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Item 1. Business

2024-02-23 compared with 2023-03-16 · 662 added, 701 removed, 384 unchanged (78% of the section changed)

BioPharma is a pre-clinical biotechnology company developing novel therapeutic candidates targeting ferroptosis, an emerging new anti-cancer

mechanism resulting in iron mediated cell death (“IMCD”), and targeted immuno-oncology novel biologics, for the treatment

drug resistant cancers.

Our most advanced product candidate, HSB-1216, is an IMCD inducer, targeting a variety of solid tumors.

clinical pilot study conducted at the University of Heidelberg, Germany, the active drug in HSB-1216 was found to reduce tumor burden

in treatment resistant cancers, including triple negative breast cancer (“TNBC”) and epithelial carcinomas.

We utilize Quatramer™,

our proprietary tumor targeting platform, to enhance the uptake of HSB-1216 in the tumor microenvironment (“TME”) with an

extended duration of action and minimal off-target toxicity.

Our goal is to submit an investigational new drug application (“IND”)

Food and Drug Administration (“FDA”) and initiate a clinical study with HSB-1216 in the second half of 2023;

however, no assurance can be provided that our IND will be accepted by the FDA in 2023, if at all.

If our IND is accepted by the FDA,

our HSB-1216 clinical studies will focus on expanding upon the clinical pilot study conducted in Germany.

If we are able to initiate

our clinical study with HSB-1216 in the second half of 2023, we anticipate that clinical data from such trial will be released either

late 2024 or early 2025.

discovery of regulated cell death processes, such as apoptosis and autophagy, has enabled novel target discovery for drug development.

Ferroptosis, a form of IMCD, is an emerging regulated cell death process which decreases intracellular iron or the Labile Iron Pool (“LIP”),

a known factor required for cell growth.

Cancer cells promote increase in the LIP leading to unregulated cell growth and metabolism.

Decreasing the LIP, induces iron-led reactive-oxygen species (“ROS”) production and lipid peroxidation, two key hallmarks

of ferroptosis/IMCD, which lead to regulated cell death.

HSB-1216 sequesters iron in the cytoplasm of cancer cells and decreases the

LIP, thereby inducing ferroptosis/IMCD, leading to regulated cell death.

Areas of interest for the development of HSB-1216 are as a treatment

of solid tumors, including small cell lung cancer (“SCLC”), TNBC, uveal melanoma, glioblastoma multiforme, head and neck

squamous cell carcinoma and other drug resistant cancers with high unmet need.

is a tumor targeting platform which allows us to leverage and exploit key tumor targets and novel emerging pathways such as IMCD to facilitate

the delivery of potent drugs directly to the TME while sparing healthy tissue.

By efficiently extending the circulation half-life, as

well as targeting delivery to the tumor site, Quatramer preferentially traps drugs in the TME.

This emerging orthogonal anti-cancer approach

leverages a fundamental recognized mechanism of iron mediated tumor growth and metabolism.

We are building a portfolio of long-acting,

potent anti-cancer drug candidates using our Quatramer platform.

Quatrabody™ provides an entry into development of next generation immune-oncology (“IO”) biologics including, bispecific

and trispecific antibodies, antibody-drug conjugates (“ADCs”), CAR-T, CAR-NKs among others.

Quatrabodies capitalize on the

long half-life of tumor targeting Quatramers combined with Picobodies™ bovine-derived antibody “knob” domains which

have potential to access and bind more tightly to “undruggable” epitopes better than full sized antibodies.

HSB-1940 is a

combination of programed cell death protein 1 (“PD-1”) targeting Picobodies bound to the surface of Quatramers.

have the potential for delivering an increased drug payload to the tumor with a longer half-life while targeting novel “undruggable”

epitopes of well-established and validated IO targets such as PD-1.

Product Candidates and Research Programs

are leveraging our proprietary technologies and developing multiple product candidates with differentiated profiles designed to address

rare and treatment resistant cancers, as shown below.

Pipeline Chart

intend to submit INDs to the FDA to gain approval to initiate clinical studies in the second half of 2023 for HSB-1216 and in 2025 for

both HSB-3215 and HSB-1940;

however, no assurance can be provided that our INDs will be accepted by the FDA based on our anticipated

timeline, if at all.

Lead Candidates

our most advanced product candidate which we intend to prepare for advancement into the clinic for multiple high unmet need solid tumors,

is an IMCD inducer delivered using the Quatramer, our proprietary tumor targeting platform.

We intend to submit an IND application to

the FDA and obtain clinical data to support our strategy in the second half of 2023;

however, no assurance can be provided that our IND

will be accepted by the FDA in 2023, if at all.

HSB-1216 exploits a key feature of certain tumors that rely on an excessive LIP inside

the cell to modify the dysregulated iron microenvironment of cancer.

We have received orphan drug designation (“ODD”) in

SCLC and uveal melanoma for HSB-1216’s active drug.

In a clinical pilot study conducted at the University of Heidelberg, Germany,

HSB-1216’s active drug was studied in seven patients with positive results in heavily pre-treated and therapy resistant cancers.

By design, HSB-1216 circulates systemically after an intravenous injection and concentrates in the TME of solid tumor masses.

The localization

of HSB-1216 has been demonstrated in multiple in vivo pre-clinical models with pharmacodynamic signals showing significant decreases

in tumor size after weekly injections over time.

How Drug-resistant Persister Cancer Cells, Using Ferroptosis/IMCD, Hijack Intracellular Iron for Unregulated Growth and the Potential

Role of HSB-1216

ability to target drug-resistant persister cancer cells has the potential to be used in cancer patients who have failed standard-of-care

for treatment resistant tumors without any approved therapies.

We intend to submit an IND to the FDA for approval in the second half

of 2023 and, if such IND is timely submitted and approved, we anticipate clinical data either late 2024 or early 2025;

however, no assurance

can be provided that our IND will be accepted by the FDA in 2023, if at all.

our second product candidate, is an

anti-HER2 monoclonal antibody candidate.

The ErbB or HER family of cell surface proteins are some of the most well-known and validated oncology drug targets including ErbB2 or

HER2 (human epidermal growth factor receptor) and Erb3 or HER3.

The family of antibodies and biologics against HER2 starting with HERCEPTIN ®

(trastuzumab) approved in 1998 for breast cancer, one of the first few anti-cancer antibodies, as well as PERJETA ®

(pertuzumab), KADCYLA ® (ado-trastuzumab emtansine) and PHESGO ® (Pertuzumab/trastuzumab/hyaluronidase) reported

2022 sales of greater than $8 billion for Roche/Genentech.

Antibodies against HER2 and HER3 bind to different domains of the extracellular

portion of the proteins or epitopes with trastuzumab primarily binding the extracellular domain IV of HER2.

HER2 is a validated tumor

antigen for antibody drug conjugates to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s KADCYLA ®

and Daiichi Sankyo/AstraZeneca’s ENHERTU ® .

Biomedical Science Institute (“ABSI”) has developed technology to target unique functional epitopes of the cancer targets

HER2 and HER3.

Monoclonal antibodies being developed at ABSI are unique from the currently approved anti-HER2 antibodies.

ABSI has granted

us an exclusive option to license technology from ABSI to develop HER2 and HER3 antibodies, including multi-specific and Quatramer-

based therapeutics incorporating portions of the antibodies.

These antibodies could be incorporated into proprietary multi-format biologics

(bi- and tri-specific antibodies, ADCs (antibody drug conjugates), CAR-T and CAR-NKs, in Quatramers and Quatrabodies) against drug resistant

cancers including HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer.

The ABSI option terminates on March 24, 2023, unless extended by the parties.

third product candidate, HSB-1940, is a Quatrabody, a proprietary IO biologic,

in development targeting PD-1.

We entered into a research collaboration and product license agreement with Minotaur Therapeutics, Inc.

(“Minotaur”) and a commercial license agreement with Taurus Biosciences, LLC (“Taurus”), for use of certain technology,

including OmniAb antibodies, to advance Picobodies ™ against novel, undruggable epitopes in high-value validated IO targets

starting with PD-1.

The technologies of Hillstream and Minotaur will be combined under the license from

Taurus to discover, develop and advance biotherapeutics against high-value validated IO targets.

Picobodies are bovine-derived antibody

“knob” domains comprised of cysteine-rich ultralong complementary determining region (“CDR”) H3 sequences of

30-40 amino acids weighing ~3-4 KDa, which have the potential to access challenging undruggable epitopes better than full size antibodies

combining Quatramers, with their long half-life, coated with a PD-1 Picobody to create HSB-1940, we believe we can more efficiently target

novel epitopes with greater binding affinity than approved anti-PD-1 antibodies.

We further believe that the development of HSB-1940

is a step toward enabling us to enter the rapidly growing IO market with additional targets thereafter.

is a clinical-stage biotechnology company developing therapeutic candidates in inflammatory and immunologic conditions with high unmet

On November 3, 2023, we entered into a patent license agreement (the “Avior Patent License Agreement”) with Avior,

d/b/a Avior Bio, LLC (“Avior”) pursuant to which we received an exclusive sublicensable right and license to Licensed

Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and

commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world.

Developments” below for additional information.

In February 2023, the U.S.

Food and Drug Administration (“FDA”) approved

an investigational new drug (“IND”) application for TH104.

is a proprietary transmucosal buccal film embedded with the active compound nalmefene onto a thin film which easily adheres inside of

the mouth on the cheek and biodegrades within minutes.

This provides key features making TH104 an ideal product candidate for multiple

liver-related and other pruritogenic inflammatory conditions.

The molecule has a dual mechanism of action affecting both the µ-opioid

and kappa opioid receptors with emerging data showing inhibition of interleukin-17, a pro-inflammatory cytokine.

