What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-01-04 compared with 2021-01-07 · 456 added, 413 removed, 44 unchanged (95% of the section changed)

Biosciences, Inc., incorporated on November 5, 1982 under the laws of the State of Delaware, is a biotechnology company developing

therapies and vaccines that are focused on critical unmet needs in oncology and infectious disease.

Our therapeutics programs

include the development of a chimeric endocrine receptor T-cell technology, a novel form of chimeric antigen receptor T-cell (“CAR-T”)

technology, initially focused on treating ovarian cancer, and the discovery and ultimately development of anti-viral drug candidates

for the treatment of COVID-19 focused on inhibiting certain viral protein functions of the virus.

Biosciences, Inc.

is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology and

infectious disease.

Our therapeutics programs include (i) the development of a chimeric endocrine receptor T-cell therapy, a novel form

of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating ovarian cancer, which is being developed

at our subsidiary, Certainty Therapeutics, Inc.

(“Certainty”), and (ii) the discovery and ultimately development of anti-viral

drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.

Our vaccine programs include

the development of a vaccine against triple negative breast cancer (“TNBC”), the most lethal form of breast cancer,

and a vaccine against ovarian cancer.

subsidiary, Certainty Therapeutics, Inc.

(“Certainty”), is developing immuno-therapy drugs against cancer.

holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute

(“Wistar”), the nation’s first independent biomedical research institute and a leading National Cancer Institute

designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology.

initially focused on the development of a treatment for ovarian cancer, but we also may pursue future applications of the technology

for the development of treatments for additional solid tumors.

The license agreement requires Certainty to make certain cash and

equity payments to Wistar upon achievement of specific development milestones.

With respect to Certainty’s equity obligations

to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty.

(i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”), the most lethal form of breast

cancer, as well other forms of breast cancer and (ii) a preventative vaccine against ovarian cancer.

subsidiary, Certainty, is developing immuno-therapy drugs against cancer.

Certainty holds an exclusive worldwide, royalty-bearing license

to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent

biomedical research institute and a leading National Cancer Institute designated cancer research center, relating to Wistar’s chimeric

endocrine receptor targeted therapy technology.

We have initially focused on the development of a treatment for ovarian cancer, but we

also may pursue applications of the technology for the development of treatments for additional solid tumors.

The license agreement requires

Certainty to make certain cash and equity payments to Wistar upon achievement of specific development milestones.

With respect to Certainty’s

equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of

in collaboration with the H.

Lee Moffitt Cancer Center and Research Institute, Inc.

(“Moffitt”), is advancing toward

human clinical testing the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.

is working with researchers at Moffitt to complete and submit an Investigational New Drug (“IND”) application with

Food and Drug Administration (“FDA”) and to perform human clinical trials.

In collaboration with researchers

at Moffitt, Certainty is currently performing tests on the clinical materials and assuming successful and timely completion of

those tests, we anticipate an IND application will be submitted with the FDA during the first calendar quarter of 2021.

April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) to discover and ultimately develop anti-viral

(“Moffitt”), is advancing toward human

clinical testing the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.

We submitted an Investigational

New Drug (“IND”) application to the U.S.

Food and Drug Administration (“FDA”) in March 2021 and in August 2021,

we received authorization from the FDA to commence enrollment and treatment of patients in a Phase 1 clinical trial.

We are performing

the activities necessary to prepare for treatment of patients in the Phase 1 clinical trial, and we anticipate treating the first enrolled

patient in the first calendar quarter of 2022.

This study is a dose-escalation trial with two arms based on injection method—intraperitoneal

or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence,

expansion and efficacy of the modified T-cells.

The study is being conducted at Moffitt and will consist of 24 to 48 patients who have

received at least two prior lines of chemotherapy.

The study is estimated to be completed in two to four years depending on multiple

factors including when maximum tolerated dose is reached and the rate of patient recruitment.

April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) to discover and ultimately develop anti-viral

drug candidates against COVID-19.

Through this collaboration, we utilized advanced computational methods, machine learning, and

molecular modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including

publicly available compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one

of two key enzymes of SARS-CoV-2, the virus that causes the disease COVID-19.

screening process resulted in identifiying over 30 potentially effective compounds that could disrupt either the function of a

viral enzyme called an endoribonuclease, known as Non-Structural Protein-15 (“NSP-15”), or the main protease (“M pro ”)

of the virus.

