D-Wave Quantum Inc. (NYSE: QBTS)

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

D-Wave and Japan Tobacco's pharmaceutical division completed a proof-of-concept project aimed at speeding up and improving the design of small molecule pharmaceuticals.

D-Wave's annealing quantum computer was used to train large language models within Japan Tobacco's AI framework.

The quantum-hybrid application outperformed classical methods in generating valid and drug-like molecules.

Japan Tobacco plans to further pursue Quantum AI in molecular design following these early results.

D-Wave Quantum (NYSE: QBTS) ("D-Wave"), a leader in the development and delivery of quantum computing systems, software, and services, will release its first-quarter fiscal 2025 results before market open on Thursday, May 8, 2025. D-Wave will host a conference call featuring CEO Dr. Alan Baratz and CFO John Markovich at 8:00 a.m. ET that day to discuss financial results and business outlook. The earnings press release and webcast replay will be available on the D-Wave Investor Relations website.

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

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 Friday's trading session at $7.53, up 2.449%, on 666,148 volume. The average volume for the last 3 months is 40,735,100 and the stock's 52-week low/high is $0.7505/$11.95.

Recent News

• D-Wave Quantum Inc. (NYSE: QBTS) - D-Wave Quantum Inc. (NYSE: QBTS) and Japan Tobacco Complete Quantum AI Project Designed to Improve Drug Discovery Outcomes
• InvestorNewsBreaks - D-Wave Quantum Inc. (NYSE: QBTS) to Report First Quarter Fiscal Year 2025 Financial Results on May 8
• BillionDollarBreaks - D-Wave Quantum Inc. (NYSE: QBTS) Advances U.S. Quantum Infrastructure with Davidson Installation Milestone 

Soligenix Inc. (NASDAQ: SNGX)

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

Soligenix (NASDAQ: SNGX) , a late-stage biopharmaceutical company focused on rare diseases, is featured in a new Benzinga video detailing clinical progress for its lead candidate HyBryte, which achieved a 75% response rate in a trial for cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer. The trial is supported by funding from a U.S. Food and Drug Administration's Orphan Products Development Grant and showcases HyBryte's potential as a first-in-class, light-activated, non-invasive therapy.

HyBryte is a first-in-class photodynamic therapy activated by safe visible light and has previously received Orphan Drug and Fast Track designations. Soligenix plans to continue advancing regulatory discussions as it positions HyBryte for potential commercialization.

To view the video, visit https://ibn.fm/zT9L1

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 Friday's trading session at $2.17, up 0.6960557%, on 21 volume. The average volume for the last 3 months is 172,830 and the stock's 52-week low/high is $1.68/$14.8299.

Recent News

• Soligenix Inc. (NASDAQ: SNGX) - Soligenix Inc. (NASDAQ: SNGX) Advances CiVax Amid Ongoing COVID-19 Threat
• BioMedNewsBreaks - Soligenix Inc. (NASDAQ: SNGX) Announces Positive Data, Continued Advancement of HyBryte(TM)
• Soligenix Inc. (NASDAQ: SNGX) Spotlighted in Recent Zacks Small-Cap Research Report, Earns a $35 Valuation

Newton Golf Company Inc. (NASDAQ: NWTG)

The QualityStocks Daily Newsletter would like to spotlight Newton Golf Company Inc. (NASDAQ: NWTG).

Newton Golf Company Inc. (NASDAQ: NWTG), a technology-forward golf equipment manufacturer committed to enhancing player performance through innovative design, has seen its Newton Motion shafts rapidly gain popularity on the Champions Tour, recently earning a feature on Golf.com for their innovative performance benefits tailored to senior players. The shafts utilize a unique variable stiffness profile—more flexible in the midsection and stiffer at the tip and butt ends—resulting in improved energy transfer, higher launch angles, and increased distance. These design advantages have made them a go-to choice for many veteran professionals seeking more consistency and power in their drives.

