What changed in this filing

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Item 1. Business

2024-03-28 compared with 2023-03-31 · 288 added, 336 removed, 276 unchanged (69% of the section changed)

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biopharmaceutical company focused on developing new generation therapies for unmet medical needs.

We are focused on developing (i) a topical

formulation for treating side effects from drugs used for the treatment of cancer (HT-001);

(ii) a treatment for mast-cell derived cancers

and anaphylaxis (HT-KIT);

We are focused on developing (i) a

topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001);

(ii) a treatment for mast-cell derived

cancers and anaphylaxis (HT-KIT);

(iii) a treatment for traumatic brain injury and ischemic stroke (HT-TBI);

and (iv) a treatment and/or prevention

for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ).

We also have assets being developed for (i) atopic dermatitis (also

known as eczema) (BioLexa);

and (iv) a treatment and/or

prevention for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ).

We also have assets being developed for (i) atopic dermatitis

(also known as eczema) (BioLexa);

(ii) a treatment for asthma and allergies using inhalational administration (HT-004);

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for acne as well as inflammatory bowel diseases (HT-003).

In addition, we are continuing to evaluate a novel peptide that may be used

to slow the transmission of SARS-CoV-2 (HT-002).

We are also developing a diagnostic device via a mobile device.

Furthermore, we have

interests in certain other assets being developed by third parties including a treatment for patients with lupus that is being developed

by Zylö Therapeutics, Inc.

and potential product candidates being developed pursuant to our agreement with Voltron Therapeutics,

for the prevention of COVID-19.

In addition, the Company also has interests in certain other assets being developed

by third parties (see Note 5 to the consolidated financial statements for a discussion of the Company’s agreements with Zylö

Therapeutics, Inc.

and Voltron Therapeutics).

Primary Development:

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license agreement with The George Washington University (“GW”) pursuant to which GW granted us a license to certain patent

rights to, among other things, make, use, offer and sell certain licensed products throughout the world with respect to HT-001 which we

intend to seek approval for use for treating dermatological side effects from epidermal growth factor receptor (“EGFR”) inhibitors,

and potentially other drugs used for the treatment of cancer.

HT-001 is a topical formulation under development for the treatment of patients

with rash and skin disorders associated with initial and repeat courses of tyrosine kinase EGFR inhibitor therapy.

EGFR inhibitors are

used for the treatment of cancers with EGFR up-regulation (such as non-small cell lung cancer, pancreatic cancer, breast cancer and colon

however, EGFR inhibitors are often associated with dose-limiting skin toxicities that can result in the interruption or reduction

of treatment.

HT-001 is targeted to treat these EGFR-induced skin disorders to allow patients to achieve the best potential outcomes of

EGFR therapy.

rights to, among other things, make, use, offer and sell certain licensed products throughout the world with respect to HT-001 which

we intend to seek approval for use for treating dermatological side effects from epidermal growth factor receptor (“EGFR”)

inhibitors, and potentially other drugs used for the treatment of cancer.

HT-001 is a topical formulation under development for the treatment

of patients with rash and skin disorders associated with initial and repeat courses of tyrosine kinase EGFR inhibitor therapy.

EGFR inhibitors

are used for the treatment of cancers with EGFR up-regulation (such as non-small cell lung cancer, pancreatic cancer, breast cancer and

colon cancer);

however, EGFR inhibitors are often associated with dose-limiting skin toxicities that can result in the interruption or

reduction of treatment.

HT-001 is targeted to treat these EGFR-induced skin disorders to allow patients to achieve the best potential

outcomes of EGFR therapy.

HT-001 has achieved positive results in its initial pre-clinical studies conducted at GW.

In November 2022, we submitted

an IND to the FDA with respect to HT-001 as a concomitant therapy with EGFR inhibitors, for a Phase 2a clinical trial in humans.

engaged Worldwide Clinical Trials (“Worldwide”) as our clinical research organization to provide clinical management, data

management, biostatistical, medical monitoring, pharmacovigilance, and other related services to support the CLEER-001 Phase 2a clinical

trial in the United States.

We received FDA approval to proceed with our clinical study on December 28, 2022.

In November 2022,

we submitted an IND to the FDA with respect to HT-001 as a concomitant therapy with EGFR inhibitors, for a Phase 2a clinical trial in

We have engaged Worldwide Clinical Trials (“Worldwide”) as our clinical research organization to provide clinical

management, data management, biostatistical, medical monitoring, pharmacovigilance, and other related services to support the CLEER-001

Phase 2a clinical trial in the United States.

