Lantern Pharma Inc. (NASDAQ: LTRN)

The QualityStocks Daily Newsletter would like to spotlight Lantern Pharma Inc. (NASDAQ: LTRN).

Lantern Pharma's AI-driven RADR(R) platform integrates over 200 billion oncology-specific data points and underpins every stage of its precision oncology pipeline.

The company has three lead drug candidates in clinical development, targeting major oncology markets including NSCLC, TNBC, and NHL.

Starlight Therapeutics extends Lantern's footprint into brain and CNS cancers, including pediatric indications supported by orphan and rare disease designations.

Lantern has received multiple FDA designations including Fast Track, Orphan Drug, and Rare Pediatric Disease status across its portfolio, enhancing regulatory pathways.

With approximately $19.7 million in cash and equivalents, the company is funded through at least mid-2026 to support pipeline advancement and platform development.

Lantern Pharma (NASDAQ: LTRN) is a clinical-stage biotechnology company leveraging artificial intelligence and machine learning to redefine oncology drug development. Through its proprietary platform, RADR(R) (Response Algorithm for Drug Positioning & Rescue), Lantern is advancing a pipeline of precision cancer therapies. The company has gained 11 FDA Designations for its portfolio of drug candidates including: Fast Track, Orphan and Pediatric Rare Disease. The company's data-driven approach enables rapid identification of promising drug candidates and the design of targeted clinical trials for specific patient subpopulations and cancer types.

Lantern Pharma Inc. (NASDAQ: LTRN) is a clinical-stage biotechnology company leveraging artificial intelligence and machine learning to redefine oncology drug development. Through its proprietary platform, RADR® (Response Algorithm for Drug Positioning & Rescue), Lantern is advancing a pipeline of precision cancer therapies. The company has gained 11 FDA Designations for its portfolio of drug candidates including: Fast Track, Orphan and Pediatric Rare Disease. The company’s data-driven approach enables rapid identification of promising drug candidates and the design of targeted clinical trials for specific patient subpopulations and cancer types.

Lantern’s vision is to transform cancer treatment by integrating large-scale genomics, AI-based biomarker discovery, and preclinical modeling to accelerate the development of oncology drugs. The company’s pipeline includes three lead small molecule candidates and an antibody-drug conjugate (ADC) program across 12 cancer indications, supported by strategic collaborations with global research institutions and clinical partners. The company has three active clinical trials enrolling patients with multiple clinical milestones expected throughout the next twelve months.

The company’s mission is centered on transforming the cost and pace of developing innovative therapies for patients with genetically defined cancers or limited treatment options. Lantern is also advancing brain and CNS cancer drug development through its wholly owned subsidiary, Starlight Therapeutics.

The company is headquartered in Dallas, Texas.

Product Portfolio

Lantern Pharma’s product pipeline consists of three lead candidates—LP-300, LP-184, and LP-284—and a preclinical ADC program. All are guided by insights from the RADR® platform, which has grown to incorporate over 200 billion oncology-specific data points.

LP-300 is in a Phase 2 trial (Harmonic™) for non-small cell lung cancer (NSCLC) in never smokers. The trial evaluates LP-300 in combination with carboplatin and pemetrexed and has shown a clinical benefit rate of 86% and an objective response rate of 43% in its initial cohort. The study is enrolling 90 patients across the U.S., Japan, and Taiwan (NCT05456256).

LP-184 is in a Phase 1a trial for advanced solid tumors and GBM (NCT05933265). The compound has received FDA Fast Track Designations for GBM and triple-negative breast cancer (TNBC), as well as four Rare Pediatric Disease Designations. Upcoming Phase 1b/2 trials are planned for TNBC (monotherapy and with olaparib) and for NSCLC patients with KEAP1/STK11 mutations in combination with nivolumab and ipilimumab.

LP-284 is currently in a Phase 1 trial for relapsed or refractory non-Hodgkin’s lymphoma (NHL) and other solid tumors (NCT06132503). The drug candidate has demonstrated complete tumor suppression in preclinical models of mantle cell lymphoma resistant to Ibrutinib and bortezomib and showed synergistic activity with rituximab in high-grade B-cell lymphoma models.

Lantern’s ADC program is based on cryptophycin conjugates and is undergoing preclinical evaluation, showing sub-nanomolar potency and improved targeting in HER2-expressing models.

The company has also launched Starlight Therapeutics, focused on CNS cancers, where STAR-001 (LP-184 for CNS cancers) is advancing toward a Phase 1b/2 trial in glioblastoma and pediatric brain cancers, including ATRT, supported by Rare Pediatric Disease Designations and preclinical validation from Johns Hopkins.

Market Opportunity

Lantern Pharma is focused on oncology indications with significant unmet medical need and multi-billion-dollar commercial potential.

• LP-300 targets non-small cell lung cancer in never smokers, a patient population estimated at over 150,000 cases globally and representing a market opportunity exceeding $4 billion annually.
• LP-184 is positioned for use in DDR-deficient tumors such as pancreatic, bladder, and triple-negative breast cancers, which collectively represent a U.S. market opportunity estimated at over $10 billion annually. Opportunities in targeted DDR-deficient tumors include the KEAP1/STK11 mutant NSCLC population targeted by LP-184, with a market potential of over $2 billion annually, and TNBC, which alone represents a $4 billion global market given its aggressiveness and high brain metastasis rate.
• LP-284 is aimed at relapsed or refractory non-Hodgkin’s lymphomas, particularly mantle cell lymphoma and HGBL, within a market sized at $3.5 to $4 billion globally.
• CNS cancers addressed by Starlight Therapeutics further expand Lantern’s reach, representing an estimated $5 billion annual global opportunity, including both adult and pediatric cancers.

