What changed in this filing

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Item 1. Business

2022-03-28 compared with 2021-03-25 · 591 added, 538 removed, 43 unchanged (96% of the section changed)

AIkido Pharma Inc.

was initially formed in 1967.

Since 2017, the Company has operated as a biotechnology company with a diverse portfolio

of small-molecule anticancer and antiviral therapeutics in development.

The Company’s pipeline consists of patented technology

from leading universities and researchers.

We are currently in the process of developing our innovative therapeutic drug pipeline

through strong partnerships with world renowned educational institutions, including the University of Texas at Austin, the University

of Maryland, Baltimore and Wake Forest University.

Our oncology therapeutics include treatments for pancreatic cancer, acute myeloid

leukemia (AML) and acute lymphoblastic leukemia (ALL).

The Company is also developing a broad-spectrum antiviral platform, in

which the lead compounds have activity against multiple viruses including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV,

MERS-CoV, and SARS-CoV-2, the cause of COVID-19.

a result of the Company’s biotechnology research and development and associated investments and acquisitions, our business

portfolio now focuses on the treatment of three different cancers and multiple types of viral infections.

Our pancreatic drug

candidate, DHA-dFdC, developed at and licensed from the University of Texas at Austin, is a new compound that we hope will become

the next generation of chemotherapy treatment for advanced pancreatic cancer.

DHA-dFdC overcomes tumor cell resistance to current

chemotherapeutic drugs and is well tolerated in preclinical toxicity tests.

Preclinical studies have also indicated that DHA-dFdC

inhibits pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine, a current standard therapy), targets

pancreatic tumors and has demonstrated activities against other cancers, including leukemia, lung and melanoma.

Our AML and ALL

compound, developed at the Wake Forest University, is a targeted therapeutic designed to overcome multiple resistance mechanisms

observed with the current standard of care.

broad-spectrum antiviral platform was developed at the University of Maryland Baltimore (“UMB”), which granted the

Company an exclusive worldwide Master License Agreement (MLA”) to technology covered by three separate patent applications.

The licensed technology comprises broadly acting pan-viral inhibitory compounds targeting multiple viral pathogens.

The technology

was invented by UMB scientists Drs.

Matthew Frieman, Alexander MacKerell and Stuart Watson.

The Company has also executed a Sponsored

Research Agreement with UMB to support the development of the technology under the direction of these inventors at UMB.

addition, we are constantly seeking to grow our pipeline of treatments in oncology indications.

For example, in January 2021,

the Company invested in Convergent Therapeutics, Inc., which has exclusive rights to technology related to next-generation dual-action

peptide receptor radionuclide therapy (“PRRT”) for prostate cancer covered by multiple issued U.S.

Since 2017, the Company has operated as a biotechnology company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics

in development.

The Company’s pipeline consists of patented technology from leading universities and researchers.

Our innovative

therapeutic drug pipeline is being advanced through strong collaborations with renowned educational institutions, including the University

of Texas at Austin, the University of Maryland, Baltimore and Wake Forest University.

Our oncology therapeutics include treatments for

pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

The Company is also developing a broad-spectrum

antiviral platform, in which the lead compounds have activity against multiple viruses including Influenza virus, Ebolavirus and Marburg

virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the cause of COVID-19.

As a result of the Company’s biotechnology

research and development and associated investments and acquisitions, our business portfolio now focuses on the treatment of three different

cancers and multiple types of viral infections.

Our pancreatic drug candidate, DHA-dFdC, developed at and licensed from the University

of Texas at Austin, is a new compound that we hope will become the next generation of chemotherapy treatment for advanced pancreatic

DHA-dFdC overcomes tumor cell resistance to current chemotherapeutic drugs and is well tolerated in preclinical toxicity tests.

Preclinical studies have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine,

a current standard therapy), accumulates preferentially in pancreatic tissue, and has demonstrated activities against other cancers,

including leukemia, lung and melanoma.

Our AML and ALL compound, developed at the Wake Forest University, is a targeted therapeutic designed

to overcome multiple resistance mechanisms observed with the current standard of care.

Our broad-spectrum antiviral platform was developed

at the University of Maryland Baltimore (“UMB”), which granted the Company an exclusive worldwide Master License Agreement

(MLA”) to technology covered by three separate patent applications.

The licensed technology comprises broadly acting pan-viral

inhibitory compounds targeting multiple viral pathogens.

The technology was invented by UMB scientists Drs.

Matthew Frieman, Alexander

MacKerell and Stuart Watson.

The Company has also executed a Sponsored Research Agreement with UMB to support the development of the

technology under the direction of these inventors at UMB.

In addition, we are constantly seeking to grow

our pipeline of treatments in oncology indications.

For example, in January 2021, the Company invested in Convergent Therapeutics, Inc.,

which has exclusive rights to technology related to next-generation dual-action peptide receptor radionuclide therapy (“PRRT”)

for prostate cancer covered by multiple issued U.S.

and foreign patents.

Convergent is currently conducting advanced human trials relating to prostate cancer treatments utilizing PRRT that targets the

prostate-specific membrane antigen (“PSMA”) present on prostate cancer cells.

The technology was developed under the

direction of Dr.

Convergent is currently conducting advanced human trials relating

to prostate cancer treatments utilizing PRRT that targets the prostate-specific membrane antigen (“PSMA”) present on prostate

cancer cells.

A phase I clinical trial on the next-generation dual-action PRRT we licensed is also currently underway.

The technology

was developed under the direction of Dr.

Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.

In addition, the Company was granted a

license to four patent applications for the use of psilocybin in cancer indications.

Additionally,

on January 6, 2021 the Company announced that it entered into an exclusive patent license agreement with Silo Pharma Inc.

Pharma”) pursuant to which Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license

to certain Silo Pharma owned provisional patent applications directed to the use of psilocybin in cancer treatment, and any patents

issuing therefrom, including all continuations, continuations-in-part, divisions, extensions, substitutions, reissues, re-examinations,

and any applications and all patents issuing from any applications and patents that claim domestic benefit or foreign priority

to the provisional patent applications.

The license is for “Field of Use”

(as defined in the exclusive patent license

agreement) of “treatment of cancer and symptoms caused by cancer, including but not limited to pain, nausea, neuroinflammation,

brain and neural dysfunction, depression, seizures, confusion, dizziness, numbness/tingling, dysfunction of the senses and all

other symptoms that are caused by cancer of any type.”

Drugs in Development

from the University of Texas at Austin

(4-(N)-Docosahexaenoyl 2´, 2´-Difluorodeoxycytidine) is patented technology licensed to the Company from the University

of Texas at Austin.

DHA-dFdC is a new compound we believe may become the next generation of second-line chemotherapy treatment

for advanced pancreatic cancer.

DHA-dFdC overcomes tumor cell resistance to current chemotherapeutic drugs and is well tolerated

in preclinical toxicity tests.

Preclinical studies, referenced in subsection DHA-dFdC Published Data below, have

also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine, a current

Additionally, on January 6, 2021 the Company

announced that it entered into an exclusive patent license agreement with Silo Pharma Inc.

(“Silo Pharma”) pursuant to which

Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license to certain Silo Pharma owned provisional

patent applications directed to the use of psilocybin in cancer treatment, and any patents issuing therefrom, including all continuations,

continuations-in-part, divisions, extensions, substitutions, reissues, re-examinations, and any applications and all patents issuing

from any applications and patents that claim domestic benefit or foreign priority to the provisional patent applications.

is for “Field of Use” (as defined in the exclusive patent license agreement) of “treatment of cancer and symptoms caused

by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures, confusion,

dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type.”

O ur Drugs in Development

DHA-dFdC from the University of Texas at Austin

DHA-dFdC (4-(N)-Docosahexaenoyl 2´, 2´-Difluorodeoxycytidine)

is patented technology licensed to the Company from the University of Texas at Austin.

DHA-dFdC is a new compound we believe may become

the next generation of second-line chemotherapy treatment for advanced pancreatic cancer.

