Longeveron Inc. (NASDAQ: LGVN)

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

Longeveron (NASDAQ: LGVN; LGVNR), a clinical-stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome ("HLHS"), Alzheimer's disease and Aging-Related Frailty, has issued a letter to its stockholders. The letter, from CEO Wa'el Hashad, contains a business update regarding the company's development of its lead investigational product, Lomecel-B(TM), as well as steps taken to strengthen the board and executive team along with details regarding the current rights offering. The letter noted that Longeveron is involved in ongoing trials of Lomecel-B, a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. The letter noted that ongoing trials are all progressing and nearing important clinical milestones, including key enrollment numbers, additional study locations and the commencement of dosing.

"To execute these compelling programs, over the last several weeks we have taken steps to strengthen Longeveron at both the board and executive leadership level," said Longeveron CEO Wa'el Hashad in the stockholder letter. "In June, we announced the election of seasoned biotechnology and corporate management experts Khoso Baluch and Jeffrey Pfeffer to our board of directors, and I am pleased to join them on our board to serve in this capacity. We also announced the appointment of Lisa Locklear as our chief financial officer and Dr. Nataliya Agafonova as chief medical officer. Both Lisa and Nataliya have had distinguished careers in the bio-pharmaceutical industry, and we look forward to their guidance as we advance clinical development of Lomecel-B. . . . We believe [the] rights offering provides a balanced approach to raising capital necessary to fund clinical development of Lomecel-B while remaining cognizant not to dilute existing shareholders. We believe this is an opportunity to participate for all shareholders, and is an important step in fully realizing the potential of Lomecel-B and to generating long-term shareholder value."

To view the full press release, visit https://ibn.fm/6YTLW

Longeveron Inc. (NASDAQ: LGVN) is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions. The Company’s research and therapies are aimed at improving the outcome of infants born with a life-threatening heart condition, as well as improving the healthspan for the aging population – the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging, with function and ability to perform activities of daily living.

Longeveron is involved in clinical trials in the following indications: Hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty.

The Company’s philosophy revolves around the idea that regenerative medicine may hold the potential to improve certain rare medical conditions and contribute to healthy aging. While there has been a remarkable rise in life expectancy over the last century due to medical and public health advancements, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging.

Longeveron’s lead investigational product is Lomecel-B™, an allogeneic Medicinal Signaling Cell therapy product isolated from the bone marrow of young, healthy adult donors. As humans age, they experience a decrease in immune system function, a decline in blood vessel functioning, chronic inflammation, and other issues. Clinical data has suggested that Lomecel-B™ may address these conditions through multiple mechanisms of action (MOA) that simultaneously target key aging-related processes.

The Company is headquartered in Miami, Florida.

Lomecel-B™

Lomecel-B™ is being evaluated in multiple clinical trials for aging-related chronic diseases and other life-threatening conditions under U.S. FDA-approved Investigational New Drug applications. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas.

The drug is made from special living cells called Medicinal Signaling Cells (MSCs) that are isolated from fresh bone marrow tissue that has been donated by adult donors aged 18 to 45. Once the MSCs have been isolated from the fresh bone marrow through a careful selection process, the cells are culture-expanded (allowed to replicate under controlled laboratory conditions) into the billions using specialized techniques and processes. After a specific number of expansion cycles, called “passages,” the cells are harvested, separated into specific doses (e.g., 50 million cells), and cryopreserved until future use.

These cells have been shown to have characteristics that allow them to be transplanted from a donor to host without triggering a harmful immune response in the recipient, and they can be administered on an outpatient basis in as little as 40 minutes after thawing. Because of these characteristics, Lomecel-B™ is considered an “off-the-shelf” product.

In some trials, such as for Alzheimer’s disease and Aging-related Frailty, Lomecel-B™ is administered via peripheral intravenous infusion, while, in the Company’s HLHS trial, Lomecel-B™ is administered via direct injection into the heart tissue.

Market Opportunity

Longeveron estimates the potential market size for Lomecel-B™ in the treatment of HLHS to be up to $1 billion annually, globally.

U.S. patients suffering from Aging-related Frailty are estimated using U.S. Census Bureau statistics to be approximately 8.1 million. That population potentially represents a market for Lomecel-B™ of between $4 billion and $8 billion globally per year, according to Company estimates.

Additionally, the Alzheimer’s Association puts the number of Americans with that disease at 5.1 million, highlighting another potentially addressable market for Lomecel-B™, that’s worth $5 billion to $10 billion annually.

Management Team

Wa’el Hashad is CEO of Longeveron. He has more than 35 years of experience in the pharmaceutical and biotech industries. He has launched several successful brands in the U.S. and worldwide markets. Prior to joining Longeveron, he was president and CEO of Avanir Pharmaceuticals. Before Avanir, he was the chief commercial officer of Seres Therapeutics. He also has held senior leadership positions at Amgen, Boehringer Ingelheim, and Eli Lilly and Company. He holds a bachelor’s degree in pharmacy from Cairo University and an MBA from the University of Akron.

Joshua M. Hare, M.D., FACC, FAHA, is Co-Founder, Chief Science Officer and Chairman of Longeveron. He is a double board-certified cardiologist and is the founding director of the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine. He is a recipient of the Paul Beeson Physician Faculty Scholar in Aging Research Award and is an elected member of the American Association of Physicians and The American Society for Clinical Investigation. He is also an elected Fellow of the American Heart Association. He received a bachelor’s degree from the University of Pennsylvania and his M.D. from The Johns Hopkins University School of Medicine.

Lisa Locklear is CFO at Longeveron. She previously served as the senior vice president and CFO for Avanir Pharmaceuticals. Prior to Avanir, she held senior financial roles at GSN Games, CoreLogic, Ingram Micro, the Walt Disney Company, and Price Waterhouse, with assignments in Paris and London. She holds a bachelor’s degree in plant science from the University of California, Davis, and an MBA from the University of California, Irvine. She is a licensed CPA (inactive) and is a member of the American Institute of Certified Public Accountants, the California Society of CPAs, and Financial Executives International.

Dr. Nataliya Agafonova, M.D., is the Chief Medical Officer at Longeveron. She previously served as clinical development lead, senior medical director, and product development chair at Otsuka Pharmaceuticals. Before that, she was the clinical development lead and senior medical director at Bristol-Myers Squibb. She previously held senior leadership positions at Ardea Bioscience, Biogen, Amgen, and Genzyme Corporation. She earned an M.D. from the Ukrainian National Medical University and completed her internal medicine residency at Kharkov State University Hospital in Ukraine.

Certain statements in this corporate profile that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this corporate profile are made as of the date of this corporate profile, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com

Date prepared: August 31, 2023

Longeveron Inc. (NASDAQ: LGVN), closed Monday's trading session at $2.43, up 0.829876%, on 101,774 volume. The average volume for the last 3 months is 288,486 and the stock's 52-week low/high is $2.2302/$5.22.