Leadership Team

Panna Sharma, President, Chief Executive Officer, and Director, leads Lantern Pharma with a deep background in oncology-focused biotechnology and artificial intelligence. He is responsible for Lantern’s strategic vision and has driven the growth of its AI-powered drug development platform. Prior to joining Lantern in 2018, he served as President and CEO of Cancer Genetics Inc. (NASDAQ: CGIX), where he raised over $100 million and expanded the company from 25 to over 250 employees across multiple continents. Earlier, he founded TSG Partners and played a key role in the IPO of iXL, a digital strategy firm.

David R. Margrave, Chief Financial Officer and Secretary, has served in executive roles in life sciences for over two decades. Before joining Lantern, he held leadership positions at BioNumerik Pharmaceuticals, including President and Chief Administrative Officer. He has also been a strategic consultant to multiple biotech firms and served as Senior Legal Advisor at MedCare Investment Corporation. Mr. Margrave holds a dual degree in Economics and Petroleum Engineering from Stanford University and a J.D. from The University of Texas School of Law.

Kishor G. Bhatia, Ph.D., Chief Scientific Officer, has more than 40 years of experience in cancer biology, including leadership at the National Cancer Institute where he served as Director of the AIDS Malignancy Program and held key roles in cancer treatment and diagnosis. He has also worked as an Adjunct Investigator and consultant to biotech firms such as Reprocell and Cancer Genetics. Dr. Bhatia earned his Ph.D. in Biochemistry from the University of Mumbai and completed postdoctoral research at Johns Hopkins University. He is a Fellow of the Royal College of Pathology in the UK.

Lantern Pharma Inc. (NASDAQ: LTRN), closed Wednesday's trading session at $3.38, up 0.2967359%, on 42 volume. The average volume for the last 3 months is 65,007 and the stock's 52-week low/high is $2.55/$6.118.

Recent News

• Lantern Pharma Inc. (NASDAQ: LTRN) - Lantern Pharma Inc. (NASDAQ: LTRN) Is 'One to Watch'
• InvestorNewsBreaks – Panna Sharma, Lantern Pharma CEO, Says FDA’s Elsa AI Rollout Underscores Urgency to Modernize
• BioMedNewsBreaks - Lantern Pharma Inc. (NASDAQ: LTRN) Highlights LP-184 Preclinical Success in Pediatric Brain Cancer ATRT 

Intelligent Bio Solutions Inc. (NASDAQ: INBS)

The QualityStocks Daily Newsletter would like to spotlight Intelligent Bio Solutions Inc. (NASDAQ: INBS).

Intelligent Bio Solutions (NASDAQ: INBS) reported continued growth in the U.S. Forensic Use Only Market through its strategic alliance with SMARTOX, a Texas-based leader in drug and alcohol screening services. SMARTOX has deployed over 50 INBS Intelligent Fingerprinting Drug Screening Readers and conducted more than 7,000 tests to date—including over 1,500 in 2024—demonstrating rising demand for INBS' rapid, non-invasive testing solution. The technology offers a fingerprint sweat-based alternative to urine and saliva tests, improving efficiency, dignity, and ease of use across corrections, rehabilitation, and drug court environments. INBS is also pursuing FDA clearance for its codeine opiate test, with plans to expand into workplace drug testing later this year.

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

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company pioneering rapid, non-invasive diagnostics through its proprietary Intelligent Fingerprinting Drug Screening System. By utilizing fingerprint sweat analysis, the company offers a cost-effective, hygienic solution to detect recent drug use — targeting substances commonly found in workplace settings such as opiates, cocaine, methamphetamine, and cannabis. This innovative approach positions INBS to transform drug testing protocols, particularly in industries where safety and speed are mission critical.

The company’s vision is to redefine drug screening by removing the pain points of traditional testing methods, including biohazardous waste, privacy concerns, and long result turnaround times. With results in under 10 minutes and no need for gender-specific collectors or laboratory facilities, the system empowers companies and organizations to screen more efficiently. INBS continues to drive adoption in international markets, with customers spanning construction, logistics, healthcare, government, and drug treatment sectors.

INBS’s mission is centered on delivering accessible, transformative solutions that improve lives and operational safety. As the company expands toward a planned U.S. market launch in 2025, it is also strengthening its intellectual property portfolio and localizing solutions for Spanish-speaking regions.

The company is headquartered in New York, New York.

Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions’ flagship offering is the Intelligent Fingerprinting Drug Screening System, a portable, three-part solution that includes a fingerprint collection cartridge, a lateral flow-based DSR-Plus reader, and software for rapid drug screening. Designed to be used on-site, this system eliminates the complexities and hazards of urine and saliva tests, offering a clean, fast, and non-invasive alternative.

The system screens for a broad range of substances including opiates, methamphetamine, cocaine, cannabis, benzodiazepines, and more. Its cost advantage is significant — point-of-care fingerprint tests cost approximately $20, compared to $300 for typical urine or saliva testing. The platform includes over 1,000 DSR-Plus Readers installed across customer sites, supporting a base of more than 450 active customer accounts globally. In clinical studies, the system demonstrated 94.1% accuracy and 100% specificity, providing a credible foundation for future FDA approvals and market expansion.

In addition to drug screening, INBS is developing a proprietary biosensor platform designed to detect specific biomarkers from non-invasive samples such as sweat, saliva, and interstitial fluid. These additional applications remain under development.

Market Opportunity

Intelligent Bio Solutions operates at the intersection of workplace safety, public health, and diagnostic innovation. The company is targeting the drug screening products market, which is projected to reach $14.9 billion by 2030, growing at a compound annual growth rate (CAGR) of 12.1%, according to Research and Markets.

