QSAM Biosciences Inc. (OTCQB: QSAM)

The QualityStocks Daily Newsletter would like to spotlight QSAM Biosciences Inc. (OTCQB: QSAM).

• Overall incidence of childhood cancer is on the increase, averaging 0.8% increase per year since 1975, reports leading advocacy organization
• QSAM developing therapeutic radiopharmaceuticals as safer, more efficacious alternatives to address unmet medical needs, underserved patient populations
• Company creating pipeline of novel radiotherapeutics to serve multiple indications with its lead product, CycloSam

With the overall incidence of childhood cancer on the rise, the work of QSAM Biosciences (OTCQB: QSAM) is becoming increasingly important. QSAM Biosciences is a clinical-stage biotechnology company focused on developing and bringing to market targeted therapeutic radiopharmaceuticals and advancing the fight against cancer, including the underserved pediatric population. Scientists have for the longest time believed that cancer begins to develop when cells in the body acquire more mutations and multiply at an abnormal rate. However, new research has shed light on how air pollution can cause cancer, a discovery that could completely change the understanding of how tumors develop. This study, which was conducted by scientists at the Francis Crick Institute in London, found that air pollution was awakening old damaged cells in the body instead of damaging healthy cells. The investigators, who are also based at University College London, were focused on finding what could trigger the damage present in cell DNA to make it cancerous. They began their research by looking into why people who didn’t smoke developed lung cancer. This is based on data showing that while the majority of lung cancer cases are primarily caused by smoking, one in 10 cases in the United Kingdom is caused by air pollution. As more entities such as QSAM Biosciences Inc. (OTCQB: QSAM) take up the mantle of seeking a better understanding of how cancer forms and spreads, as well as how it can be treated effectively, the future looks bright as new therapeutics are introduced onto the market.

QSAM Biosciences Inc. (OTCQB: QSAM) is a clinical stage biotechnology company focused on bringing to market targeted therapeutic radiopharmaceuticals. The company is committed to advancing the fight against cancer through the discovery, development and delivery of effective treatment options for adult and pediatric patients.

QSAM Biosciences was founded in 2020 by Executive Chairman Dr. C. Richard Piazza and CEO Douglas Baum. It is headquartered in Austin, Texas.

CycloSam®

CycloSam®, QSAM Biosciences’ initial technology, is a clinical-stage bone targeting radiopharmaceutical invented by world-renowned scientists at IsoTherapeutics Group LLC. By leveraging a patented, low specific activity form of Samarium-153 (resulting in far less undesirable europium impurity) and what management believes to be a superior chelating agent in DOTMP, CycloSam is designed to selectively target sites of high bone mineral turnover to deliver a prescribed tumor-killing dose of radiation to the bone tumor sites while minimizing radiation exposure to nearby healthy tissue. These parameters are currently being tested in an FDA-cleared clinical trial.

CycloSam® has been shown in laboratory testing to cause significantly less (30x less) buildup of long-lived radionuclidic impurities than prior FDA-approved drugs, which management believes will enable the ability to safely administer therapeutic doses via higher and multiple-dose regimens and effectively expand its potential clinical utility to therapeutic uses in areas of high unmet medical needs.

The indications for CycloSam® currently being evaluated by QSAM Biosciences include:

• Metastatic Bone Cancers – On April 28, 2022, QSAM Biosciences announced that the first patient had commenced treatment in its clinical trial evaluating CycloSam in patients with metastatic bone cancer. As noted in the release, the study is a Phase 1 open-label, dose-escalation trial to evaluate the safety, tolerability, dosimetry, and preliminary efficacy of CycloSam®.
• Pediatric Osteosarcoma/Ewing’s Sarcoma – On February 2, 2022, the company announced that the U.S. FDA has granted Rare Pediatric Disease Designation to CycloSam for the treatment of osteosarcoma. Combined with a previously granted orphan drug designation for osteosarcoma received in 2021, this milestone “may allow QSAM to potentially bring CycloSam® to market more rapidly through additional incentives and eligibilities,” according to CEO Douglas Baum.
• Bone Marrow Ablation – In a 2020 single patient Investigational New Drug (IND) study, an investigator concluded that high-dose CycloSam® can be administered safely to ablate bone marrow in advance of a stem cell transplant with no apparent renal toxicity and no unexpected adverse events attributable to the drug.

QSAM Biosciences’ preclinical and clinical development pipeline is supported by a strong IP portfolio. The company has secured 14 patents across three distinct patent families spanning the U.S., Japan, Canada and the European Union.

Market Outlook

Through its ongoing development of CycloSam®, QSAM Biosciences is targeting multiple large and underserved market opportunities. According to the American Cancer Society, roughly 400,000 new cases of malignant bone metastasis are diagnosed annually in the U.S. alone. Additionally, QSAM will pursue indications for osteosarcoma and Ewing’s sarcoma that are the most common primary malignancies of bone tissues in children.

Despite this pressing need, the current standard of care for bone cancer is aggressive and suboptimal, leading to marginal success with significant side effects and poor long-term survival prognosis. As a result, QSAM Biosciences estimates a sizable market opportunity for its development pipeline.

• Bone Metastasis has an estimated total addressable market of $20 billion in the U.S. based on total new cases and comparable drug pricing.
• Osteosarcoma/Ewing’s Sarcoma have a total addressable market of roughly $125 million in the U.S. based on approximately 1,000 new cases in 2021.
• The total addressable market for Bone Marrow Ablation is projected at $1 billion, with an estimated 32,000 procedures completed annually.

The company anticipates that the ability to administer CycloSam® for higher and multiple-dose regimens may expand its clinical utility for therapeutic uses in additional areas of high unmet medical needs.

Management Team

QSAM Biosciences is led by an experienced management team and board with an extensive record of FDA approvals, big pharma partnerships and M&A transactions.

Dr. C. Richard Piazza is the Executive Chairman of QSAM Biosciences. Since 2017, he has also served as President and CEO of IGL Pharma Inc., the licensor of CycloSam®, and as a consultant to IsoTherapeutics Group LLC, the inventors of the technology. Dr. Piazza also currently serves on the board of directors of NovaScan LLC, a privately held cancer detection and diagnostics company. He has more than 48 years of health care experience in both medical devices and pharmaceutical/biotech and has led several technology companies to market success, including numerous FDA approvals in both sectors. Dr. Piazza obtained a BS in Economics and a BS in Speech Pathology from the State University of New York and an MA & PhD in Economics from the University of Buffalo and Leeds University.

Douglas R. Baum is the company’s CEO and Director. He brings to QSAM Biosciences over 30 years of experience in the bioscience and biotech industries, including development, FDA/EMA approval and commercialization of multiple drugs and medical devices. Mr. Baum has overseen 15 product approvals through the FDA and EMA and raised over $85 million in capital to fund breakthrough technologies. From 2017 to 2020, he consulted with multiple medical schools and biotech and pharmaceutical companies, and, from 2012 to 2017, he served as President, Chief Executive Officer and Director of Xeris Pharmaceuticals Inc. Mr. Baum holds a Master of Science in Technology Commercialization and a BBA in International Business and Marketing from the University of Texas.

Adam King is the CFO of QSAM Biosciences. He is also the Founder and CEO of King Consulting Group, where he provides a range of financial and reporting services for clients. Before founding King Consulting Group in January 2021, Mr. King was the CFO for Netsertive, a venture-backed digital marketing company. From 2016 to 2018, he was the Office Managing Audit Director for BDO’s Greenville, South Carolina, office, in addition to serving as Audit Director in Raleigh, North Carolina, and Boston, Massachusetts. While at BDO, Mr. King worked with various clients, from tech and life science start-ups to billion-dollar publicly traded companies. He holds a Bachelor of Science in Accounting from Elon University and is a CPA in Raleigh, North Carolina.

QSAM Biosciences Inc. (OTCQB: QSAM), closed Tuesday's trading session at $6, up 20%, on 113 volume. The average volume for the last 3 months is 113 and the stock's 52-week low/high is $3.50/$19.60.

Recent News

• QSAM Biosciences Inc. (OTCQB: QSAM) - Scientists Discover Unexpected Way in Which Air Pollution Causes Cancer
• QSAM Biosciences Inc. (QSAM) Working to Halt, Regress Bone Tumors in Children Through Therapeutic Radiopharmaceuticals
• Researchers Find Cases of Osteosarcoma More Prevalent in Blacks

Knightscope, Inc. (NASDAQ: KSCP)

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

Knightscope, Inc. [Nasdaq: KSCP], a developer of advanced physical security technologies focused on enhancing U.S. security operations, today announced its Robot Roadshow - an engaging experiential event used to grab attention fast, forge direct connections with potential clients, and strike up conversations in a compelling fashion – will land at 22895 Ladbrook Dr, Sterling, VA 20166, on 20-21 September 2022 from 10:00am to 2:00pm ET. The Robot Roadshow has made 56 landings in 22 states and Washington, D.C. to date. Knightscope’s crime-fighting robots tour the U.S. in a space-age, NASA-like “pod” allowing attendees to experience all the technology that is enabling these Autonomous Security Robots (ASRs) to help make sites safer today from Hawaii to Texas to North Carolina. A short video of a past event hosted by the Los Angeles Police Department may be viewed here .

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 Tuesday's trading session at $3, up 2.7397%, on 347,305 volume. The average volume for the last 3 months is 347,855 and the stock's 52-week low/high is $2.50/$27.50.