These well-known opioid

receptors when stimulated and/or inhibited by the body’s endogenous ligands have been shown to be involved in the body’s

itch circuitry for certain conditions, including cholestatic or dysregulated bile acid-related liver conditions.

to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, primary biliary

cholangitis (“PBC”), is a chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the

buildup of bile which causes liver damage.

The disease, believed to be an autoimmune condition, affects an estimated 58 out of every

women and about 15 out of every 100,000 U.S.

Pruritus is one of the most common symptoms associated with PBC affecting

up to 75% of individuals at some point during their disease course.

It has a negative impact on health-related quality of life with limited

treatment options.

Published survey data of PBC respondents suffering from pruritus described their itch as “bugs crawling under

More than 65% of patients reported that the itch was worse at night, known as nocturnal pruritus, a high unmet need.

are also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immune-oncology (“IO”)

targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”)

and programmed cell death protein (“PD-1”).

We are developing antibodies including bispecific antibodies, antibody drug conjugates

(“ADCs”) and small molecular weight bovine- derived Picobodies™ or antibody “knob” domains which have the

potential to target and bind more tightly to “undruggable” epitopes better than full sized antibodies.

We are advancing TH3215,

a bispecific against both HER2 and HER3 antibody which targets a novel “bridging epitope” encompassing multiple domains of

the HER2 extracellular domain (“ECD”) as well as ligand-dependent and independent blocking of the ECD of HER3 into IND-enabling

studies in 2024.

In addition, we anticipate that TH0059, a HER2/HER3 bispecific ADC (“bsADC”), and TH1940, a PD-1 Picobody,

will progress into IND-enabling studies in 2025.

EGF subset known as the epidermal growth factor receptor (“ErbB”) family of receptors are a validated set of targets preferentially

overexpressed on certain solid tumors which can be clinically exploited for the treatment of drug resistant cancers.

The ErbB family

is encompassed of four members that belong to the transmembrane tyrosine kinase receptors (“TKR”), including EGFR (“HER1”),

HER2, HER3 and HER4.

The most well-known member, HER2, encodes a transmembrane TKR which is comprised of three domains:

an ECD, a transmembrane

domain and an intracellular tyrosine kinase domain.

Ligand binding results in heterodimerization or homodimerization between the ErbB

receptors leading to excitation of the intracellular tyrosine kinase domain which then activates downstream signaling pathways concerning

cellular proliferation, differentiation, migration and apoptosis.

is an orphan receptor lacking a unique endogenous ligand and preserves an active conformation, making it continuously available to dimerize

and preferred as a partner for neighboring member receptors.

Juxtaposed to this distinct HER2 characterization, HER3 has several ligands

yet it lacks intrinsic tyrosine kinase activity.

HER2-HER3 pairing exhibits a favorable and more potent signaling, suggesting a corresponding action between both receptors.

is a known oncogene recognized in numerous cancer types and dysregulation of HER2 signaling can be caused by mutation, amplification

and overexpression.

Numerous cancers exhibit high levels of HER2 compared to normal tissue, specifically tumors of the breast, colorectal,

bladder, gastric, esophageal, endometrial, and ovarian cancers, signifying that HER2 may be connected to the progression of these tumors.

Additionally, following the discovery of HER2 in breast cancer, antibody drugs targeting HER2 were introduced into the clinic.

(trastuzumab), the first monoclonal antibody developed by Genentech/Roche was approved for the treatment of HER2-positive metastatic

breast cancer in 1998.

Subsequently, tyrosine kinase inhibitors (“TKIs”) and ADCs targeting HER2 have been approved.

antibody, PERJETA® (pertuzumab) also developed by Genentech/Roche, used in combination with trastuzumab, and docetaxel was approved

in 2012, indicated for the treatment of patients with HER2-positive metastatic breast cancer.

The FDA subsequently also approved a third

biologic from Genentech/Roche in 2013, KADCYLA® (trastuzumab emtansine or T-DM1), for the treatment of patients with HER2-positive

metastatic breast cancer in patients previously treated with trastuzumab and a taxane.

T-DM1 not only retains the target-selective benefit

of trastuzumab, but also kills tumor cells by delivering a potent toxin which inhibits microtubule function and has become a classic

example of a targeted ADC treatment.

Another ADC, ENHERTU® (trastuzumab deruxtecan), developed by Daiichi Sankyo and AstraZeneca

and approved in December 2019 for the treatment of unresectable or metastatic HER2-positive breast cancer has shown anti-tumor activity

in HER2-positive cancers that were resistant or insensitive to T-DM1.

We believe this development history of multiple approved drugs

with different modalities and novel epitopes targeting HER2 has paved a de- risked regulatory pathway as well left significant room for

continued innovation in this class of therapies.

According to the Fierce Pharma, in 2022, Roche/Genentech had worldwide sales of over

$8 billion with respect to their HER2 targeted therapies (Herceptin and Perjeta) as well as more than $500 million in worldwide sales

of ENHERTU® in the first half of 2023 alone according to AstraZeneca.

function of HER3 in tumor biology is multidimensional.

Abundant HER3 expression is identified in various solid tumor types, with a proven

role in disease progression.

Overexpression of HER3 signaling is thought to be involved in resistance to other targeted therapies used

for treating several cancers, including anti-EGFR therapies gefitinib and cetuximab.

One of the many genomic changes known to be implicated

in acquired resistance to anti-EGFR TKIs in patients with EGFR-mutated advanced non-small-cell lung cancer is HER3 up-regulation promulgated

by osimertinib.

Therefore, blocking HER3/EGFR dimerization complex is thought to prevent or slow down both acquired and primary resistance

to EGFR inhibitors.

We believe combining anti-HER2 with an anti-HER3 strategy as a bispecific multifunctional agent without a toxin (TH3215)

as well as with a toxin (TH0059) could capitalize on some of the findings described in the literature to take advantage of precise tumor-killing

through two important targets with different mechanisms of action.

is an immunosuppressive checkpoint and seen in macrophages, B lymphocytes, dendritic cells, monocytes, tumor-specific activated T cells,

myeloid cells and natural killer cells in circumstances of chronic antigen contact.

PD-L1 is one of the PD-1 ligands.

PD-L1 expression

has been shown to be a valuable biomarker for the prognosis and prediction of the sensitivity of PD-1/PD-L1 inhibitors.

The expression

of PD-L1 is mainly expressed in tumor cells, tumor-infiltrating cells and antigen-presenting cells in many cancers.

Despite the noteworthy

efficacy of PD-1/PD-L1 immune checkpoint inhibitors (“ICI”) in the treatment of tumors, some problems remain such as drug

resistance and adverse events.

Acquired drug resistance may present despite resuming or continuing treatment with anti-PD-1/PD-L1 immunotherapy.

The presence of drug resistance significantly reduces the efficacy of anti-PD-1/PD-L1 immunotherapy.

We believe exploring the mechanisms

of PD-1/PD-L1 ICI resistance may assist with the discovery of new immunotherapeutic strategies to control disease progression and provide

a more sustainable survival benefit for patients.

As such, we aim to further improve on PD-1 as a breakthrough technology by developing,

TH1940, a proprietary PD-1 Picobody with unique binding affinity differently than currently available PD-1 drugs.

We believe this unique

binding difference allows for novel therapeutic possibilities both as a stand-alone agent and in combination and that our tumor immunotherapy

based on PD-1 inhibition may become a future strategy for human cancers.

have deprioritized our previous preclinical candidate, HSB-1216, due to a strategic reprioritization to focus on therapeutics in high

unmet need cancers focused on novel epitopes of certain antitumor drug targets.

currently have an IND-approved transmucosal film product, TH104 in Phase 1 clinical development, two bispecific candidates and a Picobody

candidate in pre-clinical development.

The following table summarizes our development candidate pipeline:

goal is to become a leading biotechnology company developing novel treatments in inflammatory and immunologic conditions with high unmet

Our business strategy comprises the following components:

TH104 as a transmucosal buccal film product for the treatment of chronic pruritis in PBC and other inflammatory diseases.

to advance TH3215 as an anti-HER2/HER3 BspAb for multiple tumor types including high unmet need cancers.

create a strategy to develop TH0059 as a bispecific monoclonal ADC specifically targeted to both HER2 and HER3 receptors in high

unmet need standard-of-care resistant tumors with a high capacity to metastasize.

a preclinical and clinical path forward for our third product candidate, TH1940, a unique PD-1 Picobody with unique binding differentiation

compared to full length antibodies for IO vulnerable tumors.

the discovery and development of next generation multi-specific (bi- and tri) antibodies with binding capabilities to novel epitopes

of combinations of HER2, HER3, PD-1, PD-L1, TROP2 and other validated targets with and without toxin delivery capacity to multiple

high unmet need rare cancers.

strategic collaboration opportunities to maximize the value of our pipeline to bring novel therapies to patients suffering from high

unmet need conditions.

and moderate-to-severe chronic pruritis

to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC, is a

chronic disease in where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile which causes liver

The disease, believed to be an autoimmune condition, affects both men and women with a rate higher in women, estimated at 1 out

of every 1,000 women over 40.

Pruritus is one of the most common conditions associated with PBC affecting up to 75% of individuals at

some point during their disease course.

It has a negative impact on health-related quality of life with limited treatment options.

an on-line survey focusing on certain features of patients’ itch respondents described their itch as “bugs crawling”

as well as more than 65% of participants reporting that the itch was worse at night, known as nocturnal pruritis.

Ladder for Pruritis in Primary Biliary Cholangitis

Hegade VS, Bolier R, Oude Elferink RPJ, et.

