Clene Inc. (NASDAQ: CLNN)

The QualityStocks Daily Newsletter would like to spotlight Clene Inc. (NASDAQ: CLNN) (FRA: GTD0).

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc. are reporting on long-term follow-up data for participants in the HEALEY ALS Platform Trial; patients in the study were treated with CNM-Au8(R) 30mg for up to 133 weeks. According to the announcement, data from 59 patients shows prolonged life with 49% decreased risk of death for participants compared to PRO-ACT matched placebo over long-term follow-up; data also showed prolonged life with 59% decreased risk of death for participants in an integrated meta-analysis across HEALEY ALS Platform Trial and RESCUE-ALS Trial with CNM-Au8 30mg compared to PRO-ACT matched placebo over long-term follow-up. In addition, the announcement noted that the study included more than 500 patient years of CNM-Au 8treatment exposure without any identified safety signals. The HEALEY ALS Platform Trial is a perpetual multicenter, randomized, double-blind, placebo-controlled clinical trial program designed to study and analyze the efficacy and safety of multiple investigational products with people living with ALS. Trial officials noted that improved survival status is a key measure of drug effect. "To show such profound survival improvement using the HEALEY ALS Platform Trial data set alone and a pooled HEALEY and RESCUE data set is remarkable and helps confirm the survival benefit seen in the prespecified secondary endpoint," said Clene head of medical Benjamin Greenberg, M.D. in the press release. "Clene is extremely gratified to see this consistent long-term survival data from the HEALEY ALS Platform Trial OLE, with a continued clean safety profile, adding to the totality of the survival evidence."

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

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

CNM-Au8

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

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

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

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

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

Market Opportunity

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

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

Management Team

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

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

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

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

Clene Inc. (NASDAQ: CLNN), closed Monday's trading session at $0.464, up 0.215983%, on 1,149,702 volume. The average volume for the last 3 months is 5.017M and the stock's 52-week low/high is $0.414/$3.23.

Recent News

• Clene Inc. (NASDAQ: CLNN) - InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) Releases Significant Long-Term Survival Improvement Data from ALS Trial
• Clene to Present at Upcoming September Conferences
• Clene Reports Significantly Improved Survival Benefit of 19.3 Months and Significantly Delayed Clinical Worsening in Rescue-Als Open-Label Extension Two Year Follow-Up

Knightscope, Inc. (NASDAQ: KSCP)

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

Knightscope (NASDAQ: KSCP), a leading developer of autonomous security robots and blue light emergency communication systems, has announced that the city of New York and the New York Police Department ("NYPD") launched the Knightscope K5 security robot service. The move was announced at a press conference with the support of the Metropolitan Transportation Authority ("MTA"). The first two weeks will be spent on training, configuration and setup protocols for the autonomous robot to navigate followed by patrol activities between the hours of 12:00 a.m. and 6:00 a.m. at the Times Square Subway Station.

To view the full press release, visit https://ibn.fm/eL9dI

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 Monday's trading session at $0.77, up 3.2172%, on 4,206,187 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $3.23/$.

Recent News

• Knightscope (NASDAQ: KSCP) - InvestorNewsBreaks - Knightscope, Inc. (NASDAQ: KSCP) K5 Security Robot Deployed in NYPD Pilot Program
• InvestorNewsBreaks - Knightscope, Inc. (NASDAQ: KSCP) Announces 100th Landing of Its Robot Show
• InvestorNewsBreaks - Knightscope, Inc. (NASDAQ: KSCP) Announces Upward Revision of Price Target from Ascendiant Capital Markets

Mullen Automotive Inc. (NASDAQ: MULN)

The QualityStocks Daily Newsletter would like to spotlight Mullen Automotive Inc. (MULN).

Mullen Automotive (NASDAQ: MULN), an emerging electric vehicle ("EV") manufacturer, today announced its achievement of a key milestone with full approval from the Environmental Protection Agency ("EPA") with certification for Class 3 EV Commercial Vehicles received on Sept. 22, 2023. According to the announcement, Class 3 vehicle production began in August 2023 with the first vehicles rolling off the assembly line on Aug. 21, 2023. In addition, the Mullen Class 3 EV Cab Chassis Truck has completed all required testing requirements for Federal Motor Vehicle Safety Standards ("FMVSS") and compliance. "I am extremely proud of this important milestone and, now with EPA certification and FMVSS in-hand, we are planning to begin Class 3 deliveries this week," said David Michery, CEO and chairman of Mullen Automotive. "Mullen is fully committed to our vision and plan and is focusing in now on deliveries to our customers."

To view the full press release, visit https://ibn.fm/o4Odq

Mullen Automotive Inc. (NASDAQ: MULN) is a Southern California-based automotive company that owns and partners with several synergistic businesses working toward the unified goal of creating clean and scalable energy solutions. Mullen has evolved over the past decade in sync with consumers and technology trends. Today, the company is working diligently to provide exciting EV options built entirely in the United States and made to fit perfectly into the American consumer’s life. Mullen strives to make EVs more accessible than ever by building an end-to-end ecosystem that takes care of all aspects of EV ownership.

Commencement of Trading on Nasdaq

On November 5, 2021, Mullen announced its commencement of trading on the Nasdaq Capital Market.

“Today is a monumental day for Mullen Automotive. I am especially proud of our team, investors and all who have believed in Mullen and taken us to this point as a publicly traded company on the Nasdaq Capital Market,” David Michery, CEO and Chairman of Mullen Automotive, stated in the news release. “Trading on Nasdaq now opens us up to new investors, both institutional and retail shareholders, and broadens our awareness and company profile, while increasing awareness of Mullen and our technology platform and opening new opportunities in EV and beyond. The road ahead has never been brighter for Mullen, and I am proud to lead us into the future.”