We received FDA approval to proceed with our clinical study on December 28, 2022 and it

is currently enrolling patients.

We believe that the key elements for our market success with respect

to HT-001 include:

● To our knowledge, there are

currently no drugs approved for the treatment of skin toxicities associated with EFGR inhibitor therapy and 49-100% of patients develop

skin toxicities during EGFR inhibitory therapy;

To our knowledge, there

are currently no drugs approved for the treatment of skin toxicities associated with EFGR inhibitor therapy and 49-100% of patients

develop skin toxicities during EGFR inhibitory therapy;

The main active ingredient

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time and cost;

● To our knowledge, there are

no current topical formulations available using HT-001’s active ingredient so we believe that there is no direct market competition;

● We have the potential to pursue

other indications such as chronic pruritus, atopic dermatitis and other skin toxicities that develop from anti-cancer therapies using

the HT-001 formulation.

To our knowledge, there

are no current topical formulations available using HT-001’s active ingredient so we believe that there is no direct market

We have the potential to

pursue other indications such as chronic pruritus, atopic dermatitis and other skin toxicities that develop from anti-cancer therapies

using the HT-001 formulation.

We have obtained from North Carolina State University

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The HT-KIT drug is designed to more specifically target the receptor tyrosine

kinase KIT in mast cells, which is required for the proliferation, survival and differentiation of bone marrow-derived hematopoietic stem

Mutations in the KIT pathway have been associated with several human cancers, such as gastrointestinal stromal tumors and mast

cell-derived cancers (mast cell leukemia and mast cell sarcoma).

kinase KIT in mast cells, which is required for the proliferation, survival and differentiation of bone marrow-derived hematopoietic

Mutations in the KIT pathway have been associated with several human cancers, such as gastrointestinal stromal tumors and

mast cell-derived cancers (mast cell leukemia and mast cell sarcoma).

Based on the initial proof-of-concept success, we intend to initially

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mast cell-mediated anaphylaxis, a serious allergic reaction that is rapid in onset and may cause death.

Anaphylaxis typically occurs after

exposure to an external allergen that results in an immediate and severe immune response.

We also intend to pursue the anaphylaxis indication

for HT-KIT in parallel to cancer treatment.

Anaphylaxis typically occurs

after exposure to an external allergen that results in an immediate and severe immune response.

We also intend to pursue the anaphylaxis

indication for HT-KIT in parallel to cancer treatment.

On November 15, 2021, we entered into a sponsored

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Designation (“ODD”) request to the U.S.

Food and Drug Administration (“FDA”) for HT-KIT for the treatment of mastocytosis,

and on March 10, 2022, we received such ODD.

Drugs intended to treat orphan diseases (rare diseases that affect less than 200,000 people

in the U.S.) are eligible to apply for ODD, which provides benefits such as 7-year marketing exclusivity and tax incentives to the sponsor

during development and after approval.

Food and Drug Administration (“FDA”) for HT-KIT for the treatment of

mastocytosis, and on March 10, 2022, we received such ODD.

Drugs intended to treat orphan diseases (rare diseases that affect less than

200,000 people in the U.S.) are eligible to apply for ODD, which provides benefits such as 7-year marketing exclusivity and tax incentives

to the sponsor during development and after approval.

In September 2023, we submitted a pre-IND meeting request to the FDA with respect

to HT-KIT as for the treatment of adult patients with advanced systemic mastocytosis (AdvSM), systemic mastocytosis with an associated

hematological neoplasm (SM-AHN) and mast cell leukemia (MCL).

In preparation for such pre-IND meeting, we prepared and submitted to the

FDA our IND-opening clinical trial plan which includes two phase 1 trials conducted in patients.

Based on the FDA’s feedback, we

intend to advance our IND-enabling activities for HT-KIT as planned.

In February 2021, we filed a provisional patent

application with the United States Patent and Trademark Office for the use of the active ingredient of HT-001 to treat and prevent Alzheimer’s

disease and other neuroinflammatory diseases, and in February 2022, we filed a Patent Cooperation

Treaty patent application, receiving confirmation of such filing on April 4, 2022 .

disease and other neuroinflammatory diseases, and in February 2022, we filed a Patent Cooperation Treaty patent application, receiving

confirmation of such filing on April 4, 2022.

We intend to develop HT-ALZ for use in patients

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Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (“FDCA”)

was enacted to enable sponsors to seek New Drug Application (“NDA”) approval for novel repurposed drugs without the need for

such sponsors to undertake time consuming and expensive pre-clinical safety studies and Phase 1 safety studies.

