Renovaro BioSciences Inc. (NASDAQ: RENB)

The QualityStocks Daily Newsletter would like to spotlight Renovaro BioSciences Inc. (NASDAQ: RENB) .

Renovaro BioSciences Inc. (NASDAQ: RENB) (formerly NASDAQ: ENOB), an advanced, preclinical biotechnology firm in cell, gene and immunotherapy focused on solid tumors with short life expectancy, has inked a deal with GEDi Cube Intl Ltd. The agreement is to combine the two companies with GEDi Cube becoming a wholly owned subsidiary of Renovaro in a stock-for-stock acquisition. The combined company would focus on accelerating precision and personalized medicine for longevity powered by mutually reinforcing artificial intelligence ("AI") and biotechnology platforms to enable early diagnosis, better targeted treatments and drug discovery. GEDi Cube is an artificial intelligence medical technology company. According to the announcement, the newly formed company would have a unique advantage: Renovaro Biosciences' preclinical and clinical trial data could be leveraged to accelerate GEDi Cube's AI capabilities that, in turn, could help to accelerate Renovaro's development of potential new therapies. "We believe GEDi Cube's AI technology will enhance and accelerate the development of treatments we are currently pursuing as well as power the discovery of new therapeutic approaches for cancer and other diseases," said Renovaro Biosciences CEO Dr. Mark Dybul in the press release. "The combined company will have independent operating divisions that will allow each technology to move as quickly as possible to commercialization while the collaboration between divisions will aim to drive new advances in both AI and medicine."

To view the full press release, visit https://ibn.fm/hiH0w

Renovaro BioSciences Inc. (NASDAQ: RENB), formerly Enochian BioSciences Inc., is an advanced, pre-clinical biotechnology firm in cell, gene and immunotherapy focused on solid tumors with short life expectancy. The company aims to unlock potentially long-term or life-long cancer remission in some of the deadliest cancers, and to potentially treat or cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) infection.

The oncology platform is now at the forefront of Renovaro’s development activities. While Renovaro’s current efforts focus primarily on pancreatic cancer, it plans to include other solid tumors with short life-expectancy in the first in human Phase I/IIa studies that are on track to start by mid-2024. The company’s Pre-Investigational New Drug (pre-IND) submission included a human study plan covering pancreatic cancer, as well as other cancers that are difficult to treat, potentially including triple-negative breast cancer, head and neck cancers and mesothelioma.

Renovaro’s proprietary, novel technology uses cell- and gene-therapy to promote a renewed immune response against solid tumors. Important confirmatory results from two humanized mouse models using the company’s novel dendritic cell-based therapy, independently conducted by Dr. Anahid Jewett, a renowned cancer researcher in the field of immunotherapy at UCLA, were presented previously at two scientific conferences and were the foundation supporting a pre-IND submission to the U.S. Food and Drug Administration. Notably, Dr. Jewett’s findings from these studies consistently demonstrated 80% to 90% pancreatic tumor reduction in size and weight that was correlated with significant enhancement of key aspects of the immune response.

Renovaro is headquartered in Los Angeles, California.

RENB-DC11

Renovaro’s product development strategy is anchored in the use of “non-self” or allogeneic cells that enhance targeted immune response. Its lead candidate, RENB-DC11, is an innovative therapeutic vaccination platform that could potentially be used to induce life-long remissions from some of the deadliest solid tumors.
Treatment with RENB-DC11 has now been shown to significantly reduce the size of human pancreatic tumors in humanized mice in three independent studies. The reduction in tumor size correlated with statistically significant increases in key components of an immune response.

Pre-IND was completed in June 2023, with IND filing forecast for first half of 2024. First in-human Phase I/IIa trials are predicted shortly after in H1 of 2024, including pancreatic and other solid tumors with poor treatment options and life-expectancy.

Renovaro believes that RENB-DC11 could represent the most promising and effective strategy to achieve life-long remission for a number of common and deadly tumors.

Other Development Candidates

In addition to its lead oncology platform, Renovaro’s development pipeline includes a platform targeting infectious diseases, including:

• RENB-HV12 – An engineered allogeneic T-Cell vaccine, this therapeutic HIV vaccine candidate enhances immune infiltration, immune killing and immune surveillance. Potential pre-IND submission is planned for first half of 2024, with IND-submission expected in second half of 2024.
• RENB-HV21 – Leveraging allogeneic NK plus Gamma Delta T (GDT) cells as potential therapy for HIV, ENOB-HV21 shows promising preliminary results without confounding factors. Renovaro owns an exclusive license and has completed the Pre-IND submission, with a potential IND submission and human trials expected in 2024.
• RENB-HV01 – Caring Cross, a non-profit corporation, has shown that its proprietary CAR-T cells cure HIV in a mouse model. Studies in humans have begun. Renovaro has entered into a profit-sharing sublicense with Caring Cross and would share in profits if the product is commercialized.
• RENB-HB01 – This therapeutic approach aims to eliminate all HBV rapidly (“seek and kill”) with a two to three dose treatment regimen. It is expected to be applicable for early disease to maximize impact with low risk of toxicity. Pre-IND comments have been received from the FDA for its AAV-delivery system.
  LOI to Merge with GEDi Cube International Ltd.

On August 9, 2023, Renovaro announced its execution of a binding, exclusive letter of intent to merge a subsidiary with cutting-edge health AI company GEDi Cube International Ltd. The combined company is expected to create a potential multiplier effect to accelerate earlier diagnosis, more effective therapy, and precision in silico drug discovery.

GEDi Cube’s innovative technology, developed over nearly a decade, has already validated earlier diagnoses of lung cancer in humans at a leading university hospital. GEDi Cube has likewise created the early diagnosis technology for 12 additional cancers, including pancreatic and breast cancer.

“I believe joining forces with GEDi Cube could enhance the efficacy of our upcoming trials and speed up the discovery of novel treatment approaches, thereby extending our life-saving technology to more cancer patients and renewing hope for them and their families,” Dr. Mark Dybul, CEO of Renovaro, stated in the news release.

GEDi Cube is led by CEO Craig Rhodes, who brings to that company tremendous industry experience leading life sciences groups at industry leaders Intel, Oracle and NVIDIA.

Market Opportunity

Pancreatic cancer alone is diagnosed globally in approximately 495,000 people each year, including roughly 64,000 in the U.S. Nearly 466,000 of those patients die annually, including approximately 51,000 in the U.S. Because of limited treatment options, life expectancy is very poor – with an approximately 10% patient survival rate at five years after diagnosis.

The global pancreatic cancer treatment market was valued at $2.15 billion in 2021 and is projected to grow from $2.48 billion in 2022 to $6.85 billion by 2029, according to Fortune Business Insights. That growth represents a CAGR of 15.7% for the forecast period.

A separate report from Fortune Business Insights projects that the global HIV drug market will grow from $30.46 billion in 2021 to $45.58 billion in 2028, recording a CAGR of 5.9% over the forecast period.

According to GlobalData, the value of the market for hepatitis B treatment is forecast to experience a significant increase in the coming years, with revenues expected to grow from $1.6 billion in 2022 to $10.5 billion in 2029. That represents a very rapid CAGR of 30% over the period. An estimated 296 million people suffer from the condition worldwide.

Management Team

Dr. Mark Dybul is the CEO of Renovaro. He has served as a tenured professor in the Department of Medicine at Georgetown University Medical Center since June 2017. He also served as Faculty Co-Director of the Center for Global Health and Quality from 2017-2021. Dr. Dybul has worked on HIV and public health for nearly 30 years as a clinician, scientist, teacher and administrator, including as an architect and eventually the Global Ambassador of the U.S. President’s Emergency Plan for AIDS Relief and the Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria from 2013 through May of 2017, and as the co-director of the Global Health Law Program at the O’Neill Institute for National and Global Health Law from 2009 through 2012. He is a member of the U.S. National Academy of Medicine.

Luisa Puche is the company’s CFO. She has served as a senior accounting and financial advisor and president of Puche Group LLC from 2015-2019. She served in various key executive roles, including Interim Chief Accounting Officer, at Brightstar Corp., a $10 billion global wireless device services provider. Ms. Puche began her career at Ernst & Young, where she served for approximately 10 years. Leveraging her broad global audit, advisory and corporate expertise, she has provided strong cross-functional leadership experience managing small and large projects for both publicly traded and privately held companies in various industries, including a global implementation of the latest revenue recognition accounting standard for Del Monte, as well as the global implementation of their SOX-404 program.

Francois Binette, Ph.D., is the Chief Operating Officer and Executive Vice President of Research & Development at Renovaro. He has over 25 years of product development expertise in Advanced Therapies and Regenerative Medicine. His broad industry experience spans a wide range of serious medical conditions, from orthopedics to ophthalmology, CNS and immuno-oncology. His career includes positions at Genzyme, Biosyntech, the DePuy Franchise of Johnson and Johnson, Medtronic and Lineage Cell Therapeutics. He received his Ph.D. from Laval University in Québec, followed by post-doctoral training at the Sanford-Burnham Institute in La Jolla and Harvard Medical School in Boston.

Renovaro BioSciences Inc. (NASDAQ: RENB), closed Friday's trading session at $4.47, up 9.828%, on 471,024 volume. The average volume for the last 3 months is 88,609 and the stock's 52-week low/high is $0.3928/$4.50.

Recent News

• Renovaro BioSciences Inc. (NASDAQ: RENB) - InvestorNewsBreaks - Renovaro BioSciences Inc. (NASDAQ: RENB) Enters Definitive Agreement to Combine with Leading AI Tech GEDi Cube
• Eliminating Barriers Surrounding Solid Tumors Allows T Cells to Kill Cancerous Cells
• Why Colon Cancer Is Largely Unresponsive to Immunotherapy

Lexaria Bioscience Corp. (NASDAQ: LEXX)

The QualityStocks Daily Newsletter would like to spotlight Lexaria Bioscience Corp. (NASDAQ: LEXX).

Lexaria's patented DehydraTECH(TM)-processed CBD has shown its ability to lower blood pressure in patients over multiple weeks

This technology has also shown positive impacts in obese diabetic-conditioned animals from its DIAB-A22-1 pre-clinical study

The NIC-H22-1 human nicotine study also demonstrated a statistically significant difference to achieve maximum blood saturation

These results have demonstrated DehydraTECH's potential while propping it to take advantage of vastly untapped markets with potential for growth in the coming years

Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug-delivery platforms, has entered into a securities purchase agreement with a single healthcare-focused institutional investor; the agreement is for the purchase of 1,618,330 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering. According to the announcement, Lexaria also agreed to issue and sell warrants to purchase up to 1,618,330 shares of common stock to the same investor. The combined effective offering price for each share of common stock (or pre-funded warrant in lieu thereof) and accompanying warrant is $0.97. The warrants will become exercisable six months from issuance, with an expiration date five and a half years from the issue date; the exercise price per share is $0.97. Lexaria anticipates receiving gross proceeds from the registered direct offering and concurrent private placement of approximately $1.6 million before the deduction of placement agent's fees and other offering expenses. The offering is expected to close on or about Oct. 3, 2023, and is subject to customary closing conditions. Maxim Group LLC is acting as the sole placement agent in connection with the offering.