Frontline Gastroenterology 2016;7:158–166

endobiliary nasal drainage;

MARS, molecular adsorbent recirculating system;

LT, liver transplantation

current treatment ladder in pruritis for PBC shown above is the paradigm of therapy and if there is no response with one category of

drugs, typically patients “move up” the ladder.

A patient may need a combination of treatments to achieve and/or maintain

symptom remission.

opioid peptides are commonly believed to play a role in the modulation of cholestatic itch.

In the late 1980s, data documented that nalmefene

induced opiate-like withdrawal symptoms in individuals with cholestasis.

Following this, research noted heightened levels of Met-enkephalin

in the plasma of cholestatic patients.

In animal experiments, the activation of μ-opioid receptors by agonists induced scratching

behavior, while κ-opioid receptor agonists, on the contrary, reduced the sensation of itch.

Kim BS, Inan S, Ständer S, Sciascia T,Szepietowski JC, Yosipovitch G.

Role of kappa-opioid and mu-opioid receptors in pruritus:

Peripheral and central itchcircuits.

Exp Dermatol.

31:1900-1907.

doi:10.1111/exd.14669

is a product which has been developed by embedding drug onto a proprietary transmucosal buccal film which adheres to the inside of the

TH104 has key features which we believe make it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory

The active molecule, nalmefene, has a dual mechanism of action by affecting both the µ-opioid receptor and the kappa

opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression, a cytokine known to be overexpressed in PBC patient liver

tissue and serum.

Moniaga CS, et.

Plasma dynorphin A concentration reflects the degree of pruritus in CLD Acta Derm Venereol.

2019 Apr 1;99(4):442-443.

10.2340/00015555-3139;

Bergasa N et.

Oral nalmefene therapy reduces scratching activity due to the pruritis of cholestasis:

a controlled study J Am Acad Dermatol 1999;41:431-4

data by Bergasa et.

al , reported a study utilizing oral doses of nalmefene ranging from 40 to 240 mg twice-daily for 12 weeks

in PBC patients.

Eight patients who received at least 1 course of nalmefene were available for comparison with corresponding control

data (a course of placebo and/or at baseline).

Nalmefene therapy was associated with a 75% reduction in hourly scratching activity (P

The study also achieved a decrease in the mean of a visual analogue score of the perception of pruritus in all 8 patients

(mean decrease 77%, P < .01).

the itch circuitry is imbalanced in diseased conditions, pharmacological intervention can help suppress this phenomenon which occurs

in patients suffering from chronic pruritis.

Nalmefene crosses into the circulation via a proprietary buccal delivery by adhering the

drug-coated film inside the cheek where the film biodegrades in minutes and the drug is absorbed.

The buccal delivery of the drug bypasses

the liver’s first-pass metabolism thus creating high drug concentrations in the skin, an added benefit for treating conditions

in which the liver may be impaired.

data from multiple phase 1 ex-US trials achieved the primary objective of predictable pharmacokinetic profiling with favorable safety

and tolerability.

The first human phase 1 trial was a single-dose, single-center, open-label, randomized, 2-way crossover study of TH104

transmucosal buccal film compared to a tablet formulation marketed in Europe and not the United States, with a 14-day washout period

involving 12 normal healthy volunteers under fasting conditions.

The primary outcome measure was to determine the pharmacokinetics of

a buccal dose of TH104, while secondary objectives included establishing the relative bioavailability of TH104 and evaluating its’

tolerability for potential value in clinical efficacy studies.

These data were also consistent with the comprehensive pre-clinical data

package submitted to the FDA as an IND which was approved in February 2023, including pharmacokinetic profiling in beagle dog studies

confirming once-daily dosing, fast or rapid onset and high bioavailability when comparing TH104 to intravenous nalmefene.

this study, the pharmacokinetic evaluation of TH104 transmucosal film compared to an oral tablet marketed in Europe but not the United

States, given as an equal-labelled dose in normal healthy volunteers under fasting conditions, was consistent and similar in comparison

with results from the literature.

The C max and AUC 0-∞ of TH104 was observed to be higher than the tablet

product because of a possible reduced presystemic metabolism in the lower GI and liver, which is potentially advantageous for patients

with an impaired liver.

The half-life and T max was observed to be similar for both products.

There were no deaths, other serious

adverse events, or other significant adverse events reported during the entire study with events consistent with the safety profile of

the marketed tablet in the literature including mild dizziness, headache and somnolence, nausea and vomiting.

second phase 1 study was a single-dose, single-center, open-label, parallel group design with 2 treatment groups of 2 different formulations

of TH104 with variable pH in sixteen normal healthy volunteers under fasting conditions.

The primary outcome measure was to determine

the effect of pH in the transmucosal buccal film on drug absorption profile evaluated from serial blood sample collections.

this study, the evaluation of TH104 transmucosal film given as an equal-labelled dose in 2 different pH formulations delivered buccally

to normal healthy volunteers under fasting conditions, had an insignificant effect on the performance of the film as measured by drug

concentrations in human plasma.

The low impact on pH shows that variations of oral pH due to inter-patient variability in future studies

would have a low impact on predictable drug absorption with regards to speed of delivery and drug action once absorbed into the systemic

were no new adverse events in these studies with events correlated with the previous phase 1 study and a safety profile consistent with

the literature.

launched a phase 1 pharmacokinetic trial for TH104 in early 2024 and intend to complete the study with a topline readout in 2Q24.

clinical data package is strengthened by the phase 1 clinical trials previously conducted outside of the U.S., which showed reliable

bioavailability of the active ingredient in TH104 via transmucosal film technology in healthy volunteers.

We intend to provide topline

data in 2024 for a phase 1 pharmacokinetic bridging study in the United States designed as a single-dose, single-center, open-label,

randomized 2-way crossover study of TH104 transmucosal buccal film and an intravenous dose of drug administered under fasting conditions,

with a 7 to 11-day washout period between doses.

Sixteen normal healthy volunteers will participate in the study.

The primary objective

is to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability of the formulation.

intend to complete a bridging pharmacokinetic phase 1 trial and a phase 2 proof-of-concept in PBC patients over approximately 12 months

after aligning with FDA on trial design.

We believe the completed phase 1 data coupled with the ongoing phase 1 pharmacokinetic bridging

study in the United States may complement a phase 2a efficacy study to be initiated in 3Q24 in moderate-to-severe chronic pruritis in

PBC as we begin engaging regulatory authorities in both the US and European Regulatory Authorities.

The phase 2a trial is planned as

a multiple ascending dose trial to assess the safety and tolerability of TH104 and will also evaluate the change from baseline in a validated

endpoint for itch intensity in pruritis studies.

Based on this data package, the Company expects to be able to initiate a registrational

trial in 2025 pending an FDA discussion on phase 2 results.

to the Centers for Disease control and Prevention Summary Health Statistics National Health Survey, more than 4 million patients suffer

from liver disease in the U.S.

and about 1.7 million suffer from pruritis, where PBC has the highest rate of prevalence.

We believe TH104

may also be used for treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver related

and non-liver related diseases including fatty and alcoholic liver, non-alcoholic liver disease and certain types of hepatitis.

pruritis is significant in liver diseases (40% chronic pruritis;

1.7 million patients affected) as well as chronic kidney diseases (24%

chronic pruritis;

1.3 million patients affected), hemodialysis as well as atopic dermatitis (40% pruritis;

2.7 million patients affected).

we expect TH104 to be manufactured with a high speed of manufacturing with several features including very high content uniformity, prepared

using scalable manufacturing methods and appropriate cost-of-goods.

We intend to be able to create a highly reproducible product using

a small manufacturing footprint with few contract drug manufacturing organizations in the marketplace which may allow limited entrants.

on Antibodies

human antibodies play a crucial role in drug development as therapeutic agents.

Antibodies are large Y-shaped proteins produced by the

immune system to identify and neutralize extraneous elements such as bacteria, viruses, and additional pathogens.

Their capability to

target particular molecules with high specificity and affinity are valuable tools in pharmaceutical therapeutics.

For drug development,

much research has enabled the generation of full-length human antibodies targeting a variety of pathophysiological agents, anomalous

cells, or malfunctioning proteins associated in different diseases.

Using an array of methodologies, these antibodies can be developed

using different approaches, including phage display, hybridoma technology, and techniques involving novel antibody engineering focused

on structural diversity.

The realization of numerous therapeutic antibodies has considerably affected the treatment of diverse diseases,

including cancer, autoimmune disorders, infectious, and inflammatory conditions.

Their promising therapeutic properties, including decreased

toxicity and augmented specificity compared to small molecules and other modalities with off-target effects, make them appealing candidates

for human therapeutic development.

large number of traditional antibodies are composed of immunoglobin G (IgG) format in a Y-shape molecule consisting of two heavy chains

which are identical as well as two light chains also identical.

A heavy chain pairs with a light chain to form two variable regions,

or antibody binding fragment (Fab) which binds to antigens of the target.

The constant region includes a region referred to as the fragment

crystallizable (Fc) which binds to receptors present on cells in the immune system known as effector cells.

In traditional full length

monoclonal antibodies, the variable regions are identical and bind to the same target.

antibodies are a specialized class of therapeutic antibodies designed to concurrently target two dissimilar antigens.

Unlike traditional

monoclonal antibodies that bind to a single target, bispecific antibodies can employ multi-specific targeting, offering distinctive benefits

in drug development.

By targeting two separate molecules involved in a disease process, bispecific antibodies enhance therapeutic efficacy,

improve target specificity, and potentially overcome certain treatment resistance mechanisms.

The development of bispecific antibodies

involves different engineering strategies including quadroma technology, chemical conjugation-based methods and more recent technologies

including Dual Variable Domain Immunoglobulin and two-in-one models can be employed to generate bispecific antibodies.

