Genprex Inc. (NASDAQ: GNPX)

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

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX ), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, is pleased to announce it has commenced clinical trial site recruitment for its upcoming Acclaim-1 clinical trial for the treatment of non-small cell lung cancer (NSCLC). As planned, the timing of the patient recruitment and enrollment puts the Company on track for its Acclaim-1 clinical trial to commence in the first-half of 2021.

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

Research and Development

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

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

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

Clinical Trials

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

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

The Market

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

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

Senior Management

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

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

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

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

Genprex Inc. (NASDAQ: GNPX), closed Monday's trading session at $3.23, up 4.5307%, on 1,282,112 volume with 3,751 trades. The average volume for the last 3 months is 678,012 and the stock's 52-week low/high is $0.231000006/$7.0300002.

Recent News

• Genprex Initiates Site Recruitment for Acclaim-1 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer
• BioMedNewsBreaks - Genprex Inc. (NASDAQ: GNPX) to Present at Diamond Equity Research Emerging Growth Invitational
• Genprex Inc. (NASDAQ: GNPX) to Participate in Life Sciences Summit Panel

Clean Power Capital Corp. (CSE: MOVE) (FWB: 2K6) (OTC: MOTNF)

The QualityStocks Daily Newsletter would like to spotlight Clean Power Capital Corp. (CSE: MOVE) (FWB: 2K6) (OTC: MOTNF).

Clean Power (CSE: MOVE) (OTC: MOTNF) (FWB: 2K6) on Thursday issued a news release to comment on the stock halt on the Frankfurt Exchange and IIROC-imposed trading halt, both on Nov. 24, 2020. According to the update, the company provided clarification on certain statements made in a paid promotional newsletter in Germany about the company’s investment in PowerTap Hydrogen Fueling Corp. To view the full press release, visit https://ibn.fm/FimSp

Clean Power Capital Corp. (CSE: MOVE) (FWB: 2K6) (OTC: MOTNF) is an investment holding company that focuses on investing in and providing early-stage financing to both public and private businesses. Since its original listing with the Canadian Stock Exchange (“CSE”) on January 23, 2019, the company has made investments in a number of different businesses in a variety of industries, including the energy and cannabis sectors. As per the company’s investment policy, its primary goal is to identify and capitalize on high-return investment opportunities presenting the ability to achieve capital appreciation and liquidity.

Clean Power Capital continues to be opportunistic in evaluating prospects across the renewable energy, bio-medical, pharmaceutical and naturopathic sectors, both as an investor and as an operator. The company’s main focus at the moment is to identify such opportunities in the renewable energy industry, including wind, solar and geothermal power and hydrogen and fuel cell technologies, as well as in the biomedical, pharmaceutical and naturopathic sectors, which may include medical or recreational cannabis.

Clean Power Capital currently has 10 investments in a variety of sectors and successfully held nearly C$120 million in investments during the past fiscal year (https://ibn.fm/8oktZ). It returned capital to its shareholders through the distribution of its interest in AgraFlora Organics International Inc. in May 2020 (https://ibn.fm/FRAvq).

Headquartered in Vancouver, British Columbia, Clean Power Capital was formerly named Organic Flower Investments Group Inc. As of November 10, 2020, the company officially changed its name to Clean Power Capital and started trading on the CSE under new ticker symbol ‘MOVE’.

PowerTap Acquisition, Hydrogen Fueling Infrastructure Collaboration

In alignment with its updated investment policy, a reconstituted investment committee and a revised strategy to reflect its focus on the renewable energy market, Clean Power Capital recently completed the acquisition of a 90 percent equity interest in California-based PowerTap Hydrogen Fueling Corp.

Leveraging an impressive portfolio of IP and advanced deployed technologies developed over two decades via substantial investments and partnerships, PowerTap is working on building and expanding a hydrogen filling station network, initially across North America. The company believes that its platform has a significant advantage over other hydrogen fueling stations, because it has a smaller physical footprint and further has the capacity to produce hydrogen fuel on site. As most other hydrogen fueling stations buy hydrogen for storage at higher costs, PowerTap’s model is believed to be exponentially more cost-effective and expandable.

Clean Power Capital’s investment and acquisition will allow PowerTap to step up its efforts and begin work on the hydrogen fueling station network in stages, starting with engineering and design, ongoing development of PowerTap’s third generation product and, finally, licensing & permitting and site preparation. Development is expected to begin in Q4 2021 with engineering and design. Overall, the initial portion of the project is expected to cost $17 million, with Clean Power Capital and PowerTap planning to secure government financing and credit, as well as equity, debt and convertible debt offerings, to fund the infrastructure’s development.

