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GlobeStar Therapeutics Corp (OTCMKTS: GSTC) Major Move over a Penny as Biotech Comes Back to Life (More on 10,610,592 Therapy for MS)

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GlobeStar Therapeutics Corp (OTCMKTS: GSTC) is making a highly explosive move up the charts since reversing off $0.0025 lows earlier this year. On Friday alone the stock was up over 40% surpassing a penny on around $200,000 in dollar volume on the day. GSTC has a long history of big moves skyrocketing from triple zeroes to highs near $0.09 in early 2021.

GSTC has been under accumulation over the past few weeks after the Company confirmed on November 10, they are in discussions with hospitals to move forward with planned clinical trials for its 10,610,592 therapy which consists of 3 FDA approved drugs: Minocycline, Fluconazole, and Atorvastatin. Pre-clinical trials in Italy showed the drug combination was effective in the reduction of MS co-morbidities. Previously GlobeStar reported it is initiating discussions with the FDA on clinical trial design in the U.S. in preparation for FDA submission and approval. 

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GlobeStar Therapeutics Corp (OTCMKTS: GSTC) based in Richland Washington, is a clinical stage Pharmaceutical Company introducing a patented formulation of previously approved drugs for the treatment of Multiple Sclerosis. GlobeStar Therapeutics owns the exclusive global license from the inventors, who are based in Italy. GlobeStar Therapeutics is initiating discussions with the FDA on clinical trial design in preparation for FDA submission and approval pathway.  

GSTC was formerly known as Angiosoma ($SOAN), and was formerly run by Alex Blankenship. In April 2020, Alex Blankenship was able to secure U.S. patent 10,610,592, a patent developed by Fabrizio De Silvestri (company is 7 to Stand, Inc) from Terni, Italy. In December 2020, Blankenship sought a firm that had history with bringing drugs to market, and in March 3, 2021, the board appoints Jim Katzaroff as CEO of both the subsidiary company (Somaceuticals), and parent company (Angiosoma).  In August/September Angiosoma changed its name to Globestar Therapeutics, Inc.  

The 10,610,592 therapy is a combinational tri-drug therapy that harnesses: 

  1. Minocycline – An oral tetracycline antibiotic. It’s used to treat bacterial infections including respiratory and urinary tract infections.
  2. Fluconazole – An triazole antifungal. Used to prevent and treat a variety of fungal and yeast infections by stopping the growth of CERTAIN types of fungus (candida albicans).
  3. Atorvastatin – A statin HMG CoA reductase inhibitor. Commonly used to lower blood levels of LDL cholesterol, increase levels of HDL cholesterol and to lower triglycerides. It’s also an effective immunomodulatory agent shown to prevent autoimmune encephalomyelitis in animal model studies.

Globestar is testing a worldwide patented formulation of these 3 drugs previously approved by the FDA. Pre-clinical trials in Italy showed the drug combination was effective in the reduction of MS co-morbidities. GlobeStar is initiating discussions with the FDA on clinical trial design in the U.S. in preparation for FDA submission and approval. 

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In the initial clinical study (done in Italy), the study consisted of 150 volunteers, 90 subjects ages between 25 and 65 years with MS disease course a minimum of 5 to maximum of 20 years including 60 healthy volunteers. The read out of the trial was based on mobility Barthel Index (disability evaluation) before and after the treatment regimen. The second parameter was analysis of muscle imbalance using the Kendall scale before and after the treatment. The subjects received 2 doses per day for 45 days, along with a controlled diet. 88/150 individuals had been diagnosed with MSS for ten or more years. 94/150 had an EDSS level above 5.0, 61/150 had an EDSS above 6.5, and 41/150 had an EDSS above 7.5 At the end of the Italian trials the average EDSS dropped by at least 1.3 points, to an average of 5.31 for the pre-treatment and an average of 4.02 after treatment. After 45 days of treatment, 150/150 reported an improvement in balance and motor control of all extremeties, 136/150 reported an improvement in bladder control, 3/150 dropped out for personal reasons. It is important to note that none of the above had any adverse event or a new episode of illness. 

Multiple Sclerosis or MS is an chronic neurodegenerative disease where the immune system attacks the protective fat layer (myelin)and causes problems with muscle control, vision, as well as other body functions-which may result in long term disability. MS affects over 800,000 people in the U.S., and over 2.58 billion globally. The global MS drugs market is expected to grow from $24.75 billion in 2021 to $26.29 billion in 2022 at an annual compound growth rate (CAGR) of 6.2%, expecting to reach $33.46 billion in 2026 at a CAGR of 6.2%. 

