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Item 1. Business

2025-03-28 compared with 2024-03-28 · 410 added, 503 removed, 61 unchanged (94% of the section changed)

We are a clinical-stage

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);

(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);

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

and (iii) a treatment

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

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:

On February 1, 2020, we entered into a patent

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 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

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;

The main active ingredient

of HT-001 is already approved in oral and IV dosage forms which supports pursuit of the 505(b)(2) regulatory pathway to reduce development

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

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

(“NC State”) an exclusive, worldwide, royalty bearing license to certain intellectual property to, among other things, discover,

develop, make, have made, use and sell certain licensed products and sell, use and practice certain licensed services with respect to

cancer and anaphylaxis;

are a clinical-stage 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);

and (iii) 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);

and (iii) a treatment for obesity, and obesity-related diseases and

conditions (HT-VA).

February 1, 2020, we entered into a patent 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 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.

In November 2022, we submitted an Investigational New Drug (“IND”)

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

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.

HT-001 has achieved

positive interim preliminary clinical results from its open label cohort, and we are actively enrolling in both the open label and double-blind

randomized cohorts.

believe that the key elements for our market success with respect to HT-001 include:

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;

main active ingredient of HT-001 is already approved in oral and IV dosage forms which supports pursuit of the 505(b)(2) regulatory

pathway to reduce development time and cost;

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;

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.

In January 2025, we acquired two provisional patent applications for additional

indications that could be treated using the HT-001 formulation.

have obtained from North Carolina State University (“NC State”) an exclusive, worldwide, royalty bearing license to certain

intellectual property to, among other things, discover, develop, make, have made, use and sell certain licensed products and sell, use

and practice certain licensed services with respect to cancer and anaphylaxis;

this is being developed as HT-KIT.

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

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

target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive cancer with poor prognosis.

The same target, KIT, also plays a key role in

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.

On November 15, 2021, we entered into a sponsored

research agreement with NC State to focus on characterizing the HT-KIT dose and dosing frequency for treatment of aggressive mastocytosis

and mast cell neoplasms using humanized tumor mouse models.

In December 2021, we submitted an Orphan Drug

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.

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.

We intend to develop HT-ALZ for use in patients

following the Section 505(b)(2) regulatory pathway of the FDA rules.

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 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.

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

reduces brain edema and blood brain barrier disruption post-TBI and post-stroke.

The BioLexa Platform

We have obtained an exclusive license from the

University of Cincinnati to make, use, have made, import, offer for sale, and sell products based upon or involving the use of (i) topical

compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators to inhibit biofilm formation (the “BioLexa Platform”

or “BioLexa”).

The license enables us to develop the platform for any indications in humans.

The BioLexa Platform is a proprietary,

patented, drug compound platform for the treatment of eczema.

It combines an FDA approved zinc chelator with one or more approved antibiotics

in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms and the resulting clogging

of sweat ducts.

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.

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 cells.

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).

initial proof-of-concept success, we intend to initially target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive

cancer with poor prognosis.

same target, KIT, also plays a key role in mast cell-mediated anaphylaxis, a serious allergic reaction that is rapid in onset and may

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.

November 15, 2021, we entered into a sponsored research agreement with NC State to focus on characterizing the HT-KIT dose and dosing

frequency for treatment of aggressive mastocytosis and mast cell neoplasms using humanized tumor mouse models.

These preclinical studies

are still ongoing, and the results inform the IND enabling studies also currently underway.

December 2021, we submitted an Orphan Drug 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.

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”).

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.

We are currently conducting the analytical and animal toxicology studies required for our IND submission.

November 2024, we were granted a patent by 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.

intend to develop HT-ALZ for use in patients following the Section 505(b)(2) regulatory pathway of the FDA rules.

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 received further preclinical results from the chronic dosing study in 2023 and

amended the SRA to conduct additional studies which concluded in 2024.

In 2024, we initiated formulation development to develop prototypes

We plan to continue our work on optimizing our formulation as well as conduct additional animal studies to confirm the mechanism

of action prior to submitting a pre-IND submission to FDA.

BioLexa Platform

have obtained an exclusive license from the University of Cincinnati to make, use, have made, import, offer for sale, and sell products

based upon or involving the use of (i) topical compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators to inhibit

biofilm formation (the “BioLexa Platform” or “BioLexa”).

The license enables us to develop the platform for any

indications in humans.

The BioLexa Platform is a proprietary, patented, drug compound platform for the treatment of eczema.

an FDA approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by

preventing the formation of infectious biofilms and the resulting clogging of sweat ducts.

We intend to develop the BioLexa Platform

for use in patients following the Section 505(b)(2) regulatory pathway of the FDA rules.

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.