These bispecific

agents can target a diversity of disease-related pathways, creating adaptable molecules for numerous medical ailments, including cancer.

Ongoing research and improvements over the last decade in antibody engineering allow for the design, optimization and scale-up of bispecific

antibodies for human therapeutics development.

Pipeline Candidates

is a product which has been developed by embedding drug onto a proprietary transmucosal buccal film which adheres to the inside of the

TH104 has key features which we believe make it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory

The active molecule, nalmefene, has a dual mechanism of action by affecting both the µ-opioid receptor and the kappa

opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression.

We intend to complete a phase 1 pharmacokinetic trial for

TH104 in second quarter 2024 as well as a phase 2 proof-of-concept in PBC patients over approximately 12 months after aligning with FDA

on trial design by late 2024/early 2025.

We believe TH104 may also be used for treating chronic pruritogenic conditions associated with

cholestatic liver disease as well as other liver related and non-liver related diseases including fatty and alcoholic liver, non-alcoholic

liver disease and certain types of hepatitis.

Chronic pruritis is significant in liver diseases as well as chronic kidney diseases, hemodialysis

and atopic dermatitis.

pre-clinical, current lead product candidate, TH3215, is an anti-HER2/HER3 bispecific antibody candidate.

The ErbB or HER family of cell

surface proteins are some of the most well-known and validated oncology drug targets including ErbB2 or HER2 and Erb3 or HER3.

Our antibodies

against HER2 and HER3 bind to different domains of the extracellular portion of the proteins or epitopes with trastuzumab primarily binding

the ECD IV of HER2.

HER2 is a validated tumor antigen for antibody drug conjugates to treat HER2 positive cancers with two approved antibodies,

Roche/Genentech’s KADCYLA® and Daiichi Sankyo/AstraZeneca’s ENHERTU®.

Areas of interest for the development of TH3215

are as a treatment of solid tumors in which HER2 is overexpressed including breast cancer, colorectal cancer, endometrial cancer and

gastroesophageal cancer.

ErbB family of receptor tyrosine kinases, also known as Human Epidermal Growth Factor Receptor (“HER”) family, comprises

four transmembrane receptors:

HER1 (EGFR/ErbB1), HER2 (Neu/ErbB2), HER3 (ErbB3), and HER4 (ErbB4).

These receptors play crucial roles

in the regulation of cell proliferation, survival, differentiation, and migration.

The ErbB family members are activated upon binding

to specific ligands, including EGF, transforming growth factor-alpha (TGF-α), amphiregulin (“AR”), and others, resulting

in receptor dimerization and autophosphorylation of specific tyrosine residues within their intracellular domains.

also known as EGFR, is the prototypical member of the ErbB family and is widely expressed in various tissues.

Its activation initiates

a downstream signaling cascade that involves the activation of the mitogen-activated protein kinase (“MAPK”) and phosphoinositide

3-kinase (“PI3K”)/AKT pathways, leading to cell proliferation and survival.

HER1 dysregulation has been implicated in various

cancers, making it an important therapeutic target.

also known as Neu or ErbB2, lacks a ligand-binding domain, and its activation is predominantly through heterodimerization with other

ErbB family members.

It is a key partner in heterodimerization with HER3, forming the most potent signaling complex among the ErbB receptors.

This heterodimerization is thought to cause an oncogenic signal into cells overexpressing these receptors and cause tumorigenesis.

is amplified and overexpressed in certain cancers, particularly breast cancer, contributing to aggressive tumor behavior and poor prognosis.

or ErbB3, possesses impaired tyrosine kinase activity, but its dimerization with other ErbB receptors, particularly HER2, leads to the

activation of downstream signaling pathways.

HER3 is a critical regulator of PI3K signaling, which is crucial for cell survival and proliferation.

HER3 overexpression is associated with resistance to HER2-targeted therapies, making it an attractive target for cancer treatment.

agents that may block both HER2 and HER3 signaling, in both ligand-dependent and independent pathways could be highly attractive strategies

for human therapeutic development.

or ErbB4, exists in various isoforms and exhibits diverse functions depending on tissue context.

HER4 activation can result in the activation

of both the MAPK and PI3K/AKT pathways, but its signaling outcomes are complex and context-dependent.

HER4 plays important roles in heart

development, neural development, and breast tissue differentiation.

ErbB family of receptor tyrosine kinases represent a closely synchronized signaling system that controls central cellular activities.

Dysregulation of these receptors, either through mutations, amplifications, or overexpression, provides to the development and evolution

of several cancers.

Elucidating the elaborate signaling pathways and communications within the ErbB family is fundamental for developing

targeted therapies to efficiently treat cancer and other diseases associated with aberrant ErbB signaling.

Ongoing research continues

to unveil the complexities of ErbB signaling, opening new avenues for innovative therapeutic strategies and personalized medicine approaches.

July 5, 2023 (the “ABSI Effective Date”), we entered into a Research and Development Collaboration and License Agreement

(the “ABSI Agreement”) with Applied Biomedical Science Institute (“ABSI”), pursuant to which ABSI granted us

an exclusive royalty-bearing, sublicensable license to the ABSI Patents and a non-exclusive, royalty-bearing, sublicensable license to

the ABSI Know-How to Exploit the ABSI Products for the treatment, diagnosis, prediction, detection or prevention of disease in humans

and animals worldwide (as defined in the ABSI Agreement).

Pursuant to the ABSI Agreement, the parties shall form a committee to manage

the preclinical, investigational new drug enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical

trial of the ABSI Product.

The parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against

such Target with a view to identifying or generating suitable Products (as defined in the ABSI Agreement) for our Company to Exploit.

Upon completion of the Discovery Timeline (as defined in the ABSI Agreement) for a Target, subject to the terms and conditions of ABSI

Agreement, we shall exclusively own any ABSI Products against such Target.

In the event the committee determines that the discovery activities

are unsuccessful with respect to a Target, we may propose an additional target, which, upon approval by ABSI, shall replace a failed

The antibodies from ABSI we are licensing are intended to be developed as unique from the currently approved anti-HER2 antibodies

and may be incorporated into proprietary multi-format biologics (bi- and tri-specific antibodies, ADCs, CAR-T and CAR-NKs) against drug

resistant cancers including HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer.

the past decade, cancer therapy has seen significant innovations, and one class of therapeutics gaining significant attention is bispecific

These specialized molecules are engineered to target two distinct antigens boosting their specificity and therapeutic potential.

Among the most promising targets in oncology are HER2 and HER3 receptors, which play crucial roles in cell signaling and proliferation.

and HER3 are members of the ErbB family of receptor tyrosine kinases, and their dysregulation is associated with the development and

progression of various cancers, including breast, ovarian, gastric, and lung cancers.

HER2, also known as ErbB2, is overexpressed in

approximately 20-30% of breast cancers and is linked to aggressive tumor behavior and poor prognosis.

HER3, on the other hand, lacks

intrinsic kinase activity but forms heterodimers with other ErbB family members, particularly HER2, leading to potent signaling through

the PI3K/AKT pathway.

monoclonal antibodies targeting either HER2 or HER3 have shown promising clinical outcomes in some cancer patients;

however, cancer cells

often develop resistance mechanisms, leading to treatment failure.

To overcome this challenge, researchers have turned to bispecific

antibodies as a more effective approach to disrupt multiple signaling pathways simultaneously and prevent the emergence of resistance.

antibodies that target both HER2 and HER3 receptors offer several advantages over traditional therapies.

By simultaneously binding to

both receptors, these antibodies can block the formation of heterodimers between HER2 and HER3, effectively inhibiting downstream signaling

cascades that drive tumor growth and survival.

Additionally, bispecific antibodies can also engage immune cells, such as T cells and

natural killer cells, through their Fc region, promoting the destruction of cancer cells via antibody-dependent cell-mediated cytotoxicity

and antibody-dependent cellular phagocytosis.

second product candidate, TH0059, is a bispecific anti-HER2/anti-HER3 monoclonal ADC candidate.

Research studies elucidating the biology

of HER3 reveal that triggering of HER3 signaling stimulates tumor progression via augmentation of metastatic potential and induces treatment

failure in human tumors.

Mounting evidence supports HER3 as an important target and its activation is considered to be required to overcome

therapeutic resistance, enhance efficacy, and increase patient survival.

To date, to our knowledge, there is no FDA-approved HER3-targeted

therapy for cancer treatment.

Targeting both HER2 and HER3 with a blocking antibody is a strategy we intend to explore as we progress

our pipeline.

third product candidate, TH1940, is a proprietary IO biologic, in development targeting PD-1.

On November 21, 2022, we entered into a

research collaboration and product license agreement with Minotaur and a commercial license agreement with Taurus for use of certain

technology, including OmniAb antibodies, to advance Picobodies against novel, unreachable and undruggable epitopes in high-value validated

targets starting with PD-1.

The research and collaboration agreement and product license agreement are for the development of proprietary

targeted biologics, including TH 1940, against PD-1.

It is anticipated that we will collaborate with Minotaur under the license from

Taurus to discover, develop and advance biotherapeutics against high-value validated IO targets starting with PD-1.

We extended this

agreement in July of 2023 with an additional target (HER3) and an oncology target.

are bovine-derived antibody “knob” domains comprised of cysteine-rich ultralong complementary determining region H3 sequences

of 30-40 amino acids weighing ~3-4 KDa, which have the potential to access challenging undruggable epitopes better than full size antibodies

By extending the half-life of knobs to create TH1940, we believe we can more efficiently target novel epitopes with greater binding

affinity than approved anti-PD-1 antibodies.

