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Saturday, May 28, 2022

Enzolytics Inc (OTCMKTS: ENZC) Major Reversal Brewing as Biotech Gains Traction in HIV Market (Update on: ITV-1 EMA Approval, ITV-1, anti-HIV Treatment & IPF Immune US Launch)

Enzolytics Inc (OTCMKTS: ENZC) is easily one of the most exciting stocks currently trading on the OTCQB; trading 3 tenths of a penny over 52-week lows of $0.054 the stock skyrocketed to highs of $0.958 per share in February 2021 and it still boasts a massive following of investors accumulating at current levels who believe this one is going back to where it ran to last summer. ENZC is “pink current” fully compliant and looking to uplist to sec filing OTCQB. While the stock has gotten cheaper the underlying Company has been busier than ever; since our last report on ENZC in January the Company has added Dr. Suraj Kumar Saggar to its Advisory Board, entered the booming $68 billion diagnostics market with its patent application covering identification of antigens and epitopes of SARS-CoV-2 that can be used in vaccines and to produce antibodies. They launched IPF Immune™, its immune modulator into US markets initially at the ECRM’s Weight Management, Nutrition, and Vitamin Convention and ENZC wholly-owned subsidiary Virogentics has made significant progress toward the production and use of its ITV-1, anti-HIV immunotherapy treatment in the Central and Eastern regions of Africa for patients with HIV/AIDS. When ENZC runs it runs hard and once a major reversal is initiated here, the upside will be fast and furious. 

Microcapdaily has reported on ENZC many times before, we were one of the first on the scene back on September16, 2020 when ENZC started taking off after closing at $0.0009 on September 15 with our article: BioClonetics LOI Sparks Enzolytics Inc (OTCMKTS: ENZC) 9/16/2020 long before ENZC went on a serious tear and rocketed up over $0.90 per share in the early months of 2021.We have reported on the initial merger with BioClonetics on to their work at UCLA and with HIV and Covid. Enzolytics flagship compound ITV-1, is a patented ITV-1 (Immune Therapeutic Vaccine-1) a suspension of Inactivated Pepsin Fraction (IPF), which boosts the immune system controlling HIV/AIDS according to recent studies. Enzolytics is in the process of taking its ITV-1 anti-HIV therapeutic to clinical trials and distribution throughout Europe. The Company’s ITV-1 anti-HIV therapeutic earlier progressed toward certification under the Bulgarian Drug Agency (BDA) but that process was interrupted before completion. However, in that process, significant positive clinical trial results in patients were documented. These positive results give the Company total confidence that the now planned clinical trials under the European Medicines Agency (EMA) will likewise be successful. Recently the Company brought on Scendea USA, Inc. a leading international product development and regulatory consulting group, to advance its anti-HIV therapeutic ITV-1 to production, clinical trials and market approval under both the European Medicines Act (EMA) and the U.S. FDA regulatory process. ENZC could become a major player in the enormous $30 billion annual HIV market expected to reach $37 billion in the next 5 years. In a market primarily controlled by Gilead who sold $17 billion in HIV drugs last year Enzolytic’s HIV treatment is immunotherapy, not chemotherapy. One of the things that makes Enzolytic’s  ITV-1 stand out from the pack is its 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.  

Enzolytics Inc (OTCMKTS: ENZC) is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. ITV-1 has also been shown to modulate the immune system.  

The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology, covered in its pending U.S. Patent Application for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the CoronaVirus (SARS-CoV-2) and HTLV-1. ENZC has partnered with Intel to publish a white paper titled, “Optimizing Empathetic A.I. to Cure Deadly Diseases,” highlighting Intel’s Artificial Intelligence Analytic tools and Enzolytic’s innovative approach and groundbreaking contributions to create universal, durable, and broadly effective treatment targeting all virus variants. This collaborative effort approaches the future of medicine; a future wherein the process of healthcare evolves from reactive to anticipatory, as exemplified by P4 Medicine. 

Enzolytics has a great management team behind it which speaks of big things to come here. The Company is led by majority shareholder and CEO Charles S. Cotropia, a well-known intellectual property attorney who has litigated over 200 patents in his career and served as lead counsel in several landmark patent disputes litigated in Federal Courts and the US Patent and Trademark Office 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’s 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. ENZC also just added Dr. Suraj Kumar Saggar to its Advisory Board,  

ENZC has been busy since we last reported on them in January; they announced plans for entry into the diagnostics market and filed a comprehensive U.S. and foreign Patent Cooperation Treaty (PCT) Patent Application covering its invention of a novel, innovative technology for identification of highly conserved antigens and epitopes of SARS-CoV-2 that can be used in vaccines and to produce antibodies. The patent also covers the discovery of using these identified antigens and epitopes as targets for detecting and diagnosing SARS-CoV-2 infection. 

The Company’s Artificial Intelligence platform has been used to build 3D Models of the conserved targets. The analysis of the SARS-CoV-2 spike protein revealed that all epitopes identified by the Company are linear on the spike proteins, accessible by antibodies, neutralizable, and unaffected by mutations. Enzolytics is developing tests that diagnose SARS-CoV-2 based on the presence of the conserved sites that remain unaffected by mutations.  

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Using its Artificial Intelligence technology, all the conserved sites identified by the Company have remained present in all of the variants of concern and variants of interest. Enzolytics is currently working with diagnostic companies with track records for taking this technology and the tests produced under it through regulatory approval, leading to patient use. The global in-vitro diagnostics market was valued at approximately U.S. $68.41 Billion in 2020. The market value is expected to increase to U.S. $91.25 Billion in revenue in 2026, with a CAGR of 4. 90% over the forecast period. 