To view the full press release, visit https://ibn.fm/yX2YU

Lexaria Bioscience Corp. (NASDAQ: LEXX) is a global innovator in drug delivery platforms. The company’s patented technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules. DehydraTECH promotes fast-acting, less expensive and more effective oral drug delivery and has been thoroughly evaluated through in vivo, in vitro and human clinical testing.

DehydraTECH is covered by 21 issued and more than 50 pending patents in over 40 countries around the world. Lexaria’s first patent was issued by the U.S. Patent and Trademark Office in October 2016 (US 9,474,725 B1), providing 20 years of patent protection expiring June 2034. Multiple patents have been awarded since then and are expected in the future.

Lexaria has also collaborated with the National Research Council (NRC), the Canadian government’s premier research and technology organization. The company has been granted patent protection for specific delivery of nicotine, vitamins, NSAIDs, antiviral drugs, cannabinoids and more.

Lexaria began developing DehydraTECH in 2014 and has since continued to strengthen and broaden the technology. The company has no plans to create or sell Lexaria-branded products containing controlled substances. Instead, Lexaria licenses its technology to other companies around the world to offer consumers the best possible performance across an array of ingestible product formats.

The company’s technology is best thought of as an additional layer that providers of consumer supplements, prescription and non-prescription drugs, nicotine and CBD products can utilize to improve the effectiveness of their own existing or planned new offerings. Lexaria has licensed DehydraTECH to multiple companies, including a world-leading tobacco producer for the research and development of smokeless, oral-based nicotine products, and for use in industries that produce cannabinoid beverages, edibles and oral products.

DehydraTECH is suitable for use with a wide range of product formats including pharmaceuticals, nutraceuticals, consumer packaged goods and over-the-counter capsules, pills, tablets and oral suspensions.

DehydraTECH Technology

Lexaria’s DehydraTECH is designed specifically for formulating and delivering lipophilic (fat-soluble) drugs and active ingredients. DehydraTECH increases their effectiveness and improves the way active pharmaceutical ingredients enter the bloodstream. The major benefits to a subject ingesting a DehydraTECH-enabled drug or consumer product can be summarized by the following:

• Speeds up delivery – the effects of the product are felt by the subject in just minutes.
• Increases bioavailability – the technology is much more effective at delivering a drug or product into the bloodstream.
• Increases brain absorption – animal testing suggests significant improvement in the quantity of drug delivered across the blood-brain barrier.
• Improves drug potency – more of the ingested product is made available to the body, so lower doses are required to achieve the desired effect.
• Reduces drug administration cost – lower doses mean lower overall drug costs.
• Masks unwanted taste – the technology eliminates or reduces the need for sweeteners.

Lexaria has demonstrated in animal studies a propensity for DehydraTECH technology to elevate the quantity of drug delivered across the blood-brain barrier by as much as 1,900 percent, initiating additional new patent applications and opening possibilities for improved drug delivery.

Since 2016, DehydraTECH has repeatedly demonstrated, with cannabinoids and nicotine, the ability to increase bio-absorption by up to five to 10 times, reduce time of onset from one to two hours to just minutes, and mask unwanted tastes. The technology is to be further evaluated for additional orally administered bioactive molecules, including antivirals, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and nicotine.

Market Outlook

Lexaria’s ongoing research and development efforts are mainly focused on development of product candidates across several key segments:

• Oral Cannabinoids – a market estimated to be worth $18.4 billion in 2021 and expected to reach $46.2 billion by 2025.
• Antivirals – an estimated $52.1 billion market in 2021 that’s expected to grow to $66.7 billion by 2025.
• Oral Mucosal Nicotine – smokeless tobacco products, a $13.6 billion market in 2018, is forecast to grow at 7.2 percent annually through 2025.
• Human Hormones – estrogen and testosterone replacement therapies represented a $21.9 billion market in 2019, with a forecast CAGR of 7.7 percent through 2027.
• Ibuprofen and Naproxen – NSAID sales totaled $15.6 billion globally in 2019 and are projected to reach $24.4 billion by 2027.
• Vitamin D3 – the global market size was $1.1 billion in 2021, growing at 7 percent per year and expected to reach $1.7 billion in 2026.

Management Team

Chris Bunka is Chairman and CEO of Lexaria Bioscience Corp. He is a serial entrepreneur who has been involved in several private and public companies since the late 1980s. He has extensive experience in the capital markets, corporate governance, mergers and acquisitions, as well as corporate finance. He is named as an inventor on multiple patent innovations.

John Docherty, M.Sc., is the President of Lexaria. He is a pharmacologist and toxicologist, and a specialist in the development of drug delivery technologies. He is the former president and COO of Helix BioPharma Corp. (TSX: HBP). He is named as an inventor on multiple issued and pending patents.

Greg Downey is Lexaria’s CFO. He has more than 35 years of diverse financial experience in the mining, oil and gas, manufacturing, and construction industries, and in the public sector. He served for eight years as CFO for several public companies and has provided business advisory and financial accounting services to many large organizations.

Gregg Smith is a strategic advisor to Lexaria. He is a founder and private investor with Evolution VC Partners. He is a member of the Sand Hill Angels and held previous investment banking roles with Cowen and Company and Bank of America Merrill Lynch.

Dr. Philip Ainslie serves as a scientific and medical advisor to Lexaria. He is co-director for the Centre for Heart, Lung and Vascular Health, Canada. He is also Research Chair in Cerebrovascular Physiology and Professor at the School of Health and Exercise Sciences, Faculty of Health and Social Development at the University of British Columbia.

Lexaria Bioscience Corp. (LEXX), closed Friday's trading session at $0.9999, up 3.0825%, on 50,196 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $4.50/$.

Recent News

• Lexaria Bioscience Corp. (NASDAQ: LEXX) - InvestorNewsBreaks - Lexaria Bioscience Corp. (NASDAQ: LEXX) Reports on Upcoming $1.6M Registered Direct Offering
• Lexaria Bioscience Corp. (NASDAQ: LEXX) Steadily Advancing its DehydraTECH(TM) Technology, Having Demonstrated its Potential Across Multiple Areas of Application
• Lexaria Bioscience Corp. (NASDAQ: LEXX) to Demonstrate DehydraTECH-CBD Benefits in Upcoming Investigational New Drug Application Submission

Knightscope, Inc. (NASDAQ: KSCP)

The QualityStocks Daily Newsletter would like to spotlight Knightscope, Inc. (NASDAQ: KSCP).

Knightscope (NASDAQ: KSCP), a leading developer of autonomous security robots ("ASRs") and blue light emergency communication systems, is continuing to add to its client roster. This time the company has inked deals with its first-ever ASR clients in Louisiana: two casinos, one located in Shreveport and the other in Bossier City.

According to the announcement, the two K5 ASR contracts have been executed as part of a larger agreement Knightscope received earlier this month. The contracts call for the two casinos to each receive a K5 robot. These two new ASRs bring the total robots under the contract to five, with the other robots being deployed to Las Vegas; Council Bluffs, Iowa; and Aurora, Illinois.

The ASRs at each of these locations are used to "greet guests with a friendly voice while also providing additional eyes and ears for the large human security team," stated Knightscope in the press release. "Robots also offer a two-way communication system to enhance the safety of visitors and workers."

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

Knightscope, Inc. (NASDAQ: KSCP), founded in 2013 and based in Mountain View, California, is a leader in the development of autonomous security capabilities targeting to disrupt the $500 billion security industry. Knightscope’s technology uniquely combines self-driving technology, robotics, artificial intelligence and electric vehicles.

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 multiple 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.

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. You can learn more about the crime fighting wins at www.knightscope.com/crime

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 (Made in the USA)
• Operating for more than 1 million hours in the field and securing contracts across five time zones, from Hawaii to Rhode Island
• Raising over $100 million since inception to build its technology from scratch and generating over $13 million in lifetime revenue, validating both the market opportunity and the technology

Growth Capital & Proposed Nasdaq Listing

With backing from more than 28,000 investors and four major corporations and over $100 million raised since inception, Knightscope is poised to be an industry leader in the future of public safety and security.

On December 1, 2021, Knightscope announced the commencement of an offering of up to $40 million of its Class A common stock, with shares to be listed immediately following closing on the Nasdaq Global Market under the ticker symbol ‘KSCP’. The offering is for up to 4 million shares priced at $10 per share. Learn more at www.knightscope.com/investors

Company Mission – Reimagining Public Safety

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 the 2+ million law enforcement and security professionals across the country.

Crime has an estimated negative economic impact in excess of $2 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 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 $3 to $9 per hour, compared with approximately $85 for an armed off-duty law enforcement officer and $15 to $35 for an unarmed security guard.

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 nine 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’. Learn more at www.knightscope.com/ksoc

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

The Robot Roadshow

Knightscope has created the ultimate hybrid physical and virtual event, bringing its Autonomous Security Robot technologies to cities across the country for interactive and in-person demonstrations.

Each roadshow landing is hosted virtually by a Knightscope expert, and visitors can interact directly with each of the company’s ASRs and see the Knightscope Security Operations Center (KSOC) user interface in action. Learn more at www.knightscope.com/roadshow

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.

Chief Financial Officer Mallorie Burke is a seasoned financial executive and strategic advisor for both private and publicly traded technology companies with a successful track record of mergers & acquisitions, corporate growth and exit strategies, including public listings.

General Counsel Peter Weinberg leverages 30 years of diverse corporate counsel experience, spanning from startups to well-established companies, private and public. He has significant experience training personnel at all levels in critical areas to improve corporate compliance and productivity.

Knightscope, Inc. (NASDAQ: KSCP), closed Friday's trading session at $0.7929, up 5.3828%, on 1,277,240 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.36/$3.65.

Recent News

• Knightscope (NASDAQ: KSCP) - InvestorNewsBreaks - Knightscope, Inc. (NASDAQ: KSCP) Announced Two Additional K5 ASR Orders Added to Expansion Contract
• Knightscope Receives Two More K5 Expansion Contracts for Casinos
• InvestorNewsBreaks - Knightscope, Inc. (NASDAQ: KSCP) Receives Blue Light Emergency Phone Order from Client Looking to Expand Existing System

InMed Pharmaceuticals Inc. (NASDAQ: INM)

The QualityStocks Daily Newsletter would like to spotlight InMed Pharmaceuticals Inc. (NASDAQ: INM).

InMed Pharmaceuticals (NASDAQ: INM), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, is reporting on the financial results for its fiscal year 2023, the period ending June 30, 2023. In addition, the company provided a status update on its pharmaceutical drug-development programs as well as the commercial segment for BayMedica LLC, its wholly owned subsidiary. Highlights of the report include total sales for subsidiary BayMedica of rare cannabinoids in the health and wellness sector reaching $4.1 million, an increase of 280% over the previous fiscal year and $2.3 million in revenue for the three months ended June 30, 2023, a quarter-over-quarter increase of 123%; cash, cash equivalents and short-term investments reached $9 million; completion of the phase 2 clinical trial studying the treatment of Epidermolysis Bullosa ("EB"); the launch of the INM-900 series preclinical program targeting the treatment of neurodegenerative diseases, including Alzheimer's, Huntington's and Parkinson's disease; and the publication of a peer-reviewed study showing the anti-inflammatory potential of rare cannabinoids in skin conditions.