Recent News

• Knightscope (NASDAQ: KSCP) - Knightscope Robot Roadshow Arrives in Sterling, Virginia
• InvestorNewsBreaks - Knightscope Inc. (NASDAQ: KSCP) Secures Expanded Contract with Oregon-Based Client
• InvestorNewsBreaks - Knightscope Inc. (NASDAQ: KSCP) ASR Patrols Portland Hotel, Augments 24/7 Security

Lexaria Bioscience Corp. (NASDAQ: LEXX)

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

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug-delivery platforms, is focused on establishing a stronghold in the $28 billion hypertension drug market. The company’s exclusive therapeutic, DehydraTECH-CBD, has shown exciting potential as an alternative to traditional cannabidiol (“CBD”) dosing methods; the proprietary treatment may offer improved and more rapid absorption of drugs into the bloodstream and brain. According to the announcement, only one FDA-approved CBD drug is currently available on the market; that drug is for pediatric epilepsy. Lexaria is working to offer the second-ever, FDA-approved CBD therapeutic, designed to treat hypertension. The market for the treatment is tremendous, with more than 116 million Americans and more than one billion adults worldwide dealing with high blood pressure, a life-threatening condition. The press release outlines a summary of a PCG Digital interview with Lexaria’s lead investigator in its human hypertension studies, Professor Philip Ainslie, PhD. To view the full press release, visit https://ibn.fm/JCqSc

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 a collaborative research agreement with the National Research Council (NRC), the Canadian government’s premier research and technology organization. The company has filed for patent protection for specific delivery of nicotine, vitamins, NSAIDs, testosterone, estrogen, cannabinoids, terpenes, PDE5 inhibitors (with brand names like Viagra), tobacco 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 Tuesday's trading session at $2.85, up 0.352113%, on 19,265 volume. The average volume for the last 3 months is 19,265 and the stock's 52-week low/high is $1.85/$7.19.

Recent News

• Lexaria Bioscience Corp. (NASDAQ: LEXX) - InvestorNewsBreaks - Lexaria Bioscience Corp. (NASDAQ: LEXX) Targeting Hypertension Drug Market with Proprietary Drug-Delivery Method
• Lexaria Bioscience Corp. (NASDAQ: LEXX), Growing its Market Share, One Patent at a Time
• CannabisNewsBreaks - Lexaria Bioscience Corp.'s (NASDAQ: LEXX) Hypertension Treatment Program Stands Distinct

Cybin Inc. (NEO: CYBN) (OTC: CYBN)

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

• First dose is administered as first-ever novel psilocybin analog enters clinical development
• Cybin believes CYB003 has potential to successfully address the challenges and limitations of oral psilocybin
• The high level of participant interest in the study indicates a significant unmet need for alternative treatment options for major depressive disorder (“MDD”)

Cybin (NEO: CYBN) (NYSE American: CYBN) has reached a milestone in its mission to create safe and effective therapeutics. The company is conducting a phase 1/2a trial evaluating CYB003, its lead investigational molecule and the first-ever novel psilocybin analog to enter clinical development. Late last month, the first two trial participants were dosed (https://ibn.fm/JXADp). Cybin (NEO: CYBN) (NYSE American: CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics(TM), has successfully reached key research and development (“R&D”) milestones that were identified in the company’s acquisition agreement of Adelia Therapeutics in 2020. The milestones were reached faster than expected, and have helped Cybin make progress on its path toward clinical drug development. The milestones were key in moving Cybin’s psychedelic programs from lab to clinic and have enabled the company to discover potential new drug formulations and delivery methods as well as create clinical protocols for psychedelic compounds and support clinical-stage development of CYBN’s proprietary CYB003 and CYB004 programs for major depressive disorder and anxiety disorders. “It is extremely gratifying that we have been able to progress our ambitious R&D pipeline – from discovering new drug candidates to entering the clinic – ahead of our projected schedule,” said Cybin CEO Doug Drysdale in the press release. “Our clinical development work continues in earnest, and with each day we get closer to our goal of creating new psychedelic-based treatments for mental health conditions and potentially improving the patient and therapist experience across multiple indications. Our commitment to bringing these important and new potential treatments to patients in need and delivering value to all our stakeholders is unwavering.” To view the full press release, visit https://ibn.fm/5tSky. Convergence, the biggest psychedelic culture and business conference in California, recently announced that Hamilton Morris would be a keynote speaker at the conference. Morris is a well-known advocate in the psychedelics space. In addition to being a scientific researcher, a journalist and a filmmaker, he has a television show known as “Hamilton’s Pharmacopeia.” The show, which runs on Vice TV, allows him to bring life to stories and experiences of psychedelics along with the uses of these substances and their cultural significance and the chemistry behind them. At the moment, Morris is a consultant at Compass Pathway’s Discover Center, which is based at Philadelphia’s University of the Sciences. There, he advises the company on research related to new psychedelic compounds that can be developed into treatments for unmet mental health needs. Such conferences are a good facilitator of the proper flow of information between industry actors such as Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) and the general public, which appears to be hungrier than ever for science-backed information about the potential and risks associated with different psychedelic compounds.

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

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

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

Serenity Life Sciences & Natures Journey Inc.

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

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

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

Partnership with the Toronto Centre for Psychedelic Science (TCPS)

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

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

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

Journey’s Product Monetization & Market Potential for Nutraceutical Supplements

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

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

Pharmaceutical Psychedelics

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

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

Amalgamation Agreement and Financing

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

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

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

Cybin Inc. (NEO: CYBN) (NYSE American: CYBN), closed Tuesday's trading session at $0.6687, up 2.6243%, on 1,521,061 volume. The average volume for the last 3 months is 1.514M and the stock's 52-week low/high is $0.3903/$2.43.

Recent News

• Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) - Hamilton Morris Confirmed as Keynote Speaker at Convergence Psychedelic Conference
• InvestorNewsBreaks - Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) Announces R&B Milestones, Beats Anticipated Timeframe
• Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) Clinical Trial Marks 'Tremendous' Milestone as First Participants Receive Initial CYB003 Dose

Prime Harvest Inc.

The QualityStocks Daily Newsletter would like to spotlight Prime Harvest Inc.

Recently, law enforcement personnel revealed that they had observed an increase in illicit market entities exploiting suspected victims of human trafficking to grow as well as trim cannabis sold illegally within and outside California. This comes as the cannabis legalization movement spreads across the country. Advocates and authorities stated that helping the victims was complicated, because most didn’t open up and say they were trafficked; they were also unwilling to collaborate with the law enforcement agencies to apprehend the dealers and smugglers. Earlier in May, law enforcement officers arrested suspected victims during a raid in an illegal grow operation in California’s Mojave Desert region. These workers, all of whom were Chinese nationals, attempted to flee while the officials conducted a search on the isolated farm. The dangers of black-market actors in the marijuana industry in California illustrates just how important it is for the state to do everything possible to stamp out the black market so that legitimate firms like Prime Harvest Inc. don’t have to unfairly compete with players who don’t pay taxes and other fees or support the local economy.

Prime Harvest Inc., based in San Diego, California, is a technology-focused, full-service cannabis company with horizontally diversified operations spanning various segments of the cannabis value chain, from licensing acquisition and compliance management to direct-to-consumer operations. The company is leveraging a long-term strategy of investing in the growth and scale of licensed assets anchored by the power of data-driven technology to expand its footprint throughout California.

Sustainability is key to Prime Harvest’s corporate vision. The company aims to ensure that the communities it serves capture their fair share of the fruits of the industry’s growth, including financial profit, employment opportunities, environmental enrichment and impactful innovation through R&D and education.

The company’s mission is to appeal to the ethos of the cannabis consumer by setting a new operational standard emphasizing accountability, sustainability and community. With this commitment, Prime Harvest continues to work toward positively affecting millions of lives through the creation of a world-class platform that caters to strengthening the commercial cannabis pipeline.

Jaxx Cannabis

Jaxx Cannabis is the flagship brand in Prime Harvest’s portfolio. Through Jaxx Cannabis, the company aims to use technology to facilitate a true customer-centric culture while enhancing the overall craft cannabis experience. Jaxx features an expertly curated selection of premium products from some of the most respected brands in the thriving California market.

Key values serving as the foundation of Jaxx Cannabis include:

• Creating and nurturing a welcoming culture for all
• Unlocking the true potential of customer value
• Being innovative in uncovering new ways to grow both the company and the industry
• Meeting the wants and needs of consumers to promote profitability
• Remaining accountable for the results of its operations

It is these values that differentiate Prime Harvest and Jaxx Cannabis in the California cannabis sector.

Brand Partnerships

Prime Harvest works diligently to establish strong alliances with complementary brands that are in alignment with its culture and values. Through a combination of deliberate foresight and strategic action, the company seeks to grow existing cannabis brands and continuously discover new, high-potential performers that are primed for long-term success.

These partnerships enhance Prime Harvest’s efforts to transform the world’s cannabis access and bring its consumers high-quality products that are fair for both people and the planet.

Responsibility

Prime Harvest remains committed to the goal of creating a more sustainable environment, now and in the future. Concern for human beings and the environment can be observed in every facet of its operations, including its ongoing R&D activities dedicated to exploring methods of reducing and repurposing waste into composite materials and exploring the potential of the hemp plant for industrial and wellness contributions.

