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CytoDyn Inc (OTCMKTS:CYDY) Leronlimab; One Molecule Multiple Opportunities

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CytoDyn Inc (OTCMKTS:CYDY) has been making big moves in recent days including filing a protocol with the FDA) for a Phase 2 clinical trial for leronlimab as a treatment for COVID-19 patients suffering from long-hauler symptoms entitled: ”A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers]. The Company also reported Health Canada has cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in Canada. CytoDyn said in a statement, the Company looks forward to filing its BLA in the very near future.

The Company also reported 9 of its trademark applications to register the VYROLOGIX mark have now successfully passed through formal examination. In summary, the U.S. and E.U. applications have been allowed, applications in Hong Kong, China and Russia have registered, and the Company’s applications in Australia, Israel, New Zealand and Singapore will each proceed to registration once they have passed through the opposition period unopposed.

CytoDyn Inc (OTCMKTS: CYDY) is a biotech focused on developing innovative treatments for multiple therapeutic indications. Its lead candidate Leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is one of the most advanced experimental monoclonal antibodies for HIV treatment, GVHD, NASH, stroke recovery, multiple sclerosis, Parkinson’s disease, metastatic cancer and coronavirus. Leronlimab, the Company’s CCR5 antagonist, a once a week, subcutaneous injection. One molecule with multiple opportunities.

Leronlimab is showing considerable value in potentially mitigating the “cytokine storm” believed to play an integral role in the development of acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Chemokines and chemokine receptors play a critical role in the recruitment, activation, and coordination of leukocytes in the pathophysiology of lung inflammation. The acute respiratory distress syndrome (ARDS) of COVID-19 results from the accumulation of neutrophils within the pulmonary circulation and alveolar spaces. Leronlimab (PRO 140) inhibits the migration of Tregs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, the migration of macrophages and release of pro-inflammatory cytokines in lungs.

Recent laboratory data for patients treated with leronlimab for COVID-19 infection has shown increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function by day 7. Restoration of the immune function is critical in COVID-19 patients to prevent opportunistic infections.

Leronlimab has been administered to fifteen severely ill COVID-19 patients at four hospitals, ten patients treated at a leading medical center in the New York City area, and five patients at three other hospitals. Each patient received treatment under an emergency investigational new drug (EIND), which was granted by the U.S. Food and Drug Administration (FDA) for each patient. The evaluation of leronlimab for patients with mild-moderate COVID-19 indications will be conducted under the Company’s Phase 2 randomized clinical trial. Also, CytoDyn has the approval to proceed with a Phase 2b/3 trial for 390 severely ill COVID-19 patients. This study is a double-blinded study with a 2:1 ratio (a drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of the mortality rate of 14 days. The Company will perform an interim analysis of the data from 50 patients following two weeks of leronlimab therapy.

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Health Canada recently cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in Canada. CytoDyn said in a statement, the Company looks forward to filing its BLA in the very near future. Health Canada’s decision validates the opportunity for leronlimab as a treatment for HIV patients around the world. The Company also updated health Canada on its COVID-19 trials and plans to simultaneously file its BLA for leronlimab as a combination therapy for HIV with the MHRA in the U.K. and Health Canada.”

Nine of CytoDyns trademark applications to register the VYROLOGIX mark have now successfully passed through formal examination. In summary, the U.S. and E.U. applications have been allowed, applications in Hong Kong, China and Russia have registered, and the Company’s applications in Australia, Israel, New Zealand and Singapore will each proceed to registration once they have passed through the opposition period unopposed. The name Vyrologix as the proprietary name for leronlimab is conditional on FDA approval of the Company’s Biologics License Application and new drug application.

On November 17 CytoDyn announced it has filed a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial for leronlimab as a treatment for COVID-19 patients suffering from long-hauler symptoms. According to a recent article from The Journal of the American Medical Association and a study done by British scientists, researchers estimate about 10% of COVID-19 patients become long-haulers. CytoDyn’s protocol for its Phase 2 COVID-19 long-haulers trial is entitled:”A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers].” The planned number of patients is 102 to be enrolled in up to 10 sites. The study will have an interim analysis after half of the patients are enrolled and will allow CytoDyn to report the results.

