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Todos Medical (TOMDF) & CYDY are Two Biotech Plays to Watch Monday After the Merck Expose

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Todos Medical (OTCMKTS: TOMDF) and CytoDyn Inc. (OTCMKTS: CYDY) might be looking at a pretty good week ahead of them.  in a recent article there were a lot of comments about leronlimab and Tollovir.  In the article it broke down the mechanism of action of Molnupiravir which was the top headline on Friday which almost single handedly moved the market higher.  The sell off in both CYDY and TOMDF was probably attributable to the investor rationalization that now a magic bullet exists to treat COVID-19 early; it was therefore time to trim Covid therapeutics because they won’t be necessary.  Over the weekend it’s become clear that Molnupiravir is no savior let alone a magic bullet and the road to approval is still a rocky one given the campaign to continue vaccinations. It also became clearer that both leronlimab and Tollovir might really have a better solution than a vaccine for the entire spectrum of disease.   

Merck (NYSE: MRK) is expected to be under pressure Monday as the euphoria starts to wear off and reporters start to dig and ask questions. Likewise vaccine stocks like Moderna (NASDAQ: MRNA), Pfizer (NYSE: PFE), BioNTech (NASDAQ: BNTX), Johnson & Johnson (NYSE: JNJ), Vir Technology (NYSE: VIR), and Novamax (NASDAQ:NVAX) are expected to rebound. The key points that were uncovered is that Molnupiravir is for a very limited population of patients.  It’s not for the masses, but that is precisely what investors assumed when the news broke.  Many failed to read the fine print that the drug was for unvaccinated people which happens to be a shrinking demographic and people with at least one underlying condition. Other antivirals like Pfizer’s oral antiviral are designing the same sort of clinical trial of exclusion.    

The article got over 35K hits at the time of writing, and was the top contributor article for 2 days running.  Many people got to see that Merck’s drug has a serious issue of mutagenicity.  It’s not a good idea to take Molnupiravir if you are pregnant or a man having sexual intercourse.  This point was clearly for shock value because who in their right mind would be having sexual intercourse while they have COVID-19.  The rest of the content was on point.  There are two biotechs that seem to be able to treat the entire spectrum of disease so this paired trade of CYDY and TOMDF is a good investment thesis if you believe the vaccination only strategy is flawed and that therapeutics will play an important role in getting out of the pandemic.  

There are still a lot of risks with these two names.  CytoDyn has been under pressure due to a group of disgruntled investors called the 13-D that want to displace management and of course the shorts tolling the InvestorsHub message board.  There is a key hearing on October 6th that will determine whether or not the company has to accept the ballot of the 13-D proxy group. CYDY appears to be in a commanding position because of course they are the incumbent but because they also got the 13-D group to admit they didn’t follow the rules and misled investors.  This one looks like an easy call for those investors that want to put on their lawyers hat.  “Your honor I broke the rules but I’m looking out for shareholders best interests now, not my own” will be the argument of the 13-D group.  Then the company will say 13-D broke the rules, and should they choose to follow the rules in the future they can apply again next year.  There have been many missed deadlines like the BLA filing and the Breakthrough Therapy Designation (BTD), by management that have been taxing investor patience.  Should any of CytoDyn’s initiatives like the Philippines or robust enrollment in the Brazil trial come to pass the stock is due for a mega rally.

Todos has been under a lot of structural pressure.  There was a large institutional seller that exited and was putting a cap on the stock price.  There was a financing and lockup agreement put in place last week that did not achieve much fanfare for the above market price of $.0599, but the large offers on TOMDF did disappear which means the softness in price is due to retail investor fatigue or the Molnupiravir news instead of actual dilution. Should this publicity over the weekend get some traction Monday AM TOMDF could be in for an epic run because as a COVID-10 play they are the only company that has an antiviral for the people now.  The ZeroHedge article broke the news that the drug in development is for all intents and purposes the same as the nutraceutical that can be purchased at www.mytollovid.com.  The company is also due to give some guidance on their clinical trial. TOMDF has also been in the news.  Their CEO, Gerald Commissiong has been dubbed an expert with quite a few recent interviews that include FOX Business, and might be called up to opine on Molnupiravir.   

On a technical basis both stocks are ripe for a rebound.  The 20 day moving average on TOMDF held and saw a nice bounce.  Then CYDY retraced 32% off the high which means it too is ripe to bounce.  With no pressure on the financing side in either of these stocks a good retail push could ignite a short covering rally for the short betting on the end of Covid.  It’s very reasonable that news to capture all the eyeballs on this story will come Monday.  

Besides these well known names other small cap companies working on COVID-19 may finally start to find some bids.  Next to CYDY Ampio Pharmaceuticals (NASDAQ: AMPE) has one of the most promising drugs to treat the Cytokine Storm. In their Phase 1 study they showed a 78% reduction in mortality over the standard of care.  They are currently in the process of initiating a Phase 2 trial of inhaled Ampion in critical COVID-19 patients. Organicel Regnerative Medicine (OTCMKTS: BPSR) is using its Zofin to treat Long Haulers and is shortly expected to unveil its clinical trial. First Wave BioPharma (NASDAQ: FWBI) is screening for its Phase 2b using Niclosamide to treat gastrointestinal issues that result from a concentration of the COVID-19 virus in the gut. It is expected to announce additional sites and any tweaks to the protocol. This stock is very oversold after a botched press release headline that grossly overstated the cost of acquiring their primary asset. Another stock in a strong downtrend with a slight uptick at support is Therapeutic Solutions International (OTCMKTS: TSOI).  They have a nutraceutical that helps modulate the Natural Killer cells through the release of IL-2          

Both CYDY and TOMDF look like they will be part of the therapeutic conversation that is rising to the surface after a deafening message over the past 6 months that only vaccination can save us and that this is a “pandemic of the unvaccinated.”  Washington State’s Surveillance Report health data used to show breakthrough infections as a percentage of the vaccinated and it is no longer being tracked for fear that it will send the wrong message.  This censorship has not gone unnoticed and the media is starting to report on it and asking tougher questions like Sara Eisen at CNBC. This groundswell movement for therapeutics could usher in a new renaissance in therapeutics. There is tremendous opportunity to get back into COVID-19 therapeutics. We will be updating on CYDY and TOMDF so make sure you Subscribe to Microcapdaily so you know what’s going on with with both.        

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.

We will update you on VACC 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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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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