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PaxMedica Inc. (NASDAQ: PXMD) Pursues Autism Treatment as Diagnostic App Shows Promise to Effective ASD Diagnosis

  • One in 36 children are diagnosed with autism spectrum disorder (“ASD”) – with ASD four times more common among boys than girls
  • The SenseToKnow app accurately predicted eventual autism diagnoses in a group of 475 children – according to the study, performance was similar across sex, race, and ethnicity
  • PaxMedica is leveraging historical data on the drug suramin to fund trials aimed at treating Autism Spectrum Disorder and Fragile X-Associated Tremor/Ataxia Syndrome

According to the CDC, about 1 in 36 children are diagnosed with autism spectrum disorder (“ASD”) – with ASD four times more common among boys than girls (https://ibn.fm/06kly). Currently, there is no medical test to diagnose ASD, and families often face a delay in receiving a diagnosis. Doctors must rely on developmental history and the behavior of the child to make an ASD diagnosis. A diagnosis in girls and children with minority backgrounds often has a longer wait time due to the challenges in finding appropriate experts and the variable symptoms that accompany the disorder.

In a study published in Nature Magazine, researchers introduced a digital screening device that uses machine learning to analyze different behavioral aspects to assess the likelihood of childhood ASD. The SenseToKnow app accurately predicted eventual autism diagnoses in a group of 475 children – according to the study, performance was similar across sex, race, and ethnicity (https://ibn.fm/d4xhR).

PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company focusing on the development of novel anti-purinergic therapies (“APTs”) for the treatment of ASD and other serious conditions with intractable neurologic symptoms, is focusing its lead program on ASD, which there is no approved pharmacologic treatment targeting cause and symptoms. The current ASD treatments only address the symptoms of the condition but do not target the pathophysiology itself. PaxMedica is on a promising path to address the unmet medical needs of families with ASD – bringing hope to millions.

PaxMedica is using existing research on a drug called suramin, initially created to treat a disease called Human African Trypanosomiasis (“HAT”), to support new studies for treating Autism Spectrum Disorder and a related condition known as Fragile X-Associated Tremor/Ataxia Syndrome (“FXTAS”). The original developer of suramin, the German company Bayer, had used it to treat HAT. Now, the U.S. Food and Drug Administration (“FDA”) is allowing PaxMedica to apply this old research to see if suramin can also help treat rare instances of HAT in Americans, typically caught during visits to Africa. If these trials prove that suramin is effective, PaxMedica could not only get the drug approved for use, but also receive a special coupon from the FDA called a Priority Review Voucher (“PRV”). This voucher, which can accelerate the review of a new drug, is quite valuable and could be sold to another pharmaceutical company for a significant amount of money. The company intends to channel these funds into conducting extensive trials for ASD and FXTAS treatment through its lead program, PAX-101(IV Suramin). These programs utilize a proprietary source of suramin, a century-old drug with broad therapeutic potential. Although initial FDA approval for suramin in treating sleeping sickness is anticipated within months, funding from the sale of the PRV will expedite PaxMedica’s autism application trials. The final approval for the drug’s use in treating autism may take a couple of years to materialize.

In 2024, PaxMedica is positioned to continue its momentum, sustained by achievements in 2023. The company is working to expand its product pipeline, centered on its proprietary source of suramin. PaxMedica technology is designed to help people with ASD integrate more successfully into society, enhancing their overall quality of life. PAX-101 and PAX-102’s promise extends beyond ASD, with potential applications in treating human African trypanosomiasis and other conditions characterized by intractable neurologic symptoms.

For more information, visit the company’s website at www.PaxMedica.com.

NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://ibn.fm/PXMD

Lexaria Bioscience Corp. (NASDAQ: LEXX) Banking on DehydraTECH(TM) Technology for Major 2024 Growth

  • Lexaria, a global innovator in drug delivery platforms, has, since 2016, proven its patented DehydraTECH(TM) technology, asserting its superiority in improving drug bioavailability
  • This has earned it 39 granted patents, with many pending globally
  • DehydraTECH has a number of potential pharmaceutical applications with successful early stage results in hypertension, diabetes and weight loss and many others With its focus on GLP-1 clinical studies for 2024, Lexaria looks to carve out greater market share to make 2024 its biggest year

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has been pushing the envelope and redefining drug delivery technology. Its patented DehydraTECH(TM) technology has proven itself in numerous studies since 2016, highlighting its ability to increase bio-absorption compared to standard industry formulations while also reducing time of onset, as well as delivering drugs more effectively across the blood brain barrier (https://ibn.fm/CjpYF).

The technology’s effectiveness and uniqueness have earned it 39 granted patents, with many patents pending globally. DehydraTECH has a number of potential pharmaceutical applications, a testament to its versatility and overall effectiveness. The key factor that has played a role in its adoption is its unique ability to improve drug bioavailability, a critical marker and determinant in overall drug effectiveness.

Bioavailability can be described as the extent to which a substance or drug becomes entirely available for its intended biological destination ((https://ibn.fm/txE38). It may also be referred to as a measure of the rate and fraction of the initial drug dose that ultimately gets to the targeted part of the body (https://ibn.fm/etuHD). Usually, the higher the bioavailability, the more effective the drug, and since time immemorial, scientists have been exploring various ways to improve it.

