ENZOLYTICS, INC. ANNOUNCES THE GRANT OF A DISTRIBUTORSHIP LICENSE FOR THE RIGHT TO DISTRIBUTE ITS ANTI-HIV-1 THERAPEUTIC ITV-1 AND A STOCK AGREEMENT VALUED IN TOTAL AT $7 MILLION US DOLLARS

 

College Station, TX, May 12, 2021/PRNewswire/ Enzolytics, Inc. (OTC Markets “ENZC” or the “Company”) today announced it had granted a distributorship license to a European pharma entity (the Licensing Entity) for the right to distribute the Company’s anti-HIV-1 therapeutic ITV-1 in the countries of India, Pakistan, UAE, Indonesia, Philippines, Nigeria, Benin and Togo, Kenya, Tanzania, Rwanda, Libya, Uganda, North Sudan, Egypt, Morocco, and Tunisia (the Licensed Territory). The Licensing Entity is the owner of a pharmaceutical plant in Eastern Europe. Pursuant to the Agreement, Enzolytics will received $1 Million USD and 50% ownership in the Licensing Entity valued at $8 Million. The License is granted with a commitment by the Licensee to sale and distribute the ITV-1 therapeutic in the Licensed Territory.

 

In addition, the Licensing Entity will invest $2 Million USD in the Company in exchange for Company Preferred Series E stock bringing to the Company $3 Million in cash plus a 50% ownership in the Licensing Entity. This agreement will result in establishing a committed partner for sale and distribution of the Company’s ITV-1 therapeutic in the Licensed Territory as well as 50% ownership in Licensee and its profit derived from sales in the Licensed Territory.

 

Charles Cotropia, CEO, stated, “This is yet another milestone in our Company’s progress toward producing revenue from our technology and the therapeutics produced from it. We gratefully acknowledge Harry Zhabilov’s years of commitment to the Company that are making possible the partnerships and agreements now being finalized. As a result of his efforts, we have another European transaction which we expect to consummate and report in the coming week. Just as important as the investments being made into the Company are the partners and licensees being engaged – all individuals who have strategic contacts within the countries in which they will be distributing our therapeutics. These strategic contacts and their familiarity with geographic areas being served is as significant as any aspect of the arrangements we are completing.”

 

“For many years, we have been developing and strengthening the relationships that are now leading to our current significant partnerships. With the advances the Company is making toward preparation for and completion of clinical trials in Europe, which will lead to approval from the EMA, we are meeting our goal of bring our technology to those in need”, said Harry Zhabilov, CSO.

 

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 component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also 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 is currently being employed to produce monoclonal antibody therapeutics for other infectious diseases including the Coronavirus (SARS-CoV-2).

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.

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Tom Nelson, CEO

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Company Contact

Enzolytics, Inc.
2000 North Central Expressway
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and
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44

SOURCE: Enzolytics, Inc.

PRESENTATION OF TECHNOLOGY ON THE EMERGING GROWTH CONFERENCE

Enzolytics was recently invited to present at The Emerging Growth Conference (https://emerginggrowth.com/conference/), where we discussed our technology. Those presentations may be viewed here on YouTube: https://youtu.be/LD9qeDdiRvY.

 

ENZOLYTICS REPORTS PROGRESS ON ITS MULTIPLE
THERAPEUTICS PLATFORMS AND INITIATIVES

New Release April 19, 2021
We continue to make great strides in the application of our multiple platforms for the 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

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

Status: in process. Time to completion: 1 month

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

Status; in process. Time to completion: 2 months

3rd 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.

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

Status: Completed

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

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 are 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

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

Status: Completed

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

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

3rd Milestone: Fast-Track Clinical Studies

Time to Completion: 6 months following the 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 of ITV-1 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 entered into 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 Milestones

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

Status: in process. Time to Completion: 2-3 months

2nd 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.”

CORONAVIRUS TARGETED EPITOPES CLAIMED IN ENZOLYTICS’ PENDING PATENT APPLICATIONS ARE VERIFIED AS FULLY CONSERVED IN THE UK, BRAZIL, AND SOUTH AFRICAN VARIANTS OF THE CORONAVIRUS (SARS-COV-2).

College Station, TX, April 5, 2021/PRNewswire/ Enzolytics, Inc. (OTC Markets "ENZC" or the "Company").