In the U.S., substance abuse is a $400 billion issue, with more than 70% of individuals using illicit drugs or alcohol currently employed. This presents an urgent need for scalable, workplace-compatible screening technologies. Industries such as transportation, construction, mining, and healthcare are among the highest adopters of employee drug testing protocols, driven by regulatory requirements and safety imperatives.

INBS’s non-invasive solution is well-positioned to capitalize on trends toward less invasive, faster, and more convenient testing methods — potentially displacing legacy systems reliant on urine or saliva testing, which have longer turnaround times and greater administrative burdens.

Leadership Team

Harry Simeonidis, Chief Executive Officer, has over 25 years of experience across the healthcare, pharmaceutical, and life sciences industries. He previously served as General Manager for Surgery, Asia Pacific at GE Healthcare. Prior to that, he was President and CEO of GE Healthcare ANZ, where he led significant market share growth.

Spiro Sakiris, Chief Financial Officer, brings 34 years of expertise in accounting, taxation, IPO preparation, and capital raising. He is highly experienced with IFRS and U.S. GAAP applications in the life sciences sector and is a member of the Institute of Chartered Accountants of Australia & New Zealand.

Intelligent Bio Solutions Inc. (NASDAQ: INBS), closed Wednesday's trading session at $1.98, up 8.4932%, on 6,870 volume. The average volume for the last 3 months is 155,241 and the stock's 52-week low/high is $1/$3.

Recent News

• Intelligent Bio Solutions Inc. (NASDAQ: INBS) - BioMedNewsBreaks - Intelligent Bio Solutions Inc. (NASDAQ: INBS) Expands U.S. Forensic Market Presence Through SMARTOX Partnership
• Intelligent Bio Solutions Inc. (NASDAQ: INBS) Showcases Portable Drug Testing System at RISE25 as U.S. Expansion Advances
• InvestorNewsBreaks - Why Intelligent Bio Solutions Inc. (NASDAQ: INBS) Is 'One to Watch'

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).

Indonesia, the top producer of nickel in the world, has revoked the mining permits of four companies that had been cleared to conduct operations within Raja Ampat in the east of Papua. The revocation was communicated by the energy minister. Prior to the revocation, there was an outcry by members of the public regarding the potential environmental effects of the proposed mining activities. Conflicts between mining firms and conservationists are likely to increase as the country ramps up its mining activities. For companies like Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) that have opted to conduct their exploration and mine development activities in South Africa, no such conflicts are likely to arise since the areas where they operate are far from protected zones.

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 Wednesday's trading session at $1.71, up 2.3952%, on 3,467 volume. The average volume for the last 3 months is 1,319,854 and the stock's 52-week low/high is $0.99/$2.27.

Recent News

• Platinum Group Metals Ltd. (TSX: PTM) (NYSE American: PLG) - Protests Push Indonesian Government to Cancel Nickel Mining Licenses in Raja Ampat
• RockBreaks - Platinum Group Metals Ltd. (NYSE American: PLG) (TSX: PTM) Positioning at the Center of Critical Materials, Innovation
• New Battery Tech Could Revolutionize Aviation

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).

The company's 3.79 MW Geddes facility is expected to begin generating revenue in June 2025.

The initiative marks one of the first integrations of renewable energy and Bitcoin treasury management.

Management will determine Bitcoin allocation based on market conditions and operational cash flow.

The Geddes site, built on a closed landfill, reflects SolarBank's dual focus on clean energy and land repurposing.

This move could be extended to other solar and battery energy storage projects across the company's 1+ GW pipeline.

SolarBank (NASDAQ: SUUN) (Cboe CA: SUNN) (FSE: GY2) , a premier developer and owner of renewable and clean energy projects, specializing in distributed and community solar initiatives throughout Canada and the U.S., is moving forward with its plan to integrate Bitcoin into its treasury operations by directing net revenue from its soon-to-be-operational Geddes Solar Power Project toward the digital asset. This step marks the company's first allocation of cash flow to Bitcoin since revealing its treasury strategy earlier in June 2025 ( https://ibn.fm/u9bqQ ).

Chinese researchers have come up with a radical proposal that involves generating energy using the Martian atmosphere. According to University of Science and Technology of China (USTC) scientists, the toxic atmosphere on Mars could serve as a medium for generating and storing energy in the future. This could potentially provide a secure and reliable source of energy for the first settlers on Mars and allow scientists stationed on the planet to conduct research over the long term without worrying about energy. USTC researcher Shi Lingfeng says the atmosphere could act as an ‘energy converter' as the air on Mars, which is mostly made up of carbon dioxide, nitrogen, and argon, is decent at converting heat to electricity. He noted that Martian air also has substantial molecular weight as well as a high specific heat, meaning it requires more energy to increase its temperature, which significantly boosts its ability to convert heat to electricity. Using the Martian atmosphere to both generate and store energy would significantly reduce the need to transport heavy battery systems from Earth. It would also enable future missions to harness energy locally, taking advantage of Mars' natural environment instead of relying solely on pre-delivered supplies. Most importantly, this method could provide a stable and scalable energy source capable of sustaining long-term research and development efforts on the Red Planet. The concepts that the Chinese researchers are suggesting are likely to be of interest to enterprises like SolarBank Corp. (NASDAQ: SUUN) (Cboe CA: SUNN) (FSE: GY2) since they could be modified for use here on Earth, especially to improve the existing renewable energy generation and storage technology.

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 Wednesday's trading session at $1.43, up 7.5188%, on 3,878 volume. The average volume for the last 3 months is 325,284 and the stock's 52-week low/high is $1.23/$6.65.