Studies have highlighted several factors that have shown to affect drug bioavailability, particularly for orally administered drugs. These include decomposition of the medication in the lumen, hepatic fist-pass impact, surface and time accessible for retention, as well as pH and perfusion of the small digestive system.

Lexaria, through its DehydraTECH technology, enhances the performance of several categories of fat-soluble active molecules and drugs, ultimately improving their bioavailability and efficiency. This is achieved by mixing the active ingredients as a delivery “payload” with specific fatty acids, infusing the mixture into a substrate material, and then using controlled dehydration synthesis processing to associate the payload and fatty acids together at a molecular level. This is followed by integrating the newly combined molecules into end-product production across various dosage form factors (https://ibn.fm/u1eXo).

With this technology, Lexaria looks to tap into various growing markets, among them the cardiovascular drugs market and the diabetes markets, both projected to be valued at $115.8 billion and $134.1 billion by 2028 and 2030, respectively. It also hopes to make drugs more effective, possibly reducing the cost of treatment and the patients’ overall quality of life. The company is also aggressively pushing for its patent applications and approvals globally, a show of commitment to creating shareholder value. In addition to its focus on GLP-1 clinical studies for the 2024 calendar year, Lexaria is confident that it will carve out a decent market share for itself, ultimately making 2024 its biggest year yet.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX

19th BioPharma Clinical Trials Nexus Conference to Host Industry Leaders Across Europe And Asia

Top executives, middle-level, and senior managers, working in clinical trial operations, outsourcing, digital health, patient engagement, and allied industries in the biopharma spectrum across Europe and North America, are invited to attend the 19th BioPharma Clinical Trials Nexus Conference at the Basel, Mariott Hotel, Switzerland.

A prestigious conference, this is an invite-only event featuring top executives and eminent industry leaders. The attendees discuss practical and progressive strategies that pave the path for future trends and outcomes. The platform offers a range of fresh ideas, showcasing the latest technologies and market trends, at a parade of company presentations.

Powerful speakers will address important topics giving solutions and fresh ideas that the audience can incorporate into their business. The 19th BioPharma Clinical Trials Nexus agenda includes an extensive line-up of experts showcasing company offerings and solutions involving pivotal subjects in the field of clinical trial management.

The conference commences with registration, followed by presentations and panel discussions that offer fresh perspectives and insights. Attendees can connect with peers, industry leaders, and influencers during group discussions, coffee, and lunch breaks. These connections are crucial in providing leads and business opportunities to the attendees.

This conference offers a robust forum for the invitees to develop meaningful business ties. With two days of networking among the industry giants, the event will witness the growth of strong business ties.

These business relations, fresh ideas, market trends, and strategies, can make a significant change to the future of the Clinical Trial spectrum. Clinical Trial companies can leverage the new technologies and ideas, incorporating important insights into their businesses while positively impacting the overall consumer experience.

To know more, please visit https://ibn.fm/1Qx4j

Bravo Multinational Inc. (BRVO) Is ‘One to Watch’

  • Bravo, in February 2024, entered an Asset Purchase Agreement to acquire certain assets of Streaming TVEE Inc. in a deal worth $9.76 million
  • Bravo and Pythia Experiences LLC entered an LOI to form a new company in January 2024, with Pythia owning 51%, Bravo owning 49%, Pythia contributing Vidgo Inc. and Bravo contributing a streaming platform
  • In September 2023, the company announced it would develop an advertising-based video streaming service and app
  • In June 2023, Bravo announced a strategic rebrand, positioning it for growth with a newly defined mission as an entertainment, hospitality and technology company
  • The company in May 2023 appointed entertainment industry figures Grant Cramer and Frank Hagan as CEO and President, respectively

Bravo Multinational (OTC: BRVO) actively explores opportunities in the entertainment, hospitality and technology sectors to generate long-term value for its shareholders through high-growth business ventures. Currently focused on pioneering innovative solutions in the digital content landscape, the company’s goal is to provide cutting-edge and diverse content experiences to a global audience.

In February 2024, Bravo finalized a deal to acquire Streaming TVEE Inc.’s assets, marking a pivotal step in establishing its flagship offering, aptly named TVee NOW(TM). The acquired assets provide the company with the technology and foundation to soon offer streaming services including Video-On-Demand (“VOD”) and linear TV, often referred to as traditional broadcast TV, which encompasses cable and satellite networks, through a joint venture with Pythia Experiences.

TVee NOW(TM) plans to offer a wide range of on-demand content, including movies, series, concerts and original programming, at minimal or no cost to viewers. The service, set for beta launch in Q1 2024, will be accessible across various devices, with dedicated apps available on platforms such as Roku, Apple and Google Play stores, reinforcing Bravo’s commitment to innovation and audience accessibility.

The company is based in Virginia Beach, Virginia, with a second office soon opening in Las Vegas, Nevada.