Our in silico molecular modeling indicates that any of the NSP-15 or M pro inhibitors might disrupt

the virus’

ability to replicate in humans.

Several of the most promising compounds have been synthesized and in vitro

biological assays of the compounds are ongoing.

If the biological activity of any of these compounds is verified, they will

be tested in animal studies to further evaluate their candidacy as COVID-19 therapeutics.

a number of preventative vaccines have recently been or will soon be approved for emergency use by the FDA, we believe that there

is and will continue to be a need for effective treatments for COVID-19.

There are a number of factors that may limit the effectiveness,

both in the near and long term, of the vaccines currently in use, including, but not limited to, vaccine persistence, viral escape

and long-term safety.

Furthermore, all current treatments require administration in a hospital setting, thus potentially continuing

to overburden the healthcare system, while we anticipate our treatment to use an oral formulation and to be available at pharmacies.

hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland

Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland

This technology pertains to the use of vaccines for the treatment or prevention of TNBC and other breast cancers which

express the α-lactalbumin protein.

The α-lactalbumin protein is only expressed during lactation in healthy women,

but may also be expressed in individuals with certain breast cancers, most notably TNBC.

with researchers at Cleveland Clinic, in November 2020, we submitted an IND application with the FDA to begin human clinical trials

of the vaccine.

In December 2020, we received authorization from the FDA to commence enrollment and treatment of patients in a

Phase 1a clinical trial.

We have commenced activities necessary to prepare for treatment of patients in the Phase 1a trial, and

we anticipate being prepared to treat the first enrolled patient in the spring of 2021.

Through this collaboration, we utilized advanced computational methods, machine learning, and molecular

modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including publicly available

compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one of two key enzymes of SARS-CoV-2,

the virus that causes the disease COVID-19.

screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus.

Several of these compounds were synthesized and tested in in vitro biological assays.

Upon completion of these biological assays,

we identified two of the most promising compounds and tested them in animal models.

In these animal studies, the two compounds were compared

to Remdesivir, which at the time the assays were performed was the only anti-viral drug authorized by the FDA for COVID-19.

showed that administration of the drugs to infected hamsters did not cause any noticeable adverse effects, and monitoring of weight and

general animal behavior demonstrated comparable efficacy between each of our compounds and Remdesivir.

Based on this promising data in

the animal study, we directed our team to proceed to the next stage of drug development and we selected one of the compounds around which

our team are performing combinatorial synthetic medicinal chemistry to evaluate whether potency can be increased and pharmacokinetics

May 2021, after completion of the aforementioned animal studies, OntoChem assigned its rights and obligations related to this collaboration

to MolGenie GmbH (“MolGenie”), a company spun-out from OntoChem focused on drug discovery and development.

As a result of

the MolGenie spin-out, there was no change in the personnel working on our project, and the assignment caused no interruptions to the

program’s development.

use of preventative vaccines is widespread throughout much of the developed world, we believe that there is and will continue to be a

need for effective treatments for COVID-19.

There are a number of factors that have limited the effectiveness, both in the near and long

term, of the vaccines currently in use, including, but not limited to, vaccine persistence, viral escape and perceptions of long-term

safety resulting in vaccine resistance.

Furthermore, there are currently two new anti-viral treatments, Pfizer’s Paxlovid, which

is a combination therapy consisting of the protease-inhibitor nirmatrelvir and the antiretroviral ritonavir and Merck’s polymerase-inhibitor

molnupiravir, that have recently been authorized for emergency use in the U.S.

These treatments use oral formulations, while all other

currently authorized or approved treatments require administration in a hospital setting.

As the main component of Pfizer’s treatment

is a protease-inhibitor, it is most similar to our compounds, and we therefore anticipate similar or better efficacy with our compounds.

Whereas Pfizer’s nirmatrelvir was based on research done on rhinoviruses and not designed specifically for SARS-CoV-2, our compounds

were designed specifically against the main protease of SARS-CoV-2 and at the current time we do not anticipate the need for a combination

hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic

Foundation (“Cleveland Clinic”) relating to a certain breast cancer vaccine technology developed at Cleveland Clinic.

this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast

cancer, focused specifically on TNBC.

The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during

lactation in a healthy mother’s mammary tissue.

This protein disappears when the mother is no longer lactating, but reappears in

many forms of breast cancer, especially TNBC.

