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Item 1. Business

2023-01-04 compared with 2022-01-04 · 299 added, 297 removed, 203 unchanged (75% of the section changed)

Biosciences, Inc.

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

is a biotechnology company developing vaccines and therapies 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

Our vaccine programs include (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) the development of a preventative

vaccine against ovarian cancer.

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 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

(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.

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 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.

Foundation (“Cleveland Clinic”) relating to 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

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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

Food and Drug Administration’s (“FDA”) 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.

This study, which is being funded

Department of Defense grant, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”)

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

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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.

Initial indications

from preliminary analyses suggest that an immune response is being observed.

In December 2022, we announced that we had reached the MTD.

We are now expanding the MTD cohort and are vaccinating additional participants at that dose level.

Upon completion of vaccination and

follow-up tests of the expanded cohort, we will compile and analyze the data, and we anticipate presenting the complete immunological

data from the trial at a scientific conference or similar setting in the second calendar quarter of 2023.

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

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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

designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards

clinical trials.

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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.

This work is being 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.

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

We received authorization

from the FDA in August 2021, to commence enrollment and treatment of patients in a Phase 1 clinical trial.

We began patient recruitment

for the trial in March 2022, and in August 2022, we treated the first patient in the trial.

The treatment appears to have been well-tolerated

by the patient, and we continue to monitor her condition.

The process of recruiting additional patients is ongoing.

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, the rate of patient

recruitment, and how long we maintain the two different injection methods.

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 the identification of multiple compounds that could potentially disrupt critical enzymes of the virus,

including the virus’ main protease, M pro .

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

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.

The data 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 is performing combinatorial synthetic medicinal chemistry

to evaluate whether potency can be increased and pharmacokinetics optimized.

This work is ongoing.

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.

We believe that 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 new anti-viral treatments, such as Pfizer’s

Paxlovid, which is a combination therapy consisting of the protease-inhibitor nirmatrelvir and the antiretroviral ritonavir, that have

been authorized for use in the U.S.

As the main component of Pfizer’s treatment is a protease-inhibitor targeting M pro ,

it is most similar to our compounds, and we therefore conducted a head-to-head analysis via a Fluorescence Resonance Energy Transfer

(FRET) assay that tested the ability of the compounds to inhibit the function of M pro .

The results of this head-to-head in

vitro analysis suggested that our compounds may be five times more effective at inhibiting M pro than Pfizer’s nirmatrelvir.

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

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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.

engaged in limited patent licensing activities regarding its liquid biopsy platform and in the area of encrypted audio/video conference

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

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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.

Our strategy is 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.

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.

and Ovarian Cancer vaccines

licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers

which express the α-lactalbumin protein.

This protein is only expressed during lactation in healthy women, but may also be expressed

in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer.

Further, we have licensed certain

technology from Cleveland Clinic to develop vaccines for the treatment or prevention of ovarian cancers which express AMHR2-ED.

protein regulates growth and development of egg-containing follicles in the ovary and its expression naturally and markedly declines

after menopause.

However, AMHR2-ED is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.

vaccines harness the immune system to protect people from infectious diseases.

Broad-based vaccination programs have essentially eliminated

some of the most deadly and debilitating diseases in history, small pox and polio among them.

However, there has been little success

developing a preventative (prophylactic) vaccine against cancer.

work by exposing a benign form of a disease agent to an individual’s immune system.

The immune system identifies the agent and

learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react quickly if an individual is exposed

to the disease agent months or years later.

vaccines attack pathogens, such as viruses and bacteria.

The immune system is better able to assail these agents because they come from

outside the body.

Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for

our immune system to find the diseased cells, especially as advancing age weakens our immune system.

Once these aberrant cells gain critical

mass, they become cancer.

the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval

and commercialization of revolutionary immuno-therapy drugs.

These drugs do not attack cancer directly, but rather modulate the immune

system in ways that enable it to destroy or dramatically impair cancer cells.

breast cancer vaccine technology licensed from Cleveland Clinic has identified a protein, alpha-lactalbumin, that is present in healthy

breast tissue only when a woman is lactating and disappears when she stops nursing her child.

Alpha-lactalbumin is never present on any

other cell in the body.

However, it does show up in many types of breast cancer, including TNBC, an aggressive and deadly form of the

By developing a vaccine that targets alpha-lactalbumin, we feel the immune system can destroy these breast cancer cells as they

arise and ultimately prevent breast tumors from forming.