Products

TVee NOW’s streaming service will offer a portion of its content for free, catering to the growing demographic of cord-cutters and aligning with the dynamic landscape of advertising-based video on demand (“AVOD”) streaming. Bravo’s Over-The-Top (“OTT”) streaming platform is specifically crafted to deliver content directly to viewers via the internet, accessible through a browser or freely downloadable apps on smartphones, tablets and smart TVs.

Bravo’s planned strategic approach for content is to first integrate partnered Free Ad-Supported TV (“FAST”) channels, programmatic advertising and a tiered revenue sharing model. Additionally, the company plans to complete the deal with Pythia Experiences, enabling a hybrid model comprised of AVOD, utilizing programmatic advertising through ad servers, and Subscription-based Video-on-Demand (“SVOD”), which the company plans to offer at competitive rates compared to other services. With this model completed, Bravo can bridge the gap until the company can ultimately create its own original content.

Through the asset purchase agreement with Streaming TVEE, Inc., the company obtained exclusive rights, image and likeness, label waivers and exploitation rights for streaming of 117 high-definition music and comedy performances, each offering a director’s cut and multiple camera perspectives. Some of the music artists include Snoop Dogg, H.E.R., Kings of Leon, Alicia Keys and Bone Thugs-N-Harmony, along with comedic performances from Bill Burr, Jim Gaffigan, Kristen Schaal, Rob Delaney and others. This original footage will allow Bravo to recreate shows in diverse formats, which can showcase these concert films in a compelling full-feature format.

Market Opportunity

A report from Fortune Business Insights, a global market research and reporting firm, estimated the global video streaming market at $455.45 billion in 2022. It is projected to grow from $554.33 billion in 2023 to $1.9 trillion by 2030, achieving a CAGR of 19.3% during the forecast period.

Growth drivers, according to the report, include a rising number of users of Video-on-Demand services (YouTube, for example) worldwide and the growing adoption of OTT content providers (like Netflix and Hulu, among many others) by consumers, as well as consumers’ willingness to spend more for streaming video content.

Management Team

Grant Cramer is CEO and Director of Bravo. He has more than 30 years of experience as an actor, writer, director, producer and production executive. As founder and president of Landafar Entertainment and Global Pictures Media, he has overseen development and production of 14 feature films. He executive produced Lone SurvivorNovember Man and Arctic Dogs. He produced And So It Goes, directed by Rob Reiner and starring Michael Douglas and Diane Keaton. His short film Say Goodnight, Michael won several awards, including the Grand Jury Award at the New York International Independent Film Festival.

Frank Hagan is Bravo’s President and Director. He is an Emmy-nominated producer with over 30 years of experience in the entertainment industry. He is the former Programming Director and GM of QTN. He has produced shows for major networks and companies, including Discovery Channel, History Channel and Relativity Media. Most recently, he served as a consulting producer for Electric Entertainment’s ElectricNOW! and the Saturn Awards and worked as a regular weekly panelist for Outlaw Internet Radio.

Richard Kaiser is CFO and Director of Bravo. He is also CFO at BioForce Nanosciences Holdings Inc. and Gold Rock Holdings Inc. He serves on the board of Element Global Inc., a wholly owned subsidiary of BioForce Nanosciences Holdings Inc. He previously directed investor relations for Royal Standard Minerals Inc. and Scorpio Mining Inc. He was also Head of Corporate Communication and Investor Relations at Air Packaging Technologies Inc. and Puff Pack Industries Inc.

Kayla Slick is COO and Director at Bravo. She has more than 15 years of experience in various industries, including finance, healthcare, technology, retail, hospitality and entertainment. She co-founded The PRIME Symposium and significantly increased revenues for INSIDE Public Accounting. She held positions at Interactive Digital Solutions, where she founded the Sales Development Program and was later promoted to Marketing Communications Director for IDS’ flagship virtual patient observation product.

For more information, visit the company’s website at www.BravoMultinationalInc.com.

NOTE TO INVESTORS: The latest news and updates relating to BRVO are available in the company’s newsroom at https://ibn.fm/BRVO

Sekur Private Data Ltd. (CSE: SKUR) (OTCQB: SWISF) (FRA: GDT0) Promotes Email Security Solution Amid Global Conflicts and Increasing Cyber Threats

  • Political controversies surrounding threats to the United States’ election integrity and the international aggressions of Russia’s government underscore concerns about the ever-present need to maintain the security of personal and business communications
  • Swiss hosted Sekur Private Data Ltd. provides a private and secure communications platform that the company is presently marketing to SMBs in the U.S. with plans to expand to other nations during the coming year
  • SWISF provides its encrypted data protection services under Swiss Internet protocol security laws, acknowledging that Switzerland has the strictest data privacy laws in the world
  • Sekur boasts a 100 percent-owned infrastructure and proprietary technology to help ensure customers’ data won’t be compromised by third-party operators

Recent salvos fired between ransomware-as-a-service (“RaaS”) operator LockBit and the international coalition of law enforcement agencies that seized servers in eight countries belonging to LockBit or its affiliates (https://ibn.fm/Jtvg5) highlight the global and present nature of concerns about protecting Internet-accessible data.