We further believe that the development of TH1940 is a step toward enabling us to enter

the rapidly growing IO market with additional targets thereafter.

Proceedings of the National Academy of Sciences of the United States of America “The smallest functional antibody fragment:

CDR H3 antibody knob regions potently neutralize SARS-CoV-2”

Other Product Candidates

4 unchanged sentences

same antigen, the bispecific antibody could bind its targets either on the same cell ( cis ) or on to different cells ( trans ).

Our strategy involves targeting PD-1 combined with a known, validated undisclosed antigen (HSB-9646) or using HER2 instead of PD-1 (HSB-0059),

while naturally occurring antibodies typically only target one epitope on one antigen.

At this time, we have de-prioritized the expenditures

and related activities associated with TridentAI, HSB-510, HSB-114 and HSB-888.

technology platform enables us to generate a pipeline of early-stage product candidates spanning multiple targets in oncology utilizing

diverse payloads to treat rare and treatment resistant tumors.

While the payload in our most advanced product candidate, HSB-1216, is

novel, and has pilot human data in multiple solid tumors, any solid tumor or non-oncologic disease requiring delivery of a peptide, protein

or biologic is conceivably a candidate for our Quatramer technology.

Our early-stage product candidates such as HSB-3215 and HSB-1940

are focused on rare and treatment resistant diseases;

however, we believe our technology could potentially deliver meaningful benefit

across a wide range of oncologic and viral diseases.

We have tested several peptides, nucleic acids, proteins, small molecules and antibody

constructs against multiple targets.

Platform Technologies

key aspect of oncology treatment is that effective anticancer agents do not penetrate the tumor bed in order to kill cancer cells due

to the limitation of the microenvironment of the tumor.

The TME is protected by stromal tissue comprised of multiple layers of collagen,

proteoglycans, hyaluronans and laminin layers shielding the tumor from the deployment of traditional treatments, including chemotherapy

(novel small molecule and immunotherapies).

Parts of the tumor create an environment to survive despite reduced nutrient sources whereby

hypoxic regions of the tumor continue to thrive by incorporating a shift in metabolism, including iron dysregulation.

Any drug that reaches

the tumor is effluxed out of the cell by transporter pumps upregulated by the cancer cells rendering any such drug that reaches the tumor

The TME continues to thrive by the inability of immune cells normally designed to infiltrate and kill the tumor made ineffective

by a reduction in their ability to activate their killing effect of the cancer.

Quatramer Tumor Targeting Platform with Versatile Payload Delivery

proprietary Quatramer technology overcomes the limitations that have hampered development of nanoscale and liposome derived products

as cancer therapeutics.

Limitations include, but are not limited to, drug efflux, toxicity, eluding phagocytosis, physiological barrier

penetrance and immune responses.

Our Quatramer technology incorporates a therapeutic payload and is designed to be tunable while having

a prolonged circulation within the blood, allowing a targeting of diseased tissue or cells, while providing a controlled and timely release

of the therapeutic payload.

Characteristics

of our Quatramer technology include:

circulation :

the stealth nature of Quatramer allows for a prolonged circulation time resulting in accumulation at the site of

disease prior to being cleared.

the size, shape and surface of Quatramer allows it to escape via gaps in the blood vessels in the TME allowing for release of the

payload directly into cancerous cells.

drug efflux :

Quatramer composition offers reversal of p-glycoprotein mediated drug resistance in cells via generation of poloxamers

(breakdown products comprised of small co-polymers).

Quatramer physicochemical characterization allows for optimizing size, shape and surface chemistry based on payload characteristics

to render enhanced permeation and retention into the TME.

of manufacturing :

large scale production efficiency and analysis for uniform chemistry, manufacturing and control capability

at lower costs.

regulatory path :

chemical compositions listed in the FDA Inactive Ingredients Database with known profile.

versatility and flexibility :

combined with the tunability of Quatramer, the technology allows for a variety of delivery payloads

including peptides, small molecules, nucleic acids and antibodies with the added flexibility of dual-loaded payload therapeutics.

Biodegradable :

Quatramers ultimately breakdown into known metabolites such as lactic acid and ethanol.

combine the benefits of tumor targeting and long half-life of Quatramers with novel Picobodies to enter into development of next generation

IO therapeutics.

Quatrabodies capitalize on the knob domains from bovine-derived antibodies which have the potential to access “undruggable”

epitopes on validated tumor targets better than full sized antibodies.

Picobodies are the smallest known antibody fragment, comprised

of ultra-long CDR H3 sequences of 30-40 amino acids rich with cysteines that create tightly folded structures capable of binding recessed

Quatrabodies Combine Quatramers’ Tumor Targeting and Long Half-Life with Knobs, the Smallest Known Antibody Fragments, Targeting

Undruggable Epitopes

derived from mouse or human sources use the surface formed by CDRs on the variable regions of the heavy chain/light chain heterodimer,

which typically forms a relatively flat binding surface.

Bovine’s ultralong CDR-H3 regions form an independently folding mini-domain,

which protrudes far out from the surface of the antibody and forms a “stalk and knob” structure which is diverse in both

its sequence and disulfide patterns.

The “knob” (Picobody) component can be expressed as an independent antigen binding domain.

At ~4-6 kDa, these are three times smaller than a camelid “nanobody” and are the smallest known antibody fragment.

atypical antigen binding sites of bovines potentially provide the ability to interact with different antigenic determinants, particularly

recessed or concave surfaces, compared to traditional antibodies.

Key Programs:

HSB-1216, HSB-3215 and HSB-1940

have leveraged our proprietary technologies and are developing multiple product candidates with differentiated profiles designed to address

rare and treatment resistant cancers.

Our HSB-1216 product candidate is an IMCD inducer delivered by our proprietary Quatramer platform.

We intend to submit an IND to the FDA to gain approval to initiate clinical studies in the second half of 2023 and, if such IND is timely

submitted and approved, we anticipate initial data will be released either late 2024 or early 2025;

however, no assurance can be provided

that our IND will be accepted by the FDA in 2023, if at all.

We intend to submit an IND for HSB-3215 (anti-HER2 antibody with novel conformational

epitopes) and HSB-1940 (our first Quatrabody targeting PD-1), subject to successfully completing pre-clinical identification and characterization

as well as IND enabling studies in 2024.

Our Novel Iron-Medicated Cell Death Inducer

an important factor of many organisms, satisfies an assortment of vital living processes including DNA replication, protein synthesis

and cellular respiration, essential for normal growth and propagation.

However, iron also produces ROS via a chemical process in which

there is a catalytic decomposition of hydrogen peroxide by ferrous ions, known as the Fenton reaction.

This process may cause damage

to the membrane lipid and DNA caused by ROS, known as lysosomal membrane permeabilization (“LMP”) rupturing and killing the

cell by spilling its contents into the surrounding microenvironment and causing degradation in the surrounding extracellular milieu.

Emerging evidence suggests iron may have a twofold role on cells, both stimulating cell growth and causing cell death, particularly a

new form named ferroptosis, first described by the accumulation of iron-dependent lipid peroxides.

Role of Iron in Growth of Drug-Resistant Persister Cancer Cells and Mechanism of Action of HSB-1216

that has been published by us with respect to the active drug of HSB-1216 targeting chemotherapy resistant tumors suggests that it sequesters

iron in the lysosomes of resistant tumor cells causing LMP of hard-to-treat cancer cells known as persister cells causing them to rupture

and stop replicating.

We believe an area of high interest for the development of HSB-1216 could be SCLC or TNBC or other rare cancers

with high unmet need.

HSB-1216 – Ferroptosis/IMCD Mechanism of Action:

Shifting the Intracellular Redox Balance

of the standard limitations to achieving successful cancer therapies is the manifestation of multidrug resistance (“MDR”)

which is a cross-resistance to many commonly used drugs after repeat dosing.

Extensive evidence to this point has shown that the mechanisms

related to tumor MDR are complex and there is an urgent need to decipher the nuances of this phenomenon and discover new agents capable

of evading resistance which can be applied to a clinical strategy in cancer.

MDR can be developed by various ATP-binding cassette (“ABC”)

transporters, including the well characterized ABCB1, also known as p-glycoprotein, which has been shown to be an important protein of

the cell membrane and can transport a variety of molecules across extra- and intra-cellular membranes.

The protein is an adenosine

triphosphate (“ ATP”) dependent drug efflux pump that transports foreign substances out of the cell including drugs

and xenobiotics with broad substrate specificity.

HSB-1216’s active drug has been shown to block this ABC transporter in numerous

studies as evidenced by drug efflux assays in MDR cell lines overexpressing these proteins by inducing a conformational change on the

transporter protein itself rendering it ineffective.

Furthermore, the byproduct of the Quatramer bio-degradable process results in formation

of poloxamers which blocks the p-glycoprotein transporter system.

This evidence may also allow other traditional chemotherapies, such

as paclitaxel which is highly effected by these transporters, to stay in the cell and elicit anti-tumor effects in combination with HSB-1216.

in Oncology Indications

drug candidate, HSB-1216, has novel characteristics which may benefit patients with hard-to-treat recurrent tumors, such as TNBC in a

number of ways.

HSB-1216’s active drug, traditionally used as an anti-coccidial drug in livestock and poultry, has been shown to

possess anti-cancer effects in a chemical screen on the basis that it has more than 100-fold potency compared to paclitaxel, a commonly

used FDA-approved anti-cancer drug.

The active compound is a monocarboxylic polyether compound first isolated from Streptomyces albus

strain (Strain No.

80614) shown to eliminate self-renewing cancer cells which may remain dormant or undetectable in the presence

of traditional chemotherapeutics, such as paclitaxel or other agents commonly used as first-line agents in a variety of tumors.

alone could not be advanced further after its discovery as an anti-cancer agent for a variety reasons, including a short half-life along

with a relatively narrow therapeutic index and potential toxicities.

