ev Transportation Services Inc.

The QualityStocks Daily Newsletter would like to spotlight ev Transportation Services Inc.

ev Transportation Services (“evTS”) is a designer, developer and manufacturer of all-electric lightweight commercial vehicles and fleet management solutions. The company is focused on the essential transportation services market. End-user applications for evTS vehicles include security, parking enforcement, local small package delivery, meter reading, sanitation, parks and recreation, university and corporate campuses, and warehouse operations services. To view the full article, visit https://ibn.fm/sIyCV

ev Transportation Services Inc. (“evTS”) is a designer, developer and manufacturer of all-electric lightweight commercial vehicles and fleet management solutions.

Founded in 2015 in Brookline, Massachusetts, and currently based in Boston, the company is focused on the essential transportation services market. End-user applications for evTS vehicles include services such as security, parking enforcement, local small package delivery, meter reading, sanitation, parks and recreation, university and corporate campuses, and warehouse operations.

The FireFly ESV(R)

The company’s flagship product is the FireFly ESV(R), a high-performance, low-maintenance electric vehicle with zero emissions. This utility vehicle was created specifically to meet the needs of essential services users. The FireFly ESV utilizes the safest Lithium Ion battery technology available (LiFePO4, Lithium Iron Phosphate) for superior acceleration, improved energy efficiency and enhanced reliability. As a result, it boasts a range of 100+ miles on a single charge, further than any other electric vehicle in its class.

Additionally, its design can be modified according to the requirements of virtually any task and application, from parking enforcement and security to property and grounds maintenance, last mile urban delivery, on-campus tasks and more.

Parking Enforcement

The ideal parking specific vehicle (PSV), FireFly can be equipped with features that enable parking enforcement officers to do their jobs more effectively, significantly reducing operating costs while fully integrating with existing parking enforcement systems, including advanced license plate recognition programs. Key design features of the FireFly ESV that are critical for the successful execution of parking control tasks include:

• High maneuverability with a tight turning radius and slim design, allowing the vehicle to maneuver on narrow streets and park in compact urban environments;
• Electronically governed speeds of up to 50 mph in just seconds, allowing operators to quickly enter and keep up with fast moving traffic;
• Full-height DuraGlide(TM) doors and low steps allowing for rapid ingress and egress on both sides of the vehicle;
• Superior impact protection featuring an integrated safety cage and seatbelts;
• A modular bed design allowing users to include a lockable or sectional bed to make room for boots, parking cones and other equipment; and
• Friendly size and appearance, helping change the public’s perception of parking enforcement efforts.

Security

Specifically designed for flexible and quiet operation at low speeds, the FireFly ESV is an ideal vehicle for security and perimeter patrol tasks in different environments, including cities, office buildings, retail malls, prisons and educational institutions. With a range of 100+ miles, it allows security officers to patrol for the duration of an entire shift before returning to dispatch to recharge, thus generating savings compared to fuel-powered patrol vehicles. Key features that give the FireFly ESV a significant edge over its competition in security applications include:

• Agility and speed, allowing officers to provide rapid response and engage in light pursuit at speeds exceeding 50 mph;
• Comfort and security for the driver with the help of its tubular 2” steel roll cage and three-point safety harness;
• High maneuverability with a 20-plus-degree approach angle and 6” of curb clearance, along with a tight turning radius; and
• Low energy, high intensity lighting features for traffic control while idle for several hours.

Property and Grounds Maintenance

As a durable, customizable vehicle with minimal environmental impact, the FireFly ESV can be used for a wide range of maintenance operations on sidewalks and in recreation areas on a daily basis. Key features include:

• A customizable modular design allowing the vehicle to be built according to use specific maintenance requirements, with features such as a sectional bed, an electronic lift dump, a refuse hauler, a van box, a utility bed with locking compartments and ladder racks, and other cleaning, sweeping or watering accessories;
• A strong tubular steel frame and robust suspension design including the company’s proprietary DuraSteer(TM) front end featuring best-in-class anti-dive control and 1,100 pounds of payload capacity; and
• A light, three-wheel design offering a tight turning radius and a small footprint, allowing FireFly to maneuver in landscaped areas, navigate around pylons and bollards, and operate in narrow corridors, indoors or out.

Last Mile Urban Delivery

Designed for short-range trips with stop-and-go driving, the 100% Electric FireFly ESV is ideal for delivery services in crowded urban environments, being able to accommodate anything from small packages and food delivery to spare parts, medical deliveries and more. Key features that make the vehicle a top choice for delivery services include:

• More cargo space and hauling power than its competitors, due to its modular bed design and 1,100-pound payload capacity;
• Speed and efficiency, as a fully licensable and street legal vehicle that can reach governed speeds of up to 50 mph;
• Durability and maneuverability, making it a valuable addition to any delivery service’s vehicle fleet; and
• Exceptionally low cost of operation, as a virtually maintenance-free vehicle with long-lasting battery power.

The Firefly ESV 2021 Model

On September 15, 2020, the company announced the new 2021 model of its Firefly ESV vehicle. This model will retain all of its predecessor’s original components, with added features for the new 2021 line. The upgrades and new features include, but are not limited to:

• Larger door for easier vehicle access;
• More legroom within the cab;
• Improved visibility through the redesigned windshield;
• New rear bed accessory attachment options to better accommodate specific service industries; and
• An optional trailer hitch with electronic braking control.

Each vehicle will also be equipped with the evTS Connected Vehicle System, which includes in-vehicle Wi-Fi, an internet-accessible vehicle management system, the ability to perform remote diagnostics, low battery alerts and optional 360-degree video monitoring that runs in real-time.

In a news release, David Solomont, CEO of evTS, stated, “The 2021 FireFly is our best and most advanced model yet and will enable evTS to fill the critical and rapidly expanding need for essential service vehicles, particularly for last-mile on-demand urban delivery vehicles.”

Deal with ADOMANI

In April 2020, ADOMANI Inc. (OTCQB: ADOM) signed a letter of intent to purchase 120 FireFly ESV vehicles from evTS. Under the agreement, ADOMANI, a leading provider of zero-emission purpose-built electric vehicles and drivetrain solutions, serves as a distributor of current and future evTS electric vehicle offerings in the state of California.

In addition, ADOMANI may perform final assembly and testing activities of evTS vehicles, as well as warranty repair services, at its recently-opened assembly factory in Corona, California – a location that’s close to urban centers and a variety of terrains where the FireFly ESV can be utilized, according to ADOMANI COO Rick Eckert.

“The agreement with ADOMANI represents a major milestone for evTS, and we are excited to explore a partnership with them,” Solomont added. “Our FireFly ESV all-electric lightweight commercial utility vehicle is a perfect complement to their existing lineup of EVs, and we expect to significantly expand our sales in California and surrounding states based on the quality and reach of ADOMANI’s sales, service and support organization.”

Electric Vehicle Market

In 2019, the global electric vehicle market was valued at $162.34 billion. Registering a CAGR of 22.6%, the market is projected to reach $802.81 billion by 2027, according to an Allied Market Research report (https://nnw.fm/JAMbl).

Essential services fleet vehicles represent a replacement market of approximately 100,000 vehicles. These vehicles roughly translate to a $2.5-billion market opportunity each year.

Management Team

David Solomont is the Founder and CEO of evTS. He has over 40 years of experience in information technology, software and interactive media. He is an active investor and advisor to early-stage tech companies. Solomont has a bachelor’s degree in engineering from Tufts University and a master’s degree in management from MIT’s Sloan School.

