Processa Pharmaceuticals Inc. (NASDAQ: PCSA)

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

Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, today announced that management will participate in two upcoming investor conferences. According to the update, Processa will participate in one-on-one meetings at the Craig-Hallum Alpha Select Virtual Conference on Tuesday, Nov. 17, 2020, and the Benchmark Annual Discovery 1x1 Investor Virtual Conference on Wednesday, Nov. 18, 2020. Interested parties should contact their conference representative or James@HaydenIR.com to schedule a one-on-one meeting with management. To view the full press release, visit http://ibn.fm/biHn2.

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 Monday's trading session at $4.50, up 5.3864%, on 19,877 volume with 135 trades. The average volume for the last 3 months is 30,531 and the stock's 52-week low/high is $3.40/$18.00.

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GoldHaven Resources Corp. (CSE: GOH) (OTCQB: ATUMF)

The QualityStocks Daily Newsletter would like to spotlight GoldHaven Resources Corp. (CSE: GOH) (OTCQB: ATUMF).

GoldHaven Resources Corp. (CSE: GOH) (OTCQB: ATUMF)was featured today in a publication from MiningNewsWire, examining how the natural resource sector is currently going through a fundamental change as it implements new technologies while managing social and climate challenges. To strengthen the metals and mining industry’s primary role in the evolving world economy, the industry is growing its material demand, focusing on new digital solutions and raising awareness of the challenges it faces.

GoldHaven Resources Corp. (CSE: GOH) (OTCQB: ATUMF) (formerly Altum Resources Corp.), a Canada-based company engaged in the business of acquiring and exploring mineral resource properties, recently announced its entry into agreements to acquire seven advanced gold projects in the Maricunga Gold Belt of Chile that hosts over 100 million ounces of gold within the last 10 years.

Chilean Gold Properties Being Acquired

On April 17, 2020, GoldHaven Resources entered into an agreement to purchase a 100% interest in two gold projects located in the Maricunga Gold Belt of Northern Chile. The first property, Rio Loa, is located 25 kilometers south of Gold Fields Ltd.’s Salares Norte, where, this year, a five-million-ounce discovery was made. The second property, Coya, is located only 10 kilometers east of the Kinross La Coipa open pit mine, which has produced over 7.5 million ounces of gold to date.

Rio Loa Project

Initial geophysical studies of the Rio Loa site have exposed highly anomalous ardennite and lead values, a key characteristic of gold mineralization within silicified resistive bodies. The studies have also produced initial findings which are similar to those seen at contiguous mines, such as Salares Norte (operated by Gold Fields), which has over five million ounces in estimated gold deposits.

The potential economics for the site look particularly promising when taking the unit costs at the neighboring Salares Norte mine into account. Gold Fields has estimated that its production AISC (all-in sustainable costs) will approximate $552 per ounce and have forecast a 2.3-year payback period for its initial investment, assuming a $1,300 per ounce gold price.

Coya Project

The Coya site is located within close proximity to one of the richest and largest epithermal gold and silver districts in Chile and is in close proximity to active mining sites, specifically the La Coipa mine owned by Kinross. A study carried out in 2017-2018 on the Coya site of 796 rock chip samples found favorable gold and silver values, in some cases ranking as high as 764 grams/tonne of gold and 719 grams/tonne of silver – values which are near certain indicators of potential gold and silver deposits. The La Coipa mine (Kinross) has produced over 6.9 million ounces of gold to date.

On August 11, 2020, GoldHaven Resources acquired five potential gold projects in the Maricunga Gold Belt of Northern Chile. The Maricunga hosts discoveries within the last 10 years of over 100 million ounces of gold and over 450 million ounces of silver. These newly acquired properties are in close proximity to seven other mines, which possess an estimated aggregate of 81 million ounces of gold in total reserves.

GoldHaven’s five new projects cover a total area of approximately 22,600 hectares, or 226 square kilometers, located in the northern portion of the Maricunga Belt in proximity to the 5 million-ounce gold equivalent Salares Norte project owned by Gold Fields. Gold Fields announced in April 2020 its intention to proceed with the development of Salares Norte at a cost of $860 million, with a $138 million expenditure budgeted for 2020.

The Maricunga Belt extends approximately 150 kilometers north-south and 30 kilometers east-west, straddling the border between Chile and Argentina. This region hosts known mineral resources of more than 100 million ounces of gold, 450 million ounces of silver and 1.3 billion pounds of copper.

The Maricunga project’s opportunity came about as a result of a $150 million initiative launched by the Chilean Economic Development Agency (“CORFO”), with the objective of encouraging exploration and mining prosperity in Chile and strengthening Chile’s position as a world leader in the sector.

As part of CORFO’s program, a total of $15.3 million was given to private equity fund IMT Exploration to evaluate 403 projects, beginning in 2011. This led to a generative program carried out from 2016 to 2019, resulting in 126 potential epithermal targets from which 57 field evaluations were made. Due diligence work followed on 19 of these. Work programs were then conducted, including geological mapping, rock and soil sampling and TerraSpec (PIMA) analyses on geochemical grids for alteration mapping, and, as a result, the five high-priority Maricunga projects were identified. No drilling has been carried out on any of the Maricunga projects.