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Cytodyn is among the first biotechs to have a drug that is proving to be effective in the global fight against coronavirus COVID-19 world epidemic. Leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is one of the most advanced experimental monoclonal antibodies for HIV treatment and is proving to be effecting in GVHD, NASH, stroke recovery, multiple sclerosis, Parkinson’s disease, metastatic cancer and coronavirus. Leronlimab can potentially mitigate the cytokine storm which plays an integral role in the development of acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Leronlimab inhibits the migration of Tregs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, the migration of macrophages and release of pro-inflammatory cytokines in lungs. Recent laboratory data for patients treated with leronlimab for COVID-19 infection has shown increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function by day 7. For more on CytoDyn Subscribe Right now by entering your email below. MicroCapdaily has been reporting on Cytodyn since it was pennies.

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

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1 Comment

1 Comment

  1. Bruce Morrison

    November 19, 2020 at 12:48 pm

    #Why doesn’t Cytodyn go back to “Emergency Care dosage”. at least it could be saving some lives
    doing this resurgence of the virus. I would think that would be a suggestion of the FDA if they are serious about saving lives.

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MSP Recovery (NASDAQ: LIFW) in the Spotlight: Legal Battles, Luxe Living, and Stock Surge

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MSP Recovery (NASDAQ: LIFW) has been on quite the rollercoaster ride, defying gravity with over 400% gain since September 14th, 2023 with over 240% of that gain happening this week alone. However, the exact reasons behind this meteoric rise remain elusive. Typically, when a company drops major news, you’d expect an instant stock reaction. But in this case, the last significant update from the company was about a week ago, and it’s questionable whether that news was much on the positive side, yet the stock is still zooming upwards.

Background:

Let’s delve into the nitty-gritty of what MSP Recovery, more prominently known as LifeWallet, is all about. Imagine them as the healthcare financial detectives, diligently sifting through the complexities of medical billing and reimbursements. They specialize in recovering money owed to healthcare providers. If an insurance company owes a hospital for a patient’s treatment, these folks ensure that the hospital gets the rightful compensation. But their innovation doesn’t stop there.

Enter “LifeWallet,” their brainchild—a powerful tool designed to revolutionize healthcare transactions. Picture it as a savvy assistant for healthcare professionals, standing by their side in the hustle and bustle of medical care. LifeWallet’s magic lies in its ability to decipher the complexities of healthcare billing and insurance. It guides doctors and hospitals, helping them navigate the tangled web of who should foot the bill, especially in post-accident treatments. It’s a digital ally ensuring fair compensation and smooth financial transactions in the intricate healthcare landscape.

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MSP is making waves in the healthcare domain with this innovative approach, leveraging data analytics to streamline processes and champion fair compensation for healthcare providers. Much like a rollercoaster ride, their journey promises excitement, surprises, and an undeniable thrill in the world of healthcare finances.

Legal Battles and CEO Extravagnce:

Step back and look at their stock chart—MSP has taken a major hit in value this year, and it’s not without reason. Surprisingly, digging into the company’s operations revealed some unpleasant surprises we hadn’t anticipated. It’s been a rough ride for them.

The company was just recently involved in a class action law suit led by recognized leader in shareholder rights litigation, Robbins LLP. The case revolved around MSP not providing essential information to investors transparently.

There were a number of claims mentioned, here’s a quick list.

  1. MSP didn’t reveal there was an ongoing investigation by the SEC and federal prosecutors.
  2. They gave out financial information to investors that was significantly wrong and deceptive.
  3. When admitting they needed to fix their financial results, they didn’t reveal the full extent of the issues.
  4. MSP couldn’t financially handle the claims they were assigned to manage by a major health and engaged in deceitful actions with said provider
  5. The Registration Statement had lots of wrong or misleading statements and was poorly prepared.
  6. Their Proxy also had false or misleading statements.

It all started on July 31, 2023, where The Miami Herald unveiled significant revelations. Stating the CEO John H. Ruiz has been living quite the lifestyle buying several waterfront mansions in Miami, even an entire Boeing passenger jet.

