TinyGems
Monthly Picks
BluSky AI Inc. (OTC: BSAI)
BluSky AI Inc. (OTC: BSAI) is pioneering the next generation of AI infrastructure through modular, rapidly deployable data centers that meet the escalating compute demands of artificial intelligence, machine learning, and high-performance computing. The company's mission is to empower AI innovators by eliminating infrastructure bottlenecks and accelerating time-to-compute with energy-efficient, scalable solutions.
Rather than betting on individual AI applications, BluSky AI addresses the universal need for compute power—positioning itself as a foundational layer in the AI revolution. Its infrastructure-first approach enables clients to focus on innovation while the company delivers the critical backbone powering tomorrow's breakthroughs.
BluSky AI is headquartered in Salt Lake City, Utah.
Products
BluSky AI's core offering is its SkyMod series of modular data centers—pre-assembled, scalable compute units designed specifically for AI workloads. The flagship SkyMod One delivers 1 MW of compute power in a compact 1,400-square-foot footprint, while the SkyMod XL offers 1.7 MW in 3,000 square feet. These units are fully assembled off-site, tested, and shipped ready for plug-and-play deployment either on BluSky-owned land or client facilities.
SkyMod modules integrate NVIDIA GPUs and are optimized for high-density AI applications such as generative AI, large language models, inference engines, and scientific computing. Built for rapid scaling and high efficiency, each system includes advanced cooling, secure infrastructure, and dynamic workload balancing to support evolving client needs.
The company's data centers are engineered for sustainability, incorporating renewable energy sources like solar, wind, and geothermal where available. By deploying on powered land assets, BluSky AI shortens lead times and lowers costs, creating a fast, flexible alternative to traditional monolithic data centers.
Market Opportunity
The global data center market was valued at $347.6 billion in 2024 and is projected to reach $652.0 billion by 2030, growing at a CAGR of 11.2%, driven by the rapid expansion of AI, machine learning, and IoT adoption, according to Grand View Research. As enterprises demand faster, more scalable compute solutions, modular infrastructure like BluSky AI's SkyMod series offers a compelling alternative to legacy data center models.
With North America accounting for over 40% of the global market and the U.S. expected to grow at a 10.7% CAGR from 2025 to 2030, BluSky AI is well-positioned to capture demand for AI-optimized infrastructure that can be deployed rapidly and cost-effectively. By focusing on GPU-centric, modular deployments tied to energy infrastructure, the company addresses a growing gap between compute demand and deployment speed in the AI era.
Leadership Team
Trent D'Ambrosio, Chief Executive Officer, is a seasoned executive with a track record in telecommunications, hedge fund management, and natural resource development. He previously sold the first transatlantic fiber cable, built a successful gold mining company, and now leads BluSky AI with a vision to revolutionize AI infrastructure through strategic energy integration and rapid deployment.
Julien Bedard, Chief Technology Officer, is a pioneering technologist known for launching the first Bitcoin escrow and anti-fraud service. At BluSky AI, he oversees cloud architecture, cybersecurity, infrastructure automation, and the development of AI-native data center technology, ensuring scalability and resilience across deployments.
Dan Gay, Chief Operating Officer, has Fortune 500 executive leadership in telecom, technology, and energy, as well as start-up experience with finance and blockchain companies. At MCI and Qwest, he launched new service and sales centers, and directed National Account Sales. He has been a successful CMO in brand creation, product development, partnerships, and revenue generation programs to expand company awareness, sales, and revenue.
Bollinger Innovations, Inc. (NASDAQ: BINI)
Bollinger Innovations, Inc. (NASDAQ: BINI) is a Southern California-based automotive company building the next generation of commercial electric vehicles ("EVs") with United States-based manufacturing located in Tunica, Mississippi.
In August 2023, Mullen began commercial vehicle production in Tunica. As of January 2024, both the Mullen ONE, a Class 1 EV cargo van, and Mullen THREE, a Class 3 EV cab chassis truck, are California Air Resource Board ("CARB") and EPA certified and available for sale in the U.S. The Company's commercial dealer network consists of Papé Kenworth, Pritchard EV, National Auto Fleet Group, Ziegler Truck Group, Range Truck Group, Eco Auto, and Randy Marion Auto Group, providing sales and service coverage in key West Coast, Midwest, Pacific Northwest, New England, and Mid-Atlantic markets.
In September 2022, Bollinger Motors, of Oak Park, Michigan, became a majority-owned EV truck company of Mullen Automotive. Bollinger Motors has passed numerous milestones including its B4, Class 4 electric truck production launch on Sept. 16, 2024, and the development of a world-class dealer network with over 50 locations across the United States for sales and service support.
Mullen Commercial
Mullen is defining a new era in commercial vehicles with its connected and customized solutions aimed at making businesses more efficient and profitable.
Mullen ONE Class 1 EV Cargo Van
The Mullen ONE class 1 commercial electric vehicle is the first of its kind in the U.S. market. This van was designed to navigate within narrow urban streets and residential roads, all while maximizing payload and cargo space. The Mullen ONE's height is less than 6.5 feet, meaning your driver can park the vehicle in a residential garage.
Mullen THREE Class 3 Electric Truck
The efficient urban utility low cab forward features a tight turning diameter of 38 feet and excellent visibility for superior maneuverability on narrow city streets. Even in reverse, maneuverability is a breeze with our standard backup camera and 7-inch display screen. This versatile chassis provides a clean top-of-rail for easy upfitting with bodies up to 14 feet long and over 5,300 lbs of payload. In addition, the design of the LCF chassis allows more cargo length within a given overall length.
Mullen Commercial EVs are eligible for several federal and state level EV incentives, which can be combined for maximized savings.
Mullen ONE:
- $7,500 Federal Tax Credit
- $3,500 MOR-EV Incentive (Massachusetts only)
- $7,500 ComEd Business & Public Sector EV Rebate Program (Illinois only)
Mullen THREE:
- $7,500 Federal Tax Credit
- $45,000 California's Hybrid and Zero-Emission Truck and Bus Voucher Incentive Project (HVIP) (California only)
- $15,000 MOR-EV Incentive (Massachusetts only)
- $30,000 ComEd Business & Public Sector EV Rebate Program (Illinois only)
In the last two years, Mullen has conducted over 100 vehicle demos or pilots across various industries in the U.S. resulting in significant progress, including new sales opportunities and vehicle orders received and or completed:
- Universities: Princeton University, University of Virginia (UVA), University of California, Los Angeles (UCLA)
- Local city governments: Cities of Dublin, Ohio, Raleigh, North Carolina, Los Angeles, California, Seattle, Washington and Orange County, North Carolina
- Small businesses: From local florist shops to health care providers delivering supplies
Mullen has an extensive dealer network in the U.S. with renowned dealers nationwide including:
- Papé Group (California, Oregon, Washington)
- National Auto Fleet Group (California)
- Pritchard EV (Iowa)
- Eco Auto (Massachusetts)
- Ziegler Truck Group (Minnesota)
- Range Truck Group (Washington)
- Mullen Commercial Vehicle Center (California)
Mullen Commercial EVs are available for purchase on Sourcewell under NAFG's Sourcewell Contract # 091521-NAF which offers Class 1-3 light duty trucks, cars, vans, SUVs, cab chassis, and electric vehicles with related equipment and accessories to U.S. government agencies.
Bollinger Motors
Mullen entered the medium-duty truck classes through its September 2022 acquisition of a controlling interest in EV truck innovator Bollinger Motors. The acquisition gave Mullen access to a significant pipeline of interest from large companies for commercial electric truck classes 3-6 in a wide range of markets, such as last-mile delivery, refrigeration, utilities and upfitters.
The 2025 Bollinger B4 chassis cab is an all-new, all-electric Class 4 commercial truck designed from the ground up with extensive fleet and upfitter input. Bollinger's unique chassis design protects the 158-kWh battery pack and components to offer unparalleled capability and safety in the commercial market. The vehicle also features a payload in excess of 7,300 pounds with an average driving range of 185 miles. Bollinger Motors began serial production of the B4 on Sept. 16 via its manufacturing partnership with Roush Industries at their facility in Livonia, Michigan.
Bollinger Motors has passed numerous milestones in recent months, including:
- 30 B4s delivered and paid for, worth nearly $4.5 million, since start of production
- Its production launch on Sept. 16 at Roush Industries in Livonia, Michigan
- Achieving FMVSS compliance
- Receiving the Certificate of Conformity from the Environmental Protection Agency, and CARB certification
- The creation of a world-class dealer and service network
- An agreement with Our Next Energy in Novi, Michigan, for battery packs
- Providing a full warranty coverage of the B4 chassis cab
- Announcing Syncron as its warranty administration partner and Amerit Fleet Solutions as its mobile service provider
- A partnership with EO to power EV charging infrastructure, equipment and technology solutions for Bollinger's dealers and customers
Bollinger Motors has qualified for multiple federal and state incentive programs, including:
- Inflation Reduction Act incentives of up to $40,000 per vehicle
- California: Innovative Small e-Fleet (ISEF) Pilot Program, with incentives up to $120,000 per vehicle
- Massachusetts: voucher of up to $30,000 per vehicle from Massachusetts Offers Rebates for Electric Vehicles (MOR-EV)
- New York: up to $100,000 from NYTVIP through NYSERDA
- Pennsylvania: up to a $20,000 grant from Alternative Fuels Incentive Grant Program (AFIG) of the Pennsylvania Department of Environmental Protection
Mullen FIVE RS
The Mullen FIVE RS is an ultra-high-performance EV Crossover featuring a top speed of over 200 mph and acceleration from 0-60 mph in under 2 seconds. The FIVE RS is equipped with 800-volt architecture, all-wheel drive, two-speed gearbox, and over 1,100 horsepower.
The Mullen FIVE RS is planned for launch in Germany with vehicle sales planned for December 2025. Initial vehicle market territories include the EU in 2025, followed by the UAE and South Africa in early 2026.
Mullen is partnering with Faissner Petermeier Fahrzeugtechnik AG ("FPF"), which has decades of experience in the development and production of serial components and sophisticated vehicles for global brands such as Piech Automotive, Gumpert Automotive and is in partnership with BMW of all the above. FPF is certified according to the IATF standard and fulfills all the special requirements of the Federal Motor Transport Authority in Germany.
EV Market Outlook
The global EV market was reported to consist of 3,269,671 units in 2019, a figure that is expected to grow at a CAGR of 21.1% through 2030 to a total of 26,951,318 units worldwide. This market's monetary value was estimated at $162.34 billion in 2019 and is expected to grow at a CAGR of 22.6%, resulting in an approximate value of $802.81 billion by 2027. The primary driver for this exponential growth is a worldwide increase in vehicle emissions regulations.
Management Team
Mullen is led by an executive team with extensive EV, OEM and high-growth startup experience.
