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As World Transitions away from Gas Guzzlers, Net Element Inc. (NASDAQ: NETE) Entering EV Market Through Mullen Technologies Merger

  • NETE plans to divest payments processing model to enter EV industry through proposed merger with privately-held Mullen Technologies Inc.
  • Merger allows Mullen stakeholders to obtain majority of stock while accelerating process of taking company public, funding US expansion
  • Mullen accepting reservations for Dragonfly K50 sports car and MX-05 SUV, production for both projected to start in 2021
  • California-based Mullen subsidiaries include Mullen Energy, Mullen Auto Sales, Mullen Finance Corp., CarHub digital marketplace
Future generations may look back and wonder how humanity withstood the exhaust fumes, noise and environmental degradation created by fossil fuel engines. The downsides of combustible engines, rising fuel prices and positive government incentives are all factors driving EVs into the mainstream – and some experts predict purely electric models will surpass hybrids during the transition. Net Element (NASDAQ: NETE), through its proposed merger with Mullen Technologies, is planning to divest its payments processing business model to enter the burgeoning EV industry. The strategic move will allow the stakeholders of privately held Mullen to gain a majority of the new stock while catalyzing the process of taking the company public and accelerating its expansion in the United States. The bold move comes at a time of rapid industry expansion amid growing concern for the environment among the general public and policy-makers. Falling battery prices, government mandates and consumer incentives are propelling the industry forward, prompting some industry experts to predict that the pure electric models will surpass hybrids within the next few years as the transition takes place. “I think we’ll see a faster transition to pure EVs,” said Dane Parker, an industry executive and participant at Business Insider’s IGNITION: Transportation virtual event (https://ibn.fm/cJ470). Besides his belief that hybrids are more complex to engineer, Parker predicts that by 2025 battery prices will have dropped substantially, resulting in the accelerated adoption of pure electric vehicles and their eventual dominance over hybrids. Through its subsidiaries that include Mullen Auto Sales, Mullen Finance Corp., a digital marketplace called CarHub and battery-focused Mullen Energy, Mullen Technologies has already made significant headway in the US. Among the company’s expansion plans is the production of the Dragonfly K50 luxury electric sports car at its new proposed 1.3 million square-foot assembly and manufacturing space in Spokane, Washington. Featuring a Rechargeable Energy Storage System (RESS), the Dragonfly boasts a range of up to 310 miles and can accelerate from 0-60 miles/hour in under 4.2 seconds. Limited to only 1000 units, the company has started accepting reservations with production set to begin next year. Pre-orders for another Mullen vehicle – the five-passenger MX-05 – have also begun. Production for the pure electric all-wheel SUV is set to begin in 2021 with deliveries set for mid-2022. Starting at $55,000, the MX-05 boasts a range of 325 miles on a single charge and can hit 60 miles/hour from zero in just 3.2 seconds. Formerly a global financial technology and value-added solutions group, NETE plans to leverage the increased demand for electric vehicles through a proposed merger with Mullen Technologies. Based in California, Mullen Technologies engages in electric vehicle manufacturing across an international distribution network, partnering with several original equipment manufacturers across the world to provide exciting EV options for the US market. For more information, visit the company’s website at www.NetElement.com. NOTE TO INVESTORS: The latest news and updates relating to NETE are available in the company’s newsroom at http://ibn.fm/NETE

Amid Pandemic’s Battering on Hemp / CBD Markets, HempFusion Wellness Inc. Sees Brighter Future