The milestone came in the wake of the company’s stock-for-stock merger with Net Element Inc.

The Mullen FIVE

The Mullen FIVE EV Crossover, debuting at the Los Angeles International Auto Show (LAIAS) on November 17, 2021, embodies Mullen’s Southern California roots with an inspired design focused on two complementary Golden State themes – California landscape and California urban.

The FIVE is built on an EV Crossover skateboard platform that offers multiple powertrain configurations and trim levels in a svelte design that is Strikingly Different™ and exciting to experience in person.

Prior to the start of LAIAS, the Mullen FIVE was selected as a finalist by the LA Auto Show for Top EV SUV in the ZEVA “People’s Choice” Awards.

LAIAS provides Mullen an opportunity to display multiple variants of the FIVE model while also showcasing its powertrain, battery and charging technology. The company intends to bring the FIVE to market in 2024, and reservations are currently open here.

Mullen’s development portfolio also includes EV Fleet Vans, which it intends to bring to market in Q2 2022, and the pure electric, high performance Mullen DragonFLY.

Expansion of Manufacturing Capacity

On November 2, 2021, Mullen announced plans to expand its facility in Robinsonville, Mississippi.

Mullen’s Advanced Manufacturing and Engineering Facility (AMEC) currently occupies 124,000 square feet of manufacturing space. The total available land on the property is over 100 acres, and Mullen is moving ahead with plans to build out another 1.2 million square feet of manufacturing space to support class 1 and class 2 EV cargo vans and the Mullen FIVE EV Crossover.

On the expanded site, Mullen plans to build a body shop, a fully automated paint shop and a general assembly shop.

EV Market Outlook

The global EV market was reported to consist of 3,269,671 units in 2019, a figure that is expected to grow at a CAGR of 21.1% through 2030 to a total of 26,951,318 units worldwide. This market’s monetary value was estimated at $162.34 billion in 2019 and is expected to grow at a CAGR of 22.6%, resulting in an approximate value of $802.81 billion by 2027. The primary driver for this exponential growth is a worldwide increase in vehicle emissions regulations.

Management Team

David Michery is the CEO and Founder of Mullen and has been leading the company and its divisions since inception in 2014. With over 25 years of executive management, marketing, distressed assets, and business restructuring experience, Mr. Michery brings a wealth of relevant knowledge and expertise to the Mullen brand. He has notably created 12 trademarks so far to develop the company brand and vision.

Mr. Michery is working toward a sustainable future accessible to all by creating a suite of clean-energy electric vehicles at varied price points. With entirely U.S.-based manufacturing and operations, he is also determined to have Mullen Technologies play a role in shaping a self-sustaining local economy by creating more jobs in America.

Mr. Michery manages risks and company expectations as a pathway to success and has personally overseen several businesses that totaled over $1 billion in transactions. His key strength is the ability to be fiscally responsible and lead teams to complete projects on time and within budget. As a seasoned professional in this space, Mr. Michery has demonstrated skill in building businesses from the ground up and into successful entities that subsequently sold for hundreds of millions of dollars.

Mullen Automotive Inc. (MULN), closed Monday's trading session at $0.558, up 5.283%, on 41,409,431 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.3901/$137.25.

Recent News

• Mullen Automotive Inc. (NASDAQ: MULN) - InvestorNewsBreaks - Mullen Automotive Inc. (NASDAQ: MULN) Receives EPA Certification for Class 3 EV Commercial Vehicles
• InvestorNewsBreaks - Mullen Automotive Inc.'s (NASDAQ: MULN) Cargo Vans Purchased by NYPA on Heels of Successful EV Pilot
• InvestorNewsBreaks - Mullen Automotive Inc. (NASDAQ: MULN) Receives IRS Approval as 'Qualified Manufacturer,' Qualifies for Federal EV Tax Credit

Near Intelligence Inc. (NASDAQ: NIR)

The QualityStocks Daily Newsletter would like to spotlight Near Intelligence Inc. (NASDAQ: NIR).

Near Intelligence (NASDAQ: NIR), a data intelligence platform that curates one of the world's largest sources of intelligence on people and places, has appointed two new members to its board of directors. According to the announcement, Richard J. Salute, a former director of Capital Markets and SEC Practice at J.H. Cohn and CohnReznick LLP, and Sherman Edmiston III, a managing member of HI CapM Advisors Ltd., have joined Near Intelligence's board of directors, effective Sept. 19, 2023; a CPA, Salute will also serve as chair of the board audit committee. With more than 39 years of audit, accounting and tax experience, Salute has provided accounting and complex audits for public and private companies throughout his career. He spent 29 years at Arthur Andersen, where he provided clients with strategic planning services as well as consulting on corporate finance, mergers and acquisitions, and process evaluation. Salute also serves on the board of directors and on the governance and compensation committees, and as chair of the audit committee and audit committee financial expert for Newtek One Inc. (NASDAQ: NEWT). With decades of experience providing financial and operational advisory services, Edmiston currently works as the managing member of HI CapM Advisors Ltd. as well as serving on the board of directors of ARKO Corp. (NASDAQ: ARKO), one of the largest operators of convenience stores and wholesalers of fuel in the United States. Mr. Edmiston is also serving on the board of directors at GTT Communications Inc., Energy Services Inc. and Real Alloy. He also served for several years as managing director of Zolfo Cooper LLC (now Alix Partners). "We're thrilled to bring these talented and experienced leaders to Near's board," said Near CEO Anil Mathews in the press release. "Each provides a unique perspective with diverse backgrounds across technology, accounting and business strategy. Near welcomes their partnership and values their input to further our mission helping customers extract insights from data that help them make better decisions."