Studies have shown that vaccinating against this protein prevents breast cancer in mice.

submission of an IND application with the FDA in November 2020, and the FDA’s subsequent authorization to proceed with clinical

trials in December 2020, in October 2021, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine.

Department of Defense grant, this study is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose

of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.

The study is being conducted

at Cleveland Clinic and will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer

within the past three years and are currently tumor-free but at high risk for recurrence.

During the course of the study, participants

will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.

is estimated to be completed in the third calendar quarter of 2022.

November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,

royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian

cancer vaccine technology.

This technology pertains to among other things, the use of vaccines for the treatment or prevention

of ovarian cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).

In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary.

While expression of

AMHR2-ED naturally and markedly declines after menopause, this protein is expressed at high levels in the ovaries of postmenopausal

women with ovarian cancer.

Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence

of ovarian cancer.

July 2, 2020, we implemented a strategic realignment of our business and redirected resources to exclusively focus on the development

of therapeutics and vaccines.

royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer

vaccine technology.

This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers

which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).

In healthy tissue,

this protein regulates growth and development of egg-containing follicles in the ovary.

While expression of AMHR2-ED naturally and markedly

declines after menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.

at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

We entered into a joint

development agreement with Cleveland Clinic to advance this vaccine toward human clinical testing.

May 2021, Cleveland Clinic was granted an award for our ovarian cancer vaccine technology by the National Cancer Institute’s (“NCI”)

PREVENT program.

The NCI is a part of the National Institutes of Health.

The PREVENT program is a peer-reviewed agent development program

designed to support preclinical development of innovative interventions and biomarkers for cancer prevention and interception towards

clinical trials.

The scientific and financial resources of the PREVENT program will be used for our ovarian cancer vaccine technology

to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies.

This work will be performed at

NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company,

nor the transfer of any rights to the Company’s assets.

July 2020, we implemented a strategic realignment of our business and redirected resources to exclusively focus on the development of

therapeutics and vaccines.

Accordingly, we suspended operations of our subsidiary, Anixa Diagnostics Corporation, and the development

of the Cchek™

artificial intelligence driven platform of non-invasive blood tests for the early detection of cancer.

the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic discovery

program and Certainty’s CAR-T technology to be the primary focus of the Company.

As part of our legacy operations, the Company

remains engaged in limited patent licensing activities regarding the Cchek™

liquid biopsy platform, as well as in the area

of encrypted audio/video conference calling.

We do not expect these activities to be a significant part of the Company’s

ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.

the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue

from the settlement of litigation.

of the Cchek™ artificial intelligence driven platform of non-invasive blood tests for the early detection of cancer.

the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic discovery program

and Certainty’s CAR-T technology to be the primary focus of the Company.

As part of our legacy operations, the Company remains

engaged in limited patent licensing activities regarding the Cchek™ liquid biopsy platform, as well as in the area of encrypted

audio/video conference calling.

We do not expect these activities to be a significant part of the Company’s ongoing operations

nor do we expect these activities to require material financial resources or attention of senior management.

the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from

the settlement of litigation.

We have not generated any revenue to date from our therapeutics or vaccine programs.

while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional

emerging technologies.

We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs

in the near term.

We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies

that have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines.

The eventual licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive

results from human clinical trials.

was formed to develop immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby

we obtained rights to certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.

In addition, while

we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging

technologies.

We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near

We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the

resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines.

The eventual licensing

of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human clinical trials.

was formed to develop immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby we obtained

rights to certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.

therapeutics have demonstrated positive results in B-cell cancers, but very little progress has been made on solid tumors.

CAR-T technology is initially focused on ovarian cancer and is based on engineering killer T-cells with the Follicle Stimulating

Hormone (“FSH”) to target ovarian cells that express the FSH-Receptor.

Data on this technology, including the animal

studies showing efficacy, was published in January 2017 in the journal, Clinical Cancer Research.

The FSH-Receptor has been shown

to be a very exclusive protein found on a large percentage of ovarian cancer cells, but not on a significant number of non-ovarian

healthy tissues in adult females.

have shown that the FSH-Receptor is also expressed in endothelial cells of the vasculature of neoplasias We anticipate performing

further studies to evaluate the ability of our CAR-T to disrupt the vasculature of other cancers, after we commence clinical trials

of this technology against ovarian cancer.

are working with researchers at Moffitt to complete studies necessary to submit an IND application with the FDA.

