Enzolytics Inc (OTCMKTS: ENZC) Coiled Tight Near 52 Week Lows as Biotech Looks to Disrupt Several Enormous Markets (ITV-1 for HIV, Monoclonal Antibodies & AI)
Enzolytics Inc (OTCMKTS: ENZC) is holding strong at support levels in the high $0.05’s as the overall markets have seen significant declines. ENZC was among the biggest runners of 2021 skyrocketing from well under a penny to highs of highs of 0.958 per share after it completed the historic merger between BioClonetics. The stock has an enormous investors following and shareholder base that will buy heavily on any breakout north. ENZC has been making big moves in monoclonal antibodies, a market currently worth $144 billion globally. One of the Company’s labs at the Texas A&M University Institute for Preclinical Studies lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious diseases, including SARS-CoV-2 and HIV-1. Enzolytics is also making moves in the booming Healthcare A.I. market expected to be 34 billion USD in 5 years. The Companies A.I. analysis, coupled with the ability to produce targeted monoclonal antibodies, allows Enzolytics to produce effective antibodies against multiple viruses, both human and animal.
The new biotech is getting noticed as its platform technology ITV-1 has shown strong antiviral properties against HIV. ITV-1 inhibits the infection of CD4 T-cells by HIV, reduces HIV viral loads and replaces or complements current anti-retroviral therapies. It is much less toxic then then any competitor therapeutic and is unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART). Tests have shown an 80.5% drop in viral loads in HIV and it raises CD4 T-cell counts to healthier levels, a 68% increase in CD4+T-lymphocytes and is associated with an increase in the CD4/CD8 index. Prior successful Clinical Trials were completed earlier under the Bulgarian Drug Agency requirements. The Company plans to complete further clinical trials to fulfill EMA requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America. ENZC engaged Scendea to assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA. Thereafter, CMC and GMP Requirements for FDA and EMA will be completed under the direction of Eurofin, followed by production of ITV-1 as per EMA and FDA requirements and Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements
Enzolytics Inc (OTCMKTS: ENZC) is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases. The Company is committed to creating drugs for the better health of mankind. ENZC’s flagship compound ITV-1 is a suspension of Inactivated Pepsin Fragment (IPF), which studies have shown is effective in the treatment of HIV. IPF is the active drug substance of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has been shown to modulate the immune system. IPF is a platform technology that can be used to facilitate a broad range of applications. It is free from major neurological, gastrointestinal and hematological side effects seen in the anti-retrovirals in use today. IPF has not shown to be subject to viral resistance and is cost effective.Incorporated under the laws of Delaware, ENZC currently has 2,830,435,953 shares outstanding out of 3,000,000,000 authorized, of the OS 483,789,585 are restricted. The Company has $3.1 million in assets vs. $7 million in liabilities.
ENZC continues to build its Intellectual Property portfolio. ITV-1 is covered by U.S. Patent Nos. 8,066,982 and 7,479,538. IPF Immune™ is covered by U.S. Patent No. 8,309,072. Fully human anti-HIV monoclonal antibodies and vaccines are covered by PCT Patent Application No. PCT/US/018672. Anti-Corona Virus monoclonal antibodies and vaccine covered by PCT Patent Application No. PCT/US/014916. The Company’s AI platform is covered by PCT Patent Application Nos. PCT/US/020682 and PCT/US/014936.
Microcapdaily has been reporting on the ENZC BioColnetics merger since the beginning stating in our article (BioClonetics LOI Sparks Enzolytics Inc (OTCMKTS: ENZC)) in September 2020, when ENZC was $0.003: “Enzolytics Inc (OTCMKTS: ENZC) is making a powerful move up the charts on a massive surge of volume after the Company announced the execution of a non-binding LOI to merge with BioClonetics Immunotherapeutics, Inc. a biotech company located in Dallas Texas. BioClonetics is in the final stage of development of a parent monoclonal antibody (“mAbs”) (designated as Clone 3), which is non-toxic and has shown in initial in vitro testing to be effective against more than 95% of all strains and viral subtypes of HIV-1 against which it has been tested. Final testing of BioClonetics’ anti-HIV recombinant mAbs in PBMC neutralization assays are being conducted to be followed by animal trials at the California National Primate Research Center, UCDavis (Davis, CA).