David Michery is the CEO and Founder of Mullen and has been leading the company and its divisions since inception in 2014. With over 25 years of executive management, marketing, distressed assets, and business restructuring experience, Mr. Michery brings a wealth of relevant knowledge and expertise to the Mullen brand. He has notably created 12 trademarks so far to develop the company brand and vision.
Mr. Michery is working towards a sustainable future by creating a suite of clean-energy, electric vehicles at varied price points. With entirely US based manufacturing and operations, Mr. Michery is also determined to have Mullen Technologies play a role in shaping a self-sustaining local economy by creating more jobs in America.
Mr. Michery manages risks and company expectations as a pathway to success and has personally overseen several businesses that totaled over $1 billion in transactions. His key strength is the ability to be fiscally responsible and lead teams to complete projects on time and within budget. As a seasoned professional in this space, Mr. Michery has demonstrated skill in building businesses from the ground up and into successful entities that subsequently sold for hundreds of millions of dollars.
Brera Holdings PLC (NASDAQ: BREA)
Brera Holdings PLC (NASDAQ: BREA) is an Ireland-based, international holding company focused on expanding its global portfolio of men's and women's sports clubs through a multi-club ownership approach. The company capitalizes on opportunities to earn tournament prizes, secure sponsorships, collect transfer fees, provide professional sports consulting services, and enhance the valuation of its clubs.
Brera Holdings builds on the legacy of Brera FC, an international football club (referred to as soccer in the U.S.), that it acquired in July 2022. Established in 2000 and based in Milan, Italy, Brera FC has distinguished itself by cultivating an alternative football legacy. In October 2024, the Internet Marketing Association awarded Brera FC with the Social Impact Through Soccer accolade at its IMPACT 5050 Conference, recognizing the club's global perspective and positive contributions to society.
The company's growth strategy focuses on unlocking value from undervalued sports clubs and talent, driving innovation, and generating socially impactful outcomes. Brera Holdings is actively expanding its Global Sports Group, acquiring professional football and other sports clubs in emerging markets such as Africa, Asia, and Europe.
By targeting top-division teams in less mainstream markets, Brera Holdings aims to strengthen its competitive position in regional tournaments, including those organized by the Union of European Football Associations (UEFA). These acquisitions are expected to enhance sponsorship revenues and create new growth opportunities.
Leveraging its expertise in capital raising and revenue generation, Brera Holdings also anticipates growing demand for its consulting services, providing advisory support to sports clubs, associations, investors, and others. Brera Holdings is headquartered in Dublin, Ireland, with additional offices in Milan, Italy.
Sporting Assets
Brera Holdings continues to grow its global sports portfolio with a series of strategic acquisitions and innovations, including the FENIX Trophy Tournament, a pan-European, non-professional football competition. Launched in September 2021 and organized by Brera FC, the tournament has been recognized by UEFA and described by BBC Sport as "the Champions League for amateurs." In 2023, Brera FC hosted the tournament's finals at Milan's iconic San Siro Stadium.
In March 2023, Brera Holdings expanded into Africa by establishing Brera Tchumene FC in Mozambique. Starting in the country's Second Division League, the team quickly earned promotion to Moçambola, Mozambique's First Division League, by November 2023.
In April 2023, Brera Holdings further strengthened its European presence by acquiring a 90% stake in Fudbalski Klub Akademija Pandev, a first-division football team in North Macedonia. This acquisition provides access to two major UEFA competitions, solidifying the company's position in European football.
Brera Holdings' reach extends beyond football. In July 2023, it acquired majority ownership of UYBA Volley, an Italian Serie A1 women's professional volleyball team, demonstrating its commitment to diversifying within top-tier sports.
In September 2023, Brera Holdings entered the Mongolian football market by acquiring Bayanzurkh Sporting Ilch FC, a Mongolian National Premier League team. For the 2024 season, the club was rebranded as Brera Ilch FC, further expanding Brera's global footprint.
In January 2024, Brera Holdings initiated a proactive search for an Italian Serie B football club, aligning with its goal of bringing multi-club ownership opportunities to mass investors through its Nasdaq-listed shares.
In February 2024, the Brera Holdings Advisory Board was established with MLS founder and World Cup director Alan Rothenberg, luxury lifestyle executive Massimo Ferragamo, sports business leaders Paul Tosetti and Marshall Geller, and Italian football icon Giuseppe Rossi.
In June 2024, the North Macedonian women's football club Tiverija Strumica officially became part of the Brera family with the establishment of a joint-stock company controlled by Brera Holdings called Women's Football Club Tiverija Brera AD Strumica ("Brera Tiverija"). Brera Tiverija is now a wholly-owned subsidiary of Brera Strumica FC.
In September 2024 Brera announced that it signed an exclusive letter of intent to acquire an Italian Serie B club (the "LOI" and the "Club"). According to a CFA report published in June 2024, this expected strategic transaction, for an estimated purchase price of $21.6 million, would add first-year annual revenue of $10.8 million to Brera, and that revenue would likely increase by 25% each year for the next three years. The company's capital valuation, projected the report, would also experience significant appreciation during this period.
In October 2024, Brera was recognized with the 2024 Social Impact Through Soccer Award at IMPACT 5050, an annual event honoring leaders and innovators who significantly impact their industries and communities. This is the second time Brera has won the award.
Market Opportunity
A report from IMARC Group, a global management consulting firm, reveals that the international football market generated approximately $3.3 billion in revenue in 2023, with projections to grow to $4.6 billion by 2032, reflecting a compound annual growth rate (CAGR) of 3.6%. Key drivers behind this growth include advancements in digitization, increasing sponsorship and partnership deals between brands and clubs, the rising interest in women's professional soccer leagues, and the expansion of the e-sports and gaming sector.
In particular, Serie B Italian football clubs seem to present exceptionally attractive investment opportunities. As of September 2024, more than half of these clubs had appreciated between 80-100% in total market value, post-purchase.
As the world's most-watched and most-played sport, soccer drives significant demand for football-related products and services, contributing to market growth. Broadcasting rights, sponsorships, and endorsement deals are also major revenue sources for clubs and organizations, with an expanding global fanbase generating new opportunities for financial growth, according to the report.
Management Team
With extensive experience in leadership and finance, Daniel McClory currently serves as the Executive Chairman and Director of Brera Holdings, PLC. He co-founded and held the position of Chief Executive Officer at Boustead & Company Limited, and previously served as the Managing Director, Head of Equity Capital Markets, and Head of China at Boustead Securities, LLC. Mr. McClory's governance experience includes being a Board Director for USA Track & Field and a member of the Eastern Michigan University Champions Advisory Board. Mr. McClory's expertise encompasses founding and financing equity capital markets, as well as navigating merger and acquisition transactions and initial public offerings. He holds a BS and MS from Eastern Michigan University, where he also received an honorary Doctor of Public Service. In addition to his professional qualifications, he is fluent in both English and Italian.
Pierre Galoppi serves as the CEO, Interim CFO, and director of Brera Holdings. With over 30 years of experience in strategic business and financial services, his career spans a variety of industries, including natural resources, aviation, cybersecurity, telecommunications, tourism, and international marketing. He has worked extensively across Latin America, the Caribbean, Canada, Europe, and the United States. Mr. Galoppi holds dual citizenship in Canada and Italy and is fluent in English, Spanish, Portuguese, Italian, and French. He earned a Bachelor of Commerce degree and an MBA from Concordia University in Montreal.
Maria Xing serves as the Head of Investments and Corporate Development. She is an executive who has specialized in MCO football (soccer) group investments for 777 Partners, where she was involved in sourcing, direct negotiations, due diligence, and closing deals, including acquiring a controlling stake in Brazilian Serie A football club, Vasco da Gama, and investing in Australian Premier League ("A-League") side, Melbourne Victory FC. She also played a role in other professional sports franchise portfolio management, including topflight professional football clubs in Italy, France, Germany, and Belgium. Her background is in private equity, investment banking, and finance, with prior experience at The Raine Group, Credit Suisse, and EY (Ernst & Young), as well as previous sports industry experience at Liverpool Football Club in international business development. Ms. Xing earned an MBA from the Wharton School of the University of Pennsylvania and a B.S. from the New York University, Stern School of Business.
Calidi Biotherapeutics Inc. (NYSE American: CLDI)
Calidi Biotherapeutics Inc. (NYSE American: CLDI) is a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the ability to deliver genetic payloads. Calidi has recently presented data on its breakthrough systemic technology, RedTail, at prestigious biotechnology conferences like American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO). RedTail utilizes an extracellular enveloped virotherapy and delivers genetic medicine in the form of IL-15 superagonist. RedTail is currently in IND enabling studies and has been extremely well-received by market analysts and large-cap biopharma – opening the door for potential collaboration.
These platforms are engineered to protect, amplify, and enhance the efficacy of oncolytic viruses, resulting in improved patient safety and advancing treatment outcomes for metastatic disease. By employing a dual approach that combines OV delivery with immune activation at the disease site, Calidi's therapies are designed to not only attack the tumor but train the immune system to respond and prevent recurrence.
The company's development pipeline leverages this technology to address pressing needs in cancers such as lung cancer and metastatic cancers, triple-negative breast cancer, head & neck cancer, soft tissue sarcoma, lung cancer, and glioblastoma. Calidi's approach has shown early signals of efficacy and safety, establishing it as a distinctive player in the growing OV and genetic medicine 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 genetic medicine delivery and advanced oncolytic targeted immunotherapy platforms targeting a variety of oncology indications, each offering protection to the virus from the body's immune system.
- RedTail (CLD-400): Calidi's systemic delivery platform targeting lung and metastatic cancers, RedTail employs an extracellular enveloped virotherapy (envRT-01) technology for intravenous (IV) administration while delivering a genetic medicine payload, simplifying the treatment process and expanding its potential applications. Currently in IND-enabling stages, RedTail focuses on demonstrating efficacy and safety through systemic administration. Calidi is also exploring RedTail's application outside of oncology, including autoimmune.
- SuperNova (CLD-201): Built on Calidi's foundational technology, SuperNova utilizes an engineered vaccinia virus (CAL1) loaded in 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 has an approved IND to begin a Phase 1 trial with multiple dose regimens for SuperNova.
- 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 a Phase 1trial at City of Hope for recurrent cases. FDA clearance for a Phase 1b/2 trial at Northwestern University has received FDA clearance for a Phase 1b/2 trial for newly diagnosed HGG patients.
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
Eric Poma, Ph.D., CEO, has more than 30 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development. Prior to joining Calidi, Dr. Poma served as CEO of Molecular Templates (NASDAQ: MTEM), a clinical-stage biotech focused on the development of a novel class of therapeutic agents with unique biology in oncology. At Molecular Templates he raised over $250 million in equity financing and secured over $150 million in strategic capital through agreements with Takeda, Vertex and BMS. Dr. Poma received a Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill, an M.B.A. from the Leonard N. Stern School of Business and a Bachelor of Science in Biology from the University of North Carolina at Chapel Hill.
