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. 

As we reported earlier, 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. Immune™ has also been registered with the FDA for use in the U.S. under NDI reg. no. 1083.  In tests, IPF Immune™ has demonstrated significant beneficial effects for various diseases by bolstering the immune system. ENZC recently launched the product to multiple retailers including Amazon and got NPI to be their distributor. Sales have been brisk as Immunity boosters continue to see record growth. ENZC is looking to make a mark on the North American dietary supplements market valued at over $50 Billion in 2020. 

Last week Enzolytics received a response from the European Medicines Agency informing ENZC that the required method for pharmacokinetics study will be in accordance with ELAZA standards. The Bulgarian Academy of Science will be providing the following studies on ITV-1: 1) determination of the protein concentration in the initial sample using the Bradford method, 2) electrophoretic analysis, 3) determination of the concentration of the native enzyme in samples, 4) HPLC analysis, 5) analysis of the peptides obtained after hydrolysis in samples using a UHPLC-Q-TOF mass spectrometer system including the Bruker Impact HD Q-TOF system equipped with a Captive Spray nano Booster ionization source and compass 1.7 software. LC-M-analysis of the system UHPLC-Q-TOF -LCMS samples 2 filtered through a filter 0.45 and through a filter 0.2, 6) determination of the amino acid sequence of the peptides and the concentration, 7) interpretation of the obtained results. This quantitative analysis process will be used for validation for Module 3 of the clinical trials. In addition, the ITV-1 project is finalizing negotiations with a selected German entity along with its associate laboratory to prepare a development plan for the validation of the methodology for the analysis of porcine pepsin as part of the EMA permitting requirements. 

#ENZC $ENZC $SAGA #SAGA

“#Sagaliam has built a reputation for itself as a master dealmaker and has successfully acquired several companies to date. It is evident that Graham Capital saw significant value in adding SAGA to its portfolio.” 1/3https://t.co/dXUY0Si7Ee https://t.co/Fo9pLfZUd4 pic.twitter.com/3TOhN3rwMl

— ✰𝓓𝓮𝓶𝓲𝓵𝔂𝓽𝓲𝓬𝓼✰ (@Demi6851) May 1, 2023

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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). The Company has also analyzed epitopes of animal viruses and plans to produce mAbs for treating these animal viruses. 

Enzolytics IPF Immune™ (irreversible pepsin fraction) 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.  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 size is large, valued at over $50 Billion in 2020, and expected to grow at a compound annual growth rate of 5.6% over each of the next 5 years.    

ENZC has launched a significant campaign to market IPF Immune which will be offered on multiple e-commerce platforms including Amazon which accounts for almost 40% of the US online retail market. ENZC’s distributor is Nutritional Products International (NPI), a global brand management firm based in Florida, that has the reach and expertise to successfully position IPF Immune in the market. Also, NPIs sister Company; InHealth Media, specializing in marketing health, wellness, and sports nutrition products is overseeing a national TV tagging campaign along with a public relations and social media strategy targeted to build awareness.   

$ENZC 🗓 May Slay 🗓

$250MM SPAC Deal purchase agreement set to execute on May 19th. Dividend from sales proceed to follow.

I will host a Space later this week with co-host @MarkFTW7
Time/Date TBD

Monumental Transformation underway. #IYKYK 🫡 https://t.co/nwzbIm5E1f pic.twitter.com/53ZJAYRnyH

— 𝐆𝐨𝐝𝐟𝐚𝐭𝐡𝐞𝐫 𝐂𝐚𝐩𝐢𝐭𝐚𝐥 (@GodfatherCap) May 1, 2023

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Currently trading at a $179 million market cap ENZC has 2,830,435,953 shares outstanding which is virtually the same as it was 2 years ago when ENZC ran to over $0.90 per share as the Company does not dilute its stock. ENZC recently hired accounting firm of Gries as the Company is planning to become a fully reporting 34 Act Filer with the SEC and uplist to OTCQB once the sale of Biogenysis and Virogentics to Sagaliam Acquisition Corp. (NASDAQ: SAGA) is complete and ENZC shareholders own shares in ENZC and in SAGA. Last week Enzolytics reported the Company continues to make progress on the business combination with Sagaliam which recently announced the funding of its fifth extension. The date by which Sagaliam has to complete its business combination has been extended from April 23, 2023, to May 23, 2023. We will be updating on ENZC when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.