COLLEGE STATION, TX / ACCESSWIRE / December 30, 2020 / Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") today shared the following update provided by Enzolytics' CEO Charles Cotropia. The full content of the update is presented below.
"December 30, 2020
To Our Shareholders,
On September 15, 2020, Enzolytics, Inc. and BioClonetics Immunotherapeutics, Inc. ("BCLS" or "BioClonetics") entered into a non-binding letter of intent to combine the two entities and pursue our joint mission to create therapeutics that are effective and affordable for the treatment of some of the most infectious and deadly diseases in the world, including HIV and the Coronavirus. This goal has as its foundation several components - (1) our patented anti-HIV therapeutics that have been successfully clinically tested, (2) our anti-HIV monoclonal parent antibody previously tested in vitro, demonstrating neutralization of over 95% of the HIV isolates against which it was tested and (3) our proprietary methodology for producing fully human monoclonal antibodies which is being used to produce additional anti-HIV monoclonal antibodies targeting additional immutable sites on the HIV virus as well as multiple anti-CoronaVirus monoclonal antibodies for use as a therapeutic against the SARS-CoV-2 virus.
Both management teams were committed to this mission, and even before the completion of the combination documentation, transition of our organizations began by my appointment to the Enzolytics' Board as a Director and CEO and appointment of Harry Zhabilov to the BCLS Board. This allowed us to share information for assimilating our proprietary information for research and development purposes and for streamlining the administrative function to accelerate future growth.
On December 1, 2020, the combination agreement was completed, and the control block of shares of Enzolytics was transferred in accordance with the terms of the final document to Dr. Joseph Cotropia, Dr. Gaurav Chandra, and me, officially integrating the management teams and organizations into one single-purposed organization.
Since the signing of the original non-binding letter of intent, the Company has filed two annual reports and eight quarterly reports, with the required OTC alternative reporting supplemental information, and will soon be filing the last quarterly filing and opinion letter with OTC Markets needed to bring the Company to a current status. The Company is an OTC Market Alternative Standard Reporting entity and is not fully reporting. All of the information that would be required in SEC reporting is included in our Supplemental Information filings and is current.
Currently, the Company has requested proposals from several PCAOB accounting firms to provide quotes for Audits of the Company's current and prior year Financial Statements in order to become fully reporting. Bids were requested to be provided by mid-January, and the Company anticipates making a decision by the end of January 2021.
Our new lab is being opened on the campus of Texas A&M University in the University's Institute for Preclinical Studies. Here we will expand our development capabilities for the production of additional monoclonal antibodies targeting immutable sites on the HIV and SARS-CoV-2 viruses. In addition to those primary targets on these viruses already known to us, we have engaged an artificial intelligence (AI) and genetics and molecular biology data science team to curate the thousands of isolates (strains) now known as existing in both the HIV virus and the SARS-CoV-2 virus. This process will allow us to identify conserved, immutable targets against which monoclonal antibodies are to be produced.
The significance of this step is well recognized by experts in virology due to the ability of all viruses to mutate and render ineffective, initially developed therapeutics. We have all now heard of the new variants of the CoronaVirus that have just surfaced this week in the United Kingdom and South Africa. Such variants have been found to now exist in the U.S. Due to mutation, these variants have slightly different structures from the virus as initially introduced into the U.S. and will require different therapeutics to address them. The necessary response to such mutations is to identify sites on the virus that do not mutate - that are immutable - and to produce monoclonal antibodies targeting these immutable sites. Using artificial intelligence, we expect to be able to identify these sites such that antibodies may be produced targeting them. This is one of our focuses.
Testing of the newly produced monoclonal antibodies is also being arranged. This includes testing of our now being produced recombinant anti-HIV monoclonal antibodies created from the parent antibody. Such testing is now scheduled for early 2021 at the University of Strasbourg in Strasbourg, France.
Dr. Ronald Moss has joined our team as Medical Advisor, adding significant and highly recognized experience. With his assistance, we are advancing our patented antiviral peptide that has been successfully tested in clinical trials at the National Center of Infectious and Parasitic Diseases in Bulgaria. This therapeutic, known as ITV-1, is a suspension of Inactivated Pepsin Fragment (IPF), a purified extract of porcine pepsin. ITV-1 has been shown to strengthen the immune system and may be used to facilitate a broad range of applications. ITV-1 has been tested in HIV patients in a clinical trial conducted under the strict guidelines of the European Union. The Company is in the process of GMP production of the peptide necessary for the validation process, a required step leading to its availability for patient therapy. Regarding the production of the peptide for validation, the Company is reviewing proposals from several CRO labs for such production of this required form of the therapeutic.
Enzolytics has also filed a new U.S. Patent covering an immunotherapy treatment applicable for treating Multiple Sclerosis. The Company is exploring several opportunities to collaborate with other drug development companies to expand our product reach. This product is based on the isolation of nuclear proteins from the spinal cord of a calf and is combined with Interleukin-12. We believe this recombinant protein to have immunomodulatory effect and triggers tissue repair.
In addition to these successes, we have been very successful in raising necessary funding to execute our plans. Our initial $500,000 raise is being followed with $1 million being funded in the next 30 days, and additional investment is being made into the Company by officers of the Company, bringing the total raised since the signing of the non-binding letter of intent to $1.7 million.
The Company has also negotiated a debt exchange whereby most of the existing convertible debt has been exchanged for equity instruments that have a two-year conversion clause to postpone conversions for the next two years. We believe this step, along with the reorganization under Section 251 G that was initiated prior to the closing of the combination agreement, will significantly enhance the equity position of the Company.
By combining our expertise with outside professionals and trusted consultants, we have succeeded in less than three months in accomplishing each of these items - as well as others.
The Company acknowledges the enthusiasm of our investor base, and in response to their desire for up-to-date information, we are updating our website and will be launching it in the New Year.
We, at the Company, look forward to very productive and successful 2021.
Chares S, Cotropia
CEO, Enzolytics, Inc."
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. is a Dallas, 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.
2000 North Central Expressway
Plano, TX 75074
Phone: (972) 292-9414 Fax: (972) 292-9414
Texas A&M University
College Station, TX
SOURCE: Enzolytics, Inc.
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