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

Near Intelligence Inc. (NASDAQ: NIR), a global Data Intelligence Platform, curates one of the world’s largest sources of intelligence on people and places. Near’s patented technology analyzes data to deliver insights on approximately 1.6 billion unique user IDs across 70 million points of interest in more than 44 countries. With Near’s three-pillared approach – high-quality data, privacy, and AI – operational and marketing leaders are empowered with solutions to successfully engage and grow their businesses at scale. With a presence in Pasadena, San Francisco, Paris, Bangalore, Singapore, Sydney, and Tokyo, Near serves enterprises in diverse industries, including retail, real estate, restaurants, travel/tourism, telecom, media, and more.

Established in 2012, Near employs vast data volumes to comprehend consumer behavior across digital and physical realms, ensuring privacy compliance through anonymization and aggregation. The company analyzes behavior around visited places and connected devices.

Near is headquartered in Pasadena, California.

Platform and Services

The Near platform delivers global, high-quality data in a privacy-safe environment, evaluating consumer activity across physical and digital spaces to provide business leaders with deep insights into the places their customers frequent, along with their brand and competitor preferences.
It is built on three fundamental tenets:

• Global, High-Quality Data: The Near Platform provides high-quality insights about people and places from diverse industries and applications. Through complex data refinement processes, Near converts raw data into powerful insights that empower decision-makers with actionable information.
• Privacy and Transparency: Data privacy and transparency are deeply ingrained in Near’s foundation. The platform is built on the principle of privacy by design, ensuring that data privacy considerations are integrated into every aspect of its products, processes, and practices. The Near approach empowers business decision-makers with control over their information and adheres to the most stringent global privacy regulations.
• Data Science and AI Innovation: The Near Platform employs advanced algorithms and machine learning models to deliver high-quality insights, so users can decipher complex consumer behavior patterns and trends.

In August 2023, Near illustrated the value of its intelligence platform in one such industry – quick-service restaurants (QSRs). Many of the world’s largest QSR brands count Near as a trusted partner for high-quality data insights and restaurant analytics. By harnessing Near’s advanced analytics capabilities, top QSRs with combined annual revenues approaching $90B are able to understand consumer movement and behavior patterns, brand affinities, trade areas, and trends.

The company also collaborates with partners to strengthen their datasets by integrating Near’s physical and digital world understanding. Near’s data is always delivered with a privacy-first, consent-led approach via its SaaS-based geospatial analytics platform.

Market Outlook

An analysis from Fortune Business Insights estimated the global business intelligence market was valued at $27.11 billion in 2022 and is projected to grow from $29.42 billion in 2023 to $54.27 billion by 2030, a CAGR of 9.1% during the forecast period.

According to the report, global market growth can be attributed to the increasing adoption of cloud-based Artificial Intelligence/Machine Learning services and data analytics across organizations. A surge in demand for flexible architectures and adaptable solutions opens up market expansion opportunities.

Management Team

Anil Mathews is the CEO of Near. He is a visionary who has spent the past 22 years as a serial entrepreneur, building successful businesses around engineering, messaging, and social. He is passionate about creating new market companies with a strategic vision and technology capability that can provide substantial growth. He is also an advisor and investor to numerous startups across the globe.

Shobhit Shukla is President of Near. He currently runs the company’s global business and strategic initiatives, where he is responsible for executing Near’s vision to become the most accurate and privacy-safe source of intelligence on people and places. He holds an MBA from the Indian Institute of Management and advises multiple early-stage startups on growth strategy.

Gladys Kong is COO of Near. She was previously CEO of UberMedia, a data intelligence company acquired by Near. She was also CEO of Go Interactive, a fantasy sports company. Before that, she held Engineering and R&D vice president positions at Snap.com and Idea Lab. She has a bachelor’s degree in engineering and applied science from Caltech and a master’s degree in computer science from UCLA.

Rahul Agarwal is the CFO of Near. He began his career at PwC India and later held accounting and finance roles at HT Media and InMobi, where he rose to the position of Head of Finance, North America. He is a graduate of The Institute of Chartered Accountants of India and holds an MBA in finance and strategy from the Indian Institute of Management at Bangalore.

Near Intelligence Inc. (NASDAQ: NIR), closed Monday's trading session at $0.2801, up 1.4488%, on 969,279 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.19/$18.65.

Recent News

• Near Intelligence Inc. (NASDAQ: NIR) - InvestorNewsBreaks - Near Intelligence Inc. (NASDAQ: NIR) Announces Seasoned Industry Veterans as New Board Members
• InvestorNewsBreaks - Near Intelligence Inc. (NASDAQ: NIR) Bringing High-Quality Real Estate Analytics to Leading CRE Companies
• Near Intelligence Inc. (NASDAQ: NIR) Is 'One to Watch'

Electronic Servitor Publication Network Inc. (OTCQB: XESP)

The QualityStocks Daily Newsletter would like to spotlight Electronic Servitor Publication Network Inc. (OTCQB: XESP).

XESP, through its Digital Engagement Engine(TM), is making automation, powerful data management, and an advanced workflow, more accessible to B2B companies

The company allows businesses to offer buyers meaningful and empowering experiences, making them feel appreciated and understood, and moving them to action

XESP understands businesses' concerns, especially regarding the cost of automation, and continues to refine its products, integrating new features and addressing emerging customer needs, all at a more competitive price point

By integrating new features and making new offerings, the company is staying ahead of the competition and stamping its position as a leader in the digital activation and engagement space

Electronic Servitor Publication Network (OTCQB: XESP), a market disruptor for B2B companies, is showing how unique, cutting-edge data analysis and smart technology can grow businesses and help them develop a continuous flow of customers. Through its Digital Engagement Engine(TM), the company is making advanced marketing automation, data management, and an efficient marketing workflow, more accessible to B2B companies, affording them greater reach and lift for their digital content and ensuring greater customer satisfaction and advocacy.