In a significant development, recent findings have revealed that the monoclonal antibodies being produced by the Company against targeted sites on the Coronavirus are directed against epitopes that exist conservatively on each of the variant strains of the virus from the UK, Brazil, and South African.
These findings are considered by the Company as highly significant in that the Center for Disease Control (the "CDC") recently reported this Coronavirus as "variants of concern," defining them as 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."
These Coronavirus variants are largely responsible for the recent increase in COVID-19 cases across the U.S., with the UK variant (B.1.1.7) accounting for 26 percent of all infections in the U.S. This variant, which is between 50 and 70 percent more transmissible, is the predominant strain in at least five regions of the country, according to Rochelle Walensky, MD, CDC director. Mutations in viruses are common, but most are insignificant and do not cause any change in the viruses’ ability to transmit or cause serious infection. But some mutations, like the ones in the UK or South Africa variant lineages, make the virus more infectious and, in some cases, even deadlier.
Significantly, Federal officials have halted the distribution of Eli Lilly's bamlanivimab monoclonal antibody treatment in three states (California, Arizona, and Nevada) due to concerns about a homegrown COVID-19 variant that renders it ineffective. There are reports of the "double mutant" COVID-19 variant discovered in India and the United States. "Such [double] mutations confer immune escape and increased infectivity."
The Company’s targeted approach is to produce fully human monoclonal antibodies against the identified conserved epitopes on the Coronavirus. Using computer analysis (Artificial Intelligence [AI]), the Company has identified 19 conserved sequences identified on the Coronavirus on the basis that they are 98.71% to 99.29% conserved over the entirety of the 50,512 Coronavirus isolates analyzed. Significantly, these conserved sequences have been identified in the UK, Brazil, and South African variants.
This discovery is significant in Enzolytics’ continued commitment to producing therapeutics for the treatment of COVID-19. Specifically, Enzolytics creates human heterohybridoma cell lines using convalescent human patients' peripheral "immune" human B cells to create fully human monoclonal antibodies directed individually against the identified conserved sites on the virus S1 protein and S2 (transmembrane) protein on the Coronavirus. These monoclonal antibodies will expectedly have a universal effect (on all known variants) and durable. As the virus mutates, the targeted site will still exist in the virus, subjecting it to neutralization. Such therapeutics would have universal (worldwide application), be durable (have long term successful benefit), and thereby prevent failure of successful vaccines and/or provide effective treatment, which are both points of failures that have occurred as a result of “mutational virus escape.”
This capability is highly significant in that experts, such as Dr. Paul Offit, MD, Director of the Vaccine Education Center at Children's Hospital in Philadelphia, have stated that even though successful vaccines have been developed and deployed, we can expect the Coronavirus to be with us going into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future. Additionally, the Company’s monoclonal antibodies may be used in conjunction with other pharma antibodies, such as Eli Lily’s bamlanivimab monoclonal antibody in combination therapy.
The Company’s pending patents claim the identified target sites and include patent claims to the CDR sequences of the produced antibodies. Such patent claim structure will expectedly provide the Company the exclusive rights to therapeutics based on these findings for 20 years from the date of filing. International patent coverage is also being sought.
CEO Charles Cotropia said, “The discoveries made by our AI team, and implemented by our research team, are extremely significant. The creation of monoclonal antibodies that target the Achilles’ heels of the Coronavirus, which will be present even in mutated strains worldwide, means that a therapeutic may be produced that will affect the world for the expected continuous lifecycle of the Coronavirus. These findings have their origin in the critical analysis performed by our AI team, which has used sophisticated computer analysis and years of AI experience to curate the amino acid sequences (which are in the tens of thousands) of each of the over 50,000 Coronavirus isolates now known. Our AI team has identified the “golden needles” in an enormous haystack of data from this analysis. This is a remarkable achievement.
Recently, we have become aware of commentators on our technology who, rather than fairly and validly analyzing our technology and our findings, instead propound, for what we perceive as some self-serving reasons, erroneous and irrelevant assertions to mislead those interested in knowing the fundamental truth about our discoveries. For example, one “red flag” raised by one commentator has been to criticize our AI team - not based on the technology and substance of its findings - but by focusing on the date of incorporation of the partner. The date an entity is incorporated is irrelevant when those on the research team have decades of experience with the knowledge, skill, and capability to analyze the amino acid sequences (containing thousands in number) of each of over 50,000 different Coronavirus isolates. From this sophisticated analysis and resulting findings, the Achilles’ heels of the Coronavirus are revealed, namely, those epitopes that must be and that can be targeted by monoclonal antibodies to treat the virus not only today effectively but into the future. We question the motive behind these grossly misdirected comments, made for what we perceived as self-serving reasons, and not to provide an honest, fair, and truthful dialogue about a most serious medical crisis. While we perceive such irrelevant and misleading comments as intending to divert attention from the problem at hand and the solutions that are possible, we stand resolved to focus on the science and applying our capabilities to achieve success for all who will confront this virus – a virus that has and will do societal damage around the world, not only today but in the future”.
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to commercializing 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. They 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. The Company expressly disclaims any intention or obligation to update the forward-looking statements or 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.