Andrew Jackson, CFO, has held chief executive finance roles with experience in biotech and clinical-stage companies, including Eterna Therapeutics, Ra Medical Systems, and Celladon Corporation before Calidi. Mr. Jackson holds an MSBA in Finance from San Diego State University and a BSB in Accounting from the University of Minnesota. He is a certified public accountant (inactive).
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 (RedTail) 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.
Guy Travis Clifton, M.D., Chief Medical Officer, Consultant and Advisor, is a practicing surgical oncologist with over 17 years of experience in drug development, early phase and translational clinical trials, and cancer immunotherapy. He has previously served as the Chief Medical Officer and co-founder of Parthenon Therapeutics/Incendia Therapeutics for over three years and has worked with over 20 companies in an advisory role. Dr. Clifton has over 80 peer-reviewed publications on cancer and related topics. Dr. Clifton received his Bachelor of Science in Chemistry from the United States Military Academy, West Point, and Doctor of Medicine from Vanderbilt University; completed his residency in General Surgery from the Brooke Army Medical Center; and held a fellowship in General Surgical Oncology at the University of Texas MD Anderson Cancer Center.
Clene Inc. (NASDAQ: CLNN)
Clene Inc. (NASDAQ: CLNN) is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple sclerosis (MS).
Its lead drug candidate is CNM-Au8®, an oral suspension developed to restore neuronal health and function by increasing energy production and utilization by driving critical cellular energy producing reactions that enable neuroprotection and remyelination to increase neuronal and glial resilience to disease-relevant stressors. CNM-Au8 is being studied in various clinical trials, including the Harvard/MGH Healey ALS Platform clinical trial for patients with ALS; RESCUE-ALS, a completed proof-of-concept clinical trial in patients with early symptomatic ALS; the REPAIR trials, completed target engagement clinical trials showing brain energy metabolite change with CNM-Au8; and a completed MS clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing MS. The company also has a nanotherapeutic platform of drug discovery.
CNM-Au8
CNM-Au8, Clene's lead asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Multiple pathogenic insults contribute to neuronal death. Mitochondrial dysfunction and NAD+ decline is a common final pathway in neurodegeneration, with NAD+ as a critical determinant of cell survival and function. CNM-Au8's catalytic mechanisms target the energetic deficits, oxidative stress and accumulation of misfolded proteins that are common to many neurodegenerative diseases.
The unique catalytic mechanism of action of CNM-Au8 is hypothesized to act as a neuroprotective and remyelinating therapy in neurodegenerative disease states in order to: (1) drive, support and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed and/or damaged cells, (2) directly catalyze the reduction of harmful, reactive oxygen species ("ROS") and (3) promote protein homeostasis via activation of the heat shock factor-1 pathway, recognized to dampen the cytotoxicity caused by misfolded and denatured proteins, which are known to occur ubiquitously in neurodegenerative diseases.
CNM-Au8 is used in combination with other agents, has no known drug-drug interactions, and is designed to improve function and survival. The clinical effects of both function and survival were seen in its clinical ALS trials, as earlier announced.
More than 500 estimated years of collective exposure across ALS, MS, and Parkinson's disease participants in CNM-Au8 clinical trials and Expanded Access Protocol (compassionate use) programs have been recorded without any observed safety signals.
CNM-Au8 is a federally registered trademark of Clene Inc. Clene, based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland, began in 2013.
Market Opportunity
ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide, with a life expectancy of typically three to five years. Clene estimates that global ALS treatment sales will be greater than $1 billion annually within the coming few years. Additional treatments affecting daily function and survival remain the market need.
Additionally, there are more than 2 million MS patients globally, and Clene estimates the market size to be worth more than $23 billion annually. While the MS community has been successful at limiting relapses, non-relapsing MS patients continue to clinically deteriorate even while receiving effective immunomodulatory disease-modifying therapies ("DMTs"). A critical unmet medical need remains for therapeutic interventions that protect neuronal function and myelin health independent of immunomodulation to address progression independent of relapse activity.
Management Team
Robert Etherington is President, Director and CEO of Clene. He has more than 30 years of sales, marketing and leadership experience in the pharmaceutical industry. Prior to joining Clene, he worked at Actelion Pharmaceuticals, the largest biopharma company in the European Union prior to its acquisition by Johnson & Johnson in 2017, where he led that company's U.S. commercial operations. He began his pharmaceutical sales and marketing career at Parke-Davis, a division of Pfizer, where he rose to the position of Team Leader overseeing the drug Lipitor.
Mark Mortenson is Chief Science Officer at Clene. He is co-inventor of the technology platform developed to produce the company's therapeutics. He is the inventor or co-inventor on 32 other U.S. patents and hundreds of corresponding international patents. He is a former chief patent counsel responsible for 5,500 U.S. and international patents and patent applications. He holds bachelor's degrees in physics and ceramic engineering from Alfred University, a master's degree in materials science from Penn State University and a J.D. from George Washington University.
Benjamin Greenberg, M.D., MHS, FAAN, is Head of Medical at Clene. He is an internationally recognized expert in disorders of the central nervous system. He is currently professor of neurology and Vice Chair of Clinical and Translational Research in the department of Neurology at University of Texas Southwestern Medical Center in Dallas. He holds a bachelor's degree from Johns Hopkins, a master's degree in molecular microbiology and immunology from the Johns Hopkins School of Public Health and graduated from Baylor College of Medicine. He served residency in neurology at The Johns Hopkins Hospital.
Morgan R. Brown is CFO at Clene. He has more than 30 years of finance and accounting experience, with 23 years at biotech, pharmaceutical and medical device companies. He has served in similar roles at Lipocine Inc., Innovus Pharmaceuticals, World Heart Corp., Lifetree Clinical Research and NPS Pharmaceuticals Inc. He previously worked at accounting firm KPMG. He is a CPA with a bachelor's degree in accounting from Utah State University and an M.S. in business administration from the University of Utah.
CNS Pharmaceuticals Inc. (NASDAQ: CNSP)
CNS Pharmaceuticals Inc. (NASDAQ: CNSP) is a clinical stage biotechnology company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system.
The company was founded in 2017 and is headquartered in Houston, Texas.
Organ Targeted Therapeutics
The company's lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme ("GBM"), an aggressive and incurable form of brain cancer. Berubicin also has potential to treat other central nervous system malignancies. Based on limited clinical data, Berubicin appears to be the first anthracycline to cross the blood brain barrier in the adult brain, and it was the subject of a successful Phase 1 study which found the MDT and produced efficacy data as well.
CNS holds a worldwide exclusive license to the Berubicin chemical compound. The company has acquired all requisite data and know-how from Reata Pharmaceuticals Inc. related to a completed Phase I clinical trial of Berubicin in malignant brain tumors. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. In 2017, CNS entered into a collaboration and asset purchase agreement with Reata.
CNS intends to explore the potential of Berubicin to treat other diseases, including pancreatic and ovarian cancers and lymphoma. The company is also examining plans to develop combination therapies that include Berubicin.
CNS estimates that more than $25 million in private capital and grants were invested in Berubicin prior to the company's $9.8 million IPO in November 2019.
CNS intends to submit an IND for Berubicin during the fourth quarter of 2020 and expects to commence a Phase II clinical trial of Berubicin for the treatment of GBM in the U.S. in Q1 2021. A sub-licensee partner was awarded a $6 million EU/Polish National Center for Research and Development grant to undertake a Phase II trial of Berubicin in adults and a first-ever Phase I trial in pediatric GBM patients in Poland in 2021.
The company's second drug candidate, WP1244, is a novel DNA binding agent licensed from the MD Anderson Cancer Center. In preclinical studies, WP1244 proved to be 500-times more potent than the chemotherapeutic agent, daunorubicin, in inhibiting tumor cell proliferation. The company has entered into a sponsored research agreement with the MD Anderson Cancer Center to further the development of WP1244.
CNS Pharmaceuticals recently engaged U.S.-based Pharmaceutics International Inc. and Italian BSP Pharmaceuticals SpA for the production of the Berubicin drug product. The company has implemented a dual-track manufacturing strategy to mitigate COVID-19-related risks, diversify its supply chain and provide for localized availability of Berubicin. CNS has already completed synthesis of Berubicin's active pharmaceutical ingredient (API) and has shipped the API to both manufacturers in order to prepare an injectable form of Berubicin for clinical use.
Global Brain Tumor Therapeutics Market
The high recurrence rate of malignant brain tumors is due to reappearance of focal masses, indicating that a sub-population of tumor cells in these cancers may be insensitive to current therapies and may be responsible for reinitiating tumor growth. This necessitates the development of newer drugs in the market that demonstrate greater efficacy in treating such aggressive cancers.
A global increase in neurological disorders has placed increased attention on cancers of the brain over the past decade. Neurological disorders are becoming one of the most prevalent types of disorders, due to longer life expectancy, greater exposure to infection and an increasingly sedentary lifestyle. Because few treatments for primary and metastatic cancers of the brain exist, costs are high and have acted as a restraint for the brain tumor therapeutics market.
Despite progress in surgery, radiotherapy and chemotherapeutic strategies, effective treatments for brain cancer are limited by a lack of specific therapies for the brain and the difficulty in transporting therapeutic compounds across the blood brain barrier. Therefore, there is a significant need for novel and effective therapeutic drugs and strategies that prolong survival and improve quality of life for brain tumor patients.
Several companies are making significant investments into R&D, which is expected to bring more treatment options to the market in the near future. Industry reports consistently project continued growth in the market.
One report estimates that the global brain tumor therapeutics market will reach a valuation of $2.74 billion in 2023, with the market expected to register a CAGR of 11% during the forecast period from 2018 to 2023. Another report projects that the global brain tumor therapeutics market will reach $3.4 billion by 2025, up from $2.25 billion in 2019 (http://nnw.fm/eDUjp).
Management Team
John M. Climaco is the CEO of CNS Pharmaceuticals. For 15 years, Climaco has served in leadership roles for a variety of health care companies. Recently, Climaco served as the Executive Vice President of Perma-Fix Medical S.A, where he managed the development of a novel method to produce Technitium-99. Climaco also served as President and CEO of Axial Biotech Inc., a DNA diagnostics company. In the process of taking Axial from inception to product development to commercialization, Climaco forged strategic partnerships with Medtronic, Johnson & Johnson and Smith & Nephew.
Christopher Downs, CPA, is the company's Chief Financial Officer. Downs previously served as Interim Chief Financial Officer and Executive Vice President of InfuSystem Holdings Inc. (NYSE: INFU), a supplier of infusion services to oncologists in the United States. Downs holds a Bachelor of Science from the United States Military Academy at West Point, an MBA from Columbia Business School and a Master of Science in Accounting from the University of Houston-Clear Lake.