Electronic Servitor Publication Network Inc. (OTCQB: XESP) is a digital engagement company offering a managed service which provides digital activation and engagement solutions to companies that seek to optimize their growth. Its managed service is powered by a proven, proprietary technology – the Digital Engagement Engine™. This technology provides intelligent interaction management, dynamic content provisioning, and a logic-driven workflow, which creates digital experiences that accelerate an audience from awareness to action – driving growth.

Electronic Servitor Publication Network’s services are designed to drive growth for both established and developing organizations. Through the optimization of digital interactions within current and new communities, the Digital Engagement Engine™ ensures that client content is relevant, reaches the right audience, and connects with the intended person at the right time.

The company calls it ‘Growth as a Service’.

Client implementation is nearly effortless, since the solution is completely managed by the Electronic Servitor Publication Network team. This business model allows clients to focus on their brands, core product offerings, and content creation, while the company manages the technology and outcome.

The company is headquartered in Minneapolis, Minnesota.

Technology

Electronic Servitor Publication Network’s Digital Engagement Engine™ utilizes a combination of automation, unique data management, and a modern workflow built on a microservices architecture to achieve greater reach and lift. Using sophisticated data analysis and smart technology, the Digital Engagement Engine™ provides companies with the ability to maintain complete control of their content while creating meaningful relationships with new customers and revenue streams.

The Digital Engagement Engine™ isn’t just another marketing or technology tool; it’s a way to develop real connections with target markets.

Market Outlook

According to a report by ReportLinker.com, an award-winning market research firm, the global customer engagement solutions market was estimated at $19.3 billion in 2022 and is forecast to grow to $32.2 billion by 2027, achieving a CAGR of 10.8% during the forecast period.

The report notes that these engagement solutions are vital to companies seeking to widen their customer bases, reduce customer churn rates and increase customer retention. These perceived benefits of customer engagement solutions are likely to drive their growing adoption around the globe during the forecast period, according to the report.

Management Team

Peter Hager is President and CEO of Electronic Servitor. He joined the company from Pointward Inc., a medtech customer engagement agency that provided solutions to drive market entry, growth, and commercialization for Fortune 500 health care brands and medtech startups. He has founded and managed multiple technology, professional services and medtech organizations throughout his career. Mr. Hager holds a bachelor’s degree from Macalester College in St. Paul, Minnesota, with concentrations in economics and psychology.

Jim Kellogg is CFO of Electronic Servitor. He has served as the principal of J. Kellogg & Company Inc., a business and tax consultant, since 2005. He has provided legal support to clients’ business valuations, business interruption and divorce property valuations. He has worked as a professional tax adviser since 1983. Mr. Kellogg obtained his JD with emphasis on taxation from Western State University College of Law and was certified as a financial planner by the College for Financial Planning in 1990.

Thomas (Denny) Spruce, RPh, is COO of Electronic Servitor. He oversees company infrastructure, regulatory reporting, and strategic partner relationships, among other roles and responsibilities. He joined the company in March 2022 and, since that time, has implemented foundational support processes, developed contractual relationships with service providers, managed financial and regulatory reporting and overseen contract development and management with the legal team. Mr. Spruce obtained a BS in Pharmacy from the University of Arkansas.

Electronic Servitor Publication Network Inc. (XESP), closed Monday's trading session at $0.07, up 7.6923%, on 7,142 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.03/$0.16.

Recent News

• Electronic Servitor Publication Network Inc. (OTCQB: XESP) - Electronic Servitor Publication Network Inc. (XESP) Helps Businesses Compete and Win Through The Increasingly Recognized Necessity of Marketing Automation
• TechMediaBreaks - Electronic Servitor Publication Network Inc. (XESP) Providing Tested Avenues for Elevating Customer Experiences
• Electronic Servitor Publication Network Inc. (XESP) Provides Unique Digital Engagement Offering in Revenue-Driven Customer Engagement Solutions Market

Horizon Fintex | Upstream

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

Upstream, the revolutionary retail trading app for stocks and NFTs powered by Horizon Fintex and MERJ Exchange Limited, noted that Amex recently added digital collectibles to its program, offering member collectibles to commemorate events and experiences. Consequently, the latest Upstream blog discusses five unique benefits NFTs offer, including scarcity, community, gamify, quantify and metaverse participation. In addition, the blot outlined benefits of launching NFTs through Upstream, including no upfront costs or exclusive contracts; simplified, user-friendly process; keeping all NFTs under a brand umbrella; and keeping brand and fans protected on a regulated trading platform. "Upstream makes it simple for brands to enter this world with no blockchain knowledge needed," the blog stated. "We offer the ability to create thousands, even millions of NFTs at no upfront cost to you. This means more value, gamification and revenue potential for your promotions. With NFTs, you can offer digital merchandise, rewards, exclusive content, memorialized history and unique experiences to expand your brand community."

To view the full blog, visit https://ibn.fm/KRU8q

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

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

Products

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

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

Upstream – The Horizon-Powered Trading App

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

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

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

Management Team

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

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

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

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

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

Recent News

• Horizon Fintex | Upstream - InvestorNewsBreaks – Upstream Explores How NFTs Add Unique Benefits, Value to Traditional Rewards
• InvestorNewsBreaks – Upstream Experts Explore Ways for Brands to Expand Reach, Foster NFT community growth
• InvestorNewsBreaks – Upstream Blog Defines Spinoff Share Distributions, Walks Shareholders Through Participation Process

GolfLync Inc.

The QualityStocks Daily Newsletter would like to spotlight GolfLync Inc.

GolfLync, the leading social networking platform for golfers, is thrilled to remind you about the GolfLync Pebble Beach Sweepstakes, your golden opportunity to win the golf trip of a lifetime to the iconic Pebble Beach Resorts, acclaimed as the No. 1 Golf Resort in America.