The company is a proud member of the Community Alliance Program, a foundation that seeks to make a difference in local communities by providing financial assistance for educational programs, housing homeless veterans, creating urban farms, and holding local arts initiatives for children and adults. The program also helps explore the natural healing attributes of medical cannabis through research, development, clinical trials, and advocating for the safe access of cannabis to those in need.

Market Overview

Ongoing changes in U.S. state government policies toward cannabis are expected to cause demand for legal marijuana to surge. In addition, the number of indications for which medical marijuana is prescribed continues to increase. These factors are expected to rapidly boost legal sales of cannabis products.

Legal sales across the U.S. hit a record of $17.5 billion in 2020, marking an increase of 46% over 2019, according to Forbes. This strong growth is expected to continue. According to a Grand View Research report, the global legal marijuana market is forecast to grow at a CAGR of 26.7 percent from 2021 to 2028.

California – Prime Harvest’s home state – has consistently led the pack in terms of U.S. cannabis sales. The Motley Fool pegged cannabis spending in the Golden State at $3.8 billion in 2020, more than doubling the second state on its list.

Leadership Team

The Prime Harvest team is composed of true experts in their respective fields focused on building a world-class organization capable of driving the cannabis industry and movement forward.

E. Duane Alexander is the company’s Founder and CEO. He brings to the team more than 25 years of real-world, hands-on cannabis retail, marketing and commercial operations experience. Mr. Alexander has championed 40+ cannabis license applications throughout the western U.S. to date.

John Wilczak is the COO of Prime Harvest. He has 30+ years of executive management, strategy development & configuration experience with GE, pharmaceutical and agriculture companies. Mr. Wilczak is a Brown & Columbia MBA with vast knowledge of technology driven intellectual properties.

Andrea Jenson is the Chief Financial Officer of Prime Harvest. As CFO, she is responsible for all the company’s financial functions, including accounting, corporate finance and investor relations. Her career spans more than 20 years of varied experience in financial management, business leadership and financial strategy.

John Kazanjian is the VP of Business Development of Prime Harvest. He has worked over 40 years in business operations, brand marketing, sales and investor/lender communications. Mr. Kazanjian earned his B.S. from Rutgers University and his MBA from Harvard University.

Johann Balbuena is the Chief Marketing Officer of Prime Harvest. She has more than six years of experience in California cannabis licensing acquisition and compliance management. Ms. Balbuena has led multimedia production and content marketing efforts for the likes of the Social Club TV app, The Emerald Cup, High Times, Weedmaps and Synergy.

Recent News

• Prime Harvest Inc. - 420 with CNW — Law Enforcement Raids Uncover Human Trafficking Victims in Illegal Cannabis Farms
• 420 with CNW — Director of Federal Health Agency Blasts Cannabis Research Barriers Impeding Opioid Research
• 420 with CNW — Two Marijuana Policy Reform Bills Sent to California Governor’s Desk

EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQX: EVGIF)

The QualityStocks Daily Newsletter would like to spotlight EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQX: EVGIF).

• Traditional natural gas extraction pollutes air, contaminates water, disturbs landscape
• Renewable natural gas is derived from organic sources, compatible with existing traditional natural gas pipeline grid
• EverGen operates projects in British Columbia and Alberta, recently acquired 50 percent stake in Ontario-based Project Radius located in Eastern Canada
• Company recently signed $31 million senior term loan to help fund RNG facility upgrades and expand projects 

Traditional pipeline natural gas is extracted by vertical or horizontal drilling, and hydraulic fracturing. Well-drilling activities pollute the air, disturb lands, and contaminate water, while hydraulic fracturing – widely referred to as “fracking” – has similar consequences in addition to causing earthquakes (https://ibn.fm/ldZri). In contrast, renewable natural gas (“RNG”) is derived from organic sources while still being compatible with North America’s existing gas pipeline grid. EverGen Infrastructure (TSX.V: EVGN) (OTCQX: EVGIF) is leading the movement in Canada by acquiring, developing, building, and operating a portfolio of RNG, waste-to-energy, and related infrastructure projects.

EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQX: EVGIF) is developing Canada’s Renewable Natural Gas Infrastructure Platform, starting on the west coast in British Columbia. The company is combating climate change and helping communities contribute to a sustainable future by acquiring, developing, building, owning and operating a portfolio of renewable natural gas (RNG), waste-to-energy, and related infrastructure projects.

While EverGen is currently focused on British Columbia, its continued growth is expected across other regions of North America. RNG is produced differently than conventional natural gas, without drilling wells. RNG is derived from biogas, which is captured from decomposing organic waste in landfills, food waste, agricultural waste matter and wastewater from treatment facilities. This waste feedstock is supplied to an anaerobic digester which contains bacteria that breaks down organic matter in the absence of oxygen. The resulting biogas is captured and cleaned to create carbon neutral or carbon negative RNG to be used by the existing North American gas pipeline grid. By capturing these emissions and transforming them into RNG, then combusting into CO2, the overall greenhouse gases (GHG) impact is materially less potent than allowing natural decomposition to release methane into the atmosphere. Liquid and solid digestate matter is a byproduct of the RNG production process and is used as fertilizer and in other applications.

EverGen operates three projects in British Columbia. The company was incorporated in 2020 and went public in 2021, with its common shares listed on the TSX Venture Exchange under ticker symbol ‘EVGN’. In February 2022, EverGen’s common shares began trading on the OTCQB Venture Market in the U.S. under ticker symbol ‘EVGIF’. The company is headquartered in Vancouver.

Portfolio Projects

Fraser Valley Biogas is one of three projects in EverGen’s portfolio. Located in Abbotsford, British Columbia, the facility has been digesting manure and off-farm organics since 2011 and was the first agricultural digester in Canada to produce RNG. The RNG generated through this project is part of a FortisBC program to supply renewable gas to homes, businesses and other customers. Fraser Valley Biogas also provides Abbotsford farms with renewable fertilizer via the digestate produced. EverGen acquired Fraser Valley Biogas early in 2021 and is currently enhancing and expanding the facility. These optimization projects resulted in record production during the month of September 2021, supporting the growing demand for RNG in British Columbia. Optimization activities contributed an additional 18% of RNG production for September and a 9% higher year-to-date production compared to the previous year. The facility produces approximately 80,000 gigajoules of RNG, enough to heat more than 1,000 homes for a year.

Net Zero Waste Abbotsford, a wholly owned EverGen subsidiary and portfolio project, is an existing composting and organic processing facility and RNG expansion project. The British Columbia Utilities Commission recently approved a 20-year offtake agreement between the facility and FortisBC, an electricity and gas utility. Under this agreement, FortisBC will purchase up to 173,000 gigajoules of RNG annually for injection into its natural gas system upon completion of an anaerobic digester project at Net Zero Waste Abbotsford. Once construction is complete, this project is expected to produce enough energy to meet the needs of more than 1,900 homes.

Sea to Sky Soils, a wholly owned EverGen subsidiary and portfolio project, is an existing composting and organic processing facility and potential future RNG expansion project which has been operating near Pemberton, British Columbia, on Lil’wat Nation land since 2012. The Lil’wat Nation is a key partner and supporter of the facility, which has employed a majority of its staff from the First Nation since inception. The Sea to Sky Soils facility processed approximately 160 percent of its forecast tonnage in the second half of 2021. In total, Sea to Sky Soils processed approximately 36,000 tons of organic waste in 2021. The facility is working with the Ministry of Environment to expand its operational capacity in 2022. EverGen has partnered with local municipalities – including Metro Vancouver and the municipality of Pemberton – for the delivery of additional organic waste to the facility. The facility is an important part of EverGen’s RNG infrastructure platform and serves as a source of valuable feedstock to support the company’s existing and future operations.

Market Outlook

A report from Global Market Insights states that the biogas market is projected to see significant growth over the next few years, driven by a shifting preference to utilize biogas to reduce emission levels from traditional fuels. Escalating RNG usage by gas utilities as a sustainable and low carbon alternative to supply heat and electricity in industries and buildings will further stimulate growth. RNG is increasingly deployed across the transport sector, especially for heavy vehicles and vessels, to abate GHG emissions.

Many North American gas utilities have set RNG targets of 5% to 15% of production by volume in 2030, compared to less than 1% by volume in 2020. FortisBC has a goal of including 15% RNG in its gas supply by 2030. EverGen believes this presents a potential C$16 billion+ opportunity for RNG producers.

Management Team

Chase Edgelow is co-founder and CEO at EverGen. He has over 15 years of specialized private investment, finance, and technical expertise in the energy and infrastructure sectors. His background is as a Facilities Engineer with Petro-Canada, independently managing energy infrastructure capital projects located in western Canada. He holds a Professional Engineer designation from the province of Alberta.

Mischa Zajtmann is co-founder and President at Evergen. He has 15 years of experience providing consulting and management for Canadian and American companies in the natural resources and energy space. He is a corporate securities lawyer who began his career at Blake, Cassels & Graydon LLP. His J.D. is from the University of Saskatchewan Law School. He’s a member of the British Columbia Bar.

Sean Mezei is COO at EverGen. He has 20 years of experience in the RNG industry, having served previously as the president of Greenlane Biogas and as a senior manager at QuestAir, and founder and president of Dekany Consulting. He was a co-chairman of the American Biogas Council’s RNG working group for six years. He has been a Registered Professional Engineer in the province of British Columbia since 1994.