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

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 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

is Associated with Decreased Skin Commensal Bacteria in Atopic Dermatitis,” Invest Dermatol.

Blicharz, et al, “Staphylococcus

At this time, we do not anticipate conducting any further trials in Australia.

believe that the key elements for our market success with respect to BioLexa include:

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;

proprietary formulation is not a topical corticosteroid, and provides a novel mechanism of action and potentially a preferred safety

profile as a market differentiator;

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.

et al, “MRSA Colonization is Associated with Decreased Skin Commensal Bacteria in Atopic Dermatitis,” Invest Dermatol.

et al, “Staphylococcus aureus:

an underestimated factor in the pathogenesis of atopic dermatitis?,” Adv Dermatol Allergol

Preclinical Development

On July 30, 2020 (the “Isoprene Effective

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.

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, 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.

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

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

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.

In December 2019, we entered a sponsored research

1 unchanged sentence

Preclinical proof-of-concept data was

generated in October 2020 supporting efficacy of HT-004 after inhalational delivery in a mouse model.

generated in October 2020 supporting the efficacy of HT-004 after inhalational delivery in a mouse model.

Critical proof-of-concept studies

2 unchanged sentences

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.

Product Development Pipeline

The following table summarizes our product development

Other Interests

We have interests in certain other assets being

developed by third parties.

Specifically, in December 2021, we entered into a license agreement with Zylö Therapeutics, Inc.

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 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).

The biopharmaceutical industry utilizes rapidly

advancing technologies and is characterized by intense competition.

There is also a strong emphasis on intellectual property and proprietary

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.

Manufacturing and Supply

We do not have any manufacturing capability and

therefore we currently rely on and intend to continue to rely on contract manufacturing organizations to produce our product candidates

in accordance with regulatory requirements.

believe that the key elements for our market success with respect to HT-004 include:

our knowledge, there are currently no disease-modifying agents for asthma or allergy diseases;

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

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

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

December 9, 2024, we entered into a license agreement with the Department of Veterans Affairs (the “VA”) pursuant to which

the VA 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-VA for treating obesity and obesity conditions.

HT-VA is a glial cell line derived neurotrophic factor (“GDNF”)

being developed for the treatment of obesity and obesity-related diseases and conditions.

GDNF family receptor alpha-1 (GFRα-1) agonist, important for the differentiation and survival of neurons, GDNF signals through

its receptors, including Ret and GFR-1α, by activation of the PI3K and MAPK pathways.

HT-VA is being formulated to treat or prevent

obesity, metabolic syndrome, or insulin resistance by administering an effective amount of a pharmaceutical composition comprising of

one or more GDNF receptor agonists.

Development Pipeline

following table summarizes our product development pipeline.

biopharmaceutical industry utilizes rapidly advancing technologies and is characterized by intense competition.

There is also a strong

emphasis on intellectual property and proprietary products.

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.

Manufacturing

do not have any manufacturing capability and therefore we currently rely on and intend to continue to rely on contract manufacturing

organizations to produce our product candidates in accordance with regulatory requirements.

Commercialization

4 unchanged sentences

commercialization of our products.

Intellectual Property Portfolio

Our goal is to obtain, maintain and enforce patent

protection for our products, formulations, processes, methods and other proprietary technologies, preserve our trade secrets, and operate

without infringing on the proprietary rights of other parties, both in the U.S.

and in other countries.

Our policy is to actively seek

the broadest intellectual property protection possible for our products, proprietary information and proprietary technology through a

combination of contractual arrangements and patents, both in the U.S.

Property Portfolio

goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other proprietary technologies,

preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the U.S.

Our policy is to actively seek the broadest intellectual property protection possible for our products, proprietary information

and proprietary technology through a combination of contractual arrangements and patents, both in the U.S.

and elsewhere in the world.

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

conjunction with our formulation-development partners through additional patents based on the pharmaceutical and clinical characteristics

of our product candidates in the proprietary formulation and through the introduction of line extensions such as combination drugs and

new formulations.

In addition to any granted patents, our products

may be eligible for market exclusivity to run concurrently with the term of the patent for three and a half years in the U.S.

to the Hatch-Waxman Act and pediatric exclusivity guideline and up to ten years of market exclusivity in the E.U.

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.

We currently have licenses to six U.S.

and one pending U.S.

patent application, and we have licenses to three patents issued in Europe and Australia and five pending patent

applications in foreign jurisdictions including Europe, Brazil, Canada and Hong Kong.

Hoth also holds two pending U.S.

patent applications,

one European application and one pending PCT patent application.

In addition to patents, we rely on trade secrets

and know-how and continuing technological innovation to develop and maintain our competitive position.

However, trade secrets and know-how

can be difficult to protect.