DHA-dFdC is designed to overcome tumor cell

resistance to current chemotherapeutic drugs and is well tolerated in preclinical toxicity tests.

Preclinical studies, referenced in

subsection DHA-dFdC Published Data below, have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up

to 100,000-fold more potent that gemcitabine, a current standard therapy;

for example, the IC 50 value of DHA-dFdC is more

than 100,000-fold smaller than gemcitabine), targets pancreatic tissue and has demonstrated activities against other cancer cell lines,

including leukemia, lung and melanoma.

According to the Hirshberg Foundation for Pancreatic

Research, pancreatic cancer has the highest mortality rate of all major cancers.

It is currently the 3rd leading cause of cancer-related

death in the United States after lung and colon cancer.

The Hirschberg Foundation for Pancreatic Cancer estimated in January 2021 that

60,430 Americans would be diagnosed with pancreatic cancer, and more than 48,220 would die from the disease.

For all stages combined,

the 5-year relative survival rate is 10%.

Even for the small percentage of people diagnosed with local disease, the 5-year survival is

The majority of patients are diagnosed at a distant stage, for which the 5-year survival is 3%.

Pancreatic cancer is one of the few cancers for

which survival has not improved substantially over nearly 40 years.

Treatment options for pancreatic cancer include surgery, radiation

therapy and chemotherapy, which extend survival or relieve symptoms, but seldom produce a cure.

Surgical removal of the tumor is possible

in less than 20% of patients diagnosed with pancreatic cancer because detection is often in late stages and has spread beyond the pancreas.

The current state of the art chemotherapy treatment is gemcitabine, Folfirinox cocktail or gemcitabine in combination with Abraxane.

The University of Texas at Austin has identified

a new drug, DHA-dFdC, that has shown positive results in vivo (see publications listed below), inhibiting pancreatic tumor growth in

clinically relevant transgenic mouse models.

In preclinical studies, DHA-dFdC has:

pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine, a current

standard therapy);

for example, the IC 50 value of DHA-dFdC is more than 100,000-fold smaller than gemcitabine), targets

pancreatic tumors and has demonstrated activities against other cancer cell lines, including leukemia, lung and melanoma.

to the Hirshberg Foundation for Pancreatic Research, pancreatic cancer has the highest mortality rate of all major cancers.

is currently the 3rd leading cause of cancer-related death in the United States after lung and colon cancer.

In January 2020,

the Hirschberg Foundation estimated that 60,430 Americans will be diagnosed with pancreatic cancer, and more than 48,220 will

die from the disease.

For all stages combined, the 5-year relative survival rate is 10%.

Even for the small percentage of people

diagnosed with local disease, the 5-year survival is only 39%.

The majority of patients are diagnosed at a distant stage, for

which the 5-year survival is 3%.

cancer is one of the few cancers for which survival has not improved substantially over nearly 40 years.

Treatment options for

pancreatic cancer include surgery, radiation therapy and chemotherapy, which extend survival or relieve symptoms, but seldom produce

Surgical removal of the tumor is possible in less than 20% of patients diagnosed with pancreatic cancer because detection

is often in late stages and has spread beyond the pancreas.

The current state of the art chemotherapy treatment is gemcitabine,

Folfirinox cocktail or gemcitabine in combination with Abraxane.

University of Texas at Austin has identified a new drug, DHA-dFdC, that has shown positive results in preclinical studies (see

publications listed below), inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models.

In preclinical

studies, DHA-dFdC has:

pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine, a current standard therapy);

pancreatic tumors;

5 unchanged sentences

Foundation for Pancreatic Cancer Research

Technology Summary

is a conjugate molecule containing gemcitabine linked to a fatty acid called docosahexaenoic acid (DHA).

The chemical structure

is shown in the following diagram:

DHA structure is illustrated above the dashed line in the graphic above and the gemcitabine structure is illustrated below the

The DHA-dFdC published data indicates that DHA-dFdC was more effective than gemcitabine alone in killing cancer cells

in vitro and in vivo in a certain mouse model.

In addition, conjugation of gemcitabine with fatty acids other than DHA did not

increase effectiveness over gemcitabine.

collaboration with our contract manufacturing organization, Parimer Scientific, we are currently optimizing the manufacturing

procedure for DHA-dFdC.

We have now successfully replicated the synthesis as reported in the literature with satisfactory yield

We are currently optimizing the procedure to ensure batch-to-batch consistency.

We plan to begin formulation development

in the second quarter of 2021, which will require limited animal testing to determine proper dosage.

We expect to have manufactured

20,000 mg of purified DHA-dFdC during the second quarter of 2021 to use for such purposes.

We plan to engage a contract research

organization for the purpose of such animal testing during the second quarter of 2021.

Our goal is to have acceptable intravenous

and oral formulations developed in the fourth quarter of 2021.

Published Data

science behind DHA-dFdC has been published in the following peer-reviewed scientific journals:

(2016) Synthesis, characterization, and in vitro and in vivo evaluations of 4-(N)-docosahexaenoyl 2 ́,

2 ́- difluorodeoxycytidine with potent and broad-spectrum antitumor activity, NeoPlasia 18:

(2017) Preclinical evaluation of the short-term toxicity of 4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine

(DHA-dFdC), Pharm.

(2019) A solid lipid nanoparticle formulation of 4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine

with increased solubility, stability, and antitumor activity, Int.

(2020) Effect of a Solid Lipid Nanoparticle Formulation on the Bioavailability of 4-(N)-Docosahexaenoyl 2 ́,

2 ́-Difluorodeoxycytidine After Oral Administration, AAPS PharmSciTech 21:77 .

of the published data also indicate the following:

DHA-dFdC Technology Summary

DHA-dFdC is a conjugate molecule containing gemcitabine

linked to a fatty acid called docosahexaenoic acid (DHA).

The chemical structure is shown in the following diagram:

The DHA structure is illustrated above the dashed

line in the graphic above and the gemcitabine structure is illustrated below the dashed line.

The DHA-dFdC published data indicates that

DHA-dFdC was more effective than gemcitabine alone in killing cancer cells in vitro and in vivo in clinically relevant transgenic mouse

In addition, conjugation of gemcitabine with fatty acids other than DHA did not increase effectiveness over gemcitabine.

In collaboration with our contract manufacturing

organization, Parimer Scientific, we are currently optimizing the manufacturing procedure for DHA-dFdC.

We have now successfully replicated

the synthesis as reported in the literature with satisfactory purity.

We have also developed a new procedure for producing large-scale

quantities of the key chemical intermediate in the synthesis.

We are currently optimizing the procedure to ensure that DHA-dFdC can be

produced on the same scale as the intermediate.

Once we confirm successful large-scale production, we plan to begin DHA-dFdC formulation

development, which will require limited animal testing to determine proper dosage and will require us to engage a contract research organization

for the purpose of such animal testing.

DHA-dFdC Published Data

The science behind DHA-dFdC has been published

in the following peer-reviewed scientific journals:

(2016) Synthesis, characterization, and in vitro and in vivo evaluations of

4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine with potent and broad-spectrum

antitumor activity, NeoPlasia 18:

(2017) Preclinical evaluation of the short-term toxicity of 4-(N)-docosahexaenoyl

2 ́, 2 ́- difluorodeoxycytidine (DHA-dFdC), Pharm.

(2019) A solid lipid nanoparticle formulation of 4-(N)-docosahexaenoyl 2 ́,

2 ́- difluorodeoxycytidine with increased solubility, stability, and antitumor activity,

(2020) Effect of a Solid Lipid Nanoparticle Formulation on the Bioavailability of

4-(N)-Docosahexaenoyl 2 ́, 2 ́- Difluorodeoxycytidine After Oral Administration, AAPS

PharmSciTech 21:77 .

Portions of the published date also indicate

the following:

drug unexpectedly concentrates itself in the pancreas relative to other organs.

significantly increases the lifespan of mice with pancreatic cancer in either mice predisposed to develop the cancer, or into

which human pancreatic cancer has been injected.

significantly decreases the growth of pancreatic tumors in mice, better than gemcitabine, the current standard of care.

oral formulation using lipid nanoparticles is highly effective and stable and has outstanding bioavailability.