Securing Financing for Upcoming Operations

In conjunction with its announcement regarding its acquisition of five Chilean mining interests, GoldHaven Resources also detailed plans for a non-brokered private placement of 11.5 million units at a price of $0.35 per unit, for gross proceeds of $4,025,000. Each unit will consist of one share of the company and one warrant, the latter of which can be exercised to acquire an additional share of the company for a period of 18 months from the date of issuance at a price of $0.50 per share. Net proceeds from the offering are intended to be used to fund general expenses, as well as exploration and drilling of its mineral properties.

Gold Prices Hit Record High in 2020

Gold prices have been on a remarkable run in 2020, breaking above $2,000 per ounce for the first time on record. Having begun the year at $1,515 per ounce, the precious metal has seen a huge surge on the back of widespread economic uncertainty stemming from governments’ worldwide propensity to expand the money supply, from the reduction of the value of the U.S. dollar as expressed by the decrease in the U.S. dollar index, and from the very real economic effects of the COVID-19 pandemic.

Global central banks have carried out 144 interest rate cuts thus far in 2020, reducing rates by a cumulative 5,035 basis points (http://nnw.fm/jzZt0). Meanwhile, the IMF has estimated that global governments have introduced fiscal support measures amounting to over $9 trillion since the start of the pandemic (http://nnw.fm/Or9rI). The resulting weakness in the U.S. dollar and eventual inflationary pressures stemming from these measures has prompted a number of investment banks to boost their near-term outlooks for gold prices, with Bank of America raising its 18-month gold price target to $3,000 per ounce (http://nnw.fm/PQJtc).

Leadership Team

David Smith, President, CEO and Director, has been immersed in the mining industry for the last eight years, working in corporate development and finance. Prior to GoldHaven Resources, Smith cofounded a multifaceted real estate development and sales company, which has now been in operation for over 35 years. He also cofounded two successful environment-focused companies listed on the Toronto Stock Exchange. Both companies were sold independently and returned a significant profit for shareholders.

Darryl Jones, Chief Financial Officer, is a finance executive and CPA with over 30 years of public company and project buildout experience. Most recently, Jones served as the CFO of Lupaka Gold Corp., retiring in June 2018. Prior to that, Jones serves as CFO of Corriente Resources, which was sold to CRCC-Tongguan in May 2010 for C$680 million.

Patrick Burns, VP Exploration and Director, is a Canadian geologist with over 40 years of experience throughout the Caribbean and Central and South America. He played a direct role in the discovery of the Escondida porphyry copper deposit in Chile and has been involved in publicly traded mining companies, predominantly in Chile, for 35 years.

Marla Ritchie, Corporate Secretary, brings over 25 years of experience in public markets to the GoldHaven team. Throughout this time, she has worked as an administrator and corporate secretary specializing in resource-based exploration companies. Currently, Ritchie is the corporate secretary for several companies, including International Tower Hill Mines Ltd. and Trevali Mining Corp.

Gordon Ellis, Director; has over 50 years’ experience in mining and resource development. A professional engineer and entrepreneur, he has held multiple senior management and director roles with public mining companies, as well as a multi-billion-dollar ETF fund. Ellis holds an MBA in international finance and a Chartered Directors designation.

Scott Dunbar, Director is a professor and head of multiple departments at the University of British Columbia, including mineral extraction and mining innovation, as well as mining engineering. He has been involved in projects around the world in regard to mining exploration, geotechnical engineering and mine design. Dunbar received his PhD in geophysics and civil engineering from Stanford University.

GoldHaven Resources Corp. (OTCQB: ATUMF), closed Monday's trading session at $0.385, up 13.2686%, on 160,035 volume with 37 trades. The stock's 52-week low/high is $0.3388/$0.3865.

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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: WTER) (CSE: WTER) was featured today in the 420 with CNW by CannabisNewsWire. Research carried out by the School of Public Health and Social Policy at the University of Victoria along with the Canadian Institute for Substance Abuse Research revealed that people who used medical marijuana experienced a decline in their alcohol consumption. Also today, the company announced revenue of $10.8 million for the fiscal second quarter ended September 30, 2020.

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 Monday's trading session at $1.33, up 4.7244%, on 2,629,777 volume with 5,293 trades. The average volume for the last 3 months is 1,319,217 and the stock's 52-week low/high is $0.40/$2.60.

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LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF)

The QualityStocks Daily Newsletter would like to spotlight LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF).

LexaGene Holdings (TSX.V: LXG) (OTCQB: LXXGF), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, on Friday announced the voting results of the company’s 2020 Annual General Shareholder’s Meeting held on November 10, 2020 in Vancouver, British Columbia. According to the update, a total of 48,273,080 common shares were voted at the meeting, representing 42.26% of the votes attached to all outstanding common shares of the company. All matters presented for shareholder approval at the meeting were duly authorized and approved. To view the full press releases, visit https://ibn.fm/xdrBV and https://ibn.fm/R8K3L

LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF) is a molecular diagnostics company that develops genetic analyzers for rapid detection of pathogens at the point-of-need.