In addition, the company reported a net loss for the fiscal year of $7.9 million, a decrease from the $18.6 million loss reported the previous year. "In fiscal year 2023, the company's wholly owned subsidiary, BayMedica, achieved substantial revenue growth via the supply of rare cannabinoids as ingredients to the health and wellness sector," said InMed Pharmaceuticals CEO Eric A. Adams in the press release. "In the January to June timeframe, BayMedica experienced substantial growth, as evidenced by two consecutive quarters of significant revenue increases. While we expect some fluctuations in revenue as ordering patterns in this developing market still mature, we remain optimistic about the long-term growth potential in the rare cannabinoids sector as the business dynamics and commercial opportunities continue to mature. Additionally, we continue to advance our pharmaceutical pipeline using rare cannabinoids for potential therapeutic applications in dermatology, ocular and neurodegenerative disease."

To view the full press release, visit https://ibn.fm/S2fUY

InMed Pharmaceuticals Inc. (NASDAQ: INM) is a global leader in the manufacturing and clinical development of rare cannabinoids. InMed is a clinical stage company developing cannabinoid-based pharmaceutical drug candidates, as well as manufacturing technologies for pharmaceutical-grade rare cannabinoids.

The company is dedicated to delivering new therapeutic alternatives to treat conditions with high unmet medical needs. The company is also developing a proprietary manufacturing technology to produce pharmaceutical-grade rare cannabinoids in the lab and has recently announced an LOI to acquire a leading rare cannabinoid manufacturer.

Research and Technology

There are more than 100 rare cannabinoids found in only trace amounts in the cannabis plant, together making up less than 1% of the plant’s biomass. InMed is initially focused on the therapeutic benefits of cannabinol (CBN) in diseases with high unmet medical need. Preclinical studies of CBN demonstrated an excellent safety profile and showed CBN has potential for therapeutic benefit over other cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD).

Evidence suggests there may be great therapeutic potential in rare cannabinoids. Each has a specific chemical structure, and different cannabinoids have been observed to have distinct physiological properties in humans, including therapeutic potential for specific diseases as well as unique safety profiles. CBN is the active pharmaceutical ingredient (API) in InMed’s two lead programs for dermatological and ocular diseases.

InMed’s most advanced compound, INM-755, is a CBN topical cream under clinical development for the treatment of epidermolysis bullosa, a severe genetic skin disorder. To date, INM-755 has been evaluated in two Phase 1 clinical trials in healthy volunteers. InMed has filed Clinical Trial Applications in several countries as part of a global Phase 2 clinical trial of INM-755 (cannabinol) cream in epidermolysis bullosa. Responses from the National Competent Authorities and Ethics Committees are expected throughout the summer of 2021.

InMed is also involved in developing INM-088, an ocular CBN formulation being researched for the treatment of glaucoma, the second leading cause of blindness in the developed world. InMed is currently evaluating several formulations to deliver CBN into the eye to address issues of dosing frequency, side effects and treatment penetration. INM-088 is being designed for topical delivery to the eye. This localized delivery results in very little drug being absorbed or migrating into the bloodstream, thus minimizing potential adverse side effects. INM-088 shows promise to reduce intraocular pressure and provide neuroprotection of the eye.

Manufacturing

The limited availability of rare cannabinoids like CBN makes them economically impractical to extract directly from the plant for pharmaceutical use. InMed is developing IntegraSyn, a cannabinoid synthesis manufacturing system to create rare cannabinoids in the lab that are bioidentical to the compounds derived from the cannabis plant. IntegraSyn uses multiple standard pharmaceutical processes and has achieved a cannabinoid yield of 5 grams per liter, surpassing commercial viability and significantly exceeding currently reported industry yields. InMed is now focusing on manufacturing scale-up to larger batch sizes while continuing process optimization, targeting increased cannabinoid yield and further reducing overall cost of goods.

BayMedica Inc. Acquisition

On June 29, 2021, InMed announced it had entered into a non-binding letter of intent to acquire BayMedica Inc., a private company based in Nevada and California that specializes in the manufacture and commercialization of rare cannabinoids.

As noted in the news release, BayMedica is a revenue-stage biotechnology company leveraging its significant expertise in synthetic biology and pharmaceutical chemistry to develop efficient, scalable and proprietary manufacturing approaches to produce high quality, regulatory-compliant rare cannabinoids for consumer applications. BayMedica is currently commercializing the rare cannabinoid CBC (cannabichromene) as a B2B supplier to distributors and manufacturers marketing products in the health and wellness sector. BayMedica is planning additional rare cannabinoid launches for the coming year.

Pursuant to the indicative terms of the LOI, InMed and BayMedica intend to negotiate and enter into a definitive agreement under which InMed would acquire 100% of BayMedica in exchange for 1.6 million InMed common shares to be issued to BayMedica’s equity and convertible debt holders, with any such issued InMed common shares being subject to a six-month contractual hold period.

Market Outlook

There is a rapidly growing demand for rare cannabinoids. However, their low natural concentration makes traditional harvesting of these compounds cost prohibitive. Biosynthesis allows production of rare cannabinoids in the lab that are bioidentical to compounds found in nature, with significantly higher yields which reduce costs. Biosynthesis can produce pharmaceutical-grade, bioidentical, THC-free compounds at a cost that’s 70 to 90 percent less than wholesale prices of naturally harvested rare cannabinoids.

Cannabinoid-based pharmaceuticals are expected to overtake the market as rare cannabinoids become less expensive and more available. According to Statista, the value of the consumer market for cannabinoid-based pharmaceuticals in the United States is forecast to grow to $25 billion by 2025 and to $50 billion by 2029, with cannabinoid-based pharmaceuticals used to treat health conditions including pain, respiratory conditions, autoimmune conditions and more.

Management Team

Eric A. Adams has been CEO and president of InMed since June 2016. He has more than 25 years of experience in establishing corporate entities, capital formation, global market development, mergers and acquisitions, licensing and corporate governance. He previously served as CEO at enGene Inc. Prior to enGene, he held senior positions in global market development with QLT Inc. (Vancouver), Advanced Tissue Sciences Inc. (La Jolla, CA), Abbott Laboratories (Chicago, IL) and Fresenius AG (Germany).

Bruce S. Colwill is InMed’s CFO. He has more than 25 years of financial leadership experience in public and private companies. Prior to InMed, he served as CFO of General Fusion Inc., a private clean energy company. He was also CFO at Entrée Resources Inc., a mineral exploration company, from 2011 to 2016. He has held CFO roles at Neuromed Pharmaceuticals Ltd., Response Biomedical Corp, Forbes Medi-Tech Inc. and Euronet Worldwide Inc.

Alexandra D.J. Mancini is Senior Vice President, Clinical and Regulatory Affairs at InMed. She has more than 30 years of global biopharmaceutical research and development experience. She has been an executive with numerous biotech companies, including senior vice president of Clinical and Regulatory Affairs at Sirius Genomics; senior vice president of Clinical and Regulatory Affairs at INEX Pharmaceuticals; and vice president of Regulatory Affairs at QLT Inc.

Eric C. Hsu is Senior Vice President, Pre-Clinical Research and Development at InMed. He joined InMed with more than 18 years of scientific leadership experience in the field of gene therapy. He has held various positions within enGene Inc., including vice president of Research and vice president of Scientific Affairs and Operations. He received his Doctorate from the Department of Medical Biophysics at the University of Toronto.

Michael Woudenberg is Vice President, Chemistry, Manufacturing and Controls at InMed. He has more than 20 years of successful drug development, process engineering, GMP manufacturing and leadership experience. He has held positions with 3M, Cardiome Pharma, Arbutus Biopharma and, most recently, was Managing Director of Phyton Biotech LLC.

InMed Pharmaceuticals Inc. (INM), closed Friday's trading session at $0.699899, up 1.4346%, on 32,207 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.65/$9.32.

Recent News

• InMed Pharmaceuticals Inc. (NASDAQ: INM) - InvestorNewsBreaks - InMed Pharmaceuticals Inc. (NASDAQ: INM) Releases FY 2023 Report, Shares Corporate Update
• InvestorNewsBreaks - InMed Pharmaceuticals Inc. (NASDAQ: INM) to Present at H.C. Wainwright 25th Annual Global Investment Conference
• InvestorNewsBreaks - InMed Pharmaceuticals Inc. (NASDAQ: INM) Announces Participation in Water Tower Research Fireside Chat Series

Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF)

The QualityStocks Daily Newsletter would like to spotlight Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF).

Vietnam is poised to become a major competitor to China in the critical metals supply chain and could potentially threaten China's stranglehold on the global rare earth industry. Vietnamese leaders are planning to restart the Đông Pao mine, a massive rare earth mine in Northern Vietnam. Đông Pao is among the largest rare earth mines in the country, and it has attracted significant interest from Western backers looking for alternative rare earth metal suppliers. With financial backing from Western investors, Vietnam is looking to relaunch the mine in a project with the potential to threaten China's overwhelming dominance in the sector. Rare earth elements play a vital role in the global economy and are used as components in electronic devices such as flat-screen televisions, computer hard disks, smartphones and electronic displays as well as defense and clean-energy technologies.  However, they are incredibly hard to mine because they usually occur in very small deposits and tend to bind with other minerals. Back on U.S. soil, enterprises such as Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) are setting up facilities to separate and then purify rare earths so that the local supply can be boosted. This will take the region a step closer to weaning itself off of overdependence on China for these vital metals.

Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) is a critical metals (“CM”) separation technology company executing an ESG-centered plan toward establishing a comprehensive North American critical metals supply chain. The company has developed a transformative commercial-ready technology, RapidSX™, for separating and purifying critical metals. Ucore intends to deploy this technology in pursuit of a CM supply chain independent of China for Western original equipment manufacturers (“OEMs”), most notably in the automotive and renewable energy industries.

Ucore’s vision is to become a leading advanced technology company providing best-in-class metal separation products and services to the mining and mineral extraction industry. Its initial focus is on processing heavy and light rare earth elements (“REEs”), disrupting a supply chain that is dominated by China.

China currently controls about 80% of the world’s access to REE mining projects and over 90% of the world’s REE processing capabilities, and it produces about 95% of the goods containing REE components.

 

Ucore is working to scale Western supply needs by establishing REE separation and rare earth oxide (“REO”) production capabilities in cooperation with strategic upstream supply and downstream offtake partnerships. The company, along with its industry partners, aims to unlock access to Western REEs for current consumer, energy, manufacturing and military sectors.

By 2025, Ucore expects to commercially separate U.S.-friendly sources of REEs and supply OEMs with REOs required to produce rare earth permanent magnets (“REPMs”) – the essential component of electric motors and generators required to support the world’s transition to electrification and sustainable energy sources.