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Vivakor Inc. (NASDAQ: VIVK)

The QualityStocks Daily Newsletter would like to spotlight Vivakor Inc. (NASDAQ: VIVK).

Vivakor (NASDAQ: VIVK) , a vertically integrated energy infrastructure and environmental services company, is focused on the transportation, storage, reuse, and remediation of oilfield fluids and waste. "The company operates a large-scale oilfield trucking fleet, serving key U.S. energy regions, enabling end-to-end solutions for the handling of crude oil and produced water. Through long-term contracts and strategic asset positioning, Vivakor delivers critical services to upstream energy operators seeking efficient and environmentally responsible operations," reads a recent article. "Vivakor's vision is to become a leader in sustainable energy logistics and remediation by combining innovative infrastructure with environmentally conscious practices. The company's integrated model allows it to optimize the flow and treatment of petroleum-based materials across the value chain. By owning and operating both the logistics and remediation components, Vivakor is well-positioned to support an evolving energy ecosystem."

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

Vivakor Inc. (NASDAQ: VIVK) is a vertically integrated energy infrastructure and environmental services company, focused on the transportation, storage, reuse, and remediation of oilfield fluids and waste. The company operates a large-scale oilfield trucking fleet serving key U.S. energy regions, enabling end-to-end solutions for the handling of crude oil and produced water. Through long-term contracts and strategic asset positioning, Vivakor delivers critical services to upstream energy operators seeking efficient and environmentally responsible operations.

Vivakor’s vision is to become a leader in sustainable energy logistics and remediation by combining innovative infrastructure with environmentally conscious practices. The company’s integrated model allows it to optimize the flow and treatment of petroleum-based materials across the value chain. By owning and operating both the logistics and remediation components, Vivakor is well-positioned to support an evolving energy ecosystem.

The company’s mission is to develop, acquire, accumulate, and operate assets, properties, and technologies that enhance efficiency and sustainability within the energy sector. This includes the ongoing development of oilfield waste remediation facilities, which will facilitate the recovery and reuse of petroleum byproducts.

The company is headquartered in Dallas, Texas.

Operations

Vivakor’s operations span crude oil and produced water gathering, transportation, storage, and remediation. Leveraging a large-scale oilfield trucking fleet, the company delivers mission-critical logistics services under long-term agreements with energy producers. Its integrated facility assets support efficient fluid movement and storage while aligning with evolving environmental standards.

The company is actively developing oilfield waste remediation capabilities designed to recycle and safely dispose of petroleum byproducts. These facilities will process contaminated materials and convert them into reusable resources, supporting more sustainable field operations. In 2023, Vivakor expanded its infrastructure through the acquisitions of Silver Fuels Delhi and White Claw Colorado, strengthening its midstream footprint and operational reach across key U.S. basins.

Vivakor delivered triple-digit revenue growth in 2023, reflecting increased demand for its integrated services and the impact of strategic asset expansion. This momentum positions the company for further scale as environmental regulations and logistics needs continue to evolve across the energy sector.

Market Opportunity

Vivakor operates at the intersection of energy logistics and environmental remediation—two sectors undergoing transformation amid rising regulatory pressure and sustainability goals. According to Allied Market Research, the global oilfield services market was valued at $268.1 billion in 2022 and is projected to reach $346.45 billion by 2032, growing at a CAGR of 2.6% during the forecast period. As producers seek efficiency and environmental compliance, demand for integrated logistics and remediation services is expected to grow.

Additionally, the global produced water treatment market is forecast to reach $12.2 billion by 2028, up from $8.6 billion in 2023, driven by increased recycling efforts and stricter disposal regulations. Vivakor’s remediation facilities, once operational, will directly serve this need by offering oilfield clients sustainable waste processing and reuse options.

By addressing both logistical and environmental challenges in energy production, Vivakor is strategically positioned to capture value across multiple growth verticals in a dynamic market landscape.

Leadership Team

James Ballengee, President & Chief Executive Officer, is an energy entrepreneur and operator with over 15 years of experience in oilfield logistics, midstream infrastructure, and energy asset development. Prior to leading Vivakor, he served as Managing Partner at Silver Fuels Delhi and White Claw Colorado, both of which were acquired by Vivakor in 2023. He has held executive roles in multiple energy companies where he focused on developing vertically integrated logistics and remediation systems. Ballengee specializes in contract structuring, capital deployment, and building operationally efficient service platforms across the energy sector.

Tyler Nelson, Chief Financial Officer, is a licensed CPA with extensive experience in public company financial leadership, SEC reporting, and audit readiness. Prior to joining Vivakor, he served as Corporate Controller at two Nasdaq-listed companies and held audit roles at prominent regional accounting firms. His background spans oil & gas, renewables, and technology, where he has led successful finance transformations, SOX compliance rollouts, and investor reporting improvements. At Vivakor, Nelson oversees all financial operations, capital strategy, and compliance functions.

Vivakor Inc. (NASDAQ: VIVK), closed Wednesday's trading session at $0.8558, up 7.1224%, on 2,953 volume. The average volume for the last 3 months is 1,431,508 and the stock's 52-week low/high is $0.5504/$3.45.

Recent News

• Vivakor Inc. (NASDAQ: VIVK) - InvestorNewsBreaks - Why Vivakor Inc. (NASDAQ: VIVK) Is 'One to Watch'
• InvestorNewsBreaks - Vivakor, Inc. (NASDAQ: VIVK) Declares Special Dividend in Adapti Shares 
• InvestorNewsBreaks - Vivakor, Inc. (NASDAQ: VIVK) Reports 133% Revenue Growth and Record Asset Utilization in Q1 2025 

ESGold Corp. (CSE: ESAU) (OTCQB: ESAUF)

The QualityStocks Daily Newsletter would like to spotlight ESGold Corp. (CSE: ESAU) (OTCQB: ESAUF).

