Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)

The QualityStocks Daily Newsletter would like to spotlight Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP).

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Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is a fully-integrated biopharmaceutical company dedicated to developing, licensing, and commercializing innovative therapeutics aimed at treating and preventing human diseases and alleviating suffering. The company’s development portfolio is primarily focused on central nervous system (CNS) disorders, with its lead product candidate, TNX-102 SL, showing significant promise for the management of fibromyalgia. With two successful Phase 3 studies completed, Tonix is preparing to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, which has also been granted Fast Track designation. In addition to fibromyalgia, TNX-102 SL is being developed to treat acute stress reactions, further broadening its therapeutic potential.

Tonix’s CNS portfolio also includes TNX-1300, a biologic designed to treat cocaine intoxication, which has been granted Breakthrough Therapy designation by the FDA. This designation underscores the urgency and significance of developing an effective treatment for cocaine intoxication, a critical need in the healthcare system. Beyond CNS disorders, Tonix is expanding its immunology portfolio with the development of TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154). TNX-1500 is being developed for the prevention of allograft rejection and the treatment of autoimmune diseases, highlighting Tonix’s commitment to addressing complex and challenging medical conditions.

In addition to its robust pipeline, Tonix has an established commercial presence through its subsidiary, Tonix Medicines, which markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine in adults. The company’s diverse portfolio, spanning CNS disorders, immunology, rare diseases, and infectious diseases, positions Tonix as a leader in biopharmaceutical innovation, with a strong focus on developing therapies that address unmet medical needs and improve patient outcomes.

TNX-102 SL

TNX-102 SL is a groundbreaking, non-opioid, non-addictive investigational drug developed by Tonix Pharmaceuticals for the management of fibromyalgia where patients suffer chronic musculoskeletal pain, sleep deprivation, fatigue and mood changes. This patented sublingual formulation of cyclobenzaprine hydrochloride has demonstrated remarkable efficacy in clinical trials, including the recent RESILIENT Phase 3 trial, where it achieved highly statistically significant results in reducing daily pain compared to placebo (p=0.00005). The drug also showed significant improvements in sleep quality, fatigue reduction, and overall fibromyalgia symptoms and function across all key secondary endpoints. With similar success in the earlier RELIEF Phase 3 trial, TNX-102 SL is positioned as a promising new treatment option for fibromyalgia, particularly given its favorable safety profile, where the most common side effect was mild and self-limiting tongue or mouth numbness.

Recently granted Fast Track Designation by the FDA, TNX-102 SL is on course for a New Drug Application (NDA) submission in the second half of 2024. This designation highlights the urgent need for new fibromyalgia treatments and underscores the drug’s potential to effectively address this challenging condition. With its strong clinical results and focus on improving multiple aspects of fibromyalgia, TNX-102 SL offers hope for patients seeking better management of their symptoms and represents a significant advancement in the treatment landscape for this debilitating disorder.

Market Opportunity

From an investment perspective, Tonix Pharmaceuticals is strategically positioned to capitalize on the growing demand for effective treatments in the central nervous system (CNS) disorder market, particularly within the fibromyalgia segment, which is estimated to affect up to 10 million people in the U.S. alone. With the potential approval of TNX-102 SL, Tonix could tap into a significant and underserved market, offering a non-opioid alternative for a condition that currently has limited treatment options. The recent positive results from the Phase 3 trials and the FDA’s Fast Track designation increase the likelihood of TNX-102 SL gaining market approval, which could significantly boost Tonix’s market share and revenue potential.

In addition to its lead candidate, Tonix’s diversified pipeline, which includes treatments for conditions such as cocaine intoxication and autoimmune diseases, broadens market opportunities and reduces single product dependency. The company’s established commercial presence with its migraine treatments, combined with the advancement of its CNS and immunology portfolios, positions Tonix to become a key player in the biopharmaceutical industry. As the company moves closer to potential product launches and reached new clinical milestones, it stands to attract substantial investor interest, offering significant upside potential as it addresses critical unmet needs across multiple therapeutic areas.

Leadership Team

Dr. Seth Lederman is the Co-Founder, CEO, and Chairman of Tonix Pharmaceuticals, bringing decades of experience in the biotechnology and pharmaceutical industries. A trained physician and scientist, Dr. Lederman has been instrumental in leading Tonix’s strategic direction and advancing its pipeline of innovative therapeutics. He has a strong background in immunology and infectious diseases, with numerous contributions to medical research and drug development. Dr. Lederman earned his MD from Columbia University, where he also served as an Associate Professor.

Dr. Gregory Sullivan is the Chief Medical Officer of Tonix Pharmaceuticals, where he oversees the clinical development and regulatory strategy for the company’s therapeutic programs. With extensive experience in psychiatry and CNS disorders, Dr. Sullivan plays a key role in guiding Tonix’s clinical trials and ensuring the scientific rigor of its development efforts. Before joining Tonix, Dr. Sullivan had a distinguished career in academic medicine and clinical research. He holds an MD from the University of California, San Francisco, and has published widely on topics related to psychiatry and neurological disorders.

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), QQQQQQQ

Recent News

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• Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) - InvestorNewsBreaks - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) to Present at 2025 Virtual Investor Summit
• InvestorNewsBreaks - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Reports Preliminary 2024 Financial Results
• InvestorNewsBreaks - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Reports Positive Phase 1 Results for TNX-1500 in Transplant and Autoimmune Therapy

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Clene Inc. (NASDAQ: CLNN)

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

The Q1 Virtual Investor Summit will focus on microcap companies that are undervalued, and aim to create connections between leading investors and microcap companies

Clene's presentation will be given by CEO Rob Etherington and CFO Morgan Brown

Clene's participation in the event comes as the company is moving closer to submitting a New Drug Application to the FDA to secure potential accelerated approval for CNM-Au8 ^® for ALS

The company recently partnered with German-based APST Research GmbH to analyze neurofilament light chain ("NfL") data for evaluating CNM-Au8 efficacy in ALS patients.

Clene Inc. (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis ("ALS"), and multiple sclerosis ("MS"), will attend the Q1 Virtual Investor Summit event on March 11 to showcase its latest achievements and outline the next steps for lead drug candidate CNM-Au8 ( https://ibn.fm/YHqIv ).

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 $4.4, up 3.2864%, on 4 volume. The average volume for the last 3 months is 43,970 and the stock's 52-week low/high is $3.8181/$10.4.