The company intends to contribute to this initiative through the near-term development of a heavy and light rare-earth processing facility in Louisiana and subsequent development of Strategic Metals Complexes (SMCs) in Alaska and Canada, as well as through the longer-term development of its 100%-owned Heavy Rare Earth Element (HREE) mineral resource property at Bokan Mountain on Prince of Wales Island, Alaska.

Ucore is headquartered in Halifax, Nova Scotia.

Projects & Technology

RapidSX™ Demonstration Plant

The Kingston, Ontario, RapidSX™ Demonstration Plant commissioning process is underway. Once commissioned, the plant is designed to demonstrate the commercial capabilities of the RapidSX technology platform.

The RapidSX demo plant will show:

• The techno-economic advantages of the RapidSX technology platform
• The processing of tens of tons of heavy and light mixed rare earth element concentrates in a simulated production environment
• The platform’s ability to operate for thousands of semi-continuous run-time hours
• Production of high-purity NdPr, praseodymium, neodymium, terbium and dysprosium rare earth elements for early OEM product qualification trials

The demo plant is located within Ucore’s 5,000-square-foot RapidSX Commercialization and Demonstration Facility and is run by its laboratory partner, Kingston Process Metallurgy Inc. (“KPM”).

RapidSX™ Technology

Innovation Metals Corp., acquired by the company in 2020, developed the RapidSX separation technology platform with early-stage assistance from the United States Department of Defense, later resulting in the production of commercial-grade, separated rare earth elements at pilot scale.

RapidSX combines the time-proven chemistry of conventional solvent extraction (SX) with a new column-based platform that significantly reduces time to completion and plant footprint, as well as potentially lowering capital and operating costs. SX is the international REE industry’s standard commercial separation technology and is currently used by all REE producers worldwide for bulk commercial separation of both heavy and light REEs.

Utilizing similar chemistry to conventional SX, RapidSX is not a “new” technology, but it represents a significant improvement on the well-established, well-understood, proven conventional SX separation technology preferred by REE producers.

Strategic Metals Complex

Ucore, engineering partner Mech-Chem Associates Inc. and KPM are developing the full-scale engineering for the company’s first Strategic Metals Complex (SMC). The SMC is a planned REE separation and rare earth oxide production plant slated to commence construction in Louisiana in 2023. It is scheduled to initially process 2,000 tons of total rare earth oxides by the end of 2024, increasing to 5,000 tons in 2026.

The company has three initial U.S.-friendly feedstock agreements in place for the Louisiana complex, along with multiple developing offtake agreements. It received a C$16 million+ incentive package offer from Louisiana Economic Development to support construction of the SMC.

Bokan-Dotson Ridge REE Deposit

Ucore has invested over C$35 million to establish and validate the Bokan-Dotson Ridge resource in preparation for mine design and permitting. Initial drilling is complete, and a Preliminary Economic Assessment has been issued. Next steps for the project include a feasibility study, detailed mine design and permit acquisition. The project can be “near shovel ready” for construction in less than 30 months after receipt of the next stage of development funding.

Market Opportunity

According to a report by Grand View Research, the global rare earth elements market was valued at $2.8 billion in 2018 and is forecast to reach a value of $5.6 billion by 2025, achieving a CAGR of 10.4% during the period. Market growth is driven by increasing demand for these elements in the manufacturing of magnets and catalysts for the automotive industry. Rising demand for electric vehicles to reduce CO2 emissions is expected to propel the use of permanent magnets in the production of EV batteries.

China is the major producer and consumer of REEs. To maintain self-sufficiency and to meet future demand, China has been raising the export tariffs on rare earth elements shipped to various countries, including the U.S., Japan, India, Brazil and the European Union. This led to the current supply-demand gap in these countries, as they rely on imports from China.

China reduced the exports of REEs by 72% in the second half of 2010 to preserve its reserves of these elements and continues to export REEs at reduced levels, thereby affecting industries such as automotive, oil and gas, and electronics, which require an ample amount of rare earth elements.

Management Team

Pat Ryan, P.Eng., is Chairman and CEO of Ucore Rare Metals. He began as a director with the company when he developed a heightened interest in critical metals. Before joining Ucore, he founded and led a multimillion-dollar automotive OEM design and lean manufacturing company. His understanding of complex supply chains across international markets has led to a prime positioning as the global auto industry transitions to vehicle electrification. He holds a Bachelor of Engineering degree from Dalhousie University.

Peter Manuel is Vice President and CFO of Ucore. Prior to joining the company, he practiced as a Chartered Accountant for more than 17 years, providing consulting services to companies in a range of industries, with a focus on the financial services and resource sectors. He spent 10 years in England and Ireland providing assurance, strategic planning, corporate finance and other consulting services to a portfolio of both public and private entities. He holds a Bachelor of Commerce Degree from Dalhousie University.

Michael Schrider, MEng, P.E., is Vice President and COO of Ucore. He is a multidisciplinary engineer who has been involved in manufacturing, engineering and managing complex structural and mechanical systems projects since 1989. He was the Founder, President and Chief Engineer of Schrider & Associates and Alton Bay Design, both engineering services firms. He holds a bachelor’s degree in naval architecture and marine engineering from the University of New Orleans and a master’s degree in mining, geological and geophysical engineering from the University of Arizona.

Mark MacDonald is Vice President of Investor Relations at Ucore. He has over 25 years of experience implementing award winning business development and marketing programs at regional and national levels. As Vice President of Sales, he was responsible for Mediapro Communication’s growth as AT&T Canada’s leading B2B sales partner. He subsequently became Atlantic Regional Vice President of AT&T Canada Corp. He holds a Bachelor of Commerce degree from Dalhousie University.

Ucore Rare Metals Inc. (UURAF), closed Friday's trading session at $0.52, up 1.6817%, on 20,425 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.48/$1.15.

Recent News

• Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) - How Vietnam Plans to Cut into China's Hold on Rare Earths Supply Chain
• Amid REE Market Supply Interruptions, Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) Presses Forward With Commercial Processing Plant Plans
• InvestorNewsBreaks - Ucore Rare Metals Inc. (TSX.V: UCU) (OTCQX: UURAF) Receives ITEP Approval for REE Separation Facility

GEMXX Corp. (OTC: GEMZ)

The QualityStocks Daily Newsletter would like to spotlight GEMXX Corp. (OTC: GEMZ) .

GEMXX is a mine-to-market enterprise that specializes in the production and distribution of gemstones, like Ammolite, and jewelry on a global scale

Ammolite is a rare gemstone that exhibits a unique iridescence and is only found in southern Alberta, Canada

The company recently announced that demand for its Ammolite in jewelry designs by Kenneth Bradley is growing exponentially

GEMXX plans to expand gemstone and jewelry production by 300% year over year in response to growing demand

Its shopping channel division is preparing to supply $5.5 million worth of Ammolite gemstones and jewelry over the next 12 months

Although officially recognized by the Coloured Stones Commission of the World Jewellery Confederation ("CIBJO") as a semi-precious gemstone in 1981 (https://ibn.fm/bfZNW), Ammolite has a long, rich history. Made from the fossilized shells of now-extinct sea creatures known as Ammonites, Ammolite tells the story of lifeforms that existed more than 71 million years ago. In that period, their remains underwent mineralization and transformation induced by tectonic pressure and glacier water, resulting in the "development of an iridescent, rainbow-like coloring that includes red, yellow, green, and blue, the latter hue being the rarest," according to an article in The Globe and Mail (https://ibn.fm/ryrBq). While Ammonite fossils are scattered around the world, Ammolite gemstone is only found on the eastern slopes of the Rocky Mountains – within the Bearpaw geologic formation – in southern Alberta, Canada, making it one of the rarest gems on earth and sought after around the world. The visual allure of Ammolite stems from the fact that it exhibits iridescence and vibrance, which result from the stone's multiple layers. However, because of these layers, Ammolite is quite fragile and needs to be carefully handled while mining and polishing (https://ibn.fm/B88KL), considerations that guide the meticulous work of the experienced gemstone cutters and jewelry designers at GEMXX (OTC: GEMZ), who have catapulted the company to the upper echelons of finished Ammolite production.

GEMXX Corp. (OTC: GEMZ) is a mine-to-market enterprise specializing in gold, gemstone, and jewelry production. With ownership of mining resources, production facilities, and operational assets, the company maintains control over every aspect of its production process, from gold mining and gemstone extraction to jewelry manufacturing and global distribution.

As a prominent player in the industry, GEMXX stands out as a leading producer of high-quality finished Ammolite jewelry. Notably, it holds the distinction of being the sole public company engaged in Ammolite mining worldwide. In addition to its Ammolite operations, the company is actively involved in gold mining and prides itself on its ability to design and manufacture exquisite jewelry pieces and exceptionally rare, natural fossil decor items for clientele around the globe.

One of GEMXX’s key advantages lies in mining its own gold reserves to be utilized in its jewelry production. This strategic approach provides the company with a cost-saving edge over other producers in the market.

Ammolite is similar to black opal and is a biogenic gem like amber and pearl. It is derived from the fossilized shells of ammonites, a group of extinct marine nautiluses.

GEMXX’s world class gemstone cutters and jewelry designers are continuously leading the Ammolite industry. Its team believes in the company’s philosophy, vision and goals, and works every day to continue to drive the Ammolite industry to the forefront of the gem world.

The company has offices in Las Vegas and Hong Kong.

Projects and Operations

GEMXX has formulated an ambitious growth plan that, while challenging, is deemed attainable. The company’s strategy revolves around bolstering its market share through several key initiatives. Firstly, GEMXX aims to strengthen its position in current markets by nurturing and expanding existing relationships with customers and partners.

Secondly, the company plans to venture into untapped markets strategically. By identifying and targeting new areas, GEMXX seeks to establish a presence in regions that present promising opportunities for growth.

Additionally, GEMXX envisions growth through acquisitions. By considering and integrating key services, distribution networks and retail outlets into its fold, the company aims to consolidate its market position and capitalize on synergies for enhanced success.

To cater to the rising demand for its products, GEMXX has placed a primary focus on increasing gemstone production. The company’s southern properties, situated in Alberta, Canada, hold valuable deposits of rough Ammolite gemstone. By tapping into these resources, GEMXX is poised to meet the demand for its exquisite gemstone products and further fuel its expansion plans.

 

GEMXX possesses significant mineral assets in the form of a Mineral Work Permit covering an 800-acre area and two Ammonite Shell Mineral agreements encompassing 217 acres within the same region. The company’s management effectively operated mines in close proximity to these properties. Moreover, core sampling, along with fossil outcroppings on the riverbanks, confirms a substantial Ammolite resource present in these designated areas.

Both the Mineral Work Permit and the Ammonite Shell Mineral agreements grant GEMXX unrestricted access to all Ammolite resources within their respective demarcations. Notably, the company is not obligated to pay any royalties to third parties, thereby enabling GEMXX to fully capitalize on the potential of these valuable resources.

Furthermore, there are no stringent regulatory conditions that GEMXX must fulfill to gain or retain access to the Ammolite deposits. This freedom of access allows the company to proceed with its mining and production operations unimpeded, providing an advantageous position for future growth and success.