Greg Horne is the Chief Technology Officer at evTS. He directs the company’s vehicle development efforts and is responsible for the new model year of the FireFly ESV being brought to market. He previously served as CTO of eFleets Corporation, worked on software and flight testing for the Bell/Boeing V-22 Osprey and served as a design engineer at Bell Helicopter.

Jim Sabitus is the company’s Vice President of Operations. He has experience as a corporate executive leading emerging and established publicly traded companies. Sabitus’ previous roles include CEO of Row One Brands Inc., CFO of Modern Shoe Company and various management roles at Converse Inc.

Paul Barrett is evTS’ Vice President of Marketing and Product. He is an experienced senior executive and serial entrepreneur with 45 years of experience in the automotive and electronics industries. His prior roles include serving as COO of Fixed Ops Pros, NavResearch and Cimble Corporation. Barrett also held numerous executive positions during his 20+ years at LoJack Corporation.

Eric Burmeister is the company’s Vice President of Sales and Business Development. He has held a number of positions within the specialized vehicle industry. Prior to joining evTS, he was the Director of National Sales and Business Development for Westward Industries. Burmeister also held national and regional sales positions for eFleets, Global Electric Motors and ZENN Motor Company.

Michael Tepfer is the company’s Vice President of Manufacturing Engineering. He is also the current president of Integrity Global Manufacturing Ltd. He has 30 years of experience in project management and oversight of overseas manufacturing businesses.

Todd Marcucci is evTS’ Director of Customer Satisfaction. He is a former Vice President of Research and Development for eFleets. He assembled and led a team that designed, supported and produced the original FireFly ESV. Marcucci has worked as a consultant for numerous projects related to electric vehicle powertrains.

Recent News

• QualityStocksNewsBreaks – Why ev Transportation Services Inc. Is ‘One to Watch’
• ev Transportation Services Inc. Is ‘One to Watch’
• ev Transportation Services Announces New Senior Management Team

Gage Cannabis Co.

The QualityStocks Daily Newsletter would like to spotlight Gage Cannabis Co..

On December 4, 2018, Michigan officially became the 10th state in the United States to legalize marijuana for adult recreational use. Since then, Gage Cannabis a leading vertically integrated operator in the cannabis industry led by former CEO and Chairman of Canopy Growth Corp. Bruce Linton, has sought to focus on the Michigan market, with the stated ambition of building the fastest-growing cannabis brand in the state.

Gage Cannabis Co. is a leading vertically integrated operator in the cannabis industry led by the former CEO and Chairman of Canopy Growth Corp. (TSX: WEED) (NYSE: CGC), Bruce Linton. The company is currently focused exclusively on the Michigan market, working with the declared goal of building the fastest growing cannabis brand in the state.

One of the reasons Gage targeted Michigan as its location of choice is due to the state’s fast-growing legal cannabis market and consumption habits amongst consumers. In 2018, Michigan became the 10th state to legalize the recreational use of cannabis. In light of such favorable market dynamics, Gage opened its first medical provisioning center (dispensary) shortly after, in 2019. The company now has 13 medical or adult-use locations open or in the works, with an additional 10+ planned to open during 2021. Gage’s current portfolio features 19 Class C cultivation licenses across four cultivation assets and three processing licenses.

Current Asset and Brand Portfolio

Gage’s current brand portfolio consists of five unique product classes: flower products, edibles, hardware, concentrates and vape pens/disposables.

The company has already created relationships with a wealth of exclusive brand partners, including some of the most illustrious brands in the country. Notably, Gage’s exclusive partnership with Cookies, one of the most well-respected cannabis lifestyle brands in the United States, illustrates Gage’s operational prowess in cultivating quality flower and operating its branded retail stores. Today, Gage operates the 8 Mile Cookies location in Detroit, Michigan, which is one of the top performing dispensaries in the state despite being a medical-only dispensary.

Committed to providing only products of the highest quality, Gage uses small-batch, indoor-grown, high-quality cannabis that is hand-trimmed and hung to dry. Gage ensures that every gram of cannabis sold is consistently of the highest quality and offers a superb customer experience.

The company currently has four cultivation assets, located at Monitor Township (expansion planned), Harrison Township, Warren and Lenox Township, and it operates one processing facility located in Harrison Township, with plans to operate another two processing facilities in Monitor Township and Lenox.

Its operating dispensaries include Ferndale (adult-use), Adrian (adult-use), Lansing (adult-use), Traverse City (medical) and Detroit (Cookies establishment – medical). Additional dispensaries coming soon include Battle Creek (adult-use), Kalamazoo #1 (adult-use), Bay City (adult-use), Grand Rapids (medical), Buena Vista (medical), Center Line (medical), Kalamazoo #2 (Cookies establishment – adult-use) and Lenox Township.

The company offers delivery within a one-hour radius of its dispensaries – a footprint that encompasses an estimated 90% of Michigan’s population.

Financial Highlights

In Q1 2020, the company recorded sales of $5.8 million. This number grew substantially in Q2, reaching $11.9 million. Management estimates Q3 sales at roughly $13.1 million, marking a 157% growth in sales from January to September 2020, within a year of operations.

This increase reflects the company’s significant expansion efforts since the beginning of 2020. Starting with only 200 pounds per month, Gage now estimates its monthly cultivation capacity at more than 1,000 pounds of product.

This increase in cultivation capacity has helped Gage promote rapid growth through its retail locations. Average basket size, which refers to the retail value of each consumer transaction, is estimated at $85 for the Michigan cannabis industry. As of August 2020, Gage has an average basket size of $180 at its locations, more than double the state average.

Michigan Medical and Adult-Use Marijuana Market Size

The recreational marijuana market in Michigan is expected to rival the numbers currently seen in Nevada and Colorado by 2023. Approximately 3% of Michigan’s residents are medical marijuana cardholders – a much higher rate than many other medical markets – leading Brightfield to predict that the state’s recreational market could triple in size between 2020 and 2023 (https://ibn.fm/9cO0h).

Michigan saw a steady increase in sales for the first three quarters of 2020, with a recorded growth rate of 502% from January to August. In August alone, $109 million in cannabis sales occurred within the state. The Marijuana Regulatory Agency estimates that the potential market size for cannabis within the state is around $3 billion.

Neither Gage nor the state has seen any significant drop in sales in the wake of the COVID-19 pandemic. On the contrary, demand has continued to grow steadily, as dispensaries were among the few businesses deemed essential and permitted to operate throughout the shutdown. All Gage and Cookies locations have remained operational, offering curbside pickup.

Plans to Go Public in Q1 2021

Gage Cannabis is currently planning a Canadian listing for the first quarter of 2021 (https://ibn.fm/V73dL). Additionally, Gage intends to launch a Regulation A+ offering of up to 28,571,400 subordinate voting shares priced at $1.75 per share, for gross proceeds of up to $50 million before offering expenses, assuming all shares are sold (https://ibn.fm/FteTi), but it has not yet made an announcement regarding the launch of that financing.

A Regulation A+ offering, also called a mini-IPO, allows companies to raise capital without actually listing shares on a stock exchange.

Management Team

Bruce Linton is the Executive Chairman of Gage Cannabis. He joined the company in 2019 and is the founder and former CEO and Chairman of Canopy Growth Corp. (TSX: WEED) (NYSE: CGC). Mr. Linton has extensive executive and board experience in a variety of industries and is considered to be a pioneer in the global cannabis industry. He provides incomparable support to the company’s strategic and capital markets efforts.