ESGold (CSE: ESAU) (OTCQB: ESAUF) CEO and Director Paul Mastantuono joined the Exploring Mining Podcast to discuss the company's fully permitted, near-production Montauban Project in Quebec. In the interview, Mastantuono highlighted ESGold's strategic shift toward surface-accessible resources like tailings and low-cost ore bodies, positioning the company for accelerated production without the typical drilling-heavy approach of junior miners. He also covered recent leadership additions, share structure updates—with fewer than 75 million shares outstanding—and the company's push to finalize concentration testing ahead of first gold production at Montauban.

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

ESGold Corp. (CSE: ESAU) (OTCQB: ESAUF) is a fully permitted, pre-production resource company on a clear path to near-term gold and silver production. With established infrastructure in place and a significant gold-silver resource, the company is uniquely positioned to generate near-term cash flow while unlocking the full potential of its Montauban Gold-Silver Project in Quebec—one of the top mining jurisdictions in the world.

ESGold is building a foundation for long-term growth through a dual-track strategy: cash-flow generation from tailings reprocessing to fund district-scale exploration.

The Montauban site, which operated as a mine for over 80 years, is now undergoing its first-ever systematic exploration program to determine just how large the remaining deposit may be. Near-term cash flow from tailings reprocessing will be used to fund exploration, with the goal of increasing the resource base and uncovering new discoveries across the expansive land package.

ESGold is advancing a scalable and replicable clean extraction model that turns legacy mine sites into revenue generating assets while setting a new industry benchmark for sustainable resource recovery.

The recent completion of a C$3.4M financing has enabled ESGold to initiate the final construction phase of its mill circuit—moving the company decisively toward production of gold and silver in Q3 2025.

Montauban Gold-Silver Project: Production Imminent

Located approximately 80 kilometers west of Quebec City, the Montauban Project is a past-producing gold-silver mine with surface and underground mineralization and over 900,000 tonnes of historical tailings. ESGold has invested over C$15 million to date, building out roads, power access, and a 16,000 sq. ft. processing facility. The company recently completed a C$3.4M financing to begin final construction of the mill circuit.

The company is fully permitted to enter into production that is expected to commence in Q3 2025 with a capacity of 500 tonnes per day, scaling to 1,000 tpd. An updated Preliminary Economic Assessment (PEA) is currently underway to reflect all-time high gold prices and the anticipated upside from the near-surface resource.

Parallels Between Broken Hill & Montauban

Broken Hill, discovered in 1883 in Australia, became the world’s largest source of silver, lead, and zinc—producing over $100 billion worth of metals. What made it unique was that the richest mineral zones were hidden deep underground in a twisted, boomerang-like shape, and it took decades to fully understand just how large the deposit really was.

Geologists now believe ESGold’s Montauban Project in Quebec may share similar traits. Like Broken Hill, it contains high-grade silver, lead, and zinc, along with gold—and sits within the same type of geological system known to host large, high-value mineral deposits. The rock formations, mineral assemblages, and structural complexity all suggest that Montauban could be hiding much more than what’s been historically uncovered. Academic studies now support this possible geological parallel, pointing to further evidence suggesting Montauban was formed under similar conditions as Broken Hill.

Exploration Upside

With production on the horizon, ESGold is advancing a major exploration campaign. Montauban has never undergone systematic modern exploration.

The company is currently completing a large-scale Ambient Noise Tomography (ANT) survey—a powerful 3D imaging technology that will define the size, shape, and continuity of the mineralized system. ANT is already showing strong results, with imaging going beyond the original 400m depth target and now expected to exceed 800m. This cutting-edge technology has the potential to reveal the full extent of the anomaly for the first time in Montauban’s 110-year history.

Scalable, Replicable, Clean Mining

Montauban is also part of a broader vision. Across Canada and globally, there are hundreds of orphaned or legacy mine sites that remain unrehabilitated despite containing valuable residual metals in tailings. Quebec alone is home to more than 259 of these sites, highlighting the scale of the opportunity. ESGold is advancing a scalable and replicable clean extraction model that transforms legacy sites into productive assets while setting a new benchmark for sustainable resource recovery.

The company has also performed testing that utilizes Dundee Sustainable Technologies’ CLEVR Process™, a proprietary non-cyanide extraction method that achieved 90.9% gold recovery in lab testing. This clean processing approach remains a valuable and scalable asset supporting ESGold’s near-term production and exploration growth strategy.

As a complement to its core mining operations, ESGold is developing clean technology solutions through a joint venture with DMCMS Inc. This initiative includes a polymer division that manufactures environmentally friendly products such as road stabilizers, dust suppressants, and other industrial blends—expanding the company’s sustainable commercial footprint.

Market Opportunity

ESGold is operating in a unique and specialized segment of the mining industry—reprocessing and revitalizing legacy mine sites. The Montauban Project offers both near-term cash flow and long-term growth potential by converting tailings into revenue while systematically exploring for additional high-value mineral endowments. The company’s established infrastructure, full permitting, and reclamation approvals reduce development risk and enhance execution timelines.

The broader green mining market is projected to reach $15.92 billion by 2030, according to Grand View Research. This growth is being driven by increased demand for responsible extraction methods, ESG-aligned practices, and critical mineral security. With construction underway at its fully permitted Montauban site—and exploration advancing along a Broken Hill-type geological model—ESGold is well positioned to emerge as Canada’s next premier gold and silver producer.