Enzolytics Technologies Targeting HIV and the CoronaVirus

This interview of the Company’s CEO Charles Cotropia was conducted by and published in CEOCFO Magazine.

CEOCFO: Mr. Cotropia, what is the concept behind Enzolytics, Inc?

Mr. Cotropia:

Enzolytics, Inc. is a drug development company with two separate but complementary therapy platforms for treating infectious diseases, including treatment for HIV. One technology, invented by Harry Zhabilov, the CSO of the Company, includes a patented antiviral peptide that has been tested in clinical studies at the National Center of Infectious and Parasitic Diseases in Bulgaria. In these trials, this therapeutic, known as ITV-1, demonstrated effectiveness in the treatment of HIV patients in various stages of the disease. In trials conducted in 31 patients, the therapeutic showed efficacy; specifically, in 68% of those individuals tested, there was an increase in CD4 + T lymphocytes. This increase was accompanied by an increase in the CD4/CD8 index and CD4% in over 50% of those tested. The increase in these parameters demonstrated statistical significance compared to the control group. The absolute number and the relative percent of CD8 + T lymphocytes decreased. And the viral load in 80.5% of those tested was below the threshold of detection.

This Enzolytics anti-HIV treatment is now being advanced through the certification stage to thereafter be made available for patient therapy.

The Company is now combining this technology with recently acquired technology, created by BioClonetics Immunotherapeutics, for creating fully human anti-monoclonal antibodies for treating HIV. Using this technology, the Company has produced a fully human anti-monoclonal antibody that has been tested in 5 international labs where it neutralized over 95% of all strains of the HIV virus against which it was tested. Additional neutralizing antibodies are being produced.

The therapies of Enzolytics’ two technologies, that produced by Enzolytics and that created by BioClonetics are expected to be synergistic. Additionally, because the HIV virus and the CoronaVirus have correlative structures and with our knowledge of how our monoclonal antibodies neutralize HIV, we are now developing monoclonal antibodies for treating the CoronaVirus.

CEOCFO: Isn’t HIV pretty well taken care of now?

Mr. Cotropia:

That is the view, particularly in the U.S., but it is a misconception. There are over 36 million people in the world infected with HIV. There are more than 2 million new infections every year, and over one million people die from the virus annually. Ten percent of the HIV deaths are children – amounting to over 300 child deaths per day. That number of children who die from HIV is greater than those that die from cancer.

The reason there is the belief that HIV is no longer a problem is that there is now, and has been for years, a treatment but no cure. The treatment is through administering antiretrovirals, a treatment that must be taken daily and for life. There is no effective anti-HIV monoclonal antibody on the market for treating HIV, and that is the focus of the therapies developed by Enzolytics. In recent months, the entire world has now come to know “monoclonal antibodies.” This is what was used in a treatment provided to President Trump for the CoronaVirus and is now being developed by several companies. In contrast, the current (and for decades) treatment for HIV has been antiretrovirals, which do not cure HIV patients but rather just keep the virus at bay. Monoclonal antibody therapy offers the promise of total viral neutralization and, as a result, an effective cure in place of the present antiretroviral therapy, which requires lifelong treatments.

There are several downsides to the use of antiretrovirals. Because antiretroviral drugs are chemotherapy and not a humoral immunobiological therapeutic such as monoclonal antibodies, long-term side effects of the chemotherapy can result – including kidney problems, involving kidney failure, liver damage (hepatotoxicity), heart disease, osteoporosis, heart disease, diabetes, or insulin resistance, an increase in fat levels in the blood (hyperlipidemia), and changes in how the body uses and stores fat (lipodystrophy).