Based in the greater-Boston, Massachusetts area, the company’s fully automated genetic analyzer for pathogen detection, the MiQLab™, is designed to deliver reference-quality data with ease of use. MiQLab’s technology screens samples for up to 27 different targets at once—looking for pathogens and antimicrobial resistance factors—and returns results in approximately one hour. It is designed to be operated at the site of sample collection to avoid the delay associated with shipping and manually processing samples. This technology is designed for use in multiple markets, including human and veterinary diagnostics, as well as food safety testing ($12.9B, $2.2B, and $23.4B markets, respectively).

Portfolio Benefits

Rapid, automated pathogen detection

LexaGene’s MiQLab pathogen detection system offers rapid and sensitive testing to markets in need of better vigilance against pathogens that could endanger health and harm public safety and the bottom line. The company’s disruptive technology is on-demand and offers results in approximately an hour.

End users collect a sample, load it onto the MiQLab genetic analyzer with a sample preparation cartridge, enter a sample ID and press ‘go’.

MiQLab is open-access, which allows users to easily customize their own tests, in addition to running the company’s own validated tests. No comparable technology exists on the market today for automating customized testing. The open-access market is over $20 billion in value and includes industries like pharma and biotech that currently need an automated method of performing PCR testing in a cost-efficient way.

Improved COVID-19 Testing

As the COVID-19 pandemic continues to pose a threat to global safety, the need for improved testing procedures has been well established. LexaGene’s technology is automated and designed to be used at the point-of-need, thereby avoiding the 12- to 24-hour shipping time. Plus, it performs sample preparation and the gold standard RT-PCR chemistry for exceptional data quality in about one hour.

Because LexaGene’s open-access instrument can be rapidly configured to detect novel pathogens, it is ideally suited to prevent pandemic spread with its easily deployed testing that facilitates rapid quarantine-related decision making.

This speed is in stark contrast to competitor point-of-care technologies that have reagents pre-embedded into complex and expensive cartridges that are only manufactured at specialized production sites — making it impossible to rapidly meet a swift increase in demand.

According to Dr. Jack Regan, LexaGene’s CEO and founder, the world needs easy-to-use, fully automated pathogen detection instruments operating at points-of-need that can be equipped with tests to detect a novel pathogen within a week of knowing its genetic sequence. For this pandemic, the lack of such technology forced the majority of testing to occur in distant reference laboratories, making rapid decisions on quarantine impossible and making the likelihood of successful containment remote.

Regan explained in a press release (http://nnw.fm/Vz5Ju), “LexaGene expects to be the first company to commercialize an automated open-access microfluidic technology designed for use at the point-of-need that can be configured to detect a novel pathogen in just a week’s time of its emergence — for use on-site to return results in one hour — and improve our chances of successful containment.”

Market Potential

LexaGene’s technology has a wide range of applications across many other markets, including biotech and pharma testing, water quality monitoring, agricultural testing, biodefense, and use at point-of-need at border crossings, military bases, aircraft carriers and cruise ships.

Markets for customized testing solutions are poised for significant growth. Industry analysts forecast considerable expansion of many of LexaGene’s potential target markets in the coming years, including:

• The genotyping sector, forecast to reach a valuation of $31.9 billion by 2023;
• PCR assays, expected to make up a $7 billion market opportunity by 2026;
• The sample prep market, forecast to eclipse $9.3 billion by 2025;
• Water quality monitoring, set to grow to $1.59 billion by 2022; and
• Agricultural testing, anticipated to reach $6.29 billion by 2022.

LexaGene’s patented microfluidic system was invented by company CEO Regan, a leading scientist who developed a bio-warfare surveillance instrument that has been adopted by the Department of Homeland Security. Regan is also known for developing an instrument that detects respiratory pathogens from nasal swab samples. The development of these instruments was supported by $20 million in government funding.

Management Team

LexaGene’s experienced leadership team drives company growth with a focus on innovation, pursuing unique market opportunities and providing shareholder value.

Dr. Jack Regan, Chief Executive Officer & Director, is the inventor of the company’s flagship automated pathogen detection technology, the MiQLab. Before founding LexaGene, he led a team of scientists at Bio-Rad Laboratories (NYSE: BIO) in developing tests for detecting pathogens, cancer and neurological disorders using droplet digital PCR. Prior to Bio-Rad, Regan helped QuantaLife, a startup company, bring its product from concept to commercialization, where it was subsequently acquired by Bio-Rad. He has also worked at Applied Biosystems/Life Technologies on automated sample preparation and did his post-doctoral training at Lawrence Livermore National Laboratory. His doctoral training at the University of California San Francisco focused on influenza viral replication.

Daryl Rebeck, President, has over 20 years of capital market experience with an established international financial network. Rebeck was a vice president and senior investment advisor with Canada’s largest independent investment bank, Canaccord Genuity, where he was responsible for raising significant risk capital for growth companies, with a particular focus on natural resources and medical technology. He has since worked to provide management expertise and grow shareholder value. He served as senior VP of corporate finance of Auryn Resources (NYSE: AUG), a $250 million market cap mining exploration company.

Jeffrey Mitchell, CFO, boasts over two decades of financial and SEC experience. Before joining LexaGene, he served as controller and director of finance, overseeing areas such as public company financial reporting, audits, and financial planning and analysis for Palomar Medical Technologies Inc. In addition to his many years at Palomar, Mitchell has served in numerous financial and strategic advisory roles for medical device, imaging and diagnostic companies.

LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF), closed Monday's trading session at $0.58, up 18.95%, on 943,897 volume with 278 trades. The average volume for the last 3 months is 294,415 and the stock's 52-week low/high is $0.3038/$0.9283.

Recent News

• LexaGene Holdings, Inc. (TSX.V: LXG) (OTCQB: LXXGF) Announces Annual General Shareholder's Meeting Results, Secures Order for MiQLab(TM) System
• LexaGene Announces Results of Annual General Shareholder's Meeting
• Investor Summit Group Releases Lineup of 77 Public Companies to Present at Virtual Fall Event

InsuraGuest Technologies, Inc. (TSX.V: ISGI) (OTC: IGSTF)

The QualityStocks Daily Newsletter would like to spotlight InsuraGuest Technologies, Inc. (TSX.V: ISGI) (OTC: IGSTF).

InsuraGuest Technologies (TSX.V: ISGI) (OTC: IGSTF), a leader in the insurtech industry, now offers its insurance services and products nationwide and has gained access to more markets and revenue streams after being approved as a resident surplus lines producer, receiving a license to offer surplus lines casualty and surplus lines property insurance in the state of Utah.

InsuraGuest Technologies, Inc. (TSX.V: ISGI) (OTC: IGSTF) is a leading global SaaS (Software-as-a-Service) company leveraging its proprietary, flagship insurtech (insurance + technology) software, InsuraGuest, which is integrated with the property management systems of hotels and vacation rentals to deliver custom Hospitality Liability coverages.

InsuraGuest’s Hospitality Liability coverages are purchased by hotels and vacation rental properties, which can address claims from guests and their room occupants. The combination of the integrated software and customized insurance provides the property liability coverages the guests benefit from in the event a loss is incurred during their stay.

The Hospitality Liability policy is offered through integration of InsuraGuest’s API with the clients’ property management systems. InsuraGuest’s platform is currently capable of integrating with approximately 71 different hotel and vacation rental property management systems, giving it access to millions of rooms worldwide.

InsuraGuest continues to pursue expansion opportunities in the United States, and has plans to expand to its distribution platform and Hospitality Liability coverages to the United Kingdom and Europe regions by third quarter 2020, as well as expansion into Asia by the end of 2020.

Protection that Enhances the Guest’s Experience

InsuraGuest’s Hospitality Liability coverages add a layer of protection for the property on a primary basis, should a guest experience an accident or theft while staying at an InsuraGuest member hotel or vacation rental property.

Market Opportunity

The U.S. hotel industry generated more than $218 billion in annual revenues in 2018, an increase of $10 billion from the previous year, according to STR’s 2019 HOST Almanac. The European market is more than double the size of the U.S. market. According to Oxford Economics, there were 6.4 billion nights stayed in the world, with 2.6 billion hotel nights stayed in Asia, 2.8 billion nights stayed in Europe, and 1.1 billion stayed nights in the United States. Additionally, $100 billion was spent on vacation rentals in the United States, where there approximately 4.5 million second homes are being managed by a third-party rental company.

With distribution in Europe and the United States, InsuraGuest’s combined demographics will total 3.9 billion nights stayed, and will more than double its vacation rental opportunities.

Within this burgeoning, high-demand industry is risk of liability to guest injury. For example, gym injuries are among the top five most common hotel accidents. Without proper hedges in place, the property may be liable in a personal injury claim or lawsuit that are not the properties fault.

Though the potential for accidents, slip and falls and mishaps can be widespread, it can be covered under the InsuraGuest Hospitality Liability policy to provide guests a worry-free and enjoyable stay that potentially increases loyalty for the property.

Investment Consideration

• Targeting hotels and vacation rentals, a multi-billion-dollar industry
• Providing the first line of defense in case of accident, loss or death
• Expanding distribution reach with footing in European hotel and vacation rental markets
• Expansion into Asia by 2020

Executive Team

Douglas Anderson, Chairman & Chief Executive Officer
Douglas Anderson has been a businessman in the real estate industry for nearly 30 years. His business expertise includes master planning and development implementation for larger-scale resorts, business parks and commercial developments across the USA and two provinces in Canada. His business endeavors include the founding of the 7th larger private equity fund in America focusing on multifamily and senior care (ROC Fund/Bridge IPG Fund). He serves as chairman/founder of a golf and winter sports ski holding company with operations in four major east coast markets and British Columbia, Canada.

Anderson earned a Bachelor of Science in consumer studies with an emphasis in architecture as an undergraduate at the University of Utah. He subsequently earned his MBA. He also attended a three-year OPM Program a postgraduate business education at Harvard Business School in Boston. Anderson is an avid skier and outdoor enthusiast.

Logan Anderson, CFO & Director
Logan Anderson (bachelor’s degree in communications, accounting and economics) holds the designation of ACA with the Chartered Accountants of Australia and New Zealand. He began his career as an associate chartered accountant in New Zealand and then Canada. This was followed by his position as controller of a management services company which was responsible for the management of numerous private and publicly traded companies. Since 1993, Anderson has served as president of Amteck Financial Corp. (and its predecessors), a private financial consulting services company servicing both private and public companies. He is a former director of 3D Systems, Inc. (NYSE: DDD), and was formerly a founder, officer, and director of Worldbid.com. Anderson has also been involved in raising funds for numerous private and public companies in all stages of their development and has been an officer and director for numerous public and private companies over the past 40 years.