Michael Hermiz is the Co-Founder and Director of Gage Cannabis, and he is also the founder of a federally licensed producer in Canada. Mr. Hermiz has had great success in various industries, including real estate, mortgage, telecommunications, import, export and many others.

Fabian Monaco is Gage’s President and Director. He previously worked at XIB Financial Inc., GMP Securities L.P. and Scotiabank. In addition to his vast investment banking and legal background, Mr. Monaco has 10+ years of capital markets experience. His advisory experience in the cannabis industry is also extensive.

Dr. Rana Harb is a Director of Gage Cannabis. She has 25+ years of experience handling research, compliance, quality assurance and regulatory affairs. A significant portion of her regulatory and compliance history is in the cannabis industry. Dr. Harb has worked for many pharmaceutical companies worldwide, dealing with regulatory agencies such as the FDA, the EMA and Health Canada.

Mike Finos is the President (USA) and a Director of Gage Cannabis. He is the former COO of Horizon Global, the world’s number one towing accessories company. He has experience with start-ups, M&A and business integration with both private and publicly traded companies. With 20+ years of operational leadership expertise, Mr. Finos has extensive knowledge relating to supply chain logistics, manufacturing and information technology.

David Watza is the Chief Financial Officer of Gage Cannabis. He is an experienced C-Suite executive and former CFO and board member of Perceptron Inc. (NASDAQ: PRCP). Mr. Watza has 30+ years of experience in finance, accounting, and operations, including time as a public company CFO.

Recent News

• Gage Cannabis Prepares to Capitalize on Stunning Growth Within Michigan’s Cannabis Industry
• Gage Cannabis Co.’s Lansing Location Now Offering Recreational Marijuana
• Fast-Growing Michigan Market Next in Line for Gage Cannabis Co., IPO Planned for 2021

Rritual Mushrooms Inc.

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

Rritual announced that it has received the United States Department of Agriculture (“USDA”) Organic Certification. Awarded only after a demanding vetting process, the seal confirms the high quality of Rritual’s product lineup and manufacturing process. Rritual launched its original product lineup in September, which features products formulated with mindfully selected functional mushrooms and adaptogenic herbs. To view the full press release, visit https://ibn.fm/Ai1ED

Rritual Mushrooms 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

• Rritual Receives USDA Organic Certification, Official Confirmation of Product Quality
• Rritual Mushrooms, Inc. Is Increasing Awareness of Medicinal Mushrooms and Adaptogenic Herbs
• Rritual Mushrooms Inc. Recognized at ECRM’s Whole Body & Mind Wellness Program

DarioHealth Corp. (NASDAQ: DRIO)

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

DarioHealth Corp. (NASDAQ: DRIO) was featured today in a publication from BioMedWire, examining how, in a novel study that was published in “Cell Metabolism,” researchers have discovered two pathways that may connect more than 100 types of cancer. For a long time, scientists believed that all cancers were controlled by the same set of basic processes. The researchers, who are from the University of Pennsylvania Perelman School of Medicine, may have identified a combined process that could be used to develop new therapies that would prevent cells from mutating into any type of tumor, whether it is colon, prostate or breast tumor. Also today, the company was featured in a BioMedNewsBreaks from BioMedWire, examining how DRIO has released its financial results for Q3 2020. In addition, the company reported on important third-quarter highlights and provided an update on key objectives. Dario ended the third quarter with cash and cash equivalents of $37 million and plans to focus on its U.S. commercial sales and marketing infrastructure with the end goal of B2B2C pipeline growth. In addition, through its agreements with Vitality Group and HMC Healthworks, the company is committed to becoming a B2B2C digital therapeutics leader. 

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 Thursday's trading session at $11.61, up 6.3187%, on 196,030 volume with 1,959 trades. The average volume for the last 3 months is 109,075 and the stock's 52-week low/high is $3.01999998/$22.4899005.

Recent News

• Researchers Uncover Two Factors That Turn Cells Cancerous
• DarioHealth Corp. (NASDAQ: DRIO) Releases Financial Results for Third Quarter
• Preclinical Research Shows Mothers Can Pass Allergies to Kids

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 not many people think of scooters and motorcycles when the subject of electric vehicles (“EVs”) comes up, but these two-wheeled mobility tools have witnessed a transformation as manufacturers venture into the EV space. Yamaha (OTC: YAMHF) is one of those manufacturers that now offers electric motorcycles as well as electric scooters.

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 Thursday's trading session at $7.49, up 13.8298%, on 2,176,089 volume with 11,520 trades. The average volume for the last 3 months is 1,244,896 and the stock's 52-week low/high is $1.472/$20.0783996.

Recent News

• Motorcycle Manufacturers Unveils Low-Cost Electric Scooter for Urban Use
• Bentley Plans to Make Only Electric Vehicles by 2030
• How Energy Companies Can Support EV Popularization

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 central nervous system, has scheduled a webcast today during which it will be discussing its plan to submit a phase 2 clinical trial design for FDA review. To view the webcast, visit https://ibn.fm/dx6VN. To view the full press release, visit: https://ibn.fm/xUIus.

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 Thursday's trading session at $2.22, up 0.909091%, on 68,380 volume with 169 trades. The average volume for the last 3 months is 89,740 and the stock's 52-week low/high is $1.25820004/$5.68989992.

Recent News

• CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Hosting Webcast for Discussion of Phase 2 Clinical Trial Design
• Ethicist Suggests People Should Be Paid to Accept COVID-19 Vaccine
• CNS Pharmaceuticals Inc. (NASDAQ: CNSP) to Unveil Adaptive Design for Berubicin Phase 2 Clinical Trial in Nov. 12 Webinar

Sustainable Green Team Ltd. (SGTM)

The QualityStocks Daily Newsletter would like to spotlight Sustainable Green Team Ltd. (SGTM).

Sustainable Green Team (OTC: SGTM), a leading provider of environmentally beneficial solutions for tree and storm waste disposal, today announced that its wholly owned subsidiary Mulch Manufacturing Inc. has expanded its 2021 mulch contracts with Circle K convenient stores, a subsidiary of Alimentation Couche-Tard Inc. (OTC: ANCUF) (“ANCUF”). According to the update, the original contract finalized in October was increased to add an additional region to the initial three, bringing the total to four. SGTM obtained the mulch contract expansion shortly after reporting another successful quarter in which it generated approximately $24.5 million in revenue and $5.5 million in gross profit within the nine months ending Sept. 30, 2020. To view the full press release, visit https://ibn.fm/QrfTn

Sustainable Green Team Ltd. (OTC: SGTM), through its subsidiaries, including National Storm Recovery LLC (DBA Central Florida Arbor Care and Mulch Manufacturing Inc.), provides tree services, debris hauling, removal and bio-mass recycling, manufacturing, packaging and sales of next-generation mulch products. The company’s primary corporate objective is to provide a solution for the treatment and handling of tree debris that is historically sent to local landfills and disposal sites, creating an environmental burden and pressure on disposal sites around the nation.

Environmentally Friendly

SGTM and the solutions provided by its Sustainable Green Team are founded in sustainability. The company’s vertically integrated operations begin with the collection of tree debris through its tree services division and collection sites. Tree bio-mass is then moved through the processing division for recycling and manufacturing into a variety of organic, attractive, next-generation mulch products to be packaged and sold to retailers, landscapers, installers and garden centers.

