SolarBank Corp. (Cboe CA: SUNN) (FSE: GY2) (NASDAQ: SUUN)

The QualityStocks Daily Newsletter would like to spotlight SolarBank Corp. (Cboe CA: SUNN) (FSE: GY2) (NASDAQ: SUUN).

A few weeks ago, the European Commission introduced measures aimed at streamlining and simplifying sustainability reporting for businesses. The measures housed under the Omnibus package address key regulatory frameworks, including the Corporate Sustainability Due Diligence Directive (CSDDD), the Corporate Sustainability Reporting Directive (CSRD), the EU Taxonomy and the Carbon Border Adjustment Mechanism (CBAM). Below, we explore some of the key changes proposed in this package. While the Omnibus package introduces significant changes, it hasn't yet been implemented. The Council and Parliament are currently reviewing these proposals and hold the authority to amend the proposals before adoption. Major players like SolarBank Corp. (NASDAQ: SUUN) (CSE: SUNN) focused on leveraging the energy transition to give their stockholders decent returns on investment are likely to study the Omnibus Package and assess how it could impact their participation in the EU market for green energy products and services.

SolarBank Corporation (NASDAQ: SUUN) (CSE: SUNN) is a premier developer and owner of renewable and clean energy projects, specializing in distributed and community solar initiatives throughout Canada and the United States. The company is committed to advancing the transition to sustainable energy by offering end-to-end services that include project origination, financing structuring, engineering, procurement, construction, and long-term operations and maintenance. SolarBank focuses on delivering innovative energy solutions through solar photovoltaic systems, battery energy storage systems (BESS), and electric vehicle (EV) charging infrastructure.

With a vision to provide scalable and reliable clean energy solutions, SolarBank has established itself as a leader in the renewable energy market by cultivating partnerships with utilities, commercial and industrial entities, municipalities, and residential customers. Its vertically integrated business model allows for optimized efficiency, cost management, and returns across diverse markets in North America. This end-to-end approach ensures greater control over project quality, costs, and operational outcomes, strengthening its competitive position.

Driven by a mission to create a greener future, SolarBank manages a robust portfolio of projects, including more than 100 megawatts (MW) of developed capacity and a pipeline exceeding one gigawatt (GW). The company’s commitment to sustainability and innovation makes it a recognized player in the renewable energy sector.

SolarBank has offices in Toronto, Ontario and New York.

Projects

SolarBank boasts an impressive and diverse portfolio of renewable energy initiatives that underline its leadership in the clean energy space. In the U.S., the company has over 250 MW of solar projects under development, principally in New York, focusing on community solar farms and commercial and industrial installations. Notably, SolarBank is developing several community solar projects in upstate New York, which will deliver clean energy to local residents and small businesses. Community solar projects, which are a cornerstone of SolarBank’s portfolio, provide scalable solutions for renters, homeowners, and small businesses to access affordable renewable energy, driving localized energy independence and economic savings.

In Canada, SolarBank has been a significant participant in Ontario’s Feed-in-Tariff program, where it has secured contracts for close to 200 MW of capacity. Its current management includes 70 solar power projects, totaling 28.8 MW of operational solar assets. The company’s expertise extends to the development and ownership of battery energy storage systems and EV charging stations, further diversifying its portfolio.

The company’s vertically integrated approach spans the entire project lifecycle, from initial site acquisition and grid interconnection to long-term operation and maintenance services. This ensures seamless execution and high-quality outcomes, providing value to stakeholders and supporting the transition to a clean energy future.

Market Opportunity

SolarBank operates within a growing renewable energy market driven by global demand for sustainable power solutions. In North America, favorable policies such as the Inflation Reduction Act in the United States and Canada’s investments in green technologies provide a robust foundation for renewable energy adoption. Solar PV installations and battery energy storage systems are at the forefront of this expansion, addressing energy reliability and grid stability while reducing carbon emissions.

The North American solar PV market was valued at $25.02 billion in 2019 and is projected to reach $120.74 billion by 2027, growing at a compound annual growth rate (CAGR) of 21.7% from 2020 to 2027. Likewise, the global BESS market is expected to expand from $7.8 billion in 2024 to $25.6 billion by 2029, at a CAGR of 26.9%, as reported by MarketsandMarkets. These trends are driven by the increasing integration of renewable energy sources, the need for grid resilience, and declining technology costs.

SolarBank’s operations have it well-positioned to capitalize on these opportunities. With a development pipeline exceeding one gigawatt (GW), the company is focused on meeting growing demand in community and commercial solar sectors. Decentralized energy solutions, such as virtual net metering and behind-the-meter systems, further enhance SolarBank’s market potential by addressing the critical need for flexible, cost-effective, and sustainable energy infrastructure. By leveraging its vertically integrated model and diversified portfolio, SolarBank stands as a key player in driving the renewable energy transition.

Leadership Team

Dr. Richard Lu, MD, MSc., MHSc., MBA, serves as President and CEO of SolarBank, bringing over 25 years of global energy experience. His leadership has been instrumental in advancing the company’s strategic initiatives across North America, Europe, and Asia, with a focus on renewable energy development and operational excellence.

Sam Sun, MBA, is the Chief Financial Officer of SolarBank. A Chartered Professional Accountant with more than 15 years of expertise in corporate finance, Mr. Sun has overseen financial strategies and internal controls across the cleantech, manufacturing, and mining sectors in Canada, the U.S., and China.

Andrew van Doorn, PE, serves as Chief Operating Officer, with nearly three decades of experience in engineering and construction. Mr. van Doorn has successfully led projects totaling over 200 MW of solar capacity and is a former Chairman of the Canadian Solar Industries Association.

Tracy Zheng, MBA, Chief Development Officer, has over 25 years of experience in brand marketing, business development, and solar project operations. She has spearheaded sales initiatives, conducted feasibility studies, and negotiated key partnerships that drive SolarBank’s growth.

Matt Wayrynen, Executive Chairman and Director, has a background in resource company management, venture capital, and mergers and acquisitions. Under his leadership, Solar Flow-Through Funds, where Mr. Wayrynen acted as CEO, was acquired by SolarBank, enhancing its asset portfolio and growth prospects.

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Forward Looking Statements

This report contains forward-looking statements and forward-looking information ‎within the meaning of Canadian securities legislation (collectively, “forward-looking ‎statements”) that relate to the Company’s current expectations and views of future events. ‎Any statements that express, or involve discussions as to, expectations, beliefs, plans, ‎objectives, assumptions or future events or performance (often, but not always, through the ‎use of words or phrases such as “will likely result”, “are expected to”, “expects”, “will ‎continue”, “is anticipated”, “anticipates”, “believes”, “estimated”, “intends”, “plans”, “forecast”, ‎‎”projection”, “strategy”, “objective” and “outlook”) are not historical facts and may be ‎forward-looking statements and may involve estimates, assumptions and uncertainties ‎which could cause actual results or outcomes to differ materially from those expressed in ‎such forward-looking statements. In particular and without limitation, this report ‎contains forward-looking statements pertaining to the Company’s expectations regarding its industry trends and overall market growth of the data center market; the Company’s expansion into the data center market, including its pursuit of opportunities as a developer, owner, and strategic partner in data center infrastructure; supporting the demand for high-performance, sustainable energy solutions within the sector; details of the company’s business plan including development of solar power projects, battery storage projects and EV charging projects; the completion of any contracts for, or construction of, any data center, solar power, battery storage or EV projects; the receipt of interconnection approval, permits and financing to be able to construct projects; the receipt of incentives for projects; and the size of the Company’s development pipeline. No assurance ‎can be given that these expectations will prove to be correct and such forward-looking ‎statements included in this report should not be unduly relied upon. These ‎statements speak only as of the date of this report.‎

Forward-looking statements are based on certain assumptions and analyses made by the Company in light of the experience and perception of historical trends, current conditions and expected future developments and other factors it believes are appropriate, and are subject to risks and uncertainties. In making the forward looking statements included in this report, the Company has made various material assumptions, including but not limited to: obtaining the necessary regulatory approvals; that regulatory requirements will be maintained; general business and economic conditions; the Company’s ability to successfully execute its plans and intentions; the availability of financing on reasonable terms; the Company’s ability to attract and retain skilled staff; market competition; the products and services offered by the Company’s competitors; that the Company’s current good relationships with its service providers and other third parties will be maintained; and government subsidies and funding for renewable energy will continue as currently contemplated. Although the Company believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and the Company cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements.

Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Forward-‎Looking Statements” and “Risk ‎Factors” in the Company’s most recently completed Annual Information Form, and other public filings of the Company, which include: the Company may be adversely affected by volatile solar power market and industry conditions; the execution of the Company’s growth strategy depends upon the continued availability of third-party financing arrangements; the Company’s future success depends partly on its ability to expand the pipeline of its energy business in several key markets; governments may revise, reduce or eliminate incentives and policy support schemes for solar and battery storage power; general global economic conditions may have an adverse impact on our operating performance and results of operations; the Company’s project development and construction activities may not be successful; developing and operating solar projects exposes the Company to various risks; the Company faces a number of risks involving Power Purchase Agreements (“PPAs”) and project-level financing arrangements; any changes to the laws, regulations and policies that the Company is subject to may present technical, regulatory and economic barriers to the purchase and use of solar power; the markets in which the Company competes are highly competitive and evolving quickly; an anti-circumvention investigation could adversely affect the Company by potentially raising the prices of key supplies for the construction of solar power projects; foreign exchange rate fluctuations; a change in the Company’s effective tax rate can have a significant adverse impact on its business; seasonal variations in demand linked to construction cycles and weather conditions may influence the Company’s results of operations; the Company may be unable to generate sufficient cash flows or have access to external financing; the Company may incur substantial additional indebtedness in the future; the Company is subject to risks from supply chain issues; risks related to inflation; unexpected warranty expenses that may not be adequately covered by the Company’s insurance policies; if the Company is unable to attract and retain key personnel, it may not be able to compete effectively in the renewable energy market; there are a limited number of purchasers of utility-scale quantities of electricity; compliance with environmental laws and regulations can be expensive; corporate responsibility may adversely impose additional costs; the future impact of any resurgence of COVID-19 on the Company is unknown at this time; the Company has limited insurance coverage; the Company will be reliant on information technology systems and may be subject to damaging cyberattacks; the Company may become subject to litigation; there is no guarantee on how the Company will use its available funds; the Company will continue to sell securities for cash to fund operations, capital expansion, mergers and acquisitions that will dilute the current shareholders; and future dilution as a result of financings.

The Company undertakes no obligation to update or revise any ‎forward-looking statements, whether as a result of new information, future events or ‎otherwise, except as may be required by law. New factors emerge from time to time, and it ‎is not possible for the Company to predict all of them, or assess the impact of each such ‎factor or the extent to which any factor, or combination of factors, may cause results to ‎differ materially from those contained in any forward-looking statement. Any forward-‎looking statements contained in this report are expressly qualified in their entirety by ‎this cautionary statement.‎

SolarBank Corp. (NASDAQ: SUUN), closed Thursday's trading session at $4.45, up 0.4514673%, on 5,111 volume. The average volume for the last 3 months is 223,168 and the stock's 52-week low/high is $1.95/$7.5.

Recent News

• SolarBank Corp. (Cboe CA: SUNN) (FSE: GY2) (NASDAQ: SUUN) - Trump Administration Halts EV Adoption by the Federal Government
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• GreenEnergyBreaks - SolarBank Corp. (NASDAQ: SUUN) (Cboe CA: SUNN) (FSE: GY2) Moves Forward with Silver Springs Solar Project After Key Approval 

Thumzup Media Corp. (NASDAQ: TZUP)

The QualityStocks Daily Newsletter would like to spotlight Thumzup Media Corp.(NASDAQ: TZUP).

Thumzup (NASDAQ: TZUP) , a growing force in social media branding and programmatic marketing, announced the repurchase of $126,507 of its common stock as part of its previously approved $1 million buyback program. The company views the repurchase as a strategic move to enhance shareholder value and reinforce confidence in its growth trajectory. CEO Robert Steele highlighted the buyback as a demonstration of Thumzup's commitment to capital efficiency and long-term value creation. The company has also reported surpassing 700 advertisers on its platform, with a compound annual growth rate exceeding 200%.

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

Thumzup Media Corp. (NASDAQ: TZUP) is at the forefront of modernizing the social media branding and marketing industry with its unique platform designed to connect advertisers directly with everyday social media users. The company’s mission is to empower individuals by turning their authentic social media activity into a monetizable asset while providing brands with cost-effective and impactful advertising solutions.

Through its flagship Thumzup platform, the company offers a seamless system where users post about participating advertisers and receive cash payments via Venmo or PayPal. Thumzup recently announced plans to integrate bitcoin as an additional payment option, expanding accessibility for gig economy workers.

By prioritizing accessibility and transparency, Thumzup is redefining traditional marketing strategies with an inclusive, user-driven approach. It is leveraging its scalable technology to disrupt the status quo, offering a win-win ecosystem for advertisers and users alike.

The company is headquartered in Los Angeles, California.

Products

Thumzup’s key offering, the Thumzup platform, features two integrated components: a sophisticated advertiser dashboard and an intuitive consumer-facing app. The advertiser dashboard provides companies with tools to design, manage, and analyze campaigns.

On the consumer side, the Thumzup app allows users to participate in campaigns by posting approved content to their social media accounts. In exchange, users receive direct cash rewards.

Recent enhancements to the platform include the launch of video capabilities, enabling integration with Instagram Reels. This update allows advertisers to tap into the growing popularity of short-form video content, broadening campaign possibilities.

The platform not only incentivizes users but also delivers authentic, relatable content for advertisers, bridging the gap between grassroots engagement and effective campaign management.

Market Opportunity

The global social media advertising market is projected to reach $219.8 billion in 2024, with an expected annual growth rate of 3.86%, resulting in a market volume of $255.8 billion by 2028, according to Statista. Thumzup targets the intersection of this growth with the rise of micro-influencers and everyday social media users, a segment that remains largely untapped in the advertising ecosystem.

In October 2024, Thumzup achieved 202% year-over-year growth in advertisers on its proprietary platform, demonstrating significant traction and scalability. With plans for further expansion in both advertiser partnerships and user engagement, the company is well-positioned to capitalize on the growing demand for authentic and trust-building marketing strategies. As Thumzup integrates innovative features like video support and continues its geographic expansion, it is poised to capture a larger share of the rapidly growing social media advertising market.

Leadership Team

Robert Steele, Founder and Chief Executive Officer of Thumzup, has over 25 years of experience as a technologist and entrepreneur. He has successfully launched multiple companies, including iBrite, a pioneer in mobile software development. Mr. Steele’s leadership and innovative vision drive Thumzup’s mission to democratize the social media marketing industry.

Robert Haag, Director of Thumzup, is the Managing Member of Westside Strategic Partners LLC and a Managing Director at IRTH Communications. With decades of experience in financial communications, investment, and corporate strategy, Mr. Haag provides critical guidance on strategic initiatives and business growth.

Dr. Joanna Massey, member of the company’s Board of Advisors, brings over 25 years of executive experience with Fortune 500 companies and startups to Thumzup. She has held senior roles in communications at Lions Gate Entertainment and CBS Corporation. Dr. Massey leverages her expertise to support Thumzup’s growth strategy.

Thumzup Media Corp. (NASDAQ: TZUP), closed Thursday's trading session at $3.95, up 8.8154%, on 907 volume. The average volume for the last 3 months is 100,129 and the stock's 52-week low/high is $2.02/$7.89.

Recent News

• Thumzup Media Corp. (NASDAQ: TZUP) - TechMediaBreaks - Thumzup Media Corp. (NASDAQ: TZUP) Repurchases $126,507 in Common Stock 
• TechMediaBreaks - Thumzup Media Corp. (NASDAQ: TZUP) Fuels Explosive Growth with Disruptive AdTech Platform
• Thumzup Media (NASDAQ: TZUP) Already Tops 700 Businesses Using New Social Media Marketing Solution

Massimo Group (NASDAQ: MAMO)

The QualityStocks Daily Newsletter would like to spotlight Massimo Group (NASDAQ: MAMO).

A recent report has revealed that Chinese automotive giant BYD is considering establishing an electric vehicle (EV) assembly plant in Germany. According to Reuters, the Shenzhen, Guangdong-based company is debating whether to construct a third new energy vehicle (NEV) plant in Europe. BYD is already building two NEV plants in Europe—one in Türkiye and the other in Hungary—as it works toward capturing a share of Europe's growing EV market. Executive vice president Stella Li was recently interviewed by Automobilwoche and noted that BYD was considering the construction of a third vehicle assembly plant to supply cars to the European market within two years. However, the BYD executive did not disclose where this third plant might be built. The vote was divisive. Germany, a major auto market in the EU, cautioned against imposing steep tariffs on Chinese EVs. Slovenia, Malta, Hungary, and Slovakia also voted against additional tariffs, while the Netherlands, Italy, Latvia, Poland, Bulgaria, France, Denmark, Ireland, Lithuania, and Estonia supported them. With the automotive sector rapidly evolving amid advances in the electric vehicle space and trade wars threatening to upend supply chains, entities like Massimo Group (NASDAQ: MAMO) may need to constantly revise their strategies as the realities on the ground change.