In March 2023, GEMXX made a significant announcement, revealing its acquisition of a 50% ownership stake in Crazy Horse Mining Inc., a Canadian gold mining company with assets situated in the province of British Columbia. As part of this deal, Crazy Horse’s assets, which encompass a 100% interest in two gold projects, called Snow Creek and Rosella Creek, spread across a substantial area exceeding 700 acres, now become part of GEMXX’s portfolio.

Under the terms of this strategic partnership, GEMXX and Crazy Horse will jointly share the expenses related to mining operations on these projects. Additionally, the two companies will share the gold produced from these ventures, leading to a collaborative and mutually beneficial arrangement.

Initial tests conducted on the property, combined with gold already recovered this season, confirm all expectations for the claims and substantiate the company’s estimated extraction target of over 100,000 ounces of easily recoverable gold. To validate and provide a more comprehensive assessment of this estimate, an S-K 1300-compliant Resource Report is scheduled to be conducted during the summer of 2023.

By acquiring this stake in Crazy Horse Mining Inc., GEMXX has positioned itself for further growth in the gold mining sector and is poised to capitalize on cost of goods savings in its jewelry business.

Market Opportunity

Leading independent market research companies such as Data Monitor and GIA estimate the worldwide market for luxury or premium lifestyle products, which include gems and jewelry, at over $90 billion annually and growing. Ammolite sales around the world have seen unprecedented growth over the past 20 years. Worldwide retail sales are now estimated to be over $100 million.

Ammolite jewelry and fossils are featured aboard cruise ships and can be found in specialty shops in almost every cruise port in North America. Asian markets have grown since feng shui master Edward Li called Ammolite the most influential stone of the new millennium, referring to it as the “Seven Color Prosperity Stone.” Home shopping channels in Japan, Australia, France, Germany, the UK, Canada and the U.S. have all featured Ammolite jewelry.

Ammolite and ammonites can also be found on many ecommerce sales platforms, including Amazon, eBay and Etsy. Ammolite is sold around the world in tourist and traditional jewelry markets. The company has established customers in home shopping channels, cruise tourism, jewelry retailers, Asian feng shui markets, Asian retail markets and ecommerce platforms.

Management Team

With over 160 years in Ammolite management, operations, and sales, GEMXX possesses an unparalleled wealth of knowledge and expertise. Its team members have extensive backgrounds in every facet of the Ammolite business, allowing the company to excel in product development, maintain rigorous quality control measures, and maximize profitability. The breadth and depth of the GEMXX team’s experience enable the company to navigate the industry with precision, ensuring that GEMXX remains at the forefront of the Ammolite market. GEMXX leverages its collective wisdom to drive innovation, deliver exceptional products, and optimize business strategies to achieve long-term success.

Jay Maull is Founder, CEO and Chairman of GEMXX. With a career spanning more than three decades, he has been deeply involved in the Ammolite industry, from mining and production to marketing. He has owned and operated the world’s largest Ammolite mine and has delivered exceptional Ammolite products to customers across all continents. He has also established the world’s largest Ammolite ecommerce platform.

Richard Clowater is President of GEMXX. He is a skilled sales and marketing professional with a focus on research, data analysis and strategic planning. He has successfully implemented initiatives to expand markets, boost profits and foster customer loyalty. He has an impressive track record of negotiating sales and contracts worth over $250 million with influential stakeholders, including key purchasing personnel, C-suite executives and government entities at all levels.

Tom Dryden is a Vice President of GEMXX and brings a wealth of experience and expertise to the production and marketing of Ammolite, spanning over 30 years. His extensive involvement in the industry has granted him unparalleled knowledge of the Bearpaw Ammonite bearing formations. As a recognized authority in the field, Mr. Dryden’s research and papers on Canadian Ammonites have garnered global recognition, being published worldwide. In his role at GEMXX, Mr. Dryden assumes the responsibility of overseeing the company’s Canadian-based production facilities. 

P. K. Chung is Business Manager Asia at GEMXX. With a track record of over 25 years in Ammolite business management, production and marketing in Asia, she is a recognized authority in the industry. Based in the Hong Kong gem district, she possesses an intricate understanding of the Asian gem and jewelry markets, including market dynamics, consumer preferences and industry trends specific to the region. Her strategic insights and deep connections enable GEMXX to thrive in this influential market.

GEMXX Corp. (OTC: GEMZ), closed Friday's trading session at $0.09635, up 20.4375%, on 1,955,556 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.023/$0.998.

Recent News

• GEMXX Corp. (OTC: GEMZ) - GEMXX Corp. (GEMZ) Plans 300% YoY Expansion in Gemstone and Jewelry Production to Meet Growing Demand
• InvestorNewsBreaks - GEMXX Corp. (GEMZ) Enters Binding LOI to Acquire 50% Interest in Proven Yukon Gold Project
• InvestorNewsBreaks - GEMXX Corp. (GEMZ) Featured in Bell2Bell Podcast

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

The QualityStocks Daily Newsletter would like to spotlight Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI).

The Centers for Disease Control (CDC) will provide $262 million to fund the development of a new disease outbreak response network. Per the announcement, recipients will receive grants from the pool of more than  $250 million to establish America's first-ever response network in anticipation of future disease outbreaks. The grants will fund the development and implementation of new tools meant to detect and mitigate public health emergencies such as pandemics and disease outbreaks in the future. According to a statement from the CDC, it will distribute funds for the development of the Outbreak Analytics and Disease Modeling Network (OADMN) to 13 state health departments, private healthcare providers, academic institutions and tribal organizations over a five-year period.

Passed in the wake of the coronavirus pandemic, the 2021 America Rescue Plan instructed the CDC to form a Center for Forecasting and Outbreak Analytics (CFA) to create advanced infectious disease analytical tools and models as well as modernize America's surveillance and data systems. Consequently, the CDA launched the CFA in April 2022 with an initial funding of $26 million and a focus on promoting health equity, building a competent workforce, and developing yearly models of the SARS-CoV-2 omicron variant. As the CDC works to establish a disease response network, private actors such as Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) are hard at work developing novel immunotherapies targeting infectious diseases so that those infections don't take a heavy toll on communities and the economy.

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious diseases and autoimmune diseases.

In collaboration with the prestigious Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG), both in Germany, Scinai is developing a pipeline of innovative nanosized antibody (NanoAb) therapies addressing diseases underserved by current treatments and with large and growing markets, such as COVID-19, asthma and psoriasis.

NanoAbs, also known as VHH-antibodies or Nanobodies, are alpaca-derived nanosized antibodies that exhibit multiple significant competitive advantages over existing antibody therapies, including stability at high temperatures, superior binding affinity, more effective and convenient routes of administration and efficient production. Scinai is uniquely positioned to advance nanosized antibody innovation from R&D through commercialization.

The company’s highly experienced and successful pharmaceutical industry leadership team includes former senior executives from Novartis, GSK and Bristol-Myers Squibb.

Since its founding, Scinai has executed eight clinical trials, including a seven-country, 12,400-participant Phase 3 trial of a prior influenza vaccine candidate, and it built, owns and operates a 20,000 sq. ft. state-of-the-art GMP biologics manufacturing facility housing its laboratories, production facilities and offices.

Lead Candidate: Inhaled COVID-19 NanoAb

In December 2021, Scinai signed definitive agreements with the Max Planck Society – parent organization of the Max Planck Institute for Multidisciplinary Sciences– and the UMG to enter a strategic collaboration for the development and commercialization of innovative COVID-19 NanoAbs.

The company is planning a rapid development path that leverages its expertise and capabilities in biological drug development and manufacturing. Scinai anticipates preclinical proof-of-concept results for an inhaled COVID-19 NanoAb by the end of 2022, with initial Phase 1/2a human clinical trial results expected in 2023.

The intended inhaled mechanism of delivery of Scinai’s COVID-19 NanoAb formulation may serve as a significant differentiator when compared to approved monoclonal antibodies, which are injected. Inhaled delivery has shown to be cheaper, more convenient and likely safer for patients and providers.

NanoAb Pipeline: Psoriasis, Asthma and More

The COVID-19 NanoAb development agreement is part of a broader five-year research collaboration agreement signed in March 2022 covering discovery, development and commercialization of NanoAbs for several other disease indications with large market medical needs, including asthma, psoriasis, macular degeneration and psoriatic arthritis.

Scinai has an exclusive worldwide license for development and commercialization of COVID-19 NanoAbs and exclusive options for similar worldwide licenses for NanoAbs for the above mentioned additional large market disorders currently underserved by approved therapeutic antibodies.

Academic research teams from MPG and UMG have verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. They have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. Neutralization studies of the other NanoAbs are expected to begin later in 2022.

Based on the promising results, Scinai will focus development efforts beginning with the following NanoAbs:

• NanoAbs targeting IL-17 as drug candidates for the potential treatment of psoriasis and psoriatic arthritis
• NanoAbs targeting IL-13 and NanoAbs targeting TSLP as drug candidates for the potential treatment of asthma

These are conditions for which the antibody target is validated by existing treatments and the mechanism of action is well understood. Both represent large medical needs and growing markets. Scinai anticipates preclinical proof-of-concept for at least one of these NanoAbs in 2023. This is in addition to the aforementioned human clinical Phase 1/2a for the inhaled COVID-19 NanoAb therapy, which is also anticipated in 2023.

CDMO Services

While NanoAb pipeline development is Scinai’s core focus, the company also offers its cGMP manufacturing facility, aseptic fill and finish suite, laboratories and experienced professionals for contract development and manufacturing organization (CDMO) services. This offering is designed to keep the Scinai team abreast of the latest industry developments and trends while building experience and generating revenue to support the company’s NanoAb pipeline development.

Market Opportunity

COVID-19 treatment, target of the company’s lead NanoAb therapy candidate, had an estimated market size of $22 billion in 2021.

Future Scinai drug candidates will target conditions with large markets growing at attractive CAGRs.

The global asthma treatment market was valued at $18.08 billion in 2019 and is projected to reach $26.01 billion by 2027, exhibiting a CAGR of 4.5% during the forecast period, according to Fortune Business Insights. The research firm predicts that the global psoriasis treatment market will grow from $26.37 billion in 2022 to $47.24 billion by 2029, exhibiting a CAGR of 8.7% over the forecast period.

Management Team

Amir Reichman is Scinai’s CEO. He previously was Head of Global Vaccines Engineering Core Technologies at GSK Vaccines in Belgium. Prior to that, he held leadership roles at Novartis Vaccines’ Global Vaccines Supply Chain Management organization. He was the first employee of NeuroDerm Ltd., a company focused on transdermal drug delivery, and served as Senior Scientist until his departure in 2009. He earned a M.Sc. in Biotechnology Engineering from Ben-Gurion University and an MBA in Finance and Health Care Management from the University of Pennsylvania’s Wharton School.