Leadership Team

Paul Mastantuono, Chief Executive Officer and Director, graduated with distinction from the University of Ottawa with a bachelor’s degree in social science, concentrating in criminology. He has extensive experience in the construction and transportation industries and has worked as an independent business consultant for various companies, including DNA Precious Metals Inc.

Brad Kitchen, President and Director, brings over 35 years of experience in investment banking and senior corporate management, primarily with resource-based companies. He has a detailed knowledge of regulatory, security, and tax issues, cross-border financings, and market influences, which he has applied to address business challenges for issuers and investors. Mr. Kitchen was also CEO of Eagle Hill Exploration, the company that generated in only five years the first Bankable Feasibility Study on the Windfall Lake Gold Project that was recently sold by Osisko Mining to Gold Fields for US$1.6 billion.

Andre Gautier, Senior Geologist and Director, brings over 47 years of experience in the Mining Exploration field and has worked in over 35 countries. His work experience includes entities such as: SOQUEM, Falconbridge Ltd., Noramco and Cambior Inc. Mr. Gauthier was president of MaxyGold Corp. (China), INCA Pacific Resources Inc., Lara Exploration Ltd., and Gold Holding Ltd. Mr. Gauthier also served as a Director of Vena Resources Inc., MaxyGold Corp., Lara Exploration Ltd., Western Union Peru, and Gold Holding Ltd., and from March 2015 until 2018, he served as interim Managing Director and CEO of Gold Holding Ltd., headquartered in Dubai (UAE). He has a BSC in Geology Eng. and MSC from UQAC (Chicoutimi, Quebec) and is an active member and leader of many mining and professional organizations (Canada, Peru, UAE, and China).

ESGold Corp. (OTCQB: ESAUF), closed Wednesday's trading session at $0.6642, up 2.9927%, on 506,225 volume. The average volume for the last 3 months is 313,620 and the stock's 52-week low/high is $0.0221/$0.7383.

Recent News

• ESGold Corp. (CSE: ESAU) (OTCQB: ESAUF) - InvestorNewsBreaks - ESGold Corp. (CSE: ESAU) (OTCQB: ESAUF) CEO Talks Near-Term Production and Clean Mining Focus on Exploring Mining Podcast 
• MiningNewsBreaks - ESGold Corp. (CSE: ESAU) (OTCQB: ESAUF) Advances Toward First Production at Montauban Project
• ESGold Corp. (CSE: ESAU) (OTCQB: ESAUF) Tests Potential for Streamlining Tailings Process, Offering Important Cost and Environment Benefits

Nightfood Holdings Inc. (OTCQB: NGTF)

The QualityStocks Daily Newsletter would like to spotlight Nightfood Holdings Inc. (OTCQB: NGTF).

As the world watches Foxconn and NVIDIA deploy smart robotics in Taiwan's cutting-edge hospitals, the same technology driven future is quietly taking shape across the American hospitality industry. Led by companies like SkyTech Automated Solutions, a wholly owned subsidiary of Nightfood Holdings, Inc. (OTCQB: NGTF). Foxconn's recent unveiling of its NVIDIA-powered hospital robots signals a monumental shift: combining real-time AI with robotics to improve labor efficiency, safety, and service personalization. The smart hospital model represents not just a technological leap, but a redefinition of how service delivery is imagined in labor-intensive environments. As Nightfood Holdings builds a vertically integrated hospitality ecosystem, from late-night nutritional offerings to smart robotics, the alignment of SkyTech's mission with global trends is clear. Like NVIDIA and Foxconn in the medical space, Nightfood and SkyTech are building a next-gen infrastructure for the American hotel sector, driven by automation, AI, and a new national focus on domestic technological leadership.

Nightfood Holdings Inc. (OTCQB: NGTF) is a hospitality technology and asset acquisition company revolutionizing hotel operations through AI-driven service robotics and strategic property acquisitions. By integrating advanced automation solutions with high-value hospitality assets, NGTF is setting a new standard for operational efficiency, cost reduction, and labor optimization in the hospitality industry.

With a focus on Robotics-as-a-Service (RaaS) and hotel ownership, NGTF is uniquely positioned at the intersection of technology and real estate, creating scalable, revenue-generating solutions that drive the widespread adoption of automation in the hospitality sector.

Operations

Nightfood Holdings is focused on two core business areas:

• Hotel Acquisitions & Operations – NGTF is acquiring a portfolio of independent hospitality properties, spanning various market segments from midscale to luxury. These hotels serve as real-world testbeds for automation technologies, allowing NGTF to refine its RaaS solutions before deploying them at scale.
• Robotics-as-a-Service (RaaS) for Hospitality – NGTF provides subscription-based, AI-driven robotic automation, designed to optimize hotel operations. By deploying standardized automation solutions, NGTF helps hotels reduce costs, improve labor efficiency, and enhance guest experiences.

Through this fully integrated model, NGTF ensures that its robotics solutions are tested, optimized, and proven profitable before expanding to third-party hotel operators.

Market Opportunity

The demand for automation in hospitality is accelerating, driven by labor shortages, rising costs, and increased competition. NGTF is positioned to capitalize on this shift through its combined hotel ownership and RaaS strategy.

• Total Addressable Market (TAM): The global service robotics market is projected to reach approximately $107.75 billion by 2030, driven by widespread adoption across industries including hospitality, according to Research and Markets.
• Serviceable Available Market (SAM): The global smart hospitality market, which includes AI and automation technologies for hotels, is projected to reach $186.10 billion by 2032, according to SNS Insider.
• Competitive Positioning: NGTF’s unique real estate + automation model allows it to implement cost-saving robotics solutions in real-world environments before expanding adoption across the industry.