  • Denver-based HempFusion Wellness, Inc. has developed 46 products and 8 OTC FDA listed topicals that draw on the versatile compounds in hemp for promoting effective sleep, stress reduction, pain relief, skin care and “smooth energy” pick-me-ups
  • Despite a downturn in the hemp and CBD product industries brought on by the worldwide COVID-19 pandemic, HempFusion is anticipating a market rebound amid positive developments in legal, political and medical research arenas
  • Market analysts at Brightfield Group anticipate improvement in the CBD sector to $12.4 billion by 2023 and $16.8 billion by 2025
  • HempFusion has filed a preliminary prospectus for a planned initial public offering of its stock in Canada and a listing on the Toronto Stock Exchange under the symbol CBD.U
Legal cannabis consumers have already become well aware of the hammering the industry has taken during the COVID-19 era. Market outlooks have been revised sharply downward as many retailers selling CBD products have closed temporarily or transitioned to curbside pickup and delivery, and farmers have reduced their hemp acreage. But nearly a year into the global pandemic, there have been bright spots as well. While the health crisis has impacted product movement, the legal front lines continue to advance. The European Union’s highest court declared this month that cannabidiol (“CBD”) is not a narcotic drug, despite some EU countries’ efforts to control it on such health-related grounds (https://ibn.fm/wRR8o). In the United States, the presidential elections delivered an apparent victor who favors decriminalization of marijuana, if not outright legalization, while additional states joined the drive toward relaxed legislation within their boundaries (https://ibn.fm/nTFxP). And pandemic-related stress is credited with driving sales increases in some areas (https://ibn.fm/Y3CnJ). CBD brand HempFusion Wellness is optimistic about renewed energy in the marketplace, mirroring its products’ aim to help restore energy and wellness balances to its consumers. “Researchers have newly discovered a system inside of our body that has been affectionately named the endocannabinoid system,” CEO Jason Mitchell explains in a video outlining the company’s operations (https://ibn.fm/DkCCn). “What’s really special about it is that in this identification they have found an intricate network of receptors located throughout the entire body that interconnect all of the biological systems together. They’ve deemed it a regulatory system because it helps to maintain and support homeostasis or balance inside the body.” Mitchell notes that hemp is plant source of cannabinoids that may interact with the body’s system, citing the company’s varied products as able to promote effective sleep, stress reduction, pain relief, skin care and “smooth energy” via liquid tinctures and taste-free liquid capsules, thanks in part to their full-spectrum delivery and combination with other natural elements, such as adaptogen herbs. “The name HempFusion means hemp fused together with other products,” Mitchell states. Researchers at market analysis firm Brightfield Group forecast a CBD marketplace worth $10 billion this year and $23 billion by 2023 before the pandemic swept the planet. They have since revised their outlook downward to $12.4 billion by 2023 and $16.8 billion by 2025 (https://ibn.fm/ZZ3vX). However, the rapid-response effort to deliver a potential COVID-19 vaccine has led some media outlets to predict the end of the pandemic is in sight (https://ibn.fm/kgK3d), which could open the gates to a restored sense of excitement about world economic recovery and CBD products’ return to previous expectations if the relatively new technology of mRNA-based vaccines proves sustainable. HempFusion has developed 46 products and announced last month that it has produced a preliminary prospectus with securities regulatory authorities in Canada for a proposed initial public offering that could land its common shares in all of the provinces but Quebec as it lists on the Toronto Stock Exchange. That makes HempFusion the first U.S.-based CBD company to apply to list on the TSX (https://ibn.fm/n7GXD). For more information, visit the company’s website at www.HempFusion.com/Corporate-Information. NOTE TO INVESTORS: The latest news and updates relating to HempFusion are available in the company’s newsroom at https://ibn.fm/HempFusion

Emerging Functional Mushroom Market Ripe with Potential for Rritual Superfoods’ New Product Line