Recent News

• Clene Inc. (NASDAQ: CLNN) - Clene Inc. (NASDAQ: CLNN) to Highlight Latest Achievements, Next Steps for CNM-Au8(R), at Q1 Virtual Investor Summit on March 11
• Clene Inc. (NASDAQ: CLNN) Leverages APST's NfL Database to Support FDA-Recommended Analyses for ALS Drug
• InvestorNewsBreaks - Clene Inc. (NASDAQ: CLNN) CEO and CFO to Present at Investor Summit Virtual on March 11

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

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

Scinai Immunotherapeutics (NASDAQ: SCNI) , a biopharmaceutical company focused on inflammation and immunology biological products and contract development and manufacturing organization (CDMO) services, has entered into a standby equity purchase agreement with YA II PN, Ltd., a fund managed by Yorkville Advisors Global. The agreement allows Scinai to sell up to $10 million of its American Depository Shares to Yorkville over a three-year period, subject to certain conditions, including a 9.99% beneficial ownership cap. The company retains full control over the timing and amount of any sales, with no obligations or penalties for non-use. Proceeds will support the development of Scinai's NanoAbs programs, expansion of its CDMO business, and general corporate purposes.

To view the full press release, visit https://ibn.fm/yN91u

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

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

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

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

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

Lead Candidate: Inhaled COVID-19 NanoAb

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

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

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

NanoAb Pipeline: Psoriasis, Asthma and More

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

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

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

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

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

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

CDMO Services

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

Market Opportunity

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

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

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

Management Team

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

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

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

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

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), closed Wednesday's trading session at $3.465, up 3.6804%, on 2 volume. The average volume for the last 3 months is 18,230 and the stock's 52-week low/high is $2.23/$8.92.

Recent News

• Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) - BioMedNewsBreaks - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Enters $10 Million Standby Equity Purchase Agreement
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FingerMotion Inc. (NASDAQ: FNGR)

The QualityStocks Daily Newsletter would like to spotlight FingerMotion Inc. (NASDAQ: FNGR) .

The global market for mobile payments is predicted to grow by nearly 30% over the next 8 years. Mobile payment systems have been around for well over a decade and a half, but they didn't truly become mainstream in the West until the coronavirus pandemic hit. Lockdowns and isolation orders forced tens of millions of people to avoid physical currency in favor of contactless payments. Plenty of consumers continued using mobile payment systems even after the pandemic ended due to the ease of use and the convenience they offer. The prolific use of online shopping platforms has also contributed to the increasing popularity of virtual payment services. Consequently, experts project that the fledgling mobile payment market will see a compound annual growth rate (CAGR) of 29.5% and reach $736.8 billion in value by 2033. The patchwork of different national regulations that govern mobile money also make it difficult for transnational operators to conduct business. Compliance with all these policies will be key to ensuring mobile money achieves full market penetration across different countries. Companies like FingerMotion Inc. (NASDAQ: FNGR) that have interests in the mobile payments space of countries like China need to position themselves appropriately so that they can claim a significant share of the projected growth that this market is expected to experience over the coming decade.

FingerMotion Inc. (NASDAQ: FNGR) is an evolving technological company with core competencies in mobile payment and recharge platform solutions in China. FingerMotion is in the process of developing additional value-added technologies to market to users.

Founded in 2016, FingerMotion’s goal is to serve over a billion users in the Chinese market and expand its model to other regional markets. The company has offices in Hong Kong, Shanghai and New York City.

Current Offerings

FingerMotion is analyzing and transforming mobile data to improve the lifestyle of the public through technology and innovation. The company’s current offerings include:

• Telecommunications Products and Services – FingerMotion’s proprietary universal exchange platform, ‘PigeonHole Integration System (PIS)’, offers seamless integration between telecom operators and online stores. The service platform’s offerings include top up and recharge, data plan, mobile phone, loyalty points redemption and subscription plans. The platform offers reliable and secure transactions, real-time reconciliation, simple integration for partners and efficient settlements.
• SMS and MMS Services – The integrated platform is registered as FingerMotion’s IP in China and provides a robust back-end control panel for corporate partners to manage their own messaging settings. FingerMotion’s clients range from insurance to financial industries, ecommerce firms, airlines and more. The platform offers competitive pricing for partners and provides quick and efficient review to meet timely marketing initiatives.
• Big Data Insights – FingerMotion brings Big Data-enabled insurance solutions through its Big Data Insights arm, Sapientus. The company’s strategic partnerships with the largest Chinese telecommunications giants allow access to uncover behavior insights through geolocation and mobile data usage. Its Big Data offerings include risk scoring, precise marketing, simplified underwriting and customized products.
• Rich Communication Services (RCS) – FingerMotion’s RCS platform will be a proprietary business messaging solution that enables businesses and brands to communicate their services to customers via 5G infrastructure. The company expects its RCS platform to offer a better user experience, more efficiency and cost-effectiveness when compared to other solutions.

Telecommunications and Insurtech Markets

The global telecommunications market was valued at $1.74 trillion in 2019 and is expected to grow at a CAGR of 5% from 2020 to 2027. The steady increase is expected to be driven by the adoption of 5G and the increased popularity of Internet of Things (IoT) applications.

The Chinese telecom market was valued at $254.1 billion in 2017 and is also constantly expanding. The current Chinese telecom market is dominated by three mobile operators – China Mobile, China Unicom and China Telecom, which together are responsible for around 1.6 billion active subscribers (https://ibn.fm/zfwy9).

In addition, the insurtech (insurance technology) market was valued at $2.72 billion globally in 2020 and is expected to grow at a CAGR of 48.8% from 2021 to 2028. The large increase is attributed to the rising use of technology solutions for everyday activities like acquiring insurance coverage (https://ibn.fm/TGo7D).

Through its proprietary platforms and technologies, FingerMotion is uniquely positioned to capitalize on the telecom and insurtech markets’ growth and opportunities.

Management Team

Martin J. Shen is the Chief Executive Officer of FingerMotion Inc. He has over 15 years of experience in senior management roles within entrepreneurial startups and large multinational corporations. He has acquired a wide range of corporate management, financial oversight and operation administration expertise through these roles. In his most recent role, he founded Imperial Distributors (formerly known as AP Martin Pharmaceutical Supplies Ltd.), establishing the company as the preferred choice for distributional support to regional pharmacies throughout Western Canada. Before founding Imperial, Mr. Shen served as the Chief Operating Officer and Chief Financial Officer at Wales and Son Industrial (formerly Weir Minerals), a firm specializing in global delivery and support for mining slurry equipment. He began his career at PricewaterhouseCoopers in Vancouver, with work tours in the tax department in Singapore and the tax audit and advisory group in Hong Kong. Mr. Shen is a U.S. Certified Public Accountant and holds a Bachelor of Science from the University of British Columbia.