Massimo Group (NASDAQ: MAMO) is a prominent manufacturer and distributor specializing in powersports vehicles and recreational watercraft. Established in 2009, the company has built a reputation for delivering value-packed utility terrain vehicles (UTVs), all-terrain vehicles (ATVs), and on-road vehicles to both recreational enthusiasts and professionals in the agricultural sector. In 2020, Massimo expanded its offerings by launching Massimo Marine, dedicated to crafting high-quality watercraft with advanced designs and exceptional customer service.

Massimo Group is focused on sustainability. Its recent initiatives, including the introduction of the MVR Series of electric carts, highlight the company’s commitment to eco-friendly solutions that address growing consumer demand for sustainability in the powersports and marine industries.

The company’s manufacturing capabilities have also evolved significantly. Its expanded 376,000-square-foot facility in Garland, Texas, now features advanced automation, including a vehicle assembly robot line. This addition is expected to significantly enhanced production capacity and efficiency, enabling Massimo to scale its operations and better meet market demand.

Product Portfolio

Massimo Group’s product portfolio showcases its dedication to innovation and versatility. Its diverse lineup combines advanced features, sustainability, and value to meet the needs of a dynamic market.

• Massimo Motor: This category includes a wide range of UTVs, ATVs, go-karts, and mini-bikes designed for both recreational and practical applications. Notable recent additions include the T-Boss 1000 UTV, which combines rugged performance with advanced features, and the GKD 350 All-Terrain Go-Kart, a versatile two-seater ideal for various terrains. The Buck 550-6 Crew, a six-seater UTV, further expands this lineup, providing comfort and utility for families and light-duty users at an accessible price point.
• Massimo Marine: Specializing in pontoon and tritoon boats, this division emphasizes luxury and performance. A recent collaboration between Massimo and Vision Marine Technologies has introduced electric pontoon platforms, catering to consumers seeking eco-friendly watercraft for both commercial and recreational use.
• Massimo Electric: Reflecting the company’s commitment to sustainability, Massimo Electric focuses on low-speed electric vehicles (LSVs) tailored for diverse applications. Recent launches include the MVR 2X Golf Cart and MVR Cargo Max Utility Cart, which deliver advanced features and versatility for recreational users and professionals in industries like farming and groundskeeping.

By combining practicality with cutting-edge design, Massimo Group seeks to set the standard in the powersports and marine industries.

Market Opportunity

The global ATV and UTV market is experiencing robust growth, with North America projected to reach approximately $9.18 billion in 2024 and expand at a compound annual growth rate (CAGR) of 7.8% to $13.37 billion by 2029, according to Mordor Intelligence. Likewise, the U.S. electric UTV and ATV powertrain market is rapidly expanding. It was valued at $2.46 billion in 2022 and is expected to grow at a CAGR of 10.2%, reaching $5.18 billion by 2030, as reported by Grand View Research.

The pontoon boat market complements this growth, driven by increased interest in leisure and marine tourism. The market size exceeded $7.9 billion in 2022 and is projected to grow at a CAGR of 8.3% through 2032, according to Global Market Insights. Massimo Marine’s introduction of electric pontoon platforms through its Vision Marine partnership is expected to position the company to effectively address this growing market segment.

With strategic partnerships and an expanding dealer network, Massimo believes it is poised to penetrate deeper into domestic and international markets. The company’s service coverage currently includes over 2,800 retail locations, 600 motor service centers, and 5,500 marine service centers, ensuring robust support and accessibility for customers. This extensive distribution network underpins Massimo’s ability to capture market share and drive sustained growth.

Leadership Team

David Shan, Founder, Chairman, and CEO, established Massimo Motor in 2009 and Massimo Marine in 2020. He has led the company through significant growth phases, including the development of diverse product lines and its public listing. Shan holds a bachelor’s degree in international trade from Qingdao Ocean University of China.

Dr. Yunhao Chen, CPA, serves as the company’s Chief Financial Officer, bringing extensive experience in capital markets, financial reporting, and corporate governance since her appointment in May 2023. She holds a Ph.D. in Accounting and an MBA in Finance from the University of Minnesota.

Michael Smith, Vice President, joined Massimo in 2019 and played a pivotal role in launching Massimo Marine. With a strong background in powersports retail and product innovation, he is dedicated to driving new product development. Smith studied International Business and Marketing at the University of California, San Diego.

Massimo Group (NASDAQ: MAMO), closed Thursday's trading session at $2.8, up 0.3584229%, on 4,203 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $2.42/$4.66.

Recent News

• Massimo Group (NASDAQ: MAMO) - BYD Considers Establishing an EV Plant in Germany
• InvestorNewsBreaks - Massimo Group (NASDAQ: MAMO) Exemplifies Manufacturing Trend to Deliver Innovative Solutions from US Soil
• InvestorNewsBreaks - Massimo Group (NASDAQ: MAMO) Strengthens Retail Partnerships at Industry Events

Soligenix Inc. (NASDAQ: SNGX)

The QualityStocks Daily Newsletter would like to spotlight Soligenix Inc. (NASDAQ: SNGX).

New research that appeared in the journal Oncotarget has opened the door to a new way to approach the treatment of oral ulcers induced by chemotherapy. This debilitating and painful side effect of cancer treatment lowers the quality of life of patients undergoing chemotherapy, but oral mucositis remains an unmet medical need. The study was conducted by a joint team from the Center for Research in Physics in Brazil and others from Rio de Janeiro Federal University. The lead author was Ana Chor. They sought to examine how effective an electrospun poly membrane (PLGA) was in accelerating tissue regeneration in cases of chemotherapy-triggered oral mucositis. The researchers used an animal model featuring hamsters in their study. In contrast, the hamsters that only had PLGA membranes applied to their oral ulcers had a slower rate of healing. The membranes helped, but the lack of mesenchymal cells in the membranes denied these hamsters an element that would have boosted how quickly they healed. A lot more research needs to be done before these promising findings from an animal study can be translated into approved treatments for humans. As bioengineered materials are further studied to establish how they can be leveraged to treat chemotherapy-induced oral ulcers, other efforts are being undertaken by companies like Soligenix Inc. (NASDAQ: SNGX) to develop effective drugs for similar conditions.

Soligenix Inc. (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for rare diseases with high unmet medical needs. Operating through two key segments, the company’s Specialized BioTherapeutics division is dedicated to oncology and inflammation therapies, while its Public Health Solutions segment advances vaccines and therapeutics targeting biothreats and infectious diseases.

The company is actively advancing multiple late-stage clinical programs, including HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL). Additional candidates in development target psoriasis (SGX302), oral mucositis (SGX942), and Behçet’s disease (SGX945), while its public health efforts focus on heat-stable vaccines for ricin poisoning (RiVax®), Ebola (SuVax™), and Marburg (MarVax™) viruses, that have been supported by non-dilutive government grants and contracts of approximately $60 million to date.

With a diversified pipeline, multiple orphan and fast-track designations, and collaborations with government agencies, Soligenix is uniquely positioned for potential regulatory approvals and commercialization.

The company is headquartered in Princeton, New Jersey.

Pipeline and Development Programs

Specialized BioTherapeutics

Soligenix’s Specialized BioTherapeutics division develops treatments for oncology and inflammatory diseases, focusing on conditions with few or no effective therapeutic options. HyBryte™ (synthetic hypericin) has completed a Phase 3 study for CTCL, demonstrating statistically significant efficacy, and a second confirmatory Phase 3 trial is actively enrolling patients to support potential regulatory submissions worldwide. If approved, it would be the first non-mutagenic photodynamic therapy for early-stage CTCL, addressing an unmet medical need. It has received orphan drug designations in the U.S. and Europe, as well as Fast Track designation in the U.S.

SGX302, a photodynamic therapy based on the same active ingredient as HyBryte™, is in clinical development for mild-to-moderate psoriasis, with positive Phase 1/2 proof-of-concept results, it is actively enrolling patients in a Phase 2a clinical trial.

SGX942, designed to reduce inflammation and tissue damage in oral mucositis associated with cancer treatment, is progressing as a potential first-in-class therapy.
SGX945, targeting aphthous ulcers in Behçet’s disease, is actively enrolling in a Phase 2a clinical trial and has received fast-track designation, highlighting the urgency of developing effective treatments for this rare inflammatory condition.

Public Health Solutions

The company’s Public Health Solutions segment focuses on medical countermeasures for biothreats and emerging infectious diseases, leveraging non-dilutive government funding to advance its programs. RiVax®, a ricin toxin vaccine, has demonstrated strong preclinical and early clinical results and may be eligible for government procurement under the Strategic National Stockpile initiative.

