Enzolytics Updates Permitting Progress in Europe on Its Planned Clinical Trials of Its Patented ITV-1 Anti-HIV and Other Developments

Rhea-AI Summary

Enzolytics, Inc. (ENZC) announced the establishment of International Medical Partners (IMPL), a Bulgarian LLC, in which it holds a 50% stake. The venture aims to fund clinical trials for ENZC’s patented ITV-1 therapeutics targeting HIV, adhering to European Medicine Agency (EMA) standards. The company expects EMA approval to facilitate FDA recognition as part of a Mutual Recognition Agreement. Enzolytics is preparing its financial statements for OTCQB submission, highlighting ongoing audits and filing deadlines for previous reports.

Positive

• Formation of IMPL with 50% ownership potentially strengthens financial backing for clinical trials.
• Anticipated EMA approval could lead to FDA recognition, enhancing market prospects for ITV-1.

Negative

• No current FDA approval for ITV-1 poses potential commercialization risks.
• Funding for clinical trials is still being secured, which could delay progress.

COLLEGE STATION, TX / ACCESSWIRE / February 22, 2021 / Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") today 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 are a group of successful Bulgarian businessmen who will fund the 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 should qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage Clinic Design to begin the clinical trials that may be required under EMA standards.

The Audits of the Company's current and prior year Financial Statements are in process and the 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, 2021 Annual Report Financial Statements pursuant to the OTC Markets Pink Basic Disclosure Guidelines. The Company anticipates filing the financial statements under the Basic Disclosure Guidelines for December 31, 2020 in the coming weeks 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 licensed and patented treatments the addition of IMBL and the benefits of obtaining an EMA permit has opened up new and exciting avenues for growth of the ENZC 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

SOURCE: Enzolytics, Inc.

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FAQ

What is the purpose of Enzolytics' clinical trials for ITV-1?

The clinical trials aim to evaluate the efficacy of ITV-1 in treating HIV in compliance with EMA standards.

When is Enzolytics expected to file its financial statements?

Enzolytics anticipates filing its financial statements for December 31, 2020, before the deadline of March 31, 2021.

How does EMA approval benefit Enzolytics?

EMA approval could facilitate FDA recognition of ITV-1, opening additional pathways for commercialization.

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

The partnership provides funding for clinical trials, which is crucial for advancing ITV-1 towards potential market approval.