We then anticipate

taking this therapy into human clinical testing for patients suffering from ovarian cancer.

Moffitt is one of the top cancer centers

in the country with pre-clinical and clinical expertise with CAR-T technology.

Moffitt has conducted many of the highest profile

CAR-T trials in the world.

have performed numerous studies in preparation for an IND application.

In those studies, several groups of tumor free, female

mice were intra-peritoneally infused with increasing concentrations of the murine CAR-T construct and their health status was

monitored for up to five months.

The following summarizes the results of these studies:

treated mice showed any signs of pain/stress, difficulty breathing or increased respiratory rate, reduced movement, reduced

grooming or feeding, dehydration, anorexia or any other sign of distress.

technology is initially focused on ovarian cancer and is based on engineering killer T-cells with the Follicle Stimulating Hormone (“FSH”)

to target ovarian cells that express the FSH-Receptor.

Data on this technology, including the animal studies showing efficacy, was published

in January 2017 in the journal, Clinical Cancer Research.

The FSH-Receptor has been shown to be a very exclusive protein found on a large

percentage of ovarian cancer cells, but not on a significant number of non-ovarian healthy tissues in adult females.

have shown that the FSH-Receptor is also expressed in endothelial cells of the vasculature of neoplasias.

We anticipate performing further

studies to evaluate the ability of our CAR-T to disrupt the vasculature of other cancers, after we commence clinical trials of this technology

against ovarian cancer.

have been working with researchers at Moffitt to complete the steps necessary to commence human clinical testing of our CAR-T therapy

for patients suffering from ovarian cancer.

Moffitt is one of the top cancer centers in the country with pre-clinical and clinical expertise

with CAR-T technology.

Moffitt has conducted many of the highest profile CAR-T trials in the world.

performed numerous studies in preparation for the IND application.

In those studies, several groups of tumor free, female mice were intra-peritoneally

infused with increasing concentrations of the murine CAR-T construct and their health status was monitored for up to five months.

following summarizes the results of these studies:

treated mice showed any signs of pain/stress, difficulty breathing or increased respiratory

rate, reduced movement, reduced grooming or feeding, dehydration, anorexia or any other sign

Control mice also did not show any distress.

1 unchanged sentence

Control mice also did not show any weight loss.

cohort of treated mice also had blood drawn periodically for measurement of markers for liver function (AST-Aspartate transaminase/ALT-Alanine

transaminase), kidney function (creatinine), and metabolic function (glucose).

No abnormal values were observed, as was the

case for control mice.

IL-6 (interleukin-6) increased in the treated mice, as well as mice treated with control T-cells.

This indicated that the

T-cells were inducing the expected inflammatory response.

analysis of the ovaries showed that 60% of the treated mice had significant reduction in ovarian mass, while the control mice

exhibited no reduction.

This observation confirms that the CAR-T was successfully attacking the ovaries, as we hoped and expected.

cohort of treated mice also had blood drawn periodically for measurement of markers for liver

function (AST-Aspartate transaminase/ALT-Alanine transaminase), kidney function (creatinine),

and metabolic function (glucose).

No abnormal values were observed, as was the case for control

IL-6 (interleukin-6) increased in the treated mice, as well as mice treated with control

This indicated that the T-cells were inducing the expected inflammatory response.

● Histological

analysis of the ovaries showed that 60% of the treated mice had significant reduction in

ovarian mass, while the control mice exhibited no reduction.

This observation confirms that

the CAR-T was successfully attacking the ovaries, as we hoped and expected.

these results are positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization.

In the future, we hope to achieve a profitable outcome by eventually licensing our technology to a large pharmaceutical company

that has the resources and infrastructure in place to manufacture, market and sell our technology as a cancer treatment.

October 2018, we attended a pre-IND meeting with the FDA to discuss numerous aspects of the planned clinical trial of our CAR-T

therapy for ovarian cancer.

The FDA answered a number of questions, providing a good understanding of the design for the clinical

trial in our IND application.

have completed the manufacturing of the clinical grade vector and are in the process of testing the materials and completing the

IND application.

We anticipate filing the IND in the first calendar quarter of 2021.

The IND application, after review and approval

by the FDA, will enable us to begin testing our therapy in ovarian cancer patients.

Assuming the FDA approves our IND application,

we anticipate beginning the human clinical trial as early as mid-2021.

future, we hope to achieve a profitable outcome by eventually licensing our technology to a large pharmaceutical company that has the

resources and infrastructure in place to manufacture, market and sell our technology as a cancer treatment.

anticipate beginning the human clinical trials in the first calendar quarter of 2022.