PowerTap technology is already deployed across multiple hydrogen fueling stations in public and private enterprises spanning California, Maryland, Massachusetts and Texas. The company plans to deploy its hydrogen fueling infrastructure at existing truck stops and gas stations across the country, beginning with up to 1,000 stations within the next three to five years. At the moment, there are roughly 70 active hydrogen fueling stations operational and available to consumers in the United States.

Hydrogen Industry Outlook

The project is expected to bring significant opportunities for PowerTap and Clean Power Capital on the fast-growing hydrogen market, driven by a worldwide focus on clean energies and environmentally friendly fueling solutions for the transportation industry.

Hydrogen-powered vehicles come with tremendous advantages over gas, diesel and even electric vehicles in terms of cost per mile, fueling time and driving range, as well as boasting significantly lower emissions. Well-established vehicle manufacturers such as Hyundai, Toyota, Daimler and Volvo are already including hydrogen-powered cars in their product lineups, and Nikola Motors has announced plans to manufacture hydrogen electric long-haul vehicles.

“As an experienced developer of technology in an important area that is finally having its time as a green but also economically compelling energy option, PowerTap is intent on becoming a leading part of the multi-billion dollar hydrogen fueling space,” PowerTap CEO Raghu Kilambi explained in a news release on October 28, 2020 (https://ibn.fm/oaXem).

A recent industry report developed by a coalition of major oil and gas, power, automotive, fuel cell and hydrogen companies indicates that the sector is expected to grow to $140 billion a year in revenue by 2030, creating 700,000 jobs in the U.S. alone (https://ibn.fm/UMI5q). According to Fuel Cell and Hydrogen Energy Association President Morry Markowitz, the sector could expand to $750 billion a year in revenue and 3.4 million jobs by 2050.

The U.S. is already engaged in the hydrogen economy, having more than half of the global number of fuel cell vehicles and investing hundreds of millions of dollars a year, but the country can greatly expand its global energy leadership by scaling up operations in the hydrogen economy, per the industry report.

With the upcoming change in administration in January 2021, the U.S. is expected to renew its commitment to clean energy. Moreover, the U.S. federal government is expected to invest significantly in clean energy and related infrastructure, including hydrogen, according to PowerTap.

“As the U.S. federal government has previously invested in the PowerTap technology, we are optimistic that we will have a seat at the table when USA clean energy/hydrogen infrastructure spending initiatives are designed,” Kilambi added.

Management Team

Joel Dumaresq is the CEO and interim CFO of Clean Power Capital. He is a proven executive with extensive operational and senior management experience in mining, energy and alternative energy, as well as the cannabis and hemp space. Dumaresq began his career in the corporate finance space, having spent 12 years with RBC Dominion Securities. He brings 30 years of experience in the financial sector to the company, has been instrumental in raising over $250 million in venture capital finance, and he has personally managed a number of successful public listings.

Brendan Purdy serves as a director of Clean Power Capital. An experienced businessperson who has led five different companies, Purdy brings years of experience in different industries, including cannabis, blockchain and data security, gaming, mining and energy, and finance and law. He received a graduate degree from the University of Ottawa and an undergraduate degree from the University of Western Ontario.

Theo van der Linde serves as a director of Clean Power Capital. He is a Chartered Accountant with over 20 years extensive experience in finance, reporting, regulatory requirements, public company administration, equity markets and financing of publicly traded companies. He has served as a CFO & Director for a number of TSX Venture Exchange- and Canadian Securities Exchange-listed companies over the past several years. His industry experience spans the financial services, manufacturing, oil & gas, mining and retail industries. More recently, van der Linde has been involved with future use trends of natural resources, as well as other disruptive technologies.

Raghu Kilambi is the CEO and CFO of PowerTap Hydrogen. He is a seasoned investor and entrepreneur with over 25 years of global business experience in public and private investments, building businesses and creating shareholder value. He has raised over $1 billion of equity and debt capital for private and public companies and been involved in many M&A acquisitions and exits.

Clean Power Capital Corp. (OTC: MOTNF), closed Monday's trading session at $1.31362, up 13.1651%, on 103,078 volume with 67 trades. The stock's 52-week low/high is $0.0315/$1.75.