The company’s solutions create a synergistic and environmentally beneficial solution to tree and storm waste disposal that historically has created an environmental burden on landfills and disposal sites around the nation.

SGTM’s customers include governmental, residential and commercial customers and now big box retailers. The company is headquartered in Florida.

Strategic Acquisition

SGTM in February 2020 acquired 35-year-old industry leader and innovator Mulch Manufacturing Inc., an Ohio corporation. Structured as a share exchange, this strategic partnership provides SGTM with a significantly larger footprint in the mulch industry.

The acquisition includes Mulch Manufacturing’s national and international distribution agreements, an increase in production and packaging capacity, and its sales contracts with numerous big box retailers. Mulch Manufacturing includes mulch production, sawmill operation, Natures Reflections colorant manufacturing and equipment manufacturing.

Next-Gen Products

SGTM’s vision and commitment to the environment is paired with Mulch Manufacturing’s revolutionary “next-generation” mulch product, Nature’s Reflection’s Softscape®.

Softscape mulch products, created from natural forest products, are color-enhanced with environmentally safe colorants to provide four-year color retention and are free from contaminants. Safe for people and pets, Softscape allows water and air to penetrate soil and roots, which is vital to plant health and growth.

Expansion Plans

SGTM plans to expand its operations through a combination of organic growth, through its partnership with a nationally recognized waste disposal company, and through strategic acquisitions that are both accretive to earnings and positioned for rapid growth from the resulting synergistic opportunities identified.

The company has received final zoning approval for its 100-acre site, located in Lake County, Astatula, Florida, which will serve as its flagship tree debris collection site. The facility will also house the company’s mulch manufacturing, soil composting and production bagging. This prime location includes a 5,000-square-foot building that contains warehouse and office space. The 100-acre property can accommodate millions of cubic yards of organic debris and will allow SGTM’s debris hauling division to realize significant savings on its transportation costs.

SGTM has chosen as its new headquarters the 100,000-square-foot Mulch Manufacturing building in Jacksonville, Florida. The facility comprises centralized operations of Mulch Manufacturing Inc. and National Storm Recovery LLC and has ample room to expand as needed.

Leadership

SGTM’s leadership team boasts more than 40 years of next-level experience with mulch manufacturing, treating and caring for trees. This team is guided by a roster of highly qualified professionals:

• Tony Raynor, Chief Executive Officer
• Edward Lee, Chief Operating Officer
• Ralph Spencer, Director of Business Development, Strategic Acquisitions
• Steve Ogden, ISA-Certified Arborist
• Rick Starcher, Master Chemist
• Peder K. Davisson, Esq., Corporate/Securities Counsel

Sustainable Green Team Ltd. (OTC: SGTM), closed Tuesday's trading session at $5.57, up 1.8282%, closed Thursday's trading session at $1.20, up 1.6949%, on 1,128 volume with 5 trades. The stock's 52-week low/high is $0.05/$2.4999001.

Recent News

• Sustainable Green Team Ltd. (SGTM) Announces Expansion of Mulch Contract with Circle K Convenient Stores
• Sustainable Green Team Ltd. (SGTM) Completes Audit, Moves One Step Closer to Uplisting
• Sustainable Green Team Ltd. (SGTM) Releases Financial Report; Notes More Than $5.9M in Revenue for Q3

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. (TSX: JOSE) (OTC Pink: JOSMF) was featured today in a publication from MiningNewsWire, examining how, for decades, many have talked about establishing a mine in Northern Ireland’s Curraghinalt townland. However, this has never been realized. Lack of progress on a mine in the area may be attributed to a group of locals from County Tyrone who have been protesting the establishment of a mine for more than three years. Additionally, the company announced that, effective today, its common shares have been approved for trading on the OTCQB Venture Market. Josemaria's U.S. listing will trade under the symbol “JOSMF,” while the company's primary Canadian listing will continue to trade on the TSX under the symbol “JOSE” and on the Nasdaq Stockholm also under the symbol “JOSE.” To view the full press release, visit http://ibn.fm/HDTp0

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. (OTC: JOSMF), closed Thursday's trading session at $0.54794, up 3.3069%, on 2,509 volume with 9 trades. The average volume for the last 3 months is 25,007 and the stock's 52-week low/high is $0.465299993/$0.685000002.

Recent News

• Why Mining Gold is a Lot Harder Now
• Resources Inc. (TSX: JOSE) (OTCQB: JOSMF) (OMX: JOSE) Announces New US Listing on the OTCQB Venture Market
• Why Josemaria Resources Inc. (TSX: JOSE) (OTC: JOSMF) Is 'One to Watch'

VistaGen Therapeutics Inc. (NASDAQ: VTGN)

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

VistaGen Therapeutics (NASDAQ: VTGN) CEO Shawn Singh spoke about VistaGen’s game-changing potential for the treatment of mental illness during a recent episode of InvestorBrandNetwork’s Stock2Me Podcast (https://ibn.fm/34My5). A clinical-stage biopharmaceutical company, VTGN has three drugs in its pipeline and is committed to developing and commercializing new generation medications that go beyond the standard of care for anxiety, depression and other central nervous system (“CNS”) disorders. Also today, the company was featured in a publication from BioMedWire, examining how VTGN today announced new in vitro electrophysiology data. According to the update, the data demonstrate that the mechanism of action of PH94B, the intranasal neuroactive steroid the company is preparing for Phase 3 development as a potential acute rapid-onset treatment of anxiety in adults with social anxiety disorder, does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines (“benzos”), which act as direct positive modulators of GABA-A receptors.

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 Thursday's trading session at $0.7026, up 3.6283%, on 854,804 volume with 1,293 trades. The average volume for the last 3 months is 1,034,707 and the stock's 52-week low/high is $0.294299989/$1.05999994.

Recent News

• VistaGen Therapeutics Inc. (NASDAQ: VTGN) CEO Discusses 'Game-Changing' Potential of Drug Pipeline Lineup in Stock2Me Podcast
• VistaGen Therapeutics (NASDAQ: VTGN) Reports Positive Preclinical Data on PH94B's Mechanism of Action
• VistaGen Therapeutics to Participate in the Guggenheim Healthcare Talks | Idea Forum | 2nd Annual Neuro/Immunology Day

Predictive Oncology (NASDAQ: POAI)

The QualityStocks Daily Newsletter would like to spotlight Predictive Oncology (POAI).

Predictive Oncology (NASDAQ: POAI) was featured today in a publication from BioMedWire, examining how a group of researchers from the University of Delaware have examined how suicide rates are influenced by various natural disasters. Natural disasters may include tornadoes, floods and hurricanes. and as climate change becomes more harmful, we are seeing these disasters occurring more frequently, each more serious than the last. In fact, the group measured 281 disasters over a 12-year period.

Predictive Oncology (POAI) is a knowledge-driven precision medicine company focused on applying data and artificial intelligence (AI) to personalized medicine and drug discovery. The company applies its smart tumor profiling and AI platform to extensive genomic and biomarker patient data sets to build predictive models of tumor drug response to improve clinical outcomes for the cancer patients of today and tomorrow. The company has several tools that support its mission of bringing precision medicine to the treatment of cancer.

