to commercialization, Climaco forged strategic partnerships with Medtronic, Johnson & Johnson and Smith & Nephew.

Christopher Downs, CPA, is the company’s Chief Financial Officer. Downs previously served as Interim Chief Financial Officer and Executive Vice President of InfuSystem Holdings Inc. (NYSE: INFU), a supplier of infusion services to oncologists in the United States. Downs holds a Bachelor of Science from the United States Military Academy at West Point, an MBA from Columbia Business School and a Master of Science in Accounting from the University of Houston-Clear Lake.

Dr. Donald Picker is the Chief Scientific Officer of CNS. Picker has over 35 years of drug development experience. Prior to joining CNS, Picker worked at Johnson Matthey, where he was responsible for the development of Carboplatin, one of the world’s leading cancer drugs, which was acquired by Bristol-Myers Squibb with annual sales of over $500 million. In addition, he oversaw the development of Satraplatin and Picoplatin, third-generation platinum drugs currently in late-stage clinical development.

Sandra L. Silberman, M.D., Ph.D., is the Chief Medical Officer of CNS Pharmaceuticals. Silberman is a hematologist/oncologist who earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively, and her M.D. from Cornell University Medical College. She then completed both a clinical fellowship in hematology/oncology and a research fellowship in tumor immunology at the Brigham & Women’s Hospital and the Dana Farber Cancer Institute in Boston, Massachusetts. Silberman has played key roles in the development of many drugs, including Gleevec(TM), for which she led the global clinical development at Novartis. Silberman advanced several original, proprietary compounds into Phases I through III during her work with leading biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone and Roche.

CNS Pharmaceuticals Inc. (NASDAQ: CNSP), closed Tuesday’s trading session at $2.10, off by 14.9798%, on 2,220,879 volume with 2 trades. The average volume for the last 3 months is 903,742 and the stock's 52-week low/high is $1.25820004/$5.61999988.

Recent News

• CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Moving Forward with Clinical Trials in 2021 after Receiving FDA Approval for IND for Berubicin
• What Successful Coronavirus Vaccines Should Do
• BioMedNewsBreaks - CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Hosts Conference Call to Discuss IND Approval, Phase 2 Berubicin Trial

Brain Scientific Inc. (OTCQB: BRSF)

The QualityStocks Daily Newsletter would like to spotlight Brain Scientific Inc. (OTCQB: BRSF).

Brain Scientific (OTCQB: BRSF) co-founder and CEO Boris Goldstein penned a recent article for “Healthcare” magazine. Titled “Brain Scientific: Neurology’s need for disposable solutions,” the article provides an overview of the need for new devices in the neurology market and the advantages of disposable brain diagnostic tools. Goldstein noted that his interest in brain diagnostic tools began when he was studying at college, where he used clustering analysis for Rorschach testing. As the founder of BrainRX, he was involved in pre-Alzheimer diagnostic and software development, and he was always searching for places to obtain data for artificial analysis or data correlation. To view the full article, visit http://ibn.fm/CQLUF

Brain Scientific Inc. (OTCQB: BRSF) is a commercial-stage health care company focused on developing innovative and proprietary medical devices and software. With a mission of modernizing brain diagnostics by employing cutting edge technologies to bridge the widening gap in access to quality care, the company offers two FDA-cleared products that provide next-generation solutions to the neurology market.

The company’s proprietary, clinical-grade neurological devices are supported by its intellectual property portfolio featuring patents in the United States, China and Europe.

Brain Scientific’s first commercialized devices, NeuroCap(TM) and NeuroEEG(TM), are designed to disrupt the current electroencephalogram (EEG) market by offering cost-effective and disposable substitutes to existing solutions, allowing medical professionals to collect diagnostic information quickly.

The company’s goal is to improve diagnostics by leveraging artificial intelligence and machine learning processes to analyze a database of brain readings as a method of detecting seizures and dementia. The company is also working to improve patients’ access to neurological care.

Headquartered in New York, Brain Scientific and its predecessor (and now wholly owned subsidiary, MemoryMD Inc.) was founded in 2015 and went public in 2018.