Proceeding under this

regulatory pathway, we will be able to rely upon publicly available data with respect to our active ingredient in our NDA submission to

the FDA for marketing approval.

On June 7, 2021, we entered into a sponsored research agreement with

Washington University in St.

Louis to investigate the effects of HT-ALZ on behavioral and pathological markers of Alzheimer’s disease

and to determine if HT-ALZ can improve learning and memory in an animal model of Alzheimer’s disease.

Our study will also determine

if behavior is improved utilizing HT-ALZ in blocking NK-1Rs.

The study commenced in August 2021 and after positive initial preclinical

results, a chronic dosing study in mice was initiated.

We expect preclinical results from the chronic dosing study in 2023.

In October 2022, we filed

a provisional patent application with the United States Patent and Trademark Office for the use of the active ingredient of HT-001 to

treat traumatic brain injury and ischemic stroke.

We intend to develop HT-ALZ for use in patients following the Section 505(b)(2) regulatory

pathway of the FDA rules pursuant to which we will be able to rely upon publicly available data with respect to our active ingredient

in our NDA submission to the FDA for marketing approval.

HT-TBI injection is being

developed as a ready-to-inject autoinjector for intramuscular injection to be used in both traumatic brain injuries and ischemic stroke.

was enacted to enable sponsors to seek New Drug Application (“NDA”) approval for novel repurposed drugs without the need

for such sponsors to undertake time consuming and expensive pre-clinical safety studies and Phase 1 safety studies.

Proceeding under

this regulatory pathway, we will be able to rely upon publicly available data with respect to our active ingredient in our NDA submission

to the FDA for marketing approval.

On June 7, 2021, we entered into a sponsored

research agreement with Washington University in St.

Louis to investigate the effects of HT-ALZ on behavioral and pathological markers

of Alzheimer’s disease and to determine if HT-ALZ can improve learning and memory in an animal model of Alzheimer’s disease.

Our study will also determine if behavior is improved utilizing HT-ALZ in blocking NK-1Rs.

The study commenced in August 2021 and after

positive initial preclinical results, a chronic dosing study in mice was initiated.

We received preclinical results from the chronic

dosing study in 2023 and amended the SRA to conduct additional studies.

We expect the results from the additional preclinical studies

In October 2022, we

filed a provisional patent application with the United States Patent and Trademark Office for the use of the active ingredient of HT-001

to treat traumatic brain injury and ischemic stroke.

We intend to develop HT-ALZ for use in patients following the Section 505(b)(2)

regulatory pathway of the FDA rules pursuant to which we will be able to rely upon publicly available data with respect to our active

ingredient in our NDA submission to the FDA for marketing approval.

HT-TBI injection is

being developed as a ready-to-inject autoinjector for intramuscular injection to be used in both traumatic brain injuries and ischemic

The same dose and formulation can be used across both TBI and stroke indications in age two years through adult.

Our focus of development

is for point-of-care use in ambulatory and emergency room settings.

HT-TBI’s active ingredient targets substance P/NK-1 pathway,

identified as a leading cause of post-brain injury inflammation and edema.

development is for point-of-care use in ambulatory and emergency room settings.

HT-TBI’s active ingredient targets substance P/NK-1

pathway, identified as a leading cause of post-brain injury inflammation and edema.

Preclinical data has shown an NK-1 Antagonist significantly

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We intend to develop the BioLexa Platform for use in patients following the Section 505(b)(2) regulatory pathway of the

Proceeding under this regulatory pathway, we will be able to rely upon publicly available data with respect to gentamicin and

the zinc chelator in our NDA submission to the FDA for marketing approval.

In December 2020, we received approval from the Belberry Human Research

Ethics Committee in Australia to conduct our Phase 1b clinical trial of BioLexa, and we have engaged Novotech (Australia) Pty Limited

as our local clinical research organization in Australia to provide clinical management, data management, biostatistical, medical monitoring,

pharmacovigilance, and other related services to support the first in human clinical trial of BioLexa.

Phase 1b of the trial was initiated

in 2021 and final dosing of patients concluded in September 2022.

At this time, we do not anticipate conducting any further trials/studies

in Australia.

Proceeding under this regulatory pathway, we will be able to rely upon publicly available data with respect to gentamicin

and the zinc chelator in our NDA submission to the FDA for marketing approval.