It’s not surprising the Ruiz’s lifestyle was so extravagant considering LifeWallet was once valued at more than $32 billion, but as you can see the company is now worth a small fraction of that. That said, Ruiz’s expensive lifestyle would be tough to continue.

Then again, on August 1, 2023, the Company made disclosures to the SEC (Form 8-K), confirming The Miami Herald’s findings. The stock took another substantial hit, dropping over 12%. Adding to the unfolding drama. After that, a substantial $67 million lawsuit was filed against the Company on the same day, resulting in an 18% plummet in the stock price.

The narrative continues on! On August 17, 2023, MSP acknowledged a notification letter from Nasdaq’s Listing Qualifications Department. They confirmed the Company’s non-compliance with Nasdaq’s Rule 5250(c)(1) due to a delayed Form 10-Q filing for the period ending June 30, 2023. This revelation caused a 19% stock price drop over two days.

With that said, we’ll bet you’re seriously wondering how could this company could possibly see recovery (pun intended) after all these allegations were laid out.

What happened:

Surprisingly enough, it seems Robbins LLP just recently lost the case against MSP and there was an announcement made on September 13th, 2023 about it. All those allegations have vanished into thin air. It’s baffling how a company with so many strikes against it can seemingly wrap things up so quickly. The whole situation leaves us questioning what’s really going on.

Since the announcement the other week, the company’s valuation has skyrocketed, at some points even peaking at an increase of over 400%. Naturally with that kind of trading action, it’s no surprise day traders are getting in on the action. MSP is trending all over Twitter amongst notable users like @timothysykes, @stockplaymaker1, and @AngryRed316 talking about it.

At this point, it looks like investors are basing their trades more on chart patterns and less on the company’s solid financial footing. MSP didn’t deliver great news in its latest earnings report, showing quite a large net loss of over $400 million. It’s quite likely the allegations had a role to play in this financial blow. The real question is if MSP can get its act together, start making real profits, and avoid a chapter 11. Either way, we’ll continue to follow along to see how things pan out!

We will update you on LIFW when more details emerge, subscribe to Microcapdaily to follow along!

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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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VCI Global (NASDAQ: VCIG) Joins Forces with Microsoft Azure OpenAI: A Tech Revolution Unleashed

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VCI Global (NASDAQ: VCIG) is back on the radar with another significant gain of 84%. We wrote about this company just recently in June, where it popped 156% on the announcement of their “Socializer Messenger”. The company is now teaming up with Microsoft Azure OpenAI through its subsidiary, V Galactech Sdn Bhd. This partnership brings together their AI know-how to reshape the world of business solutions, making waves in the tech scene by using Microsoft Azure OpenAI services.

This collaboration is all about meeting the growing demand for tech advancements that are fast, smooth, and globally connected, helping businesses connect better with their customers. It’s also a boost to VCI Global’s AI consulting skills.

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By tapping into what Microsoft Azure OpenAI offers, VCI Global is jumping into the tech world’s fast lane. They plan to come up with some cool innovations, like Generative Pre-trained Transformer 4 (GPT-4) and Microsoft’s new AI-powered chat tool, Bing Chat Enterprise. Plus, they’ll use Microsoft Azure OpenAI’s cutting-edge AI for their projects, including the super-smart AI-assisted sales platform, robosale software.

https://twitter.com/ShortDaPos/status/1694403174566858783?s=20

Dato’ Victor Hoo, Group Executive Chairman and Chief Executive Officer of VCI Global, is very excited about this partnership. He mentions, “We’re thrilled to dive deep into AI innovations, especially with Microsoft Azure OpenAI. We can’t wait to see how this partnership transforms how businesses connect with customers in the ever-changing tech world. The sky’s the limit, and we’re ready to help our clients ride this AI wave.”

About VCI Global Limited:

VCI Global is a versatile consulting group that’s all about helping businesses with their tech and strategy. They give advice on business strategies, help with investor relations, and provide tech know-how. They mainly work in Malaysia, but they also serve clients in Malaysia, China, Singapore, and the United States, covering a bunch of different industries.