Recent News

• Longeveron Inc. (NASDAQ: LGVN) - InvestorNewsBreaks - Longeveron Inc. (NASDAQ: LGVN; LGVNR) CEO Releases Stockholder Letter
• Longeveron Inc. (NASDAQ: LGVN) Is 'One to Watch'
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SuperCom Ltd. (NASDAQ: SPCB)

The QualityStocks Daily Newsletter would like to spotlight SuperCom Ltd. (NASDAQ: SPCB) .

SuperCom has introduced the all-in-one PureOne monitoring device with three unique tech modules, offering advanced technology for the cost-effective electronic home and civil monitoring of offenders

The electronic offender monitoring market in Europe and the Americas is expected to reach $2.1 billion in 2026 and is seeking new technologies to meet a rapidly growing demand

SuperCom's innovative solutions promise a critical technological and social impact – improving public safety worldwide and reducing governmental costs in the process

The company's growth strategy includes potential acquisitions and expansion into new regions with limited electronic monitoring capabilities

SuperCom (NASDAQ: SPCB), a leading global provider of traditional and digital identity security solutions offering advanced safety, identification, and security products and solutions to governments, introduces its all-in-one PureOne monitoring device. This device features three built-in modules – the BLE module allows the device to communicate with the Pure Beacon (home unit) Bluetooth device, the GNSS module for location positioning, and the LTE cellular module for communication with the company's Pure Monitor. The device has a portable charger, and both components feature an LED interface for easier system navigation.

SuperCom Ltd. (NASDAQ: SPCB) provides secured solutions for the e-government, IoT and cybersecurity sectors. Since 1988, the company has been a trusted global provider of traditional and digital identity offerings, providing cutting-edge electronic and digital security solutions to governments and organizations, both private and public, around the world.

SuperCom’s mission is to revolutionize the public safety sector worldwide through proprietary electronic monitoring technology, data intelligence, and complementary services.

The company is headquartered in Tel Aviv, Israel, with offices in California and other regions in the U.S.

Business Units

IoT and Connectivity

SuperCom IoT products and solutions provide advanced electronic monitoring solutions and services to criminal justice agencies, enabling customers to detect unauthorized movement of people, vehicles, and other monitored objects. The company provides an all-in-one, field-proven PureSecurity offender monitoring suite, accompanied by services such as GPS monitoring, home detention, domestic violence prevention, and more. The company’s services are specifically tailored to meet each client’s needs.

SuperCom’s proprietary Puresecurity suite of hardware, connectivity, and software components is the foundation for its criminal justice services and offerings. SuperCom is leveraging its extensive technology expertise to implement groundbreaking artificial intelligence (AI) technologies into various parts of its core offerings. By leveraging the power of AI, SuperCom’s PureSecurity platform can offer new abilities, such as amplified data analysis, predictive modeling, and streamlined automation – all geared toward optimizing decision-making and operational efficiency.

Competitive advantages of SuperCom’s technology include:

• Long Battery Life (No Tag Charging Required)
• Ultra Lightweight Form Factor
• Next-Gen Location Tech
• Protection of Domestic Violence Victims
• And More

 

Cybersecurity

In 2015, SuperCom identified the cybersecurity market as a fast-growing space with significant advantages due to synergistic technologies and a shared customer base with its e-Gov and IoT business units. Consequently, SuperCom strategically acquired Prevision Ltd., a company with a strong presence in the market and a broad range of competitive cybersecurity services.

During the first quarter of 2016, SuperCom acquired Safend Ltd., an international provider of cutting-edge endpoint data protection guarding against corporate data loss and theft through content discovery and inspection, encryption methodologies, and comprehensive device and port control.

Both acquisitions significantly expanded the breadth of the company’s global cybersecurity capabilities.

e-Gov

Through proprietary e-government platforms and innovative solutions for traditional and biometrics enrollment, personalization, issuance, and border control services, SuperCom has helped governments, and national agencies design and issue secured multi-identification, or Multi-ID, documents and robust digital identity solutions to their citizens, visitors, and lands.

The company has focused on expanding its activities in the traditional identification, or ID, and electronic identification, or e-Gov, markets, including the design, development, and marketing of identification technologies and solutions to governments in Europe, Asia, America, and Africa using SuperCom’s e-Government platforms.

Market Opportunity

Data from Berg Insight estimates the market for electronic monitoring solutions will grow from $1.2 billion in 2021 to $2.1 billion in 2026, marking a CAGR of 10.8% for the forecast period.

High recidivism rates, prison overcrowding, and soaring incarceration costs are some factors that are driving the electronic monitoring of offenders’ market growth.

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

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

Management Team

Ordan Trabelsi is President and CEO of SuperCom. He has over 15 years of experience as CEO, growing high-tech companies globally. He also has experience in research and development and product innovation, as well as hands-on experience in cybersecurity, encryption, advanced mathematics, and mobile and internet network technologies. Prior to joining SuperCom, he served as co-founder and CEO of Klikot Inc., a global social networking company. He holds an MBA from Columbia University and a B.Sc. in Computer Engineering from The Technion: Israel Institute of Technology.

Barak Trabelsi is COO of SuperCom. He has expertise in big data, cyber, mobile, and internet network technologies, as well as extensive experience in product development and strategies. Prior to joining SuperCom, he served as Senior Product Manager at Equinox Ltd. Before that, he served for four years as VP of R&D at Sigma Wave, a wireless, security, and internet-focused company. He holds a B.Sc. in Computer Science and Business, as well as an MBA from Tel Aviv University.

Gil Alfi is VP of Sales at Safend Ltd., SuperCom’s cybersecurity subsidiary. He joined SuperCom in 2016 as VP of Business Development for Safend. He has more than 18 years of experience in technology companies. He served as an R&D team technology lead for more than seven years and as Director of Product Management for various telecom and wireless companies for more than 10 years. Prior to joining SuperCom, he served as Regional Sales Director at Safend, managing sales regions in Europe and Africa. He holds a B.Sc. in Computer Science and Mathematics and an M.Sc. in Computer Science from Bar-Ilan University.

SuperCom Ltd. (NASDAQ: SPCB), closed Monday's trading session at $0.4587, up 1.9333%, on 25,886 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $5.22/$.

Recent News

• SuperCom Ltd. (NASDAQ: SPCB) - SuperCom Ltd. (NASDAQ: SPCB) Offers its Newest Solution for Increasing Public Safety, Reducing Domestic Violence, While Cutting Government Costs
• SuperCom Ltd. (NASDAQ: SPCB) Helping Governments Improve Public Safety, Reduce Recidivism Rates through Suite of Proven Products Focused on Effectiveness of Home Confinement with Electronic Monitoring
• SuperCom Ltd. (NASDAQ: SPCB) Is Helping to Lead Electronic Monitoring Industry into the Future Following Major California Contract

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 purchase of battery pack production assets from Romeo Power for approximately $3.5 million. According to the announcement, the deal includes equipment, inventory and intellectual property for high volume EV battery pack and module production. The assets include production lines for EV pack assembly and precision R&D module and pack development with associated inventory allowing for production of modules and vehicle battery packs. In addition, the purchased assets include battery testing and validation equipment, computer numerical control ("CNC") equipment for battery pack and module enclosure production. "Purchasing the Romeo assets is consistent with our battery pack production path and previous announcements for our high voltage facility in Monrovia," said David Michery, CEO and chairman of Mullen Automotive. "Overall, this purchase further enhances our capabilities for battery pack production right here in California and the U.S."