Natasha Monk is CFO at EverGen. She is a CPA with 12 years accounting, financial reporting, and tax experience in public practice and industry. She is currently a partner at Affirm LLP, where she advises and consults to a wide variety of companies in multiple industries across public and private sectors. Prior to joining EverGen, she worked at KPMG. She graduated from the University of Calgary.

EverGen Infrastructure Corp. (OTCQX: EVGIF), closed Tuesday's trading session at $2, even for the day. The average volume for the last 3 months is 2,000 and the stock's 52-week low/high is $2.00/$4.21.

Recent News

• EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQB: EVGIF) - EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQX: EVGIF) Expands Canadian RNG Projects, Achieves Key Milestones
• GreenEnergyBreaks - EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQB: EVGIF) Targeting $50-60M Annual Revenue from Production of 2M Gigajoules of RNG
• EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQX: EVGIF) Poised to Drive RNG-Led Energy Transition; Reports Q2 2022 Results and Highlights

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 research, development and manufacturing of rare cannabinoids, will be releasing its financial report for fiscal year 2022, the period ended June 30, 2022, later this month. The company has announced that it will release the financial report, along with business highlights, on Sept. 23, 2022. In addition, the company has announced a conference call and webcast to be held the same day at 1 p.m. ET. Those interested in listening in on the conference call can register for the call; they will then receive information about how to dial in to the call. To register for the event, visit https://ibn.fm/DD1MI. To view the full press release, visit https://ibn.fm/8GuDy

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 Tuesday's trading session at $7.45, off by 4.4872%, on 1,119,813 volume. The average volume for the last 3 months is 1.115M and the stock's 52-week low/high is $5.8225/$59.25.

Recent News

• InMed Pharmaceuticals Inc. (NASDAQ: INM) - InvestorNewsBreaks - InMed Pharmaceuticals Inc. (NASDAQ: INM) Announces Plans to Release FY 2022 Financial Report, Corporate Update
• InMed Pharmaceuticals to Report Full Year Fiscal 2022 Financial Results and Business Update on September 23, 2022
• InvestorNewsBreaks - InMed Pharmaceuticals Inc. (NASDAQ: INM) Closes $6M Private Placement Agreement

Aditxt Inc. (NASDAQ: ADTX)

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

Aditxt, Inc., (Nasdaq: ADTX) (the “Company” or “Aditxt”), a biotech innovation company developing and commercializing technologies focused on monitoring and modulating the immune system, today announced the closing of its previously announced public offering of 3,333,333 shares of its common stock (or common stock equivalents in lieu thereof), together with warrants to purchase up to 3,333,333 shares of its common stock at a combined offering price to the public of $6.00 per share (or common stock equivalent) and associated warrant. The warrants have an exercise price of $6.00 per share, are exercisable immediately upon issuance, and will expire five years following the date of issuance. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

Aditxt Inc. (NASDAQ: ADTX) is a biotech innovation company developing technologies focused on mapping and reprogramming the immune system. Aditxt’s immune mapping technologies are designed to provide a personalized immune profile. Aditxt’s immune reprogramming technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies.

As further discussed below, the company’s first commercial product is an immune mapping technology, AditxtScore™, which is designed to provide a personalized profile of the immune system.

The company’s preclinical immune reprogramming technology, Apoptotic DNA Immunotherapy™ (“ADi™”), aims to retrain the immune system to induce tolerance, with the goal of addressing vast unmet needs in transplanted organ rejection, autoimmune diseases, and allergies. The company is developing specific ADi™ products for psoriasis, type 1 diabetes, and skin grafting.

Headquartered in Richmond, Virginia, Aditxt also operates locations in Silicon Valley and New York.

AditxtScore™

AditxtScore™ is a proprietary platform designed to provide a personalized, comprehensive profile of an individual’s immune system. The underlying technology, licensed from Stanford University through an exclusive worldwide agreement, offers a highly sensitive and accurate method of detecting and quantifying cellular responses, allowing greater specificity, quantification, and amplification of both clinical and commercial opportunities.

The company’s first commercial application of the platform, AditxtScore™ for COVID-19, delivers timely reports on vulnerability and immune status relating to SARS-CoV-2 and its known variants, giving consumers and physicians the data needed to make informed health decisions. Potential future applications will offer early detection of an array of conditions, including diabetes, cardio-metabolic maladies and hormonal imbalances.

Aditxt’s AditxtScore™ immune monitoring center in Richmond, Virginia, is operational and designed to support the anticipated increased demand for AditxtScore™ as well as related products and services. The company is currently scaling its capabilities at this location, with a goal of processing up to 10 million immune system tests/reports annually.

ADi™

ADi™ is Aditxt’s immune reprogramming platform addressing disease-causing immune responses while maintaining the immune system’s ability to combat pathogenic infection. The company is commercializing a nucleic acid-based technology called Apoptotic DNA Immunotherapy™ (ADi™) which utilizes a novel approach that mimics the way our bodies naturally induce tolerance to our own tissues (therapeutically induced immune tolerance). Aditxt believes its ADi™ technology platform can be engineered to address a wide variety of indications.

Aditxt is currently developing ADi™ products for psoriasis, type 1 diabetes and skin grafting.

Currently, immuno-tolerance is achievable through chimerism and cell-based therapy, but there is a clinical need for a more practical and cost-effective approach which:

• Can be made into a product
• Does not require additional hospitalization
• Is simple to produce and ship

Preclinical studies have demonstrated that ADi™ treatment significantly and substantially prolongs graft survival, in addition to successfully “reversing” other established immune-mediated inflammatory processes. ADi™ treatment is not expected to require hospitalization, instead being delivered as an injection in minute amounts into the skin.

IP Portfolio

Both AditxtScore™ and ADi™ are supported by a strong IP portfolio.

AditxtScore™, built upon initial technology invented, licensed from and used at Stanford University, is protected by U.S. patents encompassing methods, systems, and kits for detection and measurement of specific immune responses.

ADi™ technology is protected by seven patent families, including:

• 8 U.S. patents
• 4 pending U.S. patent applications
• 86 foreign patents and 14 pending foreign patent applications spanning the EU, Australia, Canada, Japan, China, India and Hong Kong

These patents are broadly categorized into three groups:

• Autoimmune diseases and Type 1 Diabetes
• Organ transplantation and a method of producing plasmid DNA to prevent immune activation
• Composition of matter for a tolerance delivery system for antigens of interest

Aditxt also possesses and/or in-licenses substantial know-how and trade secrets relating to the development and commercialization of its product candidates, including related manufacturing processes and technologies.

Market Overview

The potential market opportunities presented by immune monitoring and reprogramming are extensive, particularly as Aditxt continues to evaluate additional applications for the platforms.

The company’s initial focus on organ transplantation and related autoimmune response provides some insight into the potential of its approach. According to BCC Research, the global organ and tissue transplantation and alternatives market is on course to reach $120.3 billion by 2024, recording a CAGR of 7.4% from 2019. Industry data suggest that approximately 50% of all transplanted organs are rejected within 10-12 years, further highlighting the critical need for a practical, cost-effective solution to harmful autoimmune responses.

Through its focus on the COVID-19 testing market with AditxtScore™, Aditxt demonstrated the wide-ranging potential of its portfolio. Fortune Business Insights estimated the global COVID-19 diagnostics market at $48.64 billion for 2022. While demand for COVID-19 diagnostics is expected to lessen in the coming years, Aditxt will be uniquely positioned to leverage its existing infrastructure stemming from these operations as the company works to advance broader applications for the AditxtScore™ platform.

Leadership Team

Amro Albanna is the Co-Founder, Chairman, and CEO of Aditxt. He has founded multiple startups to commercialize innovations in various industries, including healthcare, enterprise software, telecommunications, nano technology, consumer health, and biotech. Mr. Albanna has led numerous M&A and going-public transactions as a founder, co-founder, and senior executive.

Shahrokh Shabahang, D.D.S., MS, Ph.D., is the company’s Co-Founder, Chief Innovation Officer, and a member of its board. He brings to the team more than 20 years of experience in developing and commercializing life science technologies focused on product and clinical development in the fields of microbiology and immunology.

Corinne Pankovcin, CPA, MBA, is the President of Aditxt. Prior to joining Aditxt, Ms. Pankovcin served as CFO for several world class organizations, including Business Development Corporation of America, Blackrock Kelso Capital and AIG Capital Partners. In these roles, Ms. Pankovcin was responsible for executing portfolio investments and managing significant M&A transactions.

Thomas Farley is the Chief Financial Officer of Aditxt. From December 2015 to June 2020, Mr. Farley was the Controller and Treasurer of Business Development Corporation of America (“BDCA”), a publicly listed business development company. Prior thereto, from January 2011 to August 2015, Mr. Farley was the Senior Controller of Blackrock Capital Investment Corporation (NASDAQ: BKCC). Prior to joining BlackRock Capital Investment Corporation, Mr. Farley was a Senior Controller for PineBridge Investments Emerging Markets practice. Mr. Farley was also an Accounting Manager for Bessemer Venture Partners prior to his tenue at PineBridge. Mr. Farley began his career with PricewaterhouseCoopers LLP, from 1996 to 2001. Mr. Farley earned his B.S. in Accounting from Long Island University and is a Certified Public Accountant.