This study is a dose-escalation trial with two

arms based on injection method—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent

epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T-cells.

The study is being conducted at

Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of chemotherapy.

The study is estimated to be

completed in two to four years depending on multiple factors including when maximum tolerated dose is reached and the rate of patient

believe that our CAR-T technology may be used as an effective treatment against multiple solid tumor types, however, we have initially

focused on ovarian cancer.

According to American Cancer Society statistics, ovarian cancer accounts for just 2.4% of all female

cancer cases, but 5% of cancer deaths in women due to the disease’s low survival rate.

It is estimated that in 2020, 22,000

According to American Cancer Society statistics, ovarian cancer accounts for just 2% of all female cancer

cases, but 5% of cancer deaths in women due to the disease’s low survival rate.

It is estimated that in 2021, approximately 21,000

new cases of ovarian cancer will be diagnosed and 14,000 American women will die from this disease.

Despite continuous advances

made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative

survival rate for ovarian cancer patients is 48%.

However, ovarian cancer survival varies substantially by age, with the overall

five-year survival rate for women 65 and older of only 31%.

Despite continuous advances made

in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative survival

rate for ovarian cancer patients is 49%.

However, ovarian cancer survival varies substantially by age, with the overall five-year survival

rate for women 65 and older of only 32%.

biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies.

1 unchanged sentence

that may become available in the future.

While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for

treating solid tumors and scientific expertise in the field of cell therapy provide us with competitive advantages, we face potential

competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as from

academic institutions, governmental agencies and public and private research institutions.

While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for treating

solid tumors and scientific expertise in the field of cell therapy provide us with competitive advantages, we face potential competition

from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions,

governmental agencies and public and private research institutions.

of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources

than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other

regulatory approvals of treatments and commercializing those treatments.

Accordingly, our competitors may be more successful than

us in obtaining approval for treatments and achieving widespread market acceptance.

Our competitors’

treatments may be more

effective, or more effectively marketed and sold, than any treatment we may commercialize and may render our treatments obsolete

or non-competitive before we can recover the expenses of developing and commercializing any of our treatments.

and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among

a smaller number of our competitors.

These competitors also compete with us in recruiting and retaining qualified scientific and

management personnel and establishing clinical study sites and subject registration for clinical studies, as well as in acquiring

technologies complementary to, or necessary for, our program.

Smaller or early-stage companies may also prove to be significant

competitors, particularly through collaborative arrangements with large and established companies.

anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become

We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy,

safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more

effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for

ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

disease 2019 (“COVID-19”) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”).

The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread

globally, resulting in the ongoing coronavirus pandemic.

SARS-CoV-2 is highly infectious, and while in the majority of cases results

in mild symptoms, in many cases the symptoms progress to viral pneumonia and multi-organ failure.

are currently no proven broadly effective treatments.

Further, all treatments that are currently being employed require administration

in a hospital setting, thus continuing to overburden the healthcare system.

In addition, nearly all treatments currently in clinical

trials were originally developed for other indications, and were not designed specifically against SARS-CoV-2, and therefore may

have limited effectiveness.

We believe that newly designed drugs that are purposefully developed to specifically target SARS-CoV-2,

enabled by recent studies of the molecular biology of the virus, will have the potential to be far more effective than repurposing

existing drugs.

April 2020, we entered into a collaboration agreement with OntoChem for the purpose of discovering and ultimately developing anti-viral

drug candidates for COVID-19.

Our collaboration has focused on two specific proteins of the coronavirus.

The first protein is

the main protease (“M pro ”), which is an enzyme of the virus that severs a large poly-peptide into functional

proteins that enable the virus to replicate in a human host.

Our program will attempt to identify molecules that inhibit the function

of this enzyme, and potentially stop or slow the virus’

ability to replicate and cause disease.

Since this protease does

not have human analogs, potential inhibitors may not affect any human proteins and therefore toxic side effects may be minimized.

second target is an endoribonuclease, Non-Structural Protein-15 (“NSP-15”), which plays a role in breaking up the

ribonucleic acid, or the genetic content, of the virus.

Recent studies have demonstrated that the endoribonuclease of many viruses,

including the SARS virus of 2003 and, it is believed the SARS-CoV-2, binds to a human host protein.