Clinic researchers have demonstrated in animal studies that vaccination against alpha-lactalbumin completely prevented breast cancer

in mice that were specifically bred to develop breast cancer.

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

was published in March 2016 in the journal, Cancers.

ovarian cancer vaccine technology licensed from Cleveland Clinic has identified the AMHR2-ED protein, the expression of which is involved

in egg production in the ovaries and is no longer expressed after menopause.

AMHR2-ED is not meaningfully present on any other cell in

However, it does appear in many cases of epithelial ovarian cancers, the most common type of ovarian cancer.

By developing

a vaccine that targets AMHR2-ED, we feel the immune system can destroy these ovarian cancer cells as they arise and ultimately prevent

tumors from forming.

Data on this technology, including animal studies showing efficacy, was published in November 2017 in the journal,

Cancer Prevention Research.

the data thus far for both of our cancer vaccines has been positive, there are many uncertainties in drug development, and most drugs

fail to reach commercialization.

October 2021, Cleveland Clinic began treating patients in a Phase 1 clinical trial of our breast cancer vaccine.

In addition, we and

our partners at Cleveland Clinic continue working with the NCI who are or will be performing pre-clinical research and development, manufacturing

and IND-enabling studies to advance our ovarian cancer vaccine technology toward human clinical testing.

Breast Cancer Market

to American Cancer Society statistics, breast cancer accounts for over 30% of all female cancer cases, and 15% of cancer deaths in women.

It is estimated that in 2022, 288,000 new cases of breast cancer will be diagnosed in the U.S.

and 43,000 women will die from this disease.

Despite continuous advances made in the field of cancer research every year, invasive female breast cancer incidence rates have been

increasing by approximately 0.5% per year over the past 15 years.

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

doctors administer cancer drugs only after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people

who have a possibility of developing the disease.

in the U.S., 288,000 women are estimated to be diagnosed with breast cancer this year, there are approximately 82 million women age 40

and over—the time in life when women face an increased risk of developing breast cancer.

Worldwide, the number is dramatically

Ovarian Cancer Market

to American Cancer Society statistics, ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer

deaths in women due to the disease’s low survival rate.

It is estimated that in 2022, 20,000 new cases of ovarian cancer will

be diagnosed and 13,000 American women will die from this disease.

Despite continuous advances made in the field of cancer research

every year, we believe 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 33%.

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

the U.S., 20,000 women are estimated to be diagnosed with ovarian cancer this year, there are approximately 41 million women age 60 and

over—the time in life when women face an increased risk of developing ovarian cancer.

Worldwide, the number is dramatically larger.

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

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

that may become available in the future.

While we believe that our proprietary breast and ovarian cancer vaccine technologies 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 vaccines and commercializing those vaccines.

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

for vaccines and achieving widespread market acceptance.

Our competitors’ vaccines may be more effective, or more effectively marketed

and sold, than any vaccine we may commercialize and may render our vaccines obsolete or non-competitive before we can recover the expenses

of developing and commercializing any of our vaccines.

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 programs.

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 and vaccines enter the market and advanced technologies

become available.

We expect any vaccines 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 opportunities 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 approvals for their products more rapidly than we may obtain approvals for ours, which could

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

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

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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.

studies to evaluate the ability of our CAR-T to disrupt the vasculature of other cancers, after we have analyzed data from clinical trials

of this technology against ovarian cancer.

have been working with researchers at Moffitt to develop our CAR-T therapy.

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:

performed numerous studies in preparation for human clinical studies.

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

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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

August 2022, we treated the first patient in the trial.

The treatment appears to have been well-tolerated by the patient, and we continue

to monitor her condition.

The process of recruiting additional patients is ongoing.

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.

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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

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

and how long we maintain the two different injection methods.

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

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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.

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

It is estimated that in 2022, approximately

20,000 new cases of ovarian cancer will be diagnosed and 13,000 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

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%.

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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.

are currently few broadly effective treatment options.

Further, 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

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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.

the animal study, we directed our collaboration partners to proceed to the next stage of drug development and we selected one of the

compounds around which our partners and other third-party service providers are performing combinatorial synthetic medicinal chemistry

to evaluate whether potency can be increased and pharmacokinetics optimized.

This work is ongoing.

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.

compounds may be effective against multiple variants.

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 multiple variants, including the Omicron variant and its subvariants,

though there is no assurance that this will be the case.

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

been over 100 million cases of COVID-19 and nearly 1.1 million deaths.

According to World Health Organization (“WHO”)

data, globally, there have been 650 million cases and over 6.6 million people have died.