Pebble Beach Resorts, nestled on California's breathtaking Monterey Peninsula, offers an unparalleled golfing experience. With its three Top 50 public courses, including the world-famous Pebble Beach Golf Links, golf at Pebble Beach Resorts is an unforgettable journey. From the stunning coastal views at Spanish Bay to the majestic pines of Spyglass Hill, each course presents its own unique challenges and thrills.

As the greatest public golf course in America, as rated by Golf Digest, Pebble Beach has a rich history of hosting prestigious tournaments, including the U.S. Open and, for the first time in 2023, the U.S. Women's Open. This sweepstakes provides a once-in-a-lifetime opportunity for golf enthusiasts to immerse themselves in the world of championship golf and experience the magic of Pebble Beach firsthand.

To review the official rules and eligibility criteria, please visit the GolfLync website: (official rules).

GolfLync Inc. matches golfers looking for a game through the company’s smartphone app, GolfLync. The company bills GolfLync as “the social network for golfers,” matching golf games and players similar to the way a dating app matches those looking for romance.

The app allows like-minded golfers to connect for a game simply by logging in. GolfLync helps golfers who are looking to grow their golf network find other players with similar interests and on course preferences. Whether you have recently moved to a new area and are looking for new golfing buddies, travel frequently and would like to play a round of golf while on the road, or just want to meet new golfers in your area, GolfLync is your answer. Spouses who enjoy golfing together can find other golfing couples to tee it up with. For a regular group that finds itself unexpectedly down a player, GolfLync can help find that last-minute addition to complete the foursome.

The company is based in Scottsdale, Arizona.

GolfLync App

GolfLync was created for golfers of all skill levels and preferences to connect with compatible players of similar skill. Golfers can find a tee time through GolfLync, join existing tee times and create new leagues. The app allows golfers to meet fellow players before committing to spend four hours on the course with them. GolfLync allows users to find new golf friends based on their preferences, such as walking or riding a cart, listening to music, friendly wagering, imbibing a favorite beverage at the 19th Hole and more. GolfLync is available for both Android and iOS as a free download.

 

Market Opportunity

According to a report by Statista, a leading provider of market and consumer data, in 2022, the number of people participating in golf in the United States reached 25.6 million, with 15.5 million additional players participating in off-course activities like driving ranges. In 2020, over 502 million rounds of golf were played in the U.S. alone. The game, traditionally dominated by male players, is changing, with increased interest from women golfers driven by social media influencers around the game.

Lumen Sports puts the total number of golf courses in the U.S. at more than 16,700. According to Lumen, about 75% of those are public courses open to all golfers, with the rest considered private golf clubs that require a membership.

 

Management Team

Noah DiPasquale is a co-founder and CEO of GolfLync Inc., leading the marketing and operations of the platform. He is also the founder and CEO of Epic Golf Club, a premier national membership and private golf society which partners with hundreds of top tier private golf clubs allowing Epic members access to their courses and recently founded the Epic Foundation, a Scottsdale-based 501c3. He holds a B.S. in Business Administration, Management and Operations from the W.A. Franke College of Business at Northern Arizona University and an MBA in Marketing from the University of Phoenix.

Michael Quiel is a co-founder of GolfLync Inc. and the President of the organization. He leads the application development and research teams. Michael understands how to build successful companies. His deep knowledge of investment banking, finance and building successful business partnerships is unparalleled. He’s an expert at capital formation and growth hacking companies. He has raised over $250 million in capital and taken multiple companies public.

Recent News

• GolfLync Inc. - GolfLync Inc.’s Pebble Beach Sweepstakes Ends October 1, 2023: This is Your Last Chance to Win a Dream Golf Trip to Pebble Beach Resorts
• InvestorNewsBreaks – GolfLync Inc. Eyes Viral-Scale Growth Driven by Genuine Enthusiasm, User Engagement
• InvestorNewsBreaks – GolfLync Inc. Eyes Trending of Virtual Golf Clubs(TM)

CNS Pharmaceuticals Inc. (NASDAQ: CNSP)

The QualityStocks Daily Newsletter would like to spotlight CNS Pharmaceuticals Inc. (NASDAQ: CNSP).

CNS Pharmaceuticals is conducting a global clinical trial to evaluate its flagship drug candidate for treating glioblastoma, a deadly brain cancer

CNS has enrolled 200 of its planned 243 patients for its clinical trial roster, and anticipates filling out the remainder of patients by year's end

The company is also preparing the interim study analysis for release by year's end, now that more than 50 percent of the planned patient roster has reached a point necessary for effective comparison of performance of the flagship drug, Berubicin, to that of a standard of care chemotherapy agent

The company has stated that it took longer than anticipated to launch the interim analysis because many patients were living longer than historical expectations, and CNS hopes to show that Berubicin has helped patients achieve a longer Overall Survival ("OS"), driving eventual commercialization and improved treatments

Cancer drug developer CNS Pharmaceuticals (NASDAQ: CNSP) is closer to reporting the results of its drive toward a new treatment for the effectively incurable brain cancer glioblastoma ("GBM"), with 200 of the expected 243 patients now enrolled in the company's potentially pivotal study involving its flagship drug candidate Berubicin, according to a company news release (https://ibn.fm/OqKzk).

CNS Pharmaceuticals Inc. (NASDAQ: CNSP) is a clinical stage biotechnology company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system.

The company was founded in 2017 and is headquartered in Houston, Texas.

Organ Targeted Therapeutics

The company’s lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer. Berubicin also has potential to treat other central nervous system malignancies. Based on limited clinical data, Berubicin appears to be the first anthracycline to cross the blood brain barrier in the adult brain, and it was the subject of a successful Phase 1 study which found the MDT and produced efficacy data as well.