Lee Yew Hon is the company’s Chief Financial Officer. From 2006 until November 2020, he was the Chief Financial Officer of Cubinet Interactive Group of Companies, and he also took on the Chief Operating Officer role in 2011. During his tenure, he was instrumental in leading Cubinet and building teams across the Southeast Asia region, setting up financial processes within a short time. Mr. Lee spearheaded the growth of Cubinet to other regions, including Europe, the Middle East and Russia. He received his diploma from Tunku Abdul Rahman College in 1996. He is a Chartered Accountant, a member of the Malaysia Institute of Accountants (MIA) and an Associate Member of the Chartered Institute of Management Accountants, UK (ACMA).

Li Li is the Senior Vice President of FingerMotion. She recently served as Advisor to Shenzhen WuYiKa Technology Co. Ltd., a comprehensive service platform dedicated to online service distribution and payment. The company has become a fast and efficient provider of new media marketing solutions for the mobile internet. She has held high-level management positions with multiple industry names, including Hangzhou JiuYue Information Technology Co. Ltd. and Hangzhou LingXuan Information Technology. Ms. Li started her career in 2004, founding Shanghai ChuangYeZZ Network Technology Co. Ltd. and serving as its Vice President. With the close cooperation of local operators, the company launched SMS, MMS, WAP, mobile JAVA games, Hunan Satellite TV e-magazine and other wireless internet services to meet the rapid development of wireless internet and application requirements. She received her degree from Nanjing Academy of Engineering.

FingerMotion Inc. (FNGR), closed Wednesday's trading session at $1.4, up 11.1111%, on 12,482 volume. The average volume for the last 3 months is 246,055 and the stock's 52-week low/high is $1.03/$3.96.

Recent News

• FingerMotion Inc. (NASDAQ: FNGR) - ChineseNewsBreaks - FingerMotion Inc. (NASDAQ: FNGR) Announces Board Elections and Executive Appointments
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TC BioPharm Holdings PLC (NASDAQ: TCBP)

The QualityStocks Daily Newsletter would like to spotlight TC BioPharm Holdings PLC (NASDAQ: TCBP).

TC BioPharm (NASDAQ: TCBP) a clinical-stage biotechnology company developing allogeneic gamma-delta T cell therapies, announced the execution of a non-binding letter of intent to acquire a commercial-stage ophthalmic pharmaceutical company specializing in glaucoma and ocular hypertension treatments. The acquisition target has an FDA-approved once-daily eye drop and a pipeline of ophthalmology assets, with a commercial launch expected to drive revenue growth in 2025. TC BioPharm plans to finalize a binding agreement in the coming weeks and complete the all-stock transaction in the third quarter of 2025, expanding its portfolio into new therapeutic areas.

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

TC BioPharm Holdings PLC (NASDAQ: TCBP) is a clinical-stage biopharmaceutical company pioneering the development and commercialization of gamma-delta T cell therapies for the treatment of cancer, with a particular focus on acute myeloid leukemia (AML). Gamma-delta T cells are unique immune cells that possess characteristics of both the innate and adaptive immune systems, allowing them to distinguish between healthy and diseased tissues. This dual capability makes them a powerful tool in the fight against cancer, and TC BioPharm is at the forefront of harnessing this potential to develop innovative therapeutics.

As the leader in gamma-delta T cell therapy development, TC BioPharm is the first company to advance to Phase II/pivotal clinical studies in oncology. The company is currently conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line, including a Phase 2b/3 pivotal trial for the treatment of acute myeloid leukemia. This trial utilizes TC BioPharm’s proprietary allogeneic CryoTC technology, which enables the production and distribution of frozen gamma-delta T cell products to clinics worldwide, ensuring broader accessibility and consistency in treatment.

TC BioPharm’s commitment to advancing gamma-delta T cell therapies reflects its broader mission to develop cutting-edge, immune-based treatments that address significant unmet medical needs in oncology. By leveraging the unique properties of gamma-delta T cells, the company aims to revolutionize cancer treatment and improve outcomes for patients with difficult-to-treat cancers like acute myeloid leukemia. With its pioneering approach and robust clinical pipeline, TC BioPharm is well-positioned to become a leader in the field of immuno-oncology.

TCB-008

TC BioPharm’s lead candidate, TCB-008, is an innovative allogeneic gamma-delta T cell therapy currently being evaluated in the ACHIEVE UK clinical trial, a Phase II study targeting patients with acute myeloid leukemia (AML) or myelodysplastic syndromes progressing to AML (MDS/AML). The trial is designed to assess the efficacy and safety of TCB-008 in two distinct patient cohorts: those with relapsed/refractory disease and those in remission but with detectable residual disease. Recently, the trial advanced to a higher dose level, with the sixth patient receiving treatment under the amended protocol, which includes up to 230 million cells per dose—a significant increase from the previous 35 million cells. This dose escalation aligns with the medium dose cohort proposed for the company’s FDA trial in AML, highlighting the company’s commitment to optimizing treatment efficacy.

The ACHIEVE trial represents a critical milestone in TC BioPharm’s development of TCB-008 as a potentially transformative therapy for AML. The ability to advance either cohort independently to a Phase III Pivotal Trial upon meeting primary efficacy endpoints underscores the trial’s flexibility and the potential for rapid progression. With plans to enroll up to 24 patients in each cohort and interim data expected within the next six to nine months, TC BioPharm is likely to achieve key inflection points in 2024. The promising safety and efficacy data generated so far, combined with the company’s strategic efforts to refine and escalate the dose of TCB-008, reinforce the candidate’s potential as a monotherapy and support ongoing discussions for potential combination therapy partnerships.

Market Opportunity

From an investment perspective, TC BioPharm is uniquely positioned within the rapidly expanding field of immuno-oncology, a market projected to grow substantially in the coming years. The company’s focus on gamma-delta T cell therapies, particularly in the treatment of acute myeloid leukemia (AML), sets it apart from competitors in the oncology space. As traditional cancer therapies continue to face challenges in terms of efficacy and patient tolerance, the novel approach of utilizing gamma-delta T cells offers a compelling alternative that could potentially capture significant market share. Investors looking for opportunities in breakthrough cancer therapies may find TC BioPharm’s innovative platform and clinical progress highly attractive.

Additionally, the company’s strategic use of its proprietary CryoTC technology, which facilitates the global distribution of its gamma-delta T cell products, positions TC BioPharm to scale rapidly upon successful clinical outcomes. This technology not only enhances the company’s operational efficiency but also broadens its potential reach in the global oncology market, including in regions where access to advanced therapies is limited. With the oncology sector experiencing continuous demand for new and effective treatments, TC BioPharm’s unique approach and scalable technology platform offer a promising investment opportunity with the potential for significant returns as the company progresses toward commercialization.

Leadership Team

Bryan Kobel is the Chief Executive Officer of TC BioPharm, having joined the company in June 2021. Before joining TC BioPharm, he held various senior positions in healthcare investment banking, including Managing Director roles at EF Hutton and the Alberleen Group, where he led deal origination and structuring across the healthcare and technology sectors. Mr. Kobel has a BA from Franklin & Marshall College and previously held several FINRA licenses, including Series 7, 63, 82, 79, and 24.