To read the full Golf.com feature, visit https://ibn.fm/xGPt9

Newton Golf Company Inc. (NASDAQ: NWTG), a Sacks Parente Company, is a technology-forward golf equipment manufacturer committed to enhancing player performance through innovative design. Since its founding in 2018, the company has developed a growing portfolio of premium golf products, including putters, golf shafts, grips, and related accessories. Its proprietary advancements include the First Vernier Acuity putter, patented Ultra-Low Balance Point (ULBP) technology, weight-forward Center-of-Gravity (CG) design, and ultra-light carbon fiber putter shafts.

As part of its commitment to growth in golf shaft technologies, the company expanded its manufacturing operations in April 2022, opening a dedicated facility in St. Joseph, Missouri. This move reinforced its goal of maintaining high-quality production standards while manufacturing and assembling substantially all of its products in the United States. In addition to golf clubs and accessories, Newton Golf Company is exploring expansion into golf apparel and other product categories.

The company sells its products through multiple channels, including resellers, its direct-to-consumer website, Club Champion retail stores, and distributors in the U.S., Japan, and South Korea. Future expansion may include growth through mergers, acquisitions, or the development of complementary product lines.

Newton Golf Company is headquartered in Camarillo, California.

Products

Newton Golf Company is focused on delivering high-performance golf equipment with a strong emphasis on precision engineering and cutting-edge materials. The company’s key product lines include:

• Newton Motion Golf Shafts: Launched in November 2023, these shafts are engineered with proprietary flex profiles designed for greater distance, reduced dispersion, and optimized performance across swing speeds. The company’s DOT system eliminates traditional shaft flex definitions, making it accessible to all golfers.
• Gravity Putters: Introduced in October 2024, these putters incorporate patented Ultra-Low Balance Point (ULBP) technology to improve stroke consistency and tighten putt dispersion. Manufactured in the U.S., they feature premium materials such as steel, aluminum, titanium alloys, and patented magnesium face plate technology.
• Golf Grips & Accessories: The company continues to innovate in this category, providing golfers with performance-enhancing grips and accessories to complement their clubs.

All Newton Golf Company products are manufactured with strict quality control standards to ensure precision and reliability, reinforcing the brand’s reputation for premium performance.

Market Opportunity

The global golf equipment market was valued at approximately $8 billion in 2022, with the U.S. market accounting for $2.9 billion. The golf club segment dominated the industry, representing 45.7% of total market share. Increasing participation in golf, particularly among younger players and women, is driving demand for high-quality, customizable golf equipment.

Key industry trends supporting growth include:

• The increasing popularity of premium, high-performance golf equipment among both professionals and amateurs.
• A shift toward customization, as golfers seek tailored products that enhance performance.
• A growing interest in golf from younger demographics, with amateur and collegiate golfers being particularly receptive to innovation.

Newton Golf Company’s emphasis on U.S.-based manufacturing provides it with a competitive edge in terms of supply chain efficiency, quality control, and sustainability, further strengthening its position in the market.

Leadership Team

Dr. Greg Campbell, Executive Chairman and Chief Executive Officer, brings nearly 40 years of experience in emerging technologies, product development, and public company leadership. He currently serves as CEO of V-Grid Energy Systems, a California-based company focused on converting agricultural waste into renewable electricity and bio-carbon. He has successfully taken two companies public and previously managed a $1.2 billion P&L as SVP & GM at Lam Research. Campbell holds a Ph.D. in Electrical and Electronics Engineering from UCLA and a BA/MA in Engineering from Cambridge University.

Ryan Stearns, Chief Financial Officer, was appointed in 2024 and oversees financial planning and corporate strategy. He brings expertise in scaling businesses and optimizing financial performance to support the company’s growth.

Newton Golf Company Inc. (NASDAQ: NWTG), closed Friday's trading session at $1.96, up 5.3763%, on 11,861 volume. The average volume for the last 3 months is 6,389,982 and the stock's 52-week low/high is $1.35/$195.