  • Rritual Superfoods, Inc. is positioning itself to supply the emerging demand for high-potential mushrooms dietary elixirs as wellness products that combat stress, enhance immunity against disease and increase mental clarity
  • Market analysts predict the overall functional foods industry will reach revenues of $268 billion by 2027, and that the functional mushroom segment will grow at a CAGR of 8.04 percent by 2024 as part of the trend
  • Rritual was recently certified by the USDA as an organic product, providing third-party validation Rritual’s quality protocols
  • Rritual’s initial product launch includes elixirs containing mushroom and adaptogenic herb blends such as Chaga-Eleuthero, Lion’s Mane-Rhodiola and Reishi-Ashwagandha combinations
The recently concluded election cycle in the United States revealed that a growing number of people, regardless of political affiliation, are continuing to explore their options for boosting their wellness and mental flexibility, even including the use of some products that have long been classified as illegal (https://ibn.fm/0wxgz). As a prime example, Oregon has gained significant attention for passing its measure to legalize the hallucinogenic compound in “magic mushrooms” for mental health treatment in supervised settings (https://ibn.fm/tcM4A). Rritual Superfoods is pushing to become a leader in an emerging mushroom market, but not the one that’s gaining attention from hallucinogenic users and their opponents. Rather, Rritual is among innovators calling attention to the health benefits of “functional fungi” — the dietary mushrooms that have enjoyed health-promoting status for centuries in Asian countries in particular. “Mushrooms have long been used in Asia for their ability to improve health, maintain vitality, preserve a youthful appearance, and to counter the adverse health effects of chronic stress,” integrative medicine specialist Dr Andrew Weil told the United Kingdom’s Evening Standard (https://ibn.fm/GdAVg). “Research also demonstrates that a variety of traditional mushrooms possess anti-bacterial, anti-viral and immune-enhancing properties.” Rritual Superfoods recently announced the launch of three elixir varieties available in 14-stick packs and in 250-gram tubs during the fall, as well as a 14-day variety pack that includes all three formulations. The company’s website indicates that the products are currently sold out, but will be available in North America during the first quarter of 2021 (https://ibn.fm/89522). The elixirs are a Chaga blend designed to boost the immune system, a Lion’s Mane blend designed to support mental clarity and brain health, and a Reishi blend to boost the body’s ability to fight anxiety. Each elixir blend combines these superfood mushroom varieties with adaptogenic herbal roots and other non-superfood mushrooms engineered to deliver these specific benefits. “All mushrooms are good for us and contain beneficial levels of antioxidants and other plant chemicals, but those called ‘medicinal’ simply have greater levels,” nutritional therapist Grace Kingswell told the Evening Standard. Chaga, in particular, is known as the “king of mushrooms” and contains an unusually high level of antioxidants with beta glucan-rich polysaccharides that give it powerful immune system-supporting capacity, whereas Reishi has been used for over 2,000 years in China. On Nov. 12, the company announced it has secured organic certification from the U.S. Department of Agriculture (“USDA”), hailed by CEO David Kerbel because it provides “trusted, third-party validation of the quality of Rritual’s products,” whereas many wellness products market themselves as containing “all-natural” ingredients, which does not indicate regulatory examination (https://ibn.fm/2FGBV). People generally turn to wellness-boosting products during the winter season as a means of keeping their energy levels high and health intact when temperatures are colder and the sunshine is less potent, making the next few months a prime time for making Rritual’s products available to the public. Particularly during a period of pandemic-level population infection. Market analysts predict the general functional foods industry will see $268 billion in revenues by 2027, growing at a CAGR of 6.7 percent until then (https://ibn.fm/7Ycqh). Mordor Intelligence’s analysts predict the global functional mushroom market will grow with a CAGR of 8.04 percent between 2019 and 2024 (https://ibn.fm/cTBzW). For more information, visit the company’s website at https://investors.wearerritual.com. “Mental Fitness is a Daily Ritual” NOTE TO INVESTORS: The latest news and updates relating to Rritual are available in the company’s newsroom at http://ibn.fm/Rritual

As Global Cannabis Sales Grow 38% in 2020, Gage Cannabis Co. Expands to Offer Recreational Marijuana at Flagship Location

  • Research suggests cannabis sales increased 38% from 2019 to 2020
  • Gage expanding into fast-growing Michigan market, now offering recreational marijuana at flagship Ferndale location
  • Adult-use cannabis revenues in Michigan projected at $1 billion per year for 2021, surpassing $1.5 billion by 2023
  • Quarterly sales nearly doubled to $11.9 million in Q2 2020 from $5.8 million in Q1, expected to surpass $13.1 million in Q3
Recent research published by BDSA (formerly BDS Analytics) suggests that the global cannabis industry continues to grow despite COVID-19, with forecasts predicting that 2020 sales will reach $19.7 billion – an increase of 38% from 2019 (https://ibn.fm/EkGXb). One of Michigan’s fastest-growing cannabis brands, Gage Cannabis has expanded accordingly by offering recreational marijuana at its flagship Ferndale location. Gage is committed to building a solid reputation by providing top-tier cannabis experiences for the rapidly growing Michigan market. “We have been looking forward to this day since we opened our doors in September 2019,” said Gage Cannabis President and Executive Vice President of Operations Mike Finos. “We are excited to extend the Gage experience to anyone aged 21 and over. Metro Detroit is home to our biggest consumers, and we’re ready to provide the community with quality products and a unique customer experience.” Recreational use of cannabis in Michigan was first legalized in 2018, and the state has since emerged as one of the fastest-growing legal cannabis markets in the country in terms of consumption. Revenue projections by state budget planners suggest that the recreational marijuana market will be worth nearly $1 billion in fiscal 2021 with the potential to increase to $1.5 billion by 2023 (https://ibn.fm/wjWRx). “Michigan is one of the top cannabis markets in the U.S., and I am confident Gage is poised to continue building on its historical execution and fortifying its position as one of the top operators and brands in Michigan, as well as a name consumers look for across the United States,” said Gage Cannabis Executive Chairman Bruce Linton (https://ibn.fm/LLQcw). Gage produces its own in-house brands in addition to collaborating with several strategic partners and recognized names such as California-based Cookies – an iconic lifestyle brand widely known for its high-end cannabis strains and association with Berner, a rapper from the Bay Area. Sales bloomed during the COVID-19 lockdown period, nearly doubling to $11.9 million in Q2 from $5.8 million in Q1. The trend is expected to continue with management forecasting sales to surpass $13.1 million by the end of Q3 – an increase of over 150% from January to September 2020 (https://ibn.fm/OcXJh). The company is currently planning to go public with a Canadian listing in early 2021 and has launched a Regulation A, Tier 2, equity financing. To learn more about the company’s Regulation A financing, visit www.GageInvestors.com. For more information, visit the company’s website at www.GageUSA.com. NOTE TO INVESTORS: The latest news and updates relating to Gage Cannabis are available in the company’s newsroom at https://ibn.fm/GAGE