Patent Coverage

is covered by one issued patent on the drug itself and there is one application relating to the oral formulation, as listed in

the following table:

PCT/US2015013454,

significantly increases the lifespan of mice with pancreatic cancer in either mice predisposed

to develop the cancer, or into which human pancreatic cancer has been injected.

significantly decreases the growth of pancreatic tumors in mice, better than gemcitabine,

the current standard of care.

oral formulation using lipid nanoparticles is highly effective and stable and has outstanding

bioavailability.

DHA-dFdC Patent Coverage

DHA-dFdC is covered by one issued patent on the

drug itself and there is one application relating to the oral formulation, as listed in the following table:

PCT/US2015013454, filed

1/29/2015, the National Stage Entry of App.

15/115,393, filed 7/29/2016

Nucleobase Analogue

Derivatives and Their Applications

Nucleobase Analogue Derivatives and Their Applications

11,219,633, issued

1/11/22 from App.

16/576,127, filed 9/19/2019 as continuation of App.

15/115,393, filed 7/29/2016

Nucleobase Analogue

Derivatives and Their Applications

issued 11/5/2019 from App.

Nucleobase Analogue Derivatives and Their Applications

10,463,684, issued

11/5/2019 from App.

15/115,393, filed 7/29/2016

Nucleobase Analogue

Derivatives and Their Applications

PCT/US2020036603,

Nucleobase Analogue Derivatives and Their Applications

filed 12/1/2021 as continuation of App.

16/576,127, filed 9/19/2019

Lipid Nanoparticles

Containing Pharmaceutical and/or Nutraceutical agents and methods thereof

Nucleobase Analogue Derivatives and Their Applications

PCT/US2020036603, filed

Lipid Nanoparticles Containing Pharmaceutical and/or Nutraceutical agents

and methods thereof

filed 6/8/2020

Lipid Nanoparticles Containing Pharmaceutical and/or Nutraceutical agents

and methods thereof

Pursuant to the Patent License Agreement between

2 unchanged sentences

and all patents that issue from such applications (See also the Licenses section below).

Spectrum Antiviral Platform from University of Maryland, Baltimore

at UMB have discovered that the SKI complex present in all mammalian cells, including human cells, is a broad-spectrum, host-directed,

antiviral drug target.

Using computer modeling technology and database screening, the scientists identified binding pockets on

the SKI complex structure and designed compounds predicted to bind to the pockets.

Tests of the designed compounds identified

several chemical structures that had antiviral activity against influenza A virus along with the filoviruses Ebola and Marburg

and two further coronaviruses, SARS-CoV and SARS-CoV-2, the cause of COVID-19.

The tests are currently at an early stage and there

is no guarantee that the aintiviral platform will be effective on human cells.

In conjunction with the MLA, the Company has also

executed a Sponsored Research Agreement SRA with UMB to support the development of the technology, which is currently ongoing

at UMB under the direction of the inventors.

Under the MLA and SRA, to meet the first two milestones of the MLA the Company shall

make periodic payments for the support of the research outlined in the SRA totaling $3.1M over a period of two years.

under the SRA will entail initial development and optimization of the most effective compounds and will be performed by the scientists

who invented the licensed technology.

the end of 2019, cases of pneumonia of unknown etiology were identified in China.

In the first week of January 2020, a novel coronavirus

was identified as the cause and was found to be spreading between people.

Throughout 2020, the virus spread around the world with

over 28 million cases by September 2020.

Among many things that the SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2)

outbreak has demonstrated is the immense need for both specific and broadly acting antiviral therapeutics to treat known viruses

and those yet to emerge in the human population.

infection can have a major burden on human health.

Influenza has historically caused numerous large epidemics and pandemics such

as 1918 Spanish flu and swine flu.

Ebola has caused sporadic outbreaks since the 1970s, but in recent years these have been growing

The 2014 West Africa Ebola outbreak saw over 28,000 people contract the disease causing over 11,000 deaths.

Coronaviruses

have always posed a threat of mass spread because of their respiratory transmission.

In 2002 to 2003, the emergence of SARS-CoV

infected over 8,000 people, killing around 10% in nine months, while MERS-CoV-has sporadically spread since 2012, causing around

2,500 infections with a case fatality rate of around 35%.

(2020) The SKI complex is a broad-spectrum, host-directed antiviral drug target for coronaviruses, influenza,

and filoviruses PNAS 117 (48) 30687-30698, https://doi.org/10.1073/pnas.2012939117

year 2020 has seen the rapid emergence of the novel coronavirus, SARS-CoV-2, the cause of COVID-19, which rapidly spread after

its identification in Wuhan, China, caused a pandemic, and has infected almost 110 million people and killed over 2.4 million

people worldwide, with almost 490,000 deaths in the United States.

Hopkins University of Medicine, Coronavirus Resource Center, https://coronavirus.jhu.edu/

at UMB, including Drs.

Matthew Frieman, Alexander MacKerell and Stuart Watson have demonstrated that the SKI complex is a broad-spectrum

antiviral target and designed compounds using in silico drug design that target the SKI complex and inhibit replication

of several virus types, influenza A virus along with the filoviruses Ebola and Marburg and two further coronaviruses, SARS-CoV

and SARS-CoV-2.

has filed three separate patent applications on the resulting antiviral compounds and has granted the Company an exclusive worldwide

license to the technology.

UMB recently filed the following PCT application claiming priority to the first two of the three applications:

Broad Spectrum Antiviral Platform from University

of Maryland, Baltimore

Scientists at UMB have discovered that the SKI

complex present in all mammalian cells, including human cells, is a broad-spectrum, host-directed, antiviral drug target.* Using computer

modeling technology and database screening, the scientists identified binding pockets on the SKI complex structure and designed compounds

predicted to bind to the pockets.

Tests of the designed compounds identified several chemical structures that had antiviral activity

against influenza A virus along with the filoviruses Ebola and Marburg and two further coronaviruses, SARS-CoV and SARS-CoV-2, the cause

The tests are currently at an early stage and there is no guarantee that the aintiviral platform will be effective on human

In conjunction with the MLA, the Company has also executed a Sponsored Research Agreement SRA with UMB to support the development

of the technology, which is currently ongoing at UMB under the direction of the inventors.

Under the MLA and SRA, to meet the first two

milestones of the MLA the Company shall make periodic payments for the support of the research outlined in the SRA totaling $3.1M over

a period of two years.

The research under the SRA will entail initial development and optimization of the most effective compounds and

will be performed by the scientists who invented the licensed technology.

Several candidate compounds with optimized chemical structures

have been identified and will be tested in vivo in clinically relevant mouse coronavirus models.

At the end of 2019, cases of pneumonia of unknown

etiology were identified in China.

In the first week of January 2020, a novel coronavirus was identified as the cause and was found to

be spreading between people.

Throughout 2020 and 2021, the virus spread around the world with over 419 million cases and over 5.8 million

deaths confirmed worldwide by February 2022.* Among many things that the SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2)

outbreak has demonstrated is the immense need for both specific and broadly acting antiviral therapeutics to treat known viruses and

those yet to emerge in the human population.

Viral infection can have a major burden on human

Influenza has historically caused numerous large epidemics and pandemics such as 1918 Spanish flu and swine flu.

Ebola has caused

sporadic outbreaks since the 1970s, but in recent years these have been growing in scale.

The 2014 West Africa Ebola outbreak saw over

28,000 people contract the disease causing over 11,000 deaths.

Coronaviruses have always posed a threat of mass spread because of their

respiratory transmission.

In 2002 to 2003, the emergence of SARS-CoV infected over 8,000 people, killing around 10% in nine months, while

MERS-CoV-has sporadically spread since 2012, causing around 2,500 infections with a case fatality rate of around 35%.

Weston et al.