In December 2020, we

received approval from the Belberry Human Research Ethics Committee in Australia to conduct our Phase 1b clinical trial of BioLexa, and

we have engaged Novotech (Australia) Pty Limited as our local clinical research organization in Australia to provide clinical management,

data management, biostatistical, medical monitoring, pharmacovigilance, and other related services to support the first in human clinical

trial of BioLexa.

Phase 1b of the trial was initiated in 2021 and final dosing of patients concluded in September 2022.

At this time,

we do not anticipate conducting any further trials in Australia.

We believe that the key elements for our market success with respect

to BioLexa include:

the proprietary formulation of two FDA-approved drugs to treat bacterial proliferation which may reduce development time and costs by giving us the ability to rely on safety and efficacy data from the two approved drugs;

our proprietary formulation is not a topical corticosteroid, and provides a novel mechanism of action and potentially a preferred safety profile as a market differentiator;

the literature set forth below reaffirms the critical

aureus plays in the development of atopic dermatitis flare-ups within the international medical community, supporting

the targeted mechanism of action of BioLexa.

● the proprietary

formulation of two FDA-approved drugs to treat bacterial proliferation which may reduce development

time and costs by giving us the ability to rely on safety and efficacy data from the two

approved drugs;

● our proprietary

formulation is not a topical corticosteroid, and provides a novel mechanism of action and

potentially a preferred safety profile as a market differentiator;

● the literature

set forth below reaffirms the critical role that S.

aureus plays in the development

of atopic dermatitis flare-ups within the international medical community, supporting the

targeted mechanism of action of BioLexa.

Shi et al, “MRSA Colonization

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Date”), we entered into a Sublicense Agreement (the “Isoprene Sublicense Agreement”) with Isoprene Pharmaceuticals,

(“Isoprene”) pursuant to the commercial evaluation sublicense and option agreement dated March 8, 2019 by and among us,

the University of Maryland, Baltimore and Isoprene.

Pursuant to the Isoprene Sublicense Agreement, Isoprene granted us an exclusive sublicense

to certain intellectual property (i) to make, have made, use, sell, offer to sell and import certain licensed products, (ii) in connection

therewith, to use certain inventions and licensed materials and (iii) to practice certain patent rights for the treatment of dermatological

conditions or diseases, referred to as HT-003.

Retinoids, which include Vitamin A (retinol) and

its analogues (both synthetic and metabolites), play a critical role in cell signaling and biological processes, including regulation

of immune cells and inflammation, signaling pathways that control normal skin maintenance, embryonic development and cell growth/differentiation/repair.

Deficiencies in retinoids and their active metabolites have been implicated in a wide variety of diseases.

In the skin, retinol deficiency

leads to hyperkeratosis and keratinizing metaplasia that is observed in skin disorders like psoriasis and acne.

Vitamin A and retinoic

acid also play a crucial role in regulating cell proliferation, differentiation, and apoptosis and therefore, altered metabolism of retinoids

has been suspected as playing a potential role in tumorigenesis.

Accordingly, retinoids have been approved in the U.S.

for treatment of

acne and psoriasis as well as other therapeutic indications such as acute promyelocytic leukemia and cutaneous T-cell lymphoma;

the therapeutic use of exogenous retinoids has been limited due to negative effects associated with high systemic concentrations.

therapeutic approach to increase intracellular retinoic acid (the active metabolite of retinol) potentially without causing negative side

effects of exogenous retinoic acid is to use inhibitors of RAMBAs, which prolong the presence of retinoic acid.

HT-003 is a novel RAMBA

(“Isoprene”) pursuant to the commercial evaluation sublicense and option agreement dated March 8, 2019, by and among

us, the University of Maryland, Baltimore and Isoprene.

Pursuant to the Isoprene Sublicense Agreement, Isoprene granted us an exclusive

sublicense to certain intellectual property (i) to make, have made, use, sell, offer to sell and import certain licensed products, (ii)

in connection therewith, to use certain inventions and licensed materials and (iii) to practice certain patent rights for the treatment

of dermatological conditions or diseases, referred to as HT-003.

HT-003 is a novel retinoic acid metabolism blocking agents (“RAMBAs”)

under investigation for topical treatment in acne and psoriasis applications.

In December 2019, we entered into a research collaboration

agreement with Weill Cornell Medicine for the completion of pre-clinical studies investigating the mechanism of action of HT-003 that

was renewed in January 2021 as a result of positive preclinical results.