Enzolytics has quickly attracted a power house team behind it which speaks of big things to come here. They recently appointed Ronald Moss, M.D., to the Medical Advisory Board. Mr. Moss has been an executive with numerous biotech’s over the past 25 years. He has extensive clinical and regulatory management expertise in guiding programs through Phase I, II, and III clinical trials, including IND and NDA experience. The Company is led by patent attorney, Charles S. Cotropia who has litigated hundreds of cases over the years in the areas of patents, trademarks, trade dress, unfair competition and copyrights. His brother, Dr. Joseph Cotropia leads the Company’s research at the Texas A&M University Institute for Preclinical Studies. The Company’s COO Dr. Chandra is a dynamic leader with proven ability to build high performance teams and organizations who has spent years in academic/clinical research and has experience with clinical trials and medical devices. He consults for and speaks to companies, governments, and hospitals around the world.Enzolytics Chief Science Officer, Mr. Henry Zhabilov has managed several clinical trials utilizing therapeutic proteins. He is the inventor of several U.S. patents related to the immunotherapy of HIV and cancer and an immune enhancer based on the company’s IPF platform. Also, more recently, ENZC added Dr. Suraj Kumar Saggar and Dr. Lachezar Bogomilov Ivanov to its Advisory Board.
Enzolytics’ primary U.S. lab at the Texas A&M University Institute for Preclinical Studies is led by Dr. Joseph Cotropia who is assisted by multiple scientists. The lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious diseases, including SARS-CoV-2 and HIV-1. In the initial process step, AI is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics’ proprietary A.I. platform sequencing over 2 million Coronavirus isolates have been analyzed. Using 3 Dimensional models of these conserved targets, Enzolytics’ scientists produce multiple broadly neutralizing antibodies. The antibodies are produced from human “immune-B cells”, obtained from convalescent individuals who have recovered from the target virus. The team then produces broadly neutralizing antibodies using three techniques: 1) Hybridomas, 2) Fluorescent Antibody Cell Sorting (FACS) technology, and 3) Phage Display technique.
The process begins by creating the target epitopes that have been identified using A.I. as sites that are fully conserved across millions of epitopes of the targeted virus. Then, the antibody creation process begins with millions of cells that are processed to identify a single cell line that produces a single monoclonal antibody. Once produced, the monoclonal antibodies are then tested for binding activity and neutralizing activity. These characteristics are confirmed, by the Company’s partnering laboratories, Genscript Labs and the University of Strasbourg, France, respectively. After the final confirmation of antibody activity, the Company’s CDMO partner Samsung Biologics produces the recombinant antibodies in their proprietary, FDA approved stable CHO cell line suitable for Clinical Application.
Enzolytics’s Dallas laboratory is managed by Harry Zhabilov, the Company’s CSO. From the Dallas laboratory, Mr. Zhabilov coordinates the development and the production of two of the Company’s primary therapeutics, ITV-1 and IPF Immune. Both therapeutics are produced under patents invented by Mr. Zhabilov, U.S. Patent Nos. 8,066,982, 7,479,538, and 8,309,072.