Dr. Donald Picker is the Chief Scientific Officer of CNS. Picker has over 35 years of drug development experience. Prior to joining CNS, Picker worked at Johnson Matthey, where he was responsible for the development of Carboplatin, one of the world's leading cancer drugs, which was acquired by Bristol-Myers Squibb with annual sales of over $500 million. In addition, he oversaw the development of Satraplatin and Picoplatin, third-generation platinum drugs currently in late-stage clinical development.
Sandra L. Silberman, M.D., Ph.D., is the Chief Medical Officer of CNS Pharmaceuticals. Silberman is a hematologist/oncologist who earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively, and her M.D. from Cornell University Medical College. She then completed both a clinical fellowship in hematology/oncology and a research fellowship in tumor immunology at the Brigham & Women's Hospital and the Dana Farber Cancer Institute in Boston, Massachusetts. Silberman has played key roles in the development of many drugs, including Gleevec(TM), for which she led the global clinical development at Novartis. Silberman advanced several original, proprietary compounds into Phases I through III during her work with leading biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone and Roche.
D-Wave Quantum Inc. (NYSE: QBTS)
D-Wave Quantum Inc. (NYSE: QBTS) is a leader in quantum computing systems, software and services focused on delivering value to our customers via practical quantum applications for problems such as logistics, artificial intelligence, materials sciences, drug discovery, scheduling, fault detection and financial modeling. As the only provider building both annealing and gate-model quantum computers, the company is unlocking commercial use cases in optimization today, while building the technologies that will enable new solutions tomorrow. Founded in 1999, D-Wave is the world's first commercial supplier of quantum computing solutions.
D-Wave is a pioneer in quantum computing, with a history of delivering the world's first commercial quantum computer; the first real-time quantum cloud service; countless hardware and software product and research milestones; and the planned first cross-platform quantum solution which will deliver both annealing and gate-model quantum computers to customers via an integrated platform. Its current commercial product offerings include: Advantage™ (fifth generation quantum computer), Leap™ (quantum cloud service), Launch™ (quantum computing onboarding service), Ocean™ (full suite of open-source programming tools) and Quantum QuickStart™ (quantum programming training).
D-Wave's relentless pursuit of practical quantum computing has resulted in the technology being used today by some of the world's most advanced enterprises – our customers include more than two dozen of the Forbes Global 2000 companies.
D-Wave's commercial customers include blue-chip industry leaders like Volkswagen, Mastercard, Deloitte, ArcelorMittal, Siemens Healthineers, Unisys, Accenture, BBVA, NEC Corporation, Pattison Food Group Ltd., DENSO and Lockheed Martin. The company owns one of the largest quantum computer intellectual property portfolios in the industry including more than 210 issued U.S. patents. In addition, it has published more than 100 peer-reviewed papers in leading scientific journals.
Advantage™ Quantum Computer
With the Advantage™ Quantum Computer, D-Wave has incorporated two decades of experience and over 10 years of customer feedback to create the first and only quantum computer designed for business applications. The platform features a new processor architecture with over 5,000 qubits and 15-way qubit connectivity. This is 2.5x more connections and more than double the number of qubits than the company's previous generation quantum computer.
D-Wave's quantum computers, first located at the company's facilities in British Columbia, Canada, have been available to North American users through its Leap™ quantum cloud service since 2018. Over the last two years, D-Wave has since introduced new Advantage systems located in Julich, Germany and Marina Del Rey, California, which marked the availability of the first Advantage quantum computer physically located in the United States. This system is part of the USC-Lockheed Martin Quantum Computing Center (QCC) hosted at USC's Information Sciences Institute (ISI), a unit of the University of Southern California's prestigious Viterbi School of Engineering.
Leap Quantum Cloud Service
D-Wave's customers interface with the Advantage quantum computer through the Leap™ quantum cloud service. Leap delivers immediate, real-time access to the company's Advantage quantum computer and quantum hybrid solver service, all with enterprise-class performance and scalability.
Leap allows developers proficient in Python to get started building and running quantum applications. Through a seamless and secure cloud-based connection, users can easily start solving complex problems of up to 1 million variables and 100,000 constraints.
Using Leap, D-Wave customers have developed quantum hybrid applications for use cases in manufacturing, logistics, financial services, life sciences, materials science, retail and transportation. By eliminating the need to wait hours, days, or even weeks, to get good answers to a broad array of problems, D-Wave is helping businesses accelerate solutions to their complex computing problems.
The Leap quantum cloud service is available directly from D-Wave and also in AWS Marketplace.
D-Wave Launch
D-Wave Launch™ is the company's onboarding platform aimed at helping businesses easily start their quantum journey. Through this program, D-Wave's team of experts and partners aid enterprises in identifying best use cases for quantum and work with them to develop a proof of concept and a production pilot.
From there, the team coordinates with customers to get their hybrid quantum applications up and running, providing ongoing Leap quantum cloud access to ensure the application is operating smoothly and delivering real business value.
Target Verticals
While the potential applications for quantum computing are essentially limitless, D-Wave has identified a number of industry verticals as key areas of focus for its quantum architecture, providing case studies for each. These include:
- Manufacturing – D-Wave worked with Volkswagen to identify a commercial optimization application, the binary paint shop problem, which was run on D-Wave's hybrid solver service. The solver outperformed four purely classical methods on problem sizes at commercial scale (N=3,000).
- Life Sciences – Menten AI makes use of D-Wave quantum computing to assist in the design of novel therapeutic peptides—short strings of amino acids that can act as potent drugs. With the rise of COVID-19, D-Wave's Advantage system made it possible to identify molecules that might be especially well-suited for binding and inhibiting the related spike protein, producing several promising peptide designs.
- Finance – Multiverse Computing, a leader in developing quantum solutions for the financial sector, leveraged D-Wave's hybrid solver service in a collaboration with BBVA, one of the world's largest financial institutions. Multiverse helped BBVA with financial portfolio optimization, using D-Wave's quantum technology to identify a portfolio with 15% risk that yielded a 60% return on investment.
- Logistics – SavantX is using the D-Wave Advantage system to optimize operations at the Port of Los Angeles. By using our quantum technology, SavantX improved cargo handling efficiency at Pier 300 with rubber tyred gantry (RTG) cranes by 60%, and the turnaround time for the trucks picking up those cargo containers by 12%
Market Opportunity
The quantum computing total addressable market is projected by the Boston Consulting Group to grow to between $450 billion and $850 billion over the next 15 to 30 years. For quantum hardware, software and service providers, the near-term TAM (3 to 5 years) is expected to be $400 million to $1 billion, growing to $90 billion to $170 billion over the long-term (15-30 years). Driving factors behind this growth include rising investments in quantum computing tech by governments and an increasing number of commercial use-cases.
Forward-thinking organizations see quantum as an opportunity to move ahead of the competition. From finding efficiencies and reducing waste to decreasing time to solution and solving problems abandoned due to complexity, the business value is real. According to data from Hyperion Research, 80% quantum early adopters are planning to increase their commitment to quantum in the next two to three years, and one-third are planning to invest at least $15M USD in quantum efforts.
D-Wave is strategically positioned – in an industry with significant barriers to entry – as evidenced by a decades-long track record serving a roster of blue-chip customers. The company is singularly focused on helping its customers achieve clear value by leveraging quantum computing in practical business applications. As one of very few quantum companies with a full stack of systems, software, developer tools and services, D-Wave is working to enable enterprises, governments, developers and researchers to access the power of quantum computing, thereby providing an intriguing opportunity for prospective investors.
Prior to listing on the NYSE in August 2022, D-Wave raised over $300 million as a private company with significant investors including PSP Investments, Goldman Sachs, BDC Capital, NEC Corporation, Aegis Group Partners and In-Q-Tel.
Leadership Team
Dr. Alan Baratz has served as the CEO of D-Wave since 2020. Previously, as Executive Vice President of R&D and Chief Product Officer, he drove the development, delivery, and support of all of D-Wave's products, technologies, and applications. Dr. Baratz has over 25 years of experience in product development and bringing new products to market at leading technology companies and software startups. As the first president of JavaSoft at Sun Microsystems, he oversaw the growth and adoption of the Java platform from its infancy to a robust platform supporting mission-critical applications in nearly 80 percent of Fortune 1000 companies. He has also held executive positions at Symphony, Avaya, Cisco, and IBM. Dr. Baratz holds a doctorate in computer science from the Massachusetts Institute of Technology.
John Markovich has served as D-Wave's CFO since 2021. He brings over 25 years of experience serving as CFO for rapidly growing private and public technology companies across all stages of development. Mr. Markovich has directed the finance, accounting, tax, treasury, M&A, legal, operations, customer service, IR, HR, and IT functions for companies ranging from privately held pre-revenue startups to an NYSE-listed Fortune 500 multi-national company with over $1.2 billion in annual revenue. During his career, he has negotiated and closed over 150 debt, equity, M&A, and joint venture transactions exceeding $2.5 billion in value. Mr. Markovich holds a BS in Business from Miami University and an MBA from the Michigan State Graduate School of Business.
Lantern Pharma Inc. (NASDAQ: LTRN)
Lantern Pharma Inc. (NASDAQ: LTRN) is a clinical-stage biotechnology company leveraging artificial intelligence and machine learning to redefine oncology drug development. Through its proprietary platform, RADR® (Response Algorithm for Drug Positioning & Rescue), Lantern is advancing a pipeline of precision cancer therapies. The company has gained 11 FDA Designations for its portfolio of drug candidates including: Fast Track, Orphan and Pediatric Rare Disease. The company's data-driven approach enables rapid identification of promising drug candidates and the design of targeted clinical trials for specific patient subpopulations and cancer types.
Lantern's vision is to transform cancer treatment by integrating large-scale genomics, AI-based biomarker discovery, and preclinical modeling to accelerate the development of oncology drugs. The company's pipeline includes three lead small molecule candidates and an antibody-drug conjugate (ADC) program across 12 cancer indications, supported by strategic collaborations with global research institutions and clinical partners. The company has three active clinical trials enrolling patients with multiple clinical milestones expected throughout the next twelve months.
The company's mission is centered on transforming the cost and pace of developing innovative therapies for patients with genetically defined cancers or limited treatment options. Lantern is also advancing brain and CNS cancer drug development through its wholly owned subsidiary, Starlight Therapeutics.
The company is headquartered in Dallas, Texas.
Product Portfolio
Lantern Pharma's product pipeline consists of three lead candidates—LP-300, LP-184, and LP-284—and a preclinical ADC program. All are guided by insights from the RADR® platform, which has grown to incorporate over 200 billion oncology-specific data points.
LP-300 is in a Phase 2 trial (Harmonic™) for non-small cell lung cancer (NSCLC) in never smokers. The trial evaluates LP-300 in combination with carboplatin and pemetrexed and has shown a clinical benefit rate of 86% and an objective response rate of 43% in its initial cohort. The study is enrolling 90 patients across the U.S., Japan, and Taiwan (NCT05456256).
