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CytoDyn Inc (OTCMKTS: CYDY) On Watch as Company Hires Ambitious New CEO Who Charts Path Forward (Update on leronlimab)

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CytoDyn Inc (OTCMKTS: CYDY) has formed a solid base over $0.30 and is beginning to move northbound again. The stock recently made a solid bounce from new 52-week lows of $0.231 to a high of $1.26 per share. CytoDyn was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share before the Citron short attack took the wind out of the stocks sails and the long downward trend began.  CyyoDyn lows earlier this year came as the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the US. This was followed by the CEO and registered public accounting firm, Warren Averett LLC, both resigning and the Company electing to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting. All of this has culminated in CYDY being offered at a cheap discount to prices from just a few months ago and the opportunity to buy in to Cytodyn for under $0.40 per share.    

CYDY is a highly volatile stock that ran to $10 per share in 2020 with a similar share structure. The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV and leronlimab with zero side effects. leronlimab (PRO 140), is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastasis, and immune signaling. leronlimab also has a lot of big believers including many well-respected scientists. Cytodyn recently raised $21.8 million in a stock offering and signed on a new President; Cyrus Arman, Ph.D. who said upon his hiring: “I look forward to uniting our teams and individuals in the pursuit of CytoDyn’s success through a renewed focus on the entrepreneurial spirit. Leronlimab is a unique molecule with the potential to help many individuals, particularly with unmet medical needs. We will focus on enhancing shareholder value through focused execution and refining of the path forward for leronlimab.” 

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CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of Leronlimab, a monoclonal antibody CCR5 receptor antagonist, to be used as a platform drug for a variety of indications. The target of leronlimab (PRO 140) is the important immunologic receptor CCR5. The CCR5 receptor is a protein located on the surface of a variety of cells including white blood cells and cancer cells. On white blood cells, it serves as a receptor for chemical attractants called chemokines. The CCR5 receptor is also the coreceptor needed for HIV to infect healthy T-cells. Recent research has identified the CCR5 receptor as an important target for many disease processes including cancer metastasis and certain immunological conditions. 

Leronlimab is a unique humanized monoclonal antibody. Leronlimab prevents HIV from using the CCR5 receptor as an entry gateway for healthy cells; preclinical research has also shown that leronlimab blocks calcium channel signaling of the CCR5 receptor when present on the cancer cell surface. It is believed that calcium channel signaling of the CCR5 receptor is a crucial component to the spread of metastatic cancer. The CCR5 receptor has been identified as a target in HIV, GvHD, NASH, oncology, transplantation medicine, multiple sclerosis, traumatic brain injury, stroke recovery, and a variety of inflammatory conditions. As we progress in evaluating leronlimab (PRO 140) via a pathways approach, we are encouraged by the opportunity to build a broad pipeline of indications. 

Earlier this year the FDA placed a full clinical hold on CytoDyn’s COVID-19 program and a partial clinical hold on its HIV program in the United States. As the stock price was collapsing Nader Pourhassan resigned and the collapse intensified after the Company’s registered public accounting firm, Warren Averett, LLC resigned. Since than Dr. Cyrus Arman has been appointed as new President of the Company and they are looking at potential strategies including:

  • Strengthening CytoDyn’s pharmacovigilance program enabling it to remove the FDA clinical holds placed on its HIV and COVID-19 programs to allow it to conduct future clinical studies.
  • Advancing CytoDyn’s NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis associated with NASH.
  • Exploring a study for patients with HIV and NASH as well as review the Company’s strategy for its COVID-19 program.
  • Continuing CytoDyn’s Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
  • Continuing CytoDyn’s work to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab, continue its work on developing a long-acting version of leronlimab, and pursue proof of concept studies for HIV cure using leronlimab and AAV vectors.

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CYDY

Cytodyn has been beefing up its BOD recently appointing Mr. Stephen Simes, a career public company biotech CEO and Mr. Ryan Dunlap, a current CFO with public company biotech experience to its board of directors. They join Tanya Durkee Urbach, Karen J. Brunke, Ph.D. and Lishomwa C. Ndhlovu, M.D., Ph.D. The Company’s corporate website looks more like a big boards. Check out their management team here. As we have reported, on July 9 of this year Dr. Cyrus Arman was appointed President of CytoDyn. 