Ransomware attacks involve the use of virus malware by a cybersphere invader to permanently prevent victims from accessing their own data on their computer systems unless a hefty ransom is paid for the “kidnapped” computer system. In addition to LockBit’s RaaS operation allowing affiliate organizations to rent its services, LockBit has gained attention recently for seeking payment from officials in Fulton County, Georgia, to forestall its threat of publishing sensitive court data related to elections (https://ibn.fm/kQb5d).

Cybersecurity and internet privacy innovator Sekur Private Data (CSE: SKUR) (OTCQB: SWISF) (FRA: GDT0) recently highlighted a separate reported data intrusion via email vulnerability affecting the national dialogue over cyber invasion and privacy disruption.

Sekur founder and CEO Alain Ghiai discussed conservative media host Tucker Carlson’s claim that U.S. government agencies “unmasked his internet identity” and leaked emails to the media regarding his preparations to travel to Russia and interview Russian president Vladimir Putin in February of this year, as a consequence of the current White House administration’s dim view of both Putin and Carlson, during Ghiai’s “Weekly Hack” interview with the New To The Street corporate media site (https://ibn.fm/gvllD).

“I would not speculate if it happened or not but … if it did happen, it is for the simple fact that every time you use a Big Tech solution, first of all they have all the rights to read and listen to your (communications),” Ghiai said. “I always tell people that when you give your phone number away to download an application, nothing is private.”

Sekur provides Swiss-hosted solutions for secure communications and secure data management, utilizing a suite of secure cloud-based storage, disaster recovery, document management and other secure communication tools, including encrypted e-mails.

The company recently launched SekurVPN (https://sekur.com/en/vpn) is the world’s first non-big-tech-powered, Swiss-hosted, privacy-focused VPN solution using military-grade security.

“It will encrypt your connection, whether you’re on 5G or wi-fi, and that’s a big asset,” Ghiai told New To The Street on Fox Business TV. “It also will mask your true IP address and give you a Swiss IP address. … In Switzerland, it’s important to know that your IP address is considered your private property. So we can’t mess around with that. We can’t look at your traffic.”

In addition to the data mining-free, Swiss law-regulated establishment of the hub, Sekur boasts a 100 percent-owned infrastructure and proprietary technology. During the upcoming financial quarter, Sekur will launch its planned B2B platform in the United States in conjunction with Ingram Micro, followed by the expansion of its B2B platform to Latin America, the United Arab Emirates and the Kingdom of Saudi Arabia in 2025.

“We are seeing a dramatic increase in cyber-attacks in the USA due to the global conflicts at the present time, and due to the current presidential election campaign for the November 2024 presidential elections. Having our SMBs protected from BEC (Business Email Compromise) attacks is a prime directive,” Ghiai stated in a recent news release announcing the launch of small business marketing efforts (https://ibn.fm/X1Adp). “Average revenue per user is also growing and we expect moving forward to have between a 20% to 50% average revenue per user increase with all new subscribers.”

For more information, visit the company’s website at www.SekurPrivateData.com or product site at www.Sekur.com.

NOTE TO INVESTORS: The latest news and updates relating to SWISF are available in the company’s newsroom at https://ibn.fm/SWISF

D-Wave Quantum Inc. (NYSE: QBTS) and NEC Australia Introduce Quantum Services to Australian Market

  • D-Wave and NEC Australia announced two new quantum offerings for Australia’s commercial sector, federal and state governments, and academia
  • The companies’ new quantum services aim to optimize business operations and can navigate increasingly large datasets to find solutions to real-world problems
  • New offerings include a quantum consultancy service and access to D-Wave’s Leap(TM) real-time quantum cloud service

D-Wave Quantum (NYSE: QBTS), a leader in quantum computing systems, software, and services, and NEC Australia recently announced the introduction of two new quantum services to the Australian market, enhancing the quantum computing offerings available to Australia’s commercial sector, federal and state governments, and academia (https://ibn.fm/x9b2Y).

The quantum technology services from NEC Australia and D-Wave can optimize business operations faster than classical computers and navigate increasingly large datasets to find solutions to real-world problems, including logistics and supply chain management, emergency response, financial risk modeling, and drug discovery.

D-Wave and NEC Australia’s joint service offerings include:

  • Quantum Consultancy Service: NEC Australia and D-Wave develop and test quantum solutions to help address their customers’ complex challenges using Proof of Concepts (“POCs”) through a refined engagement and delivery methodology. Quantum solutions can be seamlessly migrated into practical business applications. This service, powered by D-Wave’s skilled quantum data scientists, provides hands-on support to help customers understand and transform complex business problems into optimized technical solutions for efficient and cost-effective implementations.
  • Leap Quantum Cloud Service: Customers can access D-Wave’s Leap real-time quantum cloud service, enabling them to perform their own research while tapping into the cutting-edge capabilities of quantum computing. This service provides immediate, real-time access to D-Wave’s Advantage(TM) quantum computers and quantum-hybrid solvers, offering enterprise-class performance and scalability.