Through its subsidiaries, Predictive Oncology’s portfolio of assets includes the following:

• A database of clinically validated historical and outcome data from patient tumors
• An in-house Clinical Laboratory Improvement Amendments (CLIA)-certified lab
• A “smart” patient-derived tumor profiling platform
• An in-house bioinformatics artificial intelligence (AI) platform
• A new computerized approach growing tumors in the lab to rapidly develop patient specific treatment options
• An FDA-approved fluid collection and disposal system

Using these resources, and in collaboration with key players in the pharmaceutical, diagnostic and biotech industries Predictive Oncology is working to determine the best pathways for more individualized and effective cancer treatment.

Subsidiaries

Predictive Oncology leverages the synergies of its three wholly owned subsidiaries to bring precision medicine to the diagnosis of cancer.

Helomics applies artificial intelligence to its rich data gathered from the company’s trove of more than 150,000 tumors to personalize cancer therapies for patients as well as drive the development of new targeted therapies in collaborations with pharmaceutical companies. This database, the largest of its kind in the world, is comprised of ovarian, head and neck, colon and pancreas tumors. Helomic’s CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy.

In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor™ patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary platform (D-CHIP) to provide a tailored solution to its clients’ specific needs.

TumorGenesis is developing a new, rapid approach to growing tumors in the laboratory without the use of rats or mice, allowing for the identification of biomarkers indicative of cancer. This methodology “fools” the tumor into thinking it is still in the body. As a result, the tumor reacts as it naturally would, thereby increasing the accuracy of the biomarker. Once the biomarkers are identified, they can be used in TumorGenesis’ Oncology Capture Technology Platforms which isolate and helps categorize an individual patient’s heterogeneous tumor samples to enable development of patient-specific treatment options.

Skyline Medical’s patented, FDA-cleared STREAMWAY® System is the first true, direct-to-drain fluid disposal system designed specifically for medical applications such as radiology, endoscopy, urology and cystoscopy procedures. The STREAMWAY system is changing the way healthcare facilities collect and dispose of potentially infectious waste fluid by connecting directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids.

The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. The STREAMWAY eliminates canisters, carts and evacuated bottles, which reduces overhead costs and minimizes environmental impact by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the United Sates.

Skyline has achieved sales in five of the seven continents through both direct sales and distributor partners.

Competitive Advantage

Precision medicine has become the holy grail of cancer therapeutics. Data driven predictive models of tumors and their responses are critical in both new drug development and individualized patient treatment. The race has begun to model various tumors, which takes 5 to 7 years of clinical evaluation to establish historical and outcome data.

Predictive Oncology enjoys significant competitive advantage. The company already has a vast historical collection of tumors and related data, plus the ability to obtain existing associated outcome data. While others wait for outcome data, Predictive Oncology is in a unique and powerful position, working to deliver the promise of precision medicine to reality. Predictive Oncology already has the clinical data, including how a tumor responded to certain drugs, an in-house bioinformatics AI platform, and only needs to do the tumor sequencing. The significance is underscored by the collaboration with UPMC Magee-Women’s Hospital, designed to reveal which mutations responded to which drug then develop powerful predictive models for future testing and treatment.

Leadership Team

Dr. Carl Schwartz was appointed to Skyline Medical’s board of directors in March 2015 and became interim president and CEO in May 2016. Dr. Schwartz became CEO of Plastics Research Corporation in 1988, leading the company to become the largest manufacturer of structural foam molding products in the U.S. with more than $60 million in revenues and 300 employees by the time he retired in 2001. He holds a bachelor’s degree and DDS degree from the University of Detroit.

CFO Bob Myers has over 30 years of experience in multiple industries focusing on medical device service and manufacturing. He has spent much of his career as a CFO and controller. Myers holds an MBA in Finance from Adelphi University and a BBA in public accounting from Hofstra University.

Gerald Vardzel, President of Helomics, has over 25 years of healthcare executive management experience developing and implementing commercialization strategies and models for technology launches. His Go-To-Market expertise includes equity financing, strategic planning, market intelligence, M&A, and new market development in both start-up and established settings including fortune 500 market leaders. He has developed innovative solutions for both CLIA and FDA regulatory paths defining the delivery chains from discovery to clinical acceptance. Mr. Vardzel also has significant experience designing and implementing sales and marketing programs tailored not only to expand market share, but to empirically assess client satisfaction, strengthen business processes, and maximize profitability. Mr. Vardzel was previously Vice President of Corporate Development and Strategic Initiatives at Global Specimen Solutions. Furthermore, as an executive affiliate to the healthcare industry, he routinely consults for several small-to-mid sized private equity firms advising on, in part, the feasibility of acquisition targets. Mr. Vardzel graduated from the University of Pittsburgh.

Dr. Mark Collins, Chief Information Officer of Helomics, has held multiple executive roles in a variety of discovery, informatics and bioinformatics functions within global pharma, and founded three startup software companies in the machine learning and drug discovery space. In 2001, Dr. Collins worked for Cellomics (now part of Thermo Fisher Scientific), where he played a pivotal role in establishing the High-Content Cell Analysis market, building and commercializing several key informatics and bioinformatics products. After leaving Thermo Fisher, Dr. Collins developed and commercialized informatics solutions for clinical and translational research, specifically in the specimen tracking, omics data management and NGS analysis space, through key roles at BioFortis, Global Specimens Solutions and Genedata. Dr. Collins received his undergraduate degree in Applied Science from the University of Wolverhampton, UK and his Ph.D. in Microbiology from the University of Surrey, UK.

Predictive Oncology (POAI), closed Thursday's trading session at $0.6889, up 1.2641%, on 121,656 volume with 402 trades. The average volume for the last 3 months is 1,111,440 and the stock's 52-week low/high is $0.629999995/$5.30000019.

Recent News

• Research Discovers That Suicide Rates Spike After Disasters Occur
• Predictive Oncology (NASDAQ: POAI) CEO Joins NNW Podcast to Discuss Company's Prospects; Provides Update on POAI Subsidiary
• Inadequate Nutrition May Be Making Your Child Shorter

Processa Pharmaceuticals Inc. (NASDAQ: PCSA)

The QualityStocks Daily Newsletter would like to spotlight Processa Pharmaceuticals Inc. (NASDAQ: PCSA).

Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) (“Processa” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of drug products that are intended to provide treatment for and improve the survival and/or quality of life for patients who have unmet medical needs or conditions or who have no alternative treatment, today reports financial results for the third quarter of 2020.

Processa Pharmaceuticals Inc. (NASDAQ: PCSA) aims to develop products where existing clinical evidence of efficacy already exists in unmet medical need conditions. In support of this goal, the company has assembled an unparalleled management team, board of directors and product development team featuring experts in developing drug products, from IND-enabling studies to NDA submission. In total, the team’s combined scientific, development and regulatory experience has resulted in more than 30 drug approvals by the U.S. Food and Drug Administration (FDA) and more than 100 meetings with the FDA while working on more than 50 drug development programs, including drug products targeted to orphan disease and unmet medical need conditions.

Headquartered in Hanover, Maryland, Processa has built a pipeline of drugs which already have some proof-of-concept clinical data supporting clinical use in their selected indications.

Development Pipeline

The Processa process focuses on the advancement of drugs that are ready for clinical development or have minimal pre-IND enabling studies to complete. More specifically, Processa:

1. Acquires drugs that already have some clinical data to support the targeted treatment – whether it be the drug itself, an analog of the drug or a drug with similar pharmacological targets;
2. Navigates through the FDA, collaborating with the reviewers to define a complete development program; and
3. Develops each drug over the course of 2-5 years, out-licensing the drug either just prior to pivotal study after Phase 2b or after the completion of the pivotal study.