On October 28 CytoDyn announced it has voluntarily withdrawn its pending BLA for leronlimab as a combination therapy in persons living with HIV with resistance to highly active antiretroviral therapy (HAART) in the HIV multi-drug resistant population (HIV-MDR). The decision to voluntarily withdraw was based on various factors, including systemic issues related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization (CRO) contracted to manage the trials, resulting in significant concerns with achieving a successful U.S. Food and Drug Administration (FDA) BLA approval. The Company is of the opinion that FDA approval for the HIV-MDR indication is not feasible without significant additional investment to remedy the issues. CytoDyn plans to publish soon the safety and efficacy data in which it met its primary endpoint, in its Phase 2b/3 randomized, double-blinded, placebo-controlled trial for the HIV-MDR population, in a peer-reviewed journal. 

The Company believes the data it currently possesses is sufficient to complete and submit its responses to the FDA to seek the removal of the clinical hold placed on the Company’s HIV program. Further, the Company will continue to leverage the performance of leronlimab in these and other studies to advance leronlimab in other HIV-related, non-alcoholic steatohepatitis (NASH), and oncology indications – where compelling data has been generated – that may benefit a greater number of patients and result in significant shareholder value creation. For example, the Company plans to continue to pursue other underserved HIV-related indications, where it can potentially be first to market. 

Cyrus Arman, Ph.D., President of CytoDyn, stated, “We have decided to voluntarily withdraw our BLA for the HIV-MDR population at this time only after extensive review and deliberation, including audits from three external independent regulatory quality firms. While the Company met its primary endpoints in these pivotal trials, which we think is a clear indication that leronlimab performs well in the clinic, we believe the issues identified in each of the three independent audits related to the quality of the data collection and oversight by the CRO make it difficult to support a successful BLA regulatory submission. Further, we have filed a claim against the CRO seeking damages resulting from its breach of the Master Services Agreement and related agreements and reimbursement of our attorney fees and costs associated with the action. As previously discussed, we are focusing on continued development in other HIV indications, NASH, and oncology, where we have Fast Track designation for metastatic triple-negative breast cancer. We plan to reenter the clinic in those indications and believe these steps will allow us to further build on the strong signals we have seen in these indications. I am very excited and quite optimistic about these opportunities, which are what ultimately attracted me to leronlimab and CytoDyn. I believe we have a unique opportunity to impact a significant number of patient lives while creating long-term value for our shareholders.”

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Currently trading at a $310 million market valuation CYDY is fully reporting OTCQB and while they are pre-revenue the Company has close to $100 million in assets and about the same in debt. At current levels CYDY is worth a close look; The stock was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. Now trading for under $0.40, the underlying science has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, HIV and coronavirus with zero side effects. leronlimab (PRO 140), is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor  metastasis, and immune signaling. Now that Cytodyn has completed a stock offering and brough on new CEO Cyrus Arman, Ph.D. things could be on the up and up here. With a recent low of $0.231, a high of $10 CYDY at $0.38 should be at the top of speculators watch lists. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily.

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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. Kush Smoky

    November 21, 2022 at 12:28 pm

    Nader Pourhassan was terminated, he did not resign. His termination was two years late and therefore the COB who allowed Pourhassan to ravage the company for those two years should also be terminated in the near future.

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BioPharma

Organogenesis (NASDAQ: ORGO): Latest Developments and Future Growth Prospects

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Organogenesis Holdings (NASDAQ: ORGO), a top regenerative medicine company dedicated to advanced wound care, surgical, and sports medicine solutions, gains over 30% during intraday trading and after hours combined after their latest release. According to the release, three Medicare Administrative Contractors (MACs) decided to withdraw certain coverage rules that were meant to start on October 1. These rules related to products for treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

More Background:

Organogenesis serves a range of clients, from hospitals and wound care centers to doctors’ offices. The MACs’ initial rules, set on August 9, caused concern. They specified that covered products must be particular types of skin substitutes. Unfortunately, this excluded five products from Organogenesis, impacting their financial outlook.