Subsequently, other groups have shown cytotoxicity of the compound

on human neuronal cells showing it had an increase on cytosolic Na + concentrations consequently resulting in elevated cytosolic

In addition, overdose or accidental ingestion of similar compounds has shown undesirable effects in cats, dogs, pigs,

horses, as well as humans .

These results and other data from third parties suggest it may

be prudent to develop tissue-specific strategies to deliver the drug and prevent neuro-specific adverse events and capitalize on the

specific mechanisms of HSB-1216’s active drug.

Data with HSB-1216’s Active Drug

several reasons, HSB-1216’s active drug was not established as a human drug due to several reports published by third parties in

the past decades which reveal considerable toxicity in mammals such as horses, pigs, cats and alpacas after accidental oral ingestion

or inhalation.

It has been relegated to use in livestock as a coccidiostat and growth promoter.

The European Food Safety Authority has

declared an acceptable daily intake of 5 µg/kg .

Based on these findings, the compound

was therapeutically used in a “first-in-man” clinical pilot study conducted at the University of Heidelberg, Germany, with

a cohort of 7 patients with metastatic breast, ovarian and head and neck cancers in which tumor and metastatic regression were observed

clinically in 4 patients with metastatic breast cancer, 1 patient with metastatic ovarian cancer, and 2 patients with squamous cell carcinoma

(1 of the head and neck and the other of the vulva).

Administration of 200- 250 μ g·kg −1 of active drug

intravenously every second day for three weeks in these patients resulted in partial regression of tumor metastasis.

Intravenous active

drug therapy resulted in tachycardia and mild tremor for 30-60 minutes after administration but lacked side effects observed with conventional

chemotherapeutic drugs, such as myelosuppression, neutropenia, alopecia, nausea and vomiting, or gastrointestinal, thromboembolic, and

neurological side effects.

Only 2 of the 7 cases are described in the publication relating to this trial, both of which are detailed

below showing that these promising results inducing cancer regression of heavily pretreated and therapy-resistant tumor types may define

HSB-1216’s active drug to have novel effects as a clinically significant anticancer agent.

months prior to treatment with the HSB-1216’s active drug, a 40-year-old female patient was diagnosed with unilateral ductal breast

carcinoma (post-mastectomy and axillary lymph node dissection) and subsequently experienced a recurrence of the subcutaneous multifocal

thoracic tumor that was ER, PR, and HER2 negative (i.e., “triple negative”) with vertebral bone metastasis.

After all therapeutic

options were exhausted, experimental treatment with HSB-1216’s active drug was recommended.

The patient received 12 systemic administrations

of intravenous (“IV”) treatment at a dose of 200 µg·kg -1 given every other day.

After 12 cycles,

there was a marked regression of the subcutaneous thoracic metastases (Figure 7).

A biopsy of the metastatic tissue, as investigated

by molecular histopathology, demonstrated that approximately 85% of the cells had undergone apoptosis.

Additionally, serum levels of

the tumor marker Ca 15-3 decreased from 14.3 U/mL before therapy to 7.2 U/mL after therapy.

Similarly, serum levels of Carcinoembryonic

antigen, another tumor marker, declined from 50.8 ng/mL to 15.5 ng/mL posttreatment.

These results demonstrate that the drug was not

only able to kill hard-to-treat cancers, but also more differentiated tumor cells and more importantly, highly indolent tumor cells displaying

efficient mechanisms of resistance to cytotoxic drugs, radiation, and induction of apoptosis.

Clinical Pilot Study

a second case study, 18 months prior to treatment with HSB-1216’s active drug, an 82-year-old female patient was diagnosed with

advanced and metastatic (pelvic lymphatic metastasis) squamous cell carcinoma of the vulva (after radical vulvectomy and bilateral lymph

node dissection).

Given a poor therapeutic response to existing treatments at the time and exhaustion of therapeutic options, experimental

treatment of HSB-1216’s active drug in combination with erlotinib was recommended for this patient.

The patient received 14 IV

administrations of the drug at a dose of 200 µg·kg -1 given every other day plus erlotinib 150 mg daily for 30

Significant tumor regression was observed 30 days after combination therapy, based on clinical inspection of the tumor, as well

as decreased serum level of squamous cell carcinoma (“SCC”) antigen from 11.3 ng/mL before combination therapy to 0.13 ng/mL

after therapy.

Three months post-treatment, SCC levels increased to 3.2 ng/mL, and clinical inspection demonstrated significant tumor

experiencing numerous marked adverse effects with erlotinib (including fatigue, anorexia, nausea, and inappetence), the patient refused

further treatment with erlotinib and was retreated with HSB-1216’s active drug as monotherapy.

The patient received 12 IV administrations

at a dose of 200 µg·kg -1 given every other day, which resulted in no progression and stable disease for 2 weeks,

4 weeks, and 4 months post-treatment, based on clinical inspection of the local tumor and no marked changes in SCC.

2012 - Human Serum Levels of the Tumor Marker in Squamous Cell Carcinoma in vitro

results demonstrate that the drug is able to induce partial clinical regression of heavily pretreated and therapy-resistant cancers,

particularly in combination with novel tumor-targeted drugs.

Pre-Clinical Data

active drug has been shown to target elusive cancer cells in different types of human cancers, including gastric cancer, lung adenocarcinoma,

osteosarcoma, colorectal cancer, squamous cell carcinoma, and prostate, suggesting that the drug may be effective against side populations

of many types of human cancers.

The drug is able to enhance the cytotoxic effects of conventional chemotherapeutics and novel tumor-targeted

drugs in regular cancer cells, potentially playing a central role for HSB-1216-based combination therapies in the future treatment of

HSB-1216 Inhibits Tumor Growth in Mouse Model of SCLC

to the National Cancer Institute’s Surveillance, Epidemiology and End Results, there are anticipated to be more than 230,000 new

cases of lung cancer in the United States in 2021, and according to the American Cancer Society, SCLC comprises approximately

10-15% of all lung cancers.

Although SCLC is responsive to chemotherapy, recurrence occurs rapidly, with less than 7% of patients surviving over five years.

has shown to be responsive to immunotherapy with approximately one-third of patients responding

to PD-1/PD-L1 therapy and achieving a median overall survival of approximately eight months.

The need to rapidly advance therapeutics is an urgent, unmet medical need in these recurrent cases.

In one pre-clinical mouse model of

SCLC conducted by a third party in Asia, both HSB-1216’s active drug as well as HSB-1216 showed no antitumor activity in vivo ,

believed to be due to lab dilution errors of the test articles.

The same articles showed marked antitumor activity in a tumor sphere

model owing to the potent effects of both compounds.

Our previous studies with HSB-1216 has shown a profound inhibition of tumor growth

as a once-weekly injectable product in a nude mouse xenograft models utilizing an N-H69 SCLC cell line, with three 5 mg/kg doses administered

over three weeks when compared to placebo.

HSB-1216 is 2x-4x More Potent Against Chemo-Resistant SCLC Cell in vitro

is two to four times more potent in chemoresistant SCLC.

Using chemoresistant cell lines for SCLC (NCI-H69AR), our approach demonstrates

an increased potency of our compound using our Quatramer formulation when compared to standard-of-care therapies for these resistant

Clinical Plan in Solid Tumors

intend to submit an IND for our HSB-1216 product candidate for solid tumors to the FDA in the second half of 2023, and, if approved,

we plan to conduct a Phase 1 clinical trial to obtain human pharmacokinetic data and dose optimization data on our formulation

however, no assurance can be provided that our IND will be accepted by the FDA in 2023, if at all.

Based on the data

obtained from pre-clinical studies, we believe a Phase 1 basket trial can be conducted in the US with HSB-1216 where there are

limited therapies.

Even with the advent of immune checkpoint inhibitors (“ICIs”), there remains a large patient

population which either does not benefit from allowing HSB-1216 to potentially prolong survival in ICI failures as well as recurrent

disease patients.

ErbB or HER family of cell surface proteins are some of the most well-known and validated oncology drug targets including ErbB2 or HER2

(human epidermal growth factor receptor) and Erb3 or HER3.

The family of antibodies and biologics against HER2 starting with HERCEPTIN ®

(trastuzumab) approved in 1998 for breast cancer, one of the first few anti-cancer antibodies, as well as PERJETA ®

(pertuzumab), KADCYLA ® (ado-trastuzumab emtansine) and PHESGO ® (Pertuzumab/trastuzumab/hyaluronidase) reported

2022 sales of greater than $8 billion for Roche/Genentech.

Antibodies against HER2 and HER3 bind to different domains of the extracellular

portion of the proteins or epitopes with trastuzumab primarily binding the extracellular domain IV of HER2.

HER2 is a validated tumor

antigen for antibody drug conjugates to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s KADCYLA ®

and Daiichi Sankyo/AstraZeneca’s ENHERTU ® .

Anti-ErbB2 (HER2) and Anti-ErbB3 (HER3) Antibodies

Quatramers with their long half-life coated with a PD-1 Picobody to create HSB-1940, we believe we can more efficiently target novel

epitopes with greater binding affinity than approved biologics.

We further believe that targeting PD-1 is a step toward enabling us to

enter the rapidly growing IO therapeutics market with additional IO targets such as programed death- ligand 1 (“PD-L1”),

HER-2 and trophoblast cell surface antigen 2 (“TROP-2”).

derived from mouse or human sources use the surface formed by CDRs on the variable regions of the heavy chain (V H )/light chain

(V L ) heterodimer typically forming a relatively flat binding surface which then binds the target protein.