Recent News

• InvestorNewsBreaks - Clean Power Capital Corp. (CSE: MOVE) (OTC: MOTNF) (FWB: 2K6) Issues Commentary on IIROC-Imposed Trading Halt
• InvestorNewsBreaks - Clean Power Capital Corp. (CSE: MOVE) (OTC: MOTNF) (FWB: 2K6) Appoints Industry Visionary to PowerTap Advisory Board
• Clean Power Capital Corp. (CSE: MOVE) (FWB: 2K6) (OTC: MOTNF) Is 'One to Watch'

Brain Scientific Inc. (OTCQB: BRSF)

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

Brain Scientific’s (OTCQB: BRSF) Vice President of Marketing, Stuart Bernstein, has written an article for Health Care Business News titled, “COVID's influence on neurology drives need for disposable technologies.” The piece discusses increased concern for health care and frontline workers treating emergent cases for COVID-19 patients developing neurological symptoms and conditions, as well as a critical need for testing solutions. To view the full press release, visit: https://ibn.fm/IHnkN

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

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

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

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

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

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

NeuroCap(TM) – Disposable EEG Headset

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

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

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

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

NeuroEEG(TM) – Miniature and Portable Wireless EEG Amplifier

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

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

Products in Active Development

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

Routine EEG

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

Pediatric EEG

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

Long-Term Monitoring

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

Artificial Intelligence

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

Telemedicine

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

 

Partnership with Marketing Brainology

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

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

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

Market Outlook

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

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

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

Management Team

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

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

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

Brain Scientific Inc. (OTCQB: BRSF), closed Monday's trading session at $1.00, up 5.2632%, on 6,599 volume with 6 trades. The average volume for the last 3 months is 3,878 and the stock's 52-week low/high is $0.100000001/$3.00999999.

Recent News

• BioMedNewsBreaks - Brain Scientific Inc. (BRSF) Enters Strategic Agreement for Expansion into EU Market
• BioMedNewsBreaks - Why Brain Scientific Inc. (BRSF) Is 'One to Watch'
• Brain Scientific Inc. (BRSF) Has Three-Phase Plan to Improve Access to Neurological Care

AzurRx BioPharma Inc. (NASDAQ: AZRX)

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

AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that the first two patients have been dosed in Turkey for its Phase 2 trial. The trial evaluates its investigational drug, MS1819, in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (“PERT”), for the treatment of severe exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”). To view the full press release, visit: https://ibn.fm/XGBwo

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 $0.7943, up 2.5565%, on 291,541 volume with 506 trades. The average volume for the last 3 months is 143,620 and the stock's 52-week low/high is $0.370867997/$1.93830001.

Recent News

• BioMedNewsBreaks - AzurRx BioPharma Inc. (NASDAQ: AZRX) Announces Advancement of MS1819 Combination Therapy Trial in Turkey
• Microorganisms Found in Child's Bed Dust May Boost Their Health
• AzurRx BioPharma Inc. (NASDAQ: AZRX) Planning to Test Immediate Release MS1819 Capsules in Cystic Fibrosis Study

Pure Extracts Technologies Corp. (CSE: PULL)

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

Pure Extracts Technologies (CSE: PULL) (XFRA: A2QJAJ), a plant-based extraction company focused on cannabis, hemp and the rapidly emerging functional mushroom sectors, on Thursday provided an update and overview regarding its expansion into the functional mushroom wellness sector. According to the update, interest is climbing sharply in functional and medicinal mushrooms, particularly regarding medicinal opportunities. Pure Extracts noted increased institutional interest in the field of psychedelics in general and with a focus on promising mushroom varieties such as psilocybin specifically. To view the full press release, visit https://ibn.fm/H9XpK

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 $0.67, up 6.35%, on 390,345 volume with 169 trades. The average volume for the last 3 months is 309,697 and the stock's 52-week low/high is $0.52/$0.68.

Recent News

• PsychedelicNewsBreaks - Pure Extracts Technologies Corp. (CSE: PULL) (XFRA: A2QJAJ) Advances Move into Field of Mushroom Extractions
• Pure Extracts Technologies Corp. (CSE: PULL) Strengthens Oil Extraction Business, Ventures into Functional Mushroom Space
• 420 with CNW-Longest-Serving Marijuana Offender May Be Released from Prison Soon

HempFusion Wellness Inc.