Jonathan Zippin, M.D., Ph.D., FAAD, Associate Professor of

Dermatology at Weill Cornell Medicine and our Senior Scientific Advisor, is the principal investigator for such pre-clinical studies.

The retinoic acid metabolism blocking agents (“RAMBAs”)

have the potential to be developed as a platform for multiple inflammatory-based indications.

Accordingly, we entered into a Sublicense

Agreement with Isoprene on July 2, 2021 pursuant to the option agreement dated December 22, 2020 to expand the therapeutic indication

of the sublicensed RAMBAs from Isoprene to include inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.

Preclinical proof-of-concept studies were conducted in 2021 for the investigation of RAMBAs for treatment of inflammatory bowel diseases,

including Crohn’s disease and ulcerative colitis.

In December 2019, we entered into a research

collaboration agreement with Weill Cornell Medicine for the completion of pre-clinical studies investigating the mechanism of action

of HT-003 that was renewed in January 2021 as a result of positive preclinical results.

Jonathan Zippin, M.D., Ph.D., FAAD, Associate

Professor of Dermatology at Weill Cornell Medicine and our Senior Scientific Advisor, was the principal investigator for such pre-clinical

RAMBAs have the potential to be developed as

a platform for multiple inflammatory-based indications.

Accordingly, we entered into a Sublicense Agreement with Isoprene on July 2,

2021 pursuant to the option agreement dated December 22, 2020 to expand the therapeutic indication of the sublicensed RAMBAs from Isoprene

to include inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.

Preclinical proof-of-concept studies

were conducted in 2021 for the investigation of RAMBAs for treatment of inflammatory bowel diseases, including Crohn’s disease

and ulcerative colitis.

On November 20, 2019, we entered into a license

agreement with NC State pursuant to which NC State granted us an exclusive license to, among other things, develop, make, use, offer and

sell certain licensed products throughout the world with respect to HT-004 for treating allergic diseases.

HT-004 is a potential disease-modifying

agent that uses exon-skipping oligonucleotide-targeted methods to reduce mast cell responses to immunoglobulin E (IgE)-directed antigens,

which is one of the key mechanisms in the pathophysiology of asthma, atopic dermatitis and other allergic diseases.

HT-004 is currently

under investigation for the treatment of asthma and allergies using inhalational administration.

agreement with NC State pursuant to which NC State granted us an exclusive license to, among other things, develop, make, use, offer

and sell certain licensed products throughout the world with respect to HT-004 for treating allergic diseases.

HT-004 is a potential

disease-modifying agent that uses exon-skipping oligonucleotide-targeted methods to reduce mast cell responses to immunoglobulin E (IgE)-directed

antigens, which is one of the key mechanisms in the pathophysiology of asthma, atopic dermatitis and other allergic diseases.

is currently under investigation for the treatment of asthma and allergies using inhalational administration.

In December 2019, we entered a sponsored research

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Critical proof-of-concept studies

in a humanized mouse model are planned to be initiated in 2022 and was completed in 2023.

in a humanized mouse model were completed in 2023.

Further preclinical studies are underway at NC State to study HT-004 in different

animal models.

We believe that the key elements for our market

success with respect to HT-004 include:

● To our knowledge, there are

currently no disease-modifying agents for asthma or allergy diseases;

● The active pharmaceutical ingredient

in HT-004 is a novel molecular class that we believe would prevent generic competition after commercialization;

● HT-004 is being developed for

inhalational administration by either inhaler or nebulizer for easy access at home by patients;

● HT-004 is applicable for both

adult and pediatric patient populations with asthma and/or allergies.

On May 18, 2020, we entered into an Exclusive

License Agreement with the Virginia Commonwealth University Intellectual Property Foundation (“VCU”) pursuant to which VCU

granted us an exclusive, royalty bearing license to HT-002, a novel peptide developed by researchers at VCU that may be used to slow the

transmission of SARS-CoV-2 (the “VCU Peptide”) and a non-exclusive royalty bearing, worldwide license with respect to certain

licensed technical information patents to make, have made, use, offer to sell, sell and import certain licensed products and perform certain

licensed services.

On June 29, 2020, we entered into a Sponsored Project Agreement (“VCU SPA”) with VCU for the development

of a potential COVID-19 treatment using the VCU Peptide.

The VCU SPA was amended on April 28, 2021 to extend the period of research and

to add additional scope of investigation to include the variants of SARS-CoV-2.