SKI complex is a broad-spectrum, host-directed antiviral drug target for coronaviruses, influenza, and

filoviruses PNAS 117 (48) 30687-30698, https://doi.org/10.1073/pnas.2012939117

The year 2020 saw the rapid emergence of the

novel coronavirus, SARS-CoV-2, the cause of COVID-19, which rapidly spread after its identification in Wuhan, China, caused a pandemic,

and has infected over 419 million people and killed over 5.8 million people worldwide, with over 900,000 deaths in the United States.*

Johns Hopkins University of Medicine, Coronavirus

Resource Center, https://coronavirus.jhu.edu/

Scientists at UMB, including Drs.

Matthew Frieman,

Alexander MacKerell and Stuart Watson have demonstrated that the SKI complex is a broad-spectrum antiviral target and designed compounds

using in silico drug design that target the SKI complex and inhibit replication of several virus types, influenza A

virus along with the filoviruses Ebola and Marburg and two further coronaviruses, SARS-CoV and SARS-CoV-2.

UMB has filed three separate patent applications

on the resulting antiviral compounds and has granted the Company an exclusive worldwide license to the technology.

UMB recently filed

the following PCT application claiming priority to the first two of the three applications:

PCT/US2020036482,

Int’l filing date 5/6/2020

US62/858,0710,

Int’l filing date 6/5/2020

US62/858,071, filed

6/6/2019, US62/909,352,

1 unchanged sentence

WO/2020/247860

Broad Spectrum Antiviral

Compounds Targeting the SKI Complex

from Wake Forest University

small molecule treatment for AML and ALL, developed at the Wake Forest University and called KPC34, is a next generation targeted

therapeutic designed to overcome multiple resistance mechanisms observed with the current standard of care.

is an uncommon cancer, making up about 1% of cancers.

In 2020, an estimated 19,940 people of all ages (11,090 males and 8,850

females) in the United States were be diagnosed with AML.

It is the second most common type of leukemia diagnosed in adults and

children, but most cases occur in adults.

Broad Spectrum Antiviral Compounds Targeting the SKI Complex

17/616,586, filed

US62/858,071, filed

6/6/2019, US62/909,352,

filed 10/2/2019

Broad Spectrum Antiviral Compounds Targeting the SKI Complex

PCT/US2021/06183

Int’l filing date 12/3/2021

63/121,120, filed 12/3/2020

Broad Spectrum Antiviral Compounds Targeting the SKI Complex

KPC34 from Wake Forest University

Our small molecule treatment for AML and ALL,

developed at the Wake Forest University and called KPC34, is a next generation targeted therapeutic designed to overcome multiple resistance

mechanisms observed with the current standard of care.

AML is an uncommon

cancer, making up about 1% of cancers.

In 2021, an estimated 20,240 people of all ages (11,230 men and boys and 9,010 women and girls)

in the United States will be diagnosed with AML.

AML is the second most common type of leukemia diagnosed in adults and children, but

most cases occur in adults.

AML makes up 31% of all adult leukemia cases.

AML can be diagnosed at any age, but it

is uncommon in people younger than 45.

The average age of diagnosis is age 68.

An estimated 11,180 deaths (6,470 men and boys

and 4,710 women and girls) from AML occurred in 2020.

AML can be diagnosed

An estimated 11,400 deaths (6,620 men and boys and 4,780 women and girls) from AML will occur this year.

The majority will

be in adults.

(https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics).

ALL is also a rare disease, making up only half of 1% of cancers diagnosed in the United States.

In 2020, an estimated 6,150 people

of all ages (3,470 males and 2,680 females) in the United States were diagnosed with ALL.

Most cases occur in children.

under age 20, ALL is the most common type of leukemia, accounting for 74% of all leukemia diagnosed in this age group.

younger than 5 have the highest risk of ALL.

After a child grows into adulthood, the general risk of ALL rises again after age

ALL is a rare disease, making up less than

1% of cancers diagnosed in the United States.

In 2021, an estimated 5,690 people of all ages (3,000 men and boys and 2,690 women and

girls) in the United States will be diagnosed with ALL.

A person of any age can be diagnosed with ALL, but most cases occur in children.

In children and teens under age 20, ALL is the most common type of leukemia, accounting for 74% of all leukemia diagnosed in this age

Children younger than 5 have the highest risk of ALL.

After a child grows into adulthood, the general risk of ALL rises again

after age 50.

About 4 out of every 10 people diagnosed with ALL are adults.

An estimated 1,520 deaths (860 men and boys and 660 women and

girls) from ALL will occur this year.

An estimated 1,580 deaths (900 men and boys and 680 women

and girls) from ALL will occur this year.

( https://www.cancer.net/cancer-types/leukemia-acute-lymphocytic-all/statistics ).

Technology Summary

a conjugate molecule made of a gemcitabine molecule linked to a phospholipid, has the following structure:

the illustration above, to the left of the dashed line is the phospholipid portion and to the right of the dashed line is gemcitabine.

is a chemotherapy drug used to treat a wide array of cancers, including breast cancer, ovarian cancer, non-small cell lung cancer,

pancreatic cancer and bladder cancer.

The drug interferes with DNA and its function of the phospholipid to which the gemcitabine

is linked in KPC34, is to inhibit protein kinase C-type enzymes, which are involved in multiple signaling pathways in leukemia.

strategy behind targeting both DNA synthesis and protein kinase C with one molecule is to double-target different mechanisms of

action in leukemia cells and greatly reduce the possibility of development of resistance to the drug.

is intended to treat the relatively small population of patients with AML and ALL.

Because of the low patient population, FDA

orphan drug status can be sought, which provides expedited review and seven years of exclusivity from approval of the new drug

data from preclinical studies at Wake Forest on the drug includes the following results:

KPC34 Technology Summary

KPC34, a conjugate molecule made of

a gemcitabine molecule linked to a phospholipid, has the following structure:

In the illustration above, to the left of the

dashed line is the phospholipid portion and to the right of the dashed line is gemcitabine.

Gemcitabine is a chemotherapy drug used to treat

a wide array of cancers, including breast cancer, ovarian cancer, non-small cell lung cancer, pancreatic cancer and bladder cancer.

drug interferes with DNA and the function of the phospholipid to which the gemcitabine is linked in KPC34, is to inhibit protein kinase

C-type enzymes, which are involved in multiple signaling pathways in leukemia.

The strategy behind targeting both DNA synthesis

and protein kinase C with one molecule is to double-target different mechanisms of action in leukemia cells and greatly reduce the possibility

of development of resistance to the drug.

KPC34 is intended to treat the relatively small

population of patients with AML and ALL.

Because of the low patient population, FDA orphan drug status can be sought, which provides

expedited review and seven years of exclusivity from approval of the new drug application.

Preliminary data from preclinical studies at

Wake Forest on the drug includes the following results:

leukemia cells in vitro;

2 unchanged sentences

AML exhibiting phosphorylated protein kinase C;

Forest claims KPC34 targeted gemcitabine alone or cytarabine (another chemo drug) alone;

also appears to overcome resistance to gemcitabine;

it is effective against gemcitabine-resistant cancer.

technology licensed is much broader than KPC34 represents, and includes both anticancer and antiviral conjugates, and could include

a much broader range of indications, but we have no such drug candidates in development other than KPC34.

Patent Coverage

KPC34 license includes five issued patents, but only one of them covers KPC34.

The patent is US7309696, entitled “Compositions

and methods for targeting cancer cells.”

It expires on August 11, 2021.

All five of the licensed patents will expire by

April 12, 2018, CBM entered into a patent license agreement (the “UT Agreement”) with the University of Texas at Austin

on behalf of the Board of Regents of the University of Texas System.

The UT Agreement granted to CBM an exclusive, royalty-bearing

license to certain patent applications related to nucleobase analogue derivatives and their applications, and specifically to

the DHA-dFdC drug candidate.

On November 13, 2019, the University of Texas at Austin, the Company and CBM entered into an assignment

of agreement, whereby CBM assigned all of its rights, title and interest to, and obligations under the UT Agreement to the Company.