The QualityStocks Daily Newsletter would like to spotlight HempFusion Wellness Inc..

Legal cannabis consumers have already become well aware of the hammering the industry has taken during the COVID-19 era. Market outlooks have been revised sharply downward as many retailers selling CBD products have closed temporarily or transitioned to curbside pickup and delivery, and farmers have reduced their hemp acreage. But nearly a year into the global pandemic, there have been bright spots as well. CBD brand HempFusion Wellness is optimistic about renewed energy in the marketplace, mirroring its products’ aim to help restore energy and wellness balances to its consumers.

Recent News

• Amid Pandemic’s Battering on Hemp / CBD Markets, HempFusion Wellness Inc. Sees Brighter Future
• QualityStocksNewsBreaks – Why HempFusion Wellness Inc. Is ‘One to Watch’
• HempFusion Wellness Builds Reputation for Safety in the Global CBD Market, Aims to IPO on TSX Exchange

Rritual Superfoods Inc.

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

The recently concluded election cycle in the United States revealed that a growing number of people, regardless of political affiliation, are continuing to explore their options for boosting their wellness and mental flexibility, even including the use of some products that have long been classified as illegal (https://ibn.fm/0wxgz). As a prime example, Oregon has gained significant attention for passing its measure to legalize the hallucinogenic compound in “magic mushrooms” for mental health treatment in supervised settings (https://ibn.fm/tcM4A). Rritual Superfoods is pushing to become a leader in an emerging mushroom market, but not the one that’s gaining attention from hallucinogenic users and their opponents. Rather, Rritual is among innovators calling attention to the health benefits of “functional fungi” — the dietary mushrooms that have enjoyed health-promoting status for centuries in Asian countries in particular.

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

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

Suite of Premium Rritual(TM) Products

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

The initial product line includes:

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

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

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

Rritual Timeline

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

Rritual E-Commerce Rollout Strategy

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

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

Brick-and-Mortar Rollout Strategy

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

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

Market Growth Outlook

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

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

Management Team

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

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

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

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

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

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

Investment Considerations

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

Recent News

• Emerging Functional Mushroom Market Ripe with Potential for Rritual Superfoods’ New Product Line
• Rritual Superfoods’ Extensive Distribution Network Set to Take Functional Mushrooms Mainstream
• Rritual Superfoods Inc. Delivers ‘Daily Dose’ Through Flagship Product Line

Knightscope, Inc.

The QualityStocks Daily Newsletter would like to spotlight Knightscope, Inc..

Knightscope, a developer of advanced physical security technologies utilizing fully autonomous security robots (“ASRs”), recently announced its award of eight patents. The patents cover the company’s Autonomous Data Machines and Systems (“ADMs”) (U.S. Patent Nos. 9,329,597, 9,910,436, 10,279,488 and 10,579,060), the security data analysis and display features of the KSOC (U.S. Patent Nos. 9,792,434 and 10,514,837) and its parking monitor feature (U.S. Patent Nos. 9,773,413 and 10,311,731). Knightscope has additionally filed one provisional patent covering the ADMs’ behavioral autonomous technology. The company, as it gains more experience (now having operated over 1 million hours in the field), expects to stream additional innovations out of its Silicon Valley-based headquarters in the coming months and years. To view the full update, visit https://ibn.fm/feohg

Knightscope, Inc., founded in 2013 and based in Mountain View, California, is a leader in the development of autonomous security capabilities and are on target to disrupt the $500 billion security industry. Knightscope’s technology uniquely combines self-driving technology, robotics and artificial intelligence.

Knightscope designs and builds Autonomous Security Robots (ASRs) that provide 24/7/365 security to the places you live, work, visit and study. The company’s client list covers public institutions and commercial business operations, including ten Fortune 1000 companies to date. These ASRs have been proven to enhance safety at hospitals, logistics facilities, manufacturing plants, schools and corporations. ASRs act as highly cost-effective complementary systems to traditional security and law enforcement officials, providing an additional advantage by continuing to offer uninterrupted patrolling capabilities across the country, despite the pandemic (note: robots are immune).

The company’s ASRs have assisted in the arrest of suspects involved in crimes ranging from armed robbery to hit-and-runs. Their machine-embedded thermal scanning capability even aided in preventing the breakout of a major fire.