This protein-protein interaction

appears to dramatically increase the infectivity of the virus.

Because this interaction between a viral protein and a human protein

appears to be common to many viruses, compounds that are able to effectively disrupt this interaction, could function as broad

spectrum anti-virals in addition to addressing COVID-19.

our collaboration, we utilized advanced computational methods, machine learning and molecular modeling techniques to perform in

silico screening of over 1.2 billion compounds in OntoChem’s chemistry and gene ontology database (including publicly

available compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt M pro

or NSP-15 and to evaluate the molecules’

than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory

approvals of treatments and commercializing those treatments.

Accordingly, our competitors may be more successful than us in obtaining

approval for treatments and achieving widespread market acceptance.

Our competitors’ treatments may be more effective, or more

effectively marketed and sold, than any treatment we may commercialize and may render our treatments obsolete or non-competitive before

we can recover the expenses of developing and commercializing any of our treatments.

and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller

number of our competitors.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel

and establishing clinical study sites and subject registration for clinical studies, as well as in acquiring technologies complementary

to, or necessary for, our program.

Smaller or early-stage companies may also prove to be significant competitors, particularly through

collaborative arrangements with large and established companies.

anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available.

We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience

of administration and delivery, price and the availability of reimbursement from government and other third-party payers.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors

also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result

in our competitors establishing a strong market position before we are able to enter the market.

disease 2019 (“COVID-19”) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”).

The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread globally,

resulting in the ongoing coronavirus pandemic.

SARS-CoV-2 is highly infectious, and while in the majority of cases results in mild symptoms,

in many cases the symptoms progress to viral pneumonia and multi-organ failure.

are currently few broadly available effective treatments.

Further, most treatments that are currently being employed require administration

in a hospital setting, thus continuing to overburden the healthcare system, and the orally-available treatments developed by Pfizer and

Merck have only recently received authorization by the FDA.

In addition, nearly all treatments currently in use or in clinical trials

were originally developed for other indications, and were not designed specifically against SARS-CoV-2, and therefore may have limited

effectiveness.

We believe that newly designed drugs that are purposefully developed to specifically target SARS-CoV-2, enabled by recent

studies of the molecular biology of the virus, will have the potential to be far more effective than repurposing existing drugs.

April 2020, we entered into a collaboration agreement with OntoChem, who subsequently assigned its rights and obligations under the collaboration

agreement to MolGenie, for the purpose of discovering and ultimately developing anti-viral drug candidates for COVID-19.

Our collaboration

has primarily focused on the virus’ main protease (“M pro ”), which is an enzyme of the virus that severs

a large poly-peptide into functional proteins that enable the virus to replicate in a human host.

Our program has focused on identifying

molecules that inhibit the function of this enzyme, and potentially stop or slow the virus’ ability to replicate and cause disease.

Since this protease does not have human analogs, potential inhibitors may not affect any human proteins and therefore toxic side effects

may be minimized.

our collaboration, we utilized advanced computational methods, machine learning and molecular modeling techniques to perform in silico

screening of over 1.2 billion compounds in OntoChem’s chemistry and gene ontology database (including publicly available compounds

and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt M pro and to evaluate the molecules’

potential side effects, as well as their drug-like characteristics.

screening process resulted in identifying a large number of compounds that could potentially be safe and effective against COVID-19.

selected the ten most promising compounds for synthesis and biological analysis.

Biological testing of these compounds requires

use of live virus, which limits the laboratories qualified to perform the necessary assays to Biosafety Level 3 (“BSL-3”)

or Biosafety Level 4 labs.

While availability of these labs is limited, we successfully established a relationship with a BSL-3

government lab in Europe, where biological assays, including binding assays, cellular assays, and viral activity assays, are currently

being performed.

Further, this lab has animal facilities and upon completion of the biological testing, will be prepared to test

the compounds in animals to determine which compound may be appropriate for clinical evaluation.

Centers for Disease Control and Prevention (“CDC”) data, as of the date of this Report, in the U.S., there

have been over 20 million cases of COVID-19 and over 350,000 deaths.

According to World Health Organization (“WHO”)

data, globally, there have been over 85 million cases and approximately 1.9 million people have died.

over the last three months, infections and deaths have increased.

there are no broadly effective treatments for COVID-19.

Further, the treatments that are currently being employed, such as Remdesivir

and various steroid and antibody treatments, are all in-patient therapeutics and require hospitalization, adding to the burden

on the healthcare system.