Murray Thom, Vice President of Quantum Technology Evangelism at D-Wave, said quantum computing is at an important inflection point, as it moves from experimentation to operational use, helping organizations solve their computationally complex problems through real-world applications at scale. “We’re thrilled to team up with NEC to accelerate commercial and government adoption of this transformative technology in Australia and bring its remarkable potential to bear for business and society,” Thom said.

NEC Australia’s Vice President – Technology & Innovation, Ayala Domani, said the company was delighted to work with D-Wave to provide transformative quantum solutions in Australia and ensure that its customers remain agile, efficient, and competitive in an increasingly data-driven world. “Quantum computing is no longer solely the subject of futuristic speculation or found only in top-secret research facilities; it’s a commercially available technology that is revolutionizing business and government operations today, and NEC Australia and D-Wave are proud to lead the way forward in this space,” Domani added.

Domani and Thom also recently spoke at Quantum Australia 2024 in Sydney – representing NEC Australia and D-Wave. Held at the state-of-the-art Winx Stand at Royal Randwick, the three-day in-person program explored the theme “Accelerating Impact: From Research to Commercialisation and Developing Quantum Technology Markets’.”

NEC Australia has 50 years of expertise in delivering complex technical solutions to Australian government agencies and businesses. D-Wave has over 20 years of global leadership in quantum computing solutions – together, NEC Australia and D-Wave have delivered successful local quantum applications since 2021. A shared vision unites the companies in transforming the potential of quantum computing to elevate economic prospects and opportunities for all Australians.

For more information, visit the company’s website at www.DWaveQuantum.com.

NOTE TO INVESTORS: The latest news and updates relating to QBTS are available in the company’s newsroom at https://ibn.fm/QBTS

Forward-Looking Statements

Certain statements in this press release are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of quantum computing. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management’s control, including general economic conditions and other risks; the company’s ability to expand its customer base and the customer adoption of the company’s solutions; risks within D-Wave’s industry, including anticipated trends, growth rates, and challenges for companies engaged in the business of quantum computing and the markets in which they operate; the outcome of any legal proceedings that may be instituted against the company; risks related to the performance of the company’s business and the timing of expected business or financial milestones; unanticipated technological or project development challenges, including with respect to the cost and/or timing thereof; the performance of its products; the effects of competition on the company’s business; the risk that D-Wave will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the risk that D-Wave may never achieve or sustain profitability; the risk that D-Wave is unable to secure or protect the company’s intellectual property; volatility in the price of its securities; the risk that the company’s securities will not maintain the listing on the NYSE; the risk that its restatement of certain previously issued audited and unaudited financial statements or material weaknesses in internal controls could negatively affect investor confidence and raise reputational issues; and the numerous other factors set forth in D-Wave’s Annual Report on Form 10-K for its fiscal year ended December 31, 2022 and other filings with the Securities and Exchange Commission. Undue reliance should not be placed on the forward-looking statements in this press release in making an investment decision, which are based on information available to the company on the date hereof. D-Wave undertakes no duty to update this information unless required by law.

Sigyn Therapeutics Inc. (SIGY) Therapeutic Candidates to Overcome Limitations in Healthcare

  • Sigyn Therapeutics is developing four medical device candidates – Sigyn Therapy(TM), ChemoPrep(TM), ChemoPure(TM), and ImmunePrep(TM) – designed to overcome current therapeutic limitations in healthcare
  • Sigyn Therapy(TM), the company’s lead product candidate, is a single-use disposable device to treat life-threatening inflammatory conditions that are beyond the reach of drugs
  • ChemoPrep(TM) is designed to optimize the tumor-site delivery of chemotherapy, while ChemoPure(TM) intends to reduce the toxicity of chemotherapy by sweeping off-target chemotherapy out of the bloodstream
  • ImmunePrep(TM) is designed to reduce the presence of circulating drug decoys that interfere with the delivery of immunotherapeutic antibodies to treat cancer

Medical technology company Sigyn Therapeutics (OTCQB: SIGY) is developing blood purification technologies to treat life-threatening conditions that are not addressed with current market-cleared drug agents as well as an expansive pipeline of technologies to optimize the benefit of cancer therapies. The company has a proven team of professionals with multiple first-in-industry achievements.

The company’s lead product candidate, Sigyn Therapy(TM), is a single-use disposable device that is deployable on the global infrastructure of hemodialysis and continuous renal replacement therapy (“CRRT”) machines already installed in hospitals and clinics. The device incorporates a formulation of adsorbent components to optimize the broad-spectrum reduction of viral pathogens, bacterial toxins, and inflammatory mediators from the bloodstream. The device is designed to treat life-threatening conditions that are not addressed with drug therapies.  In this regard, candidate treatment indications include drug resistant viral and bacterial infections, endotoxemia, and sepsis, which is the leading cause of hospital deaths.

The Company is preparing to file an Investigational Device Exemption (“IDE”) with the U.S. Food and Drug Administration (“FDA”) related to a human feasibility study of Sigyn Therapy in dialysis dependent end-stage renal disease (“ESRD”) patients with endotoxemia and concurrent inflammation, which are currently untreatable conditions that contribute to increased mortality in ESRD patients.