The company’s RiVax®, as well as its vaccine candidates for Ebola and Marburg viruses are based on its proprietary ThermoVax® technology, which stabilizes vaccines for long-term storage without refrigeration. This approach could be transformative in regions where maintaining cold-chain logistics is challenging.

The ongoing development of these vaccines is supported by funding from NIH, BARDA, and DTRA, with the potential for up to three priority review vouchers (PRVs) upon regulatory approval, to be used for future programs or sold. Notably, PRVs have previously sold for roughly $100 million.

Market Opportunity

Soligenix targets markets with significant commercial potential, focusing on rare diseases and biodefense applications. HyBryte™ addresses CTCL, a disease affecting over 68,000 patients across the U.S. and Europe, with a total market opportunity exceeding $250 million. SGX302, the company’s therapy for mild-to-moderate psoriasis, serves a much larger population, as over eight million people in the U.S. are affected by the condition, representing a global market opportunity exceeding $1 billion.

SGX942, developed for oral mucositis in head and neck cancer patients, is aimed at a market worth more than $500 million, while SGX945 for Behçet’s disease serves a niche segment valued at over $200 million worldwide.

In addition to its rare disease programs, Soligenix’s Public Health Solutions division has the potential to generate significant revenue through government procurement contracts. By focusing on both orphan drug markets and government-funded biodefense initiatives, Soligenix has positioned itself for sustained revenue growth through multiple high-value opportunities.

Leadership Team

Christopher J. Schaber, PhD, Chairman, President & CEO, brings to the company more than 35 years of experience in the biopharmaceutical industry. Before joining Soligenix, he held senior and operational leadership roles at Discovery Laboratories, Acute Therapeutics, Ohmeda Pharmaceuticals, The Liposome Company, and Wyeth Ayerst Laboratories. He has extensive expertise in drug development, regulatory affairs, and corporate strategy, positioning him to drive Soligenix’s growth and advancement toward commercialization.

Richard Straube, MD, Chief Medical Officer, has more than 35 years of experience in drug development and clinical research. Prior to joining Soligenix, he held key leadership roles at Stealth Peptides, INO Therapeutics, Ohmeda Pharmaceuticals, and Centocor. Throughout his career, he has played a crucial role in bringing innovative therapies to market, particularly in inflammatory diseases and immunology, making him a valuable asset in advancing Soligenix’s late-stage clinical programs.

Oreola Donini, PhD, Chief Scientific Officer, has more than 20 years of experience in pharmaceutical research and development, with expertise in immunology, inflammation, and rare diseases. Before joining Soligenix, she held leadership positions at Inimex Pharmaceuticals, ESSA Pharma, and Kinetek Pharmaceuticals, where she worked on novel drug discovery and translational medicine. Her experience in preclinical research and product development supports Soligenix’s continued innovation in biopharmaceuticals.

Jonathan Guarino, CPA, CGMA, Chief Financial Officer, has over 25 years of experience in corporate finance and strategic financial planning. Before joining Soligenix, he held financial leadership positions at Hepion Pharmaceuticals, Covance, BlackRock, and Barnes & Noble. His expertise in financial management, accounting, and capital markets plays a critical role in Soligenix’s financial strategy and operational efficiency.

Soligenix Inc. (NASDAQ: SNGX), closed Thursday's trading session at $2.38, up 2.1459%, on 38,622 volume. The average volume for the last 3 months is 26,324 and the stock's 52-week low/high is $1.8301/$14.9184.

Recent News

• Soligenix Inc. (NASDAQ: SNGX) - Study Shows Bioengineered Materials Can Treat Oral Mucositis
• BioMedNewsBreaks — Why Soligenix Inc. (NASDAQ: SNGX) Is ‘One to Watch’
• Soligenix Inc. (NASDAQ: SNGX) Is 'One to Watch'

Energy and Water Development Corp. (OTCQB: EAWD)

The QualityStocks Daily Newsletter would like to spotlightFathom Energy and Water Development Corp. (OTCQB: EAWD) .

The European Union (EU) is becoming increasingly reliant on wind energy as it transitions from fossil fuels to cleaner energy sources. Like solar power, wind energy has taken center stage as one of the primary renewable alternatives to fossil fuels such as oil, coal, and natural gas, thanks to its abundance across the EU. Wind energy is virtually inexhaustible and can be generated through both onshore and offshore farms, making it a viable option even for countries with limited available land. As a result, many EU nations are prioritizing wind power—whether onshore, offshore, or both—as a key component of their clean energy transition. Thanks to the 2022 REPowerEU Plan and its impact on green energy investments, the EU's newly installed solar and wind capacity reached 78 GW last year. As a result, the bloc generated a record 48% of its electricity from renewables in 2024, up from 45% in 2023 and 41% in 2022. As firms like Energy and Water Development Corp. (OTCQB: EAWD) continue to bring innovative solutions to major markets, the energy transition could happen a lot faster than initially anticipated.

Energy and Water Development Corp. (OTCQB: EAWD) is a green-tech engineering solutions company focused on delivering water and energy to extreme environments. The company builds water and energy systems out of already existing, proven technologies, utilizing its patent-pending systems configuration and technical know-how to customize solutions to meet clients’ needs. To date, two water systems have been sold and deployed in Mexico and Germany, and the company is working to fulfill additional orders.

Using its patent-pending design, EAWD is working to build and operate off-grid EV charging stations in Germany. The company is a United Nations-accredited vendor and offers design, construction, maintenance and specialty consulting services to private companies, government entities and non-government organizations for the sustainable supply of energy and water.

EAWD focuses on three main aspects of the water and energy business: (1) generation, (2) supply and (3) maintenance. The green tech industry is constantly evolving due to ongoing and increasing water scarcity, as well as increased energy needs in the world. Therefore, the company believes that by designing sustainable and renewable solutions to these problems, EAWD will become an essential component of a rapidly growing industry with many new markets.

EAWD’s approach seeks to assist businesses with the growth and development of their general operations by ensuring the efficient, profitable and sustainable supply and generation of water and energy, allowing its potential customers to focus on their business while adopting strategies of sustainability.

By using the state-of-the-art technological solutions and technologies identified, designed and provided by EAWD and its collaborators, the company believes that its potential clients will be free to focus on the performance of their operations, as well as with the water and energy consumption or generation regulations within their industries.

EAWD is headquartered in Saint Petersburg, Florida, with operations in Germany and Mexico.

Products

In view of the increased worldwide demand for water and energy, EAWD’s business goals are focused on self-sufficient energy-supplied water generation and green energy production. To accomplish this, the company set out to establish an outsourcing green tech platform to commercialize its state-of-the-art technologies while providing engineering and technical consultation services to design the most sustainable technological solutions that can provide water and energy.

The company has sought potential collaboration with green tech research and development centers in Europe and has established its operating subsidiaries in Hamburg, Germany, where EAWD has started to assemble its patent-pending innovative off-grid, self-sufficient energy supply atmosphere water generation (AWG) systems.

EAWD Deutschland and EAWD Logistik operate in Hamburg, Germany, to meet the increasing demands of water and energy generation projects around the world, as well as to operate the solar-powered EAWD Off-Grid EV Charging Stations, EAWD’s newest product.

The company expects to offer sustainable added value to each project it takes on, while generating revenue from the sale of EAWD Off-Grid AWG Systems, EAWD Off-Grid EV Charging Stations, EAWD Off-Grid Power Systems and EAWD Off-Grid Water Purification Systems; royalties from the commercialization of energy and water in certain cases; and licensing of its innovated technologies, along with its engineering, technical consulting and project management services.

EAWD continues to be a development stage company. It presently assembles its EAWD Off-Grid AWG Systems and EAWD Off-Grid EV Charging Stations at its workshop in Germany and outsources most of its engineering and technical services, as well as services relating to the promotion, sale and distribution of its products.

Market Opportunity

According to a report by Allied Market Research, a global market research, consulting and advisory firm, the worldwide green technology and sustainability market was valued at $10.32 billion in 2020 and is projected to reach a value of $74.64 billion by 2030, growing at a CAGR of 21.9% during the forecast period.

A surge in environmental awareness and increasing concerns among organizations and individuals about climate change drive the growth of the market. Furthermore, an increase in consumer and industrial interest for the use of clean energy resources are among some of the major factors expected to boost growth of the market in the coming years, according to the report.

The expected rise in favorable government and private initiatives to tackle climate change and air pollution represent an opportunistic factor of the market. An increase in energy consumption and rise in greenhouse gas emissions are major factors that drive the development of green technology innovations, the report states.