To view the full press release, visit https://ibn.fm/YV67g

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 $0.4435, up 5.7715%, on 56,778,889 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) Announces Strategic Acquisition of Romeo Power Assets
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FuelPositive Corp. (TSX.V: NHHH) (OTC: NHHHF)

The QualityStocks Daily Newsletter would like to spotlight FuelPositive Corp. (NHHHF).

FuelPositive (TSX.V: NHHH) (OTCQB: NHHHF), a Canadian-based, growth-stage company committed to providing commercially viable and sustainable, cradle-to-cradle, clean-energy solutions, has closed a nonbrokered private placement among other financial announcements. The private placement was comprised of 6,741,000 units at $0.06 per unit, resulting in gross proceeds of $404,460 for the company. According to the announcement, each unit consisted of one common share of the company along with one common share purchase warrant allowing holders to purchase an additional common share at an exercise price of $0.09 until today. FuelPositive anticipates using the funds for further development of its demonstration systems for the commercial production of green ammonia as well as for general working capital purposes. The company also noted that it has revised the terms of its previously announced proposal to settle outstanding $133,000 of debt.

The revision was made at the request of the TSX Venture Exchange. FuelPositive will now settle the indebtedness by issuing 2,046,154 common shares at a price of $0.065 per common shares; the company will not issue an equivalent number of share purchase warrants. The company has also reached an agreement with an additional arm's-length creditor. That agreement involves $25,000 of debt, which the company will settle by issuing 681,600 units at a price of $0.05 per settlement unit. Completion of the debt settlements is subject to the approval of the TSX Venture Exchange, and all securities issued in connection with the debt settlements are subject to applicable securities laws. In addition, the company announced that it was unable to obtain TSXV approval for the repricing of certain outstanding share purchase warrants. Consequently, those warrants have expired without exercise. FuelPositive has provided warrant holders with the opportunity to participate in the offering. The company has also granted more than two million incentive stock options to certain advisors. The options vest immediately and are exercisable at a price of $0.09 through today.

To view the full press release, visit https://ibn.fm/YpeO4

FuelPositive Corp. (TSX.V: NHHH) (OTC: NHHHF) is a growth stage company focused on licensing, partnership and acquisition opportunities building upon various technological achievements. The company is committed to providing commercially viable and sustainable clean energy solutions, including carbon-free ammonia (NH3), for use across a broad spectrum of industries and applications.

FuelPositive is headquartered in Toronto, Canada.

Hydrogen Economy Problems and FuelPositive’s Carbon-Free Technology

The hydrogen economy is currently facing many challenges. Traditional NH3 manufacturing exists on a massive scale, but centralized facilities result in some of the world’s most concentrated CO2 emissions. In total, an estimated 200 million metric tonnes of NH3 are consumed each year, with greater than 80% utilized by the agricultural sector. NH3 is also being positioned as a viable alternative to fossil fuels.

FuelPositive’s flagship carbon-free ammonia technology provides an innovative solution to these environmental concerns. Developed by Dr. Ibrahim Dincer and his team, the company’s platform allows for the in-situ production of NH3 in an entirely sustainable manner, using only water, air and sustainable electricity.

The production of hydrogen is energy intensive, but it is just one variable hindering the growth of the hydrogen economy. Other hurdles include:

• Storage – The storage of hydrogen by compression or liquification are both cost prohibitive and unsustainable.
• Distribution – The distribution network for effective hydrogen deployment has yet to be developed, as the extreme high-pressure distribution requirements to transport hydrogen would result in enormous infrastructure costs.
• End Use – R&D on the transportation-related end use applications for hydrogen is in its infancy, but almost any vehicle on the road today can be easily converted to run on NH3 at a considerably lower cost per mile traveled when compared to traditional fossil fuels.

A key benefit of FuelPositive’s patent-pending, first-of-its-kind carbon-free NH3 technology is its flexibility. The process allows for small, medium or large-scale production of NH3 on location, minimizing or even eliminating the challenges and volatility associated with storage and transportation to end use. As such, with an appropriately sized FuelPositive system and access to renewable energy, the end use applications for the company’s platform are nearly infinite.

Manufacturing Partnership

On May 19, 2021, FuelPositive announced its selection of National Compressed Air Canada Ltd. (“NCA”) to undertake manufacturing of the company’s Phase 2 hydrogen-ammonia synthesizer commercial prototype systems for carbon-free ammonia production.

In a news release detailing the partnership, FuelPositive CEO Ian Clifford noted, “This critical milestone for FuelPositive will confirm the broad application potential for our technology and is the backbone of our Carbon-Free Hydrogen-NH3 offering. Partnering with the knowledgeable and experienced team at NCA on this commercialization project will bring our development-stage program to life.”

Global Ammonia Market Outlook

The global ammonia market was valued at $52.71 billion in 2017 and is forecast to reach $81.42 billion by 2025, growing at a CAGR of 5.59%, according to data from Fior Markets (https://ibn.fm/1OfOB).

The agricultural industry consumes more than 80% of global NH3. Smaller percentages can be attributed to the waste, water treatment, refrigerants, antiseptic, textile, mining and pharmaceutical industries.

One of the most polluting industries on the planet consists of conventional agribusinesses. These polluters are responsible for more greenhouse emissions per year than transportation. This is where FuelPositive’s technology is expected to be extremely beneficial.

Management Team

Ian Clifford is Director, CEO and Founder of FuelPositive Corp. He has over 25 years of experience in the fields of technology and marketing and has successfully led the company to global brand recognition through its unique energy solutions. Since 2006, Mr. Clifford has raised over $50 million in equity financing for FuelPositive. He also co-founded digIT Interactive, a full-service internet marketing company serving Fortune 500 clients, which he sold at the peak of the market in 2000.

Greg Gooch serves as a Director and President of FuelPositive. His multifaceted career in the electronics and finance industries has positioned him as a key advisor and funding partner to start-ups and new technology companies for over 40 years. Mr. Gooch has been involved with FuelPositive since its early days and has remained a significant supporter and consultant to the company over the years. He has a bachelor’s from McGill University and an MBA from the University of Western Ontario.

Dr. Ibrahim Dincer is a scientific advisor to FuelPositive and is recognized as a pioneer and international leader in the area of sustainable energy technologies. Along with his team, Dr. Dincer invented the modular carbon-free ammonia (NH3) production technology that FuelPositive is commercializing. His area of specialty covers various topics including ammonia, hydrogen energy and fuel cells; renewable energy systems; energy storage systems and applications; carbon capturing technologies, and integrated and hybrid energy systems He is currently managing an exemplary team of researchers in this commercialization project.