Recent News

• Newton Golf Company Inc. (NASDAQ: NWTG) - InvestorNewsBreaks - Newton Golf Company (NASDAQ: NWTG) Gains Momentum on Champions Tour with Golf.com Spotlight 
• Newton Golf Company (NASDAQ: NWTG) Rides Wave of Golf's Rising Popularity with Innovation and Vision
• InvestorNewsBreaks - Newton Golf Company Inc.'s (NASDAQ: NWTG) Tech-Driven Strategy Featured in GotStocks Podcast

Brera Holdings PLC (NASDAQ: BREA)

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

On April 13, a match between SS Juve Stabia S.r.l and Cremonese was aired live with English-language commentary in the U.S., Canada, and the U.K. through Destination Calcio. Juve Stabia is a portfolio club of Brera Holdings, an Ireland-based, international holding company focused on expanding its global portfolio of men's and women's sports clubs

The broadcast marked a key milestone for the club and the company in growing their global recognition and key English-speaking markets

Brera is optimistic that initiatives such as these will expand the club's footprint beyond Italy, ultimately reaching a broader base of international supporters

In addition, its management is confident that it will further showcase the energy and ambition of the team to new audiences, including Italians living abroad

Brera Holdings (NASDAQ: BREA) , an Ireland-based international holding company focused on building a global portfolio of men's and women's sports clubs through a multi-club ownership ("MCO") model, announced that on April 13, 2025, its portfolio club SS Juve Stabia S.r.l.'s match against Cremonese was broadcast live in the United States, Canada, and the United Kingdom. This broadcast was conducted in partnership with Destination Calcio, with full English commentary, marking a key milestone for the club and the company in growing global recognition ( https://ibn.fm/9PTJw ).

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 Friday's trading session at $0.694, up 1.6552%, on 2,030 volume. The average volume for the last 3 months is 133,680 and the stock's 52-week low/high is $0.4999/$1.95.

Recent News

• Brera Holdings PLC (NASDAQ: BREA) - Brera Holdings PLC (NASDAQ: BREA) Asserts Juve Stabia's Global Recognition with U.S., Canada and U.K Live Broadcast in English of Top Italian Serie B Football Club
• InvestorNewsBreaks - Brera Holdings PLC (NASDAQ: BREA) Sees 36.9% Jump in Juve Stabia Market Value, Leading Serie B 
• Brera Holdings PLC (NASDAQ: BREA) Satisfies the FIGC's Standards in S.S. Juve Stabia S.r.l. Acquisition Review by Italian Football Authority

Nutriband Inc. (NASDAQ: NTRB)

The QualityStocks Daily Newsletter would like to spotlight Nutriband Inc. (NASDAQ: NTRB).

Nutriband (NASDAQ: NTRB) , a company focused on the development of a portfolio of transdermal pharmaceutical products, was featured in a recent article that discussed its innovative AVERSA(TM) abuse-deterrent technology and business model. "AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to patients who need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, Australia, and China, with recent extensions into Macao," the article reads.

"The company's business model is to apply its transdermal technology to existing FDA-approved drugs with a goal of improving safety, efficacy and patient comfort while qualifying for a limited-development regulatory pathway that reduces the number of clinical trials required for approval of new drugs."

To view the full article, visit https://ibn.fm/aeURJ

Nutriband Inc. (NASDAQ: NTRB) is engaged in the development of a portfolio of transdermal pharmaceutical products. The company’s AVERSA™ technology can be incorporated into any transdermal patch and includes aversive agents to prevent abuse, diversion, misuse and accidental exposure to drugs with abuse potential, specifically opioids.

AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to patients who need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, Australia, and China, with recent extensions into Macao.

The company’s business model is to apply its transdermal technology to existing FDA-approved drugs with a goal of improving safety, efficacy and patient comfort while qualifying for a limited-development regulatory pathway that reduces the number of clinical trials required for approval of new drugs.

Nutriband has three subsidiaries, including 4P Therapeutics, its clinical and regulatory subsidiary; Pocono Pharmaceutical, a contract manufacturer for a wide range of clients; and Active Intelligence, a developer of sports recovery products. This ownership of manufacturing and clinical development capabilities drastically reduces costs for AVERSA and other technologies.

In April 2024, Nutriband announced that the company had been engaged by and received a first order from Fit For Life Group, a major brand license holder. A fully executed supplier agreement is expected to follow. Nutriband’s wholly owned Active Intelligence subsidiary will act as manufacturer.

In February 2025, the company formalized its product development partnership with Kindeva Drug Delivery through a long-term exclusive agreement. The collaboration supports the commercial pathway for AVERSA Fentanyl by leveraging Kindeva’s FDA-approved transdermal fentanyl patch system.

