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Top Covid Stocks In Play After Pfizer Vaccine Approval: TOMDF ENZC TSOI

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With the FDA approval of the Pfizer-BioNTech vaccination many biotech stocks moved higher.  Leading the microcaps was Todos Medical (OTCMKTS: TOMDF).  Shares of leading vaccines makers Pfizer (NYSE: PFE), BioNTech (NASDAQ: BNTX), and Moderna (NASDAQ: MRNA) moved higher on the news due to anticipation of future approvals. The White House immediately took advantage of this approval to pitch the vaccine after hours in a press conference with President Biden claiming that COVID-19 was now a pandemic of the unvaccinated.  President biden said

“Those who have been waiting for full approval should go get your shot now.” – Pres Biden

All this attention on vaccines trickled down to some promising therapeutics drug developers. One of the most interesting plays of the day was COVID-19 diagnostics and pharmaceutical maker Todos Medical (OTMKTS: TOMDF) which surged on record volume of 74 million shares and ended the day up a whopping 103%. Before the market opened the company announced that their lab in Georgia had a fully validated neutralizing antibody test called cPass which can help in quantifying a person’s current level of immunity to the Delta Variant. Their cPass test has an EUA and their lab is the only fully automated lab which can do up to 1500 tests daily.  However, what really moved the stock was an interview on FOX Business with Stuart Varney.

Volume before the interview was a brisk 10 million but shortly after the interview volume started surging.  Investors appeared to connect the dots that the recent debate over the policy to administer the booster shots was coming under heavy fire and testing may be the saving grace.  The Biden administration is trying to walk a fine line between encouraging new people to get a shot and protecting those who were vaccinated from the delta variant.  They also unleashed a new program to make booster shots widely available to those who reach the 8 month mark.  In the interview the CEO of Todos Medical let out a bombshell that studies in Israel where the Delta Variant already surged found out the immunity from the virus wanes after 6 months and that there is potentially this 2 month window where people may be lacking protection. The debate on boosters was further complicated by a WHO announcement recommending a delay on boosters to prioritize under-vaccinated countries.  

What is clear is that testing is making its way into the narrative and since TOMDF appears to be the largest lab with neutralizing antibody tests they would be the direct recipient.  Speculation seems to be brewing that since cPass is the only EUA approved test capable of medically determining if a booster is appropriate the Biden Administration may have to compromise.  This means that booster shots may only be allowed with a cPass test that confirms the need.  This could be a game changer for the diagnostics company.  

Provista Diagnostics is the name of the testing company, and it is a subsidiary of Todos Medical.  In their latest press release, Provista indicated that they have the capability to do up to 20,000 PCR tests daily which equates to $2 million in sales daily or $60 million monthly.  With respect to the cPass Neutralizing Antibody test it appears that they can do up to $3.6 million in sales monthly.  Investors need to keep in mind these estimates assume maximum utilization.  The company closed the day with a market cap of approximately $25 million which represents about 10% of its fair value using comparable drugs.       

Todos has a diagnostics business that is slated to do $50 million in revenues this year and the stock barely trades at a multiple of projected sales including the massive bump today.  Todos also has joint venture agreement with NLC Pharma for Tollovir which is a phase 2/3 oral antiviral which by many estimates would be valued in the range of $250 – $400 million.  Last year Roche Holdings (OTCMKTS: RHHBY) licensed the ex-US rights of Atea Pharmaceuticals (NASDAQ: AVIR) for an oral antiviral for $350 million. The value gap on the pharmaceutical side is enormous.  

If investors are curious about the reason for the massive valuation gap that currently exists, it can be traced back to a restructuring done in January 2021.  The company consolidated legacy convertible notes into one primary holder who has been trickling out his investment over the past 6 months.  These stock sales have been weighing heavily on the shares, but the price action today indicates that he has finished his conversion.  The stock is back up to the price point where their strategic South Korean investor Yozma Global Genomic Fund put in a sizable investment in January and April 2021.  Both investments were at $.06 and represented a premium to the market price at the time.    