Processa’s current development pipeline features multiple drug candidates, including PCS499 and PCS100. The company has also announced three additional licensing agreements since June 2020, further bolstering its clinical efforts. Each drug is briefly described below.

PCS6422

On August 27, 2020, Processa announced its entry into a contingent precedent exclusive licensing agreement with Elion Oncology Inc. to develop, manufacture and commercialize eniluracil (PCS6422) globally. PCS6422 is an oral drug to be administered with fluoropyrimidine cancer drugs (e.g., capecitabine, 5-FU) to decrease the breakdown of the cancer drug to inactive metabolites or metabolites that are known to cause unwanted side effects and to increase the anti-cancer related metabolites.

An IND for a Phase 1B study was cleared by the FDA in May 2020. The study will evaluate the safety and tolerability of several dose combinations of PCS6422 and capecitabine in advanced GI tumor patients. Processa intends to enroll the first patient in 1H2021, obtain interim results, and have a final report completed in 2H2022.

“Having worked on 5-FU and other cancer agents in the past, adding PCS6422 to our pipeline and expanding our involvement in oncology was an easy decision given the significant impact that PCS6422 may have on improving the efficacy and safety of capecitabine or other fluoropyrimidines,” CEO Dr. David Young said of the agreement.

PCS499

PCS499 as a potential treatment for necrobiosis lipoidica (“NL”) was first presented to the FDA in a pre-IND meeting in 2018. In 2019, it was the subject of an IND submission and a promising Phase 2 safety study. On March 30, 2020, Processa announced a successful meeting with the FDA regarding the design and execution of the next clinical study to evaluate the ability of PCS499 to completely close ulcers in patients with NL.

“We are pleased with the outcome of the FDA meeting and the feedback we received from the FDA. We believe that the results from our completed Phase 2 trial in NL patients, especially those with more severe ulcerated forms of NL, are encouraging and we appreciate the guidance provided by the FDA regarding our next clinical trial and the requirements to support our NDA submission,” Dr. David Young, CEO of Processa, stated in the news release.

NL is a chronic, disfiguring condition affecting the skin and tissue under the skin, typically on the lower extremities, with no currently FDA-approved treatments. More severe complications can occur, such as deep tissue infections and osteonecrosis, threatening the life of the limb. Approximately 22,500 – 55,500 people in the United States and more than 150,000 – 400,000 people worldwide are affected by the ulcerated form of NL.

YH12852

On August 20, 2020, Processa announced its entry into an agreement with Yuhan Corporation, a South Korean firm, to license YH12852, a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders. Under the terms of the agreement, Processa will acquire the rights to a portfolio of patents with an exclusive license to develop, manufacture and commercialize YH12852 globally, excluding South Korea.

YH12852 is a novel, potent and highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. Other 5-HT receptor agonists with less 5-HT4 selectivity have been shown to successfully treat GI mobility disorders such as chronic constipation, constipation-predominant irritable bowel syndrome, functional dyspepsia and gastroparesis. The less selective 5-HT4 agonists, such as cisapride, have been removed from the market because of the cardiovascular side effects associated with the drugs binding to other receptors, especially 5-HT receptors other than 5-HT4.

CEO Dr. David Young called the agreement “further evidence of Processa’s commitment to seek out novel treatments for unmet medical conditions.” Processa intends to meet with the FDA in early 2021 to further define the clinical development program. In 2021, Processa expects to initiate a Phase 2 trial in a functional GI motility-related disorder that that needs better therapeutic options, such as postoperative ileus and opioid-induced constipation.

ATT-11T

On June 1, 2020, Processa announced its entry into a licensing agreement with Aposense Ltd. for the patent rights and know-how to develop and commercialize ATT-11T, a next generation irinotecan cancer drug. In the release, CEO Dr. David Young noted that the licensing deal fit with Processa’s strategy to “continue to bring innovative products to patients with an unmet medical need condition.”

ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Aposense molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell, with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan, such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.

The ATT-11T licensing agreement is conditioned upon Processa’s closing of a satisfactory financing round and the listing of the company’s shares on the Nasdaq or NYSE, among other conditions.

PCS100

On September 3, 2020, Processa announced its entry into an exclusive worldwide license agreement with Akashi Therapeutics to develop and commercialization Akashi’s lead drug, HT-100. Rebranded PCS100, the candidate is an anti-fibrotic, anti-inflammatory drug demonstrated to have some clinical anti-fibrotic effect in children. Processa intends to develop PCS100 first in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis (FSGS), idiopathic pulmonary fibrosis (IPF) or Scleroderma, where there are still few therapeutic options.

Management Team

David Young, Pharm.D., Ph.D. is the CEO and founder of Processa. He has over 30 years of pharmaceutical research, drug development and corporate experience. Young has served in leadership roles with a number of pharmaceutical firms throughout his career, including serving as founder and CEO of Promet Therapeutics LLC since 2015 and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. At Questcor, he was responsible for working with the FDA on modernizing the Acthar Gel label and for obtaining FDA approval in infantile spasms. In total, Young has met with the FDA more than 100 times on more than 50 drug products and has been a key team member on more than 30 NDA/supplemental NDA approvals.

Sian Bigora, Pharm.D., is Processa’s Chief Development Officer and founder. She has over 20 years of pharmaceutical research, regulatory strategy and drug development experience, working closely with Young. Prior to joining Processa, Bigora served as Co-Founder, Director and Chief Development Officer at Promet Therapeutics LLC and as Vice President of Regulatory Affairs at Questcor Pharmaceuticals from 2009 to 2015, where she led efforts to modernize the Acthar Gel label and obtain FDA approval in infantile spasms – events which were of material importance to Questcor’s subsequent success.

Patrick Lin is Chief Business & Strategy Officer and founder of Processa. He has over 20 years of financing and investing experience in the biopharma sector. Prior to joining Processa, Lin served as Co-Founder and Chairman of Promet Therapeutics LLC. He is also founder and managing partner of Primarius Capital, a family office that manages public and private investments focused on small capitalization companies.

James Stanker has served as CFO of Processa since 2018. He has over 30 years of financial and executive leadership experience in the areas of accounting principles and audit standards, regulatory reporting, and fiscal management and strategy. He served in a financial leadership role as an audit partner at Grant Thornton from February 2000 until his retirement in August 2016, where he was responsible for managing audit quality in the Atlantic Coast market territory.

Wendy Guy is the Chief Administrative Officer and founder of Processa. She has more than two decades of experience in business operations, having worked closely with Young over the last 18 years in corporate management and operations, HR and finance. Prior to joining Processa, she was Co-Founder, Director and Chief Administrative Officer of Promet Therapeutics LLC and Senior Manager, Business Operation over the Maryland office for Questcor Pharmaceuticals.

Processa Pharmaceuticals Inc. (NASDAQ: PCSA), closed Thursday's trading session at $4.21, off by 0.941176%, on 28,053 volume with 130 trades. The average volume for the last 3 months is 29,467 and the stock's 52-week low/high is $3.40000009/$18.00.