The company is headquartered in Orlando, Florida.

Products

Nutriband’s lead product candidate is AVERSA Fentanyl, an abuse-deterrent fentanyl transdermal patch. The company announced in March 2024 that it will submit a New Drug Application to the U.S. Food and Drug Administration seeking approval to market AVERSA Fentanyl. In subsequent updates, Nutriband confirmed that the NDA submission remains the company’s primary focus and is backed by a strong cash position.

Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband’s AVERSA abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system. Because Nutriband’s abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate from and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation would not be required.

In support of this commercialization strategy, Nutriband closed an $8.4 million private placement in April 2024 to fund development activities related to AVERSA Fentanyl. The company also licensed Bitrex®, a widely used aversive agent, to enhance the deterrent profile of its patch formulation.

AVERSA Fentanyl has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The company plans to seek an expedited review by the FDA, as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs.

Nutriband’s AVERSA product development pipeline also includes abuse deterrent versions of currently approved and marketed transdermal patches containing buprenorphine, an opioid used to treat opioid use disorder, and methylphenidate, a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD). Both are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure.

Market Opportunity

Nutriband cites a market analysis report from Boston-based Health Advances, a healthcare and life sciences consulting firm. According to the report, upon FDA approval, AVERSA Fentanyl has the potential to reach peak annual sales of $200 million in the U.S.

The company further states that, should non-abuse-deterrent transdermal fentanyl products lose FDA marketing approval, AVERSA Fentanyl would have greater pricing flexibility and would have the potential to generate more than $500 million in annual revenue.

Management Team

Gareth Sheridan is Co-Founder and CEO of Nutriband. He was Ireland’s ‘Young Entrepreneur of the Year’ in 2014 for establishing Nutriband. He has worked as a Business Mentor with 100 Minds, a social enterprise that brings together some of Ireland’s top college students and connects them with a cause to achieve large charitable goals. He received a B.Sc. in Business and Management from Dublin Institute of Technology.

Serguei Melnik is Co-Founder and President of Nutriband. He has been involved in general business consulting for companies in the U.S. financial markets and setting up legal and financial frameworks for operations of foreign companies in the U.S. He previously was the COO of Florida-based Asconi Corporation. He also was a lawyer in the Department of Foreign Affairs, JSC Bank “Inteprinzbanca,” in Chisinau, Moldova, and prior to that practiced law in Moldova. He is fluent in four languages.

Jeff Patrick, Pharm.D., is Chief Scientific Officer of Nutriband. He currently serves as Director of the Drug Development Institute at the Ohio State University Comprehensive Cancer Center. His prior roles included Global Vice President at Mallinckrodt Pharmaceuticals Inc.; and roles at Dyax, Myogen/Gilead, Actelion and Sanofi-Synthelabo Inc. He was a clinical pharmacist at the University of Tennessee Medical Center and a clinical assistant professor of pharmacy at the University of Tennessee College of Pharmacy.

Gerald Goodman is CFO of Nutriband. He is a certified public accountant with his own firm, Gerald Goodman CPA. He also practiced with Madsen & Associates, CPAs, and was a partner in the accounting firm of Wiener, Goodman & Company. He is also a director of Lifestyle Medical Network Inc., which provides management services to healthcare providers. He is a graduate of Pennsylvania State University, where he received a bachelor’s degree in accounting.

Nutriband Inc. (NASDAQ: NTRB), closed Friday's trading session at $5.32, even for the day, on 8,835 volume. The average volume for the last 3 months is 13,260 and the stock's 52-week low/high is $3.3/$11.78.

Recent News

• Nutriband Inc. (NASDAQ: NTRB) - BioMedNewsBreaks - Why Nutriband Inc. (NASDAQ: NTRB) Is 'One to Watch' 
• Nutriband Inc. (NASDAQ: NTRB): Building a Moat Around Abuse-Deterrent Drug Delivery
• BioMedNewsBreaks - Nutriband Inc. (NASDAQ: NTRB) CEO Named EY Entrepreneur of the Year 2025 Finalist in Established Category 

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).