April 17, 2018, CBM entered into a license agreement (the “WF Agreement”) with Wake Forest University Health Sciences

(“WF”).

The WF Agreement granted to CBM an exclusive, royalty-bearing license to WF’s and The University of

North Carolina at Chapel Hill’s patents relating to the KPC34 drug candidate.

On November 13, 2019, WF, the Company and

CBM entered into an assignment of agreement, whereby CBM assigned all of its rights, title and interest to, and obligations under

the WF Agreement to the Company.

April 13, 2020, the Company executed a Master License Agreement (the “UMB License Agreement”) with UMB, pursuant to

which UMB agreed to license inventions collectively known as “Broad Spectrum Antiviral Compounds Which Target the SKI Complex”

(the “Inventions”) to the Company.

The Inventions, which are covered by three patent applications on file with the

United States Patent and Trademark Office, are currently in the pre-clinical stage and seek to inhibit replication of multiple

viruses, including the Influenza virus, SARS-CoV, MERS-CoV, Ebolavirus and Marburg virus.

In addition, the Company entered into

a Sponsored Research Agreement with UMB to support the development of various technologies.

Pursuant to the UMB License Agreement,

UMB grants to the Company the ability to utilize the licensed products (“Licensed Products”) and patents associated

with the Inventions, subject to certain limitations described in the UMB License Agreement.

All improvements to the Inventions

are solely owned by the party improving the Inventions, unless jointly made, in which case both parties jointly own the improvements;

however, the Company grants to UMB the royalty-free license to practice the Company’s improvements.

The Company has agreed

to deliver to UMB a commercialization plan setting forth the Company’s plan for research and development required to develop

the Licensed Products and the Company’s overall commercialization strategy by December 31, 2022.

August 7, 2020, the Company entered into a fixed price agreement (the “Fixed Price Agreement”) with the University

of Kentucky Research Foundation (“UKRF”), pursuant to which the Company received an option to negotiate an exclusive

license with the UKRF for certain of its patents related to G4-1 for solid tumor treatment in exchange for $67,000.

shall involve testing of the drug G4-1 and its ability to increase the duration of survival of mice injected with tumor cells

relative to an FDA approved drug.

The patents subject to the option do not expire until 2035.

it is effective against gemcitabine-resistant

The technology licensed is much broader than

KPC34 represents, and includes additional anticancer and antiviral conjugates, and could include a much broader range of indications,

but we have no such drug candidates in development.

KPC34 Patent Coverage

The KPC34 license includes five issued patents,

but only one of them covers KPC34.

The patent is US7309696, entitled “Compositions and methods for targeting cancer cells.”

It expired on August 11, 2021.

All five of the licensed patents will expire by late 2022, and no continuation applications will be filed.

On April 12, 2018, CBM entered into a patent

license agreement (the “UT Agreement”) with the University of Texas at Austin on behalf of the Board of Regents of the University

of Texas System.

The UT Agreement granted to CBM an exclusive, royalty-bearing license to certain patent applications related to nucleobase

analogue derivatives and their applications, and specifically to the DHA-dFdC drug candidate.

On November 13, 2019, the University of

Texas at Austin, the Company and CBM entered into an assignment of agreement, whereby CBM assigned all of its rights, title and interest

to, and obligations under the UT Agreement to the Company.

On April 17, 2018, CBM entered into a license

agreement (the “WF Agreement”) with Wake Forest University Health Sciences (“WF”).

The WF Agreement granted to

CBM an exclusive, royalty-bearing license to WF’s and The University of North Carolina at Chapel Hill’s patents relating

to the KPC34 drug candidate.

On November 13, 2019, WF, the Company and CBM entered into an assignment of agreement, whereby CBM assigned

all of its rights, title and interest to, and obligations under the WF Agreement to the Company.

On April 13, 2020, the Company executed a Master

License Agreement (the “UMB License Agreement”) with UMB, pursuant to which UMB agreed to license inventions collectively

known as “Broad Spectrum Antiviral Compounds Which Target the SKI Complex” (the “Inventions”) to the Company.

The Inventions, which are covered by three patent applications on file with the United States Patent and Trademark Office, are currently

in the pre-clinical stage and seek to inhibit replication of multiple viruses, including the Influenza virus, SARS-CoV, MERS-CoV, Ebolavirus

and Marburg virus.

In addition, the Company entered into a Sponsored Research Agreement with UMB to support the development of various

technologies.

Pursuant to the UMB License Agreement, UMB grants to the Company the ability to utilize the licensed products (“Licensed

Products”) and patents associated with the Inventions, subject to certain limitations described in the UMB License Agreement.

improvements to the Inventions are solely owned by the party improving the Inventions, unless jointly made, in which case both parties

jointly own the improvements;

however, the Company grants to UMB the royalty-free license to practice the Company’s improvements.

The Company has agreed to deliver to UMB a commercialization plan setting forth the Company’s plan for research and development

required to develop the Licensed Products and the Company’s overall commercialization strategy by December 31, 2022.

On August 7, 2020, the Company entered into a

fixed price agreement (the “Fixed Price Agreement”) with the University of Kentucky Research Foundation (“UKRF”),

pursuant to which the Company received an option to negotiate an exclusive license with the UKRF for certain of its patents related to

G4-1 for solid tumor treatment in exchange for $67,000.

The research, which is currently in progress, involves testing of the drug G4-1

and its ability to increase the duration of survival of mice injected with tumor cells relative to an FDA approved drug.

subject to the option do not expire until 2035.

Commercialization

business success with our drug portfolio depends not only on the successful development and approval of the products but also

on the commercialization.

At present, our plan anticipates us making the investments necessary to build an in-house marketing

and sales capability for the U.S.

market for our drug pipeline, or to partner with a larger drug development company to commercialize

our drugs as they move through the FDA approval process.

As our drug compounds make their way through clinical development in

the U.S., we intend to approach pharmaceutical and biotechnology companies outside the U.S.

to negotiate and enter into strategic

partnerships that will enable development and commercialization of our platform outside the U.S., where we believe the market

opportunity is larger than that of the U.S.

Our business success with our drug portfolio depends not only on the

successful development and approval of the products but also on the commercialization.

At present, our plan anticipates us making the

investments necessary to build an in-house marketing and sales capability for the U.S.

market for our drug pipeline, or to partner with

a larger drug development company to commercialize our drugs as they move through the FDA approval process.

As our drug compounds make

their way through clinical development in the U.S., we intend to approach pharmaceutical and biotechnology companies outside the U.S.

to negotiate and enter into strategic partnerships that will enable development and commercialization of our platform outside the U.S.,

where we believe the market opportunity is larger than that of the U.S.

albeit far more complex to reach.

We have no operations outside the U.S., nor are

we planning to have any non-U.S.

Manufacturing

do not have any manufacturing capabilities and therefore we will have to engage a third party to assist in manufacturing.

manufacturing will need to be done in accordance with good manufacturing practice requirements (“cGMP”) regulations,

to formulate and manufacture our product candidates.

A list of third party manufacturers is currently being developed.

authorities in the U.S.

and other countries extensively regulate the research, development, testing, manufacture, labeling, promotion,

advertising, distribution and marketing of pharmaceutical products such as those being developed by us.

In the U.S., the FDA regulates

such products under the FDCA and implements related regulations.

Failure to comply with applicable FDA requirements, both before

and after approval, may subject us to administrative and judicial sanctions, such as a delay in approving or refusal by the FDA

to approve pending applications, warning letters, product recalls, product seizures, total or partial suspension of production

or distribution, injunctions and/or criminal prosecution.

We have no operations outside

the U.S., nor are we planning to have any non-U.S.

Manufacturing and Supply

We do not have any manufacturing capabilities

and therefore we will have to engage a third party to assist in manufacturing.

Such manufacturing will need to be done in accordance

with good manufacturing practice requirements (“cGMP”) regulations, to formulate and manufacture our product candidates.

A list of third party cGMP manufacturers is currently being developed.