We take measures to protect and maintain the confidentiality of proprietary information in order to protect

aspects of the business that are not amenable to, or that we do not consider appropriate for, patent protection.

We require employees,

consultants, outside scientific partners, sponsored researchers and other advisors to execute confidentiality agreements with us on or

prior to the commencement of employment or consulting relationships with us.

Government Regulations

Governmental authorities in the U.S.

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

of pharmaceutical products, including biological products, and medical devices, such as those being developed by us.

In the U.S., the

FDA regulates such products under the FDCA and the Public Health Services Act 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.

In addition, we intend to actively pursue product life-cycle management initiatives to extend our market exclusivity.

intend to cement our market exclusivity in conjunction with our formulation-development partners through additional patents based on

the pharmaceutical and clinical characteristics of our product candidates in the proprietary formulation and through the introduction

of line extensions such as combination drugs and new formulations.

addition to any granted patents, our products may be eligible for market exclusivity to run concurrently with the term of the patent

for three and a half years in the U.S.

pursuant to the Hatch-Waxman Act and pediatric exclusivity guideline and up to ten years of market

exclusivity in the E.U.

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.

currently have licenses to seven U.S.

patents and one pending U.S.

patent application, and we have licenses to three patents issued in

Europe and Australia and five pending patent applications in foreign jurisdictions including Europe, Brazil, Canada and Hong Kong.

also hold one U.S.

patent, eight pending U.S.

patent applications (including six U.S.

provisional patent applications), one European

application and one pending PCT patent application.

addition to patents, we rely on trade secrets and know-how and continuing technological innovation to develop and maintain our competitive

However, trade secrets and know-how can be difficult to protect.

We take measures to protect and maintain the confidentiality

of proprietary information in order to protect aspects of the business that are not amenable to, or that we do not consider appropriate

for, patent protection.

We require employees, consultants, outside scientific partners, sponsored researchers and other advisors to execute

confidentiality agreements with us on or prior to the commencement of employment or consulting relationships with us.

authorities in the U.S.

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

advertising, distribution and marketing of pharmaceutical products, including biological products, and medical devices, such as those

being developed by us.

In the U.S., the FDA regulates such products under the FDCA and the Public Health Services Act 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 Regulations

United States Drug Development

In the United States, the FDA regulates drugs

(including biological products, such as vaccines), medical devices and combinations of drugs and devices, or combination products, under

the FDCA and its implementing regulations.

These products 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.

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.

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 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.

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.

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

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

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

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.

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, or BLA for a biological product, requesting

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 review and evaluation of an NDA or BLA 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,

States Drug Development

the United States, the FDA regulates drugs (including biological products, such as vaccines), medical devices and combinations of drugs

and devices, or combination products, under the FDCA and its implementing regulations.

These products 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.

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.

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,

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

to the FDA of an NDA or biologics license application (“BLA”);

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;

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

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

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.

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.

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 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 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.

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,

or BLA for a biological product, requesting 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.

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

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.

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.

review and evaluation of an NDA or BLA 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.

Before approving an NDA, the FDA will conduct

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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.

and adequate to ensure 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.

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 or BLA 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.

Section 505(b)(2) Regulatory Approval Pathway

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.

FDA may require that certain contraindications, warnings or precautions be included in the product labeling or may condition the approval

of the NDA or BLA 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.

505(b)(2) Regulatory Approval Pathway

Section 505(b)(2) of the FDCA provides an alternate

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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

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

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

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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

to marketing exclusivity if supported by appropriate data and information.

Three-year new data exclusivity may be granted to the 505(b)(2)

application if one or more clinical investigations conducted in support of the application, other than bioavailability/bioequivalence

studies, were essential to the approval and conducted or sponsored by the applicant.

Five years of marketing exclusivity may be granted

if the application is for an NCE, and pediatric exclusivity is likewise available.

Orange Book Listing and Paragraph IV Certification

For NDA submissions, including those under Section

505(b)(2), applicants are required to list with the FDA certain patents with claims that cover the applicant’s product.

Upon approval,

each of the patents listed in the application is published in Approved Drug Products with Therapeutic Equivalence Evaluations ,

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;

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) applications also may be entitled to marketing exclusivity if supported by appropriate data and information.

Three-year new

data exclusivity may be granted to the 505(b)(2) application if one or more clinical investigations conducted in support of the application,

other than bioavailability/bioequivalence studies, were essential to the approval and conducted or sponsored by the applicant.

of marketing exclusivity may be granted if the application is for an NCE, and pediatric exclusivity is likewise available.

Book Listing and Paragraph IV Certification

NDA submissions, including those under Section 505(b)(2), applicants are required to list with the FDA certain patents with claims that

cover the applicant’s product.