The company has achieved several milestones since its creation in 2013, including:

• Establishing itself in a 15,000-square-foot facility located in Mountain View, California, in the heart of Silicon Valley, where Knightscope designs, engineers and builds its technology;
• Operating for more than one million hours in the field and securing contracts across five time zones;
• Navigating through the global pandemic without interruption by continuing to operate on a daily basis across the nation and supporting clients classified as essential services; and
• Continuing its hiring processes despite the current societal and economic disruption.

Growth Capital

With more than 10,000 investors and over $40 million raised since inception, Knightscope is poised to be an industry leader in the future of public safety and security.

The company is presently in the process of raising up to $50 million in growth capital as it prepares for a potential public listing. Knightscope has reserved ticker symbol ‘KSCP’ with Nasdaq.

Investors can buy shares exclusively through the company’s managing broker-dealer, StartEngine (http://nnw.fm/l9GLX) until July 20, 2020. Concurrent with this live offering and contingent upon various factors, including raising a sufficient amount of funds and meeting applicable listing standards, the company intends to begin preparation of an S-1 format Form 1-A and Nasdaq Capital Market application in anticipation of a possible public listing of the stock at the conclusion of the Regulation A+ offering.

Company Mission — The Greater Good

Knightscope’s long-term vision has an eye on the greater good. The company’s mission is to make the United States of America the safest nation in the world while supporting millions of law enforcement and security professionals across the country.

Crime has a negative economic impact in excess of $1 trillion annually. As crime is reduced, positive impacts will likely be realized across several aspects of society, including housing, financial markets, insurance, municipal budgets, local business and safety in general.

Knightscope CEO William Santana Li was recently interviewed by Kevin O’Leary, more commonly known as Shark Tank’s Mr. Wonderful. When asked to explain how the benefits provided by the ASRs outrank a human doing the same job, Li said, “First, just the simple presence of a physical deterrent causes criminal behavior to change. Second, the machines are self-driving cars that patrol all around and recharge themselves. They also generate 90 terabytes of data per year. No human would ever be able to process that. The robots are intended to be eyes and ears for the humans, not a one to one replacement.”

The Knightscope solution to reduce crime combines the physical presence of ASRs, sometimes referred to as proprietary Autonomous Data Machines, with real-time onsite data collection and analysis. The ASRs are fitted with eye-level 360° cameras, thermal scanning, public address announcements and various other features that work in tandem with humans to provide law enforcement officers and security guards unprecedented situational awareness.

Those 90 terabytes of data are then formatted in a useable way, so law enforcement can leverage that information and execute their responsibilities more effectively.

Public Safety Innovation

The company’s recurring revenue business model is set up to mimic the recurring societal problem of crime, and it takes into consideration the fact that innovation in the security and public safety industry has been stagnant for decades. Because the traditional practices of the sector have remained unchanged for years, automation has potential to drive substantial cost savings — and significant improvement in capabilities.

Human security guards are one of both the largest expenses and the largest liabilities for companies. Knightscope’s robots are offered at an effective price of $4 to $11 per hour, compared with approximately $85 and $30 per hour for an armed off duty law enforcement officer and an unarmed security guard, respectively.

This innovation has the potential to drive considerable cost savings. Based on these estimates, manufacturing costs can be recovered as soon as the first year of operation.

Product Offerings

The company has four patents and a framework of unique intellectual property. Knightscope currently offers a K1 stationary machine, a K3 indoor machine and a K5 outdoor machine. A K7 multi-terrain four-wheel version is in development.

The ASRs autonomously patrol client sites without the need for remote control, providing a visible, force multiplying, physical security presence to help protect assets, monitor changes in the area and deter crime. The data is accessible through the Knightscope Security Operations Center (KSOC), an intuitive, browser-based interface that enables security professionals to review events generated by the ASRs providing effectively ‘mobile smart eyes and ears’.

The ASRs and all the related technologies were developed ground up by the Company and are Made in the USA.

Management Team

Chief Executive Officer William Santana Li is a veteran entrepreneur, a former executive at Ford Motor Company and the founder of GreenLeaf, a company that grew to be the world’s second-largest automotive recycler and is now part of LKQ Corporation (NASDAQ: LKQ).

Chief Client Officer Stacy Dean Stephens brings his experience as a former Dallas law enforcement officer, as well as his skills as a seasoned entrepreneur, to assist on the client acquisition side.

Chief Intelligence Officer Mercedes Soria is an award-winning technologist and former Deloitte software engineer.

