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Thursday, June 1, 2023

Enzolytics Inc (OTCMKTS: ENZC) Biotech Blue Sky Breakout (ITV-1, EME, New Products) as $250 Million Deal with SPAC Sagaliam Acquisition Corp. (NASDAQ: SAGA) Moves Forward

Enzolytics Inc (OTCMKTS: ENZC) is rocketing northbound and just broke through a key resistance point at $0.1011 and is now on a blue-sky breakout with little resistance in its path. On Monday the Texas based biotech said its subsidiary, Virogenetics (VIRO), will be conducting a pilot clinical trial test for the state owned Bulgarian National Center for Endocrinology to gauge the effectiveness of the ITV-1 immunotherapy on Diabetes. ITV-1 is 100% nontoxic and has proved itself to be highly effective in treating HIV/AIDS and modulating the immune system. To facilitate the transition from laboratory production to standardized industrial production at the VetProm-Danson facility in Bulgaria, VIRO purchased a flow machine for the sterile filling of the ITV-1 treatment into individual vials. At the VetProm facility, VIRO recently fulfilled the initial order for the immunotherapy treatment for distribution to the participating hospitals in Africa that are scheduled for delivery on May 10, 2023.  

Enzolytics is also currently working with the European Medicine Agency (“EMA”) to determine the fastest and most effective path to registration of ITV-1 in Europe. This study will be conducted by the German company, Korporativ Klinik Drug Research and Development. The methodology for this research will be done on volunteer patients using pl ELAZA standards, as recommended by the EMA, in a specialized laboratory in Germany. VIRO produced several batches of ITV-1 at the Vetprom-Danson plant using standardized industrial production methods. Vials from this batch are being analyzed at the Bulgarian Academy of Sciences to determine protein concentration, native enzyme concentration and peptide analysis, and amino acid sequence. We will be updating on ENZC and SAGA when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

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VIRO is also in the process of completing the application with the US FDA for two new nutraceutical products developed by Dr. Lachezar Ivanov for detoxification of the brain and detoxification of the liver. The liver detox is currently registered and being sold in Bulgaria. The brain detox initial registration application will be filed with the FDA and subject to its approval. 

Enzolytics was one of the biggest runners in 2021 skyrocketing to over $0.90 per share and has an enormous investor base looking for a return to previous highs. ENZC currently has momentum, liquidly and legions of investors buying back in here looking for a breakout over $0.1011. Also, ENZC has the same share structure now as it did in 2021 when it ran to $0.90 as the Company does not dilute. Enzolytics is in the process of spinning of Biogenysis and Virogentics to SPAC Sagaliam Acquisition Corp. (NASDAQ: SAGA) in a deal worth $250 million. BGEN and VIRO will become wholly owned subsidiaries of Sagaliam while ENZC will continue to trade on the bulletin boards. Enzolytics shareholders will receive a dividend in Sagaliam  which has already raised $116.5 million in its IPO, and currently has $10 million in the treasury and expects to raise additional capital through a PIPE. Enzolytics shareholders will own shares in ENZC as well as in SAGA which is largely owned by institutional investors including Graham Capital Wealth Management LLC, BlackRock, Goldman Sachs, EHP Funds, Periscope Capital, and Marshall Wace LLP.   

Several weeks ago, Enzolytics representatives traveled to Africa to arrange for the delivery of its ITV-1 immunotherapy treatments to African hospitals and to finalize the information to be included on product labels as required by the African regulatory agencies. The anti-HIV treatment consists of two 8-week cycles of 16 injections with a one-week break, totaling a 17-week treatment period. After the delivery of the vials, the hospitals will administer the treatments over the 17-week treatment period and periodically provide ENZC with clinical data of its effectiveness. Once the initial patients are treated and when ITV-1 demonstrates effectiveness, the Company expects to provide additional treatments to treat up to 30,000 additional patients living in the Central and Eastern region of Africa.  

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Toxicology studies of ITV-1 confirmed it is non-toxic, a crucial step in getting the EME approved in Europ. Enzolytics is entering the markets of Rwanda, DR Congo, Botswana, and Kenya to start where there are 4 million HIV infected individuals. It is estimated that the hospitals will administer ITV-1 to 40,000 – 50,000 patients accounting for $45 million USD in sales in its first year. 

Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat 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. Enzolytics has proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases which is currently being employed to produce monoclonal antibody therapeutics for treating the CoronaVirus (SARS-CoV-2), HIV-1 and the Feline Leukemia virus. The Company has also identified conserved epitopes on and has plans to produce mAbs targeting many 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).  

Enzolytics IPF Immune™ (irreversible pepsin fraction) is a liquid nutritional supplement that acts as an immune modulator to benefit the immune system by fortifying it against infections. The active components in IPF Immune™ have been registered with the FDA for use in the U.S. under NDI reg. no. 1083. The product is produced and sold by Enzolytics pursuant to U.S. Patent No. 8,309,072. In tests, IPF Immune™ has demonstrated significant beneficial effects for various diseases, whether used alone or as a concomitant therapy, by bolstering the immune system. IPF has similar clinical benefits of Acyclovir (for treating Herpes) and Tamiflu (for treating Influenza) but those therapies were found to be 35 times more toxic to the body. The North American dietary supplements market is booming! Valued at over $50 Billion in 2020, it is expected to grow at a compound annual growth rate of 5.6% over each of the next 5 years.     

IPF Immune’s recent introduction into the U.S. market has been met with great enthusiasm, quickly selling out. IPF Immune is sold over multiple on-line sites including Amazon and Wal-Mart. Enzolytics has received many testimonials from users of IPF stating that they, individually, have experienced positive effects from IPF’s use on their bodies immune system. In response to the success of IPF Immune in the US market, VIRO has received inquiries from several European countries including Spain, Germany, Romania, Greece, and Bulgaria and is now in the process of registering IPF Immune in Europe. Enzolytics has also launched an aggressive campaign to market IPF Immune securing Nutritional Products International (NPI), a global brand management firm based in Florida to be the Company’s distributor. Also, NPIs sister Company; InHealth Media, is overseeing a national TV tagging campaign along with a public relations and social media strategy targeted to build awareness for IPF Immune™ 

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In Monday’s press release CSO of VIRO Harry Zhabilov stated: “I am proud of the success and progress that the VIRO Team has brought to ENZC through the two products currently being manufactured and developed in Bulgaria. With the expansion of the nutraceutical product line and our first administration of the ITV-1 immunotherapy in Africa, we believe that in the last half of 2023, great strides will be made toward fulfilling my vision for the ITV-1 family of products. The potential of additional funding through the previously discussed SPAC transaction will increase the opportunities for further product development especially with the Multiple Sclerosis application patent being developed.”  We will be updating on ENZC when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

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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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