Martin Thorp has been a member of the Board of Directors of TC BioPharm since March 2016 and has served as the company’s Chief Financial Officer since March 2019. He is the founder of Copernican Capital Partners Limited, a life science financial advisory firm, and has an extensive background in corporate finance, having been a partner and global managing partner at Arthur Andersen & Co. Martin holds a BA in business finance from the University of Kent and qualified as a Chartered Accountant in 1977. He served in various executive roles throughout his career, including co-founding NCL Technology Ventures, a life science advisory and investment firm.

TC BioPharm Holdings PLC (NASDAQ: TCBP), closed Wednesday's trading session at $1.37, up 12.2951%, on 17,490 volume. The average volume for the last 3 months is 483,488 and the stock's 52-week low/high is $1.7/$523.2.

Recent News

• TC BioPharm Holdings PLC (NASDAQ: TCBP) - BioMedNewsBreaks - TC BioPharm Holdings PLC (NASDAQ: TCBP) Signs Letter of Intent to Acquire Ophthalmic Pharma Company 
• InvestorNewsBreaks - TC BioPharm Holdings PLC (NASDAQ: TCBP) CEO to Speak at European Life Sciences CEO Forum
• InvestorNewsBreaks - TC BioPharm Holdings PLC (NASDAQ: TCBP) Announces ADS Ratio Change Effective Feb. 10

Gaxos.ai Inc. (NASDAQ: GXAI)

The QualityStocks Daily Newsletter would like to spotlight Gaxos.ai Inc. (NASDAQ: GXAI).

Gaxos.ai (NASDAQ: GXAI), a company developing artificial intelligence applications across various sectors, has acquired AI technology to enhance its content creation services. The acquisition expands the capabilities of Gaxos Labs, introducing advanced text-to-speech, image generation, video assembly, narration, styling, and script automation tools. The move strengthens Gaxos' AI ecosystem and accelerates its development of AI-powered content solutions.

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

Gaxos.ai Inc. (NASDAQ: GXAI) is revolutionizing the human-AI relationship, pushing the boundaries of artificial intelligence to offer solutions that resonate on a human level. The company’s mission extends beyond application development; it aims to integrate AI into various aspects of human existence, transforming how people interact with technology. With a strong commitment to enhancing quality of life, Gaxos.ai focuses on creating AI-driven solutions that address health, longevity, and entertainment, making advanced technology accessible and beneficial to all.

Gaxos.ai’s ventures into the health and wellness sectors utilize AI to promote better health outcomes and improve overall well-being. The company is developing innovative tools that harness AI to monitor, manage, and enhance physical and mental health, with a focus on extending human longevity and optimizing lifestyle choices. These solutions aim to provide personalized recommendations and insights, empowering individuals to take control of their health in a more informed and effective way.

In addition to its health and wellness initiatives, Gaxos.ai is entering the gaming industry with the goal of redefining entertainment through AI. Leveraging cutting-edge technology, the company creates immersive, adaptive gaming experiences that respond to players’ needs and preferences in real-time. Gaxos.ai’s approach not only enhances entertainment value but also explores the intersection of gaming and wellness, offering new ways for users to engage in fun and fulfilling activities. Through its diverse and innovative offerings, Gaxos.ai is poised to positively impact how people live, play, and interact with AI.

Gaxos Health

Gaxos.ai has officially launched Gaxos Health, marking a significant milestone in the company’s expansion into the health and wellness sector. The new division aims to optimize human performance by offering personalized health and wellness plans that leverage advanced science and technology. Gaxos Health provides a range of services, including biomarker testing, personalized nutrition plans, fitness and lifestyle routines, supplement plans, and live coaching. This comprehensive approach empowers individuals to take control of their health, with tailored recommendations designed to meet their specific needs and goals.

The launch of Gaxos Health not only aligns with the growing demand for personalized health services but also underscores the company’s commitment to innovation and excellence in the AI-driven health sector. By integrating AI-enabled applications with expert insights, Gaxos Health is poised to become a leader in the industry, continually expanding its offerings to include cutting-edge solutions that enhance overall well-being. As Gaxos.ai records its initial revenue from this division, it signals the company’s dedication to delivering value to both its customers and shareholders while revolutionizing the way people approach health and wellness.

Market Opportunity

From an investment perspective, Gaxos.ai is strategically positioned to capitalize on the rapidly growing AI market, particularly in the health and wellness sectors, which are experiencing significant demand for personalized, technology-driven solutions. As consumers increasingly seek tailored health services that leverage the latest scientific advancements, Gaxos.ai’s innovative approach with Gaxos Health places it at the forefront of this trend. The company’s ability to combine AI with expert-driven health insights gives it a competitive edge in a market projected to expand substantially in the coming years, offering investors a compelling opportunity for growth.

Moreover, Gaxos.ai’s expansion into the gaming industry further diversifies its market opportunities, allowing the company to tap into multiple high-growth sectors. The integration of AI in gaming not only enhances user experiences but also opens up new revenue streams through the development of adaptive and immersive entertainment products. This diversification strategy reduces the company’s risk while positioning it to benefit from advancements in both the health and entertainment industries. As Gaxos.ai continues to innovate and expand its offerings, it is well-poised to attract investor interest, offering the potential for substantial returns in a dynamic and evolving market.

Leadership Team

Vadim Mats is the Chairman and CEO of Gaxos.ai, where he leads the company’s strategic vision and growth across multiple sectors, including health, wellness, and gaming. With a background in technology and innovation, Mats has a track record of successfully launching and scaling AI-driven businesses. Under his leadership, Gaxos.ai is redefining the human-AI relationship through cutting-edge solutions that enhance everyday life.

Steven A. Shorr serves as the Chief Financial Officer of Gaxos.ai, bringing extensive experience in financial management and strategic planning. With a career spanning multiple industries, Shorr is responsible for overseeing the company’s financial operations and ensuring its long-term fiscal health. His expertise in financial strategy is instrumental in supporting Gaxos.ai’s ambitious growth initiatives and expanding its market presence.

Gaxos.ai Inc. (NASDAQ: GXAI), closed Wednesday's trading session at $1.73, off by 10.8247%, on 86,140 volume. The average volume for the last 3 months is 702,254 and the stock's 52-week low/high is $1.01/$16.27.

Recent News

• Gaxos.ai Inc. (NASDAQ: GXAI) - InvestorNewsBreaks - Gaxos.ai Inc. (NASDAQ: GXAI) Expands AI Capabilities With Technology Acquisition
• AINewsBreaks - Gaxos.ai Inc. (NASDAQ: GXAI) Completes Reincorporation from Delaware to Nevada
• InvestorNewsBreaks - Gaxos.ai Inc. (NASDAQ: GXAI) to Present at Sequire Investor Summit in Puerto Rico

NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW)

The QualityStocks Daily Newsletter would like to spotlight NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW).