CNS holds a worldwide exclusive license to the Berubicin chemical compound. The company has acquired all requisite data and know-how from Reata Pharmaceuticals Inc. related to a completed Phase I clinical trial of Berubicin in malignant brain tumors. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. In 2017, CNS entered into a collaboration and asset purchase agreement with Reata.

CNS intends to explore the potential of Berubicin to treat other diseases, including pancreatic and ovarian cancers and lymphoma. The company is also examining plans to develop combination therapies that include Berubicin.

CNS estimates that more than $25 million in private capital and grants were invested in Berubicin prior to the company’s $9.8 million IPO in November 2019.

CNS intends to submit an IND for Berubicin during the fourth quarter of 2020 and expects to commence a Phase II clinical trial of Berubicin for the treatment of GBM in the U.S. in Q1 2021. A sub-licensee partner was awarded a $6 million EU/Polish National Center for Research and Development grant to undertake a Phase II trial of Berubicin in adults and a first-ever Phase I trial in pediatric GBM patients in Poland in 2021.

The company’s second drug candidate, WP1244, is a novel DNA binding agent licensed from the MD Anderson Cancer Center. In preclinical studies, WP1244 proved to be 500-times more potent than the chemotherapeutic agent, daunorubicin, in inhibiting tumor cell proliferation. The company has entered into a sponsored research agreement with the MD Anderson Cancer Center to further the development of WP1244.

CNS Pharmaceuticals recently engaged U.S.-based Pharmaceutics International Inc. and Italian BSP Pharmaceuticals SpA for the production of the Berubicin drug product. The company has implemented a dual-track manufacturing strategy to mitigate COVID-19-related risks, diversify its supply chain and provide for localized availability of Berubicin. CNS has already completed synthesis of Berubicin’s active pharmaceutical ingredient (API) and has shipped the API to both manufacturers in order to prepare an injectable form of Berubicin for clinical use.

Global Brain Tumor Therapeutics Market

The high recurrence rate of malignant brain tumors is due to reappearance of focal masses, indicating that a sub-population of tumor cells in these cancers may be insensitive to current therapies and may be responsible for reinitiating tumor growth. This necessitates the development of newer drugs in the market that demonstrate greater efficacy in treating such aggressive cancers.

A global increase in neurological disorders has placed increased attention on cancers of the brain over the past decade. Neurological disorders are becoming one of the most prevalent types of disorders, due to longer life expectancy, greater exposure to infection and an increasingly sedentary lifestyle. Because few treatments for primary and metastatic cancers of the brain exist, costs are high and have acted as a restraint for the brain tumor therapeutics market.

Despite progress in surgery, radiotherapy and chemotherapeutic strategies, effective treatments for brain cancer are limited by a lack of specific therapies for the brain and the difficulty in transporting therapeutic compounds across the blood brain barrier. Therefore, there is a significant need for novel and effective therapeutic drugs and strategies that prolong survival and improve quality of life for brain tumor patients.

Several companies are making significant investments into R&D, which is expected to bring more treatment options to the market in the near future. Industry reports consistently project continued growth in the market.

One report estimates that the global brain tumor therapeutics market will reach a valuation of $2.74 billion in 2023, with the market expected to register a CAGR of 11% during the forecast period from 2018 to 2023. Another report projects that the global brain tumor therapeutics market will reach $3.4 billion by 2025, up from $2.25 billion in 2019 (http://nnw.fm/eDUjp).

Management Team

John M. Climaco is the CEO of CNS Pharmaceuticals. For 15 years, Climaco has served in leadership roles for a variety of health care companies. Recently, Climaco served as the Executive Vice President of Perma-Fix Medical S.A, where he managed the development of a novel method to produce Technitium-99. Climaco also served as President and CEO of Axial Biotech Inc., a DNA diagnostics company. In the process of taking Axial from inception to product development to commercialization, Climaco forged strategic partnerships with Medtronic, Johnson & Johnson and Smith & Nephew.

Christopher Downs, CPA, is the company’s Chief Financial Officer. Downs previously served as Interim Chief Financial Officer and Executive Vice President of InfuSystem Holdings Inc. (NYSE: INFU), a supplier of infusion services to oncologists in the United States. Downs holds a Bachelor of Science from the United States Military Academy at West Point, an MBA from Columbia Business School and a Master of Science in Accounting from the University of Houston-Clear Lake.

Dr. Donald Picker is the Chief Scientific Officer of CNS. Picker has over 35 years of drug development experience. Prior to joining CNS, Picker worked at Johnson Matthey, where he was responsible for the development of Carboplatin, one of the world’s leading cancer drugs, which was acquired by Bristol-Myers Squibb with annual sales of over $500 million. In addition, he oversaw the development of Satraplatin and Picoplatin, third-generation platinum drugs currently in late-stage clinical development.

Sandra L. Silberman, M.D., Ph.D., is the Chief Medical Officer of CNS Pharmaceuticals. Silberman is a hematologist/oncologist who earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively, and her M.D. from Cornell University Medical College. She then completed both a clinical fellowship in hematology/oncology and a research fellowship in tumor immunology at the Brigham & Women’s Hospital and the Dana Farber Cancer Institute in Boston, Massachusetts. Silberman has played key roles in the development of many drugs, including Gleevec(TM), for which she led the global clinical development at Novartis. Silberman advanced several original, proprietary compounds into Phases I through III during her work with leading biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone and Roche.

CNS Pharmaceuticals Inc. (NASDAQ: CNSP), closed Monday's trading session at $1.13, off by 3.4188%, on 32,444 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.6105/$6.90.