Tamar Ben-Yedidia, Ph.D., is Chief Science Officer at Scinai. She has more than 30 years of experience in immunology, with specific expertise in the development of vaccines. She began her career with Biotechnology General Ltd., working on development of a recombinant Hepatitis-B vaccine. She later joined the Weizmann Institute of Science, working on the design of a peptide-based vaccine against several pathogens. She is widely published, with numerous refereed articles and invited reviews in various scientific journals. She received her Ph.D. from the Weizmann Institute.

Elad Mark is COO at Scinai. He has over 15 years of biotechnology industry experience encompassing diverse project stages including feasibility studies, conceptual and detailed design, commissioning, qualification and process validation. Prior to joining Scinai, he led Novartis’s $800 million investment in a biologics facility in Singapore. With Biopharmax and Antero, both global pharmaceutical engineering companies, he successfully led projects in Israel, China and Singapore. He holds a BSc. in Engineering from the Afeka Tel Aviv Academic College of Engineering and an MBA from the Open University of Israel.

Uri Ben-Or is CFO at Scinai. He has served as CFO with public life science companies traded on the TASE, OTC and Nasdaq. Ben-Or provides his services to Scinai through CFO Direct, a company he founded and for which he serves as CEO. He served as the VP of Finance of Glycominds, a leading biotechnology company, and as CFO of a spin-off from Telrad Networks. He also served as a Corporate Controller at Menorah Capital Markets and as an Auditor at PWC. He holds a B.A. in Business from the College of Administration, an MBA from Bar-Ilan University, and is a CPA.

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), closed Friday's trading session at $0.87, even for the day, on 3,083 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.835/$11.49.

Recent News

• Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) - CDC Avails $262M to New Network Aimed at Responding to Future Disease Outbreaks
• Inverse Vaccines Show Promise Against Autoimmunity
• InvestorNewsBreaks - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Closes on $1.33M Registered Direct Offering

Horizon Fintex | Upstream

The QualityStocks Daily Newsletter would like to spotlight Horizon Fintex | Upstream

Upstream, the revolutionary retail trading app for stocks and NFTs powered by Horizon Fintex and MERJ Exchange Limited, is discussing the value of the "once-booming world of speculative NFTs" in its latest blog. According to the blog, the NFT world is facing a "harsh reality" as a dappGambl report has declared the vast majority of NFTs virtually worthless. The blog notes that initially celebrities and artists flocked to the digital realm followed by eager buyers hoping to make it big. However, the initial enthusiasm for speculative NFTs died down as market oversaturation, environmental concerns, the crypto winter and speculative risks began to impact the space. However, Upstream continues, the technology does offer value, "including the ability to create shared, exclusive experiences within communities and subcommunities, timestamp key events and moments in an immutable way, and even break new ground in Metaverses down the line."

Upstream has always advocated for NFTs as a means of fan engagement rather than a speculative ride because they serve as merchandise or collectibles with an immutable record of ownership, providing potential for creative campaigns for brands, personal brands, sports teams, or other type of organizations. The blog noted several forward-thinking companies that are leveraged the potential of NFTs in new ways, including American Express, which is introducing Member Collectibles; Lufthansa Innovation Hub and Miles & More, which is introducing an app that allows passengers to transform boarding passes into NFT trading cards; and Diesel, which teamed up with Hape to create a collection of NFTs aimed at fashion and Web3 enthusiasts. "As pioneers in blockchain-powered and NFT trading, Upstream's mission is to unlock the full potential of NFTs for everyone," the blog states. "Our user-friendly trading app simplifies the entire process, allowing users to create, purchase and trade NFTs effortlessly. While the speculative NFT market faces uncertainty, Upstream remains a beacon of stability with its focus on utility-based NFTs and genuine fan engagement. As the NFT landscape continues to evolve, Upstream stands ready to empower users and redefine the future of digital assets."

To view the full blog, visit https://ibn.fm/l1ad3

Horizon Fintex is a software business specializing in compliant securities solutions. The company aims to facilitate the future of capital markets by leveraging the regulatory experience of Wall Street bankers and the proven track record of technology veterans to bring focus to compliance, efficiency, security and transparency.

Horizon’s flagship product is the revolutionary trading app ‘Upstream’, a MERJ Exchange Market, and the first regulated market powered by a blockchain to offer both digital securities and NFT trading. Upstream traders experience T+0 settlement, best bids and offers displayed on a transparent public orderbook that prevents predatory market practices – all from a user-friendly trading app.

Products

Horizon Fintex offers a full suite of end-to-end blockchain-enhanced software solutions to create a seamless experience for both issuers and investors. Its product suite includes:

• Securitization & Issuance – ETSware is an end-to-end Electronic Trading System streamlining capital raising from primary issuance through compliant secondary trading.
• KYC Compliance Onboarding – KYCware is a white label Know Your Customer (KYC) and Anti-Money Laundering (AML) compliance software solution offering best-in-class cryptographic security to compliantly onboard and verify user identity through a smartphone application.
• AML Screening Software – AMLCop offers advanced Anti-Money Laundering (AML) software to streamline the verification of user details against a proprietary database of global sanctions, politically exposed persons (PEPs) and watchlists.
• Cap. Table Management Tools – CustodyWare equips registered U.S. transfer agents with next-generation cap. table management software to manage securities on behalf of their clients pursuant to an SEC-registered or exempt securities offering.
• Exchange & Trading App Technology – Open Order Book offers Ethereum blockchain securities exchange software to power the next generation of trading venues for digital assets.

Upstream – The Horizon-Powered Trading App

Upstream is a joint venture with MERJ Exchange (merj.exchange), an affiliate of the World Federation of Exchanges.

Upstream aims to be the premiere global trading hub offering issuers around the world exposure to a digital-first investor base that can trade using USDC digital currency along with credit, debit, PayPal, and USD (fiat) to increase liquidity and enhance price discovery; while also offering investors access to dual-listed companies, IPOs, crowdfunded companies, U.S. & Int’l. equities, digital coupons and NFTs directly from a user-friendly trading app.

Upstream aims to unlock liquidity for investors of all levels while offering industry-leading levels of transparency, accessibility and investor protections enforced using Ethereum blockchain technology.

Management Team

Brian Collins is the CEO of Horizon Fintex. He founded the company in 2010. From 1999-2010, Mr. Collins was CEO of Abbey Technology in Switzerland, specializing in the design of trading software for Swiss banks. Prior to this, he worked for Credit Suisse in Zürich, designing and building proprietary equity trading solutions. Mr. Collins graduated in 1990 with a BS in Computer Systems from the University of Limerick, Ireland.

Mark Elenowitz is the company’s President. He is a Wall Street veteran with over 29 years of experience. Mr. Elenowitz was the co-founder of a U.S. broker dealer and is Managing Director of two U.S. broker dealers, responsible for advising clients on compliance, capital structure and capital market navigation. He was responsible for leading the first successful Reg A+ IPO of a company to list on the NYSE and others which listed directly onto Nasdaq. He is a noted speaker at Small Cap and Reg A events, including the SEC Small Business Forum, and has been profiled in BusinessWeek and CNBC, as well as several other publications. Mr. Elenowitz is a graduate of the University of Maryland School of Business and Management with a BS in Finance and holds Series 24, 62, 63, 79, 82 and 99 licenses.

Dr. Andrew Le Gear is the CTO of Horizon Fintex. Prior to joining the company in 2013, he worked as a software engineer with Dell Inc. (2012-2013) and Lehman Brothers and Nomura Plc. (2007-2012). Dr. Le Gear was a co-founder of Juneberi Ltd., a research-driven software tech start-up (2004-2007). He graduated in 2006 with a Ph.D. in Computer Science from the University of Limerick, Ireland.

Peter Hall is the company’s CIO. Prior to joining Horizon Fintex in 2011, he worked at Microsoft (2008-2011), Atos Origin (2004-2008) and AIT Group Plc. (1998-2002). Mr. Hall has held CISSP certification since 2010. He graduated from the University of Sheffield, UK in 1995 and earned an MS from the University College London in 2006.

Mike Boswell is the CFO of Horizon Fintex. A Wall Street veteran, he co-founded a U.S. broker dealer and served as Chief Compliance Officer. Mr. Boswell was also Managing Director of TriPoint Capital Advisors, a merchant banking and financial consulting company, and CFO of Mission Solutions Group, a privately held defense sector firm. He earned an MBA from John Hopkins University and a BS in Mechanical Engineering from the University of Maryland. Mr. Boswell holds Series 24, 62, 63, 79, 82 and 99 licenses.

Recent News

• Horizon Fintex | Upstream - InvestorNewsBreaks – Upstream Discusses Value of Speculative vs. Utility-Based NFTs
• InvestorNewsBreaks – Upstream Explores How NFTs Add Unique Benefits, Value to Traditional Rewards
• InvestorNewsBreaks – Upstream Experts Explore Ways for Brands to Expand Reach, Foster NFT community growth

Clene Inc. (NASDAQ: CLNN)

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

On September 28, 2023, Clene Inc. (NASDAQ: CLNN) made an exciting announcement regarding their groundbreaking research on the investigational drug CNM-Au8. In a scientific paper published in the esteemed journal Small, Clene Inc. revealed the catalytic mechanism of action behind the therapeutic properties of CNM-Au8.

The study showcased the remarkable neuroprotective abilities of CNM-Au8, attributing its success to its unique catalytic activity. When exposed to toxins that typically lead to neuronal death, CNM-Au8 treatment exhibited a remarkable ability to promote cell survival and preserve the intricate network of neurites.

To truly understand the underlying mechanisms responsible for CNM-Au8's neuroprotective function, extensive studies were conducted. These studies focused on characterizing the catalytic reactions facilitated by CNM-Au8, aiming to unravel how it effectively regulates cellular health and metabolism. The findings were nothing short of groundbreaking, shedding light on the exceptional therapeutic potential of CNM-Au8.

Clene Inc. (NASDAQ: CLNN) is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).

Its lead drug candidate is CNM-Au8®, an oral suspension developed to restore neuronal health and function by increasing energy production and utilization by driving critical cellular energy producing reactions that enable neuroprotection and remyelination to increase neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is being studied in various clinical trials, including the Harvard/MGH Healey ALS Platform clinical trial for patients with ALS; RESCUE-ALS, a completed proof-of-concept clinical trial in patients with early symptomatic ALS; the REPAIR trials, completed target engagement clinical trials showing brain energy metabolite change with CNM-Au8; and a completed MS clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing MS. The company also has a nanotherapeutic platform of drug discovery.

CNM-Au8

CNM-Au8, Clene’s lead asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Multiple pathogenic insults contribute to neuronal death. Mitochondrial dysfunction and NAD+ decline is a common final pathway in neurodegeneration, with NAD+ as a critical determinant of cell survival and function. CNM-Au8’s catalytic mechanisms target the energetic deficits, oxidative stress and accumulation of misfolded proteins that are common to many neurodegenerative diseases.

The unique catalytic mechanism of action of CNM-Au8 is hypothesized to act as a neuroprotective and remyelinating therapy in neurodegenerative disease states in order to: (1) drive, support and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed and/or damaged cells, (2) directly catalyze the reduction of harmful, reactive oxygen species (“ROS”) and (3) promote protein homeostasis via activation of the heat shock factor-1 pathway, recognized to dampen the cytotoxicity caused by misfolded and denatured proteins, which are known to occur ubiquitously in neurodegenerative diseases.