Industry Impact: The Future of Smart Hotels

NGTF is at the forefront of next-generation hospitality automation, transforming how hotels operate. By combining AI-powered service robotics with real estate acquisitions, NGTF is pioneering the transition to smart, highly efficient hotel environments.

Hotels acquired by NGTF serve as testing grounds for robotics deployment, allowing the company to continuously refine its automation solutions. The biggest industry benefits include:

• Cost Savings for Hotel Operators – Reducing labor costs and improving operational efficiency.
• Scalability & Standardization – Offering a streamlined, subscription-based RaaS model for seamless automation adoption.
• Industry Leadership in Hotel Robotics – Driving the transformation of hospitality with AI-powered automation solutions.

Future Vision & Growth Strategy

Over the next three to five years, NGTF is committed to scaling both its hotel portfolio and RaaS adoption. By refining and optimizing its automation technologies in its own properties, NGTF will continue deploying RaaS to third-party hotel operators, positioning itself as a leader in next-generation hospitality automation.

Through strategic acquisitions and AI-driven solutions, NGTF is defining the future of smart hotels—delivering cost-efficient, scalable automation that reshapes the hospitality landscape.

Team Expertise as a Strategic Advantage

In addition to technology and real estate, NGTF’s most powerful asset is its team. The company’s leadership and operating partners bring deep expertise in both hospitality and food service, having collectively developed over 50 properties, managed more than 130 hotels, and supported more than 6,000 quick-service restaurants.

This wealth of experience enables NGTF to execute its automation and acquisition strategy with operational discipline, industry insight, and scale—further strengthening its position in next-generation hospitality.

Nightfood Holdings Inc. (OTCQB: NGTF), closed Wednesday's trading session at $0.0201, off by 14.0291%, on 1,415,695 volume. The average volume for the last 3 months is 307,900 and the stock's 52-week low/high is $0.0053/$0.0571.

Recent News

• Nightfood Holdings Inc. (OTCQB: NGTF) - Smart Hospitality: SkyTech Robots and the Future of U.S. Service Innovation Through AI
• AINewsBreaks - Nightfood Holdings Inc. (NGTF): Where Hospitality Meets High Tech
• Nightfood Holdings Inc. (NGTF) Expands Hospitality Automation with Strategic Hotel Acquisitions

Adageis

The QualityStocks Daily Newsletter would like to spotlight Adageis

The company offers a simple, AI-powered platform that helps providers identify their most valuable services, bringing clarity to complex insurance contracts, and highlighting where clinics can optimize revenue.

The platform's AI analytics help to identify high-risk patients and close care gaps efficiently, while letting providers track financial performance over time, aligning income with quality of care.

Adageis continues to grow and expects to cover 580,000 patient lives by Q2 2025 and reach $100,000 in monthly recurring revenue.

As healthcare shifts further toward value-based care, one challenge continues to frustrate providers: understanding how care quality translates into financial outcomes. Adageis, a growing healthcare technology company with a patented AI-driven platform, is offering providers tools that both simplify operations and improve financial performance under value-based care models.

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 Allows Healthcare Providers Maximum Value-Based Care Revenue with Simplicity and Visibility
• InvestorNewsBreaks – Adageis Empowers Providers with Actionable Insights for Value-Based Care Success
• AINewsBreaks – Adageis’ AI-Powered Insights Aim to Improve Outcomes, Revenue Forecasting

Calidi Biotherapeutics Inc. (NYSE American: CLDI)

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

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 Wednesday's trading session at $0.3439, up 6.8344%, on 541 volume. The average volume for the last 3 months is 462,350 and the stock's 52-week low/high is $0.312/$3.89.

Recent News

• Calidi Biotherapeutics Inc. (NYSE American: CLDI) - TinyGemsBreaks - Calidi Biotherapeutics Inc. (NYSE American: CLDI) Taps Biotech Veteran to Lead Next Phase of Growth
• TinyGemsBreaks - Calidi Biotherapeutics Inc. (NYSE American: CLDI) Unveils Promising Data on CLD-401 at ASCO 2025
• University of Houston Gets $3M to Establish Biomarker Core for Cancer Immunotherapy

FAVO Capital Inc. (OTC: FAVO)

The QualityStocks Daily Newsletter would like to spotlight FAVO Capital Inc. (NASDAQ: FAVO).

FAVO Capital Inc. (OTC: FAVO) is redefining the private credit and alternative lending industry through a strategic redevelopment of its operations and offerings. With a focus on leveraging financial technology and a client-centric approach, FAVO Capital empowers small to medium-sized businesses with fast, flexible, and reliable access to capital, bridging the gap left by traditional financial institutions.

Empowering Businesses, Redefining Private Credit

As part of its strategy to uplist to Nasdaq, FAVO Capital is enhancing its technology platform, operational scalability, and market positioning to meet higher regulatory standards and attract institutional investors. Headquartered in Fort Lauderdale, Florida, FAVO employs over 120 professionals across five global offices, delivering sustainable growth and value for clients and shareholders alike.

Products and Services

• Proprietary Lending Platform and Mobile App (In Development): FAVO Capital is in the early stages of developing an advanced digital platform designed to enhance client engagement and streamline funding processes. This platform will eventually allow businesses to apply for funding products, track progress, and manage repayment efficiencies. A complementary mobile app is also being planned to provide real-time insights and tailored recommendations, laying the groundwork for an improved borrower experience.
• Fintech-Driven Lending Solutions: FAVO Capital is exploring proprietary and third-party technology tools, including advanced analytics and algorithms, to enhance decision-making speed and reliability in the lending process.
• Flexible Financing Options: FAVO specializes in structuring customized capital solutions tailored to the diverse needs of small business owners, offering scalable and adaptable products that evolve with changing market conditions.