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ITV-1 is a therapeutic for treating individuals with HIV. It has been successfully produced and has been earlier successfully clinically tested in human trials under the Bulgarian Drug Agency requirements. The Company has also completed the production of IPF Immune™, a product shown to function effectively as an immune booster. Both ITV-1 and IPF are currently in production in accordance the precise methodology and specifications developed by Mr. Zhabilov. IPF Immune™ will now be available on the U.S. market. The Company is also planning to launch IFP Immune™ in Europe and Canada and already has distributorship contacts in Europe. ENZC plans to first deploy the therapeutic initially in countries in Africa including Rwanda, the Democratic Republic of Congo, Angola, Kenya and South Africa. Currently there are roughly 23.8 million HIV infected persons in Africa
ITV-1 inhibits the infection of CD4 T-cells by HIV, reduces HIV viral loads and replaces or complements current anti-retroviral therapies. It is much less toxic then then any competitor therapeutic and is unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART). Tests have shown an 80.5% drop in viral loads in HIV and it raises CD4 T-cell counts to healthier levels, a 68% increase in CD4+T-lymphocytes and is associated with an increase in the CD4/CD8 index. ITV-1 has shown good compatibility with other anti-retroviral drugs, with no side effects.
Prior successful Clinical Trials were completed earlier under the Bulgarian Drug Agency requirements. The Company plans to complete further clinical trials to fulfill EMA requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America.
ENZC engaged Scendeato assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA. Scendea is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. In the approval process, Scendea’s critical role is finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy.
Thereafter, CMC and GMP Requirements for FDA and EMA will be completed under the direction of Eurofin, followed by production of ITV-1 as per EMA and FDA requirements and Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements
Enzolytics’s IPF Immune™ is a science-backed immune modulator that helps strengthen the body’s defenses against viruses or other pathogens. The product works as an immune booster that increases the ability of the immune system to fight infections by stimulating antiviral activity and helping to increase cell defense. The product supports the body’s immune system thereby enhancing recovery and reducing the recovery period after an illness. The introduction of this product onto the U.S. market is described in detail in the Newswire release of January 5, 2022, and in the Company Press Release of April 11, 2022. The Company is also planning to launch IFP Immune™ in Europe and Canada. The Company has distributorship contacts in Europe and sees tremendous added potential from foreign sales. This product enters the market as sales of American Dietary Supplements in North American reach $50.11 Billion.
The Artificial Intelligence platform is being built under the leadership of Dr. Gaurav Chandra. The Healthcare A.I. market is expected to be 34 billion USD in 5 years. Enzolytics A.I. platform is unique because it has been driving the Company’s discoveries and Drug development. A.I. has helped Enzolytics move beyond big pharma’s monoclonal antibody discovery and development. As a result, Enzolytics continues to forge ahead with the immediate strategy to identify novel biomarkers and therapeutic targets, design innovative diagnostic and prognostics tests, and expand the Company’s Patent portfolio. Enzolytics’ long-term plan is to be a serious contender in the personalized medicine market.
AIDS is considered to be one of the most serious and chronic diseases, caused by the human immunodeficiency virus (HIV). According to (WHO), an estimated 34 million individuals are currently living with the HIV virus. The virus and its disease are treated by administering antiretroviral (ARV) drugs that do not cure and must be taken for life. The global HIV antiretroviral drugs market was $30.46 Billion in 2021 and is expected to rise to $45.58 billion in 2028, at a CAGR of 5.9% in the forecast period, 2021-2028.
ENZC is holding strong at support levels in the high $0.05’s as the overall markets have seen significant declines. ENZC is a major league runner and powerhouse stock and was among the biggest runners of 2021 skyrocketing from well under a penny to highs of highs of 0.958 per share after it completed the historic merger between BioClonetics. ENZC is an exciting story developing in small caps; ENZC platform technology ITV-1 has shown strong antiviral properties against HIV, and could be a disruptor in this enormous multi-billion-dollar market. ENZC has also been making big moves in monoclonal antibodies, a market currently worth $144 billion globally as well as in Healthcare A.I. another booming market. ENZC is one biotech that investors are watching carefully, trading just over 52-week lows of $0.0531 the stock has runner in its blood with a gap to fill to $0.958 and could go parabolic at any time.We will be updating on ENZC when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ENZC.
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Disclosure: we hold no position in ENZC either long or short and we have not been compensated for this article.
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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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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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.