CNM-Au8 is used in combination with other agents, has no known drug-drug interactions, and is designed to improve function and survival. The clinical effects of both function and survival were seen in its clinical ALS trials, as earlier announced.

More than 500 estimated years of collective exposure across ALS, MS, and Parkinson’s disease participants in CNM-Au8 clinical trials and Expanded Access Protocol (compassionate use) programs have been recorded without any observed safety signals.

CNM-Au8 is a federally registered trademark of Clene Inc. Clene, based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland, began in 2013.

Market Opportunity

ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide, with a life expectancy of typically three to five years. Clene estimates that global ALS treatment sales will be greater than $1 billion annually within the coming few years. Additional treatments affecting daily function and survival remain the market need.

Additionally, there are more than 2 million MS patients globally, and Clene estimates the market size to be worth more than $23 billion annually. While the MS community has been successful at limiting relapses, non-relapsing MS patients continue to clinically deteriorate even while receiving effective immunomodulatory disease-modifying therapies (“DMTs”). A critical unmet medical need remains for therapeutic interventions that protect neuronal function and myelin health independent of immunomodulation to address progression independent of relapse activity.

Management Team

Robert Etherington is President, Director and CEO of Clene. He has more than 30 years of sales, marketing and leadership experience in the pharmaceutical industry. Prior to joining Clene, he worked at Actelion Pharmaceuticals, the largest biopharma company in the European Union prior to its acquisition by Johnson & Johnson in 2017, where he led that company’s U.S. commercial operations. He began his pharmaceutical sales and marketing career at Parke-Davis, a division of Pfizer, where he rose to the position of Team Leader overseeing the drug Lipitor.

Mark Mortenson is Chief Science Officer at Clene. He is co-inventor of the technology platform developed to produce the company’s therapeutics. He is the inventor or co-inventor on 32 other U.S. patents and hundreds of corresponding international patents. He is a former chief patent counsel responsible for 5,500 U.S. and international patents and patent applications. He holds bachelor’s degrees in physics and ceramic engineering from Alfred University, a master’s degree in materials science from Penn State University and a J.D. from George Washington University.

Benjamin Greenberg, M.D., MHS, FAAN, is Head of Medical at Clene. He is an internationally recognized expert in disorders of the central nervous system. He is currently professor of neurology and Vice Chair of Clinical and Translational Research in the department of Neurology at University of Texas Southwestern Medical Center in Dallas. He holds a bachelor’s degree from Johns Hopkins, a master’s degree in molecular microbiology and immunology from the Johns Hopkins School of Public Health and graduated from Baylor College of Medicine. He served residency in neurology at The Johns Hopkins Hospital.

Morgan R. Brown is CFO at Clene. He has more than 30 years of finance and accounting experience, with 23 years at biotech, pharmaceutical and medical device companies. He has served in similar roles at Lipocine Inc., Innovus Pharmaceuticals, World Heart Corp., Lifetree Clinical Research and NPS Pharmaceuticals Inc. He previously worked at accounting firm KPMG. He is a CPA with a bachelor’s degree in accounting from Utah State University and an M.S. in business administration from the University of Utah.

Clene Inc. (NASDAQ: CLNN), closed Friday's trading session at $0.4959, off by 0.82%, on 237,110 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.414/$3.1899.

Recent News

• Clene Inc. (NASDAQ: CLNN) - Unveiling the Neuroprotective Power of CNMAu8 A Promising Breakthrough in Neurodegenerative Disease Treatment
• Clene Inc. (NASDAQ: CLNN) Is 'One to Watch'
• InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Investigational Drug Focus of Study Published in Peer-Reviewed Journal

PaxMedica Inc. (NASDAQ: PXMD)

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

Autism Spectrum Disorder ("ASD") has seen a staggering fourfold increase in the United States over the past two decades

PaxMedica proudly stands as the sole publicly traded U.S. company singularly dedicated to addressing the challenges posed by Autism

Our pioneering lead product, PAX-101, has shown significant promise in alleviating core Autism symptoms during early trials

In 2024, we're poised to submit a New Drug Application ("NDA") for PAX-101 to treat Human African Trypanosomiasis ("HAT"), a rare disease also known as African Sleeping Sickness, as part of the Neglected Rare Tropical Disease Program

With NDA approval, we anticipate the potential to secure a valuable Priority Review Voucher ("PRV") that could expedite our journey toward FDA recognition for Autism treatment

Vigorous preparations are underway for clinical trials of PAX-101 in Autism, marking a significant step forward in our mission

In a powerful and informative video message, PaxMedica's (NASDAQ: PXMD) Chairman and CEO, Howard Weisman, shares a progress report on the critical work being done to address the rising prevalence of Autism Spectrum Disorder ("ASD") in the United States. This disorder has seen a fourfold increase over the past two decades, underscoring the urgency of PaxMedica's mission.

PaxMedica Inc. (NASDAQ: PXMD) is a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic therapies (APTs) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms.

The company’s lead programs are focused on ASD, for which there are currently no approved pharmacologic treatments that target its cause and symptoms. Currently used treatments only address the symptoms of the condition, rather than targeting the pathophysiology itself.

PaxMedica is on a promising path to address these unmet medical needs, bringing hope to millions. Anti-purinergic therapies target the excess production of purines in cells. An overexpression of purines can offset homeostasis and result in an overproduction of cellular adenosine triphosphate, the main energy molecule in all living cells.

The company is headquartered in Tarrytown, New York.

Product Pipeline

PaxMedica is building a robust pipeline of products targeting ASD and related neurodevelopmental conditions. The company’s lead product in development may help eliminate, reduce or modulate some of the more troublesome aspects of ASD. That would open the potential for people with autism to integrate their behavior with others more successfully and improve their lives.

PaxMedica’s lead programs, PAX-101 and PAX-102, utilize the company’s proprietary source of suramin sodium, a broadly acting anti-purinergic therapy that has been known for over 100 years. Its current pipeline includes:

• PAX-101 (IV Suramin) for ASD – PAX-101 completed a Phase 2B study for ASD in 2021. Suramin is a broadly acting APT and has reported positive results from a dose range study. The results of PaxMedica’s Phase 2B study, which targeted 52 subjects across six sites in South Africa, were presented to AACAP in October 2021.
• PAX-102 (Intranasal Suramin) – PaxMedica has developed a proprietary intranasal formulation of suramin that is currently being evaluated in ASD and other neurodevelopmental conditions.
• PAX-101 for HAT – Given suramin’s historical use as a treatment for Human African Trypanosomiasis (HAT), or African Sleeping Sickness, the company is also developing PAX-101 as a treatment for HAT. PaxMedica’s most advanced program is the pursuit of PAX-101 for early-stage East African HAT.
• Selective APTs – PaxMedica has conducted several preclinical studies to evaluate other APTs that are more selective to specific purinergic receptors and may offer additional benefits over suramin.

Market Opportunity

According to a report by Fortune Business Insights, a leading global market research company, the global ASD therapeutics market was estimated at $1.93 billion in 2022 and is projected to grow from $2.01 billion in 2023 to $3.42 billion by 2030, a CAGR of 7.9% over the forecast period. As there is no current treatment for the core symptoms of autism, PaxMedica believes the addressable market for PAX-101, if approved, could greatly exceed these forecasts.

Autistic disorder, Asperger’s Syndrome and Pervasive Development Disorder are the three main types of ASD, affecting millions of people globally. A 2020 report by the U.S. Centers for Disease Control & Prevention estimated that one in 36 children in the U.S. have been diagnosed with autism disorder.

Several factors are expected to contribute to market growth prospects. A growing prevalence of the condition globally and rising awareness coupled with available treatment options are key factors expected to drive ASD therapeutics market growth during the forecast period. Growing investment in R&D to find effective treatments is also expected to fuel global market growth.

Management Team

Howard Weisman is Chairman and CEO of PaxMedica. He has been a founder and CEO of several specialty pharma and medical device companies. Most recently, he was executive chairman and co-founder of Sofregen, a biotech company. He also served as CEO and president of Seventh Sense Biosystems, a medical device development company. He also was founder, chairman and CEO of EKR Therapeutics, a specialty pharmaceutical company, and founder and COO of ESP Pharma, a company focused on cardio and neurovascular products. He has a bachelor’s degree in chemistry from Rutgers University.

David Hough, M.D., is Chief Medical Officer at PaxMedica. He is a neuroscience clinical development consultant who previously served as vice president at Janssen Research and Development and in various leadership roles over 17 years. Most recently, he was the compound development team leader for SPRAVATO® for treatment-resistant depression. Prior to that, he was the schizophrenia disease area leader. He played a pivotal role in the development programs for oral INVEGA®, INVEGA SUSTENNA® and XEPLION® for schizophrenia. He is a graduate of West Point and is board certified in psychiatry.

Stephen Sheldon is COO and CFO at PaxMedica. He has served as CEO of Thailand-based specialty healthcare company Indochina Healthcare Co. Ltd. since 2015. Previously, he was a consultant for PricewaterhouseCoopers Healthcare Advisory in the Chicago office. He was responsible for developing specialty pharmacy patient programs, strategy development for specialty products and compliance programs. He has an MBA from Thunderbird School of Global Management and a bachelor’s degree in computer science and visual arts from Bowdoin College.

PaxMedica Inc. (NASDAQ: PXMD), closed Friday's trading session at $0.2861, off by 1.0035%, on 56,381 volume. The average volume for the last 3 months is 788,955 and the stock's 52-week low/high is $0.2537/$4.07.

Recent News

• PaxMedica Inc. (NASDAQ: PXMD) - PaxMedica Inc. (NASDAQ: PXMD) Releases Compelling Video: Progress Report on ASD and Hope for the Future
• PaxMedica Inc. (NASDAQ: PXMD) Is 'One to Watch'
• PaxMedica to Present at the H.C. Wainwright 25th Annual Global Investment Conference

Sekur Private Data Ltd. (CSE: SKUR) (OTCQB: SWISF) (FRA: GTD0)

The QualityStocks Daily Newsletter would like to spotlight Sekur Private Data Ltd. (CSE: SKUR) (OTCQB: SWISF) (FRA: GTD0).