While TOMDF is more of a pure play in COVID-19 Enzolytics (OTCMKTS: ENZC) is more of a focused play in HIV with exposure to COVID-19 as a potential label expansion in the future should they get their HIV drug approved.  Most of the excitement surround ENZC is coming from an initiation of their HIV trials.  One of the things that makes their drug ITV-1 stand out from the pack is the drugs safety profile. ITV-1 is really a form of immunotherapy that strengthens the immune system.  Most of the HIV drugs are part of the Highly Active Antiretroviral Therapy (HAART) which does its best to use chemotherapy in multiple ways to disrupt the proliferation of the HIV virus.  The point to make is all the drug has to do is keep the viral load at bay and the safety profile will be what drives the approval process forward.       

There are some major catalysts that have impacted ENZC.  The letter of intent with Creative Biolabs to license anti-HTLV-1 was a major step forward in advancing the clinical trials by completing the commercial manufacturing of the drug.  ENZC was able to leverage the financial balance sheet of Creative Biolabs in order to get the production manufacturing ready for sale. In addition, the LOI provided for Artificial Intelligence to screen for conserved sites on the virus and potentially use them in the development of a compound. They have identified these conserved targets for HIV, COVID-19, HTLV-1, Influenza-A, Influenza-B, H1N1 influenza, Herpes Zoster, and many more.   

The value proposition of ENZC can be found in its platform technology which has the capability to produce monoclonal antibodies that can target the conserved regions of various viruses.  According to their last press release they have a partner willing to fund the initial round of production.  Clinical trials in HIV are due to start shortly in the European Union.  The key

The market cap is $357 million and there are 2.8 billion outstanding shares out of 3.0 billion authorized.  The potential dilution at this point is minimal which means the stock could run if a small amount buying hits the tape.    

Therapeutic Solutions International (OTCMKTS: TSOI) has been on a tear after the FDA gave it the go ahead to start its pivotal Phase 3 trial for COVID-associated lung failure using its JadiCell universal donor stem cell treatment.  Since that kickoff announcement it has been a news bonanza that keeps building on the story.  They are also planning on filing an EUA which is a very bold initiative given the past failures of other COVID-19 companies like CytoDyn Inc. (OTCMKTS: CYDY) which appears to have a drug that works but was denied due to their lack of data.  The treatment is called Jadi Cell and they had excellent clinical trial data supporting their EUA application.  In a randomized controlled clinical trial the JadiCell treatment showed 100% effectiveness in saving COVID-19 ICU patients under age 85. This was the rationale for the application.

The story continued to build with the all encompassing Mechanism of Action (MOA).  At the heart of the MOA are the CD73 expressing T-Cells.  They were able to show that a small dose of IL-2 had a noticeable effect in expanding the class of this type of cell. Many stem cell therapies have been struggling for years to overcome the body’s natural suppressor function and the stem cell desire to differentiate quickly.  Donor stem cells simply don’t last long in the body due to suppression so by expanding the colony of stem cells it allowed for a durable response in these studies.  

The company has a market cap of $270 million with 3.5 billion authorized shares.  There are 2.2 billion shares issued and outstanding.  The company made a statement in a blog post that dilution was something that they were going to try to avoid by going after government funding.  Sticking to this mindset could allow the stock to continue its run higher unimpeded.  

Investment Summary

The rising tide in COVID is managing to lift many COVID stocks.  These focus stocks have tremendous potential to outperform the rest of the market.  At the core of their story is a platform technology.  When looking at biotech investments it is essential that the underlying science that underpins the company is sound.  Having this fundamental element in place derisks the stock in the long run.  These biotech runners are set to scale new heights so make a place in your portfolio for them.   Investors should pay special attention to TOMDF because that stock was depressed due to structural reasons and NOW it’s poised for an epic run with a short term target price of $.34 which represents a $250 million market cap now that the overhang of the seller is gone. 

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

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4 Comments

4 Comments

  1. George Luniv

    August 24, 2021 at 11:24 am

    For those stuck of scientific validity of what you read. It is daunting at times to make a decision whether to by or not. Myself, I learned the science, to help me in making the correct decision. I recommend making time in our schedules to financially benefit you in the long run, with a deep peace of mind knowing the results and the superiority of a product will catch up to the narrative. Just like in the discovery that the current x-19 vaccines’ effect only lasted 6 months, not 8 months and this 2 month gap actually corresponds to the number of vaccinated people becoming I’ll again. I myself was wondering if the vaccine could be causing the mutated Delta strain within the vaccinated people, as opposed to the unvaccinated becoming infected. Now with the knowledge and scientific proof from being able to MEASURE the amount of antibodies inside us, and comparing it against the data of vaccinated people at varying times from the date of their vaccination on a monthly basis, a biological truth was discovered that invalidated a previously know fact which has led to an increase in DELTA infections, straining hospital and medical resources. This discovery is not momentary, but will remain a FACT OF NATURE, perpetually, allowing mankind to get a grip on deadly viruses around the world.. thanks for reading this far. . It will improve your life in more ways than one. Hosea 4:6 !