Marek Warunkiewicz is the company’s Communications & Branding Specialist. He brings more than 40 years of entrepreneurial expertise to the FuelPositive team, having held marketing, branding, advertising, project management and graphic design positions with various companies. Mr. Warunkiewicz has successfully created business-to-business marketing and advertising campaigns for a diverse group of clients ranging from high-tech to agriculture. He co-founded digIT Interactive and ZENN Motor Company alongside Ian Clifford.

Luna Clifford is the Director of Communications for FuelPositive. She has over 10 years of experience as a business owner and advisor, helping build and operate several successful start-up enterprises while managing complex stakeholder relationships. Ms. Clifford excels in strategic planning and team building, and she has completed extensive studies in the fields of communications and health care.

FuelPositive Corp. (NHHHF), closed Monday's trading session at $0.0476, up 5.4264%, on 18,970 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.035/$0.1348.

Recent News

• FuelPositive Corp. (TSX.V: NHHH) (OTC: NHHHF) - InvestorNewsBreaks - FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) Closes on Nonbrokered Private Placement, Announces Debt Conversion Details
• FuelPositive Seeks Approval for Warrant Repricing
• GreenEnergyBreaks - FuelPositive Corp. (TSX.V: NHHH) (OTCQB: NHHHF) Eyes 2024 Delivery of FP300 Commercial Systems, Answering Larger-Scale Need with FP1500

SOHM Inc. (OTC: SHMN)

The QualityStocks Daily Newsletter would like to spotlight SOHM Inc. (OTC: SHMN).

SOHM (OTC: SHMN), a pharmaceutical, nutraceutical and cosmeceutical company that manufactures and markets generic drugs covering numerous treatment categories, has appointment a new vice president of quality. The company announced that Wm. Dewey Rushing will be serving as SOHM vice president for quality. Rushing has been serving on the company's advisory board member and that experience combined with his impressive background in management and leadership make him ideally qualified for his new role. A well-known expert in the field of pharmaceutical quality validation and cGMP compliance, Rushing has a resume that includes cell therapy IND readiness, quality systems audits, aseptic processing, cGMP compliance and regulation, along with process validation and transfer. He brings invaluable insights and expertise to his new role and will be integral as the company diversifies its portfolio with new products and expands to new markets. "Wm. Dewey Rushing is a senior compliance remediation and quality professional with more than 30 years of experience in quality assurance and cGMP compliance for FDA-regulated products," said SOHM president and CEO Baron Night in the press release. "He joined SOHM's advisory board last year and has been providing his expertise on validation and compliance issues. SOHM has appointed him as the vice president of quality, recognizing his exceptional qualifications and experience in pharmaceutical quality validation and cGMP compliance."

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

SOHM Inc. (OTC: SHMN) is a generic pharmaceutical manufacturing and marketing company with a vision of “Globalè Prospèro” (Global Prosperity). SOHM was founded in 1998 and is headquartered in Chino Hills, California.

The company’s primary goal is to create and produce cutting-edge generic medications that span a wide range of treatment areas, all while ensuring top-tier quality and keeping prices affordable. SOHM is dedicated to fully complying with all relevant regulatory prerequisites and upholding the most rigorous industry benchmarks, including the guidelines set forth by WHO-CGMP and USFDA.

Achievements and Milestones

SOHM is a recognized generic pharmaceutical manufacturer, with production and marketing of generic drugs covering all major treatment categories. SOHM also markets innovative formulations and packaging for various therapeutic segments, such as cosmeceuticals, nutraceuticals and OTC oral dosage formulations, with operations spanning India, the Philippines, Uganda, the U.S., the UK and the EU.

SOHM successfully launched a unique and innovative Salic-2 face wash, FōHM by SOHM, during the Oscar after party in Hollywood. The innovative Salic-2 offering in translucent gel form is marketed as an acne medication in the U.S. cosmeceutical market.

With proficiency in both manufacturing and marketing, SOHM stands out. The company holds licenses for producing over 300 products and has established distribution partnerships with firms in the United States, the Philippines and Uganda. Additionally, SOHM’s repertoire includes the launch of an innovative protein supplement, I-Prolec, featuring a distinct composition—a first-of-its-kind in India.

In 2012, SOHM gained recognition as “the most emerging company in the recent past” at the National Integrated Medical Association Conference. The company’s growth was underscored by its inclusion in the roster of ‘Fastest Growing Public Companies’ according to the Orange County Business Journal.

SOHM Today

SOHM brings all of its expertise and market knowledge toward a new vision. The company continues to develop, manufacture and market generic pharmaceutical drugs for various treatment categories. It offers its products in various dosage forms, including tablets and capsules, creams and topicals, ointments and liquids. The company also provides anti-arthritic/analgesics, dermatological drugs, gastrointestinal and respiratory drugs, biotechnology products, anesthetics, immunosuppressive agents and other various treatments. In addition, it offers a skincare line that includes dry dermatoses, mixed skin infection, acne vulgaris and seborrheic dermatitis products.

SOHM markets its products directly and through partner alliance agreements to drug wholesalers, mass merchandisers, chain drug stores and mail-order pharmacies primarily in the U.S. and has previously done business in the Far East, Africa and Southeast Asia. The company is working with its alliance partner in the African continent and Latin American countries.

SOHM has developed a comprehensive marketing strategy encompassing a diverse range of tactics to promote all products. SOHM uses the power of digital marketing channels, social media campaigns and targeted advertising to significantly enhance awareness and recognition of product offerings.

All distribution networks are strengthened through valuable partnerships. SOHM has gained access to the extensive U.S. market through a strategic alliance with different wholesalers catering to C-stores and retailers. The company has likewise partnered with a distribution firm that holds a remarkable network of more than 4,500 independent pharmacy accounts.

Additionally, a strong partnership with a prominent distribution network in New Jersey enables SOHM to facilitate nationwide distribution to big distribution houses, hospitals and retail chain stores which include but are not limited to Walmart, Publix, Sam’s and many more retail giants, thus extending the company’s market presence.

SOHM Long-Term

A report by Grand View Research estimated the global nutraceuticals market at $291.33 billion in 2022 and forecasts expansion at a compound annual growth rate (CAGR) of 9.4% from 2023 to 2030. The report states primary factors driving the market growth are preventive health care, increasing instances of lifestyle-related disorders, and rising consumer focus on health-promoting diets. Additionally, increasing consumer spending power in high-growth economies is projected to contribute to the growing demand for nutraceutical products.

Grand View valued the global NSAID market at $19.55 billion in 2021 and forecast it would expand to nearly $30 billion by 2030, marking a CAGR of 5.36% for the period. Projected growth is attributed to factors like the rising prevalence of chronic pain across the world, coupled with a growing global geriatric population. In addition, increasing demand for OTC NSAIDs and the rising adoption of NSAIDs in treating headaches, migraine, toothaches and menstrual pain is expected to boost market growth.