Charles James Cayias, President & Director
Charles James Cayias is also the president and owner of Charles James Cayias Insurance Inc. He is a third-generation insurance professional whose creativity and artistic vision have enabled him to establish a full-service agency combined with the personal service each client deserves. His outstanding people skills, honesty, integrity and fairness are evident by his loyal and growing clientele, the majority of which are referrals who become long-time customers and friends. Cayias began his insurance career in the early 1970s and has been licensed since 1977. He is licensed in all 50 states and specializes in niche programs. He has extensive expertise in all aspects of the insurance industry including commercial insurance, employee benefits, workers’ compensation, professional liability, risk management and bonding.

Tony Sansone, COO & VP of Finance
Tony Sansone has over 30 years of financial, operations and business development experience which includes serving as CFO in the health care, foodservice distribution, manufacturing and technology sectors, including public company experience. He has held senior finance positions in the banking, telecommunications, medical products, and food & drug retailer industries, closing over $430 million of private debt, equity and line of credit financings and over $350 million of a merger, acquisitions, real estate and state incentive transactions, including due diligence, negotiations, closing, and integration. Sansone coordinated and was the executive sponsor for four ERP implementations and multiple other best-in-class software & technology solutions. He received his MBA from the University of Utah and a Bachelor of Science in accounting from Utah State University. Sansone also currently serves as president-elect of the Utah Chapter of Financial Executives International and a past president and current member of the board of trustees for Catholic Community Services of Utah. He is the proud father of three children.

Christopher J. Panos, Vice President & Director
Christopher J. Panos is a highly competitive sales professional with over 15 years of territory manager sales experience and an award-winning record of achievements. He is exceptionally well organized with a proven work history that demonstrates self-discipline, superb communication skills, and the initiative to achieve both personal and corporate goals. Panos is successful in building relationships with a large network of industry professionals in order to grow and maintain new and existing business, exceed new sales objectives and provide in-depth product training to authorized dealers and sales personnel.

Alexander Walker III ESQ, Corporate Counsel & Director
Alexander Walker III ESQ has served as director of the company since September of 2018 and as counsel to the company since July of 2018. Walker is an attorney and has been a member of the Utah Bar Association since 1987 and a member of the Nevada State Bar since 2003. His practice has involved general business litigation, in both federal and state courts, and transactional work, including securities offerings and registration, corporate formation and periodic reporting compliance. Walker has provided legal services to emerging businesses throughout his carrier and at times has served as an officer and board member as well as legal counsel public companies. His duties as legal counsel for a public company engaged in the business of ownership and operation of coal-producing properties in the western United States included oversight of corporate-related legal matters including securities reporting, corporate compliance, federal and state mining regulation, and employment law oversight. He also has served as the chair of the Mining Committee of the Energy, Natural Resources and Environmental Law Section of the Utah State Bar, a member of the board of directors of the South East Utah Energy Producers Association, the co-chair of the board of the Western Energy Training Center, a board member of the Utah Supreme Court Committee to Review the ABA Recommendations Regarding the Office of Professional Conduct, and a board member of the University of Utah Crimson Club.

Jennifer Epperson, Vice President of Sales
Jennifer Epperson has over 20 years of B2B sales experience with exceptional success history. She has grown and developed sales territories across multiple industries. Her ability to find and develop strategic relationships has given her top-level performance throughout her career. Epperson’s passion and knowledge provide an inherent ability to connect and retain relationships for the growth of the company. Throughout her professional career, she has achieved peak performance sales results and awards year after year. She captures the vision of the company and drives it forward with enthusiasm and expertise. Her commitment to providing an exceptional customer experience has been the key to her success.

Richard Matthews, Interim Financial Controller
Richard Matthews joined the InsuraGuest team in March 2019 as the interim financial controller. Leading the Finance and Audit team, Matthews is responsible for the delivery of financial services such as accounting, treasury, reporting, budgeting and insurance management, in accordance with legislative requirements and organizational policies and strategies. He has over 30 years of experience in providing professional services across a broad range of finance areas including compliance, business process, audit, and financial reporting. He holds a degree in accounting from the University of Utah and is a licensed CPA in the state of Utah.

Roger Bloss, Corporate Consultant & Board Advisor
Roger Bloss joined InsuraGuest in August of 2019 to advise the company and its board on hotel transactions, contributing his knowledge from more than 40 years in the hospitality industry. Bloss previously served in executive positions with several major hotel franchise companies and in 1996 founded Vantage Hospitality Group hotel brands. Under his leadership, Vantage became a Top 10 global hotel company and made the Inc. 500/5000 list of Americas’ fastest-growing private companies for eight straight years. Bloss was named Lodging Magazine’s “Innovator of the Year” in 2006 and 2010, and in 2009 earned a spot on HSMAI’s “Top 25 Extraordinary Minds in Sales and Marketing.” Bloss joined Red Lion Hotels Corporation (RLHC) in September 2016 in conjunction with the acquisition of Vantage.