  2. FranNeo

    August 25, 2021 at 5:05 pm

    The Covid shots will turn us into Gods enemies like unto those that hate Him. The fear of the Lord is the beginning of wisdom.! Is the
    Very first lesson we need to learn as custodians of the vessels of God.

  3. Jim Johnson

    August 26, 2021 at 10:20 am

    Let people get the vaccine if they want it but don’t force it on anyone. Same with masks if you want to wear one go ahead but respect those that don’t want to wear one. Live and let live, if you don’t want to be around ppl not wearing masks avoid sporting events and keep your distance when you see someone not wearing one. But don’t force anyone to wear a mask and there is little evidence that masks stop the spread of covid among children anyway. Anything that fauci says is highly suspect and probably false.

  4. lussie kanye

    September 18, 2021 at 11:21 pm

    If getting herpes cure was that easy then why do people still suffer from herpes? I was diagnosed of herpes back in 2014 and i was also told it has no cure,I have been leaving with it since then, but i kept praying and doing everything possible to get cured, so i never stop doing research about finding a cure,I came across testimonies about people getting cured through herbal medication and i have always believe in herbs and its medical properties, after doing so many research about it i found DRASHAOSEMUDIAMEN and I discovered he was a professional in herbal medication and he has also helped many people,I contacted him through his mail: DRASHAOSEMUDIAMEN@GMAIL. COM, and +2349135214547 we talked on phone and i confirmed he was genuine,I did all what he told me to do, i received the medicine,use it as he prescribed,and glory be to God almighty i am completely cured, i went back to my doctor to confirm it. do not be deceived THERE IS A CURE FOR HERPES. He is also good at saving you from any kind of diseases like Herpes. HIV/aids.Gonorrhea.Cardiac problem.cold sore.Hpv cure.Cancer.Watering sperm.Womb fertilization.Penis erection.Witch craft attack.S T D diseases.Internal heat Rashes.Fibroid.Low sperm count.Dairy.long sickness.I promise I will always testify for your good work.you can contact the doctor on email drashaosemudiamen@gmail. com or whatsapp +2349135214547.
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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.

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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

ZyVersa Therapeutics’ (NASDAQ: ZVSA) Breakthrough: A Super Tool for Tackling Inflammation in ALS and Beyond

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ZyVersa Therapeutics (NASDAQ: ZVSA) had a spectacular day on the market, with its stock surging by almost 50% following a significant announcement about one of their promising drug candidates, IC-100. This drug is designed to combat inflammation in the context of Inflammatory Diseases, and the latest data is incredibly promising. For those who are new to this field of investment, we’ve taken the liberty of rephrasing the press release in simpler terms.

The Release:

When you’re dealing with diseases like ALS that affect your brain and nerves, shutting down the inflammasome pathway NLRP3 (a multi-protein that regulates the immune system and inflammatory signaling), is not enough.

To address this, ZyVersa is working on something called Inflammasome ASC Inhibitor IC-100. It’s like a super tool designed to block not just NLRP3 but a bunch of other inflammasome pathways too – up to 12 of them. This helps keep inflammation in check, whether it’s in the central nervous system (CNS) or other parts of the body where inflammation is causing problems.

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In a recent paper published in Frontiers in Immunology, they pointed out that focusing only on NLRP3 might not do the trick when it comes to calming CNS inflammation in ALS and similar diseases. They did experiments with cells and even used mice to back up their point. Turns out, just targeting NLRP3 didn’t stop the release of those pesky proinflammatory chemicals or the damage they were causing in the spinal cord.

The authors of the paper basically said, “Maybe we should aim to tackle multiple inflammasome pathways when it comes to diseases like ALS, where lots of inflammasomes are going haywire.”