Rowena Albanna is the company’s Chief Operating Officer. Ms. Albanna has over two decades of experience in senior leadership roles for both technology startups and public companies. Ms. Albanna’s experience spans a wide variety of industries, including biotechnology, insect control, nanotechnology, consumer electronics, financials, telecommunications, e-commerce, online marketing, medical, and defense.

Matthew Shatzkes is the Chief Legal Officer and General Counsel of Aditxt. As a former partner at an AM Law 50 law firm, Mr. Shatzkes advised a wide variety of healthcare related entities, including biotech companies, on corporate, regulatory, and strategic business matters. Mr. Shatzkes will oversee all aspects of the legal functions at Aditxt, including, providing advice and counsel on governance, regulatory matters, strategic alliances, mergers and acquisitions, and commercial transactions.

Aditxt Inc. (NASDAQ: ADTX), closed Tuesday's trading session at $4.19, off by 3.4562%, on 2,642,222 volume. The average volume for the last 3 months is 2.705M and the stock's 52-week low/high is $3.82/$136.00.

Recent News

• Aditxt Inc. (NASDAQ: ADTX) - Aditxt Announces Closing of $20.0 Million Public Offering
• The US Reaches One Million Organ Transplants
• InvestorNewsBreaks - Aditxt Inc. (NASDAQ: ADTX) Releases Pricing of Public Offering

Cerberus Cyber Sentinel Corp. (NASDAQ: CISO)

The QualityStocks Daily Newsletter would like to spotlight Cerberus Cyber Sentinel Corp. (NASDAQ: CISO).

• The UK's fastest-growing platform for startups, TechRound, named Cerberus in the top 10 cybersecurity startups and companies
• Cerberus Sentinel is a nationwide provider of cybersecurity consulting and managed services, with offices and resources across the country
• Company believes culture is the foundation of every successful cybersecurity and compliance program

Cerberus Cyber Sentinel (NASDAQ: CISO) was named in the top 10 cybersecurity startups and companies by TechRound, the voice of UK startups and the UK's fastest-growing platform for startups (https://ibn.fm/cHuEr). Chosen by TechRound’s internal team, the companies were ranked based on “the experience of the team, founders and staff; how the companies have generated success through funding rounds, concept or generating revenue; and the companies’ abilities to overcome issues and help social issues.”

Cerberus Cyber Sentinel Corp. (NASDAQ: CISO) is an industry leader in cybersecurity and compliance services. The company leverages an integrated approach to reduce noise and bridge common silos that often limit the effectiveness of cybersecurity programs. Pulling disparate technologies, teams, and vendors together, Cerberus helps its clients enjoy a simpler and more successful journey to cyber resilience. Since 2019, Cerberus Sentinel has worked to rapidly expand by acquiring world-class cybersecurity and compliance businesses with top-tier talent who utilize the latest technology to create innovative protection solutions.

The Cerberus Sentinel workforce is comprised of cybersecurity experts spanning not only global geographies, but also specialties, industries, regulatory frameworks and focus areas. Its team includes audit and compliance specialists, certified forensics experts, ethical hackers, IEEE® certified biometric professionals, security engineers, around-the-clock analysts, and more – all backed by the most respected credentials in the industry. On an ongoing basis, the company works to identify cyber talent that is culturally aligned and that offers operating leverage through both existing customer revenue and relationships.

Cerberus Sentinel has invested in enterprise solutions and executive talent to integrate its different organizations into an ecosystem that works together to provide complete cybersecurity through cross-pollination of solutions that begin at the network level and extend through technologies, people, policy, and practices. This ecosystem is intended to foster additional growth opportunities and drive overall recurring revenue. Once engaged, the company strives to become trusted advisors for customers’ cybersecurity and compliance demands by providing tailored security solutions based upon their organizational needs.

While cyber resilience requires cycles of continuous improvement, it is a journey that few in the current business and security climate seem to understand. With its deep bench of seasoned experts, Cerberus Sentinel works to simplify that journey for its growing customer base, straightening out the curves and speeding up the process to resilience along the way.

Cybersecurity is a Culture, Not a Product

Integrating compliance and security, including principles of security by design, Cerberus Sentinel helps its clients create an organization-wide culture of cybersecurity. Its offerings include audit and compliance, security operations center services, security engineering, virtual Chief Information Security Officer services, incident response, certified forensics, technical assessments and cybersecurity training.

In contrast to the majority of cybersecurity firms that specialize in a specific technology or service, Cerberus Sentinel seeks to differentiate itself by remaining technology agnostic, focusing on accumulating highly sought-after subject matter experts. Cerberus Sentinel believes that bringing together a world-class team of technological experts with multi-faceted proficiency in the critical aspects of cybersecurity is key to providing technology agnostic solutions to its clients in a business ecosystem that suffers from a chronic lack of highly skilled professionals.

Cerberus Sentinel’s goal is to create a culture of security and to help quantify, define and capture a return on investment from information technology and cybersecurity spending. Its end-to-end, holistic process covers every aspect of clients’ cybersecurity and compliance requirements in an effort to promote greater efficiency and strengthen awareness about the integral role of internal team members in the cybersecurity culture of an organization.

As a result of this strategy, Cerberus Sentinel customers receive an efficient engagement from a single partner that covers a wide range of their needs – addressing challenges more thoroughly and resolving problems more rapidly when compared to working with a host of vendors.

Market Outlook

According to an analysis by the firm Research and Markets, the global managed security services market was valued at $22.45 billion in 2020 and is projected to reach $77.01 billion by 2030, growing at a CAGR of 12.8% through the forecast period.

An expected increase in cybercrime, cost effectiveness of provided solutions and stringent mandatory government regulations aimed at protecting corporate data will drive the global managed security services market for the foreseeable future.

In addition, the documented and growing use of mobile devices in the workplace and the rise in captured and stored digital data serve to fuel market growth. Moreover, growing awareness about the critical nature of data security, the growing importance of e-business and demand for customized services is expected to offer ample opportunities for expansion of the market during the forecast period.

Management Team

David Jemmett is CEO and founder of Cerberus Sentinel. He has more than 35 years of executive management and technology experience with telecommunications, managed services, and cybersecurity consulting services. He previously held positions as CEO of GenResults, a leading provider of security consulting services and technology solutions, and as CTO and founder at ClearData Networks, a HIPAA-compliant HealthDATA cloud hosting platform.

Dave Bennett is COO at Cerberus Sentinel. Since 2015, he has served on the President’s STEM Advisory Board of Grand Canyon University. Before joining Cerberus Sentinel, he served as Chief Product Officer at Experian Health and as Senior Vice President, Product for Gainwell Technologies. He has also held positions as Vice President and Worldwide Head of Build, Healthcare and Life Sciences at DXC Technology, and as EVP, Product and Strategy at Orion Health.

Ashley Devoto is President and Chief Information Security Officer at Cerberus Sentinel. Over the past 17 years, Devoto has worked with the cybersecurity elite to design, build, and operate world-class cybersecurity programs for large, diverse organizations in both government and commercial enterprises. Prior to joining Cerberus, Devoto served as CISO for Booz Allen Hamilton, as business information security officer (BISO) at Bank of America, and as a cyberspace operations officer in the United States Air Force.

Deb Smith is CFO at Cerberus Sentinel. Prior to assuming that position, she was the company’s EVP, Finance and Accounting. She has also served as SVP, Global Accounting at International Cruise and Excursions Inc., and as Chief Accounting Officer for BeyondTrust, an information security software company. She has also held the positions of Corporate Controller at Aspect Software and Assistant Controller at JDA Software.

Cerberus Cyber Sentinel Corp. (NASDAQ: CISO), closed Tuesday's trading session at $2.43, off by 2.4096%, on 45,378 volume. The average volume for the last 3 months is 45,378 and the stock's 52-week low/high is $2.15/$49.00.

Recent News

• Cerberus Cyber Sentinel Corp. (NASDAQ: CISO) - Cerberus Cyber Sentinel Corp. (NASDAQ: CISO) Ranked in Top 10 of Cybersecurity Startups
• Cerberus Cyber Sentinel Corp. (NASDAQ: CISO) Building Reputation as Industry Leader in Cybersecurity, Compliance Services
• InvestorNewsBreaks - Cerberus Cyber Sentinel Corp. (NASDAQ: CISO) Appoints Seasoned Veteran as M&A Legal Counsel

HeartBeam Inc. (NASDAQ: BEAT)

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

• HeartBeam is a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere
• In September 2022, the company announced it was granted a patent for its 12-lead ECG Patch Monitor, opening a pathway to ischemia and arrhythmia detection innovation in ECG Patch products
• In August 2022, the company announced it was seeking FDA approval for its HeartBeam AIMI platform technology used to detect and diagnose heart attacks
• On November 15, 2021, HeartBeam had its IPO on the Nasdaq under ticker symbol ‘BEAT’
• The company’s management team has significant experience in software and medical device product development, with over $1 billion in successful exits over the past 18 months
• HeartBeam was selected as a winner at the annual Cardiovascular Innovations (“CVI”) 2022 Innovation Summit, which recognizes state-of-the-art cardiac technologies

HeartBeam (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere. The company today announced that, in conjunction with its upcoming virtual roadshow webinar taking place at 4:30 p.m. ET on Tuesday, Sept. 20, 2022, it has released a new video that takes viewers behind the scenes for a featured look at the HeartBeam AIMIGo technology. “This new video provides a compelling overview and explanation of our technologies and highlights our continued progress toward making the AIMIGo device available for remote heart attack detection,” said Branislav Vajdic, PhD, HeartBeam CEO and founder. “We look forward to sharing the video at our upcoming webinar along with recent announcements, ongoing initiatives and key 2022 and 2023 milestones.” To view the full press release, visit https://ibn.fm/F4O2h.