Management Team

Irma Velazquez is CEO and Vice Chair at EAWD. She brings certified expertise in sustainable development and large-scale project management to the company. She formerly worked for United Nations agencies including the World Health Organization, Farmaciens Sans Frontieres, Red Cross and Crescent Societies, where she served in the positions of Information Technology Manager, Sustainable Development Manager, Programme Manager and Disaster and Crisis Management Coordinator. She has a master’s in sciences from the Erasmus University of Rotterdam. She speaks French, English and Spanish.

Ralph Hofmeier is Chief Technology Officer and Chairman at EAWD. He brings a mechanical engineering background to the company and previously served as President of Powermax Energy & Business Solutions Inc. When that company merged with EAWD, he served as President and CEO of Directors of EAWD. Over the last 20 years, he has established and developed several multinational companies in green tech distribution and commercialization. He speaks German and English.

Energy and Water Development Corp. (OTCQB: EAWD), closed Thursday's trading session at $0.0025, up 4.1667%, on 25,000 volume. The average volume for the last 3 months is 1,964,190 and the stock's 52-week low/high is $0.0012/$0.099.

Recent News

• Energy and Water Development Corp. (OTCQB: EAWD) - The EU is Increasingly Leaning on Wind Energy in its Energy Transition
• Courts are Holding More Firms Accountable as Greenwashing Incidents Increase
• Key Trends Driving the Renewable Energy Certificate Market

Adageis

The QualityStocks Daily Newsletter would like to spotlight Adageis

Adageis is surpassing its Q1 2025 growth targets, reflecting expanding market demand, with investment focused on team expansion, financial infrastructure, and AI development.

Adageis' patented AI-driven platform, already covering over 250,000 patient lives, optimizes quality healthcare for patients and revenue for healthcare providers.

The company projects 580,000 patient lives covered by the end of Q2 2025.

Adageis, a healthcare technology company reshaping patient care through flexible AI-centric software solutions for healthcare organizations, is set to exceed its Q1 2025 growth expectations as its AI-powered platform continues to gain traction in the healthcare sector. The company now covers more than 250,000 patient lives, a sharp increase from its previously reported 150,000. This growth highlights a rising demand for technology that helps providers successfully transition from fee-for-service models to value-based care.

Adageis is a healthcare technology company dedicated to revolutionizing patient care through innovative solutions. By integrating artificial intelligence (AI) and machine learning, Adageis addresses inefficiencies in healthcare delivery, enabling providers to enhance patient outcomes and streamline operations. The company focuses on leveraging advanced technology to meet the growing demand for value-based care and quality incentives in the healthcare sector.

With a commitment to innovation and practical solutions, Adageis empowers clinics, healthcare centers, and care networks to implement its ProActive Care Platform without the need for expensive platform changes or extensive staff training. This approach reduces barriers to adoption and helps healthcare organizations maximize their potential in an increasingly complex industry landscape.

Recent collaborations, including its partnership with HealthyU Clinics and integration with AthenaHealth as a marketplace partner, underscore Adageis’s industry relevance and adaptability.

Adageis is headquartered in Mesa, Arizona.

Services

Adageis offers the ProActive Care Platform, an AI-driven solution designed to integrate seamlessly with existing Electronic Medical Records (EMR) systems.

This platform enables healthcare providers to deliver patient-centric care while maximizing reimbursements from quality metrics and value-based contracts. Key features include:

• Predictive Analytics: Utilizes AI to analyze patient data, identifying high-risk individuals and care gaps to improve health outcomes and reduce costs.
• Efficiency and Cost Reduction: Continuously monitors patient health, allowing providers to offer proactive care even outside traditional office visits, thereby enhancing efficiency and lowering expenses.
• Flexible Integration: Compatible with various EMR systems, including AthenaHealth, Cerner, eClinicalWorks, Allscripts, and Epic, facilitating easy adoption without the need for extensive staff training or platform changes.

Market Opportunity

The global AI in healthcare market is experiencing rapid growth, driven by the increasing demand for enhanced efficiency, accuracy, and better patient outcomes. In 2023, the market was valued at approximately $19.27 billion by Grand View Research, and it is projected to grow at a compound annual growth rate of 38.5% from 2024 to 2030. This growth is fueled by the increasing need for solutions that can analyze large datasets, reduce costs, and improve care delivery across the healthcare continuum.

Adageis is well-positioned to capitalize on these trends. Its ProActive Care Platform offers AI-driven predictive analytics and proactive care solutions that align with the industry’s shift toward value-based care. By providing seamless integration with existing EMR systems and focusing on operational efficiency, Adageis enables healthcare providers to meet the demands of a rapidly evolving market.

Leadership Team

Shane Speirs, MD, MBA serves as the company’s CEO. He is a board-certified physician in family and geriatric medicine with extensive experience in healthcare leadership, data modeling, and AI applications in healthcare delivery. He holds an MBA in Healthcare Management from the W.P. Carey School of Business and has a proven track record in managing telehealth and AI-focused healthcare companies.

Bill Jentarra, MBA is the CTO of Adageis, bringing over 25 years of experience in architecting and implementing complex client relationship management (CRM) and business intelligence (BI) solutions across various industries, including healthcare. His expertise encompasses the entire lifecycle of CRM and BI projects, ensuring practical and cost-effective technology applications to solve complex business problems.

Recent News

• Adageis - Adageis on Track to Exceed Q1 Growth Target, Expanding Healthcare AI Platform
• InvestorNewsBreaks – Adageis Navigates Complexities of Value-Based Care with Tailored Solution
• InvestorNewsBreaks – Adageis’ AI-Driven Approach: A Game-Changer in Efficient, Patient-Centered Healthcare

Platinum Group Metals Ltd. (TSX: PTM) (NYSE American: PLG)

The QualityStocks Daily Newsletter would like to spotlight Platinum Group Metals Ltd. (TSX: PTM) (NYSE American: PLG).

Rare-earth elements (REEs) have dominated the news lately after the explosive meeting between President Trump and Ukraine's president Zelenskyy resulted in a minerals deal falling through between the two countries. However, America needs to be more concerned about expected supply shortages of copper. While copper mining has been going on for centuries, its demand has been surging. Consequently, the price of this metal has seen a nearly 75% uptick since 2020. The increased demand is partly due to efforts to switch to greener forms of energy as well as the electrification of vehicular transport. As the years drag by during the permitting process, the industries utilizing copper are ramping up their production. For example, an internal combustion engine vehicle requires just 25% of the copper needed in EV manufacturing. More EVs are being made, which is straining existing copper supplies. EVs also require charging infrastructure, which calls for more copper in upgrading grids. Urgent attention therefore needs to be directed towards finding all that extra copper that will be needed over the coming years and decades. Companies like Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) are working as best they can to develop new copper mines to address the surge in the demand for this metal around the world.

Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) is the operator of the Waterberg Project, a bulk underground platinum group metals (PGM) deposit discovered by Platinum Group in 2011 and located on the Northern Limb of the Bushveld Complex in South Africa. The Waterberg Project is planned as a fully mechanised platinum, palladium, rhodium and gold mine, including by-product copper and nickel production, and is projected to be one of the largest and lowest cost PGM mines globally.

The project is a joint venture between Platinum Group; integrated PGM producer Impala Platinum Holdings Ltd. (OTCQX: IMPUY); Japanese consortium HJ Platinum, which includes trading house Hanwa Co. and the government-backed Japan Organization for Metals and Energy Security (JOGMEC); and local empowerment partner Mnombo Wethu Consultants (Pty) Ltd. Platinum Group has an effective 50.22% interest in the Waterberg Project.

The company’s primary business objective is to advance the Waterberg Project to a development and construction decision. An update to the 2019 Definite Feasibility Study is expected in 2024.

PGMs are essential and precious metals that include platinum, palladium, rhodium, iridium, osmium and ruthenium. These metals are known for their purity, high melting points and unique catalytic properties. They are utilized in a number of industrial processes, technologies and commercial applications and play a critical role in autocatalysis and pollution control in the automotive sector. The bulk of global PGMs are mined in Southern Africa and Russia.

The unique properties of PGMs are being applied to various technologies as possible solutions for more efficient energy generation and storage, which may create new demand for PGMs. The company’s battery technology initiative through Lion Battery Technologies Inc., using platinum and palladium in lithium battery technologies, represents one such new opportunity in the high-profile lithium battery research and innovation field.

Platinum Group Metals Ltd. founded Lion Battery Technologies Inc. in partnership with Anglo American Platinum Ltd. (AMS: JNB) to support the use of palladium and platinum in lithium battery applications. Lion Battery has entered into an agreement with Florida International University to further advance a research program that uses platinum and palladium to unlock the potential of Lithium Sulfur (Li-S) battery chemistries.