Proof-of-Concept preclinical studies were completed in

Direct Detect Breath Diagnostic Device

On August 7, 2020, we entered into a Patent License

Agreement (“GW Patent License Agreement”) with GW pursuant to which GW granted us an exclusive, worldwide, royalty bearing

license to certain intellectual property that can be used to develop a device designed to detect the presence of viruses.

Specifically,

the GW Patent License Agreement permits us to make, have made, use, import, offer for sale and sell certain licensed products in the field

of virus sensing and detection.

We have engaged a company to develop a platform prototype and, once developed, we will select target analytes

for further development.

To our knowledge, there

are currently no disease-modifying agents for asthma or allergy diseases;

The active pharmaceutical

ingredient in HT-004 is a novel molecular class that we believe would prevent generic competition after commercialization;

HT-004 is being developed

for inhalational administration by either inhaler or nebulizer for easy access at home by patients;

HT-004 is applicable for

both adult and pediatric patient populations with asthma and/or allergies.

Product Development Pipeline

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with respect to the development of HT-005.

We had previously entered into a sublicense agreement with Zylö pursuant to which we had

advanced the development of HT-005 for patients with lupus.

(See Note 6 to the consolidated financial statements for a discussion of our

agreement with Zylö).

In addition, in March 2020, we entered into a Royalty and Development Agreement (the “Voltron Agreement”)

with Voltron Therapeutics, Inc.

(“Voltron”) with respect to the development of potential product candidates for the prevention

We had previously entered into a sublicense agreement with Zylö pursuant to which we

had advanced the development of HT-005 for patients with lupus.

(See Note 5 to the consolidated financial statements for a discussion

of our agreement with Zylö).

In addition, in March 2020, we entered into a Royalty and Development Agreement (the “Voltron

Agreement”) with Voltron Therapeutics, Inc.

(“Voltron”) with respect to the development of potential product candidates

for the prevention of COVID-19.

(See Note 5 to the consolidated financial statements for a discussion of our agreement with Voltron).

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There is also a strong emphasis on intellectual property and proprietary

In the segment of the biopharmaceutical industry, competition from different sources including major biopharmaceutical companies,

In our segment of the biopharmaceutical industry, competition from different sources including major biopharmaceutical companies,

academic institutions, government agencies, and public and private research institutions will continue.

Many of our competitors have significantly

greater financial resources and expertise in product candidate development and may have progressed further toward approval and marketing.

In addition, smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements

with large and established companies.

Many of our competitors have

significantly greater financial resources and expertise in product candidate development and may have progressed further toward approval

and marketing.

In addition, smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative

arrangements with large and established companies.

Manufacturing and Supply

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If and when our product

candidates receive regulatory approval, we intend to engage third-parties such as pharmaceutical and biotechnology companies for the commercialization

of our products.

candidates receive regulatory approval, we intend to engage third-parties such as pharmaceutical and biotechnology companies for the

commercialization of our products.

Intellectual Property Portfolio

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and elsewhere in the world.

In addition, we intend to actively pursue

product life-cycle management initiatives to extend our market exclusivity.

In addition, we intend to actively

pursue product life-cycle management initiatives to extend our market exclusivity.

We intend to cement our market exclusivity in

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which includes eight

years of data exclusivity and two years of market exclusivity from the date we file an NDA or the European equivalent referred to as Marketing

Authorization Application.

years of data exclusivity and two years of market exclusivity from the date we file an NDA or the European equivalent referred to as

Marketing Authorization Application.

We currently have licenses to six U.S.

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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,

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.

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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 regulations;

● 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, referred to

as good clinical practice (“GCP”), to establish the safety and efficacy of the proposed drug for its proposed indication;

● submission to the FDA of an

NDA or biologics license application (“BLA”);

● satisfactory completion of

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

completion of extensive

pre-clinical laboratory tests, animal studies and formulation studies in accordance with applicable regulations, including the FDA’s

Good Laboratory Practice regulations;

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, referred

to as good clinical practice (“GCP”), to establish the safety and efficacy of the proposed drug for its proposed indication;

submission to the FDA of

an NDA or biologics license application (“BLA”);

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 current good manufacturing practice (“cGMP”) requirements;

● potential FDA audit of the

clinical trial sites that generated the data in support of the NDA or BLA;

● FDA review and approval of

the NDA or BLA prior to any commercial marketing or sale.

potential FDA audit of

the clinical trial sites that generated the data in support of the NDA or BLA;

FDA review and approval

of the NDA or BLA prior to any commercial marketing or sale.

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.