Rritual Superfoods’ Extensive Distribution Network Set to Take Functional Mushrooms Mainstream

  • Functional Mushrooms Market Set for CAGR of 5.6%
  • Expected to Reach $24.85 billion by 2026
  • Rritual Superfoods Has Launched Three Mushroom-based Products
  • Products Boost Immune System, Brain Power and Relieve Stress
  • Company’s Extensive Distribution Network Set to Accelerate Sales
Consumers today shop for food with a number of considerations in mind, including food safety and the health benefits of their selected grocery items. This has resulted in increased demand for functional foods, with one sector — functional mushrooms — projected to increase at a CAGR of 5.6% during 2021–2026. This would put the market for functional mushrooms at $24.85 billion by the end of the forecast period. Rritual Superfoods is one of the companies operating in this nascent market. Founded in 2019, Rritual has, to date, brought three mushroom-based products to market and is in the process of developing others. Rritual is working to ensure that its offerings not only augment the physical and psychological condition of consumers but also provide a healthy return for shareholders. Functional foods, which are becoming increasingly popular, are foods that promote good health beyond the requirements of basic nutrition. Although the term “functional foods” may be relatively new, some traditional foods that fall into that category, such as oatmeal and orange juice fortified by calcium, are already staples in many diets. Rritual is going a step beyond fortification. Rather than enhance the health benefits of food by adding nutrients, the company has developed its superfood offerings to be standalone supplements, which offers greater flexibility for consumers. With Rritual, consumers don’t need to consume more protein, carbohydrates or fats to receive the benefits. Presently, Rritual Superfoods has three products derived from the chaga, lion’s mane, and reishi mushrooms. Rritual’s chaga blend boosts the immune system. Combined with the eleuthero root, the chaga-infused product, which also contains bioactive polysaccharides, increases resilience in the immune system and helps ward off infection. The lion’s mane product is a brain booster. Its unique blend of lion’s mane mushroom and rhodiola root supports cognitive function and brain health, while also improving the body’s ability to cope with stress. The reishi-based product also helps in dealing with stress. It includes the Ashwagandha root to help in combating anxiety and is rich in triterpenes, polysaccharides, fatty acids, and amino acids. Long-term use is said to improve the quality of sleep. Rritual has devised a global sales and distribution strategy that covers three major markets: the United States, Canada, and Japan, through a growing network of online sales together with brick-and-mortar distribution. For more information, visit the company’s website athttps://investors.wearerritual.com. Mental Fitness Is A Daily Ritual. NOTE TO INVESTORS: The latest news and updates relating to Rritual are available in the company’s newsroom at http://ibn.fm/Rritual

Knightscope, Inc. Reimagines Public Safety Across the U.S. Through Autonomous Security Capabilities