In a recent press release CEO James C. Katzaroff stated: “We have accelerated our exposure dramatically, and with the stunning results from the Italian trials, we believe in the near-term we will be able to move with alacrity with these studies. Furthermore, I am delighted to announce that through ongoing relationships that was the result of contacts at the Gala, that we have on-boarded two highly desirable and successful agencies to assist us with telling our fascinating story to MS patient advocacy groups as well as to hospitals, clinics, and more.” 

https://twitter.com/Kanye_Invest/status/1596353182396923904

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Currently trading at a $10 million market valuation GSTC OS is 770,360,616 with around 450 million shares in the float. The Company has a fairly clean balance sheet with little assets, pre revenues and only about $1 million in total liabilities. CEO James C. Katzaroff has managed to attract a solid bod that includes William J. Farley, Steven F. Penderghast, Brooke Greenwald and Dr. Leon Wisneski and they look like they are ready for action now. As we have discussed the Company is currently initiating discussions with the FDA on clinical trial design in preparation for FDA submission and approval pathway for its 10,610,592 therapy for MS that has proved effective in the reduction of MS co-morbidities in clinical trials in Italy. The global MS market was worth over $24 billion in 2021 and is growing. Last week on Thanksgiving the Company gave another update stating: ” Should be an exciting end of the year here at $GSTC a lot of amazing things going on that will be shared in a timely manner. Hope you all have a wonderful Thanksgiving.” We will be updating on GSTC when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with GSTC.

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Disclosure: we hold no position in GSTC either long or short and we have not been compensated for this article

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Wearable Devices Ltd. (NASDAQ: WLDS) Breaking Boundaries with AI

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Israeli technology company Wearable Devices Ltd. (NASDAQ: WLDS) announced that the Mudra Band for Apple Watch is now available for pre-order on their website.

Israeli technology company Wearable Devices Ltd. (NASDAQ: WLDS), known for developing AI-powered touchless sensing wearables, has announced that their flagship consumer product, the Mudra Band for Apple Watch, is now available for pre-order on their website. The company has received thousands of pre-orders as they gear up for their first large-scale manufacturing batch.

In a remarkable turn of events, the company’s shares experienced an astounding surge of 265% at the time of writing, accompanied by a staggering total of 48 million shares being traded. Having operated under NASDAQ compliance standards since September of last year, the company has largely flown under the radar with relatively low trading volume. Currently, approximately 5.88 million shares are available for trading, a significant portion of which are closely held by insiders. The recent groundbreaking news marks a pivotal moment for the company, setting a trajectory for future growth as they assert its dominance in the realm of AI for wearable devices.

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The Mudra Band was initially designed to allow the touchless operation of the Apple Watch using neural signals. However, it has since expanded its features with Air-Touch, which enables users to operate various Apple devices through intuitive finger movements and hand gestures, eliminating the need for physical touch. The latest features also provide seamless device switching and toggling between iPhone, iPad, Mac computer, Apple TV, smart glasses, and mobile gaming devices.

Wearable Devices CEO, Asher Dahan, expressed his belief that the Mudra Band is setting a new standard for user interactions with connected devices, extended reality, and gaming. The company is scaling its marketing and support capabilities to meet the high demand for the product and aims to start shipping in the second half of 2023.

The Mudra Band is compatible with different models of the Apple Watch and is being extensively tested and approved by a global community of Apple enthusiasts. It is the ultimate aftermarket accessory for controlling Apple devices within their ecosystem.

Quick overview of the company

Wearable Devices Ltd. is a growth-oriented company that develops AI-based neural input interface technology for both consumer and business markets. In addition to the Mudra Band, they also offer the Mudra Inspire as a B2B product, providing businesses the same functionality and technology through licensing. The company aims to create disruptive technology that leverages AI and proprietary algorithms, software, and hardware to establish the input standard for the rapidly expanding Metaverse landscape in the tech industry.

More on the Mudra Brand and latest Event

Wearable Devices Ltd. (NASDAQ: WLDS) recently attended a big event called the TinyML Summit. They recently had the chance to show their technology firsthand and have users experience their award-winning aftermarket band for the Apple Watch – enabling touchless control of Apple products using subtle finger and wrist movements.

The tinyML Summit is a vibrant gathering that attracts a diverse range of professionals and enthusiasts from various industries. Engineers, developers, managers, executives, and founders involved in developing sensors, silicon, software, machine learning tools, or systems for the tiny ML (machine learning) market come together at this event. It also appeals to system designers and integrators seeking to incorporate low-power, low-cost machine learning into their devices and products across different verticals, such as consumer electronics, industrial applications, extended reality (XR), healthcare, and more.