Chief Design Officer Aaron Lehnhardt brings over two decades of two- and three-dimensional product and industrial design in modeling and VR to the table, on top of his experience as a senior designer at Ford Motor Company.

Recent News

• QualityStocksNewsBreaks – Knightscope Inc. Secures Many New Patents
• Knightscope, Inc. Reimagines Public Safety Across the U.S. Through Autonomous Security Capabilities
• QualityStocksNewsBreaks – Knightscope Inc. K5 to Soon Patrol Arizona Campus

Sugarmade, Inc. (SGMD)

The QualityStocks Daily Newsletter would like to spotlight Sugarmade, Inc. (SGMD).

Sugarmade Inc. (OTCQB: SGMD) was featured today in the 420 with CNW by CannabisNewsWire. Back in April 2019, a group of cities in California that have banned recreational cannabis sales sued Gov. Gavin Newsom’s administration. The state allows recreational pot deliveries even in cities that haven’t opted into the cannabis market, and the 24 cities argued that this violated Proposition 64, which allowed recreational sales in California. The lawsuit was filed against the California Bureau of Cannabis Control at the Fresno County Superior Jail. Also today, the company was featured again in the evening 420 with CNW by CannabisNewsWire. Since the 2018 Farm Bill legalized the growing and sale of hemp and its different extracts, cannabidiol (CBD) has become immensely popular. Extracted from industrial hemp, a variety of cannabis that is not psychoactive, CBD is part of a group of compounds called cannabinoids that have diverse medicinal properties. Although research into CBD’s medical abilities is still ongoing, plenty of users claim the hemp extract successfully alleviates a variety of conditions, including insomnia, chronic pain and anxiety, among others.

Sugarmade, Inc. (SGMD) is headquartered in Monrovia, California, where the company recognizes new opportunities in the cannabis delivery space and in the market for supplies to the quick-service restaurant industry – both of which have fast-changing dynamics due to the recent outbreak of coronavirus in the United States.

The Coronavirus Cannabis Boom Market

Retailers across the nation are closing their doors and curtailing operations due to the coronavirus pandemic, inherently pinching sales. In the California cannabis sector, however, business has never been better – especially relative to home delivery.

California’s cannabis industry continues to operate, and media reports reveal booming cannabis sales as the state’s citizens stay home to wait out current events. The Los Angeles Times recently published the headline, “Marijuana Sales on Fire amid Virus Outbreak; New York Post “Cannabis sales hit new highs”; USA Today “American Stock Up on Pot” Fox News “California marijuana sales surge”; and ABC News Cannabis Shops thrive in coronavirus pandemic.

The state of California benefits from the ultra-high taxes paid by the highly regulated cannabis industry, and has thus deemed cannabis companies as “essential” businesses, allowing for full operations to continue. While pot shops are seeing strong foot traffic, the real growth action is in-home delivery as consumers seek to embrace social distancing. Many delivery operators are reporting difficulty in meeting demand with sales growth of up to 10% sequentially each week. It is certainly a boom time for the industry.

Sugarmade Growth Strategy

Recognizing new investment and operational opportunities within California’s cannabis market, Sugarmade is strategizing to take advantage of opportunity specifically in delivery services (non-storefront retailer), manufacturing via co-branding, and selective genetic cultivation. The company is taking a highly selective approach, targeting only the best of these opportunities for company growth.

In line with this strategy is northern California delivery service Budcars, in which Sugarmade owns a 40% interest and an option to gain a controlling interest. Budcars connects consumers with premium products sourced from top-tier farms and extractors, offering a curated menu of fully compliant cannabis products. The company maintains a competitive advantage by sourcing premium cannabis offerings and same-day delivery. In addition to maintaining its own cars, California licenses, and fulfillment center, Budcar orders its premium products in bulk at lower prices, enabling the company to rein in costs and maintain competitive pricing for its customers. Currently serving major communities within the metropolitan area of Sacramento, Budcars plans to continue the expansion of the company’s delivery reach.

Sugarmade plans to continue its expansion into burgeoning new sectors of the cannabis market through the following avenues:

• Geographic expansion of Budcars delivery scope
• New delivery geographies
• Cannabis cultivation as a key component of a hybrid vertical integration strategy
• Product technology expansion—including products containing exotic and lesser-known cannabinoids

 

Diversified Portfolio

Sugarmade has positive market exposure to cannabis delivery, as well as to the restaurant industry, at a time when these businesses are being force to move toward take-out and delivery models in order to survive.