While the infection and death rates have

reduced significantly since the peak of the pandemic, according to the most recent CDC data, in the U.S.

the current 7-day average

of weekly new cases is approximately 65,000, the 7-day average daily hospitalizations is approximately 5,000 and the 7-day average

daily deaths is over 400.

there are few broadly effective treatment options 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.

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

effectiveness.

In addition, the orally-available anti-viral treatment developed by Pfizer has limitations as it requires a combination

therapy with an antiretroviral drug commonly used to treat HIV and is known to have challenging side effects.

market for orally delivered COVID-19 treatments that are effective against multiple variants of the virus, with limited side effects

would be significant.

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

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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.

Further, the current

leading treatment is the orally-available combination protease-inhibitor-antiretroviral Paxlovid, developed by Pfizer.

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.

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.

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

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

and Ovarian Cancer vaccines

licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers

which express the α-lactalbumin protein.

This protein is only expressed during lactation in healthy women, but may also be expressed

in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer.

Further, we have licensed certain

technology from Cleveland Clinic to develop vaccines for the treatment or prevention of ovarian cancers which express AMHR2-ED.

protein regulates growth and development of egg-containing follicles in the ovary and its expression naturally and markedly declines

after menopause.

However, AMHR2-ED is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.

vaccines harness the immune system to protect people from infectious diseases.

Broad-based vaccination programs have essentially eliminated

some of the most deadly and debilitating diseases in history, small pox and polio among them.

However, there has been little success

developing a preventative (prophylactic) vaccine against cancer.

work by exposing a benign form of a disease agent to an individual’s immune system.

The immune system identifies the agent and

learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react quickly if an individual is exposed

to the disease agent months or years later.

vaccines attack pathogens, such as viruses and bacteria.

The immune system is better able to assail these agents because they come from

outside the body.

Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for

our immune system to find the diseased cells, especially as advancing age weakens our immune system.

Once these aberrant cells gain critical

mass, they become cancer.

the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval

and commercialization of revolutionary immuno-therapy drugs.

These drugs do not attack cancer directly, but rather modulate the immune

system in ways that enable it to destroy or dramatically impair cancer cells.

breast cancer vaccine technology licensed from Cleveland Clinic has identified a protein, alpha-lactalbumin, that is present in healthy

breast tissue only when a woman is lactating and disappears when she stops nursing her child.

Alpha-lactalbumin is never present on any

other cell in the body.

However, it does show up in many types of breast cancer, including TNBC, an aggressive and deadly form of the

By developing a vaccine that targets alpha-lactalbumin, we feel the immune system can destroy these breast cancer cells as they

arise and ultimately prevent breast tumors from forming.

Clinic researchers have demonstrated in animal studies that vaccination against alpha-lactalbumin completely prevented breast cancer

in mice that were specifically bred to develop breast cancer.

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

was published in March 2016 in the journal, Cancers.

ovarian cancer vaccine technology licensed from Cleveland Clinic has identified the AMHR2-ED protein, the expression of which is involved

in egg production in the ovaries and is no longer expressed after menopause.

AMHR2-ED is not meaningfully present on any other cell in

However, it does appear in many cases of epithelial ovarian cancers, the most common type of ovarian cancer.

By developing

a vaccine that targets AMHR2-ED, we feel the immune system can destroy these ovarian cancer cells as they arise and ultimately prevent

tumors from forming.

Data on this technology, including animal studies showing efficacy, was published in November 2017 in the journal,

Cancer Prevention Research.

the data thus far for both of our cancer vaccines has been positive, there are many uncertainties in drug development, and most drugs

fail to reach commercialization.

2021, we worked with researchers at Cleveland Clinic to advance the breast cancer vaccine technology toward human clinical testing, and

in October 2021, began treating patients in a Phase 1 clinical trial.

In addition, in May 2021, we and our partners at Cleveland Clinic

began working with the NCI who will perform all pre-clinical research and development, manufacturing and IND-enabling studies to advance

our ovarian cancer vaccine technology toward human clinical testing.

Breast Cancer Market

to American Cancer Society statistics, breast cancer accounts for 30% of all female cancer cases, and 15% of cancer deaths in women.

It is estimated that in 2021, 282,000 new cases of breast cancer will be diagnosed in the U.S.

and 44,000 women will die from this disease.

Despite continuous advances made in the field of cancer research every year, there has been little change in breast cancer incidence

rate over the last ten years.