In March ENZC reported IPF Immune™, its immune modulator, is hitting US markets; it was initially introduced by the Company’s representative Nutritional Products International (https://nutricompany.com/) to large and small retailers at the ECRM’s Weight Management, Nutrition, and Vitamin Convention. IPF Immune™ is a liquid nutritional supplement that acts an immune modulator to benefit the immune system by fortifying it against infections.  

The active components in the supplement have been registered with the FDA for use in the U.S. under NDI reg. no. 1083. The product is produced and sold by the Company pursuant to U.S. Patent No. 8,309,072. The Company’s ‘072 Patent, entitled “Irreversibly-Inactivated Pepsinogen Fragments for Modulating Immune Function”, covers the use of Irreversibly Inactivated Pepsin Fragments (IPF) which has been shown in tests to perform an immune modulating function. In tests, this therapeutic has demonstrated significant beneficial effects for various diseases, whether used alone or as a concomitant therapy, by bolstering the immune system. The North American dietary supplements market size is large, valued at over $50 Billion in 2020. 

The Company’s wholly-owned subsidiary Virogentics, Inc. recently announced its progress toward the production and use of its ITV-1, anti-HIV immunotherapy treatment in the Central and Eastern regions of Africa for patients with HIV/AIDS. Toxicology, pharmacodynamic and pharmacokinetic studies (toxicology studies) of the immunotherapy are planned, a prerequisite to use of the immunotherapy in certain African countries. These toxicology studies will also be used in the Company’s progress toward clinical trials necessary for EMA approval.  

The ITV-1 therapeutic has succeeded in clinical trials earlier and the Company is planning additional trials leading to EMA approval. As that approval is underway, the ITV-1 therapeutic will be provided to the Central and Eastern regions of Africa once toxicology studies are completed. The only therapy for treating infected patients is antirational (ARV) drugs, but these drugs are not available to 27% of those infected. The ARV therapy Biktarvy produced by Gilead costs $42,635 per year. The global HIV market is estimated to be over $30 billion this year and is expected to grow to over $36 billion globally by 2027. 

On March 25 ENZC reported on its PCT patent application covering discovered target epitopes on the SARS-CoV-2 and HIV viruses. In submissions under the Patent Cooperation Treaty (PCT), Enzolytics, Inc. has pending international patent applications covering the use of any of its discovered numerous conserved Coronavirus epitopes or conserved HIV epitopes in the production of monoclonal antibodies, the production of vaccines or use in diagnostic tests for detecting the viruses in patients.  

By using computer analysis (AI), the Company has analyzed over 2 million different isolates of the Coronavirus. From that analysis, the Company identified 19 conserved, immutable sites (epitopes) on the virus. The 19 conserved sequences identified on the isolates analyzed have been identified on the basis that they are 98.71% to 99.29% conserved over the entirety of the over 2 million Coronavirus isolates which have been analyzed by the Company using AI. Additionally, the Company has analyzed over 100,000 HIV isolates using AI and has identified 9 conserved sites, some with over 98% conserved sequences. 

In its PCT Patent Applications, the Company has claimed its discoveries including the use of these identified conserved epitopes for (1) producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus, (2) producing a vaccine against HIV or the CoronaVirus, or (3) for use in any diagnostics to identify whether a person has HIV or the CoronaVirus.  

Charles Cotropia, the Company CEO, said: “The breadth of patent coverage that is sought and expected is extremely far-reaching based on the discovery of the critical target epitope sites necessary to effectively neutralize these viruses. The Company has also identified conserved epitopes using its AI platform on multiple other viruses, including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). These findings will also be protected by patent coverage.” 

https://twitter.com/PoetsAndKings21/status/1517080413319139329

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Currently trading at a $162 million market valuation ENZC has 2,830,435,953 shares outstanding of which 483,789,585 are restricted. For a biotech, the most explosive sector in small caps ENZC has good numbers with $2.23 million in the treasury and manageable debt including some convertibles. ENZC is easily one of the most exciting stocks currently trading on the OTCQB; trading 3 tenths of a penny over 52-week lows of $0.054 the stock skyrocketed to highs of $0.958 per share in February 2021 and it still boasts a massive following of investors accumulating at current levels who believe this one is going back to where it ran to last summer. While the stock has gotten cheaper the underlying Company has been busier than ever. Currently ENZC subsidiary Virogentics, is seeing progress toward the production and use of its ITV-1, anti-HIV immunotherapy treatment in the Central and Eastern regions of Africa for patients with HIV/AIDS. Toxicology, pharmacodynamic and pharmacokinetic studies (toxicology studies) of the immunotherapy are planned, a prerequisite to use of the immunotherapy in certain African countries. These toxicology studies will also be used in the Company’s progress toward clinical trials necessary for EMA approval. The ITV-1 therapeutic has succeeded in clinical trials earlier and the Company is planning additional trials leading to EMA approval.  ENZC could become a major player in the enormous $30 billion annual HIV market expected to reach $37 billion in the next 5 years. In a market primarily controlled by Gilead who sold $17 billion in HIV drugs last year Enzolytic’s HIV treatment is immunotherapy, not chemotherapy. One of the things that makes Enzolytic’s  ITV-1 stand out from the pack is its 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. Don’t underestimate ENZC potential here, it’s a biotech right at 52 week lows, has one of the biggest audiences on the OTCQB, recent highs near $1 and is seeing significant progress with multiple upcoming catalysts in several different billion-dollar sectors.  Microcapdaily first reported on ENZC on September 16 just as it was taking off after closing at $0.0009 the day before. 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.

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