New to The Street's "Sekur Privacy & Sekur Security Segment – The Weekly Hack " with Alain Ghiai, an internationally acclaimed internet privacy expert and the CEO of Sekur Private Data, Ltd . (OTCQX: SWISF) (CSE: SKUR) (FRA: GDT0) and TV Host and Multi-media Journalist Ana Berry talk about United Kingdom charity cybersecurity hack case. An internationally recognized charity based in the UK is the latest hack victim, with about 93,000 donors' information and data stolen. Many famous stars and musical performers are donors whose information was compromised. Emails, credit cards, bank information, and addresses are most likely now in the hands of hackers. Alain states that the US non-profit organizations are many times larger than in the UK. Donors need to use secure and private email platforms when sending online donations; using free Big Tech email addresses have limited cybersecurity features and are more likely susceptible to hacking. Sometimes, a donor will leave credit card information for further use on a donor's website. Alains says never to do so, and it is like leaving your credit card in a store for future use. The best way to minimize your internet footprint and reduce hacking chances is through subscription products offered at Sekur. com om . SekurMail , with SekurSend/SekurReply options, protects both the subscriber and the recipient, even if the recipient is not a Sekur subscriber. The Company's newest product, SekurVPN is a proprietary virtual private network with technological advance encryption and operates on Sekur's servers in Switzerland. SekurVPN adds an extra layer of cybersecurity, whereas the end-user's IP address will always appear in Switzerland, no matter where the subscriber uses the internet. Sekur Private Data, Ltd. operates its internet platforms and security businesses under the country of Switzerland's very tough privacy laws. Sekur has several video tutorials and a fully staffed customer service department, available 9 AM-5 PM, Monday-Friday. The Company has a PROMO CODE: PRIVACY; subscribers can get an additional 15% off monthly and yearly subscriptions for five years. With Sekur's enhanced security features, end-users can significantly minimize a possible cybercriminals attack. It never data mines, sells data, asks for a phone number, tracks internet traffic, or uses 3 ^rd party platforms/software. The on-screen QR code is available during the show to download more info or visit Sekur Private Data, Ltd. – http://www.Sekur.com . What is your privacy worth?

Sekur Private Data Ltd. (CSE: SKUR) (OTCQB: SWISF) (FRA: GTD0) is a Cybersecurity and Internet privacy provider of Swiss hosted solutions for secure and private communications. The company distributes a suite of encrypted e-mails, secure messengers and secure communication tools. Sekur Private Data Ltd. sells its products through its own website at www.Sekur.com, approved distributors, and telecommunications companies. Sekur Private Data Ltd. serves consumers, businesses and governments worldwide.

Customer information is completely confidential and safely stored in Switzerland using military grade security. All data, whether physical, network-based or encryption security, is stored in bank-approved, state-of-the-art ISO-certified data centers used by Swiss and global banks and most United Nations organizations, as well as many corporations and governmental organizations. All user data is protected by the Swiss Federal Data Protection Act and the Swiss Federal Data Protection Ordinance, which offer some of the strongest privacy protection in the world for both individuals and organizations.

The company owns 100% of its own infrastructure and, unlike its competitors, does not rely on third party cloud services like Amazon Web Services, Microsoft Azure Cloud or Google cloud infrastructure.

Sekur Private Data has chosen Switzerland to locate its data storage because of the country’s neutrality, independence, strong privacy laws, long standing political stability and excellent international relations. Switzerland is also home to several large multinational corporations and is ranked as having one of the strongest and most competitive economies in the world.

The company is headquartered in Toronto, Ontario.

Products

Sekur Private Data distributes a privacy communications suite offering encrypted and private email, the only Swiss-hosted privacy VPN, and a secure and private messaging application. All solutions cater to consumers, SMBs, enterprises and governments.

• SekurMail® is an encrypted email service offering a private, safe and powerful tool to communicate with everyone, either within the Sekur ecosystem or outside. SekurMail protects personal information and communications from being accessed by unauthorized parties. Its encryption and other security measures prevent messages from being intercepted, modified or tampered with, either in transit or while stored. SekurMail empowers the client to access information and communicate with anyone in the world, regardless of geographical or political barriers.
• SekurVPN® creates a secure, encrypted connection between the client’s device and the Internet, giving clients access to the web safely and privately by routing their connections through a server and hiding their online actions. All the data sent and received is hidden from prying eyes. This includes the clients’ Internet Service Providers, as well as potential hackers and even government surveillance agencies. It can also help clients bypass geographical restrictions and censorship.
• SekurMessenger® is a Swiss-hosted private and secure messaging communications app providing secure and private chat, self-deleting chat, voice recording and file transfer via any mobile device, tablet or desktop computer. Communications are transmitted only within secure servers. It’s designed for organizations that need to protect their flow of information and secure their communications with customers and partners. SekurMessenger is designed to provide military-grade encryption and privacy by ensuring that only the sender and intended recipient can read the messages exchanged. It works for both licensed users of the app and intended message recipients who do not have the app.

Market Opportunity

An analysis from ReportLinker forecasts that the global cybersecurity market will grow from an estimated $173.5 billion in 2022 to $266.2 billion by 2027, recording a CAGR of 8.9% for the period.

The increased number of data breaches worldwide, the ability of malicious actors to operate from anywhere in the world, the links between cyberspace and physical systems and the difficulty of reducing vulnerabilities and consequences in complex cyber networks are some factors that are driving cybersecurity market growth, according to the report.

The global data privacy software market was estimated to be worth $1.68 billion in 2021 and is expected to grow from $2.36 billion in 2022 to $25.85 billion by 2029, achieving an eye-popping 40.8% CAGR during the forecast period, according to a Fortune Business Insights report titled ‘Data Privacy Software Market 2022-2029’.

The widespread shift toward remote working culture, evolving government data privacy regulations and the rapidly increasing adoption of Internet-of-Things devices are among the major factors propelling market growth, per the report.

Management Team

Alain Ghiai is founder, CEO and Director at Sekur Private Data. He also founded GlobeX Data S.A. (GDSA) in 2007 and has served as Director and CEO since then. He founded GlobeX Data Inc. (GlobeX US) in August 2012 and has served as Director and CEO since that time. He attended the California College of Arts in San Francisco, where he earned a Bachelor of Architecture. He has over 15 years of experience in the software industry and was instrumental in taking Sekur Private Data public in July 2019.

Scott Davis, CPA, CGA, is CFO at Sekur Private Data. He is also a partner at Cross Davis & Company LLP Chartered Professional Accountants. His experience includes CFO positions at several companies listed on the TSX Venture Exchange. He spent four years at Appleby as an Assistant Financial Controller. Prior to that, he spent two years at Davison & Company Chartered Professional Accountants as Auditor, five years with Pacific Opportunity Capital as Accounting Manager and two years at Jacobson Soda and Hosak, Chartered Professional Accountants. He obtained his CPA, CGA in 2003.

Learn more about the company’s management team by visiting its corporate page.

Sekur Private Data Ltd. (OTCQB: SWISF), closed Friday's trading session at $0.115, off by 14.8148%, on 172,605 volume. The average volume for the last 3 months is 92,254 and the stock's 52-week low/high is $0.027/$0.1576.

Recent News

• Sekur Private Data Ltd. (FRA: GTD0) (CSE: SKUR) (OTCQB: SWISF) - New to The Street Announces its Four Corporate Interviews Airing on Newsmax and The FOX Business Network
• New to The Street Announces its Five Corporate Interviews, airings on Newsmax and FOX Business Network
• Sekur Private Data Ltd. (CSE: SKUR) (OTCQB: SWISF) (FRA: GTD0) Is 'One to Watch'

GeoSolar Technologies Inc.

The QualityStocks Daily Newsletter would like to spotlight GeoSolar Technologies Inc.

GeoSolar Technologies Inc. (“GST”) is a Colorado-based climate technology company and the creator of the Smart Green Home® system for newly built and existing residences and commercial buildings. The company is focused on revolutionizing the way we heat, cool and power homes with 100% natural energy sources. Its patent-pending integrated system harnesses energy from the earth and sun to power and purify homes and automobiles without the use of fossil fuels.

In a GST home, the sun’s energy is captured on the roof to generate all of the electricity required. Additionally, the consistent climate of the earth is used to keep the home at a perfect temperature year-round, and the company’s proprietary air purifying unit ensures that the air inside the home is safe and healthy.

GST’s home technology has been installed in multiple test homes in Colorado and achieved exceptional results, including some of the most impressive energy efficiency ratings (HERS) in the industry.

GeoSolar Technologies is currently accepting investment as part of a Regulation A+ offering. Everyone* can invest now for as little as $300. For more information, visit the company’s profile on Manhattan Street Capital and review its Offering Circular.

GeoSolar Technologies Inc. (“GST”) has been qualified by the U.S. Securities and Exchange Commission (SEC) to conduct a Regulation A+ capital raise. GST is already a publicly traded company who makes quarterly and annual filings with the SEC and is subject to quarterly PCAOB audits. This is the first time shares of GeoSolar Technologies are being made available for public purchase. Upon completion of this Regulation A+ offering, the company intends to seek a listing of its stock.

 

The Decarbonization Movement

Soaring and unstable energy/fuel costs continue to highlight the importance of rethinking the traditional approach to powering homes, from top to bottom. While most everyone is well aware of the remarkable, multi-trillion-dollar opportunity the electric vehicle transformation offers to investors (in addition to the benefits to the climate problem), few recognize that the all-electric home market is as large as electric vehicles and equally important to reducing carbon emissions.

U.S. energy expenditures clocked in at $3,891 per person in 2018, leading to estimated spending of $1.3 trillion on energy that year alone. Despite this, fewer than 3% of U.S. homes are currently powered by solar. This number is poised to increase exponentially as both new and existing residences transition to zero carbon models.

GST estimates that if all the homes in America were powered by its technology, carbon pollution could be reduced by an estimated 1.9 trillion pounds per year, greatly reducing the negative impacts on our climate.

GeoSolarPlus®

The GeoSolarPlus (“GSP”) system combines solar power, geothermal ground-sourced energy and other clean energy technologies into one fully integrated system.
Key benefits of the GSP system include:

• Making a real planet-changing difference in reducing air pollution
• Eliminating or significantly reducing homeowners’ future utility bills
• Enjoying lifetime energy independence and protection from price escalation and energy shortages
• Eliminating greenhouse gas emissions from operation of home and daily life
• Increasing home value
• An integrated design for seamless operation of renewable energy systems
• Maintaining a significantly healthier living environment
• Leveraging existing renewable energy tax credits and electrification incentives
• Creating stable jobs capable of supporting families in the decarbonized future

Click here to learn more about how GeoSolarPlus works.

Management Team

The GST leadership and management team includes some of the world’s most experienced and respected leaders in the fields of decarbonization and sustainable homes.

Stone Douglass is the Chairman and CEO of GST. He is a seasoned, 30-year public company executive and former Chairman and CEO of the Piper Aircraft Company.

Brent Mosbarger is the company’s Co-Founder and leads its commercial operations. He is a highly respected solar engineer whose experience includes roles with Chevron Energy’s green operations and serving as project manager and executive for a $400 million solar/geothermal innovation project.

Peter Romenesko is a Senior Strategic Advisor with GST. He brings to the company considerable experience as an engineer and large-scale project manager for Johnson Controls and Siemens.

Dr. Norbert Klebl is the company’s Co-Founder and Development Director. Recognized as one of the world’s leading experts in the field of zero-carbon innovation, he is a former McKinsey partner of 16 years with an MBA from Columbia.

Dar-Lon Chang is GST’s Director of New Product Development. Prior to joining GST, he had a 16-year career with ExxonMobil Energy Research. He received his PhD in engineering from the University of Illinois.

* Must be over 18, certain states are not currently available and will be added soon.

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