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

doctors administer cancer drugs only after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people

who have a possibility of developing the disease.

in the U.S., 282,000 women are estimated to be diagnosed with breast cancer this year, there are approximately 75 million women over

the age of 40—the time in life when women face an increased risk of developing breast cancer.

Worldwide, the number is dramatically

Ovarian Cancer Market

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, 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 49%.

ovarian cancer survival varies substantially by age, with the overall five-year survival rate for women 65 and older of only 32%.

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

the U.S., 21,000 women are estimated to be diagnosed with ovarian cancer this year, there are approximately 30 million women over the

age of 60—the time in life when women face an increased risk of developing ovarian cancer.

Worldwide, the number is dramatically

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

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

that may become available in the future.

While we believe that our proprietary breast and ovarian cancer vaccine technologies 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 vaccines and commercializing those vaccines.

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

for vaccines and achieving widespread market acceptance.

Our competitors’ vaccines may be more effective, or more effectively marketed

and sold, than any vaccine we may commercialize and may render our vaccines obsolete or non-competitive before we can recover the expenses

of developing and commercializing any of our vaccines.

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 programs.

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 and vaccines enter the market and advanced technologies

become available.

We expect any vaccines 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 opportunities 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 approvals for their products more rapidly than we may obtain approvals for ours, which could

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

of October 31, 2022, we had five employees, four full-time and one part time, working for our Company and subsidiaries.

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have a history of losses and may incur additional losses in the future.

will need additional funding in the future which may not be available on acceptable terms,

or at all, and, if available, may result in dilution to our stockholders.

will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result

in dilution to our stockholders.

may have difficulty in raising capital and may consume resources faster than expected.

Related to our Research & Development, Clinical and Commercialization Activities

therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early stage

biotechnology company.

current business model relies on strategic collaborations with commercial partners to provide

the resources and infrastructure to manufacture and ultimately market and/or sell our technologies.

We may have difficulty in timing the establishment of these partnerships to achieve the greatest

economic benefit for the Company, or in establishing these partnerships at all.

product liability lawsuits are brought against us, we may incur substantial liabilities and

may be required to limit commercialization of our product candidates.

have never generated any revenue from biotechnology and pharmaceutical product sales and

our biotechnology and pharmaceutical products may never be profitable.

therapeutics and vaccines that we are developing are novel and present significant challenges

to successfully reaching market.

pre-clinical testing of our product candidates has been positive, we may experience unfavorable

results and unforeseen delays once we commence human clinical trials.

therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early stage biotechnology company.

current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to

manufacture and ultimately market and/or sell our technologies.

We may have difficulty in timing the establishment of these partnerships

to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.

product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization

of our product candidates.

have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products

may never be profitable.

therapeutics and vaccines that we are developing are novel and present significant challenges to successfully reaching market.

pre-clinical testing of our product candidates has been positive, we may experience unfavorable results and unforeseen delays once

we commence human clinical trials.

are dependent on third parties to conduct our pre-clinical and clinical trials.

we encounter difficulties enrolling patients in our clinical trials, our clinical development

activities could be delayed or otherwise adversely affected.

face significant competition from other biotechnology and pharmaceutical companies, and our

operating results will suffer if we fail to compete effectively.

we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise

adversely affected.

face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail

to compete effectively.

Related to our Intellectual Property

rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast

and ovarian cancer vaccine technologies, and if we lose any of these licenses we may be subjected

to future litigation.

rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies,

and if we lose any of these licenses it may remove or limit our ability to develop and commercialize products and technology covered

by these license agreements and we may be subjected to future litigation.

Related to our Common Stock

issuance or sale of shares in the future to raise money or for strategic purposes could reduce

the market price of our common stock.

have issued a significant number of securities pursuant to our incentive plans and may continue

to do so in the future.

The vesting and, if applicable, exercise of these securities and

the sale of the shares of common stock issuable thereunder may dilute your percentage ownership

interest and may also result in downward pressure on the price of our common stock.

issuance or sale of shares in the future, including in connection with our current “at the market offering” program,

to raise money or for strategic purposes could reduce the market price of our common stock.

have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.

and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage

ownership interest and may also result in downward pressure on the price of our common stock.

Related to the COVID-19 Pandemic

business activities, including our clinical trials, are expected to be delayed

or otherwise adversely affected by the ongoing COVID-19 pandemic.

business activities, including our clinical trials, may be delayed or otherwise adversely affected by the ongoing COVID-19 pandemic.

were incorporated on November 5, 1982 under the laws of the State of Delaware.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business