The CEO and president at ZyVersa, Stephen C. Glover mentioned “Our research shows that to really put the brakes on inflammation driven by multiple inflammasomes, we need more than just NLRP3 inhibition.” He added that IC-100 is like a superhero in the world of inflammation control. It stops the formation of different types of inflammasomes, preventing the start of the inflammation chain reaction, and also puts a halt to something called ASC specks, which keep the inflammation going. You can dive deeper into how IC 100 works by checking out their website here.

So, in plain speak, ZyVersa is cooking up a promising solution for folks dealing with inflammation-related problems, especially those tied to the brain and nerves. They’re not just focusing on one troublemaker; they’re going after a whole gang to keep things under control.

Overall ZyVersa is a company on a mission to create groundbreaking treatments for kidney and inflammatory diseases, and IC-100 could help them in this mission.

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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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Creative Medical Technology NASDAQ: CELZ) Major Breakthrough: Allogeneic Cell Line Paves the Way for Diabetes Treatment

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Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has recently seen a substantial intraday gain of over 15% in its share price. Despite the absence of any recent news or filings, this surge could suggest significant progress in the realm of allogeneic cell therapy.

Background:

The company is known for its regenerative approaches in various medical areas, including immunotherapy, endocrinology, urology, gynecology, and orthopedics, and made a significant announcement. In the fourth quarter of 2022,They successfully developed a new allogeneic cell line called AlloStem™. AlloStem™ is derived from human perinatal tissue and includes a Master Cell Bank and a Drug Master File. Now, with FDA approval, their program, known as CELZ-201, is being used in an early clinical trial for type 1 diabetes and will continue to be developed for both type 1 and type 2 diabetes treatment.

Additionally, the company is using the AlloStem™ line for its StemSpine® procedure to help treat chronic back pain. They report remarkable results, including over a 90% reduction in narcotic usage, more than an 80% reduction in pain scores, and over a 50% reduction in the Oswestry score in patients treated with AlloStem™.

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Allogeneic Cell Therapy:

Allogeneic Cell Therapy is a treatment that uses cells from healthy donors to treat patients with otherwise untreatable diseases. These cells can come from various sources, like bone marrow, blood, or umbilical cord blood. This approach shows great promise in the medical field.

Allogeneic cell therapy offers potentially curative options for patients when traditional treatments fall short. While still a relatively new field, ongoing research into allogeneic cell therapies holds great potential for patients suffering from these diseases. Companies like Argan Inc. are also exploring the benefits of allogeneic cells.

With FDA approval and ongoing clinical trials, Creative Medical Technology’s recent developments open doors to innovative treatments that could significantly enhance the lives of those dealing with diabetes and other diseases. The global market for allogeneic cell therapy reached $255.6 million in 2022 and is expected to grow at a rate of 27.4% from 2023 to 2030, emphasizing the importance of continued research. As the company remains dedicated to medical innovation, their efforts have the potential to improve the health outcomes of people worldwide.

Latest Release:

The company recently shared key updates on its financial status and drug pipeline for Q3 2023. The biotech company, known for its regenerative medical solutions, reported being debt-free with $14.6 million in cash and $14.4 million in working capital, sufficient to cover expenses through 2024.

Their advancements in treating type 1 diabetes include FDA clearance for a groundbreaking clinical trial using CELZ-201 (AlloStem™). The company obtained Institutional Review Board approval and partnered with Syneos Health for this study. They also filed for Orphan Drug Designation to tackle brittle type 1 diabetes.

Promising results emerged from the CELZ-001 treatment for type 2 diabetes, demonstrating substantial reductions in insulin requirements with no safety concerns.

A pilot study on the StemSpine® procedure, using donor cells (AlloStem), showed impressive reductions in narcotic usage, pain scores, and improved functionality for chronic lower back pain patients.

Creative Medical Technology’s ImmCelz platform proved efficient, requiring fewer donor cells and yielding high-quality results.

They also collaborated with Greenstone Biosciences Inc. to develop a human-induced pluripotent stem cell (iPSC) pipeline, iPScelzTM, aimed at expediting drug discovery. The development of this cell line is expected to save the company two to three years in research and development time, along with associated expenses. Additionally, it will accelerate its drug discovery program by leveraging artificial intelligence.

We will update you on CELZ 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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