Brain Scientific’s first phase of development, from 2018 to 2019, saw the inception of portable, clinical-grade, easy-to-use neurological devices. The second phase, currently ongoing, aims to create cloud-based, secure infrastructure to transmit patient data between patients and their neurologists. The company’s third phase of development is scheduled for 2021-2022 and is expected to focus on the use of AI-assisted diagnostic analysis to increase the efficiency, consistency and accuracy of neurology specialists.

NeuroCap(TM) – Disposable EEG Headset

The NeuroCap is a disposable pre-gelled EEG headset featuring 22 electrodes and 19 active EEG channels, all adhering to the international 10-20 system. The NeuroCap was FDA-cleared in 2018. The headset can be used for recording EEGs in virtually any setting, including urban and rural emergency departments, neurology clinics, urgent care clinics, ICUs, nursing homes, assisted living facilities and remote clinical research labs.

Through a universal cable adapter, the NeuroCap is compatible with other EEG amplifiers. The cap also works in parallel with Brain Scientific’s NeuroEEG amplifier, initiating EEG studies in less than five minutes.

The company is currently seeking FDA approval for additional features for the NeuroCap, as the device has the potential to fill a gap in EEG testing availabilities during the current coronavirus pandemic: in October 2020, Brain Scientific filed an Emergency Use Authorization (EUA) application. The EUA is required for the rapid distribution of the NeuroCap device to emergency departments, intensive care units and other treatment centers to administer prescriptive EEGs safely on critically ill patients or those suspected of being diagnosed with COVID-19.

With more than 80 percent of hospitalized patients infected with COVID-19 displaying neurological symptoms, the NeuroCap could prove to be a valuable device by offering fast testing with limited contact between technicians and patients.

NeuroEEG(TM) – Miniature and Portable Wireless EEG Amplifier

The NeuroEEG is a compact, portable and affordable wireless EEG amplifier intended for prescription use. The 16-channel, FDA-cleared, clinical-grade device acquires, records, transmits and displays electrical brain activity for patients of all ages.

Both the NeuroCap and NeuroEEG are delivered by MemoryMD Inc., a wholly owned subsidiary of Brain Scientific.

Products in Active Development

Currently, Brain Scientific and MemoryMD are working on leveraging their existing products and drawing from ongoing research to develop and commercialize the next generation of solutions for the brain diagnostics market. The devices under development are being designed to address the following issues:

Routine EEG

• NeuroCap-8 is an 8-channel EEG cap. The reduced number of electrodes is vital in emergency room situations, where the time it takes to set up the EEG is critical.

Pediatric EEG

• NeuroCap Pediatric is positioned to become the first disposable and pre-gelled headset available for the pediatric market.

Long-Term Monitoring

• NeuroCap LTM for adult and pediatric patients is a disposable cap designed to monitor rhythmic and periodic patterns for up to 72 hours, providing essential diagnostic capabilities.
• NeuroEEG 24 Channel Amplifier is a portable and wireless amplifier with over 24 hours of battery life.

Artificial Intelligence

• Brain E-Tattoo is a minimally invasive four-channel EEG electrode designed for long-term monitoring.
• An AI database of brain biomarkers collects data on both normal and abnormal brain data to detect neurological diseases. The goal is for machine learning algorithms to enhance understanding of brain-behavior related to epilepsy, memory dementia and pre-Alzheimer’s diagnostics.

Telemedicine

Brain Scientific is expanding the vision for telemedicine in neurology. The company aims to address the current acute neurologist shortfall (20 states have less than 10 neurologists per 10,000 patients) through the use of teleneurology.

 

Partnership with Marketing Brainology

Brain Scientific has a longstanding partnership with Marketing Brainology, a neuromarketing firm using neuroscience approaches to understand consumer behavior. In 2019, Marketing Brainology conducted a study using NeuroCap and NeuroEEG to determine the most effective Super Bowl commercials.

“Thanks to Brain Scientific’s NeuroCap and NeuroEEG, we are able to better understand the art and science of the human decision-making process,” Michelle Adams, Ph.D, Founder of Marketing Brainology, stated in a news release.

In April 2020, Marketing Brainology again conducted a study leveraging Brain Scientific’s disposable EEG cap to determine how brains were reacting to COVID-19 messaging. Subjects were presented with multiple media impressions, and Marketing Brainology analyzed their responsive biomarkers. The results identified the most effective messaging for engaging with an audience during a crisis.