Moreover, the antiretroviral treatment is only accessible to 40% of the over 36 million people infected in the world – leaving 60% of the 36 million infected HIV patients with no treatment.

Thus, these issues can be resolved by the implementation of a better HIV treatment, using immunotherapy with the administration of our technologies, including broadly neutralizing monoclonal antibodies.

CEOCFO: I think to a lot of people, it seems the crisis is over.

Mr. Cotropia:

Your observation is exactly right! The perception is that the HIV crisis is over, but it is a misconception. The extent of the world crisis can be appreciated by the facts I just mentioned; namely, there are over 36 million people in the world infected, and only 40% of those have access to the antiretroviral therapy now used to treat HIV. There are over two million new infections per year, and more than one million people die from the virus annually.

The current antiretroviral therapy is not a cure, and as mentioned earlier, the side effects of lifelong use are significant. Also, the yearly average costs of treatment on antiretrovirals are $14,000 to $20,000 per year, and the average lifetime cost is calculated as $379,000. The cost of an anti-HIV therapy we are proposing would be a fraction of this cost since the treatment would be for a limited time and would not require life-long use.

Just as monoclonal antibodies were made available to successfully treat President Trump when he contracted the CoronaVirus, monoclonal antibodies can be made available to treat HIV patients, and we believe we are on the verge of providing and validating specific therapies in order to safely and successfully treat HIV.

CEOCFO: From your recent press release, you have a proprietary methodology for producing fully human OGG1 monoclonal antibodies. How is your approach different?

Mr. Cotropia:

There are a number of different ways of producing monoclonal antibodies. The procedure is significant, and our procedure differs from those used by other pharma companies.

In some cases, other pharma companies produce “humanized” rat and mouse monoclonal antibodies where the original antibody affinity and specificity are not maintained, and the chances of immunogenicity are increased. Our methodology also differs significantly from other pharma approaches using the transgenic mouse model, which is a human immune system that has been “grafted” within a mouse model having been "vaccinated" with specific and selected purified virus proteins.

In contrast, our method starts with human "immune-B cells," obtained from convalescent individuals who have recovered from the target virus. The primary distinction of our process for creating fully human monoclonals is the starting point – namely from human “immune-B cells” obtained from humans who have survived successfully from a "natural" infection. From these human “immune-B cells,” we then produce antibodies that target conserved immutable sites (neutralizable epitopes) on the virus’ surface envelope proteins – which will thereby avoid “virus escape,” which has been frequently demonstrated to occur as a consequence of mutations in the HIV virus surface structure.

Additionally, our antibodies retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, in what is called the camelid structure form, and, in the recombinant form, will have greater accessibility to the virus binding sites not accessible with a whole antibody. We believe that our method is one that produces an antibody that will be more effective with less risk of adverse reaction.

There is an infinite number of distinct anti-HIV and anti-CoronaVirus monoclonal antibodies that can exist – some disease neutralizing, some perhaps of no benefit, and some perhaps disease enhancing. Thus, specific antibodies that neutralize are necessary to provide effective therapy. Enzolytics’ method of producing effective monoclonal antibodies focuses on identifying immutable binding sites on the virus and then creating monoclonal antibodies that bind to such sites and neutralize the virus. In this way, the virus cannot mutate around the therapy. For example, the antibodies administered to President Trump to treat him for the CoronaVirus may target a site on the virus that will mutate. Thus, the same antibodies may not be effective for you or me later if the CoronaVirus has mutated, changed structure at this binding site. Our anti-HIV monoclonal antibody binds to a site on the HIV virus that is conserved in 98% of the more than 6000 strains of the HIV-1 viruses now known, sequenced, and archived in the Los Alamos National Laboratory HIV Database. The same will have to be achieved for successful anti-CoronaVirus monoclonal antibodies.

CEOCFO: What are you looking at regarding COVID?