Fortune Business Insights estimated that the global cosmeceuticals market was worth $54.57 billion in 2022 and projects the market will grow to a value of $96.23 billion by 2029, marking a CAGR of 8.4% during the forecast period. The report credits the projected growth to the prevalence of skin disorders around the world and the inclination of dermatologists to prescribe or recommend these products as compared to other treatments.

SOHM envisions a future where it evolves into a prominent global corporation, expanding its reach across international borders while upholding its fundamental core values. The company aspires to extend its export portfolio to encompass 11 countries, showcasing a robust international presence.

Aiming for financial stability, SOHM is committed to maintaining sufficient working capital to support its growth endeavors. The company’s forward trajectory involves strategic collaborations, mergers with diverse brands and a focused approach to business expansion through vertical integration and a balanced mix of organic and inorganic strategies.

In this pursuit, SOHM is dedicated to establishing its proprietary network of partners within the over the counter (OTC) sector. Furthermore, the company seeks heightened recognition within crucial therapeutic domains, including oncology, HIV, cardiovascular health, diabetes care and skincare-dermatology, solidifying its prominent standing in these pivotal segments.

Management Team

Baron Night is CEO, President, and Director at SOHM Inc. He has over 40 years of experience in various industries with extensive contacts in emerging markets. His leadership and track record are great assets to the company as SOHM continues to strengthen its position and develop large-scale distribution of generic drug lines.

David Aguliar, Ph.D., is the COO of SOHM. He has 22 years of experience in the pharmaceutical industry, including multiple research positions and scientific publications. He has an extensive background in pharmaceutical Chemistry Manufacturing and Controls (CMC), as well as quality assurance experience in preclinical and Investigational New Drug (IND) application filings of allogeneic cell-based therapies. He has a deep understanding of regulatory and clinical pathways, coupled with an extensive scientific and technical background in the fields of pharmaceuticals, biopharmaceuticals and gene editing tools research.

Dr. Krishna Bhat, MD PHD, FACC, has a cardiology practice of over 35 years in the field of Clinical and Interventional Cardiology. He is a recipient of the 2021 Hall of Fame Award from the American Heart Association, which was awarded in recognition of his commitment to excellence in the field of Cardiovascular Care through his leadership as an outstanding physician, researcher, and educator. He is also a recipient of the Miles Canada Fellowship Award and the J. Louis Levesque Fellowship Award from Montreal Heart Institute in Montreal, Canada.

Dewey Rushing is a Senior Compliance Remediation and Quality Professional with over 30 years of experience in Quality Assurance and cGMP Compliance for products regulated by the U.S. Food and Drug Administration (FDA). He served as a trained Consumer Safety Investigator at the FDA and Instructor at the Los Angeles District. He has in-depth knowledge in technology transfer of biologics and pharmaceutical products, as well as validation of manufacturing equipment, facility cleaning and critical utility systems maintenance. He has an extensive background in auditing GMP facilities, implementing quality systems and performing gap assessments of manufacturing processes and facilities. He has also directed remediation projects in response to federal compliance audit observations.

Sowmya Jacob, MBA-PGP, possesses over a decade of accomplished and evolving expertise in human resources management, along with manufacturing and operations management. She earned an MBA, complemented by advanced marketing certifications. Demonstrating a track record of achievement, she excels in cultivating collaborative work environments and orchestrating transformative changes that lead to heightened productivity. With adeptness in business analysis, she has occupied senior managerial roles, showcasing her mastery. An engaged participant in professional circles, she maintains active memberships in SPHR and CHRP.

SOHM Inc. (OTC: SHMN), closed Monday's trading session at $0.0011, up 10%, on 9,966,000 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.0005/$0.0018.

Recent News

• SOHM Inc. (OTC: SHMN) - InvestorNewsBreaks - SOHM Inc. (SHMN) Names Seasoned Veteran as VP of Quality
• InvestorNewsBreaks - SOHM, Inc. (SHMN) Announces Strategic Board Appointment of Dr. Krishna Bhat, MD, Ph.D., FACC
• SOHM, Inc. Announce the Appointment of Dr. David Aguilar, Ph.D. as a Chief Operating Officer with the Company with Immediate Effect

First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF)

The QualityStocks Daily Newsletter would like to spotlight First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) .

First Tellurium (CSE: FTEL) (OTCQB: FSTTF) has scheduled its drill program in Deer Horn to begin later this month; the program will focus on the Pond zone copper-gold porphyry target. According to the announcement, the objective of the program will be to intersect disseminated mineralization and help locate the main mineral zone in the subsurface. Information obtained from the program will be combined with results from work conducted over the past two years to inform a larger drill program scheduled for 2024. The company will also be conducting an Induced Polarization ("IP") geophysical survey this month, which will be following up on successful rock sampling, channel sampling and prospecting. "Our prospecting, mapping and sampling over the past two years has given us an extensive base of information to support the drilling and IP survey," said First Tellurium president and CEO Tyrone Docherty in the press release. "What we have learned is that both the copper-gold porphyry target and gold-silver-tellurium vein system extend much farther than we first understood. Even more important is the discovery last month that the two mineralized systems are connected, supporting the premise that the property could support a large copper-gold porphyry across ground that has never been explored."

In addition, First Tellurium announced a nonbrokered private placement. The placement is designed to raise up to $600,000 through the sale of an estimated five million flow-through shares at $0.12 and up to $400,000 through the sale of up to four million units at $0.10. First Tellurium president, CEO and director Tyrone Docherty will participate in the offering through his private company, Docherty Capital Corp., which is considered a related-party transaction. "I continue to be a major investor and big believer in the future of the Deer Horn Property, especially with the results of the past two years," said Docherty. "We've kept this financing deliberately small, believing that the upcoming drilling and IP will allow us to conduct subsequent financings on better terms."

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

First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) is committed to exploring for and providing essential and critical metals, including tellurium, gold, silver, copper and tungsten, for North American markets. This objective is anchored by the company’s Deer Horn tellurium-gold-silver-copper project in British Columbia, Canada, and further enhanced by its property option on the Klondike tellurium-gold prospect located in Colorado, USA.

First Tellurium’s unique business model is to generate revenue and value through mineral discovery, project development, project generation and cooperative access to untapped mineral regions in indigenous territory with sustainable exploration potential.

The company is headquartered in Vancouver, British Columbia.

Tellurium and the Green Energy Revolution

Tellurium has a key role to play in the ongoing green energy revolution. It is widely used in the manufacturing of photovoltaic cells for solar panels.

Despite this utility, ongoing trade tensions between China and the U.S. create implications for both tellurium and the production of cadmium-tellurium solar cells. Earlier this year, China announced plans to restrict exports of critical metals gallium and germanium, both essential for the production of semiconductors. For reference, China produces around 80% of the world’s gallium and approximately 60% of the world’s germanium.