The healthcare industry is at a crossroads. For years, experts have pushed for better data-sharing systems to improve patient care, research, and innovation. In response, a U.S. government agency implemented a national initiative for health information interoperability commonly called TEFCA as part of an initiative to enhance healthcare data accessibility and interoperability. However, political and regulatory uncertainties now put TEFCA's future in doubt. With traditional reforms facing roadblocks, a new contender has entered the conversation: Web3. Driven by blockchain technology, distributed storage and tokenized ecosystems, Web3 presents a revolutionary way to manage healthcare data. But can it truly transform the industry? If these challenges are overcome, Web3 could usher in a new era of patient-centric healthcare where individuals have greater control over their medical information and researchers can access high-quality data for groundbreaking discoveries. With continued innovation and collaboration, Web3 may be the key to unlocking a more efficient, transparent, and equitable healthcare system. It would be interesting to hear what firms like NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW) with interests in healthcare e-commerce have to say about the ways in which the existing challenges facing the use of Web3 technologies in the healthcare field can be addressed.

NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW), a next generation e-commerce platform, was created with vision and purpose to capitalize on high growth sectors and global markets. The company collaborates with businesses – large and small – to simplify and accelerate online commerce and uniquely enables customers and partners to optimize their e-commerce reach, presence and revenue. NextPlat recently launched a new e-commerce development program to provide American businesses with easy access to the massive Chinese consumer market.

Current Initiatives

NextPlat provides cutting edge technology in an advanced e-commerce ecosystem. The company is actively expanding its global network of online storefronts serving thousands of consumers, enterprises and governments. The company also has developed a next generation platform built for Web3 that enables the creation and sale of digital assets, as well as optimizing e-commerce transactions and business building activities. The company’s current initiatives include:

• E-Commerce Development Program – In April 2023, NextPlat announced it had entered into a merchant sourcing agreement with Alibaba.com Singapore E-Commerce Private Limited (“Alibaba”) and its Tmall Global e-commerce platform whereby the two companies will collaborate to increase the sale of products produced and sold by American companies to the multi-trillion-dollar Chinese consumer market. Alibaba’s Tmall Global e-commerce platform will provide NextPlat customers a turn-key solution through which products can be sold to the Chinese consumer market. The launch of the Florida E-Commerce Development Program is the first in a series of new NextPlat programs designed to assist U.S. businesses in expanding their online sales capabilities to reach new international customers in the Chinese market. NextPlat intends to rapidly expand this unique e-commerce development opportunity to businesses throughout the United States and all of North America, as well as Central and South America. The new development program features NextPlat’s turnkey global e-commerce solution for customers and leverages NextPlat’s relationships with key partners, including Tmall Global, China’s largest cross-border B2C online marketplace.
• Progressive Care Inc. – In August 2022, NextPlat completed a strategic $7 million investment in Progressive Care Inc. (OTCQB: RXMD), a personalized health care services and technology company. In a news release announcing the investment, NextPlat CEO Charles M. Fernandez noted that the company is “committed to harnessing the power of digital technologies to capitalize on the ongoing digital transformation of Progressive Care and the entire health care industry.” NextPlat intends to accelerate Progressive Care’s digital health care transformation with the launch of a new e-commerce platform for health care products later this year.
• NextPlat NFT Platform – Building on its existing e-commerce initiatives, NextPlat is working to bridge the gap between tangible and digital e-commerce marketplaces by incorporating burgeoning Web3 technologies. The company intends to launch a fully integrated NFT platform in the coming months that will enable brands to create, manage and authenticate digital assets while serving as a new source of revenue for NextPlat. Through this model, the company will receive a portion of the revenue generated from branded NFT drops, as well as subsequent secondary market transactions.
• Global Telesat Communications and Orbital SatCom Corp. – Targeting both domestic and international markets, NextPlat’s subsidiaries leverage partnerships with major e-commerce platforms such as Amazon, Alibaba, eBay and Walmart to serve a growing base that includes more than 50,000 corporate, governmental and individual customers. In total, the brands market more than 10,000 individual products, with a focus on satellite-based connectivity solutions. In addition to exploring accretive M&A opportunities, NextPlat aims to diversify its range of products and broaden its geographic footprint moving forward in an effort to better capitalize on the tremendous growth potential in the United States, Europe and Asia.

“Our goal for 2023 and beyond is to leverage our improved operational capabilities and enhanced leadership team as we expand our offerings in communications and connectivity into the high-growth health care market where we intend to launch an array of innovative new offerings,” Fernandez said in a March 2023 news release detailing the company’s record top-line performance. “Although there remain supply chain headwinds and the challenge of global inflation, we are confident that we have the right combination of market-tested expertise, technology and partnerships that will enable us to bring the power of e-commerce to more customers, brands and industries in the United States and abroad.”

Market Opportunity

The rapid growth of e-commerce over the last decade is expected to continue for the foreseeable future. According to data published by Forbes, roughly 20.8% of all retail purchases are expected to take place online in 2023, accounting for total sales of $6.31 trillion worldwide. It total, e-commerce sales are expected to grow by 10.4% YoY in 2023, accounting for a whopping 24% of all retail purchases by 2026.

For NextPlat, existing partnerships in the industry could be key to capitalizing on this growth. The Forbes report indicates that Amazon accounts for roughly 38.7% of e-commerce sales, while sites like Walmart, eBay and Alibaba round out the list of most visited e-commerce websites. Alibaba is especially interesting due to NextPlat’s recent strategic merchant sourcing agreement with Tmall Global. The Chinese market is “mammoth,” as a recent Alizila report noted. The country’s annual online retail sales of physical goods have nearly doubled in the last five years, reaching approximately 13.8 trillion yuan in 2022, which is nearly $2 trillion USD.

The health care portion of the e-commerce market is generating particularly bullish forecasts, bolstered by the continued adoption of the 340B Drug Pricing Program in the U.S., which requires most drug manufacturers to provide outpatient drugs to covered entities at significantly reduced prices. Industry reports suggest that the global health care e-commerce market will expand at a compound annual growth rate of 16.8% from 2022 to 2030, climbing to a value of more than $1.37 trillion by the end of the forecast period.