Jim Kilduff, Board Advisor
James “Jim” C. Kilduff has nearly 40 years of experience in the insurance and risk management sectors. He is a dynamic and energetic team leader and builder with extensive experience in the changes affecting the insurance business through Gas, alternative distribution, insurtechs and program business. His skillset includes experience as chief insurance officer with Outdoorsy Insurance Group, CEO with Harbor Hill Solutions Inc., and senior vice president and chief marketing officer with State National Insurance Companies. His career has spanned MGA creation and management, insurance company management, business development and underwriting, primary insurance and reinsurance.

Don Archibald, Board Advisor
Don Archibald brings to InsuraGuest’s advisory board 54 years of experience as an insurance agent. Archibald is the founder and former owner of Archibald Clarke and Defieux (ACD Insurance), as well as the co-founder and former equity partner of Sussex Insurance, and an agent with Sussex since 2014.

InsuraGuest Technologies, Inc. (TSX.V: ISGI), closed Monday's trading session at $0.17, even for the day, on 20,000 volume with 2 trades. The average volume for the last 3 months is 17,841 and the stock's 52-week low/high is $0.045/$0.34.

Recent News

• Utah Surplus Lines Insurance Licensing Opens Up New Markets and Opportunities for InsuraGuest Technologies, Inc. (TSX.V: ISGI) (OTC: IGSTF)
• InsuraGuest Technologies, Inc. (TSX.V: ISGI) (OTC: IGSTF) Changing Small Business Insurance with Customized Plans and Launch of Business Owner Policy Portal
• InsuraGuest Technologies Inc. (TSX.V: ISGI) (OTC: IGSTF) Enters Strategic Vendor Agreement with Guesty

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 researchers have found a genetic signature that can forecast whether cancer is likely to metastasize or spread in the early stages of localized prostate cancer. The signature can also predict whether the disease will respond to anti-androgen therapy. In addition, the new signature may be beneficial in helping evaluate the disease’s response to treatment as well as creating new treatments to treat or avert the advanced stages of prostate cancer. This groundbreaking study was reported in “Nature Cancer.”

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 Monday's trading session at $12.68, off by 3.2061%, on 145,573 volume with 1,235 trades. The average volume for the last 3 months is 109,707 and the stock's 52-week low/high is $3.02/$22.49.

Recent News

• Gene Marker Suggests Likelihood of Prostate Cancer Metastasizing
• Researchers Uncover Two Factors That Turn Cells Cancerous
• DarioHealth Corp. (NASDAQ: DRIO) Releases Financial Results for Third Quarter

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, at the moment, many countries are pinning their plans of recovering from the pandemic-induced economic downturn on investments that will be directed towards developing or deepening green technologies, such as electric vehicles and renewable energy. However, the catchy phrases being flashed around will not help the world operate more sustainably if careful planning isn’t directed towards making the leap workable in the long term. Also today, the company was featured in a publication from Green Car Stocks, examining how NETE announced today its financial results for the third quarter ended Sept. 30. To view the full press release, visit http://ibn.fm/i7NfQ

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 Monday's trading session at $7.35, off by 3.9216%, on 715,987 volume with 4,101 trades. The average volume for the last 3 months is 1,341,801 and the stock's 52-week low/high is $1.47/$20.08.

Recent News

• Switching to Sustainable Technologies Will Depend on Meticulous Planning
• Net Element Inc. (NASDAQ: NETE) Announces Q3 2020 Financial Results
• Net Element Inc. (NASDAQ: NETE), Mullen Technologies Positioned at the Forefront of Reduced EV Manufacturing Costs

SRAX Inc. (NASDAQ: SRAX)

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

SRAX (NASDAQ: SRAX), a financial technology company that unlocks data and insights to publicly traded companies through Sequire, announced results for the three months ended September 30, 2020. Among the highlights, the company reported $2.6 million in total revenue for Q3, which represents 161% year-over-year (“YoY”) and 124% sequentially quarter-over-quarter (“QoQ”) growth. To view the full press release, visit http://ibn.fm/po8vK

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

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

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

SRAX Verticals

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

BIGtoken

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

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

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

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

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

International Expansion

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

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

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

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

Leadership

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

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

SRAX Inc. (NASDAQ: SRAX), closed Monday's trading session at $2.96, off by 0.3367%, on 277,695 volume with 1,006 trades. The average volume for the last 3 months is 128,226 and the stock's 52-week low/high is $1.04999995/$3.35739994.

Recent News

• SRAX Inc. (NASDAQ: SRAX) Announces 161% YoY, 124% QoQ Revenue Growth
• SRAX Inc. (NASDAQ: SRAX) to Discuss Q3 Financials During Nov. 16 Call
• SRAX to Host Third Quarter 2020 Financial Results Conference Call on Monday, November 16, 2020

Pressure BioSciences Inc. (PBIO)

The QualityStocks Daily Newsletter would like to spotlight Pressure BioSciences Inc. (PBIO).

Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company") today announced that the Company will host a teleconference to discuss its Third Quarter 2020 financial results and to provide a business update. Anyone interested may listen to the teleconference either live (by telephone) or through a replay (by telephone or via a link on the Company's website) approximately one day after the teleconference.

Pressure BioSciences Inc. (PBIO) develops, markets and sells proprietary laboratory instrumentation and associated consumables to the life sciences sample preparation market. Sample preparation refers to the wide range of activities that precede most forms of scientific analysis. It is often complex and time-consuming, yet a critical part of scientific research. The market for sample preparation products is currently estimated at $6 billion worldwide.