HeartBeam Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector 12-lead electrocardiogram (ECG) platform for heart attack detection anytime, anywhere. The company’s proprietary ECG telehealth technology aims to redefine the way high risk cardiovascular patients are diagnosed in ambulatory and acute care settings. HeartBeam’s initial focus is on providing diagnostic data to help physicians with care management of patients with cardiovascular disease.

In August 2022, HeartBeam announced that it submitted its HeartBeam AIMI™ software for approval from the U.S. Food and Drug Administration (FDA). HeartBeam AIMI is a platform technology to improve the speed and accuracy of heart attack detection in acute care settings. The company expects FDA approval by the end of 2022, and a full commercial roll-out of HeartBeam AIMI is targeted for Q1 2023.

HeartBeam sees submission of its first product based on its platform technology as an important milestone toward commercialization, which underscores the company’s continued progress toward making the HeartBeam AIMI platform widely available to help emergency department physicians quickly and accurately identify a heart attack.

While the FDA conducts its regulatory review, HeartBeam will focus on executing key components of its commercialization plan and subscription revenue model. It will also continue to engage in discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize HeartBeam products.

The company is based in Santa Clara, California.

Products

HeartBeam’s development portfolio includes two products:

• HeartBeam AIMI is software that provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack in acute care settings and, as noted above, has been submitted for FDA approval; and
• HeartBeam AIMIGo™, the first and only credit card-sized 12-lead output ECG device coupled with a smartphone app and cloud-based diagnostic software system for remote heart attack detection.

HeartBeam is developing AIMIGo, a medical-grade detection and monitoring technology for use in remote heart attack detection, thereby allowing physicians to diagnose a patient’s heart attack as it occurs, even if the patient is not at a medical facility. The company’s system, once approved by the FDA, can be used by patients at home or almost anywhere and anytime to help their physicians assess whether chest pain is the result of a heart attack or another cause. While approximately 82% of chest pain ED visits are unnecessary, patients delay approximately 3 to 4 hours after symptoms begin, increasing mortality rates by 40%. The company’s goal is to shorten the time to treatment outside of the medical facility to improve patients’ well-being.

HeartBeam’s AIMIGo is a powerful, portable and easy-to-use prescription-based product. It comprises a smartphone app, a credit card-sized ECG device placed on a patient’s chest, the HeartBeam cloud platform, and a digital portal for the physician to view ECG results and direct patient action. For the first time outside of a medical setting, HeartBeam AIMIGo enables patients and their clinicians to determine if symptoms are due to a heart attack, quickly and easily, so care can be expedited, if needed.

Pending FDA clearance, AIMIGo is initially intended to be available by prescription, and is reimbursable under existing remote patient monitoring codes (RPM codes). This provides a new revenue stream to physicians who before did not have a way to monitor these high-risk patients. The RPM codes provide a monthly reoccurring revenue stream to the company, as well. On average, at current reimbursement rates, the practice will receive $1,300+ per year per patient they monitor, and the company will receive $600 per year per patient from this RPM reimbursement.

Market Overview

Adoption rates of telehealth services increased dramatically in recent years, with the COVID-19 pandemic serving as a major driver of growth. Among the areas seeing the greatest expansion are cardiology, radiology, behavioral health and online consultation.

Encouraging this growth, governments are actively developing new policies and reimbursement guidelines to promote the use of digital health platforms. The U.S. Centers for Medicare & Medicaid Services (CMS), for example, has recently expanded reimbursement for telehealth services. U.S. market growth is also being driven by the rising prevalence of chronic conditions and the growing geriatric population.

Remote heart attack detection is a previously unsolved problem with a massive and underserved market that is several times larger than the $2 billion total addressable market (TAM) in the U.S. for ECG cardiac arrhythmia monitoring.

Approximately 8 million Americans have suffered at least one heart attack, and a total of 18 million have been diagnosed with coronary artery disease (CAD). Based on these figures, HeartBeam projects a total addressable U.S. market TAM valued at $10 billion annually for its AIMIGo solution for remote heart attack monitoring of CAD.

Management Team

Branislav Vajdic, Ph.D., Chief Executive Officer and Founder of HeartBeam, Inc, combines over 30 years of experience in technology development and senior management positions. Dr. Vajdic has been deeply involved with the development of HeartBeam’s technology to fit his vision for the company. Prior to HeartBeam, from 2007 to 2010, Dr. Vajdic was CEO and Founder of NewCardio, a publicly traded company in the cardiovascular devices space. From 1984 to 2007, Dr. Vajdic was at Intel, where he held various senior management position. At Intel, Dr. Vajdic was the designer of first Flash memory and two key inventions that enabled Flash as a product and led engineering groups responsible for Pentium 1 through Pentium 4 designs. Dr. Vajdic was awarded two Intel Achievement Awards, the highest level of award for outstanding contributions to Intel. Dr. Vajdic is author of numerous patents and publications in the fields of cardiovascular devices, as well as chip design. Dr. Vajdic holds a Ph.D. in Electrical Engineering from the University of Minnesota.

Jon Hunt, Ph.D., has over 35 years’ experience in the medical/medical device industry with extensive domestic and international experience in general management, clinical/regulatory, sales and marketing. He also has diverse experience in Fortune 500 companies, as well as start-up environments. Dr. Hunt was the Vice President of Clinical Science and Technology, Medical Device Innovation Consortium, from July 2019 to July 2021, and Vice President of Clinical and Regulatory Affairs, Cryterion Medical from January 2018 to June 2019 (acquired by Boston Scientific Corporation in July 2018 for $202M). Dr. Hunt was the Founding President and CEO of Bardy Diagnostics, Inc. from October 2013 to November 2017 (acquired by Hill-Rom Holdings, Inc.). Prior to joining Bardy Diagnostics, Dr. Hunt spent the previous 11 years as the Vice President of Clinical & Regulatory Affairs with Cameron Health, Inc. (acquired by Boston Scientific Corporation). Dr. Hunt spent the previous 10 years with Cardiac Pacemakers, Inc., St. Jude Medical and Cardiac Pathways Corporation. Dr. Hunt began his career with Cardiac Pacemakers, Inc. (now Boston Scientific Corporation) as the Director of Clinical Programs. He subsequently held positions at St. Jude Medical in Clinical Affairs and as the Business Unit Director for the Cardiac Rhythm Management division for Europe, the Middle East and Africa. At Cardiac Pathways Corporation, Dr. Hunt held various executive positions as Vice President of International Sales and Marketing and Vice President of Worldwide Sales and Marketing (acquired by Boston Scientific Corporation). Dr. Hunt received his Ph.D. in Motor Control from The Pennsylvania State University, his Master’s from California State University, Long Beach and his undergraduate degree from Keele University in the United Kingdom.

Rick Brounstein, HeartBeam’s Chief Financial Officer, combines over 30 years of experience in health technology senior management. Since 2017, Mr. Brounstein has been and is currently a partner of Hardesty, LLC, a financial services firm, and Mr. Brounstein is currently a managing director of CTRLCFO, LLC, a firm Mr. Brounstein founded in 2016 to support funded start-ups in life science and technology. From 2008 to 2011, Mr. Brounstein was Chief Financial Officer of NewCardio, Inc., a microcap public company in the cardiology space, and, over his career, he has been with nine other companies in life science or technology, holding positions including Chief Financial Officer, Chief Operating Officer, Treasurer and Accounting Manager. From June 2001 through November 2007, Mr. Brounstein held several positions at Calypte Biomedical Corporation, a publicly traded medical device company, including Chief Financial Officer and Executive Vice President. In January 2007, Mr. Brounstein was appointed as the National Member Representative for the 2007 COSO Monitoring Project, which published new guidelines for monitoring internal financial controls in February 2009; Mr. Brounstein subsequently was a member of the FEI task force that issued the updated COSO Internal Control Framework in 2013. In March 2005, Mr. Brounstein was appointed to the SEC Advisory Committee on Smaller Public Companies. Mr. Brounstein earned his Certified Public Accountant (CPA) certification while working at Arthur Andersen LLP, formerly a public accounting firm. Mr. Brounstein holds a B.A. in accounting and an M.B.A. in finance, both from Michigan State University.

Ken Persen, HeartBeam’s Chief Technology Officer, combines over 28 years of experience in the medical device and digital health industries in engineering and senior management positions. Mr. Persen has been involved in several companies in Cardiac Rhythm Management, holding positions including Chief Executive Officer, Chief Technology Officer, Executive Vice President and Director of Engineering. Since 2016 and prior to joining HeartBeam, Mr. Persen was the Chief Technology Officer at LIVMOR, Inc., a digital health company. In addition, from 2016 through November 2021, he was also Chief Executive Officer of LIVMOR. Prior roles included Director of Engineering at Cameron Health (acquired by Boston Scientific), a late-stage medical device start up, and engineering and management positions at Guidant Corp. (acquired by Boston Scientific), a large medical device manufacturer. He has an undergraduate degree from University of Minnesota, Duluth, with a BA in Computer Science.