If you want to know more about them, just head to https://v-capital.co/.

About Microsoft Azure Open AI:

Microsoft Azure OpenAI is like a treasure chest of artificial intelligence tools and solutions made to help businesses. They offer everything from AI Services to Machine Learning and AI infrastructure, all aimed at helping businesses make the most of AI for their growth and innovation.

We will update you on VCIG when more details emerge, subscribe to Microcapdaily to follow along!

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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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Mobilicom (NASDAQ: MOB) Secures Landmark Deal with Top Global Manufacturer

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Mobilicom (NASDAQ: MOB), a company providing cybersecurity and reliable solutions for drones and robotics secures its largest order to date from Teledyne Technologies Incorporated (NYSE: TDY) – shares rocket 123%. $TDY is one of the world’s largest manufacturers of small-sized drones and robotics.

Overview:
This $19B Tier-1 customer has now incorporated Mobilicom’s SkyHopper PRO into its latest small-sized drone platform. This is yet another testament to Mobilicom’s systems as they have already successfully integrated into 44 design wins by various drone and UAV manufacturers.

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More importantly, Teledyne has made significant progress in transitioning from the design phase to production and commercial sales with the U.S. Department of Defense. The company’s latest purchase order appears to reflect only the beginning of potentially multiple recurring orders as they prepare for their first-ever production order for the U.S. DOD.

“As Teledyne-FLIR continues to win additional orders for its small-sized drone platforms with end users such as the U.S. DOD, other federal agencies, and commercial customers, Mobilicom is well positioned for more sales of its Skyhopper Pro,” stated Mobilicom CEO Oren Elkayam. “We see the sales of these systems to the U.S. DOD, one of the largest and most selective procurers of technology, as a strong testament to the excellence of Mobilicom’s market-leading end-to-end solutions.”

 

About SkyHopper PRO:
The SkyHopper PRO is a communication system for drones that ensures secure data transfer. It offers a number of advantages and customization compared to competitors, here’s a quick overview:

Cybersecurity: Prioritizes cybersecurity, ensuring the secure transfer of data between the drone and the ground control station. This feature helps protect sensitive information and prevents unauthorized access or interference.

Reliability: The system is designed to provide robust and reliable communication even in challenging environments. It supports long-range and non-line-of-sight communication, enabling seamless connectivity between the drone and the ground station, even when obstacles are present.

Versatility: Supports multiple transmission modes, including point-to-point and point-to-multipoint communication. This versatility enables various communication setups, such as multi-drone operations and communication to multiple receivers, enhancing flexibility in drone missions.

Industry Integration: Systems have been integrated into numerous design wins by drone and UAV manufacturers indicating their compatibility and suitability for a wide range of platforms. The proven track record of integration demonstrates the system’s adaptability and reliability.

End-to-End Solution: End-to-end solutions for cybersecurity and robust communication. This comprehensive approach ensures seamless integration, streamlined operations, and enhanced overall performance for drone missions.

About Mobilicom:
Mobilicom is a leading provider of end-to-end cybersecurity and robust solutions for drones and robotics. They focus on serving global manufacturers in these industries, offering patented Mobile Mesh networking technology and a proven portfolio of commercialized products. With a growing high-profile global customer base, including corporations, governments, and the military, Mobilicom stands out for its outstanding security capabilities and performance in harsh environments. They derive revenue from hardware and software sales, licensing fees, and professional support services.

About Teledyne Technologies (NYSE: TDY):
Teledyne Technologies is a global leader known for its innovative solutions in aerospace and defense, environmental sensing, and digital imaging. The company’s success stems from a strong emphasis on research and development, enabling them to introduce cutting-edge technologies and meet customer needs effectively. With a focus on quality and customer satisfaction, Teledyne Technologies has earned a solid reputation in the industry. Strategic acquisitions have further strengthened their capabilities, expanding their product offerings and market reach. Through adaptability and a commitment to delivering value, Teledyne Technologies has established itself as a prominent player in various verticals in multiple industries, ultimately paving the way for the company’s current $19B stature in the market.

We will update you on MOB when more details emerge, subscribe to Microcapdaily to follow along!

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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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