Management Team

Charles M. Fernandez, CEO, Executive Chairman and Director of NextPlat, has over three decades of experience in identifying profitable start-up and dislocation opportunities, building significant value and executing exit strategies as an entrepreneur and global investor. Successful across multiple sectors, Fortune Magazine actually labeled Fernandez ‘a restructuring whiz’. As President of Fairholme Capital Management, which he joined in 2008, Mr. Fernandez co-managed all three Fairholme funds and brought in a $2 billion gain for shareholders. Throughout his impressive career, he has participated in more than 100 significant mergers, acquisitions and product development projects across multiple industries. Mr. Fernandez was the founder, Chairman and CEO of eApeiron Solutions LLC, a brand protection and e-commerce company in partnership with Alibaba (NYSE: BABA) and Eastman Kodak (NYSE: KODK), which was successfully sold to Smartrac, a unit of Avery Dennison Corp. (NYSE: AVY).

Rodney Barreto is Chairman and CEO of the Barreto Group and Director of Nextplat. Mr. Barreto’s business career spans over 35 years, including his role at the Barreto Group and, earlier, as the founding partner of Floridian Partners LLC, a corporate and public affairs consulting firm recognized by policy makers as one of the top in its industry in Florida. He chaired the Super Bowl Host Committee in 2007, 2010 and 2020, helping to raise more than $100 million for the success of Miami Super Bowls. As a philanthropist and conservationist, Mr. Barreto is also a three-time appointee to the Florida Fish and Wildlife Conservation Commission, where he has served for over 10 years including holding the title of Chairman eight times. He has twice chaired the Annual U.S. Conference of Mayors, was Chairman of the 1999 Breeder’s Cup Championship held in South Florida and was the Chairman of the 1999 Sister Cities International Convention in Miami. Currently, Mr. Barreto is the Membership Chairman of the Florida Council of 100, and a member of the Boards of Fairchild Tropical Botanic Garden, the Baptist Health South Florida Giving Society, the Bonefish and Tarpon Trust, the Guy Harvey Ocean Foundation, and a member of Miami Dade County Schools Superintendent Carvalho’s Business Advisory Council. Prior to his career in public affairs and real estate, Mr. Barreto was a City of Miami police officer and is a member of the Florida Highway Patrol Advisory Council.

NextPlat Corp. (NXPL), closed Wednesday's trading session at $1.29, up 16.2162%, on 32 volume. The average volume for the last 3 months is 61,492 and the stock's 52-week low/high is $0.71/$2.68.

Recent News

• NextPlat Corp. (NASDAQ: NXPL) (NASDAQ: NXPLW) - Web3 Aims to Transform the Healthcare Industry
• Upcoming Amsterdam Blockchain Week to Showcase Web3 Collaboration and Innovation
• Why Web3 Should Adopt the Mentality of Amazon

Calidi Biotherapeutics Inc. (NYSE American: CLDI)

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

Calidi's RTNova platform leverages engineered enveloped vaccinia viruses designed for systemic delivery.

Calidi's groundbreaking virotherapy holds "immense promise in revolutionizing the treatment landscape for cancer patients with advanced solid tumors," says CEO.

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company at the forefront of developing innovative immunotherapies for cancer treatment. Most recently, the company has captured the spotlight for the development of its proprietary systemic platform, RTNova ( https://ibn.fm/Z4pM3 ). The platform represents a significant advancement in systemic virotherapy, particularly in the utilization of enveloped virotherapies to target metastatic tumors across the body.

Calidi Biotherapeutics (NYSE American: CLDI) is leveraging innovative platforms in a commitment to transform cancer treatment using advanced biotechnology. "The company is pioneering therapies that combine stem cells with antitumor viruses to create powerful cancer treatments. Antitumor viruses or virotherapies selectively infect and destroy cancer cells while sparing normal cells and, when paired with stem cells, their therapeutic potential is significantly amplified," reads a recent article. "Calidi's pipeline includes the proprietary SuperNova (‘SNV') platform, which utilizes allogeneic adipose-derived mesenchymal stem cells (‘AD-MSCs') as carriers for antitumor virotherapy. This approach has shown promise in preclinical studies and safety studies, with potential applications for hard-to-treat cancers such as head and neck, triple negative breast and soft tissue sarcoma. Additionally, the NeuroNova platform is designed to treat aggressive brain tumors."

To view the full article, visit https://ibn.fm/hBc8r

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 $0.94, up 2.1739%, on 8,978 volume. The average volume for the last 3 months is 2,392,113 and the stock's 52-week low/high is $0.58/$8.3.

Recent News

• Calidi Biotherapeutics Inc. (NYSE American: CLDI) - BioMedNewsBreaks - Calidi Biotherapeutics Inc. (NYSE American: CLDI) Stands at the Forefront of Integrating New Oncology Therapies
• Calidi Biotherapeutics Inc. (NYSE American: CLDI) Pioneers Systemic Virotherapy with RTNova Platform
• BioMedNewsBreaks - Calidi Biotherapeutics Inc. (NYSE American: CLDI) and OS Therapies (NYSE American: OSTX) to Appear on RedChip's Bloomberg TV Show

Nightfood Holdings Inc. (OTCQB: NGTF)

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

Nightfood Holdings (OTCQB: NGTF) , a company specializing in AI-powered automation for the hospitality industry, has signed a letter of intent to acquire Skytech Automated Solutions Inc., a Delaware-based innovator in robotic automation and smart service technologies. The deal, valued at approximately $6.2 million, includes $1.2 million in Series C Preferred Stock at closing and up to $5 million in performance-based earnout payments tied to revenue milestones. The acquisition aligns with Nightfood's strategy to scale AI-driven automation across hospitality, food service, and senior care sectors, reinforcing its leadership in the Robot-as-a-Service market. A definitive agreement is expected in Q2 2025 following a 30-day due diligence period.

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

Nightfood Holdings Inc. (OTCQB: NGTF) is a visionary holding company focused on identifying and capitalizing on explosive market trends within hospitality, food services and consumer packaged goods. By leading newly emerging categories and seizing opportunities in markets undergoing transformational upheaval, the company’s mission is to create unparalleled upside potential in industries ripe for innovation and growth.

Subsidiaries

Nightfood Inc.

The company’s flagship subsidiary, Nightfood Inc., is changing the way the world snacks at night. Humans are biologically hard-wired to crave sweets and fats at night – a survival mechanism from our hunter-gatherer days. Modern consumers know bingeing excess calories before the long nightly fast is no longer necessary for survival, but exploding screen time and decreased willpower at night results in over 90% of American adults snacking between dinner and bed every week, contributing to an estimated one billion nighttime snack occasions weekly (according to SleepFoundation.org).

The most popular choices – ice cream, cookies, chips and candy – are not only unhealthy but also impair sleep quality due to their nutritional profiles. Nightfood snacks are uniquely formulated by sleep and nutrition experts to satisfy nighttime cravings AND support better sleep.

Market Opportunity

Euromonitor International projects the American snack market will grow from $150 billion in 2022 to $170 billion in 2027. Snacking between dinner and bed is estimated to account for over $60 billion annually, creating an opportunity for a multi-billion-dollar sub-category to emerge in the coming years: sleep-friendly snacking.