Market Outlook

The current global market for EEG devices is estimated at $956.1 million. It is expected to rise with a CAGR of 8.7% from 2019 to 2026, reaching $1.6 billion in value by 2026, according to Grandview Research.

In total, there are approximately 6,150 hospitals in the U.S., according to the American Hospital Association. Critically, though, just 254 of those hospitals are certified Level 4 Epilepsy centers with 24/7 EEG coverage. Since very few non-Level 4 centers have extensive EEG tech coverage, this creates a significant opportunity for Brain Scientific to bridge the gap by providing over 5,900 hospitals with lower cost amplifiers and disposable EEG caps.

The company also see opportunities to work with other businesses, such as EEG manufacturers hoping to package Brain Scientific’s solutions with their products, which could greatly expand Brain Scientific’s addressable target market.

Management Team

Dr. Baruch “Boris” Goldstein, Ph.D., is co-founder and Chairman of Brain Scientific. He is a seasoned executive with a proven talent for aligning global business strategies with established and emerging management teams. Goldstein’s growth-focused leadership style has helped him raise over $750 million in venture capital for the development of innovative companies and startups in diverse industries, including financial services, biomedicine, alternate energy and new materials, as well as groundbreaking work in artificial intelligence. His recent achievements include important advancements in neurology and unlocking the potential of AI correlations and machine learning applied to life sciences and medical research. He built a suite of first-to-market companies as a technology-oriented leader, including Ryah Medtech, Brain Scientific, GrapheneCA, E-Forex and Intelligent Video Systems. He also co-founded BrainRX, a company specializing in pre-Alzheimer’s diagnostics.

Dr. Nikolay Kukekov, Ph.D., is a Director of Brain Scientific and a partner at HRA Capital. Before joining HRA Capital, Kukekov was Managing Director of Healthcare Investment Banking at Summer Street Research. His scientific background includes a bachelor’s degree in Molecular, Cellular and Developmental Biology from the University of Colorado at Boulder. He earned his Ph.D. in neuroscience from Columbia University – College of Physicians and Surgeons in New York.

Stuart Bernstein is the company’s Vice President of Marketing. He was recently named to the role after spending the first part of his professional career in senior technical management roles with Fortune 500 companies such as NCR (NYSE: NCR), IBM (NYSE: IBM) and Control Data Corp. He was the CEO of BioSignal, an EEG medical device company. He is also a co-founder of several software engineering and telemedicine firms. One of them, Brain Saving Technology, is now Specialist on Call (SOC Telemed) – a leading telemedicine company that powers over 850 facilities for teleneurology, telepsychiatry and critical care telemedicine with over 200 physicians.

Brain Scientific Inc. (OTCQB: BRSF), closed Tuesday’s trading session at $0.87, off by 3.3333%, on 11,000 volume. The average volume for the last 3 months is 3,635 and the stock's 52-week low/high is $0.100000001/$3.00999999.

Recent News

• BioMedNewsBreaks - Brain Scientific Inc. (BRSF) CEO Talks Benefits of Disposable Brain Diagnostic Tools
• BioMedNewsBreaks - Brain Scientific Inc. (BRSF) Announces NeuroCap for Children, Enters Pediatric Market
• Scientists Compare, Contrast Different Masks' Protective Abilities

Josemaria Resources Inc. (TSX: JOSE) (OTC: JOSMF)

The QualityStocks Daily Newsletter would like to spotlight Josemaria Resources Inc. (TSX: JOSE) (OTC: JOSMF).

Josemaria Resources Inc. (OTCQB: JOSMF) (TSX: JOSE) was featured today in a publication from MiningNewsWire, examining how Fieldfisher, a European company with market-leading practices in many sectors globally, recently released its third-edition mining guide for alternative financing. The report looks into the finance landscape in mining, based on the experience of the metals and mining team working with lenders and borrowers in times that are changing rapidly for early-stage and junior-exploration mining firms.

Josemaria Resources Inc. (TSX: JOSE) (OTC: JOSMF) is a Canadian natural resources company based in Vancouver, British Columbia. The company’s current focus is on advancing the development of its wholly owned Josemaria copper-gold mining project.

Josemaria Resources is part of The Lundin Group of companies, a conglomerate of 13 business entities operating in the mining, oil and gas and renewables sectors all around the world.