HeartBeam Inc. (NASDAQ: BEAT), closed Tuesday's trading session at $1.89, off by 4.5455%, on 558,211 volume. The average volume for the last 3 months is 570,502 and the stock's 52-week low/high is $1.12/$5.4699.

Recent News

• HeartBeam Inc. (NASDAQ: BEAT) - HeartBeam Inc. (NASDAQ: BEAT) Is 'One to Watch'
• InvestorNewsBreaks - HeartBeam Inc. (NASDAQ: BEAT) Releases New Video Exploring Its Technologies, Progress of AIMIGo(TM) Device
• InvestorNewsBreaks - HeartBeam Inc. (NASDAQ: BEAT) Secures Additional IP Protection for Breakthrough ECG Patch Technology

Flora Growth Corp. (NASDAQ: FLGC)

The QualityStocks Daily Newsletter would like to spotlight Flora Growth Corp. (NASDAQ: FLGC).

• Flora Growth is a global cannabis brand-builder focused on the cultivation of product at a central Colombian facility and marketing through a design-led international supply chain
• Flora recently announced an agreement with Colombia’s Misak tribe for cooperative processing and distribution of cannabis, drawing on the tribe’s licensing advantage to accelerate the pair’s marketing capacity
• Flora is headquartered in Canada, but its strength lies in its Colombian-based cultivation operations centered in Colombia, one of the largest licensed outdoor operations in the world
• In recent years, Colombia’s government has been working to create a legalization framework for cannabis cultivation, processing and exportation to shake off its legacy of illegal drug trade violence

Canada-headquartered global cannabis brand-builder Flora Growth (NASDAQ: FLGC) is increasing the strength of its supply chain, centered in its 100-hectare (about 247-acre) cultivation facility located in the heart of Colombia’s green climate, by finalizing a distribution agreement with the Misak indigenous tribe’s pharmaceutical arm. Adult-use cannabis sales in the state of Illinois have already surpassed the $1 billion threshold this year. The state’s marijuana sales for the month of August totaled $129,441,315, which brought its total sales for 2022 to $1,015,700,115. Data from the Illinois Department of Financial and Professional Regulation also shows that the space has officially exceeded its $3 billion mark for adult-use marijuana purchases since dispensaries first launched in 2020. In 2021, adult-use cannabis purchases took until October to surpass the $1 billion mark. The state’s market has significantly grown these last few years, especially considering that in 2020, consumers purchased about $669 million worth of cannabis.

Flora Growth Corp. (NASDAQ: FLGC) is an internationally focused cannabis brand builder that leverages natural, cost-effective cultivation practices to supply cannabis derivatives to its diverse business divisions, including cosmetics, hemp textiles, and food and beverage. Flora Growth operates one of the largest outdoor cultivation facilities in the world with an aim of marketing a higher-quality premium product at below-market prices. By prioritizing natural ingredients and value-chain sustainability across its portfolio, the company creates premium products that help consumers restore and thrive.

Flora Growth completed the first traditional cannabis IPO on Nasdaq in May 2021. Although currently headquartered in Toronto, Ontario, with plans to relocate its head office to Miami, Florida, the company’s base of operations is in Colombia, where it has built an extensive distribution network that includes Colombia’s largest distributors.

Currently, Flora Growth is organically growing market share for its existing brand portfolio (pharmaceuticals, textiles, cosmetics, and food & beverage) while seeking revenue-generating acquisitions that offer an accretive distribution network to amplify revenue growth.

Existing Brand & Product Portfolio

Flora Growth’s portfolio spans a number of verticals – each with a thoughtful brand designed to resonate with its intended end consumer. In line with the company’s mission, each brand prioritizes natural ingredients and value-chain sustainability.

Flora Lab S.A.S

Flora Lab is the company’s GMP certified manufacturing and R&D center focused on producing pharmaceuticals, cosmetics, and nutraceuticals for domestic and international markets. Its offerings include product lines that are private label, white-label, and custom formulas.

Through Flora Lab, Flora Growth has relationships with 1,500+ distribution channels, manufactures 63+ OTC products registered with INVIMA (Colombia National Food and Drug Surveillance Institute), and holds multiple GMP certifications enabling international export in an effort to leverage Flora Lab’s capacity to produce a wide range of CBD-infused products.

Flora Beauty

Flora Beauty is the company’s CBD beauty and cosmetics division founded by fashion and beauty industry icon Paulina Vega. Its current offerings include two CBD skincare brands targeting the U.S. and Latin American markets – MIND NATURALS and AWE. These lines exemplify Flora Growth’s socially conscious approach to business.

Currently, Flora Beauty products are offered globally through e-commerce, as well as through Falabella’s 111 retail locations across Latin America. The company is in negotiations with major department stores to launch the line in the U.S. and is also exploring opportunities in the U.K. and other European markets.

KASA Wholefoods

KASA Wholefoods is a Colombian manufacturer of food and beverages leveraging responsibly sourced exotic fruits from the Amazon. KASA has a $10 million+ distribution agreement with Tropi, Colombia’s largest food distributor, which has 130,000+ distribution points across the country.

Mambe, KASA’s leading brand, is already offered through over 980 distribution points across Colombia. Flora Growth expects this network to grow to over 1,200 distribution points in 2021, including one of Colombia’s largest coffee chains, Tostao Café & Pan.

Hemp Textiles & Co.

Through its Hemp Textiles division, Flora Growth intends to utilize its large land package and cultivation infrastructure to capture market share in the rapidly growing hemp industrials segment.

The company’s first brand through this division, Stardog Loungewear, offers a line of comfortable loungewear made from natural, organic materials. Stardog has been distributing globally through e-commerce and brick and mortar channels in Bogota since fall 2020, and the company intends to open U.S. brick and mortar locations in 2021.

Accretive M&A

Flora Growth is targeting transactions to complete the supply chain via key infrastructure to enhance its global distribution with the aim to compete on low-cost, high-quality inputs paired with premium brands that create business lines with robust margins.

To date, Flora has announced two major transactions.

Koch & Gsell (Acquisition)

• Amplify CPG portfolio’s revenue growth through leading brand, Heimat, currently with TTM revenues of $7.6 million.
• Leverage Koch &Gsell’s distribution network of 2,500+ stores to introduce Flora to the Swiss, European and Asian markets.
• Bring patented hemp cigarette manufacturing technology into new markets utilizing Flora’s high-quality cannabis.

Hoshi International (Investment)

• Equity Investment of €2 million into Hoshi to establish Flora as a preferred supplier to two EU processing facilities.
• Opens gateway for Flora Growth’s cannabis through international distribution agreements in the EU and U.K.
• Hoshi’s experienced team and increased access to the EU cannabis market to serve as a catalyst for revenue growth.

Cultivation

Key to Flora Growth’s expansion efforts is its cultivation strategy. The company’s Cosechemos farm, located in Bucaramanga, Colombia, is currently licensed to cultivate 247 acres of cannabis. Through three successful pilot crop plantings, the location has demonstrated a production cost of just $0.06/gram. For comparison, the average cost of North American cannabis (based on 2019 figures from Aphria, Tilray, Sundial, and Aurora) equates to roughly $1.89/gram.
Flora Growth is uniquely positioned to capitalize on Colombia’s favorable growing conditions, low-cost infrastructure, and affordable local workforce as it looks to ramp up its cultivation efforts moving forward.

Leadership Team

Bernard Wilson is the Chairman of Flora Growth. A senior financial professional, Dr. Wilson is the former Vice-Chairman of PricewaterhouseCoopers LLP and is the Chairman of the Founders Board of the Institute of Corporate Directors. He has also served as Chairman of the Canadian Chamber of Commerce; Chairman of the International Chamber of Commerce – Canada; and Member of the Canada/U.S. Trade Committee. Dr. Wilson draws on this experience to ensure Flora Growth adheres to effective corporate governance practices.

Luis Merchan is the company’s President and CEO. He is a proven executive with over a decade of experience in enterprise sales management, corporate strategy, merchandising and expense management, and customer experience. Mr. Merchan previously served as Macy’s Inc.’s Vice President of Workforce Strategy and Operations, where he managed the enterprise’s multi-billion-dollar P&L expense line for the entire 540 store portfolio. Throughout his tenure at Macy’s, he led various sales and marketing initiatives, including the B2B corporate sales team that was responsible for $160 million in annual revenue. Mr. Merchan obtained his Bachelor of Industrial Engineering from Pontifical Xaverian University in Bogota, Colombia, and his MBA from McNeese State University. He also holds a Graduate Certificate in Marketing Management from Harvard.

Juan Manuel Galan is a Strategic Advisor to the Flora Growth management team. Mr. Galan currently serves as a senior consultant to The World Bank. He is a politician and former senator of Colombia, serving three terms from 2006 to 2018 as a member of the Colombian Liberal Party. He is also a former professor at the University of Rosario and holds more than 20 years of journalistic, academic, governmental and parliamentary experience. During his time as a senator, Mr. Galan was a key leader, with 29 bills and 27 debates on political control, and 17 laws to his name. The most relevant of those laws was authoring the medical cannabis law that resulted in the legalization of medical cannabis in Colombia.

Stan Bharti is a Director of Flora Growth. Mr. Bharti currently serves as Executive Chairman of Forbes & Manhattan. He has more than 30 years of professional experience in business, finance, markets, operations and more, with a focus on the resource and technology sectors. To date, Mr. Bharti has amassed over $3 billion worth of investment capital for the companies with which he has worked and their shareholders. He is a Professional Mining Engineer and holds a master’s degree in engineering from Moscow, Russia, and University of London, England.