  • Violent crimes in the U.S. occur every 24.6 seconds, and property crime occurs every 4.1 seconds
  • There are over 320 million people in the U.S., with only two million+ law enforcement and security professionals to protect them
  • Knightscope’s autonomous security robots are currently in operation across five U.S. time zones, with over one million hours in the field
  • The K1 is an award-winning ASR whose achievements were recognized with the 2018 Security Today New Product of the Year
Knightscope, a leader in the development of autonomous security capabilities, is reimagining public safety to make the United States the safest country in the world, through an innovative line of Autonomous Security Robot (“ASR”) products that combine self-driving technology, robotics, and artificial intelligence (https://ibn.fm/RLzlv). In the United States, a violent crime occurs every 24.6 seconds and a property crime every 4.1 seconds, according to Knightscope statistics. Moreover, it is estimated that there are only a little over two million law enforcement and security officers across the country to help and protect a population of over 300 million people across all 50 states. Knightscope’s ASRs are helping to bridge the gap, offering valuable assistance and coverage and supporting law enforcement personnel to do their jobs more effectively. The ASRs are typically used for patrolling and peacekeeping, as a means of physical deterrence by providing a visible, force multiplying, physical security presence to help protect assets and deter crime. However, they have also taken a more active role in fighting crime by assisting law enforcement and security with the arrests of suspects in crimes that range from armed robbery to hit-and-run accidents. More information about the work Knightscope is doing to fight crime is available at www.Knightscope.com/crime. Knightscope’s current offering includes three ASR models being utilized across five time zones in the United States: K1, K3, and K5. Recognized for its achievements with the 2018 Security Today New Product of the Year Award, K1 is a stationary machine that can be used in indoor or outdoor environments and is suitable for use in a wide range of spaces including parking structures, lobby and reception areas, high-risk areas, help or assistance points, transportation shuttle stops and more. K3 is an indoor ASR that moves at speeds up to three miles per hour. It runs on its own 24/7/365 and can autonomously recharge itself without human intervention. It is the smart eyes and ears that cover many areas without the need for monotonous patrols. The K3 is suitable for environments such as malls, warehouses lobbies or offices, hospitals, airports, casinos, etc. K5 is primarily used outdoors, even though it does have the capability of being used indoors. It features 24/7/365 operation and the ability to recharge autonomously without human intervention. This ASR model is best suited for large outdoor spaces and moves up to three miles per hour. The K5 has been operated for nearly one million hours in the field, including three winters. The K5 can be used in many large-spaced venues, including but not limited to hospitals, police departments, municipalities, airports, stadiums, manufacturing facilities, corporations and others. All three of the ASR models feature the Knightscope Securities Operations Center (KSOC), which features force-multiplying physical deterrence, facial recognition, 360-degree HD video streaming, automatic license plate recognition, thermal anomaly detection, and so much more. Knightscope has plans to develop other security solutions in the near future and is already in the process of raising additional growth capital while also preparing for a potential public listing. The company has already reserved the NASDAQ ticker symbol ‘KSCP’ and you can learn more reading the blog “Are You Going Public?!” (https://ibn.fm/78rrz). Since its foundation in 2013, Knightscope has raised more than $70 million to build all of its technology from scratch and is now backed by more than 16,000 investors and four major corporations. For more information, visit the company’s website at www.Knightscope.com. Visit www.Knightscope.com/invest for a summary of Knightscope as an investment, with a blue Instant Messaging button for direct contact with their CEO. NOTE TO INVESTORS: The latest news and updates relating to Knightscope are available in the company’s newsroom at https://ibn.fm/Knight

Pure Extracts Technologies Corp. (CSE: PULL) Strengthens Oil Extraction Business, Ventures into Functional Mushroom Space