LP-184 is in a Phase 1a trial for advanced solid tumors and GBM (NCT05933265). The compound has received FDA Fast Track Designations for GBM and triple-negative breast cancer (TNBC), as well as four Rare Pediatric Disease Designations. Upcoming Phase 1b/2 trials are planned for TNBC (monotherapy and with olaparib) and for NSCLC patients with KEAP1/STK11 mutations in combination with nivolumab and ipilimumab.
LP-284 is currently in a Phase 1 trial for relapsed or refractory non-Hodgkin's lymphoma (NHL) and other solid tumors (NCT06132503). The drug candidate has demonstrated complete tumor suppression in preclinical models of mantle cell lymphoma resistant to Ibrutinib and bortezomib and showed synergistic activity with rituximab in high-grade B-cell lymphoma models.
Lantern's ADC program is based on cryptophycin conjugates and is undergoing preclinical evaluation, showing sub-nanomolar potency and improved targeting in HER2-expressing models.
The company has also launched Starlight Therapeutics, focused on CNS cancers, where STAR-001 (LP-184 for CNS cancers) is advancing toward a Phase 1b/2 trial in glioblastoma and pediatric brain cancers, including ATRT, supported by Rare Pediatric Disease Designations and preclinical validation from Johns Hopkins.
Market Opportunity
Lantern Pharma is focused on oncology indications with significant unmet medical need and multi-billion-dollar commercial potential.
- LP-300 targets non-small cell lung cancer in never smokers, a patient population estimated at over 150,000 cases globally and representing a market opportunity exceeding $4 billion annually.
- LP-184 is positioned for use in DDR-deficient tumors such as pancreatic, bladder, and triple-negative breast cancers, which collectively represent a U.S. market opportunity estimated at over $10 billion annually. Opportunities in targeted DDR-deficient tumors include the KEAP1/STK11 mutant NSCLC population targeted by LP-184, with a market potential of over $2 billion annually, and TNBC, which alone represents a $4 billion global market given its aggressiveness and high brain metastasis rate.
- LP-284 is aimed at relapsed or refractory non-Hodgkin's lymphomas, particularly mantle cell lymphoma and HGBL, within a market sized at $3.5 to $4 billion globally.
- CNS cancers addressed by Starlight Therapeutics further expand Lantern's reach, representing an estimated $5 billion annual global opportunity, including both adult and pediatric cancers.
Leadership Team
Panna Sharma, President, Chief Executive Officer, and Director, leads Lantern Pharma with a deep background in oncology-focused biotechnology and artificial intelligence. He is responsible for Lantern's strategic vision and has driven the growth of its AI-powered drug development platform. Prior to joining Lantern in 2018, he served as President and CEO of Cancer Genetics Inc. (NASDAQ: CGIX), where he raised over $100 million and expanded the company from 25 to over 250 employees across multiple continents. Earlier, he founded TSG Partners and played a key role in the IPO of iXL, a digital strategy firm.
David R. Margrave, Chief Financial Officer and Secretary, has served in executive roles in life sciences for over two decades. Before joining Lantern, he held leadership positions at BioNumerik Pharmaceuticals, including President and Chief Administrative Officer. He has also been a strategic consultant to multiple biotech firms and served as Senior Legal Advisor at MedCare Investment Corporation. Mr. Margrave holds a dual degree in Economics and Petroleum Engineering from Stanford University and a J.D. from The University of Texas School of Law.
Kishor G. Bhatia, Ph.D., Chief Scientific Officer, has more than 40 years of experience in cancer biology, including leadership at the National Cancer Institute where he served as Director of the AIDS Malignancy Program and held key roles in cancer treatment and diagnosis. He has also worked as an Adjunct Investigator and consultant to biotech firms such as Reprocell and Cancer Genetics. Dr. Bhatia earned his Ph.D. in Biochemistry from the University of Mumbai and completed postdoctoral research at Johns Hopkins University. He is a Fellow of the Royal College of Pathology in the UK.
Massimo Group (NASDAQ: MAMO)
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.
NRx Pharmaceuticals Inc. (NASDAQ: NRXP)
NRx Pharmaceuticals Inc. (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders, particularly Suicidal Depression and PTSD. The company is leveraging its patented NMDA receptor modulation platform with two drugs, NRX-100 (preservative-free ketamine) and NRX-101 (D-cycloserine/lurasidone), that have received FDA Fast Track and Breakthrough Therapy Designations respectively. Both address acute unmet medical needs, in that there is no FDA-approved medication for suicidal depression and PTSD. The only approved treatment today is electroshock therapy.
A New Drug Application (NDA) for its lead investigational drug, NRX-100 (preservative free intravenous ketamine), is being filed for use as treatment for suicidal depression, a condition for which existing treatments remain limited. FDA has approved the Company's Pediatric Study Plan and granted a $4.3 million filing fee waiver to support this application. Additionally, the company is working to bring NRX-101 (D-cycloserine/lurasidone) to the market; the product is positioned to be the first FDA-approved oral therapy for suicidal bipolar depression.
Both new drugs are part of the growing focus on neuroplastic therapies that treat life-threatening CNS diseases by stimulating the growth of new synaptic connections within the brain. Research has shown that suicidal depression is associated with high levels of NMDA receptor activity in the brain, with atrophy of brain cell connections. Administration of NMDA antagonist drugs such as NRX-100 and NRX-101 is associated in increased levels of brain glutamate, formation of new synapses, and documented clinical improvement in well controlled clinical trials.
NRx has also established HOPE Therapeutics, a wholly-owned subsidiary focused on delivering interventional psychiatric care through a nationwide clinic network. HOPE Therapeutics aims to become the first coordinated system of care for suicidal depression, treatment resistant depression and PTSD, combining ketamine therapies, Transcranial Magnetic Stimulation (TMS), digital therapeutics, and other precision psychiatry tools in a safe, professional clinical environment. NRx plans to spin HOPE out as an independent, publicly traded company in the near term.
NRx is headquartered in Wilmington, Delaware. HOPE is headquartered in Miami, Florida.
NRx Product Portfolio
NRx Pharmaceuticals' pipeline includes multiple late-stage therapeutic candidates targeting psychiatric and neurological disorders:
- NRX-100: A preservative free intravenous ketamine formulation (patent pending); an NDA for the product is being filed with the FDA for acute suicidal depression, backed by strong clinical trial data and Fast Track designation from the FDA.
- NRX-101 (oral D-cycloserine/lurasidone): A patent protected oral therapy with a dual mechanism targeting NMDA and 5-HT2A receptors, designed for patients with suicidal treatment-resistant bipolar depression. The drug has received Breakthrough Therapy designation from the FDA; an NDA for Accelerated Approval is planned for 2025.
- Expanded Research: The company is further evaluating NRX-101 as a potential non-opioid treatment for chronic pain and as a therapy for complicated urinary tract infections.
NRx's therapeutic pipeline is designed to address conditions with limited or no treatment options, with the potential to improve patient outcomes and expand the standard of care.
HOPE Therapeutics
HOPE Therapeutics, a wholly owned subsidiary of NRx Pharmaceuticals, is establishing a national network of psychiatry-led clinics focused on suicidal depression, treatment resistant depression, PTSD and related Central Nervous System (CNS) disorders. Its care model integrates ketamine therapy, TMS, digital therapeutics, and supervised psychiatric support to deliver rapid, measurable outcomes.
The company is targeting more than 30 clinic acquisitions by year-end 2025. Recent progress includes agreements to acquire Kadima Neuropsychiatric Institute and Dura Medical and a letter of intent with Neurospa TMS, strengthening HOPE's foundation in interventional psychiatry.
HOPE projects $100 million in forward looking annual revenue and profitability by year-end 2025. Positioned as a stand-alone care delivery company, HOPE offers NRx a potential future spinout opportunity to unlock additional shareholder value.
Market Opportunity
The need for innovative treatments in mental health and pain management is substantial. Suicide is a leading cause of death in the United States, claiming nearly 50,000 lives each year, with over 12 million adults seriously considering suicide annually, according to the CDC.
Suicidal depression, an acutely life-threatening condition, affects approximately 12 million Americans. Despite this prevalence, the only approved intervention remains electroconvulsive therapy (ECT), a treatment with significant side effects and limited access. NRx aims to address this urgent gap with NRX-100, a preservative-free intravenous ketamine formulation being developed as the first FDA-approved treatment for suicidal depression.
Additionally, approximately 7 million Americans suffer from bipolar depression, a condition where nearly half of patients will attempt suicide during their lifetime and one in five may die by suicide. NRX-101, NRx's oral drug candidate, targets this critical unmet need as a potential first-in-class therapy specifically for bipolar depression.
Beyond mood disorders, chronic pain affects over 50 million individuals in the U.S., and PTSD impacts more than 12 million people—conditions for which few non-opioid or fast-acting treatments are available. By addressing these high-risk, underserved populations, NRx Pharmaceuticals is positioned to enter multiple billion-dollar markets and reshape the standard of care for severe psychiatric and neurological illnesses.
Leadership Team
Jonathan C. Javitt, Founder, Chairman & Chief Executive Officer or NRx, and Co-CEO of HOPE, brings four decades of experience in pharmaceutical and medical device development. He has led blockbuster drug and device programs at major companies, including Allergan, Merck, and Novartis, and has served as an advisor to four U.S. presidential administrations.
Michael Abrams, Chief Financial Officer, has nearly 30 years of experience in finance, having served in executive roles as an SEC-licensed securities professional, followed by executive roles as a CFO including positions at Arch Therapeutics and FitLife Brands. His expertise spans investment banking, corporate finance, and business strategy.
Matthew Duffy, Chief Business Officer, NRx, Co-CEO of HOPE, has over 35 years of experience in healthcare commercialization, business development and investment banking. He has held leadership roles at Pfizer, MedImmune, and Lev Pharmaceuticals. He has also served as an SEC-licensed professional at Laidlaw Venture Partners, and several other financial institutions, specializing in corporate strategy and partnerships.
Rick Panicucci, Chief Technology Officer, has more than 25 years of leadership in pharmaceutical manufacturing and process development. He has held key positions at Novartis, WuXi AppTec, and other major companies, leading multiple approved New Drug Applications.
Nutriband Inc. (NASDAQ: NTRB)
Nutriband Inc. (NASDAQ: NTRB) is engaged in the development of a portfolio of transdermal pharmaceutical products. The company's AVERSA™ technology can be incorporated into any transdermal patch and includes aversive agents to prevent abuse, diversion, misuse and accidental exposure to drugs with abuse potential, specifically opioids.
AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to patients who need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, Australia, and China, with recent extensions into Macao.
The company's business model is to apply its transdermal technology to existing FDA-approved drugs with a goal of improving safety, efficacy and patient comfort while qualifying for a limited-development regulatory pathway that reduces the number of clinical trials required for approval of new drugs.