On top of the band, the company also highlighted its multi-device functionality that allows for seamless control across not just the Apple watch but also other Apple devices like iPhones, iPads, Mac computers, and Apple TVs

As mentioned, the summit provides a dynamic platform for showcasing cutting-edge technology in machine learning on edge devices and fostering knowledge exchange among industry leaders. In the past year, the company behind this groundbreaking technology has meticulously fine-tuned its product, remaining relatively low-key as it devoted its efforts to perfecting its innovation. 

The company is strategically leveraging events like the tinyML Summit to gain exposure. The response has been remarkable, as the product has already generated tremendous buying interest, evident from the large pre-order numbers they are experiencing. This surge in interest signifies the excitement surrounding their offering and the anticipation of what this groundbreaking technology can achieve.

We will update you on WLDS when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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CohBar Inc. (NASDAQ: CWBR) and Morphogenesis Join Hands to Create TuHURA Biosciences

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Shares surged nearly 200% on CohBar, Inc. (NASDAQ: CWBR) as they entered a definitive agreement with Morphogenesis Inc.

Shares surged nearly 200% on CohBar, Inc. (NASDAQ: CWBR) as they entered a definitive agreement with Morphogenesis Inc. for an all-stock transaction to merge the two companies. The recent merger announcement has sparked a flurry of trading activity, resulting in a significant change in trading volume. Before the merger news, the average daily trading volume for CohBar stood at approximately 3.5K shares. However, at the time of writing, the company’s stock has experienced a tremendous influx, with shares being traded at a rate eight times higher than their float. A remarkable 16.2 million shares have exchanged hands, indicating substantial investor interest and enthusiasm.

The merger combines their expertise and resources to advance their late-stage oncology pipeline. The merged company will operate under “TuHURA Biosciences, Inc.” and trade on The Nasdaq Capital Market. The transaction is expected to be completed in the third quarter of 2023.

The combined company will focus on advancing Morphogenesis’s two technologies that aim to overcome the limitations of current immunotherapies in treating cancer. These technologies include personalized cancer vaccines called Immune Fx (IFx) and tumor microenvironment modulators. IFx is designed to activate the immune response against patient-specific tumor antigens, while the tumor microenvironment modulators target myeloid-derived suppressor cells (MDSCs) to address resistance to immunotherapies.

The merger is seen as a promising opportunity to develop new therapies to overcome resistance to current immunotherapies, a significant unmet need in cancer treatment.

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The merger agreement includes terms for the stockholders of both companies and a $15 million private placement is expected to be conducted alongside the merger. The proceeds from the private placement will be used to fund the development pipeline of the combined company, with sufficient funds expected to last until 2024.

The merger has been approved by the boards of directors of both companies and is subject to stockholder approval and customary closing conditions. Following the merger, the combined company will be headquartered in Tampa, Florida, with Dr. James Bianco as Chief Executive Officer and Dan Dearborn as Chief Financial Officer. The board of directors will consist of seven members, five designated by Morphogenesis and two by CohBar.

More on the Pipeline

  • Immune Fx (IFx) Personalized Cancer Vaccines: IFx is designed to prime and activate an innate immune response against patient-specific tumor antigens, overcoming primary resistance to checkpoint inhibitors. Morphogenesis is currently preparing for a single Phase 2/3 registration trial of its lead personalized cancer vaccine, IFx-Hu2.0, as an adjunct to Keytruda® (pembrolizumab) in first-line treatment for advanced Merkel Cell Carcinoma (MCC). This study is expected to be conducted under a Special Protocol Assessment (SPA) agreement with the FDA and to commence in early 2024. Additionally, Morphogenesis is advancing IFx-Hu3.0, its mRNA vaccine, toward IND-enabling studies in 2024 to treat aggressive diffuse large B-cell lymphoma (DLBCLs).
  • Tumor Microenvironment (TME) Modulators: TME Modulators are designed to address one of the primary causes of acquired resistance to immunotherapies, including checkpoint inhibitors or cellular therapies like CAR-T. Leveraging its new class of novel bi-functional antibody-drug conjugates (ADCs), Morphogenesis is targeting a recently identified delta receptor on myeloid-derived suppressor cells (MDSCs). MDSCs comprise a major component of cells in the tumor microenvironment and are responsible for suppressing the immune system’s attack against the tumor. Morphogenesis is constructing several MDSC-targeted, bi-functional ADCs for in vitro and in vivo characterization, targeting lead selection by the end of 2024.