  • Pure Extracts carried out its initial oil extraction, distillation trials in early November, plans to commence extraction tolling services in December
  • Once Sales License is obtained from Health Canada, the Company plans to begin marketing its own ‘Pure Pulls’ branded cannabis derived product range
  • Pure Extracts will simultaneously seek to market Company’s white-labelling prowess, offering oil extraction capabilities to Licensed Producers currently operating in cannabis space
  • Company also announced its interest in joining functional mushroom sector, with its first products set to be launched in 1Q2021
  • Separately, Pure Extracts named Dwight Duncan to its Board of Directors
Pure Extracts Technologies (CSE: PULL), a plant-based extraction company focused on the cannabis, hemp, and functional mushroom sectors, has seen its business operations scale to new heights following the award of its Standard Processing license from Health Canada on September 25, 2020. The receipt of the license enabled Pure Extracts to begin producing THC and CBD extracts in its purpose-built extraction facility located near Whistler, British Columbia, whilst adhering to EU Good Manufacturing Practices (“GMP”)—a process which ensures that molecules will be extracted to the highest possible quality. On November 4, Pure Extracts ran the first oil extraction and distillation trial under its license, in the wake of a six-week process during which the Company commissioned the equipment required for commercial production. The occasion marked the initial step of a trial required for the Company to apply for its Sales License with Health Canada, following which Pure Extracts will seek to begin marketing its own-branded Pure Pulls and Pure Chews products. Simultaneously, the Company is also set to begin its extraction tolling business in December – a process through which biomass is converted into THC and CBD oil. Pure Extracts is set to specialize in the production of full-spectrum oil (“FSO”), a product which contains all the cannabinoids and other chemicals which naturally occur in the plant prior to extraction. With demand for full spectrum oil witnessing an exponential increase as of late, the Company revealed that it had bid on a number of contracts and anticipated capturing a meaningful amount of business by the first quarter of next year (https://ibn.fm/WBoiy). Pure Extracts has sought to combine its oil extraction enterprise – which will consist of the Company’s extraction tolling business, white-label product manufacturing as well as the marketing of its own branded products with a new venture into the functional mushroom space. Functional mushrooms have increasingly been identified as a new ‘wonder’ product within the wellness space, gaining popularity for both their apparent health benefits and ability to help slow or even reverse certain diseases. The Company is exploring strategic relationships with established players in the North American sector and intends to launch its initial product range in the first quarter of 2021 through an online portal which is currently under development. Pure Extracts has sought to combine its growing business prospects with a simultaneous focus on strengthening its management and corporate governance functions. The Company announced its appointment of Dwight Duncan, a strategic advisor to Canadian law firm McMillan LLP and former Member of the Ontario legislature where he served as Deputy Premier and Minister of Finance, to its Board of Directors. “We are pleased to welcome Dwight Duncan to the Board of Pure Extracts” noted Chief Executive Officer Ben Nikolaevsky. “Dwight has tremendous experience in both government regulatory affairs and corporate finance, and we are looking forward to working closely with him as we build Pure Extracts into a preeminent global extraction company” (https://ibn.fm/clZv2). For more information, visit the company’s website at www.PureExtractsCorp.com. NOTE TO INVESTORS: The latest news and updates relating to PULL are available in the company’s newsroom at https://ibn.fm/PULL

Predictive Oncology’s (NASDAQ: POAI) Skyline Medical Sells 15 Streamway(R) Systems in Q3 2020 as COVID-era Drives Need for Sanitation Systems

  • Closed design of Streamway(R) System provides safety from potential hazards of drips and spills during endoscopy, radiology, cystoscopy, urology procedures
  • The Streamway(R) System reduces costs, minimizes environmental impact of 50 million potentially disease-infected canisters disposed into landfills
  • POAI’s Skyline Medical sells 8 Streamway(R) Systems to large university hospital in Virginia, 15 sold halfway into Q3 2020
In the age of COVID-19, the need for sanitation and safety during hospital procedures has reached an all-time high. Health professionals have reported an inhibited level of performance due to a lack of protection, comfort, and increased fatigue during surgery (https://ibn.fm/87UEr). Sanitary disposal systems, able to offer maximum protection to healthcare workers, have become incredibly necessary—and companies like Predictive Oncology are answering the call. Produced by Skyline Medical, a subsidiary of Predictive Oncology (NASDAQ: POAI), the patented Streamway(R) System features an entirely closed design, ensuring that medical professionals are safe from the potential hazards of drips and spills. It’s the first FDA-cleared direct-to-drain fluid disposal system that is designed specifically for medical applications such as endoscopy, radiology, cystoscopy and urology procedures. The proprietary system automates the collection, measurement and disposal of potentially infectious waste that includes blood and irrigation fluids. By connecting directly to a facility’s plumbing system, the Streamway(R) System has the potential to change the way healthcare facilities manage fluid disposal by minimizing human intervention and increasing compliance with Occupational Safety and Health Administration (“OSHA”) and other regulatory agency safety guidelines. Along with addressing safety concerns, the use of the Streamway(R) System reduces costs and minimizes environmental impacts by eliminating carts, evacuated bottles and the approximately 50 million potentially disease-infected canisters that go into landfills each year in the United States. COVID-era concerns have increased sales of the Streamway(R) System in 2020, with 15 sales in Q3 (including eight to a large university hospital organization in Virginia) in addition to sales throughout the world through direct sales and distributor partners. Along with Skyline, POAI leverages the synergies of its other three wholly-owned subsidiaries – Helomics, TumorGenesis, and Soluble Biotech – to fulfill its mission of bringing precision medicine to the diagnosis of cancer. Besides the Streamway(R) System, POAI’s portfolio assets also include an AI-enhanced “smart” patient-derived tumor profiling platform, an in-house bioinformatics artificial intelligence (AI) platform, and a data-based approach to growing patient-specific tumors in a lab for the development of personalized treatment options. The importance of precision medicine in cancer therapeutics has grown substantially, driven specifically by data-based predictive models of tumors and their responses to pharmaceutical treatments. Modeling various tumors can be both time and data-intensive, requiring five to seven years of clinical evaluation and observation to produce both historical and outcome data. To that end, POAI has a significant competitive advantage through its vast collection of tumors and their related data, in addition to the company’s ability to access associated outcome data. The application of AI to its trove of more than 150,000 tumors assists oncologists in providing individualized patient treatments while driving forward the development of new targeted therapies in collaborations with pharmaceutical companies. POAI is bringing precision medicine, or tailored medical treatment using the individual characteristics of each patient, to the treatment of cancer. Through its Helomics division, the company leverages its unique, clinically validated patient derived (“PDx”) smart tumor profiling platform to provide oncologists with a roadmap to help individualize therapy. In addition, the company is leveraging artificial intelligence and its proprietary database of over 150,000 cancer cases tumors to build AI-driven models of tumor drug response to improve outcomes for the patients of today and tomorrow. For more information, visit the company’s website at www.Predictive-Oncology.com NOTE TO INVESTORS: The latest news and updates relating to POAI are available in the company’s newsroom at http://ibn.fm/POAI