Government Regulation

Governmental authorities in the U.S.

countries extensively regulate the research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing

of pharmaceutical products such as those being developed by us.

In the U.S., the FDA regulates such products under the FDCA and implements

related regulations.

Failure to comply with applicable FDA requirements, both before and after approval, may subject us to administrative

and judicial sanctions, such as a delay in approving or refusal by the FDA to approve pending applications, warning letters, product

recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution.

Food and Drug Administration Regulation

States Drug Development

the United States, the FDA regulates drugs, medical devices and combinations of drugs and devices, or combination products, under

the FDCA and its implementing regulations.

Drugs are also subject to other federal, state and local statutes and regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign

statutes and regulations requires the expenditure of substantial time and financial resources.

Failure to comply with the applicable

requirements at any time during the product development process, approval process or after approval, may subject an applicant

to administrative or judicial sanctions.

These sanctions could include, among other actions, the FDA’s refusal to approve

pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, requests for voluntary product

recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions,

fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties.

Any agency or judicial enforcement

action could have a material adverse effect on us.

process required by the FDA before a drug may be marketed in the United States generally involves the following:

of extensive pre-clinical laboratory tests, animal studies and formulation studies in accordance with applicable regulations,

including the FDA’s Good Laboratory Practice regulations;

to the FDA of an IND, which must become effective before human clinical trials may begin;

of adequate and well-controlled human clinical trials in accordance with an applicable IND and other clinical study related

regulations, sometimes referred to as good clinical practices, or GCPs, to establish the safety and efficacy of the proposed

drug for its proposed indication;

to the FDA of an NDA;

completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the product, or components

thereof, are produced to assess compliance with the FDA’s cGMP requirements;

FDA audit of the clinical trial sites that generated the data in support of the NDA;

review and approval of the NDA prior to any commercial marketing or sale.

a pharmaceutical product candidate is identified for development, it enters the pre-clinical testing stage.

Pre-clinical tests

include laboratory evaluations of product chemistry, toxicity, formulation and stability, as well as animal studies.

An IND sponsor

must submit the results of the pre-clinical tests, together with manufacturing information, analytical data and any available

clinical data or literature, to the FDA as part of the IND.

The sponsor must also include a protocol detailing, among other things,

the objectives of the initial clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to

be evaluated if the initial clinical trial lends itself to an efficacy evaluation.

Some pre-clinical testing may continue even

after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns

or questions related to a proposed clinical trial and places the trial on a clinical hold within that 30-day period.

case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

Clinical holds also

may be imposed by the FDA at any time before or during clinical trials due to safety concerns or non-compliance, and may be imposed

on all drug products within a certain class of drugs.

The FDA also can impose partial clinical holds, for example, prohibiting

the initiation of clinical trials of a certain duration or for a certain dose.

clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCP regulations.

These regulations include the requirement that all research subjects provide informed consent in writing before their participation

in any clinical trial.

Further, an IRB must review and approve the plan for any clinical trial before it commences at any institution,

and the IRB must conduct continuing review and reapprove the study at least annually.

An IRB considers, among other things, whether

the risks to individuals participating in the clinical trial are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the information regarding the clinical trial and the consent form that must be provided to each clinical

trial subject or his or her legal Representative and must monitor the clinical trial until completed.

new clinical protocol and any amendments to the protocol must be submitted for FDA review, and to the IRBs for approval.

detail, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria,

and the parameters to be used to monitor subject safety.

clinical trials are typically conducted in three sequential phases that may overlap or be combined:

The product is initially introduced into a small number of healthy human subjects or patients and tested for safety, dosage

tolerance, absorption, metabolism, distribution and excretion and, if possible, to gain early evidence on effectiveness.

the case of some products for severe or life-threatening diseases, especially when the product is suspected or known to be

unavoidably toxic, the initial human testing may be conducted in patients.

Involves clinical trials in a limited patient population to identify possible adverse effects and safety risks, to preliminarily

evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage and

Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population

at geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk/benefit

relationship of the product and provide an adequate basis for product labeling.

Post-approval

trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These studies are

used to gain additional experience from the treatment of patients in the intended therapeutic indication.

In certain instances,

the FDA may mandate the performance of Phase 4 trials.

Companies that conduct certain clinical trials also are required to register

them and post the results of completed clinical trials on a government-sponsored database, such as ClinicalTrials.gov in the United

States, within certain timeframes.

Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA,

and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events, findings

from other studies that suggest a significant risk to humans exposed to the product, findings from animal or in vitro testing

that suggest a significant risk to human subjects, and any clinically important increase in the rate of a serious suspected adverse

reaction over that listed in the protocol or investigator brochure.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed

successfully within any specified period, if at all.

The FDA or the clinical trial sponsor may suspend or terminate a clinical

trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial

is not being conducted in accordance with the IRB’s requirements or if the product has been associated with unexpected serious

harm to patients.

Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the

clinical trial sponsor, known as a data safety monitoring board or committee.

This group provides authorization for whether a

trial may move forward at designated check points based on access to certain data from the study.

The clinical trial sponsor may

also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate.

with clinical trials, companies usually complete additional animal studies and must also develop additional information about

the chemistry and physical characteristics of the product and finalize a process for manufacturing the product in commercial quantities

in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the

product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and

purity of the final product.

Additionally, appropriate packaging must be selected and tested and stability studies must be conducted

to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

and FDA Review Process

results of product development, pre-clinical studies and clinical trials, along with descriptions of the manufacturing process,

analytical tests conducted on the drug, proposed labeling and other relevant information, are submitted to the FDA as part of

an NDA for a new drug, requesting approval to market the product.

The submission of an NDA is subject to the payment of a substantial

user fee, and the sponsor of an approved NDA is also subject to an annual program user fee;

although a waiver of such fee may

be obtained under certain limited circumstances.

For example, the agency will waive the application fee for the first human drug

application that a small business or its affiliate submits for review.

FDA reviews all NDAs submitted before it accepts them for filing and may request additional information rather than accepting

an NDA for filing.

The FDA typically makes a decision on accepting an NDA for filing within 60 days of receipt.

The decision to

accept the NDA for filing means that the FDA has made a threshold determination that the application is sufficiently complete

to permit a substantive review.

Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act (“PDUFA”),

the FDA’s goal to complete its substantive review of a standard NDA and respond to the applicant is ten months from the

receipt of the NDA.

The FDA does not always meet its PDUFA goal dates, and the review process is often significantly extended

by FDA requests for additional information or clarification and may go through multiple review cycles.

the NDA submission is accepted for filing, the FDA reviews the NDA to determine, among other things, whether the proposed product

is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMPs to assure and

preserve the product’s identity, strength, quality and purity.

The FDA may refer applications for novel drug products or

drug products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes

clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and

under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations

carefully when making decisions.

The FDA will likely re-analyze the clinical trial data, which could result in extensive discussions

between the FDA and us during the review process.

The review and evaluation of an NDA by the FDA is extensive and time consuming

and may take longer than originally planned to complete, and we may not receive a timely approval, if at all.

approving an NDA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine

whether they comply with cGMPs.

The FDA will not approve the product unless it determines that the manufacturing processes and

facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required

specifications.

In addition, before approving an NDA, the FDA may also audit data from clinical trials to ensure compliance with

GCP requirements.

After the FDA evaluates the application, manufacturing process and manufacturing facilities, it may issue an

approval letter or a Complete Response Letter.

An approval letter authorizes commercial marketing of the drug with specific prescribing

information for specific indications.

A Complete Response Letter indicates that the review cycle of the application is complete

and the application will not be approved in its present form.

A Complete Response Letter usually describes all the specific deficiencies

in the NDA identified by the FDA.

The Complete Response Letter may require additional clinical data and/or an additional pivotal

Phase 3 clinical trial(s), and/or other significant and time-consuming requirements related to clinical trials, nonclinical studies

or manufacturing.

If a Complete Response Letter is issued, the applicant may either resubmit the NDA, addressing all the deficiencies

identified in the letter, or withdraw the application.