A better approach, which we are employing, would be a therapeutic that can be formulated as a pill and

taken as soon as there is a positive test for COVID-19.

market for an orally delivered COVID-19 treatment that would dramatically reduce hospitalization rates would be significant given

the current infection rates.

The most recent CDC predictions indicate that in the U.S.

alone new infections will remain at over

1.3 million cases per week and deaths will be nearly 20,000 per week through January 2021.

This screening process resulted in identifying a large number of

compounds that could potentially be safe and effective against COVID-19.

screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus.

Several of these compounds were synthesized and tested in in vitro biological assays.

Upon completion of these biological assays,

we identified two of the most promising compounds and tested them in animal models.

In these animal studies, the two compounds were compared

to Remdesivir, which at the time the assays were performed was the only anti-viral drug authorized by the FDA for COVID-19.

showed that administration of the drugs to infected hamsters did not cause any noticeable adverse effects, and monitoring of weight and

general animal behavior demonstrated comparable efficacy between each of our compounds and Remdesivir.

Based on this promising data in

the animal study, we directed our team at OntoChem to proceed to the next stage of drug development and we selected one of the compounds

around which OntoChem and other third-party service providers are performing combinatorial synthetic medicinal chemistry to evaluate

whether potency can be increased and pharmacokinetics optimized.

SARS-CoV-2 has continued to mutate over the course of the pandemic, we have performed genomic variant analysis to determine whether our

compounds may be effective against new variants as they have arisen.

To date, the results of such analyses have shown that either

no significant mutations have been found in or near the active site of the M pro enzyme or any known mutations do not change

the function of the enzyme, and therefore we believe that our compounds should be effective against the Delta variant, as well as the

newly identified Omicron variant, which has become the most common form of the virus circulating in the U.S., though there is no assurance

that this will be the case.

According to U.S.

for Disease Control and Prevention (“CDC”) data, as of the date of this Report, in the U.S., there have been nearly 54

million cases of COVID-19 and over 820,000 deaths.

According to World Health Organization (“WHO”) data, globally,

there have been over 280 million cases and over 5.4 million people have died.

there are few broadly available effective treatments for COVID-19.

Further, the most common treatments that are currently being employed,

such as Remdesivir and various steroid and antibody treatments, are all in-patient therapeutics and require hospitalization, adding to

the burden on the healthcare system.

We believe that a better approach, which we are employing, would be a therapeutic that can be formulated

as a pill and taken as soon as there is a positive test for COVID-19.

While two orally-available anti-viral treatments developed by Pfizer

and Merck have recently been authorized for emergency use by the FDA, both have limitations as Pfizer’s treatment requires a combination

therapy with an antiretroviral drug commonly used to treat HIV and the Merck treatment has shown limited efficacy.

market for orally delivered COVID-19 treatments that would dramatically reduce hospitalization rates would be significant, especially

if such treatments were effective against multiple variants of the virus.

in the COVID-19 treatment and prevention market is fierce, with hundreds of therapies and vaccines currently in development.

a number of preventative vaccines have received regulatory approvals in the U.S.

There are still many questions

about these vaccines, such as persistence and viral escape, and it will take time before it is known how well and for how long

they will provide protection from infection.

Any product candidates that we successfully develop and commercialize will have to

compete with existing therapies and vaccines and new therapies and vaccines that may become available in the future.

believe that our proprietary compounds for treating COVID-19 and scientific expertise in the field of synthetic chemistry provide

us with competitive advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical

and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions.

currently a number of preventative vaccines that have received regulatory approvals globally.

While these vaccines have been effective

in reducing the spread of COVID-19, there remain challenges regarding persistence and viral escape as well as the resistance to vaccination

by a significant portion of the population and also the difficulty in vaccinating and boosting the world population.

Further, there are

currently two new orally-available anti-viral treatments, the combination protease-inhibitor-antiretroviral Paxlovid developed by Pfizer

and the polymerase-inhibitor molnupiravir developed by Merck, that have recently been authorized for emergency use in the U.S.

candidates that we successfully develop and commercialize will have to compete with existing therapies and vaccines and new therapies

and vaccines that may become available in the future.

While we believe that our proprietary compounds for treating COVID-19 and scientific

expertise in the field of synthetic chemistry provide us with competitive advantages, we face potential competition from various sources,

including larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies

and public and private research institutions.