Alternative species,

particularly camelids and bovines, provide a paradigm for antigen recognition through novel domains which form the antigen binding site.

However, for camelids, heavy chain antibodies bind antigen with only a single heavy chain variable region (V H ), in the absence

of light chains.

Meanwhile, in bovines, ultralong CDR-H3 regions form an independently folding mini-domain, which protrudes far out from

the surface of the antibody and forms a “stalk and knob” structure.

The “knob” is diverse in its structure, small

size and weight, sequence and disulfide patterns.

The “knob” (Picobody) component can be expressed as an independent antigen

binding domain with three times smaller size (~4-6 kDa) than a camelid “nanobody” making it the smallest known antibody fragment.

These atypical antigen binding sites of bovines potentially provide the ability to interact with different antigenic determinants or

epitopes, particularly recessed or concave surfaces, compared to traditional full-length mouse or human antibodies.

Quatrabodies Combine Unique Features of the Knob Domain of Bovine-derived Antibodies with Quatramers’ Long Half-life

Mediated Cell Death Inducer Analogues Program

December 2019, we acquired intellectual property and data related to analogues of HSB-1216’s active drug with varying molecular

constructs with increased efficacy against a subgroup of tumors consisting of breast, pancreatic and prostate cancers.

Several lead analogues

have demonstrated increased potency when compared to HSB-1216’s active drug, whereby the increased potency of these compounds is

expected to have ferroptotic effects greater than HSB-1216’s active drug at micro-dosage levels, creating an increased therapeutic

index as novel small molecules.

We expect to develop these advanced compounds as follow-on therapeutics to HSB-1216 to treat a variety

of high unmet needs, including orphan cancers, which are sensitive to the ferroptotic pathway.

proprietary Quatramer technology is based on know-how and permits manufacture of uniform size polymer aggregates that can be packaged

and tuned specifically to interact with pharmaceutical drugs, biological molecules and/or combinations of molecules to bypass delivery

The system is biocompatible and can be tailored to form therapeutics which solubilize the drug in aqueous media such as human

plasma and blood which dramatically increases the amount of drug available at the disease site while administering a lower dose.

studies have shown that targeted delivery of drugs to a site of action, including tumors, is directly related to the length of time of

a circulating therapeutic in the bloodstream.

This is an expected outcome as most drug delivery formulations delivering payloads to sites

of action are cleared extremely rapidly by the reticuloendothelial system (“RES”) in the liver.

The stealth nature of our

technology allows for a prolonged circulation time whereby there is accumulation at the site of disease prior to being cleared.

“Leaky” Tumor Vasculature Allows Quatramers to Selectively Accumulate in the TME

size, shape and surface of our Quatramer allows it to escape via gaps in the blood vessels in the TME allowing for release of the payload

directly into cancerous cells.

Furthermore, the system functions as a “peeling onion” in coordinated and precise acidic versus

basic conditions depending on the TME as well as inside cancerous cells.

Certain portions of the technology release a payload due to

its own physicochemical characteristics while the core of the Quatramer system would release a different payload depending on its own

chemical and physical properties.

This type of a profile for certain of our Quatramer therapeutics, particularly our combination products,

are specifically designed to cleave or disperse in response to external stimuli causing internal changes for delivery and is a designed

approach to our size tunable vehicles.

Quatramer Platform – Intracellular Payload Delivery and Disintegration

designed size tunable feature of certain of our Quatramer compositions offer further advantages, as certain cleaved materials create

a reversal of drug resistance in cells.

Drug resistance can be classified into two categories:

de novo resistance or acquired resistance.

Cancer patients that exhibit de novo resistance do not respond to chemotherapy

from the start.

However, in acquired resistance, the cancer cells initially respond to a drug but eventually acquire resistance to it

and the cells might also show cross-resistance to other structurally and mechanistically unrelated drugs, a phenomenon commonly known

as MDR whereby treatment regimens that combine multiple agents with different targets are no longer effective.

Our Quatramer technology

circumvents this phenomenon upon cleavage of the payload from the system, whereby the remnants of the system, such as certain hydrophobic

chains flanked by hydrophilic chains which are not related to therapeutic efficacy, cause drug efflux pump blockage and allow the payload

to continue to be effective in MDR cellular systems both in vitro and in vivo .

physicochemical characterization allows for optimizing size, shape and surface chemistry based on payload characteristics to render enhanced

permeation and retention into the TME.

Our scientific know-how and scientific expertise in developing Quatramer based therapeutics has

led to understanding the optimal conditions for encapsulating therapeutics of different physicochemical characteristics into our proprietary

delivery, and the combination of multiple materials used varies depending on the drug itself, causing a highly specific tunability platform

that can be scaled.

The proprietary know-how behind our Quatramer structures with multiple layering allows for therapeutics of different

levels of hydrophilicity and hydrophobicity to interact within aqueous mediums of varied acid-base conditions, including human serum

The importance of the Quatramer structure extends the certain aspects of the core and thereby has the capacity to increase

drug uptake and sustain its release over long periods of time, including over many days and weeks in both in vitro and in vivo

Quatramer technology has been designed to be a scalable process with production efficiency whereby the analysis of the output of a designed

chemistry, manufacturing and controls system creates a predictable and uniform product with controllable capability and cost efficiency.

Chemical compositions listed in the FDA Inactive Ingredients Database with known profile.

Combined with the tunability of Quatramer,

the technology allows for a variety of delivery payloads including peptides, small molecules, nucleic acids and antibodies with the added

flexibility of dual-loaded payload therapeutics.

The payload diversity and flexibility of the system coupled with its numerous advantages

allows for a targeted system with prolonged circulation time, which takes advantage of an efficient EPR effect with numerous mechanistic

features deployed at various conditions with the TME as well as in intracellular environments, which makes the methodology of Quatramer

therapeutics, a highly advantageous platform to deliver low doses of therapeutics directly to tumors.

a proprietary tumor targeting platform, with their long

half-life are coated with a Picobody ™ to create unique IO antibodies.

Picobodies are

antibody “knob” domains comprised of cysteine-rich ultralong CDR H3 sequences of 30-40 amino acids, which have the potential

to access challenging epitopes better than full size antibodies can.

We believe we may be able to more efficiently target novel

epitopes with greater binding affinity than approved biologics.

Targeting PD-1, PDL-1, HER-2 and TROP-2 is a step toward enabling us

to enter the rapidly growing IO markets.

Bovine Antibody “Knob” Peptides are the Smallest Independent Antigen Binding Domain

Comparison of Dissociation Constants Amongst Leading PD-1 Antibodies

The Unique and Differentiated Binding Sites for Approved Anti-PD-1 Antibodies

Depiction of Human Antibody, Bovine Knob and the Quatrabody

goal is to disrupt the biotechnology landscape by developing novel therapeutics by leveraging our targeted-delivery Quatramer platform-based

therapeutic to address significant unmet medical needs, with a focus on treatments for cancer.

We believe that our technology has the

potential to generate differentiated products that have the potential to treat rare and treatment resistant tumors.

business strategy includes:

drug candidate, HSB-1216, in solid tumors.

from a clinical pilot study conducted at the University of Heidelberg, Germany, led us to progress HSB-1216 into IND-enabling studies

with the goal of submitting an IND to the FDA in 2023.

These IND-enabling trials are pre-clinical in nature and include toxicology and

pharmacokinetic profiling as well as bioanalytical assay development.

After discussions with the FDA, we expect to use the 505(b)(1)

FDA approval pathway and conduct a Phase 1 trial to obtain initial pharmacokinetic and dosing information in patients.

We intend to evaluate

the development of HSB-1216 in other high-unmet need oncology indications, including certain brain, breast and prostate cancers, and

in combination with other cancer therapies.

drug candidate, HSB-3215

ErbB family of cell surface proteins

are some of the most well-known and validated oncology drug targets including ErbB2 or HER2 (human epidermal growth factor receptor) and

Erb3 or HER3.

Antibodies against HER2 and HER3 bind to different domains of the extracellular portion of the proteins or epitopes with

trastuzumab primarily binding the extracellular domain IV of HER2.

HER2 is a validated tumor antigen for antibody drug conjugates to treat

HER2 positive cancers with two approved antibodies, Roche/Genentech’s KADCYLA ® and Daiichi Sankyo/AstraZeneca’s

Monoclonal antibodies being developed at ABSI are unique from the currently approved anti-HER2 antibodies.

has granted us an exclusive option to license certain of its proprietary technology which will allow us to develop HER2 and HER3 antibodies,

including multi-specific and Quatramer- based therapeutics incorporating portions of the antibodies.

The ABSI option terminates on March 24, 2023, unless extended by the parties.

drug candidate, HSB-1940

Quatrabody™ provides an entry into next generation of IO biologics including, bispecific and trispecific antibodies, ADCs, CAR-T,

CAR-NKs and others.

Quatrabodies capitalize on the long half-life of tumor targeting Quatramers, combined with Picobodies™, bovine-derived

antibody “knob” domains which have potential to access and bind more tightly to “undruggable” epitopes better

than full sized antibodies.

HSB-1940 is a combination of the Quatramer and PD-1 targeting Picobodies.

Quatrabodies have the potential

for delivering an increased drug payload to the tumor with a longer half-life while targeting novel “undruggable” epitopes

of well-known and validated IO targets such as PD-1.

our novel platform to develop a pipeline of high value Quatramer leads.

tunability of our technology allows us to efficiently expand our pipeline of Quatramer, both on our own and in collaboration with others,

through various combinations of targeted DNA encoded for anti-tumor cytokines and therapeutic payloads, which enables us to move into

other areas of oncology, including IO whereby we could potentially increase the effectiveness of immune checkpoint inhibitors (“ICIs”).

and commercializing Quatramer in collaboration with leading pharmaceutical companies.

addition to our internal development programs, we actively seek opportunities to collaborate with recognized biopharmaceutical companies

to develop Quatramer incorporating therapeutic payloads from their proprietary product portfolios.