Even if such data and information are submitted, the FDA may ultimately

decide that the NDA does not satisfy the criteria for approval.

United States Drug Development

In the United States, the FDA regulates drugs,

medical devices and combinations of drugs and devices, or combination products, under the FDCA and its implementing regulations.

are also subject to other federal, state and local statutes and regulations.

The process of obtaining regulatory approvals and the subsequent

compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and

financial resources.

Failure to comply with the applicable U.S.

requirements at any time during the product development process, approval

process or after approval, may subject an applicant to administrative or judicial sanctions.

These sanctions could include, among other

actions, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters,

requests for voluntary product recalls or withdrawals from the market, product seizures, total or partial suspension of production or

distribution injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties.

or judicial enforcement action could have a material adverse effect on us.

The process required by the FDA before a drug

may be marketed in the United States generally involves the following:

completion of extensive pre-clinical laboratory tests,

animal studies and formulation studies in accordance with applicable regulations, including the FDA’s Good Laboratory Practice

submission to the FDA of an IND, which must become

effective before human clinical trials may begin;

performance of adequate and well-controlled human

clinical trials in accordance with an applicable IND and other clinical study related regulations, sometimes referred to as good

clinical practices, or GCPs, to establish the safety and efficacy of the proposed drug for its proposed indication;

submission to the FDA of an NDA;

satisfactory completion of an FDA pre-approval inspection

of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with the

FDA’s cGMP requirements;

potential FDA audit of the clinical trial sites that

generated the data in support of the NDA;

FDA review and approval of the NDA prior to any commercial

marketing or sale.

Once a pharmaceutical product candidate is identified

for development, it enters the pre-clinical testing stage.

Pre-clinical tests include laboratory evaluations of product chemistry, toxicity,

formulation and stability, as well as animal studies.

An IND sponsor must submit the results of the pre-clinical tests, together with

manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND.

must also include a protocol detailing, among other things, the objectives of the initial clinical trial, the parameters to be used in

monitoring safety and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation.

Some pre-clinical testing may continue even after the IND is submitted.

The IND automatically becomes effective 30 days after receipt

by the FDA, unless the FDA raises concerns or questions related to a proposed clinical trial and places the trial on a clinical hold

within that 30-day period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial

Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety concerns or non-compliance,

and may be imposed on all drug products within a certain class of drugs.

The FDA also can impose partial clinical holds, for example,

prohibiting the initiation of clinical trials of a certain duration or for a certain dose.

All clinical trials must be conducted under the

supervision of one or more qualified investigators in accordance with GCP regulations.

These regulations include the requirement that

all research subjects provide informed consent in writing before their participation in any clinical trial.

Further, an IRB must review

and approve the plan for any clinical trial before it commences at any institution, and the IRB must conduct continuing review and reapprove

the study at least annually.

An IRB considers, among other things, whether the risks to individuals participating in the clinical trial

are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the information regarding the clinical trial

and the consent form that must be provided to each clinical trial subject or his or her legal Representative and must monitor the clinical

trial until completed.

Each new clinical protocol and any amendments

to the protocol must be submitted for FDA review, and to the IRBs for approval.

Protocols detail, among other things, the objectives

of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject

Human clinical trials are typically conducted

in three sequential phases that may overlap or be combined:

The product is initially introduced into a small number of healthy human subjects or patients

and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion

and, if possible, to gain early evidence on effectiveness.

In the case of some products for

severe or life-threatening diseases, especially when the product is suspected or known to

be unavoidably toxic, the initial human testing may be conducted in patients.

Involves clinical trials in a limited patient population to identify possible adverse

effects and safety risks, to preliminarily evaluate the efficacy of the product for specific

targeted diseases and to determine dosage tolerance and optimal dosage and schedule.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety

in an expanded patient population at geographically dispersed clinical trial sites.

clinical trials are intended to establish the overall risk/benefit relationship of the product

and provide an adequate basis for product labeling.

Post-approval trials, sometimes referred to as

Phase 4 clinical trials, may be conducted after initial marketing approval.

These studies are used to gain additional experience from

the treatment of patients in the intended therapeutic indication.

In certain instances, the FDA may mandate the performance of Phase

Companies that conduct certain clinical trials also are required to register them and post the results of completed clinical

trials on a government-sponsored database, such as ClinicalTrials.gov in the United States, within certain timeframes.

Failure to do

so can result in fines, adverse publicity and civil and criminal sanctions.

Progress reports detailing the results of the

clinical trials, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted

to the FDA and the investigators for serious and unexpected adverse events, findings from other studies that suggest a significant risk

to humans exposed to the product, findings from animal or in vitro testing that suggest a significant risk to human subjects, and any

clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

The FDA or the

clinical trial sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research

subjects or patients are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical

trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product

has been associated with unexpected serious harm to patients.

Additionally, some clinical trials are overseen by an independent group

of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee.

This group provides

authorization for whether a trial may move forward at designated check points based on access to certain data from the study.

trial sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate.

Concurrent with clinical trials, companies usually

complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the

product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

The manufacturing

process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer

must develop methods for testing the identity, strength, quality and purity of the final product.

Additionally, appropriate packaging

must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable

deterioration over its shelf life.

NDA and FDA Review Process

The results of product development, pre-clinical

studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the drug, proposed labeling

and other relevant information, are submitted to the FDA as part of an NDA for a new drug, requesting approval to market the product.

The submission of an NDA is subject to the payment of a substantial user fee, and the sponsor of an approved NDA is also subject to an

annual program user fee;

although a waiver of such fee may be obtained under certain limited circumstances.

For example, the agency will

waive the application fee for the first human drug application that a small business or its affiliate submits for review.

The FDA reviews all NDAs submitted before it

accepts them for filing and may request additional information rather than accepting an NDA for filing.

The FDA typically makes a decision

on accepting an NDA for filing within 60 days of receipt.

The decision to accept the NDA for filing means that the FDA has made a threshold

determination that the application is sufficiently complete to permit a substantive review.

Under the goals and policies agreed to by

the FDA under the Prescription Drug User Fee Act (“PDUFA”), the FDA’s goal to complete its substantive review of a

standard NDA and respond to the applicant is ten months from the receipt of the NDA.

The FDA does not always meet its PDUFA goal dates,

and the review process is often significantly extended by FDA requests for additional information or clarification and may go through

multiple review cycles.

After the NDA submission is accepted for filing,

the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, and

whether the product is being manufactured in accordance with cGMPs to assure and preserve the product’s identity, strength, quality

The FDA may refer applications for novel drug products or drug products which present difficult questions of safety or efficacy

to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as

to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendations of an advisory committee,

but it considers such recommendations carefully when making decisions.

The FDA will likely re-analyze the clinical trial data, which

could result in extensive discussions between the FDA and us during the review process.

The review and evaluation of an NDA by the FDA

is extensive and time consuming and may take longer than originally planned to complete, and we may not receive a timely approval, if

Before approving an NDA, the FDA will conduct

a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMPs.

not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements

and adequate to assure consistent production of the product within required specifications.

In addition, before approving an NDA, the

FDA may also audit data from clinical trials to ensure compliance with GCP requirements.

After the FDA evaluates the application, manufacturing

process and manufacturing facilities, it may issue an approval letter or a Complete Response Letter.

An approval letter authorizes commercial

marketing of the drug with specific prescribing information for specific indications.

A Complete Response Letter indicates that the review

cycle of the application is complete and the application will not be approved in its present form.

A Complete Response Letter usually

describes all the specific deficiencies in the NDA identified by the FDA.

The Complete Response Letter may require additional clinical

data and/or an additional pivotal Phase 3 clinical trial(s), and/or other significant and time-consuming requirements related to clinical

trials, nonclinical studies or manufacturing.

If a Complete Response Letter is issued, the applicant may either resubmit the NDA, addressing

all the deficiencies identified in the letter, or withdraw the application.

Even if such data and information are submitted, the FDA

may ultimately decide that the NDA does not satisfy the criteria for approval.