Mr. Cotropia:

We have produced an HIV monoclonal antibody that had been successfully tested in five international labs where it neutralized 95% of all strains against which it was tested. There are 6000 different strains of the HIV virus now known. We know that our antibody is effective, and we know the target site on the virus resulting in neutralization of the HIV virus. For an antibody to be effective, it has to attack a neutralizable site on the virus that is always there, does not mutate from strain to strain. Knowing the binding site of our HIV monoclonal antibody and then examining the CoronaVirus amino acid sequence, a correlation in the structures has been identified by our CSO, Dr. Joseph Cotropia, between the CoronaVirus and the HIV virus. With knowledge of these homologous viral structures, monoclonal antibodies will be created that target the corresponding “Achilles Heel” site on the CoronaVirus, an expected conserved immutable and neutralizable site on the virus. Additionally, using artificial intelligence, we will examine the numerous different strains of the virus to identify other conserved sites and produce additional monoclonal antibodies targeting them. This is for the purpose of producing a “collection” or “cocktail” of antibodies for therapeutic use. We recognize that there are now known over 16,000 different variations or strains of the CoronaVirus, each slightly different due to mutation. A successful monoclonal antibody “cocktail” therapy must include multiple antibodies that specifically target several immutable sites and which results in neutralization.

For example, we all now know that President Trump received a combination of two Regeneron antibodies. Eli Lilly has also produced an anti-CoronaVirus antibody. However, what we do not know is whether those antibodies will be successful as the virus mutates. As I mentioned, there are now known 16,000 different variants to the CoronaVirus, and immutable sites must be targeted in order to be effective in the long run.

Also, as all experts in the field of monoclonal antibodies agree, including Dr. Anthony Fauci, head of the NIAID/NIH, to have an effective therapy, we must have multiple monoclonal antibodies that target various sites on the virus - and in fact, even President Trump was given a cocktail of two. Therefore, it is imperative to identify conserved neutralizing binding sites on the CoronaVirus and create multiple monoclonal antibodies that target these critical neutralizable and immutable structures. It is like finding a needle in a haystack and retrieving the needle; you must identify the immutable sites on the virus and then create and characterize fully human monoclonal antibodies that target those sites. The process described here will be our focus, and for a reason that success has already been achieved with regard to the production of broadly neutralizing antibodies directed against the HIV virus, we expect success will likewise be achieved in the production of broadly neutralizing human monoclonal antibodies directed against the CoronaVirus.

CEOCFO: I realize your brother is the medical person behind the Company, but what led you to take on this role. You have been a practicing attorney for many years. Why this challenge now?

Mr. Cotropia:

Obviously, it is very rewarding to hope that we will produce something that will be so meaningful to so many people. Our initial focus has been on HIV, a still devastating disease that is very much still with us and certainly more so in other counties. That is because, in the U.S., the focus is on HIV; because most U.S. citizens who contract HIV can afford $20,000 a year, through insurance or otherwise, and be treated. Unfortunately, many of those who have taken antiretroviral for thirty years or less have to suffer side effects caused by the current therapy, so there are a great reward and a great challenge in the hope that we can produce something that is better. We see a better therapy and a therapy that can be produced inexpensively for all, and particularly for the 60% and the 36 million people who have no access to currently available antiretroviral therapy. In many countries, like the U.S., this situation no longer makes the headlines in the news. For us, we recognize the need for better therapy.

Now, we turn to the CoronaVirus, and that is something that is on the front page of the U.S. and world news. We definitely have taken note of that. How do you address it? The antibodies that are being produced by other pharma companies may very well have initial beneficial effects. However, a solution requires more than one antibody to be effective. If their antibody targets a site that mutates, and that is what has happened to every other monoclonal antibody produced by the NIH and big pharma in their attempts to treat HIV, it is ultimately not going to be effective. The virus will mutate around it. Therefore, what worked, perhaps, for President Trump, will not necessarily work for you or me in the future. Consequently, as the virus mutates over and over again—in order to be therapeutically successful—you have to target a site that is immutable.

We also note that even those who have been fully vaccinated against the Coronavirus have now contracted the virus. This means that going forward; there will be a continuing need for therapeutics that will treat those that contract the virus. Additionally, experts, such as Dr. Paul Offit, MD, Director of the Vaccine Education Center at Children's Hospital in Philadelphia, have stated that even though successful vaccines have been developed and deployed, we can expect the CoronaVirus to be with continuously into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future.

We do know that our identified initial target on the CoronaVirus is significantly different from the targets of the antibodies produced by Regeneron and Eli Lily. Thus, with a combination of our proposed broadly neutralizing anti-CoronaVirus antibodies, the administration of a “cocktail” of several antibodies could be expected to produce a more significant neutralizing effect.