China’s recent trade restrictions amplify the fragility of the North American tellurium supply, as the Asian nation currently produces about 60% of the world’s tellurium. This sustained supply vulnerability is why First Solar, the United States’ largest solar panel producer, set up a worldwide search for tellurium deposits in the mid-2000s.

“In North America alone, our understanding is that First Solar looked at over a hundred tellurium properties,” First Tellurium CEO Tyrone Docherty stated in a news release. “Their number one property by far, which they acquired, was the Colorado Klondike which we now control.”

The U.S. is now looking to secure safe, domestic sources of tellurium and many other critical metals to pre-empt potential shortages. The Biden administration has instituted a stream of policies, particularly the U.S. Inflation Reduction Act, to source solar components from North America and other “friendly” jurisdictions.

As the only junior mining company in the world focused on tellurium exploration, First Tellurium is ahead of the curve in capitalizing on these initiatives to establish strategic, domestic supplies of key resources for solar panel manufacturers.

First Tellurium’s ESG Initiatives

Through its exploration and partnerships with Fenix Advanced Materials, Cheona Metals and IRMA, First Tellurium strives to generate a measurable, beneficial social or environmental impact alongside a financial return. The company conducts a diversified search for metals, working in alliance with indigenous peoples, NGOs, governments and leading metals buyers. First Tellurium believes this is the future of mineral exploration — generating revenue by exploring responsibly and leveraging diverse partnerships.

First Tellurium proudly adheres to, and supports, the principles and rights set out in the United Nations Declaration on the Rights of Indigenous Peoples and, in particular, the fundamental proposition of free, prior and informed consent.

 

Projects

Deer Horn Tellurium-Gold-Silver-Copper Project

Deer Horn is located on 51.33 square kilometers (km) in west-central British Columbia, 36 km south of the prolific Huckleberry copper-molybdenum mine and 135 km southwest of the community of Burns Lake. It is one of few significant tellurium discoveries outside Asia and includes a 2.4 km-long vein system of high-grade gold, silver and tellurium, as well as broader zones of bulk-tonnage gold, silver and tellurium mineralization. The company completed a positive Preliminary Economic Estimate and has begun permitting for a 10,000-tonne bulk sample program to advance the project toward mine feasibility. It is North America’s only silver-gold-tellurium property with an NI 43-101 compliant tellurium resource, and it hosts a number of other mineralized targets and zone containing critical metals such as copper, tungsten and zinc.

First Tellurium owns 50% of the property, with an option to acquire up to a 75% interest. The company has engaged Dias Geophysical of Saskatoon, Saskatchewan, to conduct induced polarization (IP) geophysics on the Deer Horn Project in summer 2023. The program is designed to help develop drill targets for a subsequent drilling program.

Klondike Gold-Tellurium Project

The Klondike property is located in Saguache County, Colorado, southwest of Buena Vista in the state’s historical mining district. The company reports it has engaged Burgex Mining Consultants of Sandy, Utah, to stake additional claims around the Klondike property. The claims have been filed with the Bureau of Land Management.

Klondike demonstrates exceptional tellurium grades. Tellurium, used in high-efficiency cadmium telluride (Cd-Te) solar panels, next-generation lithium-ion batteries and thermoelectric devices to change heat into energy, is an essential element for the world’s transition to green energy.

The Klondike property was a top tellurium prospect owned previously by First Solar Inc., one of the world’s largest solar panel producers. First Solar terminated its worldwide raw materials exploration program in 2012 and sold the property to Colorado Klondike LLC, which optioned the project to First Tellurium. Colorado Klondike, led by First Solar’s former Exploration Manager in North America, is managing the upcoming exploration program.

The Colorado Geological Survey (CGS), in partnership with the Colorado School of Mines, reported on First Solar’s exploration at Klondike in 2015, noting: “Surface sampling by First Solar, Inc. in 2006 found very high tellurium grades of up to 3.3% (33,000 ppm), along with locally high gold grades. Tellurium grades at Klondike were the highest encountered in the company’s nationwide exploration program.”

Market Outlook

First Tellurium in spring 2023 referenced recent forecasts by the International Energy Agency (IEA) pointing to rapid growth in solar photovoltaic (solar PV) deployment worldwide. According to the agency, solar PV installations will generate more power by 2027 than any other energy source, including coal, natural gas and hydro. To meet this demand, consumption of both silver and tellurium, key components of solar panels, is expected to surge in coming years.

Chen Lin, founder of Lin Asset Management, has written in his investment newsletter for clients that solar PV is now the largest industrial usage of silver. He said that in 2022 solar PV production used about 12% of total silver demand, or about 120 million ounces of silver. Lin expects this number to rise dramatically in the coming years, and that is likely to lead to silver supply deficits for decades to come.

Lin points out that solar power is now the cheapest source of energy in many parts of the world and that all forecasts point to dramatic expansion of solar PV in the coming two decades. Conservative estimates forecast 300 gigawatts of solar PV production by 2027, up from the current level of about 200 gigawatts.

Management Team

Tyrone Docherty is President, Director and CEO of First Tellurium Corp. He previously served as President and CEO of Quinto Mining Inc., taking over when it had a market cap of $4 million. With limited resources in a difficult market environment, he raised more than $30 million and advanced Quinto’s Quebec iron ore property to a viable project. Quinto later sold for $175 million, with Quinto management taking shares of the purchaser, Consolidated Thompson Iron Mines, amounting to approximately 20-21% of that company. Consolidated Thompson Iron Mines sold two years later for $4.9 billion, giving the former Quinto team an enterprise value of approximately $1 billion. From 2012 to 2018, Mr. Docherty was Director and Chairman of Mason Graphite Inc. He has worked in the financial and minerals markets for more than 30 years.

Tony Fogarassy, M.Sc. LL.M., is Chairman of First Tellurium Corp. He is a lawyer and a geologist. His extensive legal and technical expertise includes minerals, oil and gas, coal and renewable energy projects and environmental and aboriginal/indigenous law in North America, Africa and Asia. He graduated as gold medalist in geological sciences from the University of British Columbia and in law from the London School of Economics.

First Tellurium Corp. (OTCQB: FSTTF), closed Monday's trading session at $0.08, even for the day, on 28,028 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.071/$0.1765.