Nutriband has three subsidiaries, including 4P Therapeutics, its clinical and regulatory subsidiary; Pocono Pharmaceutical, a contract manufacturer for a wide range of clients; and Active Intelligence, a developer of sports recovery products. This ownership of manufacturing and clinical development capabilities drastically reduces costs for AVERSA and other technologies.
In April 2024, Nutriband announced that the company had been engaged by and received a first order from Fit For Life Group, a major brand license holder. A fully executed supplier agreement is expected to follow. Nutriband's wholly owned Active Intelligence subsidiary will act as manufacturer.
In February 2025, the company formalized its product development partnership with Kindeva Drug Delivery through a long-term exclusive agreement. The collaboration supports the commercial pathway for AVERSA Fentanyl by leveraging Kindeva's FDA-approved transdermal fentanyl patch system.
The company is headquartered in Orlando, Florida.
Products
Nutriband's lead product candidate is AVERSA Fentanyl, an abuse-deterrent fentanyl transdermal patch. The company announced in March 2024 that it will submit a New Drug Application to the U.S. Food and Drug Administration seeking approval to market AVERSA Fentanyl. In subsequent updates, Nutriband confirmed that the NDA submission remains the company's primary focus and is backed by a strong cash position.
Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband's AVERSA abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. Because Nutriband's abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate from and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation would not be required.
In support of this commercialization strategy, Nutriband closed an $8.4 million private placement in April 2024 to fund development activities related to AVERSA Fentanyl. The company also licensed Bitrex®, a widely used aversive agent, to enhance the deterrent profile of its patch formulation.
AVERSA Fentanyl has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The company plans to seek an expedited review by the FDA, as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs.
Nutriband's AVERSA product development pipeline also includes abuse deterrent versions of currently approved and marketed transdermal patches containing buprenorphine, an opioid used to treat opioid use disorder, and methylphenidate, a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD). Both are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure.
Market Opportunity
Nutriband cites a market analysis report from Boston-based Health Advances, a healthcare and life sciences consulting firm. According to the report, upon FDA approval, AVERSA Fentanyl has the potential to reach peak annual sales of $200 million in the U.S.
The company further states that, should non-abuse-deterrent transdermal fentanyl products lose FDA marketing approval, AVERSA Fentanyl would have greater pricing flexibility and would have the potential to generate more than $500 million in annual revenue.
Management Team
Gareth Sheridan is Co-Founder and CEO of Nutriband. He was Ireland's 'Young Entrepreneur of the Year' in 2014 for establishing Nutriband. He has worked as a Business Mentor with 100 Minds, a social enterprise that brings together some of Ireland's top college students and connects them with a cause to achieve large charitable goals. He received a B.Sc. in Business and Management from Dublin Institute of Technology.
Serguei Melnik is Co-Founder and President of Nutriband. He has been involved in general business consulting for companies in the U.S. financial markets and setting up legal and financial frameworks for operations of foreign companies in the U.S. He previously was the COO of Florida-based Asconi Corporation. He also was a lawyer in the Department of Foreign Affairs, JSC Bank "Inteprinzbanca," in Chisinau, Moldova, and prior to that practiced law in Moldova. He is fluent in four languages.
Jeff Patrick, Pharm.D., is Chief Scientific Officer of Nutriband. He currently serves as Director of the Drug Development Institute at the Ohio State University Comprehensive Cancer Center. His prior roles included Global Vice President at Mallinckrodt Pharmaceuticals Inc.; and roles at Dyax, Myogen/Gilead, Actelion and Sanofi-Synthelabo Inc. He was a clinical pharmacist at the University of Tennessee Medical Center and a clinical assistant professor of pharmacy at the University of Tennessee College of Pharmacy.
Gerald Goodman is CFO of Nutriband. He is a certified public accountant with his own firm, Gerald Goodman CPA. He also practiced with Madsen & Associates, CPAs, and was a partner in the accounting firm of Wiener, Goodman & Company. He is also a director of Lifestyle Medical Network Inc., which provides management services to healthcare providers. He is a graduate of Pennsylvania State University, where he received a bachelor's degree in accounting.
PowerBank Corporation (NASDAQ: SUUN) (Cboe CA: SUNN) (FSE: 103)
PowerBank Corporation (NASDAQ: SUUN) (Cboe CA: SUNN) (FSE: 103) is a premier developer and owner of renewable and clean energy projects, specializing in distributed and community solar initiatives throughout Canada and the United States. The company is committed to advancing the transition to sustainable energy by offering end-to-end services that include project origination, financing structuring, engineering, procurement, construction, and long-term operations and maintenance. PowerBank focuses on delivering innovative energy solutions through solar photovoltaic systems, battery energy storage systems (BESS), and electric vehicle (EV) charging infrastructure.
With a vision to provide scalable and reliable clean energy solutions, PowerBank has established itself as a leader in the renewable energy market by cultivating partnerships with utilities, commercial and industrial entities, municipalities, and residential customers. Its vertically integrated business model allows for optimized efficiency, cost management, and returns across diverse markets in North America. This end-to-end approach ensures greater control over project quality, costs, and operational outcomes, strengthening its competitive position.
Driven by a mission to create a greener future, PowerBank manages a robust portfolio of projects, including more than 100 megawatts (MW) of developed capacity and a pipeline exceeding one gigawatt (GW). The company's commitment to sustainability and innovation makes it a recognized player in the renewable energy sector.
PowerBank has offices in Toronto, Ontario and New York.
Projects
PowerBank boasts an impressive and diverse portfolio of renewable energy initiatives that underline its leadership in the clean energy space. In the U.S., the company has over 250 MW of solar projects under development, principally in New York, focusing on community solar farms and commercial and industrial installations. Notably, PowerBank is developing several community solar projects in upstate New York, which will deliver clean energy to local residents and small businesses. Community solar projects, which are a cornerstone of PowerBank's portfolio, provide scalable solutions for renters, homeowners, and small businesses to access affordable renewable energy, driving localized energy independence and economic savings.
In Canada, PowerBank has been a significant participant in Ontario's Feed-in-Tariff program, where it has secured contracts for close to 200 MW of capacity. Its current management includes 70 solar power projects, totaling 28.8 MW of operational solar assets. The company's expertise extends to the development and ownership of battery energy storage systems and EV charging stations, further diversifying its portfolio.
The company's vertically integrated approach spans the entire project lifecycle, from initial site acquisition and grid interconnection to long-term operation and maintenance services. This ensures seamless execution and high-quality outcomes, providing value to stakeholders and supporting the transition to a clean energy future.
Market Opportunity
PowerBank operates within a growing renewable energy market driven by global demand for sustainable power solutions. In North America, favorable policies such as the Inflation Reduction Act in the United States and Canada's investments in green technologies provide a robust foundation for renewable energy adoption. Solar PV installations and battery energy storage systems are at the forefront of this expansion, addressing energy reliability and grid stability while reducing carbon emissions.
The North American solar PV market was valued at $25.02 billion in 2019 and is projected to reach $120.74 billion by 2027, growing at a compound annual growth rate (CAGR) of 21.7% from 2020 to 2027. Likewise, the global BESS market is expected to expand from $7.8 billion in 2024 to $25.6 billion by 2029, at a CAGR of 26.9%, as reported by MarketsandMarkets. These trends are driven by the increasing integration of renewable energy sources, the need for grid resilience, and declining technology costs.
PowerBank's operations have it well-positioned to capitalize on these opportunities. With a development pipeline exceeding one gigawatt (GW), the company is focused on meeting growing demand in community and commercial solar sectors. Decentralized energy solutions, such as virtual net metering and behind-the-meter systems, further enhance PowerBank's market potential by addressing the critical need for flexible, cost-effective, and sustainable energy infrastructure. By leveraging its vertically integrated model and diversified portfolio, PowerBank stands as a key player in driving the renewable energy transition.
Leadership Team
Dr. Richard Lu, MD, MSc., MHSc., MBA, serves as President and CEO of PowerBank, bringing over 25 years of global energy experience. His leadership has been instrumental in advancing the company's strategic initiatives across North America, Europe, and Asia, with a focus on renewable energy development and operational excellence.
Sam Sun, MBA, is the Chief Financial Officer of PowerBank. A Chartered Professional Accountant with more than 15 years of expertise in corporate finance, Mr. Sun has overseen financial strategies and internal controls across the cleantech, manufacturing, and mining sectors in Canada, the U.S., and China.
Andrew van Doorn, PE, serves as Chief Operating Officer, with nearly three decades of experience in engineering and construction. Mr. van Doorn has successfully led projects totaling over 200 MW of solar capacity and is a former Chairman of the Canadian Solar Industries Association.
Tracy Zheng, MBA, Chief Development Officer, has over 25 years of experience in brand marketing, business development, and solar project operations. She has spearheaded sales initiatives, conducted feasibility studies, and negotiated key partnerships that drive PowerBank's growth.
Matt Wayrynen, Executive Chairman and Director, has a background in resource company management, venture capital, and mergers and acquisitions. Under his leadership, Solar Flow-Through Funds, where Mr. Wayrynen acted as CEO, was acquired by PowerBank, enhancing its asset portfolio and growth prospects.
Forward Looking Statements
This report contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements") that relate to the Company's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result", "are expected to", "expects", "will continue", "is anticipated", "anticipates", "believes", "estimated", "intends", "plans", "forecast", "projection", "strategy", "objective" and "outlook") are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. In particular and without limitation, this report contains forward-looking statements pertaining to the Company's expectations regarding its industry trends and overall market growth of the data center market; the Company's expansion into the data center market, including its pursuit of opportunities as a developer, owner, and strategic partner in data center infrastructure; supporting the demand for high-performance, sustainable energy solutions within the sector; details of the company's business plan including development of solar power projects, battery storage projects and EV charging projects; the completion of any contracts for, or construction of, any data center, solar power, battery storage or EV projects; the receipt of interconnection approval, permits and financing to be able to construct projects; the receipt of incentives for projects; and the size of the Company's development pipeline. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this report should not be unduly relied upon. These statements speak only as of the date of this report.
Forward-looking statements are based on certain assumptions and analyses made by the Company in light of the experience and perception of historical trends, current conditions and expected future developments and other factors it believes are appropriate, and are subject to risks and uncertainties. In making the forward looking statements included in this report, the Company has made various material assumptions, including but not limited to: obtaining the necessary regulatory approvals; that regulatory requirements will be maintained; general business and economic conditions; the Company's ability to successfully execute its plans and intentions; the availability of financing on reasonable terms; the Company's ability to attract and retain skilled staff; market competition; the products and services offered by the Company's competitors; that the Company's current good relationships with its service providers and other third parties will be maintained; and government subsidies and funding for renewable energy will continue as currently contemplated. Although the Company believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and the Company cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements.