The Company’s product line can be used to exquisitely control the sample preparation process. It is based on a patented, enabling technology platform called pressure cycling technology (“PCT”). PCT uses alternating cycles of hydrostatic pressure between ambient (14.5 psi) and ultra-high levels (up to 100,000 psi) to safely and reproducibly control critical biological processes, such as the lysis (breakage) of cells, the digestion of proteins, and the inactivation of pathogens.

Pressure BioSciences’ product line is led by its newly released, next-generation Barocycler 2320EXTREME instrument. Named a finalist in the prestigious 2017 R&D Awards (also known as the “Oscars of Innovation”), the Barocycler 2320EXT is already being touted by some key opinion leaders as an essential element of the $1.8 billion U.S. “Cancer Moonshot” program. For example, Professor Phil Robinson, Co-head of the cancer research center of the Children’s Medical Research Institute (Sydney, Australia), said in a recent interview: “We are collecting the whole proteome on 70,000 tumor samples from all classes where complete clinical outcome is known. Due to its unique capabilities, the Barocycler 2320EXT has become a critical part of our program. It is the primary enabler of the high-throughput component of the project. Without this step, our project simply could not be done. In fact, the Barocycler 2320EXT works so well we have just purchased two more.”

Momentum is building when it comes to the potential for using the Company’s unique PCT technology platform. Leading scientists are intrigued by Pressure BioSciences’ approach, which among other attributes, revolutionizes the process of rupturing cells (lysis) for further study, yielding superior biomolecules for investigation. The Company’s technology transcends current methods of breaking open cells, which use chemicals, blades, metal beads, or other damaging and altering methods that can ultimately adversely affect the result for researchers. Pressure BioSciences’ PCT technology utilizes customized, controlled hydrostatic (water) pressure to rupture cells in a chamber, enabling exquisitely customized levels of pressure to optimally break open different types of cells at prescribed pressure levels—something never before accomplished in a commercial setting. Using this pioneering method, the result is a truer, more legitimate sample, which boosts the efficacy of research and the quality of results. The potential impact of this technology on scientific advancement is enormous, enabling research scientists to begin their studies with biological samples of unprecedented integrity, with the potential to improve research outcomes at the earliest, most critical step. PCT can additionally inactivate pathogens (e.g., viruses, bacteria) using hydrostatic pressure, making the samples safer to study—another innovation with astronomical potential for application in a variety of markets.

The Company’s high-pressure instruments for research purposes are marketed throughout the United States, Europe, China and Japan. To date, Pressure BioSciences has installed nearly 300 PCT Systems in over 165 leading academic, government, biotech and pharma laboratories around the world. Its primary applications are in biomarker discovery, forensics, agriculture and pathology. Over 100 scientific papers have been published on the advantages of the PCT platform, which is also being used in the specialized fields of drug discovery and design, bio-therapeutics characterization, soil and plant biology, vaccine development and histology.

Impressive as their biotech business is, there is more to the PBI story. Pressure BioSciences recently received two patents in China for its novel Ultra Shear Technology (UST), a process that has potential in a wide range of industrial applications, including extending the shelf life of some food products and making two insoluble liquids (like oil in water) soluble. Patents have also been filed in many other countries worldwide. UST is a novel technique based on the use of intense shear forces generated from ultra-high-pressure valve discharge.

This important technology has the potential to play a significant role in a number of commercially important areas through its ability to create high-quality, stable nanoemulsions. Scientific studies indicate that improved absorption, higher bioavailability, greater stability, lower surfactant levels and other advantages can be achieved with nanoemulsions — all hugely important factors in the fields of nutraceuticals, cosmetics, pharmaceuticals, and in various medical products. There is an enormous opportunity in the cannabis market, since the technology can potentially reduce oil droplets containing cannabidiol (CBD) to nanoparticles, after which they can be safely suspended in a stable water solution—something many companies have endeavored to achieve without success. Researchers looking for a way to increase the bioavailability of cannabinoids in the body will find this technology a game changer.

The Company’s UST technology also has possibilities in the production of clean label foods, which are currently processed using several innovative methods, including high-pressure treatments (such as Starbucks’ Evolution line of juices). In 2015, the worldwide market for high-pressure processed (HPP) food was estimated at U.S. $10 billion. UST uses ultra-high pressures and certain valves to generate intense shear forces under controlled temperature conditions to produce nanoemulsions, and which also significantly reduces food-borne pathogens. Pressure BioSciences’ initial focus with this technology will be to evaluate UST for the production of high-quality dairy products and beverages.

Pressure BioSciences Inc. (PBIO), closed Monday's trading session at $1.65, off by 2.9412%, on 22,368 volume with 28 trades. The average volume for the last 3 months is 17,382 and the stock's 52-week low/high is $0.60/$4.49.