Market Opportunity

The private credit market is experiencing exponential growth as traditional banks reduce their focus on small business lending. According to industry reports, the global private credit market is projected to surpass $1.5 trillion by 2025, driven by increasing demand for alternative financing options.

FAVO Capital is uniquely positioned to capture market share within this booming sector by leveraging fintech innovation to meet the needs of underserved small businesses. With a focus on efficiency, speed, and client satisfaction, FAVO addresses critical gaps in the financial ecosystem while building a platform for long-term growth.

Recent Highlights

• Fintech Innovation: Initial investments in app development and analytics lay the groundwork for future operational efficiency and improved borrower experience.
• Operational Scale: A global footprint with over 120 employees combines the agility of a local lender with the reach of an international financial institution.
• Proven Growth: FAVO’s technology-driven approach has enabled consistent expansion, solidifying its reputation as a trusted partner for small businesses.

Leadership Team

Vincent Napolitano is a Founder and CEO of FAVO Capital Inc. With over two decades of experience in finance and business development, Vincent has been instrumental in building FAVO Capital into a trusted partner for businesses seeking innovative financial strategies. Prior to founding FAVO Capital, Vincent spent 25 years on Wall Street, holding key positions at prominent firms and developing expertise in structuring complex financial deals. He also served as Chief Investment Officer for multiple special purpose vehicles (SPVs), acquiring private stock in pre-IPO unicorn companies such as Facebook and Twitter.

Shaun Quin is a Founding Member and President of FAVO Capital Inc., overseeing the company’s mission to deliver innovative and efficient private credit solutions to small and medium-sized businesses. With over 20 years of global experience as a partner, investor, and director, Shaun brings a strategic and customer-focused approach to his leadership. His expertise in fostering collaboration, building high-performance cultures, and empowering businesses has positioned FAVO Capital as a trusted leader in private lending.

Vaughan Korte, CFO, brings over 15 years of global financial expertise to his role with FAVO Capital Inc. His track record includes managing financial operations for Adidas across 60 countries with budgets exceeding $500 million. Vaughan’s leadership ensures FAVO Capital remains financially resilient, aligning financial strategy with organizational goals and fostering shareholder value.

Glen Steward, Chief Strategy Officer, is a seasoned entrepreneur with over 28 years of experience in the investment and trading industries. He drives FAVO Capital’s strategic initiatives, ensuring the company remains competitive and agile in a rapidly evolving market. Glen has held directorships and board memberships across Mauritius, South Africa, and the United States. His strategic acumen has been pivotal in integrating the FAVO Group of Companies into FAVO Capital Inc., fueling growth and market leadership.

Advisory Board

Bilal Adam, Accounting & Financial Counsel, is a financial expert with over 20 years of experience, including roles as CEO of Stewards Investment Capital. His insights into bespoke investment solutions, including fixed income, equity, and digital assets, support FAVO Capital’s innovative approach to private credit.

Honorable Earnest Hart, Corporate Governance Counsel, brings decades of legal and governance experience, having served as a New York Supreme Court Judge and COO at Columbia University Medical Center. His guidance ensures FAVO Capital maintains robust corporate governance standards.

Rocco Trotta, Business Leadership and Scalability Counsel, is the co-founder of LiRo-Hill and has decades of experience scaling businesses. His expertise in organizational efficiency and talent development strengthens FAVO Capital’s ability to attract excellence across all aspects of the business.

As FAVO Capital redevelops its operations and prepares for an uplisting to Nasdaq, the company is laying the foundation to redefine private credit with emerging fintech solutions and exceptional leadership. Learn more by visiting investors.favocap.com.

FAVO Capital Inc. (OTC: FAVO), closed Wednesday's trading session at $1.68, even for the day, on 7,050 volume. The average volume for the last 3 months is 1,010 and the stock's 52-week low/high is $0.162/$1.75.

Recent News

• FAVO Capital Inc. (OTC: FAVO) - InvestorNewsBreaks - AI-Driven Lending: FAVO Capital Inc. (FAVO) Sets New Standard in Funding Solutions for SMBs
• FAVO Capital Inc. (FAVO): Positioned to Capitalize on Small Business Lending Revival
• FAVO Capital Inc. (FAVO): Filling the Financing Gap for Underserved SMBs

Soligenix Inc. (NASDAQ: SNGX)

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

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 Wednesday's trading session at $1.89, up 1.0695%, on 89 volume. The average volume for the last 3 months is 21,561 and the stock's 52-week low/high is $1.68/$14.8299.

Recent News

• Soligenix Inc. (NASDAQ: SNGX) - Soligenix Inc. (NASDAQ: SNGX) Offers Hope on the Horizon with HyBryte(TM) Treatment Targeting CTCL
• BioMedNewsBreaks - Soligenix Inc. (SNGX) Highlights HyBryte Progress in CTCL via New Podcast Featuring Dr. Ellen Kim
• New Swallowable Pill Provides Real-Time Gut Inflammation Tracking

Clene Inc. (NASDAQ: CLNN)

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

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

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

CNM-Au8

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

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

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

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

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

Market Opportunity

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

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

Management Team

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

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

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

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

Clene Inc. (NASDAQ: CLNN), closed Wednesday's trading session at $4.2, off by 1.4085%, on 3,755 volume. The average volume for the last 3 months is 136,313 and the stock's 52-week low/high is $2.2801/$8.6.

Recent News

• Clene Inc. (NASDAQ: CLNN) - InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) CEO Rob Etherington to Present at June 10 Investor Summit Virtual
• Study Links Autism to Increased Risk of Developing Parkinson's Disease
• Researchers Discover Potential Missing Connection Between EBV and Multiple Sclerosis