Recent News

• CNS Pharmaceuticals Inc. (NASDAQ: CNSP) - Nottingham University Researchers Find Way to Make Brain Cancer Cells Self-Destruct
• BioMedNewsBreaks - CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Optimistic Berubicin May Provide Much-Needed Benefit for GBM Patients
• Microdevices to Enable Simultaneous Multiple Studies on Potential Brain Cancer Treatments

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

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

University of Chicago Pritzker School of Molecular Engineering (PME) researchers have developed a new vaccine that has completely reversed autoimmune disorders in laboratory settings. This "inverse vaccine" works by wiping out the immune system's memory of a perceived irritant rather than suppressing the immune system to limit autoimmunity symptoms. The immune system is essentially a battle-ready system of defenses ready to attack and destroy any threats at the drop of a hat. In some people, the immune system is overly sensitive and will react aggressively after mistaking harmless substances such as proteins, pollen and healthy tissues, for threats. This results in the immune system attacking and even destroying healthy cells and tissues in the body and causing autoimmune disorders such as type 1 diabetes, multiple sclerosis, pernicious anemia, reactive arthritis, rheumatoid arthritis and systemic lupus erythematosus. There are more than 80 identified autoimmune disorders, and experts estimate that around 50 million Americans suffer from at least one or more autoimmune diseases. These reverse vaccines could be a good complement to the immunotherapies that are being developed by entities such as Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) to help in combating the increasing burden of autoimmune conditions in the world's population.

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

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

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

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

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

Lead Candidate: Inhaled COVID-19 NanoAb

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

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

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

NanoAb Pipeline: Psoriasis, Asthma and More

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

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

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

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

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

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

CDMO Services

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

Market Opportunity

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

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

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

Management Team

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

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

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

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

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), closed Monday's trading session at $0.901, off by 1.5301%, on 5,991 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.901/$11.49.

Recent News

• Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) - Inverse Vaccines Show Promise Against Autoimmunity
• InvestorNewsBreaks - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Closes on $1.33M Registered Direct Offering
• Study Shows Climate Change Impacts Infectious Disease Risks

Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF)

The QualityStocks Daily Newsletter would like to spotlight Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF).

The global rare earth elements market is expected to grow from 167.99 million tons in 2023, and to 206.25 million tons by 2028 – growing at a CAGR of 4.19%

Since starting the project, Appia has commenced diamond drilling in addition to its current reverse circulation and auger drilling campaigns

Specimens from the drilling efforts will be submitted to SGS Geosol laboratory, with assays expected two months from submission

The global rare earth elements ("REE") market is expected to grow from 167.99 million tons in 2023 to 206.25 million tons by 2028 – growing at a CAGR of 4.19%. The driving factors for the increase in REE production come from a global demand from emerging economies for "green technology" (https://ibn.fm/UuCTZ). With the high growth and demand, several companies are pursuing the REE industry, including Appia Rare Earths & Uranium (CSE: API) (OTCQX: APAAF), a mineral exploration company focused on exploration activities in Brazil and Canada. The company is funded no debt, and has an aggressive exploration program underway.

Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) is a mineral exploration company focused on exploration activities at its newly acquired Cachoeirinha rare earths project (“PCH Project”) in Brazil, as well as delineating high-grade critical rare earth elements (REE) and gallium at its Alces Lake property in Saskatchewan. Other properties in Appia’s portfolio include its Elliot Lake Property in Ontario’s historic mining camp, with a large NI 43-101 uranium and rare earths resource. Fully funded with over $5 million (CDN) in cash, no debt, aggressive exploration currently underway, and experienced management, Appia is progressing rapidly on multiple fronts in highly desired market sectors.

The company is headquartered in Toronto, Canada.

Projects

PCH Project-Brazil

The PCH project hosts REE mineralization in both ionic clays developed from the weathering of alkaline granites and in-situ rare earth mineralization associated with the underlying granite and a carbonatite intrusion to depths greater than 100 meters. Sampling data shows enrichment in rare earth minerals to depths of between eight meters and +30 meters.

In early 2023, Appia announced a definitive agreement to acquire a 70% interest in the PCH Project, which is 17,551 hectares in size and located in the Tocantins Structural Province of the Brasília Fold Belt, Goiás State, Brazil. It is classified as an alkaline intrusive rock occurrence with the potential for highly anomalous REE and Niobium mineralization.

The region around Iporá, a city located roughly 30 km from the PCH Project, has significant mineral exploration and mining activity and well-developed infrastructure.

In July 2023, Appia commenced an aggressive auger and reverse circulation (RC) drill campaign to delineate a potential resource estimate at the PCH project. Initial results at the site revealed significant exploration potential with impressive values that often surpass known ionic clay deposits in Brazil, particularly for the highly valuable heavy rare earths Terbium and Dysprosium.

The auger holes drilled at Target 4 have exhibited a range of total REE grades, ranging from 274 ppm to 16,648 ppm (1.66%), with an average of 1,291 ppm total REE. The valuable rare earths used in magnet applications – praseodymium, neodymium, terbium and dysprosium (Pr, Nd, Tb, and Dy) plus yttrium (Y) accounted for approximately 14% of total rare earths, reaching a maximum of 28.4%. Notably, the deposit also contains anomalous values of niobium and scandium, with average values of 736 ppm for Nb and 62 ppm for scandium in a composite sample from Target 4.

Heavy rare earths (HREEs) show maximum values of 1,624 ppm and average values of 1,291 ppm, primarily as terbium and dysprosium. Light rare earths (LREEs) show maximum values of 14,024 ppm (1.54%) with an average of 1,145 ppm. Neodymium and praseodymium, the main magnetic light rare earths, show respective maximum values of 3,131 ppm (Nd) and 885 ppm (Pr) and average values of 216 ppm (Nd) and 61.7 ppm (Pr). The overall HRRE/LREE ratio has a maximum of 39.5% and an average value of 16.67%.

“Appia is thrilled with the progress made and the promising results thus far,” CEO Tom Drivas stated in a news release. “The company remains committed to advancing its exploration plans, aiming to promptly gather significant data throughout the year, and to work towards estimating a maiden mineral resource in the coming months.”