China's Contemporary Amperex Technology Co., Limited (CATL) has launched a brand new lineup of sodium-ion batteries dubbed Naxtra as well as a second generation of its first charging Shenxing electric vehicle battery. According to CATL, the new lineup of Naxtra batteries will begin mass production in December. Most battery electric vehicles (BEVs) on the market currently use lithium ion battery packs but there has been a notable push to develop alternative EV batteries that are more energy dense and are less likely to combust. CATL was the first large auto battery maker to introduce the sodium-ion battery, a new type of battery that uses sodium-ions rather than lithium ions to store and transfer energy. During a recent Shanghai event, CATL's Chief Technology Officer Gao Huan said the Shenxing battery will be installed in 67 new EV models in 2025. CATL's advancements in sodium-ion and fast-charging battery technologies signify a significant leap forward in the EV industry. These innovations promise to make electric vehicles more accessible and efficient, potentially accelerating the global shift towards sustainable transportation. We are likely to see new battery designs from other existing players in the industry, such as SolarBank Corp. (NASDAQ: SUUN) (Cboe CA: SUNN) (FSE; GY2), as the EV and energy storage landscape evolves to cut costs and increase performance.

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 Friday's trading session at $2.23, even for the day, on 1,358 volume. The average volume for the last 3 months is 208,278 and the stock's 52-week low/high is $1.95/$6.87.

Recent News

• SolarBank Corp. (Cboe CA: SUNN) (FSE: GY2) (NASDAQ: SUUN) - China's CATL Unveils a Sodium-Ion Battery Lineup
• Group Says Trump Policies Have Triggered Cancellations Worth $8Bn in Clean Energy Investments
• Zacks Initiates Coverage on SolarBank Corp. (NASDAQ: SUUN) (Cboe CA: SUNN) (FSE: GY2)

Adageis

The QualityStocks Daily Newsletter would like to spotlight Adageis

Adageis offers an AI-powered financial technology platform tailored to healthcare providers seeking a financially positive transition to value-based care.

The company's patented analytics engine predicts revenue performance and simplifies contract reimbursement analysis to maximize financial efficiency.

Adageis acts as an advocate for providers, helping them understand what payments they should expect from insurers.

The platform integrates with over 90 EHR systems and supports providers through improved cash flow and access to funding.

With growing adoption, Adageis continues to expand investor partnerships and develop superior tools for smaller healthcare practices.

Adageis, a forward-thinking healthcare technology company, has a comprehensive suite of AI-powered solutions aimed at providers shifting from fee-for-service to value-based care. With growing policy support and payer incentives, value-based care has become a pressing priority across U.S. healthcare systems. But many providers—especially smaller ones—lack the tools to navigate this transition efficiently and profitably. Adageis makes it all possible.

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 Offering Comprehensive Healthcare AI Tools to Support Profitable Shift to Value-Based Care
• Adageis Helps Medical Providers Track and Build Revenue Through Efficient Application of Value-Based Care
• InvestorNewsBreaks – Adageis Brings Power of AI to the Frontlines of 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).

Platinum Group Metals (NYSE American: PLG) (TSX: PTM) is strategically positioning itself to become a key player in the expanding platinum group metals ("PGMs") sector, driven by the essential role of PGMs in next-gen technology and industrial applications. PGMs serve critical functions in catalytic converters, fuel cells, catalysts in various industrial processes, electronics and the medical sector. These metals are also expected to play an even more crucial role in advancing sustainable technologies amid global efforts to reduce carbon emissions. The company's Waterberg Project, located in South Africa's renowned Bushveld Complex, is a large-scale, low-cost, bulk-mineable deposit with a particular focus on palladium, platinum, rhodium and gold as well as byproduct copper and nickel. Expected to be a game-changer for Platinum Group Metals, the project offers a substantial resource base and the opportunity to develop a high-margin operation that can supply PGMs to meet growing global demand. To view the full article, visit https://ibn.fm/FulBa