Platinum Group is headquartered in Vancouver, B.C., and Johannesburg, South Africa.

Waterberg Project

Platinum Group’s sole material mineral property, the Waterberg Project, is presently in process with pre-construction permitting; engineering work, including road upgrade and traffic studies; finalization of power and water infrastructure design; and construction camp design.

The company’s principal product from the Waterberg Project is planned to be a PGM-bearing concentrate. The concentrate will contain economic amounts of six elements comprising platinum, palladium, rhodium, gold, copper and nickel. The company’s partner in the Waterberg Project, Impala Platinum Holdings, has acquired a right of first refusal to enter into an offtake agreement, on commercial arm’s-length terms, for the smelting and refining of mineral products from the Waterberg Project.

The Waterberg project has proven and estimated reserves of 19.5 million ounces of PGMs and gold. When fully operational, the mine is projected to produce more than 400,000 ounces of PGMs annually during the peak period of steady state production. The life of the mine is projected at 45 years.

South Africa’s PGM mining sector remains closely tied to economic developments in the global automotive industry, which in 2022 accounted for approximately 43% of the total global demand for platinum and 82% of the total global demand for palladium.

Market Opportunity

According to a report from Straits Research, a global market and business research firm, the worldwide platinum market had an estimated value of $7.72 billion in 2022 and is projected to reach $11.95 billion by 2031. That represents a CAGR of 5.13% over the forecast period.

Platinum, one of the rarest of precious metals, is about 30 times scarcer than gold. It is crucial to the automotive and electronics industries and is also used to make jewelry. Stricter emissions regulations around the world have led to an increased demand for platinum to be used in catalytic converters to reduce automotive emission, the report states.

A report from Allied Market Research estimated the global palladium market at $16.3 billion in 2021 and projects the market will reach $28.6 billion by 2031, growing at a CAGR of 5.8% over the period.

Palladium is also used in automotive catalytic converters for reducing emissions and in jewelry, dentistry, watchmaking, blood sugar test strips, aircraft spark plugs, surgical instruments, electrical contacts and musical instruments.

An increase in demand for consumer electronics has driven demand for palladium-based multilayer ceramic capacitors (MLCC) used to store energy in electronic devices such as broadcasting equipment, mobile telephones, computers, electronic lighting and high voltage circuits, according to the report.

Management Team

Frank R. Hallam is Co-Founder, Director, President and CEO of Platinum Group. He has over 30 years of experience in the mining, minerals and petroleum industry as an operator, principal and founder. He was a co-founder and former CFO of MAG Silver Corp. He was also co-founder and director of West Timmins Mining Inc. and a director of Lake Shore Gold Corp. In addition, he was CFO and director with gold exploration company Tan Range Exploration Corp. He is a Chartered Professional Accountant and was formerly an auditor in the public mining practice of PwC. He holds a Bachelor of Business Administration from Simon Fraser University.

Greg Blair is CFO of Platinum Group. He has been with Platinum Group since 2010 in various roles, most recently as Interim CFO. Prior to joining Platinum Group, he was at a public accounting firm working on public company (mainly mining) audits. He is a Chartered Professional Accountant and holds a degree in Economics from Simon Fraser University and has completed the Canadian Securities Course.

Kris Begic is VP Corporate Development of Platinum Group. He has over 25 years of experience in the mining industry and capital markets and has been involved with the raising of over $500 million for various exploration and development projects globally. His efforts are focused on project generation, mergers and acquisitions, capital markets, investor relations and marketing.

Platinum Group Metals Ltd. (NYSE American: PLG), closed Thursday's trading session at $1.31, even for the day, on 1,014 volume. The average volume for the last 3 months is 550,120 and the stock's 52-week low/high is $1.06/$2.27.

Recent News

• Platinum Group Metals Ltd. (TSX: PTM) (NYSE American: PLG) - Copper, Not REE Shortages Could Be a Bigger Threat to the US
• RockBreaks - Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) Poised for Growth Amid Potential 2X Price Surge
• Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) Looks to Benefit from Higher Palladium Price

D-Wave Quantum Inc. (NYSE: QBTS)

The QualityStocks Daily Newsletter would like to spotlight D-Wave Quantum Inc. (NYSE: QBTS).

Jensen Huang, Nvidia's CEO, will defend the company's dominance in the AI chip market amid growing concerns about costs during the upcoming firm's annual developer conference. As the industry leader in high-performance chips, Nvidia has benefited from the surge in AI demand, but competition and shifting market trends are putting pressure on its position. The conference follows a shake-up in the market caused by DeepSeek, which launched a chatbot that reportedly required less processing power than its competitors. DeepSeek's announcement rattled U.S. investors and contributed to a dip in Nvidia's stock. The company's business model relies on selling powerful chips, often priced at thousands of dollars each, a strategy that has driven its revenue to $130.5 billion over the last three years. In response, Google and Microsoft pushed back, claiming the technology is closer to viability. Nvidia has since decided to dedicate a day at the conference to talking about quantum developments and its role in the industry. Huang's keynote speech on Tuesday will also touch on Nvidia's push into CPUs for personal computers, signaling the company's ambition beyond AI chips. With other industry players like D-Wave Quantum Inc. (NYSE: QBTS) making strides in advancing quantum computing systems tailored to the specific needs of their customers, Nvidia could be given a run for its money in this segment.

D-Wave Quantum Inc. (NYSE: QBTS) is a leader in quantum computing systems, software and services focused on delivering customer value via practical quantum applications for problems such as logistics, artificial intelligence, materials sciences, drug discovery, scheduling, fault detection and financial modeling. As the only provider building both annealing and gate-model quantum computers, the company is unlocking commercial use cases in optimization today, while building the technologies that will enable new solutions tomorrow.

D-Wave is a pioneer in quantum computing, with a history of delivering the world’s first commercial quantum computer; the first real-time quantum cloud service; countless hardware and software product and research milestones; and the planned first cross-platform quantum solution which will deliver both annealing and gate-model quantum computers to customers via an integrated platform. Its current commercial product offerings include: Advantage™ (fifth generation quantum computer), Leap™ (quantum cloud service), Launch™ (quantum computing onboarding service) and Ocean™ (full suite of open-source programming tools).

D-Wave’s relentless pursuit of practical quantum computing has resulted in the technology being used today by some of the world’s most advanced enterprises – more than 25 of the Forbes Global 2000 use D-Wave.

D-Wave’s commercial customers include blue-chip industry leaders like Volkswagen, Accenture, BBVA, NEC Corporation, Save-On-Foods, DENSO and Lockheed Martin. The company boasts an extensive IP portfolio featuring more than 200 issued U.S. patents and over 100 peer-reviewed papers published in leading scientific journals.

Founded in 1999, D-Wave is the world’s first commercial supplier of quantum computers. With headquarters and the Quantum Engineering Center of Excellence based near Vancouver, Canada, D-Wave’s U.S. operations are based in Palo Alto, California.

Advantage™ Quantum Computer

 

With the Advantage™ Quantum Computer, D-Wave has incorporated two decades of experience and over 10 years of customer feedback to create the first and only quantum computer designed for business. The platform features a new processor architecture with over 5,000 qubits and 15-way qubit connectivity. This is 2.5x more connections and more than double the number of qubits than the company’s previous generation quantum computer.

D-Wave’s quantum computers, first located in its facilities in British Columbia, have been available to North American users through its Leap™ quantum cloud service since 2018. It has since introduced new Advantage systems in Julich, Germany, and most recently, Marina Del Rey, California, which marked the availability of the first Advantage quantum computer physically located in the United States.

That new deployment is part of the USC-Lockheed Martin Quantum Computing Center (QCC) hosted at USC’s Information Sciences Institute (ISI), a unit of the University of Southern California’s prestigious Viterbi School of Engineering. Additionally, Amazon Web Services (AWS) and D-Wave announced that the U.S.-based system is available for use in Amazon 2racket, expanding the number to three different D-Wave quantum systems available to AWS users.

Leap Quantum Cloud Service

 

D-Wave’s customers interface with its systems through the Leap™ quantum cloud service. Leap delivers immediate, real-time access to the company’s Advantage quantum computer and quantum hybrid solver service, all with enterprise-class performance and scalability.

Leap allows developers proficient in Python to get started building and running quantum applications. Through a seamless and secure cloud-based connection, users can easily start solving complex problems of up to 1 million variables and 100,000 constraints.

Using Leap, D-Wave customers have developed quantum hybrid applications for use cases in manufacturing, logistics, financial services, life sciences, materials science, retail and transportation. By eliminating the need to wait hours, days or weeks to get good answers to a broad array of problems, D-Wave is helping businesses move forward.