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

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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

These clinical trials are intended to establish the overall risk/benefit relationship of the product and provide an adequate

basis for product labeling.

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

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

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 Institutional Review Board (“IRB”), which

oversees the conduct of clinical trials, 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

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.

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 Institutional Review Board (“IRB”),

which oversees the conduct of clinical trials, 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

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approval to market the product.

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

an approved NDA or BLA is also subject to an annual program user fee;

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

circumstances.

The FDA reviews all NDAs submitted before it accepts

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

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 submission of an NDA or BLA is subject to the payment of a substantial user fee, and the sponsor

of an approved NDA or BLA is also subject to an annual program user fee;

although a waiver of such fee may be obtained under certain

limited circumstances.

The FDA reviews all NDAs submitted before it

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

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 review and evaluation of an NDA or BLA by

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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.

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.

Section 505(b)(2) Regulatory Approval Pathway

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Specifically, Section

505(b)(2) permits the submission of an NDA where one or more of the investigations relied upon by the applicant for approval was not conducted

by or for the applicant and for which the applicant has not obtained a right of reference.

The applicant may rely upon published literature

and/or the FDA’s findings of safety and effectiveness for an approved drug already on the market.

Approval or submission of a 505(b)(2)

application, like those for abbreviated new drugs (“ANDAs”), may be delayed because of patent and/or exclusivity rights that

apply to the previously approved drug.

A 505(b)(2) application may be submitted for a

new chemical entity (“NCE”) when some part of the data necessary for approval is derived from studies not conducted by or

for the applicant and when the applicant has not obtained a right of reference.

505(b)(2) permits the submission of an NDA where one or more of the investigations relied upon by the applicant for approval was not

conducted by or for the applicant and for which the applicant has not obtained a right of reference.

The applicant may rely upon published

literature and/or the FDA’s findings of safety and effectiveness for an approved drug already on the market.

Approval or submission

of a 505(b)(2) application, like those for abbreviated new drugs (“ANDAs”), may be delayed because of patent and/or exclusivity

rights that apply to the previously approved drug.

A 505(b)(2) application may be submitted for

a new chemical entity (“NCE”) when some part of the data necessary for approval is derived from studies not conducted by

or for the applicant and when the applicant has not obtained a right of reference.

Section 505(b)(2) applications also may be entitled

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commonly referred to as the Orange Book.

Any applicant who subsequently files an ANDA or 505(b)(2) NDA that references a drug listed in

the Orange Book must certify to the FDA that (1) no patent information on the drug product that is the subject of the application has

been submitted to the FDA;

Any applicant who subsequently files an ANDA or 505(b)(2) NDA that references a drug listed

in the Orange Book must certify to the FDA that (1) no patent information on the drug product that is the subject of the application

has been submitted to the FDA;

(2) such patent has expired;

(3) the date on which such patent expires;

or (4) such patent is invalid or will

not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted.

or (4) such patent is invalid

or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted.

This last certification

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If an applicant has provided a Paragraph IV Certification

to the FDA, the applicant must also send notice of the Paragraph IV Certification to the holder of the NDA for the approved drug and the

patent owner once the application has been accepted for filing by the FDA.

The NDA holder or patent owner may then initiate a patent infringement

lawsuit in response to notice of the Paragraph IV Certification.

The filing of a patent infringement lawsuit within 45 days of the receipt

of a Paragraph IV Certification prevents the FDA from approving the ANDA or 505(b)(2) application until the earlier of 30 months from

the date of the lawsuit, the applicant’s successful defense of the suit, or expiration of the patent.

United States Medical Device Regulation

Medical devices, including diagnostic test

devices, also are subject to extensive and rigorous regulation by the FDA under the FDCA, as well as other federal and state

regulatory bodies in the United States, and laws and regulations of foreign authorities in other countries.

FDA requirements

specific to medical devices are wide ranging and govern, among other things, the design, development and manufacturing, human

clinical trials, preclearance or approval, advertising and promotion, and product import and export.

Unless an exemption applies,

medical devices distributed in the United States must receive either premarket clearance under Section 510(k) of the FDCA or

premarket approval of a premarket application (“PMA”).

During the COVID-19 public health emergency, the FDA had

authorized COVID-19 diagnostic tests under its Emergency Use Authorization (“EUA”) authority;

however, on January 31, 2023, President Biden issued a Statement

of Administration Policy indicating that the administration intends for the COVID-19 national emergency and public health emergency to

end on May 11, 2023.