Alces Lake Project – Saskatchewan

Appia’s Alces Lake project, located in northern Saskatchewan, encompasses some of the highest-grade total and critical REEs and gallium mineralization in the world, hosted within several surface and near-surface monazite occurrences that remain open at depth and along strike.

Following the company’s acquisition of additional new mineral claims in the area in February 2023, Appia’s Alces Lake claim block now totals 38,522 contiguous hectares (95,191 acres) – 100% owned by the Company.

Appia announced the completion of a NI43-101 technical report on the property in June 2023, providing an update on exploration previously reported in March 2021.The report is available on SEDAR under the company’s profile.

Extensive diamond drilling and geophysics surveys are underway to explore a more than 25-kilometer structural corridor. In July 2023, the company issued an update on its diamond drill program having completed the first phase of drilling at the project’s Magnet Ridge Zone to further test the extent of the mineralization to the south south-east (SSE). President Stephen Burega noted the presence of “continued mineralization at significantly thicker intercepts.”

As part of its 2023 exploration program at Alces Lake, Appia plans to target priority areas that extend SSE from the Wilson, Richard, Charles, Bell, Ivan, Dylan, Dante and AMP zones through the Magnet Ridge Zone and beyond, covering an area extending approximately 20 kilometers in length and 5 to 7 km in width. Appia will also undertake reconnaissance drilling on priority regional geological and geophysical targets in the Western Anomaly area.

Other Projects

• Appia holds a total of 75,314 hectares (186,106 acres) of land on four uranium claim blocks in the prolific Athabasca Basin (Loranger, North Wollaston, Eastside and Otherside). Exploration plans for these properties are expected to be announced once permits are in hand.
• Appia also has a 100% interest in 12,545 hectares (31,000 acres), with rare earth element and uranium deposits over five mineralized zones, in the Elliot Lake Camp, Ontario.

Market Opportunity

A report from Mordor Intelligence forecasts the global REE market is expected to grow from 168 million tons in 2023 to 206.25 million tons by 2028, marking a CAGR of 4.19% during the forecast period. The market is gradually improving following the economic and production restrictions of the COVID-19 pandemic.

Factors driving the market’s growth include high demand from emerging economies and the dependency of environmentally friendly technologies on rare earth elements.

According to UxC, one of the nuclear industry’s leading market research and analysis companies, the uranium market is rapidly becoming production-driven, where spot and long-term prices more closely correlate to the marginal cost of uranium production.

Although global reactor requirements are projected to be flat through 2024, UxC forecasts that significant demand growth from 2025 to 2040 will necessitate new production as resources are exhausted at several uranium projects. In addition, a large percentage of production exists in regions of the world with high geopolitical risk, which makes the market vulnerable to future disruptions and price volatility.

Management Team

Tom Drivas is CEO of Appia Rare Earths & Uranium Corp. He is an entrepreneur with over 30 years of experience in various industries, including over 20 years in the mineral resource industry. He is also currently a director of Romios Gold Resources Inc., a publicly traded company he founded in 1995.

Stephen Burega is President of Appia. He brings 16 years of management and operations experience in the mining and natural resources sectors. His extensive emerging markets background, along with a deep understanding of stakeholder management, social development and structured community engagement, position him well to lead Appia’s First Nations community engagements. He is also President and CEO of Romios Gold Resources which is focused on base and precious metal exploration in North America.

Frank van de Water is the company’s CFO. He holds CPA and CA designations and has been involved with international mining, metals and resource companies in North America, Latin America, Europe and Africa for more than 40 years.

Dr. Irvine R. Annesley, Ph.D., is VP Exploration at Appia. He is a licensed geoscientist (P.GEO.) and Professor in Economic (Mining and Mineral Exploration) Geology at École Nationale Supérieure de Géologie in France and an Adjunct Professor in Geology at the University of Saskatchewan. He has over 35 years of global exploration and applied research experience in uranium, gold and base metals exploration, most recently with Athabasca uranium explorer JNR Resources Inc.

Don Hains, P.Geo., is the company’s Consulting Geologist and Qualified Person Consulting Industrial Minerals Expert.

Antonio Vitor is Appia’s Country Manager, Brazil. He has a track record as a portfolio manager and board member. He has held multiple significant positions, including Territory Manager at Shell, as well as Senior Project Planning and Consulting roles at PwC and Petrobras.

Jack Lifton is the company’s Senior Technical Advisor and Consultant. He is an author and lecturer on the market fundamentals of technology metals.

Appia Rare Earths & Uranium Corp. (OTCQX: APAAF), closed Monday's trading session at $0.1467, off by 13.9589%, on 133,170 volume. The average volume for the last 3 months is 132,566 and the stock's 52-week low/high is $0.10/$0.40.

Recent News

• Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) Commences Diamond Drilling with Third Drill Hole at PCH Project in Brazil
• Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) Is 'One to Watch'
• InvestorNewsBreaks - Appia Rare Earths & Uranium Corp. (CSE: API) (OTCQX: APAAF) (FSE: A0I0) Announces Deployment of Third Drill at PCH Ionic Clay Project

InMed Pharmaceuticals Inc. (NASDAQ: INM)

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

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 Monday's trading session at $0.731, off by 4.4444%, on 41,844 volume. The average volume for the last 3 months is 45,317 and the stock's 52-week low/high is $0.7301/$9.32.

Recent News

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• InvestorNewsBreaks - InMed Pharmaceuticals Inc. (NASDAQ: INM) Issues Update on BayMedica Rare Cannabinoid Business

HeartBeam Inc. (NASDAQ: BEAT)

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

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 Monday's trading session at $2.06, off by 4.6296%, on 24,415 volume. The average volume for the last 3 months is 90,950 and the stock's 52-week low/high is $1.82/$6.74.

Recent News

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