Thanks.
Looking ahead as ENZC approaches catalysts.
Enzolytics, Inc. (ENZC) is starting 2022 with a bang forming a massive reversal and rocketing up the charts on massive accumulation from investors and significant growing volume trading $6 million in dollar volume on Tuesday alone. ENZC was one of the biggest runners of 2021 skyrocketing from subs to highs of $0.958 per share in February 2021. ENZC has a massive following of investors, huge liquidity, parabolic momentum and legions of new shareholders bidding the stock higher. On January 4 ENZC reported production and sale in the U.S. and North America of “Enzolytics IPF Immune™,” a science-backed liquid nutritional supplement that acts to strengthen the body’s immune system. The immune modulator benefits 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, and the immune booster is being produced and sold pursuant to the Company’s exclusive North America license under U.S. Patent No. 8,309,072 (the ‘072 Patent). According to Grand View Research, the North American dietary supplements market was $50.11 Billion in 2020.
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. (ENZC) is a Texas-based biotechnology company that focuses on therapeutics to treat numerous human health medical conditions. In addition to Enzolytics IPF Immune™, now coming to the market in the U.S. market, the Company is in the process of producing other therapeutics for treating multiple infectious diseases, such as COVID-19, HIV and cancer. ENZC flagship, 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 attracted a stellar management team with Charles S. Cotropia, a corporate lawyer who was a partner for Dallas law firm Sidley Austin LLP and an intellectual property lawyer for many years as CEO, Harry H. Zhabilov, the inventor named in several U.S. patents covering technology related to the immunotherapy of HIV and cancer and an immune enhancer based on the IPF (Inactivated Pepsin Fragment) platform as Chief Scientific Officer, Joseph P. Cotropia who previously worked at the M.D. Anderson Cancer Center and the Food and Drug Administration Center, and the Food and Drug Administration Center for Biologics Evaluation and Research as CSO and Gaurav Chandria, MD, whose scientific contributions and advancements have been recognized globally. He also brings experience in applying Artificial Intelligence to the field of biomedical therapeutic development as Executive Vice President. On the advisory board are Ronald Moss, MD, YVonne J. Brysonm MD and Ellen S. Vitetta, Ph.D. The Company bought on Steve Sharabura as President of its wholly owned subsidiary RobustoMed, Inc. (A/K/A ENZO SUB) based in Atlanta, GA. RobustoMed will be initiating a new business model focused on developing international partnership opportunities for medical development stage drug and product companies. Mr. Sharabura will focus on revenue and partnership expansion in key markets worldwide, including specific initiatives in Brazil, Costa Rica and other emerging markets.
ENZC flagship is called ITV-1, this patented ITV-1 (Immune Therapeutic Vaccine-1) is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in boosting the imune system and controlling HIV/AIDS. ENZC recently announced plans to take 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. ITV-1 appears to work across a range of infectious diseases, from coronaviruses to HIV by boosting the immune system and controlling HIV/AIDS most likely acting as a superantigen—inducing polyclonal expansion of T cells and stimulating a broad immune response against the virus, and by binding directly to gp41 and gp120 of the HIV virus.
Enzolytics formed a partnership with Intel publishing a white paper called: “Optimizing Empathetic A.I. to Cure Deadly Diseases,” that looks at Intel’s Artificial Intelligence Analytic tools as well as Enzolytic’s new approach and groundbreaking contributions to create a broadly effective treatment targeting all virus variants. The white paper concludes that ENZC use of Artificial Intelligence underscores a novel approach in assessing millions of virus sequences to identify the conserved segments essential for virus survival. ENZC has reported identifying immutable sites on the HTLV-1 virus against which it will produce targeted anti-HTLV-1 monoclonal antibodies (mAbs). Utilizing the Company’s proprietary Artificial Intelligence (AI) methodology, conserved target sites were identified against which fully human anti-HTLV-1 monoclonal antibodies will be produced in its lab on the campus of Texas A&M University. Enzolytics own Artificial Intelligence team it busy identifying the critical sites on viruses against which monoclonal antibodies will be produced.
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.
On January 4 ENZC announced production and sale in the U.S. and North America of “Enzolytics IPF Immune™,” a science-backed liquid nutritional supplement that acts to strengthen the body’s immune system. The immune modulator benefits 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, and the immune booster is being produced and sold pursuant to the Company’s exclusive North America license under U.S. Patent No. 8,309,072 (the ‘072 Patent).
In addition to announcing these plans to begin the production of Enzolytics IPF Immune™, the Company has engaged a national marketing and branding agency as its distributor to advance the product through multiple distribution channels throughout the U.S. The Company will significantly benefit from the extensive capacity of the agency to place this product in major outlets, large and small, throughout the country. In addition, the marketing agency’s long-stating presence and capability in the industry is a significant benefit to the Company. According to Grand View Research, the North American dietary supplements market was $50.11 Billion in 2020, and the revenue forecast in 2028 is estimated at $77.1 Billion. This year-over-year increase has led to record sales of immunity-enhancing supplements. In 2020, immunity-boosting supplements had record sales, making up one-third of all new supplements sales.
Source : Microcap Daily
Sunday, February 13, 2022
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