The company has various business operations in diverse marketplaces, including food, safe packaging and sanitary supplies for various industries, and agricultural supplies. Sugarmade entered the industrial hemp and CBD space by investing in Hempistry, Inc., a privately held Nevada corporation. Hempistry began planting an ultra-high cannabidiol (CBD) industrial hemp strain on a land option it holds on 5,000 acres of prime Kentucky farmland. The strain of industrial hemp being grown by Hempistry is ultra-rich in CBD but contains less than 0.3% of THC, the psychoactive ingredient found in cannabis.

CarryOutSupplies.com, the leader in paper and plastic take-out supplies, serves nationwide customers by offering a wide array of high-quality products that are cost-efficient, custom-made and delivered on time. This business unit currently serves 2,000 quick service restaurants, garnering from 30%-40% of the market share. Sugarmade plans to expand operations via the addition of market share and the introduction of new product offerings.

Market Opportunity

There is little doubt among industry participants, and recently confirmed by Forbes, that California is the single largest cannabis market in the world. The state is expected to produce more than $3.5 billion in cannabis sales during 2020, with growth topping 23% annually. The global industrial hemp market size was estimated at $4.71 billion in 2019 and is expected to register a revenue-based CAGR of 15.8% over the forecast period of 2016-2027, according to Grandview Research. Market growth drivers include the 2018 Farm Bill and society’s increasing knowledge of the benefits of hemp products.

Overall industry growth is great, but specific vertical sector growth is even better. Cannabis delivery is clearly the fastest growing sector of the marketplace and with coronavirus fears the already robust growth rate has accelerated.

Sugarmade seems to be in the right industry at the right time in history.

Management

CEO Jimmy Chan is an experienced business executive instrumental in growing multiple business operations with a strong expertise in international trade and banking, and international manufacturing and importation. He is also the founder of CarryOutSupplies.com, a company that revolutionized the custom-printed paper supplies subsector of the quick-service restaurant industry, which merged with Sugarmade in 2014.

Dedicated to getting the highest caliber of THC and CBD to its customers’ door, the company’s priority is to ensure that they receive the highest quality cannabis product free from logistical hassles. Sugarmade specializes in growing and acquiring innovative brands to maximize value for company employees, shareholders and other stakeholders. Sugarmade believes its future is very bright as the company expands operations within the cultivation sector and rapidly increases its revenue base.

Sugarmade, Inc. (SGMD), closed Monday's trading session at $0.0015, even for the day, on 45,771,835 volume with 166 trades. The average volume for the last 3 months is 31,370,975 and the stock's 52-week low/high is $0.001249999/$0.0161.

Recent News

• 420 with CNW-California Court Throws Out Lawsuit Against Marijuana Delivery Services
• 420 with CNW-Four Predictions for the Future of CBD Products
• 420 with CNW - Interesting Facts You Didn't Know About Marijuana

Net Element (NASDAQ: NETE)

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

Future generations may look back and wonder how humanity withstood the exhaust fumes, noise and environmental degradation created by fossil fuel engines. The downsides of combustible engines, rising fuel prices and positive government incentives are all factors driving EVs into the mainstream - and some experts predict purely electric models will surpass hybrids during the transition. Net Element (NASDAQ: NETE), through its proposed merger with Mullen Technologies, is planning to divest its payments processing business model to enter the burgeoning EV industry. The strategic move will allow the stakeholders of privately held Mullen to gain a majority of the new stock while catalyzing the process of taking the company public and accelerating its expansion in the United States.

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 $10.24, off by 10.1754%, on 908,396 volume with 6,780 trades. The average volume for the last 3 months is 1,860,634 and the stock's 52-week low/high is $1.472/$20.0783996.

Recent News

• As World Transitions away from Gas Guzzlers, Net Element Inc. (NASDAQ: NETE) Entering EV Market Through Mullen Technologies Merger
• Switching to EVs Triggers Burst of Innovation in Manufacturing
• Net Element Inc. (NASDAQ: NETE) Set to Benefit as China, U.S. Gear up to Promote Electric Vehicle Sales

Cybin Inc. (NEO: CYBN)

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

Cybin Inc. (NEO: CYBN) was featured today in a publication from PsychedelicNewsWire, examining how, in a webinar hosted by the Petrie-Flom Center for Health Law Policy of the Harvard Law School, speakers championed for psychedelics decriminalization. The webinar, which gathered more than 200 individuals, had panelists who discussed the benefits of the decriminalization of psychedelics while debating on the history and safety of the substances and how they affected people of color.