Recent News

• Processa Pharmaceuticals Announces Third Quarter 2020 Results, Provides Corporate Update
• Researchers Discover New Cause of Chronic Inflammation in HIV Patients
• Engineers Develop Heated Face Mask to Kill COVID-19

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 current leading U.S. producer of uranium, the top U.S. producer of vanadium in 2019, and focused on the potential to begin producing a rare earth element (“REE”) concentrate at its White Mesa Mill, will be presenting at this year's virtual Fall Investor Summit. The event is slated to take place from Nov. 16-18 in a virtual format and feature 75 companies and over 300 institutional and retail investors. Interested parties should visit https://ibn.fm/fpEn2 for more details and to register for the Fall Investor Summit. To view the full press release, visit https://ibn.fm/A4Lxs

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 Thursday's trading session at $1.74, off by 5.4348%, on 1,593,126 volume with 4,476 trades. The average volume for the last 3 months is 1,316,764 and the stock's 52-week low/high is $0.779999971/$2.3499999.

Recent News

• Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) to Present at Virtual Fall Investor Summit
• Motorola Unveils Next-Gen Radio for the Mining Sector
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The Alkaline Water Company Inc. (CSE: WTER) (NASDAQ: WTER)

The QualityStocks Daily Newsletter would like to spotlight The Alkaline Water Company Inc. (CSE: WTER) (NASDAQ: WTER).

The Alkaline Water Company Inc. (NASDAQ and CSE: WTER) (the “Company”), is a producer of premium bottled alkaline water, flavor-infused waters, and CBD infused products sold under the brand names Alkaline88®, A88™, and A88CBD™, respectively. Today the Company announces that President and CEO Richard Wright and Chief Financial Officer David Guarino will host a teleconference with investors and analysts to review fiscal second-quarter 2021 financial results. Also today, the company was featured in the 420 with CNW by CannabisNewsWire. With several states legalizing cannabis use, marijuana tourism has been on the rise. Cannabis tourism, or traveling across state lines to purchase and consume the infamous plant, attracts millions of visitors and dollars to states that allow recreational cannabis. However, with the coronavirus pandemic raging, traveling across state lines for cannabis may not be safe, says Connecticut Gov. Ned Lamont.

Founded in 2012, The Alkaline Water Company Inc. (CSE: WTER) (NASDAQ: WTER) is headquartered in Scottsdale, Arizona. Its flagship product, Alkaline88®, is a leading premier alkaline water brand available in bulk and single-serve sizes, along with eco-friendly aluminum packaging options. With its innovative, state-of-the-art proprietary electrolysis process, Alkaline88® delivers perfect 8.8 pH balanced alkaline drinking water with trace minerals and electrolytes and boasts the company’s trademarked label ‘Clean Beverage’. Quickly being recognized as a growing lifestyle brand, Alkaline88® launched A88 Infused™ in 2019 to meet consumer demand for flavor-infused products. A88 Infused™ flavored water is available in six unique all-natural flavors, with new flavors coming soon. Additionally, in 2020, the company launched the A88CBD™ brand, featuring a broad line of topical and ingestible products. These products are made with lab-tested full and broad-spectrum hemp and include salves, balms, lotions, essential oils, bath-salts, CBD infused drinks, tinctures, capsules, gummies and powder packs.

Innovation and Expansion

Founded in 2012, The Alkaline Water Company began with a mission to create the best-tasting water in the world. At the time, there were two emerging trends in health-conscious consumers: a growing interest in the alkaline diet and perceived health benefits of pink Himalayan rock salt. By combining these two concepts in an alkaline water and trademarking the name Alkaline88, The Alkaline Water Company began offering what it calls the smoothest tasting Clean Beverage™ in the U.S. enhanced-water category.

Now a top bulk alkaline-water brand (the company reported record sales in March and April 2020, surpassing March and April 2019 numbers by 114% and 171%, respectively), The Alkaline Water Company is committed to growing its national footprint through innovation and expansion. That mindset was evident as the company introduced eco-friendly aluminum bottles and branched out into flavor-infused waters; the company currently offers six different flavors: peach/mango, lemon/lime, raspberry, watermelon, blood orange and lemon.

The company’s commitment to innovation may be most evident in its newest product line: A88CBD. This line of CBD-infused products includes tinctures, capsules, gummies, salves, balms, hand and foot lotions, essential oils, bath bombs and bath salts, as well as CBD-infused drinks, water and beverage shots. These quality, CBD-infused offerings are all made with lab-tested, full-spectrum hemp and are conveniently packaged and perfect for on-the-go or at home use.

In addition, The Alkaline Water Company has implemented an aggressive growth strategy, with numerous organic initiatives focused on national multichannel, mass-market expansion through a direct-to-warehouse model and co-packing facilities that are strategically located within 600 miles of 95% of the U.S. population. In addition to this strong brick-and-mortar approach, the company recently launched a B2C e-commerce platform (www.A88CBD.com) and aggressive digital-marketing campaigns.

Clear Advantages in a Growing Market

With consistent growth year over year, the company reported $32.2 million in revenue in fiscal 2019 and has emerged as a growth leader in the functional (value-added) waters space, which is the fastest-growing segment of the bottled water industry.

The Alkaline Water Company’s efforts are focused on its clear competitive advantages, including its strong marketing (the inclusion of alkaline in product names); existing grocery channels, which feature excellent relationships and a nationwide broker network; distinctive branding; proprietary technology, which produces great-tasting, high-quality water, infused drinks and other products; and price, with a broad range of products in all formats, from bulk bottles to single serve.

As the company focuses on strategic growth, it is eyeing the impressive potential of a market that is on a strong upswing. Annual bottled water sales have now surpassed soda consumption, with soda sales in the United States having declined by $1.2 billion over the past five years. Some research indicates that the global bottled water market will reach an estimated $280 billion this year, while the CBD market is forecast to top $20 billion by 2024.

With its products available in all major trade channels, including grocery stores, drug stores, c-stores and big-box retailers, The Alkaline Water Company is also looking to expand into new spaces, such as health and beauty, hospitality and specialty retailer locations.

Seasoned Management Team

The Alkaline Water Company is led by an experienced team focused on the company’s core strategy of building a national retail footprint and extending its lifestyle brands into other consumer packaged goods categories.

Richard A. Wright, President, CEO and Co-Founder of The Alkaline Water Company Inc., oversees all aspects of the business, successfully guiding the company through strategic opportunities and delivering greater than 50% growth since the company’s inception. A passionate and versatile leader with a strong track record of innovation, collaboration and achieving goal-driven results, Wright is a serial entrepreneur with more than 41 years of experience. Early in his career, he spent years at one of the ‘Big Four’ accounting firms, working his way up to Regional Director of Tax and Financial Planning. As a CPA, entrepreneur and former CFO, Wright brings extensive knowledge of finance, operations, sales and marketing to the team, and he has participated in hundreds of M&A transactions throughout his career.

David Guarino, CFO, Secretary, Treasurer and Director, earned a Bachelor of Science in accounting and a Master of Accountancy from the University of Denver. From 2008 to 2013, Guarino was President and a Director of Kahala Corp., a worldwide franchisor of multiple quick-service restaurant brands with locations in 49 states and more than 25 countries. From 2014 to 2015, Guarino was President of HTI International Holdings Inc., a technology company focused on forward osmosis water filtration technology.

Frank Chessman, National Sales Manager, is a graduate of the University of Southern California’s Marshall School of Business. He spent 25 years with Ralph’s Grocery, Kroger’s largest division, working at many levels before ultimately becoming Vice President of Advertising & Marketing. He then served 14 years as Executive Vice President at Simon Marketing. Chessman has more than a decade of experience in the beverage manufacturing industry.

