Enzolytics Finalizes Documentation with International Medical Partners, Ltd for Clinical Trials and Initial Production of ITV-1 Company Also Provides Update on Year End Reporting

Rhea-AI Summary

Enzolytics, Inc. (OTC: ENZC) has formalized legal agreements to establish International Medical Partners (IMPL), a Bulgarian LLC, in which it holds a 50% stake. This partnership aims to advance the production and certification of ITV-1, a patented therapeutic for HIV, targeting upcoming clinical trials under the European Medicines Agency (EMA). Funding arrangements for these trials are in place. The company is also preparing for OTCQB submission upon completion of its financial audits and intends to file its Annual Report by March 31, 2021.

Positive

• Formalization of IMPL partnership could enhance operational capacity.
• Funding for clinical trials under EMA guidelines has been secured.
• Progress towards clinical trials with ITV-1 may attract investor interest.

Negative

• ITV-1 remains unapproved by the FDA, posing significant market entry risks.
• The company is still in the audit stage, which could delay OTCQB application.

COLLEGE STATION, TX / ACCESSWIRE / March 16, 2021 / Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") today announced the formalization of corporate legal documents pursuant to Articles of Association forming International Medical Partners ("IMPL") a Bulgarian Limited Liability Company of which the Company is 50% owner. The agreements are with the Company's partners in IMBL formed with a group of successful Bulgarian businessmen.

As a team, the Company with IMPL is moving forward to complete the initial production and certification of its ITV-1 patented therapeutics for treating HIV leading to the planned clinical trials under the European Medicine Agency (the "EMA"). A commitment for funding of the cost of clinical trials under EMA guidelines and cost associated with the issuance of an EMA permit are part of the negotiated agreements. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the Company's belief is that issuance of the EMA permit for the ITV-1 compound should qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage Clinic Design to begin the clinical trials that is expected to be required under EMA standards. In addition, the Company is negotiating with an International known and respected European Contract Manufacturing organization ("CMO") to manufacture the required quantities of the ITV-1 Treatment to facilitate the clinical trials and permitting process under EMA guidelines.

The Company continues audits of the Company's current and prior year Financial Statements. An application for OTCQB is being prepared for submission upon issuance of the Audited Statements. The Company plans to complete the two-year audit as quickly as possible but will file the December 31, 2020 Annual Report Financial Statements pursuant to the OTC Markets Pink Basic Disclosure Guidelines. The Company plans the filing of the financial statements under the Basic Disclosure Guidelines for December 31, 2020, before the filing deadline of March 31, 2021.

CSO Harry Zhabilov stated, "As the Company progresses in its efforts to commercialize all the current and yet to be discovered opportunities of its patented treatments, the addition of IMBL and the benefits of obtaining an EMA permit has opened up new and exciting avenues for growth of our Company and the associated potential increase in value to its shareholders."

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
Phone: (972) 292-9414 Fax: (972) 292-9414
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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https://www.accesswire.com/635741/Enzolytics-Finalizes-Documentation-with-International-Medical-Partners-Ltd-for-Clinical-Trials-and-Initial-Production-of-ITV-1-Company-Also-Provides-Update-on-Year-End-Reporting

FAQ

What is Enzolytics' ITV-1 compound?

ITV-1 is a patented therapeutic aimed at treating HIV, using a purified extract from porcine pepsin.

What are the next steps for Enzolytics regarding ITV-1?

Enzolytics plans to initiate clinical trials in Europe under EMA guidelines.

What is the significance of the partnership with International Medical Partners?

This partnership is expected to facilitate the production and certification of ITV-1.

When will Enzolytics file its annual financial statements?

The company plans to file its financial statements by March 31, 2021.

What risks does Enzolytics face in its clinical trial process?

The company faces regulatory hurdles as ITV-1 is not yet FDA approved, which could impact market entry.