If you look back to the history of HIV, the NIH, with Vaccine Research Center, and all the other companies that the NIH has supported, they all attempted for forty years to produce an effective anti-HIV monoclonal antibody and the ones that they produced, VRC01 and VRC02, to name just a few, failed in years-long testing because of what is called “virus escape.” Virus escape is a euphemism for the fact that the virus mutated around what they spent decades trying to produce. Hence, there is a challenge to develop a successful therapy. To answer your question more directly, it is the challenge, and more than that, it is the hope of having a successful therapeutic that drives us. Also, at Enzolytics, we also have a therapeutic which will, we expect, be synergistic with our monoclonal antibodies. It is a peptide that binds to the virus and provides a clinically tested therapeutic effect, which will be examined in combination with our monoclonal antibodies. Again, this combination hopefully will be synergistic and provide a therapeutic that will be highly effective.

CEOCFO: What is your funding position? Development and eventually commercialization are very expensive.

Mr. Cotropia:

Yes, that is a very relevant question. We will be securing long-term financing for advancing our technology. We have begun the process of producing variants of our existing anti-HIV monoclonal antibodies and identifying the target site on the CoronaVirus for producing multiple antibodies against that virus. We have extended our lab capabilities on the Texas A&M University campus at its Institute for Pre-clinical Studies, where we will be producing both additional monoclonal antibodies against HIV and the against the CoronaVirus. For HIV, we will be combining the anti-HIV neutralizing antibodies with the anti-HIV peptide—which is also immunomodulating—that has been previously clinically tested by Enzolytics to have a beneficial effect in HIV patients. The funding we arrange will take us through that development which will include animal trials to be followed by human clinical trials of these therapeutics.

Success in these steps will bring the necessary funding for success. Demonstrating positive results will translate into the necessary funding due to the dire need for these therapies. As I mentioned, there is not going to be one bullet that fends off either the HIV virus or the CoronaVirus. It will be necessary to have more than one. We welcome Eli Lilly and Regeneron in their initial antibody production, and that success is all to be rewarded and celebrated. However, as we have seen in the past with HIV, it is going to be very difficult to completely control the CoronaVirus and all of its mutated forms. Success will require multiple therapeutics, and we know that monoclonal antibodies will certainly be in the picture and in the front line of successful treatments.

Another important aspect of our technology is that identification of a neutralizable binding site on the virus can lead to the creation of a vaccine – one that would be of a different format from the current mRNA vaccines now being produced. Specifically, the vaccine would be based on the known broadly neutralizing antibody and the highly conserved binding site to produce an active immunization that would not comprise nor incorporate an immunization process using nucleic acid constructs. In this process, an active protective immunization would use the neutralizable binding site on the virus as a subunit peptide vaccine. The use of peptide sub-unit immunogens in active immunization obviates the concerns for weak humoral immune response, theoretical risks of insertional mutagenesis, and provocation of an autoimmune response; in other words, concerns associated with immune response outcomes that are related to DNA and mRNA vaccination.

Therefore, different vaccines may be produced in very different ways, some of which hopefully will be very effective and very safe as to their long-term effect on the human body. A safe vaccine can be expected based on a subunit peptide vaccine formulation using the neutralizable bind site on the virus in its development.

CEOCFO: There are so many new ideas, especially around COVID. Why does Enzolytics’s approach stand out?

Mr. Cotropia:

We have a patented anti-HIV peptide, ITV-1, that has been tested in clinical studies. It is now being advanced through the next certification stage in preparation for patient application.

As a complementary treatment for HIV, we have created monoclonal antibodies for treating HIV. These antibodies can accurately be identified as being “fully human,” broadly neutralizing monoclonal antibodies in that the starting point is from human “immune-B cells,” providing the basis for the production of the antibodies. Antibodies created in this way retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency and stability as a single-domain camelid molecule. Our technology then further stands out in that we are able to identify conserved, immutable sites on the targeted virus, and we have the ability to specifically create monoclonal antibodies that target these identified sites. The whole process is, in our view, a perfect approach to producing therapeutics that are safe and effective and that address and overcome the effect of virus mutation - all the while being able to be produced inexpensively, so they may be provided throughout the world.