Whether actual results, performance or achievements will conform to the Company's expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under "Forward-Looking Statements" and "Risk Factors" in the Company's most recently completed Annual Information Form, and other public filings of the Company, which include: the Company may be adversely affected by volatile solar power market and industry conditions; the execution of the Company's growth strategy depends upon the continued availability of third-party financing arrangements; the Company's future success depends partly on its ability to expand the pipeline of its energy business in several key markets; governments may revise, reduce or eliminate incentives and policy support schemes for solar and battery storage power; general global economic conditions may have an adverse impact on our operating performance and results of operations; the Company's project development and construction activities may not be successful; developing and operating solar projects exposes the Company to various risks; the Company faces a number of risks involving Power Purchase Agreements ("PPAs") and project-level financing arrangements; any changes to the laws, regulations and policies that the Company is subject to may present technical, regulatory and economic barriers to the purchase and use of solar power; the markets in which the Company competes are highly competitive and evolving quickly; an anti-circumvention investigation could adversely affect the Company by potentially raising the prices of key supplies for the construction of solar power projects; foreign exchange rate fluctuations; a change in the Company's effective tax rate can have a significant adverse impact on its business; seasonal variations in demand linked to construction cycles and weather conditions may influence the Company's results of operations; the Company may be unable to generate sufficient cash flows or have access to external financing; the Company may incur substantial additional indebtedness in the future; the Company is subject to risks from supply chain issues; risks related to inflation; unexpected warranty expenses that may not be adequately covered by the Company's insurance policies; if the Company is unable to attract and retain key personnel, it may not be able to compete effectively in the renewable energy market; there are a limited number of purchasers of utility-scale quantities of electricity; compliance with environmental laws and regulations can be expensive; corporate responsibility may adversely impose additional costs; the future impact of any resurgence of COVID-19 on the Company is unknown at this time; the Company has limited insurance coverage; the Company will be reliant on information technology systems and may be subject to damaging cyberattacks; the Company may become subject to litigation; there is no guarantee on how the Company will use its available funds; the Company will continue to sell securities for cash to fund operations, capital expansion, mergers and acquisitions that will dilute the current shareholders; and future dilution as a result of financings.
The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for the Company to predict all of them, or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this report are expressly qualified in their entirety by this cautionary statement.
Safe Pro Group Inc. (NASDAQ: SPAI)
Safe Pro Group Inc. (NASDAQ: SPAI) is a mission-driven technology company delivering advanced AI-powered security and defense solutions. It is focused on serving customers in the defense, homeland security, humanitarian, law enforcement, and commercial markets where its AI, drone-based services and ballistic protective gear can synergistically deliver safety and operational efficiency.
At the heart of Safe Pro's mission is its patented artificial intelligence (AI), machine learning (ML), deep learning and applied computer vision software technology. These tools are currently being used to rapidly detect small objects in drone-based video and imagery such as landmines and unexploded ordnance (UXO), enabling safer and more efficient field operations across global conflict and post-conflict zones and supporting efforts to improve the reliability of critical infrastructure. The company's vision is to lead the evolution of security and threat detection through AI innovation, while its mission is to empower governments, enterprises, and humanitarian organizations with tools to respond to evolving threats at scale.
With a team of leaders and subject matter experts drawn from the defense, technology, and public safety sectors, Safe Pro Group delivers U.S.-developed next-generation AI and drone services through its Safe Pro AI and Airborne Response units and high-performance, American-made ballistic protective solutions through its Safe-Pro USA subsidiary.
The company is headquartered in Aventura, Florida.
Products
Safe Pro Group's three business units operate across software, hardware, and field services to deliver a comprehensive suite of solutions. Each division plays a distinct role in supporting defense, humanitarian and public safety missions around the world.
Safe Pro AI
Safe Pro AI's core AI-powered computer vision technology enables the rapid analysis of drone-based imagery to autonomously detect objects of interest. Its flagship product, SpotlightAI™ can detect and label over 150 types of explosive threats including landmines, cluster munitions, and unexploded ordnance (UXO). Built on more than two years of real-world usage in Ukraine and now including additional imagery being gathered from the Asian-Pacific region and Africa, SpotlightAI™ rapidly processes and creates high-resolution maps supported by the hyper scalability of the Amazon Web Services (AWS) cloud or detects threats in real-time locally through its OnSite Windows-based software application. Today, the platform boasts one of the world's largest datasets built on over 1.6 million real-world battlefield images from Ukraine, identifying 28,000+ threats across more than 6,750 hectares, an area equivalent in size to Manhattan.
Airborne Response
Airborne Response is a leading provider of mission critical drone services using U.S. Government-compliant small uncrewed aircraft systems (sUAS) (drones). It serves enterprises in utilities & telecom and insurance with a full-range of drone-based critical infrastructure inspection and monitoring solutions as well as Drone-as-a-First Responder (DFR) services for law enforcement and public safety. It provides customers with actionable intelligence though data capture, analytics and processing powered by AI.
Safe-Pro USA
Safe-Pro USA manufactures ultra-premium, American-made ballistic protection systems including advanced body armor and ballistic plates as well as complete Explosive Ordnance Disposal (EOD) suits, demining aprons, and bomb blankets. All products exceed U.S. and NATO standards and are designed, engineered, and produced in the U.S., supporting customers across military, humanitarian, and law enforcement sectors.
Market Opportunity
Harnessing its patented, real-time, AI-powered processing of drone-based imagery, Safe Pro is creating a uniquely powerful 'Next-Gen' approach to situational awareness supporting ground-based personnel in safely completing their defense/military, humanitarian, law enforcement & commercial missions.
The global threat posed by landmines and UXO spans nearly 60 countries, affecting millions of civilians and imposing significant economic burdens, particularly in agriculture and infrastructure. In Ukraine alone, the contamination of 17 million hectares has resulted in $50+ billion in agricultural losses, with World Bank estimates projecting $30 billion needed in demining costs. According to the Landmine Monitor 2024, regions in Asia, Africa, and Latin America continue to report high casualty rates.
Safe Pro is positioned to capture a portion of the $15 billion+ global defense tech market, especially in AI-driven battlefield intelligence, drone surveillance, and threat detection. As a U.S.-based AI and defense technology provider with a HUBZone-certified manufacturing arm, Safe Pro is eligible for federal and state procurement programs, public safety grants, and critical infrastructure contracts, as well as global humanitarian demining efforts.
Leadership Team
Dan Erdberg, Chairman and CEO, brings over 20 years of experience as a C-level technology executive. He has led multiple Nasdaq listings in the drone, 5G, and satellite communications sectors, raised over $50 million in growth capital, and spearheaded Safe Pro Group's corporate strategy and acquisitions.
Theresa Carlise, Chief Financial Officer, has more than 30 years of experience in financial leadership roles for public companies. Her expertise includes equity transactions, strategic planning, and financial restructuring. She served as Chief Financial Officer, Secretary, Treasurer and Director of various publicly traded companies within the retail, telecommunications, distribution, transportation, mortgage banking and construction sectors.
Pravin Borkar, CTO and Director (President, Safe-Pro USA), has over 30 years of experience in the engineering and manufacturing of ballistic protection systems for the U.S. Department of Defense. He has developed armor solutions for personnel and aircraft platforms including the CH-53 and Blackhawk.
Christopher Todd, President (Airborne Response), is a drone industry veteran and Certified Emergency Manager (CEM®) with more than 30 years of experience. He founded Airborne Response and is President of AUVSI Florida, with expertise in public safety drone deployment and emergency response.
Silvercorp Metals Inc. (NYSE American: SVM) (TSX: SVM)
Silvercorp Metals Inc. (NYSE American: SVM) (TSX: SVM) is a Canadian mining company producing silver, gold, lead, and zinc, with a long history of profitability and growth. The company focuses on creating shareholder value by generating free cash flow from long-life mines, expanding through organic growth opportunities in China and Ecuador, and pursuing strategic mergers and acquisitions. Silvercorp has built a reputation as a low-cost producer with a commitment to responsible mining practices.
With over 18 years of operating experience, Silvercorp has developed a diversified portfolio of mining assets and investments in China, Ecuador, and Bolivia. The company leverages its expertise in exploration and operational efficiency to enhance the value of its projects while maintaining a strong balance sheet. Silvercorp's disciplined approach to mine expansion and resource development ensures long-term sustainable growth.
The company's mission is to build and operate profitable mines that generate sustainable economic, social, and environmental benefits for stakeholders. Silvercorp is committed to responsible mining, with a focus on environmental stewardship and community engagement.
The company is headquartered in Vancouver, Canada.
Portfolio
Silvercorp operates a diverse portfolio of producing mines, construction-stage projects, and exploration assets across multiple jurisdictions. The company focuses on optimizing production from existing operations while strategically advancing new projects to drive future growth.
- Ying Mining District (China) – The company's flagship operation consists of several underground mines producing silver, gold, lead and zinc in concentrates. In fiscal 2025, Ying produced 6.9 million ounces of silver and 7,495 ounces of gold, along with lead and zinc by-products. Fiscal 2026 guidance calls for continued production growth as ongoing mine optimization efforts continue to bear fruit.
- GC Mine (China) – A silver-lead-zinc mine with a history of consistent production and ongoing resource expansion through drilling. While production dipped slightly in fiscal 2025, output is expected to increase in fiscal 2026.
- El Domo (Ecuador) – A fully-permitted, copper-gold project under construction. In April 2025, Silvercorp announced a detailed and fully-funded $240.5 million construction plan. Major contracts have been awarded and construction activities are underway, with commissioning expected by December 2026.
- Condor Project (Ecuador) – A gold exploration asset with significant resources. In May 2025, Silvercorp published an updated mineral resource estimate focusing on high-grade underground zones. A revised PEA is expected by the end of 2025, alongside continued permitting and community engagement efforts.
- Kuanping Project (China) – A permitted gold-lead-zinc satellite project north of Ying. Mine construction is underway and Kuanping will be an underground mine with ore to be milled at the Ying complex.
- BYP Mine (China) – A gold-lead-zinc project that operated previously and is now undergoing permitting as a gold mine.
- Bolivian Assets – Silvercorp holds a 28% stake in New Pacific Metals (TSX: NUAG, NYSE American: NEWP), providing indirect exposure to two world class silver projects: Silver Sand and Carangas.
Through its diversified portfolio, Silvercorp delivers exposure to operations generating growing cash-flow, as well as high-potential growth projects that will create long-term value for shareholders.
Market Opportunity
The global demand for silver, gold, and base metals remains strong, driven by industrial applications, investment demand, and renewable energy initiatives. Silvercorp is well positioned to capitalize on rising silver demand, particularly in China, where 80% of the world's solar panels are manufactured—an industry heavily reliant on silver.
Ecuador's mining sector is experiencing rapid growth, with government support for foreign investment and infrastructure improvements. Mining exports in the country surged from $275 million in 2018 to $3.3 billion in 2023, highlighting the sector's increasing economic importance. Silvercorp's El Domo and Condor projects are poised to become key contributors to Ecuador's mining expansion.