Javier Franco is the company’s VP of Agriculture. Mr. Franco is a master horticulturist with more than 25 years of experience in the design, implementation, and management of cultivation and propagation facilities of more than 30 species of cut flowers in Latin America. He completed his agricultural studies at Zamorano University in Honduras and later at an International Exchange Program at Ohio State University. Mr. Franco has directed technical, commercial, and research groups in the cut flower, fruit and vegetable markets in Latin America and has participated in the commercial development of new technologies applied in agribusiness. He has also led the agri-management of organic crops and certifications of Good Agricultural Practices.

Flora Growth Corp. (FLGC), closed Tuesday's trading session at $0.9178, off by 8.22%, on 340,657 volume. The average volume for the last 3 months is 340,641 and the stock's 52-week low/high is $0.586/$7.48.

Recent News

• Flora Growth Corp. (NASDAQ: FLGC) - 420 with CNW - Adult-Use Cannabis Sales in Illinois Surpass $3B Since Recreational Market Launched
• Flora Growth Corp. (NASDAQ: FLGC) Agreement with Colombian Tribe Strengthens Cannabis Production Supply Chain
• 420 with CNW - Missouri Court Dismisses Suit Against Cannabis Ballot Initiative

Freight Technologies Inc. (NASDAQ: FRGT)

The QualityStocks Daily Newsletter would like to spotlight Freight Technologies Inc. (NASDAQ: FRGT).

• Freight Technologies is a technology company that develops solutions aimed at optimizing and automating the supply chain process
• The company’s solutions include Fr8App Platform, Fr8FMS, cloud-based Fr8TMS, Fr8Radar, Fr8Data, and Fr8Fleet
• Early this year, Freight Technologies unveiled Fr8Fleet, a technology solution for committed capacity planning, and announced it had secured its first contract for this product with Kimberly Clark de Mexico (“KCM”)
• The company recently reported an expanded relationship with KCM following an agreement to include the Fr8App platform for cross-border logistics for shipments from Mexico to the U.S.

An insights report by multinational KPMG, entitled “The challenges of cross-border international trade,” lists logistics and supply chain as one of the major impediments businesses and suppliers must overcome to build effective and adequate cross-border trading capacity. “Tracking orders, determining liabilities for in-transit goods, and meeting promised delivery timeframes can all be more challenging in cross-border trade due to multicarrier handoffs and border delays,” the report underlines (https://ibn.fm/8qQPg). In addition to choosing between cross-border shipping or localized fulfillments – two core options to handle the complexity of international logistics – the report recommends the use of technology. “Technology can further simplify the challenges through multi carrier software platforms (also known as logistics control towers), which can select the most appropriate shipping partners and plan routes, prepare parcels for export, and pass on the exporter of record and liability elements to third parties,” the report explains. Freight Technologies (NASDAQ: FRGT) (“Fr8Tech”), a technology company that develops solutions aimed at optimizing and automating the supply chain process, has always understood the importance of integrating technology into logistics. Through its wholly owned subsidiary Freight App, Inc. (“Fr8App”), the company offers solutions such as the Fr8App Platform, a B2B cross-border shipping marketplace powered by artificial intelligence (“AI”) and machine learning; Fr8FMS, a solution that enables transportation companies and owners to handle their own fleet, thereby reducing operational costs; cloud-based Fr8TMS that allows users to manage fleet and request freight services on the marketplace; Fr8Radar; and Fr8Data.

Freight Technologies Inc. (NASDAQ: FRGT) (“Fr8Tech”) is a technology company developing solutions to optimize and automate the supply chain process, providing a platform for B2B cross-border shipping in the NAFTA region. The company’s mission is to revolutionize cross-border shipping by providing carriers with increased growth opportunities and shippers with flexibility, visibility and simplicity for the once-complex process of international over-the-road shipping.

Freight Technologies, formerly known as Hudson Capital Inc., assumed its current name and ticker symbol on May 27, 2022. Its primary operating subsidiary and its marketplace are known as Fr8App, and it conducts operations throughout North America under the names of Fr8App and/or Freight App. The company is headquartered in Houston, Texas, with multiple locations across the U.S. and Mexico.

The Fr8Tech Solutions Suite

Fr8Tech leverages artificial intelligence to provide cloud-based platforms aimed at automating the over-the-road transportation process, effectively reducing human touch points and expediting load booking times. The company’s suite of solutions includes:

• Fr8app – A B2B marketplace powered by AI and Machine Learning offering a real-time broker portal to connect shippers with qualified carriers
• Fr8Radar – A tracking solution providing shippers and carriers real-time locational data via Fr8app’s mobile solution or through integration with third-party GPS alternatives
• Fr8TMS – A transportation management system designed to help shippers manage their freight and all of the documents involved in shipping transactions, including invoices, customs documents, confirmation rates and proof of deliveries
• Fr8FMS – A fleet management system allowing transportation companies to better manage their fleets, reduce operational costs and provide better service to their customers
• Fr8Data – A data solution offering real-time dashboards and reports to shippers and carriers in an effort to increase visibility and control while supporting better business decisions
• Fr8Fleet – A platform that provides private fleet management, enabling large corporate shippers to purchase dedicated capacity secured by Fr8app in exchange for a fixed fee

Commitment to the Environment

Through its core focus on technology, Fr8Tech seeks to reduce the carbon footprint of the logistics industry. Its solutions aim to minimize empty miles for transportation firms and reduce overall paper consumption.

Fr8University

Fr8University is an educational program offering classroom and on-the-job training for Fr8Tech team members. Through the program, employees learn in-depth business fundamentals and applications along the truckload freight industry value chain.

Led by corporate educator Mario Mena, Fr8University is designed as an investment in the company’s human capital, providing an opportunity to communicate Fr8Tech’s corporate culture while accelerating operational growth.

Market Outlook

Fr8Tech’s established foothold in Mexico is key to its current efforts to promote sustainable growth in the cross-border shipping industry. Ongoing disruption in U.S.-Chinese trade relations have strengthened Mexico’s status as the largest trading partner of the U.S., with cross-border annual freight spending estimated at $385 billion according to data from the U.S. Department of Transportation. Annual domestic shipping in Mexico is estimated at $34 billion, while annual domestic shipping in the U.S. is estimated to total $732 billion.

Despite the size of this industry, fragmentation and inefficiencies prevail in the space. Thousands of legacy brokers, tens of thousands of shippers and hundreds of thousands of carriers still rely on outdated systems to arrange transport, spending hours on the phone negotiating pricing, waiting days to find trucks and drivers, preparing and printing forms, and operating without tracking or visibility. Add in cross-border complexity relating to customs and additional paperwork, and you have an industry ripe for technological disruption.

Fr8Tech’s recent revenue growth trends have highlighted the company’s efforts to capitalize on this opportunity. In 2021, Fr8Tech achieved revenues of $21.5 million, marking a year-over-year increase of 134%. The company issued revenue guidance for fiscal 2022 of $40 million in a February 9, 2022, press release, which would account for a further 86% year-over-year increase.

Management Team

Javier Selgas is CEO and a Director of Freight Technologies Inc. and Freight App Inc. He brings to the company over 15 years of experience developing technology and digital marketing strategies, including serving as Country Manager for Osigu, Spain, and as head of AJEgroup’s IT division for the Asia-Pacific region. Prior to joining Fr8Tech, Mr. Selgas founded digital marketing agency Lanzadera Online. He has also served as an IT consultant to major corporations, including Endesa and Ibermatica.

Mike Flinker is President of Fr8Tech. He has over four decades of experience in the transportation industry, with 30+ years focused on cross-border logistics. Prior to joining Fr8Tech, Mr. Flinker founded FLS Transportation, the largest cross-border logistics company in Canada. He also previously held positions with Clarke Transport Inc., Canadian Pacific and Reimer Express Inc. (a division of Roadway Express).

Paul Freudenthaler is the company’s CFO and Secretary to the company Board. He has over 30 years of financial expertise, having previously served as CFO for several leading companies across multiple countries, including Macquarie in Mexico, Old Mutual in Latin America and Ascentium Capital in the U.S. Mr. Freudenthaler’s experience include leadership roles from which he guided IPOs and M&A transactions.

Luisa Lopez is COO of Fr8Tech. She brings to the company 25+ years of management experience in logistics, supply chain, operations and customer service. Ms. Lopez previously served as a Director of Landstar, where she was responsible for commercial and client development strategies in the Mexican market. Additionally, she managed more than 2,000 transport units specialized in staff and school mobility while with Traxion in Mexico.

Freight Technologies Inc. (NASDAQ: FRGT), closed Tuesday's trading session at $0.74, off by 7.5%, on 127,903 volume. The average volume for the last 3 months is 128,003 and the stock's 52-week low/high is $0.7201/$8.734.

Recent News

• Freight Technologies Inc. (NASDAQ: FRGT) - Freight Technologies Inc. (NASDAQ: FRGT) Using Technology to Help Customers Overcome Challenges of Cross-Border Logistics, Greatly Improving Efficiency
• Trucking Supply Chain Tech Innovator Freight Technologies Inc. (NASDAQ: FRGT) Reports New Revenue Growth on B2B Marketplace Solution
• Freight Technologies Inc. (NASDAQ: FRGT) Marks Milestone Intended to Foster Company Growth