The company is also deploying novel strategies to enhance the performance of cancer therapies.  In this regard, ChemoPrep(TM), is designed to optimize the delivery of chemotherapy, the most commonly administered cancer drug, while ImmunePrep(TM) is designed to enhance the benefit of immunotherapeutic antibodies, which account for 9 of the top 15 selling cancer drugs. These technologies, the company says, extract circulating factors that obstruct these drug agents from reaching their intended therapeutic targets.

Studies have shown that tumor-released exosomes contribute to cancer progression (https://ibn.fm/TSleY) and reduce patient responses to chemotherapy as exosomes can sequester the delivery of chemotherapy to intended cancer cell targets (https://ibn.fm/gBuG7). As a result, only about 0.05% to 3.5% of the chemotherapy dose is delivered to the target tumor site, according to Sigyn Therapeutics (https://ibn.fm/ZNk6T), a figure the company is out to improve.

ChemoPrep(TM) is designed to be administered prior to chemotherapy infusion. The therapeutic candidate works by sweeping cancer-related exosomes out of the bloodstream, a mechanism of action that the company believes will improve chemotherapy delivery. Relatedly, Sigyn has recognized that if a vast majority of chemotherapy is missing its target, then patients are at risk of toxicities and unwanted side effects. To address this issue, the company is developing ChemoPure(TM) to be a post-treatment solution that sweeps off-target chemotherapy out of the bloodstream to further reduce toxicity.

Beyond chemotherapy, Sigyn is targeting the antibody-based immunotherapy market with its ImmunePrep(TM) platform. While monoclonal antibodies (“mAbs”) have revolutionized the treatment of incurable diseases, including cancer, their treatment benefit has been suboptimal, with researchers observing that only a tiny percentage of infused antibodies ever reach their intended therapeutic target. The cause: circulating mAb decoys express the same surface protein that mAbs are designed to lock onto on the surface of the target. This means the mAbs will often end up attaching to the decoys rather than their targets.

The ImmunePrep(TM) is an adjunct device designed for deployment on blood processing systems that can be located in facilities that infuse immunotherapeutic antibodies to treat cancer and other conditions. The device uses a reverse-decoy mechanism: it allows for a mAb to be the active component in the device. This allows the antibody to both attach to circulating decoys that would block the delivery of the same antibody, thus eliminating them, and optimize the availability of the antibody to interact with their intended therapeutic target. “The infusion of mAb therapy is intended to occur immediately after an ImmunePrep(TM) device has depleted mAb decoys from the bloodstream,” Sigyn states on its website (https://ibn.fm/cBi8h).

Sigyn Therapeutics believes that if ImmunoPrep(TM) is demonstrated to be clinically effective, the technology would overcome a therapeutic limitation in healthcare and likely provide a competitive advantage to biopharmaceutical organizations that develop therapeutic antibodies.

“We don’t make the drugs; we make the drugs perform better,” said James A. Joyce, Sigyn Therapeutics’ Co-Founder, Chairman, and CEO, in his concluding remarks during last year’s Emerging Growth Conference.

For more information, visit the company’s website at www.SigynTherapeutics.com.

NOTE TO INVESTORS: The latest news and updates relating to SIGY are available in the company’s newsroom at https://ibn.fm/SIGY

SenesTech Inc. (NASDAQ: SNES) Posts Fiscal Year 2023 Results; Reports Revenue Growth, and Gross Margin and Operating Expense Improvement 

  • This success has been attributed largely to the company’s development and recent release of its Evolve soft bait product, a key addition to its growing product line
  • Year to date 2024, SenesTech reported 80% year-to-date revenue growth compared to the same period in 2023
  • Going forward, the company looks to introduce a soft bait contraceptive product for mice, having proven that its products work effectively on rats

SenesTech (NASDAQ: SNES), a rodent fertility control expert and the inventor of the only EPA-registered contraceptive for male and female rats, just released its financial results for the 2023 financial year. Of note was the 80% year-to-date (“YTD”) revenue growth and the 45.2% year-over-year (“YOY”) growth in gross profit, a significant milestone which Joel Fruendt, President and CEO of SenesTech attributed to the development of Evolve(TM), the company’s all-new soft bait product (https://nnw.fm/mYQOl). (https://ibn.fm/ykfl9).

“Since the full launch of Evolve in January 2024, we have seen a significant uptick in interest and orders from a wide range of sales channels and geographies,” noted Mr. Fruendt.

“For instance, we were recently approved as a vendor for a major nationwide hardware retailer; we have signed distribution and stocking agreements for grain management and open field agricultural applications; and we have expanded our geographical reach outside the United States, including Hong Kong, Macau, the United Arab Emirates, Singapore, Australia, New Zealand, and The Netherlands,” he added.

In 2022, SenesTech’s revenue stood at $1 million and increased by 17% in 2023. Agribusiness and new distribution agreements were the primary drivers for this growth. With the company’s shift in focus to the development of Evolve in the fourth quarter, the growth was temporarily slowed. Following the successful launch of Evolve for rats, there was a significant uptick in demand.