Brian Sudano, Director, is managing partner of Beverage Marketing Corporation and BMC Strategic Associates. Sudano’s experience covers nearly the entire beverage industry, from energy drinks to wine, with special expertise in beverage alcohol by virtue of varied industry experience across a broad range of projects. Sudano manages several major clients, providing ongoing strategic and market advice and leading projects in strategic planning, market entry analysis and planning, sales/distribution, business modeling, brand repositioning and international opportunity assessment. He has spoken at many beverage industry events and is a contributing editor at Beverage World magazine.

Aaron Keay, Chairman, has been a successful investor, entrepreneur and financier to multiple small cap and startup companies over the last decade. During his time with these companies, he served in advisor, board-member and senior-management roles. His experience ranges across multiple sectors in mining, biotech, health and wellness, tech and cannabis, where he has invested and raised more than $500 million.

The Alkaline Water Company Inc. (NASDAQ: WTER), closed Thursday's trading session at $1.28, off by 5.8824%, on 1,528,881 volume with 4,026 trades. The average volume for the last 3 months is 1,311,756 and the stock's 52-week low/high is $0.400000005/$2.5999999.

Recent News

• The Alkaline Water Company to Host Conference Call to Discuss Fiscal Second Quarter 2021 Results
• 420 with CNW - Connecticut Governor Says Legalizing Pot Good for Public Health Amid Pandemic
• Alkaline88 Eyes Professional Sports (NASDAQ: WTER) (CSE: WTER)

Cybin Inc. (NEO: CYBN)

The QualityStocks Daily Newsletter would like to spotlight Cybin Inc. (NEO: CYBN).

NetworkNewsWire Editorial Coverage: Drug development means big money these days as big pharma and life science companies work to discover treatments that make a difference in the world. Investors are showing strong interest in the drug-development industry, and savvy companies are also making strategic M&A moves to strengthen their positions in the growing space. Life sciences company Cybin Inc. (NEO: CYBN) (Cybin Profile) exemplifies what is happening. The company, which focuses on developing psychedelic therapeutics along with unique delivery mechanisms that target depression as well as other psychiatric and neurological condition, just completed a reverse takeover. 

Cybin Inc. (NEO: CYBN) is a Canada-based life sciences company focused on the pharmaceutical development of psychedelic products, as well as the functional mushroom market.

The early-stage company boasts an experienced management team featuring industry veterans from pharmaceutical and consumer product backgrounds who have run multiple clinical trials and collectively helped facilitate billions of dollars in product revenues. The team is dedicated to the development of products and protocols within the psychedelic, pharmaceutical and nutraceutical industries.

In particular, Cybin aims to further build upon and expand its intellectual property (IP) portfolio, which is structured around unique psilocybin delivery mechanisms that target a number of different therapeutic indications. In addition, the company has dedicated itself toward furthering its research and IP within the fields of synthetic compounds, extraction methods, the isolation of chemical compounds, new drug formulations and protocol regimes.

Serenity Life Sciences & Natures Journey Inc.

The company’s business model is centered around its two core subsidiaries, Serenity Life Sciences and Natures Journey Inc., which comprise Cybin’s two-pronged approach toward delivering fungi-derived psychedelic and medicinal products.

Serenity Life Sciences is focused on furthering research and development of psilocybin-based medications. Psilocybin is found in certain species of mushrooms and is a non-habit forming, naturally occurring psychedelic compound. Research into psilocybin has shown positive results for the treatment of depression, anxiety, PTSD, addiction, eating disorders, ADHD and other indications.

Natures Journey Inc. operates the Journey brand, which specializes in developing proprietary medicinal mushroom products that target and promote mental wellness, immune boosting detoxification and overall general health and wellbeing.

Partnership with the Toronto Centre for Psychedelic Science (TCPS)

Staying true to its axiom of being a research-first medicinal mushroom life sciences company, Cybin recently announced its entry into a strategic partnership with the Toronto Centre for Psychedelic Science (TCPS), with the goal of furthering its ongoing psilocybin research efforts and expanding Cybin’s psilocybin IP portfolio (http://nnw.fm/9EUkI).

“While there is evidence to support psilocybin as a treatment for certain indications, the Toronto Centre for Psychedelic Science is taking a clinical approach to prove or disprove the safety and efficacy of psilocybin-based microdosing through an open science approach,” Paul Glavine, CEO of Cybin, stated in a news release.

“We are excited to join forces with Cybin and to offer our expertise. A number of firms had approached TCPS, but Cybin demonstrated a superior commitment to high-quality research and integrity in product development. Our high standards for scientific rigor and transparency will find a fitting home within the culture Cybin is cultivating in Canada and abroad,” Thomas Anderson, co-founder of the Toronto Centre for Psychedelic Science, added.

Journey’s Product Monetization & Market Potential for Nutraceutical Supplements

Although Cybin is at the forefront of companies seeking to conduct clinical trials aimed at gaining regulatory approval for psilocybin and other psychedelic products, the company has also placed a great deal of emphasis on generating meaningful revenue from its very outset.

Cybin’s Journey brand has is launching a range of supplements comprised of popular fungi-derived ingredients such as Reishi, Lion’s Mane and Cordyceps. Purported to aid focus and concentration while promoting neurogenesis, Journey’s range of nutraceutical products provides Cybin with a crucial foothold within the non-psychedelic legal supplement market, which is valued at over $25 billion globally and growing at a 9% year-over-year rate.

Pharmaceutical Psychedelics

In addition to the company’s range of non-psychedelic supplements, Cybin has plans to carry out a clinical trial with a new delivery system for its psilocybin-based medications later this year. Ultimately, the company aims to enter into technology transfer agreements with global pharmaceutical companies after phase 1 & phase 2 clinical trials are complete in order to accelerate regulatory approvals in major indications in global markets with entire lifecycle product management.

With products such as psilocybin truffles already legal in nations such as the Netherlands, Jamaica and Bulgaria, Cybin has positioned itself to capitalize on an eventual legalization of psychedelic mushroom-derived products in the future. Working within a regulatory environment with strong similarities to that which dealt with cannabis prior to the industry’s eventual legalization by the Canadian government in 2018, Cybin is laying the groundwork for the moment pharmaceutical psychedelics gain acceptance in North America and abroad.

Amalgamation Agreement and Financing

Cybin recently announced its entry into an amalgamation agreement dated June 26, 2020, with Clarmin Explorations Inc. (TSX.V: CX) and 2762898 Ontario Inc., a wholly owned subsidiary of Clarmin (http://nnw.fm/w04LH). Completion of the transactions contemplated in the amalgamation agreement will result in the reverse takeover of Clarmin by Cybin.

In connection with the proposed transaction, Cybin plans to complete a “best-efforts” brokered private placement of subscription receipts of Cybin, with a syndicate of agents co-led by Stifel Nicolaus Canada Inc. (Stifel GMP) and Eight Capital, to raise a minimum of C$14 million ($10 million) and a maximum of C$21 million ($15 million), with a 15% agents’ option.

To date, Cybin has raised approximately C$10,400,000 through an initial financing round and its series A financing round.

Cybin Inc. (NEO: CYBN), closed Thursday's trading session at $0.88, off by 4.35%, on 693,295 volume with 337 trades. The average volume for the last 3 months is 1,181,269 and the stock's 52-week low/high is $0.79/$1.09.

Recent News

• Savvy Companies Making Moves in Drug-Development Space
• Cybin Goes Public on NEO Exchange
• CYBIN Inc. Completes Reverse Takeover Transaction