Recent News

• First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) - InvestorNewsBreaks - First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) to Begin Deer Horn Drill Program, Announces Private Placement Financing
• First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) CEO Discusses Metal-Rich Properties, Potential in Recent Podcast
• InvestorNewsBreaks - First Tellurium Corp. (CSE: FTEL) (OTCQB: FSTTF) Reports on Mapping Program, September Drilling Targets

Electronic Servitor Publication Network Inc. (OTCQB: XESP)

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

XESP continues to affirm its commitment to optimizing companies' growth, mainly through its managed service that offers digital activation and engagement solutions

Its proprietary technology, the Digital Engagement Engine(TM), which utilizes automation, unique data management, and a modern workflow, has proven to offer what no other competitor offers in the market

This product is founded on critical principles integral to building customer loyalty, among them the importance of meeting customers' demands for the modern digital experience

Through this proprietary technology, XESP offers a solution that makes addressing the changing consumer demands a lot easier, faster, and more efficient

Electronic Servitor Publication Network (OTCQB: XESP), is a digital engagement company and a market disruptor offering cutting-edge data analysis and intelligent technology to help enterprises reach their target markets. Through its managed service, which offers digital activation and engagement solutions, the company looks to provide superior intelligent interaction management, dynamic content provisioning, and a logic-driven workflow, all tested avenues for elevating customer experiences and response.

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 $0.065, even for the day. 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) Creating Digital Experiences that Elevate Customer Response
• TechMediaBreaks - Electronic Servitor Publication Network Inc.'s (XESP) Unique Digital Engagement Engine(TM) Creates CX Edge
• Electronic Servitor Publication Network Inc. (XESP) Committed to Improving Client Outcomes and Creating Shareholder Value

Horizon Fintex | Upstream

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

Upstream, a MERJ Exchange market, a globally accessible trading app for securities and NFTs powered by blockchain technology, has announced a spinoff share distribution, and a recent Upstream blog discusses how investors can leverage that to their advantage. The blog noted that Upstream features the future of transparent, instant, peer-to -peer trading and is actively accepting dual listing applications from issuers around the world looking for access to a global, digital-first investor base that can trade Upstream securities with credit/debit card, PayPal, and USD along with USDC digital currency. The recent blog explains that a spinoff is when a parent company creates a new company then distributes shares in that subsidiary or business division to current shareholders.

Shareholders wanting to participate in the spinoff can download Upstream from either the Google or Apple app store, then sign up. They must complete KYC identity verification before the established distribution date, then after they have received brokerage statements confirming their shareholding by the record date, they can request their share distribution and verify their shareholding. That request can be made on the Upstream app. "Once the parent company has completed their regulatory approvals in their primary market or jurisdiction, the parent company will set a record date where all parent company shareholders as of that set record date (i.e., shares purchased and held two days or more prior to the record date) will be entitled to receive an equal proportion of shares in the spinoff company," states the blog. "Upstream is thrilled to support spinoff share distributions for our forward-thinking issuers."

To view the full blog, visit https://ibn.fm/VOx04

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 Blog Defines Spinoff Share Distributions, Walks Shareholders Through Participation Process
• InvestorNewsBreaks – Upstream Blog Points Out Benefits of Adding NFTs to More Traditional Customer/Fan Rewards Programs
• InvestorNewsBreaks – Upstream Announces Enhanced Geofenced NFT Feature Now Available

CNS Pharmaceuticals Inc. (NASDAQ: CNSP)

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

University of California Los Angeles (UCLA) scientists have published research findings that could provide deeper insight into why some types of brain tumors respond to immunotherapy while others don't. While many types of brain tumors typically respond to immunotherapy, an aggressive type of brain cancer called glioblastoma is quite difficult to treat even with immunotherapy. Immunotherapy is a type of cancer treatment that essentially trains the immune system to identify and kill cancer cells, making them more effective at destroying tumors. Glioblastomas start growing from cells in the spinal cord or brain called astrocytes and quickly invade the rest of the brain, destroying healthy tissue and causing symptoms such as seizures, memory problems, muscle weakness and speech problems. Researchers from UCLA set out to find out why glioblastomas are so hard to treat with immunotherapy even though other types of brain cancers typically respond to the treatment. Senior study author and UCLA David Geffen School of Medicine professor of molecular and medical pharmacology and neurosurgery Dr. Robert Prins says the researchers were keen on understanding the underlying antitumor immune responses in cancers that respond to immunotherapy. They would then contrast these antitumor responses to the responses seen in brain tumors such as glioblastoma that originate from the brain and are hard to treat. As brain cancer is kept under the spotlight by numerous entities such as CNS Pharmaceuticals Inc. (NASDAQ: CNSP), a time could come when some of the most hard-to-treat malignancies can be treated effectively.

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 $1.45, off by 2.027%, on 35,781 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.6105/$8.64.

Recent News

• CNS Pharmaceuticals Inc. (NASDAQ: CNSP) - Study Shares Insights on Why Brain Tumors Are Unresponsive to Immunotherapy
• CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Looking Forward to Upcoming Interim Results for Potentially Pivotal GBM Study
• InvestorNewsBreaks - CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Announces 200-Patient Enrollment Milestone in Potentially Pivotal Berubicin Study

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

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

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company formerly known as BiondVax Pharmaceuticals Ltd., today announced that its CEO Amir Reichman and Chairman of the Board Mark Germain will be attending the H.C. Wainwright 25th Annual Global Investment Conference in New York today and tomorrow (Sept. 11 and 12) and the LSX USA Congress 2023 in Boston this Wednesday and Thursday (Sept. 13 and 14). Investors and potential business partners interested in meeting with Reichman and Germain are invited to contact Scinai investor relations at ir@scinai.com to request a meeting. In addition, members of Scinai's senior leadership team will be attending the CPHI Barcelona conference taking place in October. A listing of events that Scinai plans to attend is available on Scinai's new website.

To view the full press release, visit https://ibn.fm/3dyxW

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 $1.3001, off by 1.1331%, on 15,295 volume. The average volume for the last 3 months is 26,181 and the stock's 52-week low/high is $1.24/$11.80.

Recent News

• Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) - InvestorNewsBreaks - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Announces Participation in H.C. Wainwright, LSX USA Congress 2023 and Upcoming Conferences
• InvestorNewsBreaks - BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) Rebrands as Scinai Immunotherapeutics Ltd.
• BioMedNewsBreaks - BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) Positioned Favorably with Worldwide License to Anti-IL-17 NanoAbs

RVL Pharmaceuticals plc (NASDAQ: RVLP)

The QualityStocks Daily Newsletter would like to spotlight RVL Pharmaceuticals plc (NASDAQ: RVLP).

RVL Pharmaceuticals' CEO Brian Markison and COO JD Schaub will participate in a fireside chat and 1-on-1 investor meetings on Tuesday, September 12, 2023, during this year's H.C. Wainwright Annual Global Investment Conference in New York City

The company will discuss UPNEEQ(R) and its use as the first non-surgical treatment option approved by the FDA for acquired blepharoptosis

RVL Pharmaceuticals plans to continue marketing to medical aesthetics providers and will launch a direct-to-consumer campaign later this year

The medical aesthetics market was valued at $13.9 billion in 2022 and is expected to reach $23.4 billion by 2027

RVL Pharmaceuticals (NASDAQ: RVLP), a specialty pharmaceutical company, recently announced that its CEO Brian Markison will be participating in a fireside chat and hosting 1-on-1 investor meetings during the H.C. Wainwright 25th Annual Global Investment Conference in New York City on Tuesday, September 12, 2023. Mr. Markison will be discussing the company and its commercialization of UPNEEQ(R) (oxymetazoline hydrochloride ophthalmic solution), 0.1%, which is available by prescription for the treatment of acquired blepharoptosis, also known as ptosis or low-lying eyelid(s), in adults (https://ibn.fm/097y6).