In addition, the company’s venture into new markets played a role in expanding its reach and growing the number of its potential customers. This, coupled with its aggressive push for its industry-leading Evolve product, helped stamp its position as a leader in its space while also growing its brand recognition and asserting itself as the go-to company for pest control.

Going forward, SenesTech looks to introduce a soft bait contraceptive product for mice. Having proven that its products work on rats, a product for the control of mice is a logical extension of the company’s rodent fertility control solutions, and the company expects to have the product on the market by mid-2024.

For more information, visit the company’s website at www.SenesTech.com.

NOTE TO INVESTORS: The latest news and updates relating to SNES are available in the company’s newsroom at https://ibn.fm/SNES

Astiva Health Inc. CEO Featured Podcast Guest, Talks Commitment to Help Patients Enjoy ‘Active, Healthy and Meaningful’ Lives

  • In addition to providing full medical-care prescription drugs, Astiva focuses on providing rich supplemental benefits to enrollees
  • CEO explains that “effective healthcare hinges largely on patient involvement”
  • Astiva’s recent expansion is a crucial step in extending invaluable benefits and commitment to quality healthcare to a growing, diverse population

Astiva Health CEO Dr. Tri Nguyen was the featured guest in a recent Bell2Bell Podcast release (https://ibn.fm/0Rufk). During the podcast, Nguyen talked provided an in-depth look at how Astiva Health is reshaping healthcare delivery, including an overview of the company’s commitment to patient involvement in healthcare and highlights the company’s innovative strategies in offering comprehensive care.

During the interview, Nguyen chatted with Bell2Bell about the history of the company, noting that it it started operations on Jan. 1, 2021, in Orange County and San Diego with recent expansions into Los Angeles, San Bernardino, and Riverside. “The name Astiva blends ‘ast’ — an old English, Nordic, and German word meaning ‘love’ or ‘enjoy’ — with ‘viva,’ meaning ‘life,’” explained Nguyen.

“[The name] encapsulates our philosophy of loving life, which is central to our healthcare approach,” he continued. “So Astiva, other than providing full medical-care prescription drugs, we also focus on providing a very rich supplemental benefits to our enrollees and getting them involved, participate and aim for an active, healthy and meaningful life.”

Nguyen’s journey to heading up Astiva, the growing Medicare Advantage prescription drug health plan, includes more than two decades of medical practice and an association with esteemed institutions such as Stanford Medical School, UC Davis, and UC San Diego.

“In my over 25 years of medical practice, I’ve realized that effective healthcare hinges largely on patient involvement,” he observed. “It’s about active participation rather than passivity. At Astiva, we emphasize this in our care approach, leading to healthier lives and reduced medical costs. Leveraging technology and efficient operations as a startup, we’ve been able to reinvest savings into rich supplemental benefits for our members.”

Nguyen explained that active participation by enrollees involves exercising, following diet guidelines, and taking medication as prescribed, and when individuals did these things, they enjoyed healthier lifestyles and reduced medical costs, which are primary objective for Astiva.

During his remarks, Nguyen said that Astiva’s recent expansion is a crucial step in extending these benefits and this commitment to quality healthcare to a growing, diverse population. However, Nguyen noted that “the expansion is not just about growth — it’s about deepening our impact in these communities and enhancing our ability to meet the diverse healthcare needs of more people.”

Astiva Health is dedicated to innovative health plans that meet the unique requirements of its members, emphasizing a culturally responsive healthcare model and serving underserved populations. This not only addresses critical societal needs but positions Astiva to capitalize on significant market growth potential. Astiva Health’s goal is to foster lasting relationships and improve the overall well-being of the communities it serves.

For more information, visit the company’s website at www.AstivaHealth.com.

NOTE TO INVESTORS: The latest news and updates relating to Astiva Health are available in the company’s newsroom at https://ibn.fm/Astiva

Zoned Properties Inc. (ZDPY) Is ‘One to Watch’

  • Zoned Properties in January 2024 acquired an investment property in Chicago and signed a long-term lease agreement for Justice Cannabis Co. to operate a retail dispensary there
  • The company reported revenues of $720,450 for the quarter ended September 30, 2023, compared to $614,988 for the same quarter in 2022, an increase of 17.2%
  • Zoned Properties reported net income of $114,523 for the September 2023 quarter, compared to a net loss of $77,328 for the same quarter a year earlier
  • The company continues to build out its proprietary cannabis technology platform, REZONE, in preparation for commercial launch
  • Zoned Properties in August 2022 closed a debt financing deal on its Tempe, Arizona, property by securing an initial debt facility of up to $4.5 million at a 7.65% interest rate through a commercial real estate lender
  • Since 2021, Zoned Properties Brokerage has closed over $80 million of commercial real estate deals nationally for clients

Zoned Properties (OTCQB: ZDPY) is a technology-driven property investment company focused on acquiring value-add real estate within the regulated cannabis industry in the United States. The company aspires to innovate within the real estate development sector, focusing on direct-to-consumer real estate that is leased to best-in-class cannabis retailers.