Earlier this week, Barrick Gold Corporation announced that it'd be selling its 50% holding in the Donlin Gold Project for $1 billion in cash to affiliates of NOVAGOLD Resources Inc. and Paulson Advisers LLC. The project is found in Southwest Alaska, within the historic Kuskokwim Gold Belt. The project holds approximately 39 million gold ounces and is said to be one of the biggest known undeveloped open-pit gold deposits today. The Kuskokwim Corporation owns the surface and mineral rights to this gold project, while Donlin Gold LLC manages the project that is equally owned by NOVAGOLD and Barrick Gold. The transaction's completion is expected towards the end of Q2 or in early Q3, once the required regulatory approvals have been obtained and customary closing conditions have been satisfied. Holland & Hart LLP and Davies Ward Phillips & Vineberg LLP are acting as legal counsel to Barrick while CIBC World Markets Inc. is acting as its financial advisor. The growing number of deals in which gold-rich properties are changing hands indicates that firms like Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) that are operating gold mines stand to record significant gains as the gold market sustains its current bull run and attracts more investors.

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 Friday's trading session at $1.2, off by 4%, on 985 volume. The average volume for the last 3 months is 719,883 and the stock's 52-week low/high is $0.99/$2.27.

Recent News

• Platinum Group Metals Ltd. (TSX: PTM) (NYSE American: PLG) - Barrick Gold Divests its Donlin Gold Stake
• MiningNewsBreaks - Platinum Group Metals Ltd.'s (NYSE American: PLG) (TSX: PTM) Waterberg Project Poised to Fuel Modern Tech with Critical PGMs
• Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) Advances Waterberg Project as Global Demand for PGMs Continues to Rise

Thumzup Media Corp. (NASDAQ: TZUP)

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

The Academy of Motion Picture Arts and Sciences has officially confirmed that movies incorporating AI are eligible to compete for Oscars. In a recent update to its guidelines, the organization clarified that using AI tools will not give films an advantage or disadvantage when being considered for nominations. Generative AI (Gen AI), which can produce everything from scripts and visuals to audio elements based on written instructions, has already contributed to recent Oscar-winning films. Still, the Academy emphasized that it will prioritize human involvement and creativity when selecting winners. Even so, not everyone in the industry is convinced AI can truly rival human talent. Some animators say the technology isn't yet capable of matching the depth and nuance required for award-winning work. Jonathan Kendrick of Rokit Flix likened AI's current capabilities to those of a mediocre writer—useful for basic structure but lacking the emotional depth needed to produce something truly exceptional. While AI may continue to play a growing role in the film industry, its creative limits and ethical challenges remain at the center of the conversation. With more companies like Thumzup Media Corp. (NASDAQ: TZUP) commercializing ways to use AI in marketing, branding and other use cases, it is just a matter of time before these technologies become commonplace in all industries.

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 Friday's trading session at $4.8, off by 1.0411%, on 41,241 volume. The average volume for the last 3 months is 127,158 and the stock's 52-week low/high is $2.02/$7.89.

Recent News

• Thumzup Media Corp. (NASDAQ: TZUP) - Academy Says AI-Made Movies Can Be Awarded Oscars
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Mullen Automotive Inc. (NASDAQ: MULN)

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

As countries worldwide move to phase out fossil fuels in favor of renewables, Pacific nations are adopting a variety of clean energy strategies to keep pace with the global green transition. While these nations may lack the financial power of larger economies, they've taken innovative steps to promote renewable energy generation and use. One major focus for Pacific countries is solar energy. The falling cost of solar inputs over the past two decades has made it a viable option for nations seeking low-cost, non-polluting alternatives to fossil fuels. Papua New Guinea, for instance, has worked to expand access to affordable, off-grid clean energy. The country has installed solar systems at three innovation hubs that support local entrepreneurs, economic development, and skill-building, all while promoting sustainable energy use. Through solar, hydro, and electric vehicle initiatives, Pacific countries are showing that even small nations can make significant strides in the clean energy transition with creativity, collaboration, and commitment. This increasing adoption of clean energy initiatives could open new market opportunities for electric vehicle makers like Mullen Automotive Inc. (NASDAQ: MULN) that are looking to expand their reach beyond the known major markets.

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 Friday's trading session at $0.69, off by 6.6432%, on 145,592 volume. The average volume for the last 3 months is 3,043,760 and the stock's 52-week low/high is $0.672/$4710000.