The Josemaria Copper-Gold Project

The company’s flagship Josemaria Copper-Gold Project is located in the San Juan Province of Argentina – a well-known mining hub supporting a wide variety of mining service companies. The Lundin Group has been active in Argentina for approximately 30 years. Committed to advancing the project, Josemaria Resources has already begun the bridging phase, with basic and detailed engineering planning expected to commence in early 2021.

The company recently announced the results of a feasibility study at the Josemaria Project. The study, prepared by a team of engineering and consulting providers including Fluor Canada Ltd., SRK Consulting (Canada) Inc. and Knight Piésold Ltd., highlights a robust, low-risk project with rapid payback expected via an open pit operation with forecast capacity to feed a conventional process plant at a rate of 152,000 tonnes a day over a 19-year mine life.

According to the feasibility study, the project is expected to yield an average annual production of 136,000 tonnes of copper, 231,000 ounces of gold and 1,164,000 ounces of silver. Other highlights of the study include:

• The optimized mining production plan provides average grades in the first three years of production that are notably better than the life-of-mine average. This supports a forecast 3.8-year payback period from the start of production.
• The project’s total initial cost, including engineering, procurement, construction, management, on- and off-site infrastructure, contingency and pre-construction engineering work, amounts to roughly $3.09 billion.
• The location provides readily available access to essential resources, including water, grid power, transportation and logistics infrastructure within San Juan Province.
• An Environmental and Social Impact Assessment (ESIA) of the project is already underway and is expected to be submitted to relevant authority agencies for review during Q1 2021.

The Josemaria Copper-Gold Project has been designed to incorporate the latest technology. Per the feasibility study, the project will include the use of autonomous trucks and production drill fleets, with the option of incorporating green energy, indicating the company’s commitment to minimizing and mitigating the adverse effects of mining on the environment.

To this end, the company intends to leverage suitable planning, impact assessment and monitoring tools while also incorporating water and energy efficiency systems and ecosystem conservation services in the design and implementation of its operations.

Josemaria Resources President and CEO Adam Lundin welcomed the results of the study as confirming that this is one of the very few readily developable copper-gold projects in the world and forecasting an attractive economic outcome for the asset, comparable with other copper-gold projects in development.

“We believe that Josemaria is perfectly positioned to commence production by mid-decade, meeting rising copper demand from a rapidly electrifying global economy. I believe the study results will allow us to unlock various financing opportunities as we move toward construction,” Lundin said in a news release.

Market Outlook

The global smart mining market was estimated at $6.8 billion in 2019. It is forecast to reach $20.31 billion by 2025. The significant increase is expected to be driven by technological advancements within the sector.

Global demand for copper is also growing steadily, due to the metal’s versatility and multiple uses for industrial, domestic and high-technology indications. The global copper market is expected to reach $222.1 billion by the end of 2026.

Management Team

Adam Lundin is the President, CEO and Director of Josemaria Resources. He has several years of experience in managing capital markets and public companies across the natural resources sector. His background includes oil, gas, mining technology, investment advising, international finances and executive management. Lundin began his career working for several of the Lundin Group mining companies. He is currently engaged in multiple roles, as he is also the Chairman for Filo Mining Corp. and Africa Energy Corp. and a Director of NGEx Minerals Ltd. and the Lundin Foundation.

Ian Gibbs serves as CFO of Josemaria Resources. He is a Canadian Chartered Accountant and a graduate of the University of Calgary, holding a Bachelor of Commerce degree. Gibbs has held many prominent positions within the Lundin Group of companies over the last 15 years, most recently as the CFO of Africa Oil Corp.

Arndt Brettschneider is the company’s Vice President of Projects. He has over 23 years of international mining, consulting and project development experience. Before joining Josemaria Resources, he was Vice President of the mining consulting businesses of two globally recognized engineering companies. Brettschneider obtained a Bachelor of Science with Honors from the University of Queensland in Brisbane, Australia. He received his MBA from Queen’s University in Ontario, Canada.

Bob Carmichael is the company’s Vice President of Exploration. He joined Josemaria Resources from Lundin Mining Corporation’s UK office. In his UK role, he was the General Manager of Resource Exploration. Carmichael is a registered Professional Engineer in the Canadian province of British Columbia. He obtained a Bachelor of Applied Science from the University of British Columbia. His dual role includes serving as Vice President of Exploration for Filo Mining Corp. and NGEx Minerals Ltd.