In conclusion, the proposed merger between CohBar and Morphogenesis represents a significant step forward in advancing personalized cancer vaccines and tumor microenvironment modulators. With Morphogenesis’ Immune Fx (IFx) Personalized Cancer Vaccines and Tumor Microenvironment (TME) Modulators, there is great potential to overcome resistance to current immunotherapies and improve treatment outcomes for patients with various cancers. The merger agreement, subject to stockholder approval, will result in a combined company named TuHURA Biosciences, with a strong management team and a focus on advancing the late-stage oncology pipeline. The transaction, backed by Ladenburg Thalmann & Co., Inc., and H.C. Wainwright & Co., is expected to close in the third quarter of 2023, paving the way for innovative advancements in cancer treatment.

We will update you on CWBR when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Aemetis Inc. (NASDAQ: AMTX) Pioneers Renewable Fuel Market with EPA Approval

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Aemetis (NASDAQ: AMTX) shares surged 105% this week. The renewable natural gas and renewable fuels company received approval from the EPA.

Aemetis, Inc. (NASDAQ: AMTX) shares surged 105% this week. The renewable natural gas and renewable fuels company received approval from the U.S. EPA to generate renewable identification numbers (RINs) under the federal Renewable Fuel Standard. They have six dairy biogas digesters up and running, with a seventh one scheduled to start operating in June 2023.

Aemetis plans to generate multiple sources of revenue from its renewable natural gas. They will sell the gas to replace petroleum diesel in transportation, sell California Low Carbon Fuel Standard credits to fuel blenders who need to meet carbon reduction requirements in California, sell the RINs generated under the federal Renewable Fuel Standard, and benefit from production tax credits starting in 2025 under the Inflation Reduction Act.

They have completed constructing and operating six dairy digesters, a biogas pipeline spanning over 40 miles, a central facility to upgrade biogas to renewable natural gas, and a utility pipeline interconnection unit. The renewable natural gas is injected into the utility gas system and stored underground until Aemetis Biogas obtains carbon intensity (CI) pathway approvals from the California Air Resources Board (CARB) to sell credits under the California Low Carbon Fuel Standard.

They have already completed 90 days of renewable natural gas production and data collection required for the CARB approval process. While the final pathway is under review by CARB, Aemetis can use a temporary CI pathway with a value of -150, allowing them to start generating revenue in the third quarter of 2023.

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Andy Foster, the president of Aemetis Biogas Inc., expressed excitement about the approval of Aemetis Biogas for generating D3 RINs, as it marks a significant milestone towards generating full product revenue. He emphasized that the company’s investments since 2019 have directly reduced greenhouse gas pollution, improved air quality in Central Valley communities, and created jobs. Aemetis is committed to expanding their network of dairy digesters and producing more carbon-negative renewable natural gas to replace petroleum diesel.

The dairy digesters, pipeline project, and biogas-to-RNG facility funding includes grants from the California Department of Food and Agriculture and the California Energy Commission. Aemetis also closed a $25 million long-term financing deal with Greater Commercial Lending last fall, supported by a loan guarantee from the USDA. This project financing has a low fixed interest rate for the first five years and spans over 20 years.

Aemetis has plans to file applications for an additional $100 million of loans from the USDA’s REAP loan program. These funds will support the engineering, permitting, and construction of 31 more dairies. Each loan application will be limited to a maximum of $25 million and carry a 20-year repayment term.

https://twitter.com/Theweedfarmer/status/1658946668052504576?s=20

Where could Aemetis, Inc. (NASDAQ: AMTX) be in 5 years?

The company has an ambitious Five Year Plan to generate substantial revenue and reduce air and carbon pollution. The plan projects $2.0 billion in revenues, $496 million in net income, and $682 million in adjusted EBITDA by 2027, with strong compound annual growth rates. Aemetis aims to expand its operations by producing Renewable Natural Gas (RNG), Sustainable Aviation Fuel (SAF), Renewable Diesel fuel (RD), and other low-carbon products. The plan emphasizes the positive financial impact of the Inflation Reduction Act.

The plan highlights the financial benefits of the Inflation Reduction Act, which enables the transfer of tax credits and incentives related to production, projected to improve net income by $341 million in 2027.

The plan also focuses on revenue growth in all product lines, including expanding the dairy RNG business, constructing a renewable jet/diesel plant, implementing carbon sequestration, and improving energy efficiencies. 

The company has already achieved significant milestones, such as completing biogas pipeline construction, upgrading facilities for biogas-to-RNG production, and progressing in carbon sequestration and renewable jet/diesel plant development. The company has also secured a biodiesel purchase agreement in India and made strides in constructing a solar microgrid and implementing energy-efficient measures.

We will update you on AMTX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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