AzurRx BioPharma Inc. (NASDAQ: AZRX) Planning to Test Immediate Release MS1819 Capsules in Cystic Fibrosis Study

  • The company plans to add another study arm to its ongoing Phase 2b OPTION 2 clinical study which currently tests delayed release capsules
  • If it receives FDA approval, AzurRx would be able to identify the optimal delivery method for its drug candidate MS1819 without significant extra costs or delays
  • Enrollment in this arm of the study could begin as early as December 2020
AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, has submitted a protocol amendment request to the U.S. Food and Drug Administration that would allow it to test immediate release capsules of its exocrine pancreatic insufficiency drug candidate MS1819. According to a company press release, if the amendment is approved, AzurRx would modify its current Phase 2b OPTION 2 trial of MS1819 in cystic fibrosis patients to add a study arm that uses immediate release capsules (https://ibn.fm/Ws66z). The existing arm of the study uses delayed release capsules. This would allow AzurRx to compare data from both arms to determine the best delivery method for its lead product. “As this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819,” AzurRx Chief Medical Officer Dr. James Pennington said. The addition of a new arm would not impact the overall trial objectives, endpoints and statistical analysis of the Phase 2b OPTION 2 trial. “We are pleased to announce that our OPTION 2 trial is well ahead of schedule and almost fully enrolled without any safety issues being observed,” Dr. Pennington added. He also explained that determining appropriate dosage and delivery method is an important goal for any Phase 2 clinical trial, along with testing for safety and efficacy, before entering a Phase 3 program. He added that if the amendment is accepted by the FDA, AzurRx expects to begin enrollment into the new study arm as soon as December 2020. AzurRx CEO James Sapirstein also said that the protocol amendment is a unique opportunity for the company to acquire valuable additional clinical data with no significant delays in the study timeline and no significant increase in overall costs. The Phase 2b OPTION 2 trial consists of testing MS1819 doses in enteric capsule form with two concentrations: 2240mg and 4480mg. Initial results from the study indicated that the MS1819 non-porcine recombinant lipase is well tolerated at both dose levels and produces no adverse effects. AzurRx is also conducting a Phase 2 cystic fibrosis combination trial, using MS1819 together with porcine pancreatic enzyme replacement therapy (“PERT”), the current standard of care. This study uses daily PERT doses in combination with different MS1819 dosages (700mg, 1120mg and 2240mg) and results made available so far have shown clinically meaningful improvements in subjects, with no adverse safety events. According to Sapirstein, the company remains on target to release to line data for its Phase 2b trial in the first quarter of 2021. Top line data for the combination trial is expected in the second quarter. Pending the Phase 2b trial outcome, the company will initiate a Phase 3 trial in cystic fibrosis and to this end, it has already identified and signed a binding letter of intent with a potential partner for the development and production of MS1819 for the study. Under the agreement, Asymchem, a leading global contract development and manufacturing service provider, will implement fermentation, verify protein expression, and fine-tune the technology for MS1819 production to help AzurRx optimize manufacturing and prepare for commercialization (https://ibn.fm/HJwT4). AzurRx is determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy, significantly reducing the pill burden of cystic fibrosis patients. The company believes that due to its safety and efficacy, its proposed therapy has the potential to improve the quality of life and help achieve healthier nutrition for many patients suffering from severe exocrine pancreatic insufficiency, including those with cystic fibrosis, chronic pancreatitis, pancreatectomy, and other indications. For additional information, visit www.AzurRx.com or contact the following: AzurRx BioPharma, Inc. Phone: (646) 699-7855 info@azurrx.com NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) IND Application for Cancer Drug Berubicin Accepted for Review