When the public health emergency ends, the FDA will continue to have the authority to issue EUAs until that authority

is formally terminated by the Secretary of HHS through a separate process.

Medical devices are

classified into one of three classes-Class I, Class II, or Class III-depending on the degree or risk associated with each medical

device and the extent of control needed to ensure safety and effectiveness.

Medical devices deemed to pose relatively low risk are

placed in either Class I or II.

Class II devices generally require the manufacturer to submit a premarket notification under Section

510(k) of the FDCA requesting permission for commercial distribution.

Devices deemed by the FDA to pose the greatest risk, such as

life-sustaining, life-supporting or implantable devices are placed in Class III requiring PMA approval.

to the FDA, the applicant must also send notice of the Paragraph IV Certification to the holder of the NDA for the approved drug and

the patent owner once the application has been accepted for filing by the FDA.

The NDA holder or patent owner may then initiate a patent

infringement lawsuit in response to notice of the Paragraph IV Certification.

The filing of a patent infringement lawsuit within 45 days

of the receipt of a Paragraph IV Certification prevents the FDA from approving the ANDA or 505(b)(2) application until the earlier of

30 months from the date of the lawsuit, the applicant’s successful defense of the suit, or expiration of the patent.

Reimbursement

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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.

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

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Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan

designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than

200,000 individuals in the United States, or more than 200,000 individuals in the United States for which there is no reasonable expectation

that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be

recovered from sales in the United States for that drug or biologic.

Orphan drug designation must be requested before submitting an NDA

After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed

publicly by the FDA.

The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or

approval process.

Under the Orphan Drug Act, the FDA may grant

orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects

fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States for which there is no reasonable

expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition

will be recovered from sales in the United States for that drug or biologic.

Orphan drug designation must be requested before submitting

an NDA or BLA.

After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use

are disclosed publicly by the FDA.

The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory

review or approval process.

If a product that has orphan drug designation

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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 or services.

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.

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.

“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 or services.

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.

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 March 26, 2024, we employed a total of 2

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Our Corporate Information and History

were incorporated as a Nevada corporation on May 16, 2017.

On October 20, 2022, we filed a Certificate

of Change with the Nevada Secretary of State to effectuate a 1-for-25 reverse stock split of our issued and outstanding and authorized

shares of common stock.

The reverse stock split became effective on October 26, 2022.

All share data, per share data and related

information contained in this Annual Report on Form 10-K has been retrospectively adjusted to reflect the effect of the reverse stock

On November 2, 2022, we filed a

Certificate of Designation of the Series B Preferred Stock (the “Certificate of Designation”) with the Secretary of State

of the State of Nevada to create a new class of Series B Preferred Stock, par value $0.0001 per share (“Series B Preferred Stock”),

designating 2,000,000 shares of our authorized preferred stock as Series B Preferred Stock.

November 2, 2022, we also entered into a Subscription and Investment Representation Agreement

with an investor pursuant to which we issued and sold 2,000,000 shares of our newly designated Series B Preferred Stock to such investor

for an aggregate purchase price of $1,000.

The Series B Preferred Stock were not entitled to receive dividends or any other distributions.

The Series B Preferred Stock were entitled to ten votes per share and voted together with the issued and outstanding shares of our common

stock as a single class exclusively with respect to the Authorized Stock Increase (as defined in the Certificate of Designation).

Series B Preferred Stock had no rights as to any distribution or assets of our Company upon a liquidation, bankruptcy, reorganization,

merger, acquisition, sale, dissolution or winding up of our Company.

The 2,000,000 outstanding shares of Series B Preferred Stock were

redeemed for an aggregate price of $10 on December 13, 2022 in connection with the filing of the Amendment (as defined herein) with the

Secretary of State of the State of Nevada.

Pursuant to the Certificate of Designation, the shares of Series B Preferred Stock redeemed

by us were automatically retired and restored to the status of an authorized but unissued share of preferred stock.

13, 2022, we filed a Certificate of Amendment (the “Amendment”) to our Articles of Incorporation, as amended, to increase

our authorized shares of common stock from 3,000,000 shares to 50,000,000 shares.

Our principal executive offices are located at 1 Rockefeller Plaza,

Suite 1039, New York, New York 10020 and our telephone number is (646) 756-2997.

We were incorporated as a Nevada corporation

on May 16, 2017.

Our principal executive offices are located at 590 Madison Ave, 21 st FL, New York, New York 10022 and our

telephone number is (646) 756-2997.

Available Information

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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