Recent News

• Mullen Automotive Inc. (NASDAQ: MULN) - Why EVs Help in Combating Climate Change
• US Renewable Energy Overtakes Fossil Fuels in March
• InvestorNewsBreaks - Mullen Automotive Inc. (NASDAQ: MULN) Secures Class 3 EV Truck Order From Cashflow on Wheels

Calidi Biotherapeutics Inc. (NYSE American: CLDI)

The QualityStocks Daily Newsletter would like to spotlight Calidi Biotherapeutics Inc. (NYSE American: CLDI).

Calidi Biotherapeutics (NYSE American: CLDI) a clinical-stage biotechnology company advancing targeted antitumor virotherapies, announced the approval of an inducement non-qualified stock option grant to new Chief Executive Officer Eric Poma, Ph.D. The grant includes the option to purchase 726,412 shares at an exercise price of $0.469, the closing price of Calidi's common stock on April 22, 2025. The options will vest over four years, with 25% vesting on April 22, 2026, and the remainder vesting in equal monthly installments through April 22, 2029, in accordance with Section 711 of the NYSE American LLC Company Guide.

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

Calidi Biotherapeutics Inc. (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering proprietary technology that empowers the immune system to combat cancer. Calidi’s innovative, off-the-shelf cell-based platforms use allogeneic stem cells to deliver potent oncolytic viruses (OVs) across multiple oncology indications, including high-grade glioma (brain cancers) and solid tumors. In addition, Calidi has presented a breakthrough systemic technology, RTNova, which utilizes an exteracellular enveloped virotherapy. RTNova is pre-clinical and has been extremely well-received by market analysts and large-cap biopharma – opening the door for potential collaboration.

These cell-based platforms are engineered to protect, amplify, and enhance the efficacy of oncolytic viruses, resulting in improved patient safety and potentially advancing treatment outcomes for metastatic disease. By employing a dual approach that combines OV delivery with immune activation, Calidi’s therapies aim to not only treat but potentially prevent the spread of metastatic cancers.

The company’s development pipeline leverages this technology to address pressing needs in cancers such as glioblastoma (brain cancer), metastatic melanoma, triple-negative breast cancer, head & neck cancer, and lung cancer. Calidi’s approach has shown early signals of efficacy and safety, establishing it as a distinctive player in the growing OV market, which is projected to increase significantly in value over the next decade.

Calidi is headquartered in San Diego, California.

Products

Calidi’s product pipeline includes advanced cell-based platforms targeting a variety of oncology indications, each designed to harness the power of oncolytic virotherapy for improved cancer treatment outcomes.

• NeuroNova (CLD-101): A platform designed for treating high-grade gliomas (HGG), NeuroNova employs neuronal stem cells combined with an engineered adenovirus (CRAD-s-Pk7) to selectively target glioma cells. After a successful Phase 1 safety study in newly diagnosed HGG, NeuroNova has now progressed into Phase 1/1b trials for recurrent cases. FDA clearance for a Phase 1b/2 trial at Northwestern University was received in September 2024, with patient enrollment expected to begin in Q1 2025. This trial will utilize multiple-dose intracerebral administration to maximize safety and efficacy in newly diagnosed HGG patients.
• SuperNova (CLD-201): Built on Calidi’s foundational technology, SuperNova utilizes an engineered Vaccinia virus (CAL1) delivered via allogeneic adipose-derived mesenchymal stem cells to target advanced solid tumors, including head & neck, triple-negative breast cancer, and soft tissue sarcomas. Early studies with autologous stem cells demonstrated both safety and promising efficacy, and Calidi plans to begin a Phase 1 trial with multiple dose regimens for SuperNova in the coming months.
• RTNova (CLD-400): Calidi’s systemic delivery platform for lung and metastatic cancers, RTNova employs an extracellular enveloped virotherapy (envRT-01) technology for intravenous (IV) administration, simplifying the treatment process and expanding its potential applications. Currently in preclinical stages, RTNova focuses on demonstrating efficacy and safety through systemic administration. A clinical trial targeting metastatic lung cancer is anticipated for Q2 2026, using a single-arm monotherapy with dose escalation. Calidi has partnered with SIGA Technologies (NASDAQ: SIGA) to support the development of this program.