Data obtained from clinical trials are not always conclusive,

and the FDA may interpret data differently than we interpret the same data.

is no assurance that the FDA will ultimately approve a product for marketing in the United States, and we may encounter significant

difficulties or costs during the review process.

If a product receives marketing approval, the approval may be significantly limited

to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value

of the product.

Further, the FDA may require that certain contraindications, warnings or precautions be included in the product

labeling or may condition the approval of the NDA on other changes to the proposed labeling, development of adequate controls

and specifications, or a commitment to conduct post-market testing or clinical trials and surveillance to monitor the effects

of approved products.

For example, the FDA may require Phase 4 clinical trials to further assess drug safety and effectiveness

and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.

FDA may also place other conditions on approvals, including the requirement for a risk evaluation and mitigation strategy (“REMS”),

to assure the safe use of the drug.

If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS;

There is no assurance that the FDA will ultimately

approve a product for marketing in the United States, and we may encounter significant difficulties or costs during the review process.

If a product receives marketing approval, the approval may be significantly limited to specific diseases and dosages or the indications

for use may otherwise be limited, which could restrict the commercial value of the product.

Further, the FDA may require that certain

contraindications, warnings or precautions be included in the product labeling or may condition the approval of the NDA on other changes

to the proposed labeling, development of adequate controls and specifications, or a commitment to conduct post-market testing or clinical

trials and surveillance to monitor the effects of approved products.

For example, the FDA may require Phase 4 clinical trials to further

assess drug safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that

have been commercialized.

The FDA may also place other conditions on approvals, including the requirement for a risk evaluation and mitigation

strategy (“REMS”), to assure the safe use of the drug.

If the FDA concludes a REMS is needed, the sponsor of the NDA must

submit a proposed REMS;

the FDA will not approve the NDA without an approved REMS, if required.

A REMS could include medication guides, physician communication

plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization

Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or

dispensing of products.

Product approvals may be withdrawn for non-compliance with regulatory requirements or if problems occur

following initial marketing.

A REMS could include medication guides,

physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other

risk minimization tools.

Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription

or dispensing of products.

Product approvals may be withdrawn for non-compliance with regulatory requirements or if problems occur following

initial marketing.

Reimbursement

sales of any of our product candidates, if approved, will depend, at least in part, on the extent to which such products will

be covered by third-party payors, such as government health care programs, commercial insurance and managed healthcare organizations.

These third-party payors are increasingly limiting coverage and/or reducing reimbursements for medical products and services.

A third-party payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate

will be approved.

Further, one payor’s determination to provide coverage for a drug product does not assure that other payors

will also provide coverage for the drug product.

Potential sales of any of our product candidates,

if approved, will depend, at least in part, on the extent to which such products will be covered by third-party payors, such as government

health care programs, commercial insurance and managed healthcare organizations.

These third-party payors are increasingly limiting coverage

and/or reducing reimbursements for medical products and services.

A third-party payor’s decision to provide coverage for a drug

product does not imply that an adequate reimbursement rate will be approved.

Further, one payor’s determination to provide coverage

for a drug product does not assure that other payors will also provide coverage for the drug product.

In addition, the U.S.

government, state legislatures and foreign governments

have continued implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements

for substitution of generic products.

Adoption of price controls and cost-containment measures, and adoption of more restrictive

policies in jurisdictions with existing controls and measures, could further limit our future revenues and results of operations.

Decreases in third-party reimbursement or a decision by a third-party payor to not cover a product candidate, if approved, or

any future approved products could reduce physician usage of our products, and have a material adverse effect on our sales, results

of operations and financial condition.

the United States, the Medicare Part D program provides a voluntary outpatient drug benefit to Medicare beneficiaries for certain

We do not know whether our product candidates, if approved, will be eligible for coverage under Medicare Part D, but

individual Medicare Part D plans offer coverage subject to various factors such as those described above.

Furthermore, private

payors often follow Medicare coverage policies and payment limitations in setting their own coverage policies.

Laws and Regulations

of our product candidates, if approved, or any other future product candidate will be subject to healthcare regulation and enforcement

by the federal government and the states and foreign governments in which we might conduct our business.

The healthcare laws and

regulations that may affect our ability to operate include the following:

federal Anti-Kickback Statute makes it illegal for any person or entity to knowingly and willfully, directly or indirectly,

solicit, receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including

the purchase, order, lease of any good, facility, item or service for which payment may be made under a federal healthcare

program, such as Medicare or Medicaid.

The term “remuneration”

has been broadly interpreted to include anything

false claims and false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person

or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including

Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent.

Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes that

prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare

benefit program, including private third-party payors or making any false, fictitious or fraudulent statement in connection

with the delivery of or payment for healthcare benefits, items or services.

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations,

impose obligations on certain types of individuals and entities regarding the electronic exchange of information in common

healthcare transactions, as well as standards relating to the privacy and security of individually identifiable health information.

federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for

which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions,

to report annually to the Centers for Medicare & Medicaid Services information related to payments or other transfers

of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their

immediate family members.

many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may

apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Additionally,

we may be subject to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical

industry’s voluntary compliance guidelines, state laws that require drug manufacturers to report information related to

payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state

and foreign laws governing the privacy and security of health information, many of which differ from each other in significant

ways and often are not preempted by HIPAA.

Additionally,

to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.

of December 31, 2020, we have four full-time employees and one part-time employee, none of which are represented by a labor union

or covered by a collective bargaining agreement.

state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions

on reimbursement and requirements for substitution of generic products.

Adoption of price controls and cost-containment measures, and

adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our future revenues and

results of operations.

Decreases in third-party reimbursement or a decision by a third-party payor to not cover a product candidate,

if approved, or any future approved products could reduce physician usage of our products, and have a material adverse effect on our

sales, results of operations and financial condition.

In the United States, the Medicare Part D program

provides a voluntary outpatient drug benefit to Medicare beneficiaries for certain products.

We do not know whether our product candidates,

if approved, will be eligible for coverage under Medicare Part D, but individual Medicare Part D plans offer coverage subject to various

factors such as those described above.

Furthermore, private payors often follow Medicare coverage policies and payment limitations in

setting their own coverage policies.

Healthcare Laws and Regulations

Sales of our product candidates, if approved,

or any other future product candidate will be subject to healthcare regulation and enforcement by the federal government and the states

and foreign governments in which we might conduct our business.

The healthcare laws and regulations that may affect our ability to operate

include the following:

The federal Anti-Kickback Statute makes it illegal

for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that

is in exchange for or to induce the referral of business, including the purchase, order, lease of any good, facility, item or service

for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.

The term “remuneration”

has been broadly interpreted to include anything of value.

Federal false claims and false statement laws, including

the federal civil False Claims Act, prohibits, among other things, any person or entity from knowingly presenting, or causing to

be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or services, including

drugs, that are false or fraudulent.

Health Insurance Portability and Accountability Act

of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit among other actions, knowingly and willfully

executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors or

making any false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items

HIPAA, as amended by the Health Information Technology

for Economic and Clinical Health Act of 2009 and their implementing regulations, impose obligations on certain types of individuals

and entities regarding the electronic exchange of information in common healthcare transactions, as well as standards relating to

the privacy and security of individually identifiable health information.

The federal Physician Payments Sunshine Act requires

certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or

the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid

Services information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership

and investment interests held by physicians and their immediate family members.

Also, many states have similar laws and regulations,

such as anti-kickback and false claims laws that may be broader in scope and may apply regardless of payor, in addition to items and

services reimbursed under Medicaid and other state programs.

Additionally, we may be subject to state laws that require pharmaceutical

companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines, state

laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare

providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many

of which differ from each other in significant ways and often are not preempted by HIPAA.

Additionally, to the extent that our product

is sold in a foreign country, we may be subject to similar foreign laws.

As of December 31, 2021, we have four full-time

employees and one part-time employee, none of which are represented by a labor union or covered by a collective bargaining agreement.

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