Industry forecasts indicate continued growth in silver and base metal prices, benefiting producers with strong operational performance and cost controls. Silvercorp's diversified asset base and low-cost production profile provide resilience against market fluctuations, positioning the company for long-term value creation.
Leadership Team
Rui Feng, Ph.D., Chairman & CEO, founded Silvercorp and has over 30 years of experience in mineral exploration and mining. He has been instrumental in leading the company's strategic vision, transforming it into a profitable, low-cost silver producer with a diversified asset base. Under his leadership, Silvercorp has expanded its global footprint, acquiring and developing high-value mining projects across China, Ecuador, and Bolivia. Dr. Feng's expertise in geology and resource development has contributed to major mineral discoveries, and his disciplined approach to capital allocation has positioned the company for long-term growth.
Derek Liu, MBA, CGA, CPA, Chief Financial Officer, brings over two decades of financial leadership experience in the mining sector, overseeing capital allocation, financial strategy, and risk management. He has played a crucial role in maintaining Silvercorp's strong balance sheet and financial discipline, ensuring the company remains well-capitalized for organic growth and strategic acquisitions. His expertise in financial planning, compliance, and investor relations has supported Silvercorp's continued profitability and operational efficiency in a competitive global mining landscape.
Lon Shaver, CFA, President, has extensive experience in corporate finance, equity research, and capital markets, providing strategic guidance on business development and investor relations. Before joining Silvercorp, he held senior roles in investment banking and asset management, where he advised mining companies on financing, mergers, and acquisitions. His deep understanding of capital markets and industry dynamics helps drive Silvercorp's corporate growth initiatives, enhance shareholder value, and strengthen relationships with institutional investors and stakeholders.
Soligenix Inc. (NASDAQ: SNGX)
Soligenix Inc. (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for rare diseases with high unmet medical needs. Operating through two key segments, the company's Specialized BioTherapeutics division is dedicated to oncology and inflammation therapies, while its Public Health Solutions segment advances vaccines and therapeutics targeting biothreats and infectious diseases.
The company is actively advancing multiple late-stage clinical programs, including HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL). Additional candidates in development target psoriasis (SGX302), oral mucositis (SGX942), and Behçet's disease (SGX945), while its public health efforts focus on heat-stable vaccines for ricin poisoning (RiVax®), Ebola (SuVax™), and Marburg (MarVax™) viruses, that have been supported by non-dilutive government grants and contracts of approximately $60 million to date.
With a diversified pipeline, multiple orphan and fast-track designations, and collaborations with government agencies, Soligenix is uniquely positioned for potential regulatory approvals and commercialization.
The company is headquartered in Princeton, New Jersey.
Pipeline and Development Programs
Specialized BioTherapeutics
Soligenix's Specialized BioTherapeutics division develops treatments for oncology and inflammatory diseases, focusing on conditions with few or no effective therapeutic options. HyBryte™ (synthetic hypericin) has completed a Phase 3 study for CTCL, demonstrating statistically significant efficacy, and a second confirmatory Phase 3 trial is actively enrolling patients to support potential regulatory submissions worldwide. If approved, it would be the first non-mutagenic photodynamic therapy for early-stage CTCL, addressing an unmet medical need. It has received orphan drug designations in the U.S. and Europe, as well as Fast Track designation in the U.S.
SGX302, a photodynamic therapy based on the same active ingredient as HyBryte™, is in clinical development for mild-to-moderate psoriasis, with positive Phase 1/2 proof-of-concept results, it is actively enrolling patients in a Phase 2a clinical trial.
SGX942, designed to reduce inflammation and tissue damage in oral mucositis associated with cancer treatment, is progressing as a potential first-in-class therapy.
SGX945, targeting aphthous ulcers in Behçet's disease, is actively enrolling in a Phase 2a clinical trial and has received fast-track designation, highlighting the urgency of developing effective treatments for this rare inflammatory condition.
Public Health Solutions
The company's Public Health Solutions segment focuses on medical countermeasures for biothreats and emerging infectious diseases, leveraging non-dilutive government funding to advance its programs. RiVax®, a ricin toxin vaccine, has demonstrated strong preclinical and early clinical results and may be eligible for government procurement under the Strategic National Stockpile initiative.
The company's RiVax®, as well as its vaccine candidates for Ebola and Marburg viruses are based on its proprietary ThermoVax® technology, which stabilizes vaccines for long-term storage without refrigeration. This approach could be transformative in regions where maintaining cold-chain logistics is challenging.
The ongoing development of these vaccines is supported by funding from NIH, BARDA, and DTRA, with the potential for up to three priority review vouchers (PRVs) upon regulatory approval, to be used for future programs or sold. Notably, PRVs have previously sold for roughly $100 million.
Market Opportunity
Soligenix targets markets with significant commercial potential, focusing on rare diseases and biodefense applications. HyBryte™ addresses CTCL, a disease affecting over 68,000 patients across the U.S. and Europe, with a total market opportunity exceeding $250 million. SGX302, the company's therapy for mild-to-moderate psoriasis, serves a much larger population, as over eight million people in the U.S. are affected by the condition, representing a global market opportunity exceeding $1 billion.
SGX942, developed for oral mucositis in head and neck cancer patients, is aimed at a market worth more than $500 million, while SGX945 for Behçet's disease serves a niche segment valued at over $200 million worldwide.
In addition to its rare disease programs, Soligenix's Public Health Solutions division has the potential to generate significant revenue through government procurement contracts. By focusing on both orphan drug markets and government-funded biodefense initiatives, Soligenix has positioned itself for sustained revenue growth through multiple high-value opportunities.
Leadership Team
Christopher J. Schaber, PhD, Chairman, President & CEO, brings to the company more than 35 years of experience in the biopharmaceutical industry. Before joining Soligenix, he held senior and operational leadership roles at Discovery Laboratories, Acute Therapeutics, Ohmeda Pharmaceuticals, The Liposome Company, and Wyeth Ayerst Laboratories. He has extensive expertise in drug development, regulatory affairs, and corporate strategy, positioning him to drive Soligenix's growth and advancement toward commercialization.
Richard Straube, MD, Chief Medical Officer, has more than 35 years of experience in drug development and clinical research. Prior to joining Soligenix, he held key leadership roles at Stealth Peptides, INO Therapeutics, Ohmeda Pharmaceuticals, and Centocor. Throughout his career, he has played a crucial role in bringing innovative therapies to market, particularly in inflammatory diseases and immunology, making him a valuable asset in advancing Soligenix's late-stage clinical programs.
Oreola Donini, PhD, Chief Scientific Officer, has more than 20 years of experience in pharmaceutical research and development, with expertise in immunology, inflammation, and rare diseases. Before joining Soligenix, she held leadership positions at Inimex Pharmaceuticals, ESSA Pharma, and Kinetek Pharmaceuticals, where she worked on novel drug discovery and translational medicine. Her experience in preclinical research and product development supports Soligenix's continued innovation in biopharmaceuticals.
Jonathan Guarino, CPA, CGMA, Chief Financial Officer, has over 25 years of experience in corporate finance and strategic financial planning. Before joining Soligenix, he held financial leadership positions at Hepion Pharmaceuticals, Covance, BlackRock, and Barnes & Noble. His expertise in financial management, accounting, and capital markets plays a critical role in Soligenix's financial strategy and operational efficiency.
Solowin Holdings (NASDAQ: SWIN)
Solowin Holdings (NASDAQ: SWIN) is a versatile financial services provider focused on delivering comprehensive investment solutions from traditional finance as well as decentralized finance to high-net-worth and institutional clients. Operating through its wholly owned subsidiary, Solomon JFZ (Asia) Holdings Limited, Solowin is licensed by the Hong Kong Securities and Futures Commission and offers access to a full suite of financial services through its secure, one-stop electronic platform, Solomon Win.
Driven by a vision to create a modernized financial services infrastructure, especially to bridging traditional finance and the Web3 technology, Solowin has prioritized innovation, agility, and client-first experiences. The firm has experienced robust growth, aligning itself with evolving capital markets and emerging technologies. Its investment strategy is designed to enable seamless access to capital markets and diversified investment opportunities through cutting-edge financial technology.
Solowin is committed to building a global brand rooted in client success, regulatory compliance, and operational excellence. Its mission is to empower clients with flexible, integrated tools to grow and protect wealth in an increasingly complex financial landscape.
Portfolio
Solowin's operations span five core verticals: securities brokerage, investment banking, asset management, virtual assets, and wealth management. Through its Solomon Win platform, the company provides individual and institutional clients with seamless access to financial markets around the world.
In investment banking, Solowin offers strategic advisory and capital formation services including IPO/SPAC listings, follow-on offerings, private placements, and debt financing. Its team assists issuers in aligning their business objectives with optimized listing strategies and investor targeting. Solowin also supports clients through financial advisory services such as mergers and acquisitions, business restructuring, and capital strategy development, alongside risk management and tax compliance services.
In wealth and asset management, Solowin delivers personalized financial planning via its securities brokerage and integrated investment solutions. Clients can access both in-house funds and top-tier international funds through the Solomon VA+ App, which also supports managed account services. On the frontier of fintech, Solowin offers Web3-based solutions such as virtual asset ETFs, cryptocurrencies, security token offerings, and tokenized real-world assets—positioning itself as a key player in the evolving digital finance space.
Market Opportunity
Solowin operates at the intersection of traditional finance and Web3 innovation, targeting a rapidly expanding global wealth management and fintech market. According to a report by Boston Consulting Group, global assets under management are projected to reach $147.4 trillion by 2027, up from $111.2 trillion in 2021, driven by increased demand for personalized and tech-enabled financial services. Additionally, the virtual asset market is poised for significant growth, with Boston Consulting Group forecasting that the tokenization of global illiquid assets could reach $16 trillion by 2030.
Hong Kong's progressive stance on virtual assets has also positioned it as a regional hub for digital finance. Regulatory support from the Securities and Futures Commission has opened the door for regulated crypto trading platforms and tokenized asset solutions, which aligns with Solowin's digital-first approach.
As wealth migrates toward hybrid portfolios combining traditional and virtual assets, Solowin is uniquely positioned to capitalize on both sectors.
Leadership Team
Peter Lok, Chief Executive Officer, an accomplished finance professional with extensive expertise in fund management, capital markets, and fundraising. His strategic insights in finance and capital allocation have been instrumental in driving capital growth.
Lily Liu, Chief Financial Officer, has more than a decade of experience in corporate finance, investment banking, and financial services. Her background includes IPOs, mergers and acquisitions, and private placements in both Hong Kong and U.S. capital markets, with a strong focus on risk management.
Ben Cheng, Chief Operating Officer, has 15+ years of operational expertise in securities brokerage and asset management. His specialties include regulatory compliance and Anti-Money Laundering/Counter-Financing of Terrorism (AML/CFT) oversight.
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