Alfredo Vitaller is Josemaria Resources’ General Manager in Argentina. He has been involved in the mining industry since 1993. He graduated as a Licentiate in Geological Sciences from Buenos Aires University and has an M.Sc. from Mackay School of Mines at the University of Reno. Vitaller has worked with the Lundin Group since 1993 and was a part of the exploration teams for Filo, Helados and Josemaria.

Notable Directors

Ashley Heppenstall, chairman of the Josemaria Resources board of directors, has over 30 years of experience in the oil and gas and resources sectors. From 2002 to 2015, Heppenstall served as the President, CEO and Finance Director of Lundin Petroleum AB, an oil and gas exploration and production company with core assets in Norway and Southeast Asia. He is credited with building Lundin Petroleum into the largest independent oil firm in the world today, leveraging a single equity raise of $50 million to guide Lundin in the design and implementation of a strategy that’s led it to a current market cap of roughly $6 billion.

Ron Hochstein has worked for the Lundin family directly as a consultant for over 20 years and is currently the President and CEO of Lundin Gold, a gold-producing business whose key asset is the Fruta del Norte gold deposit in Ecuador. Hochstein led construction efforts on the first mine in Ecuador, which went into production in 2019 and was completed on time and on budget.

Paul Conibear has been with The Lundin Group for over two decades, including serving as the CEO and Director of Lundin Mining from 2011 through 2018. Lundin Mining’s current market cap is estimated at $3.5 billion. In total, Conibear has more than 35 years of experience in progressively more responsible positions in the resource sector ranging through management of all phases of mine investment, including exploration, economic assessments, construction, operations and closure.

Josemaria Resources Inc. (TSX: JOSE), closed Tuesday’s trading session at $0.74, off by 1.33%, on 170,678 volume. The average volume for the last 3 months is 170,678 and the stock's 52-week low/high is $0.465299993/$0.685000002.

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Pure Extracts Technologies Corp. (CSE: PULL)

The QualityStocks Daily Newsletter would like to spotlight Pure Extracts Technologies Corp. (CSE: PULL).

Pure Extracts Technologies Corp. (CSE: PULL) was featured today in a publication from PsychedelicNewsWire, examining how the announcement of the coronavirus vaccines from Pfizer, Moderna and Oxford is a hopeful sign for many. Nonetheless, there’s still a lot that we do not know about the coronavirus infection. However, researchers continue to work diligently to learn more about the SARS-CoV-2 virus, which causes the infection. Also today, the company was featured in the 420 with CNW by CannabisNewsWire. Cannabis has been having a great year compared to other industries. As one of the few industries considered essential during the coronavirus pandemic, cannabis has shown to be surprisingly recession-proof, bringing in millions of dollars in much-needed tax revenue. In addition, voters in five states approved some form of cannabis reform legislation on the November ballot, and shortly after that, the House of Representatives passed a historic cannabis legalization bill that would decriminalize marijuana at the federal level and expunge marijuana-related offenses.

Pure Extracts Technologies Corp. (CSE: PULL), headquartered in Pemberton, British Columbia, is a plant-based extraction company with a new vertical in functional mushrooms. The firm is positioned to be the dominant extraction company and a leader in the rapid development and commercialization of functional and medicinal psychedelic products.

The Company’s business model consists of three verticals: in-house brands; toll processing, offering contract cannabis and hemp processing to Canadian Licensed Producers and international partners to sell under their own brands; and white labelling, supplying products, including edibles and custom formulated oils, in consumer-ready packaging for companies licensed to sell cannabis oil extracts and for CPG brands seeking licensed cannabis manufacturing partners.

Market Position

The psychedelic and functional mushroom industries are among the fastest growing in North America. As the industry transitions from dry biomass to extracts, many companies are unprepared for this new opportunity. The global medicinal mushroom market is expected to grow by $13.88 billion annually by 2024.

When assessing investment strategy, market analysts suggest that psychedelics are more comparable to biotech than to cannabis. Unlike traditional biotech, however, psychedelics can claim years of human consumption. Because their efficacy and safety are already well understood, the hurdles for development are likely to be lower. As known molecules, psychedelics won’t spend as much time in discovery and pre-clinical development.