Upon approval, each of the patents listed in the application is published in Approved Drug Products

with Therapeutic Equivalence Evaluations , 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;

(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.

This last certification

is known as a Paragraph IV Certification.

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.

(3) the date on which such patent

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 is known as a Paragraph IV Certification.

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.

NDA holder or patent owner may then initiate a patent infringement lawsuit in response to notice of the Paragraph IV Certification.

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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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.

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

In addition, the U.S.

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setting their own coverage policies.

These policies, including government-funded health care as a whole, face uncertainty under the new

Trump Administration.

Drug Designation

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

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

subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug

exclusive approval (or exclusivity), which means that the FDA may not approve any other applications, including a full NDA or BLA, to

market the same drug for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority

to the product with orphan drug exclusivity.

Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic

for the same disease or condition, or the same drug or biologic for a different disease or condition.

Among the other benefits of orphan

drug designation are tax credits for certain research and a waiver of the application user fee.

A designated orphan drug may not receive orphan

drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation.

exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially

defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare

disease or condition.

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.

“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.

As of March 26, 2024, we employed a total of 2

full-time employees, 3 employee consultants, and 1 part-time employee.

We are not a party to any collective bargaining agreements.

believe that we maintain good relations with our employees.

Our Corporate Information and History

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

Our website address is www.hoththerapeutics.com.

The contents of, or information accessible through, our website are not part of this Annual Report on Form 10-K, and our website address

is included in this document as an inactive textual reference only.

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.

a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation,

the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve any other applications,

including a full NDA or BLA, to market the same drug for the same indication for seven years, except in limited circumstances, such as

a showing of clinical superiority to the product with orphan drug exclusivity.

Orphan drug exclusivity does not prevent the FDA from

approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition.

Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the application user fee.

designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which

it received orphan designation.

In addition, exclusive marketing rights in the United States may be lost if the FDA later determines

that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product

to meet the needs of patients with the rare disease or condition.

Orphan drugs face additional risk due to the Drug

Price Negotiation Program as part of the Inflation Reduction Act (“IRA”).

The IRA currently excludes from the Drug Price Negotiation

Program orphan drugs that treat one rare disease, which disincentivizes companies to test whether existing treatments for rare diseases

also benefit other rare diseases.

To expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program, the ORPHAN

Cures Act was introduced in 2023, which, if passed, would amend the IRA to exclude orphan drugs treating one or more rare diseases from

pricing negotiations.

This would incentivize critical follow-on investment into rare disease drug development.

The ORPHAN Cures Act was

recently re-introduced, has bi-partisan support, and could be passed in the near future.

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

The term “remuneration” has been broadly interpreted to include anything of value.

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 March 28, 2025, we employed a total of 2 full-time employees, 3 employee consultants, and 1 part-time employee.

We are not a party

to any collective bargaining agreements.

We believe that we maintain good relations with our employees.

Corporate Information and History

We were incorporated as a Nevada corporation on

May 16, 2017.

On June 5, 2019, we formed our wholly owned subsidiary, Hoth Therapeutics Australia Pty Ltd, under the laws of the State

of Victoria in Australia and, on October 4, 2023, we formed our wholly owned subsidiary, merveille.ai, under the laws of the State of

Our principal executive offices are located at 1177 Avenue of the Americas, 5 th Floor, Suite 5066, New York, New York

10036 and our telephone number is (646) 756-2997.

website address is www.hoththerapeutics.com.

The contents of, or information accessible through, our website are not part of this Annual

Report, and our website address is included in this document as an inactive textual reference only.

We make our filings with the U.S.

Securities and Exchange Commission

(“SEC”), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments

to those reports, available free of charge on our website as soon as reasonably practicable after we file such reports with, or furnish

such reports to, the SEC.

The public may read and copy the materials we file with the SEC at the SEC’s Public Reference Room at

100 F Street, NE, Washington, DC 20549.

The public may obtain information on the operation of the Public Reference Room by calling the

SEC at 1-800-SEC-0330.

Additionally, the SEC maintains an internet site that contains reports, proxy and information statements and other

Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current

Reports on Form 8-K and all amendments to those reports, available free of charge on our website as soon as reasonably practicable after

we file such reports with, or furnish such reports to, the SEC.

The public may read and copy the materials we file with the SEC at the

SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549.

The public may obtain information on the operation of the

Public Reference Room by calling the SEC at 1-800-SEC-0330.

Additionally, the SEC maintains an internet site that contains reports, proxy

and information statements and other information.

The address of the SEC’s website is www.sec.gov.

The information contained in the SEC’s website is not intended

to be a part of this filing.

The information contained in

the SEC’s website is not intended to be a part of this Annual Report.

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