Nightfood is the brand pioneering that category.

Nightfood’s innovation has led to partnership overtures from global giants, including the largest food and beverage company in the world, Nestlé, with whom Nightfood completed a “test-and-learn” joint initiative in 2023.

Management believes that successfully scaling Nightfood’s 2024 direct-to-consumer launch of sleep-friendly cookies will bring the category to life, opening the door for partnerships with and potential acquisition by global snack giants seeking to lead this potential billion-dollar emerging sub-category.

Future Hospitality Ventures Holdings Inc. (d/b/a roboOp365)

Future Hospitality Ventures Holdings, operating under the brand roboOp365, is revolutionizing the hospitality industry with cutting-edge automation and robotic solutions.

roboOp365 enhances operational efficiency and guest experiences through innovative technologies, including automated culinary bot, server robots and AI-enhanced applications. roboOp365 helps hospitality providers reduce costs, streamline operations and deliver superior service by integrating these advancements.

Market Opportunity

The robots-as-a-service (RaaS) business model has gained significant traction, super-charged by the COVID-19 pandemic, which instantly catalyzed game-changing growth and application. According to Verified Market Research, the service robotics market is projected to reach $173.17 billion by 2030, growing at a compound annual growth rate (CAGR) of 21.25%. Compared to Asia, the United States market is in the early stages of adopting these technologies, but acceptance is accelerating aggressively.

Several factors are driving this trend. Key industries such as hotels and restaurants are still struggling to rebound from the pandemic’s impact, hoping to return to pre-pandemic levels, if possible. Such recovery will largely be dependent upon service robots. In California specifically, factors such as rising labor costs, more rigorous labor laws and ongoing high turnover rates in labor-intensive sectors make it impossible for businesses to survive, thrive and compete without robotics.

Innovation Across Sectors

Nightfood Holdings Inc. is dedicated to driving innovation across its focus sectors of food services, automation and hospitality applications. In food services, the company leverages automation technology to drive operational efficiency for operators while meeting evolving consumer needs. In the hospitality industry, it’s deploying solutions that redefine guest experiences. Nightfood’s consumer-packaged goods initiatives are key to breakthrough trends in health and wellness.

Synergizing Food and Technology

The synergy of food and technology within Nightfood Holdings Inc. creates a holistic approach to innovation and automation. By integrating these areas, the company offers comprehensive solutions that address multiple facets of market needs. Its automation and artificial intelligence solutions in food service and hospitality create a seamless and enhanced consumer experience.

Through this integrated approach, Nightfood Holdings Inc. not only meets current market demands but also anticipates and influences future trends, positioning itself as a leader in innovation across these interconnected sectors. Synergies in these related and explosive categories result in operational efficiency and benefits for the company’s customers and partners and outsized upside and opportunity for its investors.

Management Team

Sean Folkson is the Chairman and President of Nightfood. He founded Nightfood when he couldn’t find a solution to his nighttime snacking problem. Recognizing the growing body of research linking nutritional intake with sleep quality, he launched the first snack brand specifically formulated to give consumers better, healthier and more sleep-friendly snacks for that peak-cravings slot between dinner and bed. He is a serial entrepreneur and problem-solver, having previously founded Specialty Equipment Direct, an online distributor of floor removal equipment, and AffiliatePros.com, a pioneering company in online affiliate marketing.

Lei Sonny Wang is the CEO of Nightfood Holdings. He is a strategist and business driver for early-stage and growth-stage companies. He is the founder and former CEO of Future Hospitality Ventures Holdings Inc., which was acquired by Nightfood Holdings Inc. At Future Hospitality, he leveraged his significant international business development experience into distribution relationships with leading global robotics manufacturers. At Nightfood, he is working to grow revenue and improve performance and profitability across all subsidiaries.

Nightfood Holdings Inc. (OTCQB: NGTF), closed Wednesday's trading session at $0.871, up 6.9368%, on 267,980 volume. The average volume for the last 3 months is 150,820 and the stock's 52-week low/high is $0.0053/$0.035.

Recent News

• Nightfood Holdings Inc. (OTCQB: NGTF) - InvestorNewsBreaks - Nightfood Holdings Inc. (NGTF) Signs LOI to Acquire Skytech Automated Solutions
• TinyGemsBreaks - Nightfood Holdings Inc. (OTCQB: NGTF) Expands AI Robotics and Hospitality Footprint with M&A Strategy
• InvestorNewsBreaks - Nightfood Holdings Inc. (NGTF) Expands AI Robotics Strategy in Hospitality

Adageis

The QualityStocks Daily Newsletter would like to spotlight Adageis

Adageis offers AI-driven solutions that help providers transition to and optimize value-based care models. "Healthcare is undergoing a major transformation as more organizations shift from fee-for-service to value-based care. Under value-based care models, providers are reimbursed based on patient outcomes rather than the volume of services rendered. This approach incentivizes proactive care, chronic disease management and overall cost efficiency," a recent article explains. "Adageis, a forward-thinking healthcare technology company reshaping patient care through flexible AI-centric software solutions, is helping providers streamline their transition to value-based models. Through its ProActive Care Platform, Adageis enables healthcare organizations to optimize patient care while maximizing financial performance… By leveraging advanced analytics and machine learning, Adageis enables providers to shift from reactive to proactive care—essential for success in a value-based environment."

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

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 - InvestorNewsBreaks – Adageis: Shaping the Future of Healthcare with AI-Powered Solutions
• InvestorNewsBreaks – Adageis Tackling Healthcare’s Value-Based Shift with AI-Driven Insights, Seamless Integration
• Adageis Drives Value-Based Care Transition as Healthcare Switches from Artificial General Intelligence to Specific Use Cases

Software Effective Solutions Corp. (OTC: SFWJ)

The QualityStocks Daily Newsletter would like to spotlight Software Effective Solutions Corp. (OTC: SFWJ).

The proliferation of intoxicating hemp products has seen states across the country approve various regulations making these intoxicants illegal. Now legislators in Tennessee are set to discuss proposals that may ban these products in their jurisdiction. While these proposals may help regulate these intoxicants, many believe that they will also adversely affect the legal hemp industry if approved. Maggie Clark, a Crossville businesswoman, believes that the measures will negatively affect small businesses and pave the way for conglomerates to occupy a larger share of the market. Her business, Cann I Help, grows, manufactures and retails hemp products. Other proposed measures would clamp down on businesses that sold these intoxicating products to individuals under the age of 21, regulate and tax businesses in the hemp industry, and eliminate THCP and THCA from the list of approved cannabinoids derived from hemp. THCA is a non-intoxicating compound found in hemp flowers. When it is smoked or heated, this compound converts into delta-9 THC. Major hemp industry players around the country like Software Effective Solutions Corp. (d/b/a MedCana) (OTC: SFWJ) recognize that while businesses need to operate, their activities shouldn't pose a risk to minors. Regulations are therefore good, though a balance between public health concerns and enabling innovation and growth needs to be attained.