D-Wave Launch

D-Wave Launch™ is the company’s onboarding platform aimed at helping businesses easily start their quantum journey. Through this program, D-Wave’s team of experts and partners aid enterprises in identifying best use cases for quantum and work with them to develop a proof of concept and production pilot.

From there, the team coordinates with customers to get their hybrid quantum applications up and running, providing ongoing Leap quantum cloud access to ensure the application is operating smoothly and delivering real business value.

Target Verticals

While the potential applications for quantum computing are effectively limitless, D-Wave has identified a number of industry verticals as key areas of focus for its quantum architecture, providing case studies for each. These include:

• Manufacturing – D-Wave worked with Volkswagen to identify a commercial optimization application, the binary paint shop problem, which was run on D-Wave’s hybrid solver service. The solver outperformed four purely classical methods on problem sizes at commercial scale (N=3,000). In a separate project, similar inputs were tested using a leading ion trap system, which failed to find any commercial solution.
• Life Sciences – Menten AI makes use of D-Wave quantum computing to assist in the design of novel therapeutic peptides—short strings of amino acids that can act as potent drugs. With the rise of COVID-19, D-Wave’s Advantage system made it possible to identify molecules that might be especially well-suited for binding and inhibiting the related spike protein, producing several promising peptide designs.
• Finance – Multiverse Computing, a leader in developing quantum solutions for the financial sector, leveraged D-Wave’s hybrid solver service in a collaboration with BBVA, one of the world’s largest financial institutions. Multiverse demonstrated management strategies that far exceeded the granularity of traditional returns in a fraction of the time, helping BBVA identify a low-risk portfolio for investment.

Market Opportunity

The quantum computing total addressable market is projected to grow between $450 billion and $850 billion over the next 15 to 30 years, with between $5 billion and $10 billion of anticipated TAM growth coming in the next three to five years, according to Boston Consulting Group. Driving factors behind this growth include rising investments in quantum computing tech by governments and an increasing number of commercial use-cases.

Forward-thinking organizations see quantum as an opportunity to move ahead of the competition. From finding efficiencies and reducing waste to decreasing time to solution and solving problems abandoned due to complexity, the business value is real. According to data from 451 Research, 40% of large enterprises are already experimenting with quantum computing.

D-Wave is strategically positioned – in an industry with significant barriers to entry – as evident by a decades-long track record serving a roster of blue-chip customers. The company is singularly focused on helping its customers achieve clear value by leveraging quantum computing in practical business applications. With a full stack of systems, software, developer tools and services, D-Wave is working to enable enterprises, governments, developers and researchers to access the power of quantum computing, thereby providing an intriguing opportunity for prospective investors.

D-Wave’s current investor base includes PSP Investments, Goldman Sachs, BDC Capital, NEC Corporation, Aegis Group Partners and In-Q-Tel.

Leadership Team

Dr. Alan Baratz has served as the CEO of D-Wave since 2020. Previously, as Executive Vice President of R&D and Chief Product Officer, he drove the development, delivery, and support of all of D-Wave’s products, technologies, and applications. Dr. Baratz has over 25 years of experience in product development and bringing new products to market at leading technology companies and software startups. As the first president of JavaSoft at Sun Microsystems, he oversaw the growth and adoption of the Java platform from its infancy to a robust platform supporting mission-critical applications in nearly 80 percent of Fortune 1000 companies. He has also held executive positions at Symphony, Avaya, Cisco, and IBM. Dr. Baratz holds a doctorate in computer science from the Massachusetts Institute of Technology.

John Markovich is the company’s CFO. He brings to D-Wave over three decades of experience working with rapidly growing private and public technology companies across all stages of development. Mr. Markovich has directed the finance, accounting, tax, treasury, M&A, legal, operations, customer service, IR, HR, and IT functions for companies ranging from privately held pre-revenue startups to an NYSE-listed Fortune 500 multi-national company with over $1.2 billion in annual revenue. During his career, he has negotiated and closed over 150 debt, equity, M&A, and joint venture transactions exceeding $2.5 billion in value; over a dozen private placements; nearly a dozen M&A transactions; and several international joint ventures. Mr. Markovich holds a BS in Business from Miami University and an MBA from the Michigan State Graduate School of Business.

D-Wave Quantum Inc. (NYSE: QBTS), closed Thursday's trading session at $8.69, off by 18.0189%, on 3,542,524 volume. The average volume for the last 3 months is 84,605,929 and the stock's 52-week low/high is $0.7505/$11.95.

Recent News

• D-Wave Quantum Inc. (NYSE: QBTS) - Nvidia CEO to Reassure the AI Industry of the Firm's Dominance This Week
• D-Wave Quantum Inc. (NYSE: QBTS) Demonstrates Quantum Supremacy on a Real-World Problem
• Meta Starts Testing its Maiden Internal AI Chip

Life Electric Vehicles Holdings Inc. (OTC: LFEV)

The QualityStocks Daily Newsletter would like to spotlightFathom Life Electric Vehicles Holdings Inc. (OTC: LFEV) .

Kairos Pharma (NYSE American: KAPA) , a clinical-stage biopharmaceutical company, has published a peer-reviewed study highlighting a potential breakthrough in addressing drug resistance to EGFR-targeted therapies for non-small cell lung cancer (NSCLC). The study, published in Drug Resistance Updates, identifies CD105 (endoglin) as a key factor in mediating resistance to osimertinib, a frontline treatment for EGFR-mutant NSCLC. Preclinical models demonstrated that targeting CD105 with ENV105 (carotuximab), a CD105-neutralizing antibody, restored treatment sensitivity, suggesting a novel combination therapy strategy to overcome drug resistance. Kairos Pharma is currently evaluating this approach in clinical trials.

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

Life Electric Vehicles Holdings Inc. (OTC: LFEV) (d/b/a Life EV Group), along with its subsidiaries, is a developer, manufacturer and distributor in the light electric vehicle industry. The company’s business model focuses on the launch, acquisition and consolidation of multiple brands of e-bikes, e-trikes, e-scooters and light EVs with the aim of positioning itself as an industry leader for the American micro-mobility market.

The light electric vehicle industry, mainly e-bikes, is fast becoming a leading form of EV sales in the U.S. and Europe. In addition to offering ready-to-ride electric vehicles, Life EV Group intends to distribute individual components, including motors, batteries, chargers, controllers and EV parts, to third party manufacturers in both the U.S. and worldwide.

The company’s first acquisition was completed in 2023 with a 40% equity stake in LEV Manufacturing Inc., a related company and American manufacturer of e-bikes. LEV Manufacturing’s assembly utilizes free-trade zone processes with a U.S. Certificate of Origin, eliminating middle layer costs and resulting in cost-effective production and lower MSRPs.

LEV Manufacturing recently completed the acquisition of Serial 1 Cycle Company LLC. Serial 1 is an e-bike maker founded by U.S. motorcycle manufacturer Harley-Davidson in 2018 and spun off as an independent brand in 2020. The acquisition positions Serial 1 for even greater success and long-term growth.

Life EV Group is headquartered in Deerfield Beach, Florida.

Market Opportunity

An analysis from Mordor Intelligence, a market research and advisory firm, estimates the e-bike market to be worth $34.98 billion in 2024 and projects it will expand to reach a value of $51.78 billion by 2029, representing a CAGR of 8.16% during the forecast period.

Mordor attributes forecast market growth primarily to the increasing adoption of electric bikes as a mode of daily transportation around the world. The market is seeing an upsurge in unit sales based on their attractive consumer characteristics, including health benefits, affordability and convenience.

The North American electric bike market is growing as the preference for low-speed two- and three-wheelers has increased in recent years. Various bike-sharing operators are including electric bikes in their fleets, which is expected to support the sales growth of these bikes in the near future.

Management Team

Robert Provost is the CEO of Life EV Group. He was Founder and CEO of Prodeco Technologies, a maker of e-bikes and e-bike parts and accessories. He also serves as President and CEO of LEV Manufacturing Inc. He is Chairman of the board for Serial 1 Cycle Company.

Daniel Del Aguila is COO at Life EV Group. He co-founded Prodeco Technologies and serves as COO of LEV Manufacturing Inc.

Ivan Drusc is CFO at Life EV Group. He is a seasoned accounting and finance professional with a proven track record in industries from insurance to IT and property management. He has served as a key player in businesses ranging in size from startups to publicly traded global companies. He has experience in cost reduction, risk mitigation, IT and ERP systems, outsourcing and restructuring. He is a graduate of the University of Akron with a bachelor’s degree in accounting.

Life Electric Vehicles Holdings Inc. (OTC: LFEV), closed Thursday's trading session at $0.98, up 4.2553%, on 252 volume. The average volume for the last 3 months is 111,755 and the stock's 52-week low/high is $0.8506/$4.

