Enzolytics Reports Progress On Its Multiple Therapeutics Platforms and Initiatives

Rhea-AI Summary

Enzolytics, Inc. (OTC: ENZC) reported advancements in its therapeutic platforms for treating infectious diseases, including HIV and COVID-19. Ongoing milestones include anti-HIV monoclonal antibody testing and AI-driven identification of virus target sites. The company is preparing for clinical trials of its patented ITV-1 therapy for HIV under EMA standards, with potential FDA recognition. Enzolytics aims to expedite monoclonal antibody development for COVID-19 variants. The CEO emphasized the portfolio's strength, addressing various viruses through innovative technologies.

Positive

• Positive feedback from pharmaceutical companies interested in partnerships.
• Multiple milestones progressing, including AI-driven target identification.
• ITV-1 therapy development under EMA standards with potential FDA recognition.

Negative

• No revenue or financial metrics disclosed, creating uncertainty around financial health.

COLLEGE STATION, TX / ACCESSWIRE / April 19, 2021 / Enzolytics, Inc. (OTC Markets "ENZC" or the "Company").

We continue to make great strides in the application of our multiple platforms for production of therapeutics for treating infectious diseases. Our future success will follow as we meet our goals to bring these therapeutics to market with new developments made possible by our extensive platform for producing new and effective therapies.

We acknowledge our partners Genscript (https://www.genscript.com), STC Biologics (https://stcbiologics.com) and California National Primate Research Center (University of Southern California) for their continued support in our research and development efforts. We are also grateful for the overwhelming support from world-renowned scientists and continue to expand our team of advisors to build a strong company based on research and development.

We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon achievement of defined milestones. The milestones we have set include the following:

Monoclonal Antibodies for Treatment of HIV Milestones

1^st Milestone: Testing of anti-HIV Monoclonal Antibodies at University of Montana

Status: in process. Time to completion: 1 month

2^nd Milestone: Broad-based neutralization testing of existing anti-HIV Monoclonal Antibodies at University of Strasbourg, France

Status; in process. Time to completion: 2 months

3^rd Milestone: Animal Studies of anti-HIV Monoclonal Antibodies at California National Primate Research Center, University of Southern California

Time to completion: 6 months following in vitro testing in process.

4^th Milestone: Using Artificial Intelligence, identification of additional conserved immutable target sites (epitopes) on the HIV-1 virus

Status: Completed

5^th Milestone: Production of additional Monoclonal Antibodies targeting identified sites (epitopes) on the HIV virus

Status: in process. Time to completion: 5-6 months

COVID-19

We are proud of the significant advances we have made in the development of Monoclonal Antibodies for treating Covid-19. We have reported that the Monoclonal Antibodies being produced by the Company will target immutable, conserved sites on SARS-CoV-2 (Coronavirus) that exist on the variant strains of the virus from the UK, Brazil, and South African.

These findings are considered highly significant in that the Center for Disease Control ("CDC") has reported these "variants of concern" are ones "for which there is evidence of an increase in transmissibility, more severe disease (meaning increased hospitalizations or deaths), a significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures."

Our AI platform developed in collaboration with Denver Scientific has been one of our many successes. The patentable discoveries will be significant in our ongoing partnering dialogue with pharmaceutical companies interested in treatments for the Coronavirus and numerous other infectious diseases.

We intent to expedite our development of anti-Coronavirus Monoclonal Antibodies including an eventual fast-track clinical trial to progress to market.

SARS-CoV-2 (Coronavirus) Monoclonal Antibodies Milestones

1^st Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the Coronavirus

Status: Completed

2^nd Milestone: Production of Monoclonal Antibodies targeting identified sites (epitopes) on the SARS-CoV-2 virus

Status: In process. Time to completion: 3-4 months

3^rd Milestone: Fast-Track Clinical Studies

Time to Completion: 6 months following production of Monoclonal Antibodies

ITV-1 anti-HIV Therapeutics

Clinical trials are planned for the Company's patented anti-HIV therapeutics ITV-1. Earlier this year, we announced the execution of Articles of Association to form International Medical Partners ("IMPL"), a Bulgarian Limited Liability Company of which the Company is 50% owner. The Company's partners in IMBL will fund the total cost of the Clinical trials under the European Medicine Agency (the "EMA") standards and the application cost for the EMA permit for the Company's ITV-1 patented therapeutics for treating HIV. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the Company believes that issuance of the EMA permit for the ITV-1 compound could qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage a CRO to begin the clinical trials required under EMA standards.

We will have a definitive timeline for the expected date of initiation and completion of clinical trials in the coming weeks.

Production of Monoclonal Antibodies for HTLV-1/2

We are committed to developing "universal, durable and broadly neutralizing" Monoclonal Antibodies for many infectious diseases. We have an "intent to partner" agreement with a pharmaceutical company to create Monoclonal Antibodies against HTLV-1/2. We expect to complete the production by the end of 2021.

Monoclonal Antibodies for HTLV-1/2

1^st Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the HTLV1/2 virus

Time to Completion: 2-3 months

2^nd Milestone: Creation of anti-HTLV1/2 Monoclonal Antibodies

Time to completion: 6-8 months following identification of target epitopes

CEO Charles Cotropia said, "The strength of our company lies in our multiple technology platforms and the ability to produce fully human Monoclonal Antibodies against conserved and immutable targets on identified viruses. The viruses that may be addressed using our technology range from HIV to the Coronavirus to HTLV-1/2 to Ebola and many more. These numerous targeted viruses and bacteria are listed on our website [http://enzolytics.com/proprietary-therapeutics/]. We will continue to provide updates on our developments and progress toward completing the milestones we have set. We thank all our shareholders for their ongoing support of our Company and its technologies."

About Enzolytics, Inc.

Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases.

Enzolytics' flagship compound ITV-1 (Immune Therapeutic Vaccine-1) is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of HIV/AIDS. 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.

About BioClonetics Immunotherapeutics, Inc.

BioClonetics Immunotherapeutics, Inc., a wholly owned subsidiary of Enzolytics, is a Dallas and College Station, Texas biotech company with proprietary technology for producing fully human Monoclonal Antibodies (mAbs) against infectious diseases including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human Monoclonal Antibodies may be used to produce therapeutics treatments for many infectious diseases including the Coronavirus.

Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of ITV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of ITV-1 in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release, and the Company expressly disclaims any intention or obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements.

IR Contact:

Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074

and

Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-4478

SOURCE: Enzolytics, Inc.

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FAQ

What progress has Enzolytics made in its HIV monoclonal antibody development?

Enzolytics is currently testing anti-HIV monoclonal antibodies at the University of Montana and conducting neutralization testing in France.

What milestones has Enzolytics set for COVID-19 monoclonal antibodies?

The company is producing monoclonal antibodies targeting conserved sites on SARS-CoV-2, aiming for completion in 3-4 months.

Is Enzolytics planning clinical trials for ITV-1?

Yes, the company plans clinical trials for its ITV-1 anti-HIV therapeutics funded by its partners.

What is the timeline for Enzolytics' clinical trials?

A definitive timeline for the initiation of clinical trials is expected to be announced in the coming weeks.

How does Enzolytics plan to address COVID-19 variants?

Enzolytics is developing monoclonal antibodies targeting immutable sites on SARS-CoV-2 to tackle variants of concern.