The company is redefining the approach to commercial real estate investment through its standardized investment process backed by its proprietary property technology. Zoned Properties has developed a national ecosystem of real estate services to support its real estate development process, including a commercial real estate brokerage and a real estate advisory practice.

With a decade of national experience and a team of experts devoted to the emerging cannabis industry, Zoned Properties is addressing the specific needs of a modern market in highly regulated industries. The company targets commercial properties that face unique zoning or development challenges, identifies solutions that can potentially have a major impact on their commercial value and then works to acquire the properties while securing long-term, absolute-net leases.

Zoned Properties targets commercial properties that can be acquired and rezoned for specific purposes, including the regulated and legalized cannabis industry. It does not grow, harvest, sell or distribute cannabis or any substances regulated under United States law.

The company is headquartered in Scottsdale, Arizona.

Portfolio

The company’s investment properties are located in Arizona, Michigan and Illinois, with 100% occupancy and a weighted average lease term over 10 years. Each of the company’s leased properties is occupied by a commercial cannabis tenant. The company is expecting rental revenue from its property investment portfolio of greater than $2.5 million in calendar-year 2024.

Zoned Properties maintains a portfolio of properties that it owns, develops and leases. As of February 2024, the company leases land and/or building space at the six properties in its portfolio to licensed and regulated cannabis tenants in areas with established cannabis regulations and zoning procedures. Four of the leased properties are zoned and permitted as regulated cannabis retail dispensaries, and two of the leased properties are zoned and permitted as regulated cannabis cultivation and processing facilities.

The company considers the two cultivation sites in its portfolio as legacy properties and may consider selling or leveraging those properties to unlock equity and create capital availability in the future. The Zoned Properties investment thesis has evolved over the years as the cannabis industry has emerged, and the company is currently focused on investing capital into direct-to-consumer properties, located in state-markets with robust cannabis consumer demand in the industry.

Zoned Properties is in pursuit of property acquisitions that can be characterized as consumer-facing, retail dispensary properties that are positioned to be leased to retail dispensary cannabis tenants under net leasing structures. As of September 2023, the company has agreements in place to acquire new investment properties with new cannabis tenants located in Arizona, Missouri and Illinois. The company plans to initiate and target its investment process in Ohio and Maryland.

With a strategic shift in focus to direct-to-consumer real estate that is leased to best-in-class cannabis retailers in the industry, the company will continue to utilize its competitive edge when identifying excellent investment properties. Zoned Properties has a full pipeline of acquisition prospects and continues to utilize an extremely disciplined capital allocation approach.

Market Opportunity

According to MJBizDaily, a publication that has covered the North American cannabis business since 2011, combined U.S. medical and recreational cannabis sales were estimated at approximately $33.6 billion at the end of 2023, largely driven by the opening of new adult-use markets.

The publication projects that combined U.S. retail cannabis sales will reach upwards of $53.5 billion by 2027, according to an analysis published in its volume of cannabis market research, the MJBiz Factbook.

As of February 2024, 38 U.S. states had legalized medical, recreational or other limited use of cannabis. The Pew Research Center reports that, in January 2023, there were more than 11,000 licensed cannabis dispensaries in the U.S. In addition, global research firm IBISWorld reports that more than 40,000 U.S. localities have adopted regulations governing cannabis usage, production, processing and/or dispensing.

Management Team

Bryan McLaren is the Chairman and CEO of Zoned Properties. Previously, he worked as a Sustainability Consultant for Waste Management Inc., where he led the strategic development and operational implementation of zero-waste programs for clients. He was also appointed as a city Sustainability Commissioner. He holds a bachelor’s degree in business administration from the University of San Diego, a master’s degree in sustainable development from Northern Arizona University, an executive master’s degree in business leadership from Arizona State and an MBA with a specialty in sustainable development.

Berekk Blackwell is the President and COO of Zoned Properties. He previously spent time in developing domestic and international markets for Kahala Brands, a conglomerate of over 15 QSR franchises, including Cold Stone Creamery and Blimpie Subs. He later worked on developing QSR concepts for Revamp Corp. in Tokyo. After returning to the U.S., he served as president of Daily Jam, a limited-service breakfast and brunch chain. He holds a bachelor’s degree in business administration in finance from Fort Lewis College.

Patrick Moroney is the Director of Real Estate Acquisitions for Zoned Properties. Previously, he was one of the most successful Associate Brokers at Kidder-Mathews, focusing primarily on the regulated cannabis industry. He also worked as a commercial real estate broker rep at Cushman & Wakefield and Colliers International. He graduated from Arizona State University, after which he spent four years as a local sports broadcaster in Georgia and Iowa.

Kyle Gere is the Director of Advisory Services at Zoned Properties. He has years of licensing experience across multiple U.S. states in the medical and recreational cannabis markets. Since 2015, he has been involved in cannabis real estate transactions in Arizona and Michigan, managing a portfolio of medical marijuana properties. He attended Northern Arizona University, graduating with a bachelor’s degree in business administration in both management and marketing.

For more information, visit the company’s website at www.ZonedProperties.com.

NOTE TO INVESTORS: The latest news and updates relating to ZDPY are available in the company’s newsroom at https://ibn.fm/ZDPY

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