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

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

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

Serenity Life Sciences & Natures Journey Inc.

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

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

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

Partnership with the Toronto Centre for Psychedelic Science (TCPS)

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

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

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

Journey’s Product Monetization & Market Potential for Nutraceutical Supplements

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

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

Pharmaceutical Psychedelics

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

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

Amalgamation Agreement and Financing

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

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

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

Cybin Inc. (NEO: CYBN), closed Monday's trading session at $0.89, off by 4.30%, on 980,293 volume with 460 trades. The average volume for the last 3 months is 718,275 and the stock's 52-week low/high is $0.64/$1.09.

Recent News

• Speakers at Harvard Law School Webinar Voice Support for Psychedelics Decriminalization
• Canadian Government Gives Formal Response to Petition to Decriminalize Psychedelics
• Psychedelics Alter How Humans Recognize Facial Emotions

VistaGen Therapeutics Inc. (NASDAQ: VTGN)

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

VistaGen Therapeutics (NASDAQ: VTGN) has reported new preclinical findings differentiating the mechanism of action of PH94B from that of benzodiazepines (https://ibn.fm/Al4ur). PH94B is an intranasal neuroactive steroid VistaGen is preparing for Phase 3 development as a potential acute rapid-onset treatment of anxiety in adults with social anxiety disorder. As a solution to anxiety notably lacking the notorious side effects of traditional medications, the formulation could be a game-changer to the world of mental health.

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

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

New Generation Medications

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

PH94B

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

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

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

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

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

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

PH10

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

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

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

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

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

• Postpartum Depression
• Treatment-resistant Depression
• Suicidal Ideation

AV-101

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

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

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

CNS Therapeutics Market Outlook

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

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

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

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

Management Team

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

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

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

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

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

VistaGen Therapeutics Inc. (NASDAQ: VTGN), closed Monday's trading session at $0.7625, off by 0.974026%, on 671122 volume with 00 trades. The average volume for the last 3 months is 000,000 and the stock's 52-week low/high is $0.300000011/$1.05999994.

Recent News

• VistaGen Therapeutics Inc. (NASDAQ: VTGN) Announces Positive Preclinical Data for Potential Anxiety Treatment
• VistaGen Therapeutics (NASDAQ: VTGN) Seeks to Address Rising Incidence of Mental Health Disorders in United States
• VistaGen Therapeutics Inc. (NASDAQ: VTGN) Announces Q2 Results, Provides Update on CNS Pipeline and Business Progress

Predictive Oncology (NASDAQ: POAI)

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

Predictive Oncology (NASDAQ: POAI) was featured today in a publication from BioMedWire, examining how, in the last month, COVID-19 cases have increased significantly in New Jersey and Pennsylvania. The recent numbers top the figures recorded during the first wave of the coronavirus when the pandemic first hit. The rising numbers isn’t the most puzzling factor about this; more puzzling may be the fact that, despite the rising cases, people continue to make plans to meet up with family and friends during the upcoming Thanksgiving holiday, instead of social distancing.

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 $0.7022, off by 5.1081%, on 635863 volume with 00 trades. The average volume for the last 3 months is 000,000 and the stock's 52-week low/high is $0.629999995/$5.30000019.

Recent News

• Psychologist Explains Reason Behind Reckless Behavior Amid Worsening Pandemic
• Predictive Oncology's (NASDAQ: POAI) Skyline Medical Sells 15 Streamway(R) Systems in Q3 2020 as COVID-era Drives Need for Sanitation Systems
• Researchers May Have Found a New Way to Predict Cancer Susceptibility

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. (OTCQB: ATUMF) (CSE: GOH) was featured today in a publication from MiningNewsWire, examining how we’ve seen the world change in many ways during these past few months, affecting different sectors globally and wreaking havoc on the economies of different countries. The mining industry has not been spared from change, with various issues plaguing the industry. Today we look at some of the biggest issues that this industry needs to overcome, in addition to what can be incorporated into the industry to gain a competitive advantage.

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 $0.3235, off by 6.2319%, on 113565 volume with 00 trades. The average volume for the last 3 months is 000,000 and the stock's 52-week low/high is $0.109999999/$0.446000009.

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