RVL Pharmaceuticals plc (NASDAQ: RVLP) is a specialty pharmaceutical company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, which is available by prescription for the treatment of acquired blepharoptosis, or low-lying eyelid(s), in adults.

UPNEEQ® (RVL-1201) is the first non-surgical treatment option approved by the U.S. Food and Drug Administration (FDA) for acquired blepharoptosis. The company received FDA approval in July 2020 and launched UPNEEQ® in September 2020 to a limited number of eye care professionals, with commercial operations expanded in 2021 among ophthalmology, optometry, and oculoplastic specialties.

In February 2022, UPNEEQ® was launched into the medical aesthetics market in the United States. Patients can purchase UPNEEQ® from eye care or medical aesthetic professionals, or through RVL Pharmacy LLC, the company’s wholly owned pharmacy. The company plans to promote UPNEEQ® to people with acquired ptosis and those who are bothered by low-lying lids. RVL Pharmaceuticals believes there is a significant commercial opportunity for UPNEEQ®, given the meaningful unmet need for a non-invasive treatment across millions of acquired-ptosis patients in the United States. The company’s near-term focus is to continue the rollout of UPNEEQ® into the medical aesthetics market through its dedicated aesthetics sales force while continuing to support ongoing utilization and expanded penetration of UPNEEQ® in ocular medicine markets.

RVL Pharmaceuticals continues to raise patient and physician awareness of acquired ptosis and UPNEEQ® through medical conferences, HCP and DTC advertising, social media (e.g., Facebook and Instagram), and marketing partnerships.

The company is incorporated in Ireland and headquartered in Bridgewater, New Jersey.

UPNEEQ®

UPNEEQ® is an oxymetazoline hydrochloride ophthalmic solution for the treatment of acquired blepharoptosis, or low-lying eyelid(s), in adults. It is the first and only FDA-approved ophthalmic solution for this indication.

The once-daily UPNEEQ® eye drop has been shown in clinical trials to result in an average one-millimeter lift of the upper eyelid, and to improve superior visual field in patients with a functional deficit. Patients’ eyelids demonstrate lift in as little as five minutes post dose, with the lift effect lasting as long as eight hours. The preservative-free solution is safe and well-tolerated. Trials demonstrated side effects similar to those of placebo.

The active ingredient in UPNEEQ® is oxymetazoline 0.1%, a direct-acting α-adrenergic receptor agonist that targets receptors in the Müller’s muscle, which causes the muscle to contract and lift the upper eyelid. UPNEEQ® delivers eye-opening results for patients along the entire spectrum of age and condition severity.

UPNEEQ’s health care provider customers include optometrists, ophthalmologists, oculoplastic surgeons, facial plastic surgeons, dermatologists and a broad range of practitioners qualified to diagnose and treat acquired blepharoptosis in adults.

The target patient population comprises adults with droopy or low-lying eyelids, the majority of whom are female. While the exact prevalence of acquired ptosis is unknown, RVL Pharmaceuticals believes it to be a common age-related condition.

Market Opportunity

A survey of eye care providers and medical aesthetics specialists revealed that they believe that approximately half of adult patients visiting their practices are affected by droopy or low-lying eyelids. Further, the company estimates that approximately 60% of adult women self-identify as having some degree of droopy or low-lying eyelids, and a majority of those women indicate that they are bothered by the position of their eyelids.

The global medical aesthetics market is expected to reach a value of $18 billion in 2027, rising at a compound annual growth rate of over 10%, with North America representing the largest share of the global market. Similarly, the global eye care market is expected to reach a value of $86 billion by 2026, rising at a compound annual growth rate of over 6%. An estimated 100 million adults visit an eye care provider each year in the United States alone.

RVL Pharmaceuticals believes the growth in medical aesthetics and eye care markets will be driven by an aging population and increasing life expectancy, which is resulting in more consumers with a desire for improved appearance and well-being over a longer period of time. Other contributing factors include rising disposable income globally and in the U.S.; growing awareness, utilization, and acceptance of elective or minimally invasive and non-invasive interventions; and continued innovation and improved accessibility to treatments due to an increase in the number of physicians who offer eye care and medical aesthetics services.

Management Team

Brian Markison is Chairman of the Board and Chief Executive Officer of RVL Pharmaceuticals. He has more than 30 years of operational, marketing, commercial development, and sales experience with international pharmaceutical companies. He previously served as the President and CEO of Fougera Pharmaceuticals Inc., a specialty pharmaceutical company. Before that he was Chairman and CEO of King Pharmaceuticals Inc. He also held various senior leadership positions at Bristol-Myers Squibb. He received a bachelor’s degree from Iona College.

James Schaub is Executive Vice President and Chief Operating Officer of RVL Pharmaceuticals. Prior to that he served as COO of Trigen Laboratories. He previously was Vice President, M&A of Fougera Pharmaceuticals. Before that he spent five years with King Pharmaceuticals. Mr. Schaub holds a bachelor’s degree in economics from Middlebury College and an M.B.A. from Rutgers Business School.

RVL Pharmaceuticals plc (NASDAQ: RVLP), closed Monday's trading session at $0.1047, off by 2.6047%, on 3,369,991 volume. The average volume for the last 3 months is 1.747M and the stock's 52-week low/high is $0.0929/$2.99.

Recent News

• RVL Pharmaceuticals plc (NASDAQ: RVLP) - RVL Pharmaceuticals plc (NASDAQ: RVLP) to Attend H.C. Wainwright 25th Annual Global Investment Conference and Discuss UPNEEQ(R) for Treating Acquired Blepharoptosis
• BioMedNewsBreaks - Why RVL Pharmaceuticals plc (NASDAQ: RVLP) Is 'One to Watch'
• InvestorNewsBreaks - RVL Pharmaceuticals plc (NASDAQ: RVLP) Announces Participation at Upcoming H.C. Wainwright Global Investment Conference

PaxMedica Inc. (NASDAQ: PXMD)

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

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

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

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

The company is headquartered in Tarrytown, New York.

Product Pipeline

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

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

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

Market Opportunity

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

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

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

Management Team

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

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

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

PaxMedica Inc. (NASDAQ: PXMD), closed Monday's trading session at $0.2822, off by 12.3602%, on 318,735 volume. The average volume for the last 3 months is 742,022 and the stock's 52-week low/high is $0.272/$5.47.

Recent News

• PaxMedica Inc. (NASDAQ: PXMD) - PaxMedica to Present at the H.C. Wainwright 25th Annual Global Investment Conference
• PaxMedica Appoints David Hough M.D. as Chief Medical Officer
• PaxMedica, Inc. Announces Second Quarter 2023 Financial Results and Business Update