Recent News

• Pressure BioSciences, Inc. to Discuss Third Quarter 2020 Financial Results and Provide Business Update
• Pressure BioSciences Inc. (PBIO) Awarded First US Patent for Revolutionary UST(TM) Platform
• Pressure BioSciences Inc.'s (PBIO) Path to Commercialization Targets Multibillion Hemp-Derived CBD Market

Sustainable Green Team Ltd. (SGTM)

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

Discretionary spending across almost all sectors has taken a dive in recent months as the global recession deepens. Despite the negative performance across many consumer goods and service sectors, some businesses continue to survive - and even thrive. Among them is Sustainable Green Team (OTC: SGTM), a leading provider of solutions for tree and storm waste disposal that turns problems into profits through the transformation of natural waste into products that benefit the environment. Also today, the company was featured in a publication from InvestorWire, examining how SGTM today announced that it has engaged Anthony L.G. PLLC to initiate the FORM-10 process to become fully reporting, uplist and assist with all SEC legal matters. To view the full press release, visit http://ibn.fm/qSXnY

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 Monday's trading session at $1.30, off by 4.4118%, on 200 volume with 2 trades. The stock's 52-week low/high is $1.30/$1.30.

Recent News

• As Millennials Drive Socially Responsible Investing, Sustainable Green Team Ltd. (SGTM) Offers Ethical, Profitable Investment Opportunity
• Sustainable Green Team Ltd. (SGTM) Announces Engagement of Anthony L.G. PLLC
• Sustainable Green Team Ltd. (SGTM) Announces Expansion of Mulch Contract with Circle K Convenient Stores

AzurRx BioPharma Inc. (NASDAQ: AZRX)

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

AzurRx BioPharma Inc. (NASDAQ: AZRX) was featured today in a publication from BioMedWire, examining how a new study by the University of Georgia has shown that while grown-ups exercise mostly to lose weight, children should exercise to build endurance, or how well their bodies can handle long periods of exercise. Physical education for children should be centered on motivating children to be active, educating them on the benefits of exercise and improving their physical skills.

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

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

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

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

MS1819 Clinical Trials

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

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

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

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

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

Financial Highlights

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

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

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

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

Management Team

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

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

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

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

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

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

AzurRx BioPharma Inc. (AZRX), closed Monday's trading session at $0.7005, off by 4.0411%, on 301,871 volume with 462 trades. The average volume for the last 3 months is 162,176 and the stock's 52-week low/high is $0.371/$1.938.

Recent News

• Physical Fitness in Children is More Important Than BMI
• Mothers' Lifestyles Provide Pointers to Likely Onset of Stroke or Heart Attacks in Offspring
• AzurRx BioPharma Inc. (NASDAQ: AZRX) Enters LOI with Asymchem for MS1819 Development, Production

Predictive Oncology (NASDAQ: POAI)

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

During a recent NetworkNewsWire exclusive audio interview, Predictive Oncology (NASDAQ: POAI) CEO Carl Schwartz noted recent company milestones and outlined strategic goals. In addition, Schwartz provided key updates on the company’s four impressive subsidiaries: Skyline Medical, TumorGenesis, Soluble Biotech and Helomics. Also today, the company reported financial results for the quarter ended September 30, 2020 and provided a business update.

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 Monday's trading session at $0.68, off by 2.5647%, on 149,840 volume with 342 trades. The average volume for the last 3 months is 1,091,175 and the stock's 52-week low/high is $3.01999998/$22.4899005.

Recent News

• Predictive Oncology (NASDAQ: POAI) CEO Discusses Subsidiaries' Proprietary Tech, Innovative Media
• Predictive Oncology Reports Third Quarter 2020 Financial Results, Provides Business Update
• Research Discovers That Suicide Rates Spike After Disasters Occur

Pure Extracts Technologies Corp. (CSE: PULL)

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

Pure Extracts Technologies Corp. (CSE: PULL) was featured today in a publication from PsychedelicNewsWire, examining how researchers from George Washington University and the Johns Hopkins Bloomberg School have discovered that the data used to approve opioid pain medications by the FDA from 1997 to 2018 depended on intermediate or short-term studies that largely didn’t sufficiently examine safety outcomes. The findings, which were obtained from a cross-sectional analysis, were reported in the “Annals of Internal Medicine.” Also today, the company was featured in the 420 with CNW by CannabisNewsWire.

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

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

Market Position

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

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

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

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

Research on Psychedelics

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

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

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

Extract Segment Leader with Cannabis

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

Management Team

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

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

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

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

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

Pure Extracts Technologies Corp. (CSE: PULL), closed Monday's trading session at $0.57, off by 5.00%, on 208,459 volume with 80 trades. The average volume for the last 3 months is 422,527 and the stock's 52-week low/high is $0.52/$0.63.

Recent News

• Opioid Drugs Approved in Last Two Decades Lack Sufficient Safety Assessments
• 420 with CNW - Texas Legislators Pre-File Bills to Legalize Marijuana
• Pure Extracts Technologies Corp. (CSE: PULL) Announces Board Appointment of Dwight Duncan

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

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

Josemaria Resources (TSX: JOSE) (OTCQB: JOSMF) (OMX: JOSE), a Canadian-based natural resources company, on Friday announced its results for three months ended September 30, 2020. To view the full press release, visit https://ibn.fm/CQNWg

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 Monday's trading session at $0.53865, off by 1.6883%, on 2,880 volume with 7 trades. The average volume for the last 3 months is 23,578 and the stock's 52-week low/high is $0.37/$0.69.

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