  • CNS Pharmaceuticals wants to obtain FDA authorization for an Investigational New Drug application for drug candidate Berubicin, a novel treatment for Glioblastoma Multiforme
  • Company believes it’s on track to start in Q1 2021 a potentially pivotal Phase II Berubicin trial with adult GBM patients who have failed their primary treatment for the disease
  • Separately, a Phase II adult trial and a first-ever Phase I pediatric trial are slated to begin in 2021 in Poland in collaboration with sub-licensee partner, WPD Pharmaceuticals
  • Members of CNS’s management team attended A.G.P.’s Virtual Health Symposium, meeting 1-on-1 with investors
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, recently announced that it has filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its lead drug candidate Berubicin. This application has been accepted for review (https://ibn.fm/6NnwH). Berubicin is proposed for the treatment of Glioblastoma Multiforme (“GBM”), an aggressive form of brain cancer currently considered incurable, and may prove beneficial in treating other central nervous system malignancies. Since gaining the rights to Berubicin, and securing from Reata Pharmaceuticals, Inc. (NASDAQ: RETA) the Phase 1 trial data and assets, CNS has worked diligently to complete the requirements to bring the drug to trial. John Climaco, CEO of CNS Pharmaceuticals, Inc., made a statement about the IND filing and how the tireless efforts of the team during the last year have helped reach this important milestone. “Our laser focus from the beginning has been to start the next phase of the investigation of Berubicin for the treatment of this deadly disease as quickly as possible,” he added. The company believes it is well positioned to execute its plan and initiate a potentially pivotal Phase II trial for Berubicin in Q1 2021 beginning in the United States and expanding to a global trial. The Phase II Berubicin trial that is currently planned in Q1 2021 will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for the disease. Results will be compared with the current second-line standard of care. The trial will be executed with a 2 to 1 randomization of the participating 243 patients to Berubicin or Lomustine (as standard of care). This trial could potentially provide data to the FDA needed for approval of an expedited pathway for further development or approval. CNS Phamaceuticals, in collaboration with sublicensee partner WPD Pharmaceuticals (CSE: WBIO) (FSE: 8SV1), is preparing two other clinical trials for Berubicin in Poland. The two studies include a Phase II trial in adults (set to begin in February 2021) and the first-ever Phase I trial for pediatric patients (scheduled to start later in 2021) (https://ibn.fm/p1zJ8). The IND announcement came a few days before CNS management members attended A.G.P.’s Virtual Healthcare Symposium that took place Thursday, November 19, 2020. The virtual event brought together numerous healthcare and biotech companies for one-on-one meetings with investors, engaging panels and discussions with leading healthcare executives and a keynote speaker address (https://ibn.fm/jNkR6). The IND filing and the upcoming clinical trials make Berubicin an interesting opportunity for investors, as CNS believes its novel treatment can fill the current gap in available GBM treatments and help position the company as a market leader in this fast-growing sector. The overall global brain tumor therapeutics market is targeted to reach an estimated $3.4 billion by 2025, from $2.25 billion in 2019, reflecting a CAGR of 7.20% during the forecast period of 2019 to 2025, Market Study Report research shows (https://ibn.fm/SQkrD). Another report estimated that this market would reach $2.74 billion in 2023, registering a CAGR of 11% during the forecast period of 2018 to 2023 (https://ibn.fm/EnB3Q). For more information, visit the company’s website at www.CNSPharma.com NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

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