Software Effective Solutions Corp. (d/b/a MedCana) (OTC: SFWJ) is a global infrastructure and holding company in the cannabis industry. MedCana currently has five companies focused on pharmaceutical cannabis production, as well a software company focused on managing processes for plant-to-patient operations. The recent acquisition of an irrigation and greenhouse technology company has rounded out MedCana’s portfolio of holdings.

MedCana’s focus is on developing clients and companies in Latin America, initially in Colombia, and partnerships with laboratories, research facilities and hospitals throughout the world. MedCana is building the technology, laboratories, growing facilities and scientific teams to provide premium pharmaceutical-grade cannabis extracts to the world.

MedCana’s goal is to be the world’s premier resource for pharmaceutical cannabis products. The company believes its advantage is its global view and reach. From initial cultivation to final product, MedCana aims to help partners produce pharmaceutical CBD and other extracts that will have no equal.

The company’s mission is to utilize its technology to partner with and develop companies that provide premium pharmaceutical-grade cannabis extracts with absolute integrity, sustainability and social responsibility. MedCana’s team of pharmaceutical scientists includes some of the most respected chemists in the world. They aim to ensure that the company’s customers and partners create premium cannabis extracts that meet the growing worldwide demand. MedCana’s software is designed to ensure traceability and quality from seed to finished product.

MedCana is headquartered in Austin, Texas, with offices in Colombia.

Production

MedCana announced in May 2023 the beginning of full-scale production of non-THC cannabis for export to Europe in response to high demand in that market. This expansion comes after the successful completion of full crop cycle testing and infrastructure development at production sites in Columbia.

The recent acquisition of the assets of Tokan Corp., a software company focused on creating an enterprise resource planning (ERP) platform for the cannabis industry, and Eko2O S.A.S., a greenhouse and irrigation engineering company, has positioned MedCana for explosive growth in the region.

As a MedCana subsidiary, Eko2O SA will increase the company’s revenue potential in Central and South America. The subsidiary specializes in the construction and distribution of greenhouses and sophisticated irrigation platforms. A positive outlook has resulted from the company’s expansion as it investigates new opportunities for greenhouse and irrigation system installations in Panama and Uruguay. These opportunities are expected to accelerate Eko2O’s development and strengthen its position as a top supplier of innovative agricultural solutions in cannabis and other sectors that are quickly moving to high technology agricultural production.

In addition, MedCana has started talks with the government in Argentina about possible incentives for beginning operations in that country as part of its ongoing worldwide development strategy. Support from the Argentinean government and the start of new operations there would greatly increase MedCana’s market share in Latin America and solidify the company’s position as the market leader in the cannabis industry.

Market Opportunity

According to a report by Grand View Research, a San Francisco-based market research and consulting company, the global cannabis extract market was valued at $3.5 billion in 2022 and is expected to expand at a CAGR of 20% from 2023 to 2030 to be worth more than $15 billion.

Growing demand for cannabis extracts, including oils and tinctures, and the increased legalization of marijuana for the treatment of different chronic ailments like arthritis, Alzheimer’s, anxiety and cancer are driving the expansion of the industry. The marijuana derivative industry is flourishing due to a greater understanding of its various medical benefits.

Management Team

Jose Gabriel Diaz is CEO of MedCana. He has successfully built, grown and sold multiple telecom companies. He was senior vice president of sales at IP Communications, a national high-speed data provider. He also founded Reallinx, a national data carrier later sold to GTT Communications. Additionally, he is currently president of the A.E.M. Business and Entrepreneurship Association in Austin, Texas.

Claudio Jiménez Cartagena, QF, Ph.D. is Chief Scientific Officer at MedCana. He joined MedCana after working with Sosteli Pharma as Technical Director and serving as a director consultant for the Corporation for Agricultural Industrial Development at the University of Antioquia in Colombia. Before that, he worked as the scientific director at the Institute of Food Science & Technology. He holds a bachelor’s degree in pharmaceutical chemistry, a master’s degree in basic biomedical sciences and a doctoral degree in Environmental Engineering from the University of Antioquia.

Julián Alberto Londoño Londoño, Ph.D., is Senior Vice President of Operations at MedCana. He previously served as general manager for the Corporation for Agricultural Industrial Development, and as Chief Scientific Officer at Sosteli Pharma in the Resource Management Department. He has developed multiple U.S. patents, and recently served as senior advisor to the Secretariat of Agriculture Development for the Government of Antioquia. He holds a doctorate in Chemical Sciences from the University of Antioquia.

Software Effective Solutions Corp. (OTC: SFWJ), closed Wednesday's trading session at $, even for the day, on 10,800 volume. The average volume for the last 3 months is and the stock's 52-week low/high is $0.0071/$0.064.

Recent News

• Software Effective Solutions Corp. (OTC: SFWJ) - Tennessee Hemp Industry Faces Existential Risk as Lawmakers Mull Banning Intoxicating Products
• The 2018 Farm Bill Loophole and What Can Be Done To Address It
• Almost 2 Dozen Hemp, Marijuana Bills Up for Consideration in Texas

Massimo Group (NASDAQ: MAMO)

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

Massimo Group (NASDAQ: MAMO) , a manufacturer of powersports vehicles, is deepening relationships with key retail partners through participation in major industry events. The company recently attended the Rural King Vendor Summit in Mattoon, Illinois, and is currently engaging with Tractor Supply Company & PetSense representatives at their ASM and Partner Trade Show in Nashville, Tennessee. These events allow Massimo to collaborate with store managers, buyers, and executives to align its UTVs, ATVs, and outdoor equipment with customer needs. The company aims to enhance its market presence by leveraging direct feedback from retail partners and expanding its strategic partnerships.

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

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

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

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

Product Portfolio

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

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

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

Market Opportunity

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

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

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

Leadership Team

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

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

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

Massimo Group (NASDAQ: MAMO), closed Wednesday's trading session at $0.01, even for the day, on 19 volume. The average volume for the last 3 months is 46,147 and the stock's 52-week low/high is $2.42/$4.66.

Recent News

• Massimo Group (NASDAQ: MAMO) - InvestorNewsBreaks - Massimo Group (NASDAQ: MAMO) Strengthens Retail Partnerships at Industry Events
• InvestorNewsBreaks - Massimo Group (NASDAQ: MAMO) Driving 'Made in the USA' Momentum, Enhancing Production with Advanced Automation
• Massimo Group (NASDAQ: MAMO) Relocates MVR Golf Cart Production to Texas Amid Trade Tariffs