Market Opportunity

The global oncology drugs market was valued at $201.75 billion in 2023 and is projected to grow to $518.25 billion by 2032, with a CAGR of 11.3%. The oncolytic virotherapy market in particular is growing rapidly, driven by increasing approval rates and significant unmet needs.

The market for OV treatments is expected to expand from one approved product generating $150 million in the U.S. in 2021 to 6-8 approved therapies generating $2.4 billion by 2030. As a leader in OV technology, Calidi is well-positioned to address these high-demand areas in oncology.

Alongside global trends, the American Cancer Society projects nearly two million new cancer diagnoses in the U.S. in 2024, reflecting a 28% increase since 2010. This underscores the urgent need for novel therapies that not only treat disease progression but also enhance patient quality of life, reinforcing the demand for Calidi’s innovative approaches.

Management Team

Allan Camaisa, CEO, Chairman, and co-founder, is a seasoned leader with extensive experience in scaling businesses to successful exits. Mr. Camaisa previously led High Technology Solutions, growing it from two employees to over 500 with $50 million in revenue. He also served as CEO of Parallel6 Inc. and is a U.S. Naval Academy graduate with further studies at Harvard Business School.

Antonio Santidrian, Ph.D., Chief Scientific Officer, leads all research and development initiatives at Calidi and is the coinventor of the company’s CLD-201 (Supernova) and CLD-400 (RTNova) platforms. Since joining Calidi in 2015, he has applied his 20+ years of expertise in academia and biotech, focusing on anti-cancer translational research, to drive the company’s innovative drug pipeline. Before Calidi, Dr. Santidrian led translational studies at The Scripps Research Institute, advancing treatments for breast cancer metastasis, and contributed to the development of ACADRA for chronic lymphocytic leukemia (CLL) at the University of Barcelona, Spain.

Boris Minev, M.D., President of Medical and Scientific Affairs, is a renowned physician-scientist with expertise in Immuno-Oncology, stem cell biology, and oncolytic viruses. Previously, Dr. Minev served as Director of Immunotherapy and Translational Oncology at Genelux Corporation and remains an adjunct professor at the Moores UCSD Cancer Center. His background includes research at the National Cancer Institute.

Andrew Jackson, CFO, has held executive finance roles with experience in biotech and clinical-stage companies, including Eterna Therapeutics and Ra Medical Systems. Mr. Jackson holds an MSBA in Finance from San Diego State University and a BSB in Accounting from the University of Minnesota.

Calidi Biotherapeutics Inc. (NYSE American: CLDI), closed Friday's trading session at $0.483, off by 2.8755%, on 167 volume. The average volume for the last 3 months is 381,574 and the stock's 52-week low/high is $0.35/$4.9.

Recent News

• Calidi Biotherapeutics Inc. (NYSE American: CLDI) - BioMedNewsBreaks - Calidi Biotherapeutics Inc. (NYSE American: CLDI) Grants Inducement Stock Option to New CEO Eric Poma
• How Stem Cells Help in Blood Cancer Treatment
• BioMedNewsBreaks - Calidi Biotherapeutics Inc. (NYSE American: CLDI) Appoints Eric Poma as CEO to Lead Next Phase of Clinical Growth

CNS Pharmaceuticals Inc. (NASDAQ: CNSP)

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

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

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

Organ Targeted Therapeutics

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

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

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

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

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

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

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

Global Brain Tumor Therapeutics Market

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

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

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

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

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

Management Team

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

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

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

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

CNS Pharmaceuticals Inc. (NASDAQ: CNSP), closed Friday's trading session at $1.09, up 4.8077%, on 7,603 volume. The average volume for the last 3 months is 311,635 and the stock's 52-week low/high is $0.7715/$800.

Recent News

• CNS Pharmaceuticals Inc. (NASDAQ: CNSP) - Study Identifies Key Enzyme That Could Be Targeted to Fight Brain Cancers
• The Global Market for Brain Tumor Treatments Will Reach $7.15 Billion by 2035
• Study Uncovers Drivers of Brain Tumor Growth, Could Open New Treatment Approaches