Fast forward, the MACs pulled back these rules just in time, preventing potential harm to Organogenesis. Even before these rules, the company was facing challenges. In the second quarter, revenue was slightly down compared to the same period last year. Despite this, the company is doing better than the previous year in a six-month comparison.

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Gary S. Gillheeney, Sr., the head of Organogenesis, expressed deep gratitude for the MACs and the Centers for Medicare & Medicaid Services (CMS). He praised their thoughtful consideration of stakeholder concerns and putting patients first. This decision will positively affect the lives of many.

He also thanked the stakeholders, including doctors, patient advocacy groups, and various associations. Their unified support played a vital role in challenging these rules, considering the potential harm they could cause patients. Their advocacy shed light on the possible negative health outcomes and treatment disparities, especially for those with higher rates of diabetes and related conditions. Their collective efforts made a significant difference.

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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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Vaccitech (NASDAQ: VACC) Gains Unprecedented Support—What’s Behind It?

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On September 25, 2023, Vaccitech (NASDAQ: VACC) experienced a jaw-dropping 90% surge in its stock price in just one day of trading. Now, this kind of jump usually happens when a company drops a major announcement or puts out a significant SEC filing. But, surprise, surprise—there was nothing of that sort this time .So naturally we did some digging, explored further online and guess what? Turns out retail traders were also not on a main reason for this rollercoaster ride. Curious to uncover what’s really behind this financial rollercoaster? Before we go any further, let’s get to know Vaccitech a bit better. There’s some pretty important aspects on the company you might like.

 

Background:

Vaccitech operates as a clinical-stage biopharmaceutical company, dedicated to discovering and developing innovative T cell immunotherapies. These therapies are crafted to leverage the immune system’s potency for treating conditions like chronic infectious diseases, cancer, and autoimmune disorders.

What sets Vaccitech apart is their distinctive, multi-platform approach, demonstrating the capacity to generate higher quantities of T cells compared to alternative technologies. This places Vaccitech in a unique position to cater to the needs of substantial, yet underserved patient populations. Their diverse clinical-stage pipeline includes potential treatments for severe diseases with limited available treatments, presenting significant public health risks.

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Among their lead product candidates are VTP-300, an immunotherapeutic designed to contribute to a potential functional cure for chronic hepatitis B viral (HBV) infection. Additionally, VTP-200 is a non-invasive, early-stage investigational treatment targeting persistent, high-risk human papillomavirus (HPV). VTP-850 stands out as a novel T cell investigational therapy aimed at prostate cancer, while VTP-1000, a preclinical T cell therapeutic candidate, focuses on reinstating immune tolerance in celiac disease.

Vaccitech possesses well-established expertise in drug development and scientific knowledge within the immunization realm. Notably, they co-developed a COVID-19 vaccine in collaboration with the University of Oxford. As many of you know, their vaccine has been successfully approved and holds an exclusive license worldwide with AstraZeneca.

What happened:

The one and only thing that happened today was Alliance Global Partners adding coverage of Vaccitech with a favourable buy recommendation.What’s truly eye-catching are the projections made, suggesting some pretty significant upside. The average one-year price target for Vaccitech is $12.24. Forecasts within this period have a bit of a spectrum, reaching from a low estimate of $7.07 to a high of $15.75. With that said, from today’s closing price that’s nearly 400% gain.

What’s The Big Deal?:

Alliance Global Partners giving the green light to cover Vaccitech is like a thumbs-up from a respected expert. It’s like a top-tier food critic saying, “This restaurant is a must-try.”

Think of it as Vaccitech stepping into the spotlight. It’s like a talented musician getting featured on a famous music blog—suddenly, more people start paying attention.

When a big player like Alliance Global Partners says, “Hey, this stock is a good buy,” it’s like a friend recommending a must-watch movie. You’re more likely to check it out based on that suggestion.

This kind of recommendation can also affect the stock price. It’s similar to when a popular influencer talks about a cool product—lots of people want to try it.

In a nutshell, this coverage is like a stamp of approval, making Vaccitech catch the attention of more potential investors and possibly giving the stock a boost. But it’s important to mention that just because a well established financial firm gives a price target, does not mean it’s accurate. In fact, tons of these projections are made daily with many being totally off the mark. Always do your own due diligence.

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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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BioPharma

Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

We will update you on ELUT 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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