Recent News

• Life Electric Vehicles Holdings Inc. (OTC: LFEV) - Why Trump May Be Unlikely to Stop Public EV Charger Construction
• New EV Using Solar Can Go for 40 Miles Every Day
• Recent Battery Breakthrough Could Revolutionize EV Industry

Brera Holdings PLC (NASDAQ: BREA)

The QualityStocks Daily Newsletter would like to spotlight Brera Holdings PLC(NASDAQ: BREA).

Brera Holdings PLC (NASDAQ: BREA) is an Ireland-based, international holding company focused on expanding its global portfolio of men’s and women’s sports clubs through a multi-club ownership approach. The company capitalizes on opportunities to earn tournament prizes, secure sponsorships, collect transfer fees, provide professional sports consulting services, and enhance the valuation of its clubs.

Brera Holdings builds on the legacy of Brera FC, an international football club (referred to as soccer in the U.S.), that it acquired in July 2022. Established in 2000 and based in Milan, Italy, Brera FC has distinguished itself by cultivating an alternative football legacy. In October 2024, the Internet Marketing Association awarded Brera FC with the Social Impact Through Soccer accolade at its IMPACT 5050 Conference, recognizing the club’s global perspective and positive contributions to society.

The company’s growth strategy focuses on unlocking value from undervalued sports clubs and talent, driving innovation, and generating socially impactful outcomes. Brera Holdings is actively expanding its Global Sports Group, acquiring professional football and other sports clubs in emerging markets such as Africa, Asia, and Europe.

By targeting top-division teams in less mainstream markets, Brera Holdings aims to strengthen its competitive position in regional tournaments, including those organized by the Union of European Football Associations (UEFA). These acquisitions are expected to enhance sponsorship revenues and create new growth opportunities.

Leveraging its expertise in capital raising and revenue generation, Brera Holdings also anticipates growing demand for its consulting services, providing advisory support to sports clubs, associations, investors, and others. Brera Holdings is headquartered in Dublin, Ireland, with additional offices in Milan, Italy.

Sporting Assets

Brera Holdings continues to grow its global sports portfolio with a series of strategic acquisitions and innovations, including the FENIX Trophy Tournament, a pan-European, non-professional football competition. Launched in September 2021 and organized by Brera FC, the tournament has been recognized by UEFA and described by BBC Sport as “the Champions League for amateurs.” In 2023, Brera FC hosted the tournament’s finals at Milan’s iconic San Siro Stadium.

In March 2023, Brera Holdings expanded into Africa by establishing Brera Tchumene FC in Mozambique. Starting in the country’s Second Division League, the team quickly earned promotion to Moçambola, Mozambique’s First Division League, by November 2023.

In April 2023, Brera Holdings further strengthened its European presence by acquiring a 90% stake in Fudbalski Klub Akademija Pandev, a first-division football team in North Macedonia. This acquisition provides access to two major UEFA competitions, solidifying the company’s position in European football.

Brera Holdings’ reach extends beyond football. In July 2023, it acquired majority ownership of UYBA Volley, an Italian Serie A1 women’s professional volleyball team, demonstrating its commitment to diversifying within top-tier sports.

In September 2023, Brera Holdings entered the Mongolian football market by acquiring Bayanzurkh Sporting Ilch FC, a Mongolian National Premier League team. For the 2024 season, the club was rebranded as Brera Ilch FC, further expanding Brera’s global footprint.

In January 2024, Brera Holdings initiated a proactive search for an Italian Serie B football club, aligning with its goal of bringing multi-club ownership opportunities to mass investors through its Nasdaq-listed shares.

In February 2024, the Brera Holdings Advisory Board was established with MLS founder and World Cup director Alan Rothenberg, luxury lifestyle executive Massimo Ferragamo, sports business leaders Paul Tosetti and Marshall Geller, and Italian football icon Giuseppe Rossi.

In June 2024, the North Macedonian women’s football club Tiverija Strumica officially became part of the Brera family with the establishment of a joint-stock company controlled by Brera Holdings called Women’s Football Club Tiverija Brera AD Strumica (“Brera Tiverija”). Brera Tiverija is now a wholly-owned subsidiary of Brera Strumica FC.

In September 2024 Brera announced that it signed an exclusive letter of intent to acquire an Italian Serie B club (the “LOI” and the “Club”). According to a CFA report published in June 2024, this expected strategic transaction, for an estimated purchase price of $21.6 million, would add first-year annual revenue of $10.8 million to Brera, and that revenue would likely increase by 25% each year for the next three years. The company’s capital valuation, projected the report, would also experience significant appreciation during this period.

In October 2024, Brera was recognized with the 2024 Social Impact Through Soccer Award at IMPACT 5050, an annual event honoring leaders and innovators who significantly impact their industries and communities. This is the second time Brera has won the award.

Market Opportunity

A report from IMARC Group, a global management consulting firm, reveals that the international football market generated approximately $3.3 billion in revenue in 2023, with projections to grow to $4.6 billion by 2032, reflecting a compound annual growth rate (CAGR) of 3.6%. Key drivers behind this growth include advancements in digitization, increasing sponsorship and partnership deals between brands and clubs, the rising interest in women’s professional soccer leagues, and the expansion of the e-sports and gaming sector.

In particular, Serie B Italian football clubs seem to present exceptionally attractive investment opportunities. As of September 2024, more than half of these clubs had appreciated between 80-100% in total market value, post-purchase.

As the world’s most-watched and most-played sport, soccer drives significant demand for football-related products and services, contributing to market growth. Broadcasting rights, sponsorships, and endorsement deals are also major revenue sources for clubs and organizations, with an expanding global fanbase generating new opportunities for financial growth, according to the report.

Management Team

With extensive experience in leadership and finance, Daniel McClory currently serves as the Executive Chairman and Director of Brera Holdings, PLC. He co-founded and held the position of Chief Executive Officer at Boustead & Company Limited, and previously served as the Managing Director, Head of Equity Capital Markets, and Head of China at Boustead Securities, LLC. Mr. McClory’s governance experience includes being a Board Director for USA Track & Field and a member of the Eastern Michigan University Champions Advisory Board. Mr. McClory’s expertise encompasses founding and financing equity capital markets, as well as navigating merger and acquisition transactions and initial public offerings. He holds a BS and MS from Eastern Michigan University, where he also received an honorary Doctor of Public Service. In addition to his professional qualifications, he is fluent in both English and Italian.

Pierre Galoppi serves as the CEO, Interim CFO, and director of Brera Holdings. With over 30 years of experience in strategic business and financial services, his career spans a variety of industries, including natural resources, aviation, cybersecurity, telecommunications, tourism, and international marketing. He has worked extensively across Latin America, the Caribbean, Canada, Europe, and the United States. Mr. Galoppi holds dual citizenship in Canada and Italy and is fluent in English, Spanish, Portuguese, Italian, and French. He earned a Bachelor of Commerce degree and an MBA from Concordia University in Montreal.

Maria Xing serves as the Head of Investments and Corporate Development. She is an executive who has specialized in MCO football (soccer) group investments for 777 Partners, where she was involved in sourcing, direct negotiations, due diligence, and closing deals, including acquiring a controlling stake in Brazilian Serie A football club, Vasco da Gama, and investing in Australian Premier League (“A-League”) side, Melbourne Victory FC. She also played a role in other professional sports franchise portfolio management, including topflight professional football clubs in Italy, France, Germany, and Belgium. Her background is in private equity, investment banking, and finance, with prior experience at The Raine Group, Credit Suisse, and EY (Ernst & Young), as well as previous sports industry experience at Liverpool Football Club in international business development. Ms. Xing earned an MBA from the Wharton School of the University of Pennsylvania and a B.S. from the New York University, Stern School of Business.

Brera Holdings PLC (NASDAQ: BREA), closed Thursday's trading session at $0.705, up 2.5007%, on 16,791 volume. The average volume for the last 3 months is 3,515,245 and the stock's 52-week low/high is $0.4999/$1.95.

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Mullen Automotive Inc. (NASDAQ: MULN)

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

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 Thursday's trading session at $0.3401, off by 14.975%, on 964,261 volume. The average volume for the last 3 months is 7,097,943 and the stock's 52-week low/high is $0.3355/$47100.

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Clene Inc. (NASDAQ: CLNN)

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

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

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

CNM-Au8

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

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

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

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

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

Market Opportunity

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

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

Management Team

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

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

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

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

Clene Inc. (NASDAQ: CLNN), closed Thursday's trading session at $4.27, off by 0.9280742%, on 1 volume. The average volume for the last 3 months is 39,818 and the stock's 52-week low/high is $3.8181/$9.2.

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