Current research is finding psychedelic benefits including anti-tumor, anti-viral, detoxification, immune function, and mental wellness. As such, psychedelic compounds are now being examined by leading medical research and academic institutions for treatment of depression, PTSD, anxiety, bi-polar disorder, obesity, narcolepsy, OCD, Alzheimer’s, ADHD and drug and alcohol dependence. In 2020, the FDA granted breakthrough therapy status to psychedelics for treatment-resistant depression, with approvals anticipated in 2021.

Pure Extracts is well positioned to partner with organizations planning to develop both functional and psychedelic products. A dealer’s license with Health Canada will enable buying, selling and producing of psychedelics in an EU-GMP-compliant environment. The Company’s 10,000 square foot facility is designed for EU-GMP certification, which allows for international sales. The Company has signed NDAs to explore joint development endeavors for Q4 2020 product launches, as well as an advisory agreement with Dr. Alexander MacGregor, founder of Transpharm Canada Inc. (“TCI”), the parent company of Toronto Institute of Pharmaceutical Technology, whose facility is a fully compliant Health Canada licensed Good Manufacturing Practice (“GMP”) manufacturing and testing facility and is a full-service clinical development business that provides clinical trial services to biotechnology companies.

Research on Psychedelics

Naturally occurring psychedelics, like psilocybin mushrooms, peyote and ayahuasca, have been used by humans for centuries. First seen as potentially medicinal in 1938 by a chemist at Sandoz Pharmaceuticals (now Novartis), the desired stimulant effect was unsuccessful and therefore the drug was shelved. Twenty years later, in 1958, Sandoz began selling lysergic acid diethylamide (LSD) to treat mental disorders. From 1950 to 1965, over a thousand scientific papers on these compounds were published. During the 1960s, however, psychedelics made their way out of the lab and onto the street. The war on drugs followed, and psychedelic research essentially ended.

Research continued slowly on the fringes. The Multidisciplinary Association for Psychedelic Studies was formed in 1986 with the goal of becoming a leading non-profit psychedelic pharmaceutical company. Still being researched, psychedelics’ primary and most common mechanism of action is agonism of serotonin receptors in the brain, which promotes serotonin production in order to regulate mood.

Growing societal awareness and acceptance of mental illness as a legitimate disease due, in part, to its increasingly prevalence have been a catalyst for a new search for innovative treatments. As such, interest in psychedelic medicines has been revived in recent years.

Extract Segment Leader with Cannabis

Canada’s cannabis industry is dominated by dried flower products. Extract products are estimated to represent only 13% of the market share. With no dominant brands in the cannabis sector, Pure Extracts is the development leader in this segment, which is estimated by Deloitte to be worth $2.7 billion annually. Pure Pulls, the company’s private label brand, is nationally recognized through compliant event sponsorship and ongoing product engagement.

Management Team

Pure Extracts is led by a team of dedicated professionals leveraging extensive industry knowledge.

Ben Nikolaevsky, the company’s CEO, has more than a decade of experience in corporate leadership roles across the natural products, agriculture and cannabis sectors. Nikolaevsky has served as CEO at Natura Naturals Inc. and Blue Goose Capital Corp., as well as market vice president at CIBC and chief credit officer & capital markets manager at IBM Global Financing Canada.

Doug Benville founded Pure Extracts and serves as the company’s COO. He is highly proficient in cannabis cultivation, system operations and oil extraction.

Alexander Logie, Pure Extracts’ vice president of business development, has over 30 years of experience in the financial services sector, having most recently served as interim CFO, COO and senior vice president of business development at Natura Naturals Inc., a licensed cannabis producer acquired at the start of 2019.

Andy Gauvin is vice president of sales for Pure Extracts. Gauvin is an accomplished senior sales leader with over 30 years of experience in the cannabis space. Gauvin also brings extensive knowledge of the complex federal and provincial regulatory environment to the Pure Extracts team.

Pure Extracts Technologies Corp. (CSE: PULL), closed Tuesday’s trading session at $0.60, 3.23%. The average volume for the last 3 months is 427,856 and the stock's 52-week low/high is $0.47/$0.89.

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