We intend to establish collaborations

with industry leaders and strategic pharmaceutical organizations.

Commercializing

proprietary Quatramer based products, including HSB-1216, directly in the United States and with collaborators outside the United

own HSB-1216 and our other proprietary pipeline and expect to maintain similar rights with respect to other proprietary Quatramer we

Following FDA approval in the United States, we may partner with a larger biopharmaceutical company as well as potentially build

a focused oncology sales organization to market Quatramer-based therapeutics.

Outside of the United States, we intend to rely on collaborators

to commercialize proprietary approved Quatramer.

to extend and protect our product technology and Quatramer through our intellectual property portfolio.

seek to protect our novel platform through U.S.

and international patents as well as know-how and trade secrets relating to the design

and manufacturing of our technology.

We expect to continue to file patent applications as we apply our technology to new targets and

therapeutic payloads.

In addition, we believe the heightened regulatory requirements for generics of this technology may strengthen the

protection afforded by our intellectual property portfolio.

Chief Executive Officer and directors have extensive scientific, drug development, and commercialization experience across pertinent

disciplines including oncology;

small molecule, peptide and antibody drug manufacturing and quality;

clinical drug development, and commercialization.

Our Chief Executive Officer and directors have held various research, clinical development, artificial intelligence, strategy, corporate

development and operational positions at large biopharmaceutical companies ,

public biotechnology companies, and universities having worked at companies such as DuPont Merck

Pharmaceuticals, Amgen Inc., Exelixis, Inc., Salix Pharmaceuticals, Inc., Global Cancer Research Institute, Sanofi and UCLA School of

Our Chief Executive Officer and directors have been involved in the discovery, development, manufacturing and commercialization

of multiple marketed products across various therapeutic areas, including, but not limited to, Cabometyx ® (cabozantinib),

Remicade ® (infliximab) and Clolar ® (clofarabine).

Our strategy involves targeting PD-1 combined with a known, validated undisclosed antigen or using HER2 instead of PD-1 while naturally

occurring antibodies typically only target one epitope on one antigen.

the Avior Effective Date, we entered into the Avior Patent License Agreement with Avior pursuant to which we received an exclusive sublicensable

right and license to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made,

use, sell, import, export and commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing,

throughout the world.

Pursuant to the Avior Patent License Agreement, we shall pay Avior a mid six digit up front license fee within

ten days of the Avior Effective Date and an additional mid six digit license fee which shall be paid in four equal installments within

ten days of the end of each fiscal quarter following the Avior Effective Date.

In addition, we shall pay Avior a high single digit percentage

of any upfront payments received by us as a result of the grant of any sublicenses with respect to AV104.

We shall also pay Avior milestone

payments in the aggregate amount of $24,250,000 upon the occurrence of various development milestones.

Furthermore, we shall pay Avior

certain fees based upon sales milestones.

The payments for such sales milestones range from the low seven digits to the low eight digits

with higher sales being subject to higher fees.

Finally, we shall pay Avior royalties based on net sales.

Such royalties range from low

single digit percentages to mid single digit percentages with higher sales being subject to lower percentages.

The Avior Patent License

Agreement shall expire upon the expiration of the final payment obligation due to Avior as set forth in such agreement.

Upon the expiration

of the Avior Patent License Agreement, we shall have a fully paid, irrevocable, freely transferable and sublicensable worldwide license

to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made, use, have used, sell, offer for sale,

have sold, import, have imported, export, have exported, commercialize or have commercialized any and all Licensed Products and to practice

the Licensed Technology worldwide.

Pursuant to the Avior Patent License Agreement, we may terminate the agreement at any time without

cause, upon 30 days’ prior written notice to Avior along with payment of the next unpaid Development Milestone Payment, if any.

Furthermore, either we or Avior may terminate the Avior Patent License Agreement (i) on written notice to the other party if the other

party materially breaches any provision of the Avior Patent License Agreement and fails to cure such breach within 30 days after the

breaching party receives written notice thereof or (ii) on written notice in the event that either party (A) becomes insolvent or admits

its inability to pay its debts generally as they become due;

(B) becomes subject, voluntarily or involuntarily, to any proceeding under

any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within 60 days;

or takes any corporate action for such purpose;

(D) makes a general assignment for the benefit of creditors;

or (E) has a receiver, trustee,

custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of

its property or business.

Upon termination of the Avior Patent License Agreement, the license granted pursuant to such agreement shall

terminate and all rights in the Licensed Patent Rights and Licensed Products shall revert back to Avior.

pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis

on proprietary products and intellectual property.

We face competition from m ajor

multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, emerging and start-up

companies, universities and other research institutions both in the United States and internationally.

Any drug candidates that we successfully

develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

We face competition from major multinational pharmaceutical companies, established

biotechnology companies, specialty pharmaceutical companies, emerging and start-up companies, universities and other research institutions

both in the United States and internationally.

Any drug candidates that we successfully develop and commercialize will compete with existing

therapies and new therapies that may become available in the future.

of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical

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

Some of our competitors

include BridgeBio Pharma, Inc.

(Ferro Therapeutic, Inc.), Kojin Therapeutics, Inc., Bayer AG, Moderna Inc., Roche/Genentech, Daiichi

We anticipate some

of our competitors for TH104 will include Mirum Pharma, Ipsen Pharma, Cara Therapeutics, Moonlake Therapeutics, Apogee Therapetuics,

and Regeneron.

In addition, some of our competitors for our early-stage pipeline include Bayer AG, Moderna Inc., Roche/Genentech, Daiichi

Sankyo/Astra Zeneca, Merck, Bristol-Myers Squibb and Takeda Pharmaceutical Company.

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ability to compete may be affected in many cases by insurers or other third-party payers seeking to encourage the use of generic products.

Generic products are currently on the market, including the therapeutics payload in HSB-1216, for the indications that we are pursuing,

Generic products are currently on the market, including the active ingredients which may be used for the indications that we are pursuing,

and additional products are expected to become available on a generic basis over the coming years.

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Some of these drugs are branded and subject to patent protection, and others are available on a generic basis, including

drugs in the same therapeutic class as the payloads contained in HSB-1216.

drugs in the same therapeutic class as the payloads in product candidates contained in our pipeline.

of these approved drugs are well established therapies and are widely accepted by physicians, patients and third-party payers.

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which may have an adverse effect on our operating results and estimated timelines.

intellectual property that is available to us is important for our business, and we strive to protect it, including by obtaining, maintaining, defending, and enforcing patent protection in the United States and internationally for our proprietary technology, improvements, platforms, products and components

thereof, novel biological discoveries, new therapeutic approaches and potential indications, and other inventions that are important

to our business.

For our product candidates, generally we initially pursue patent protection covering compositions of matter,

methods of production, and methods of use.

Throughout the development of our product candidates and technologies, we will seek to

identify additional means of obtaining patent protection.

of March 10, 2023, our patent portfolio includes 11 patent families.

families include 14 issued patents and 43 pending applications related generally to our polymeric nanoparticle technologies, methods of

making our polymeric nanoparticle technologies, and methods of using our polymeric nanoparticles therapeutically ( e.g ., for delivery

of therapeutic compounds).

Specifically, our patent portfolio currently includes four issued U.S.

patents, and ten granted patents

in foreign jurisdictions, as well as six pending applications in the U.S.

and 37 abroad.

Patent protection for the earliest-filed family

is expected to expire in 2033, absent any applicable patent term adjustments or extensions, with more recently-filed families expiring

approximately between 2033 and 2042.

We may file other patent applications in the future.

intellectual property that is available to us is important for our business, and we strive to protect it, including by obtaining, maintaining,

defending, and enforcing patent protection in the United States and internationally for our proprietary technology, improvements, platforms,

products and components thereof, novel biological discoveries, new therapeutic approaches and potential indications, and other inventions

that are important to our business.

For our product candidates, generally we initially pursue patent protection covering compositions

of matter, methods of production, and methods of use.

Throughout the development of our product candidates and technologies, we will

seek to identify additional means of obtaining patent protection.

patent portfolio includes 3 patent families with 2 issued U.S.

patents and 14 pending applications related generally to treatment of

The claims of these patents and applications cover devices and their method of manufacture, as well as methods of treating.

Specifically, our patent portfolio currently includes two issued U.S.

patents, as well as a pending application in the U.S.

and 13 pending

applications abroad.

Patent protection is expected to expire in 2039, absent any applicable patent term adjustments or extensions.

may file other patent applications in the future.

also have issued patents and pending applications related generally to our polymeric nanoparticle technologies, methods of making our

polymeric nanoparticle technologies, and methods of using our polymeric nanoparticles therapeutically ( e.g ., for delivery of therapeutic

Patent protection for the earliest-filed family is expected to expire in 2033, absent any applicable patent term adjustments

or extensions, with more recently filed families expiring approximately between 2033 and 2042.

We have collaborations with Minotaur Therapeutics,

and Applied Biomedical Science Institute regarding applications of this technology with a variety of multispecific binders including

binders for HER2 and HER3, as well as an anti-PD-1 binder.

These collaborations will likely lead to filing of additional patent applications

in the future.

term of individual patents depends upon the legal term for patents in the countries in which they are obtained.

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a patent may be lengthened by patent term adjustment (“PTA”), which compensates a patentee for administrative delays by the

Patent and Trademark Office (“USPTO”) in examining and granting a patent or the term of a patent may be shortened if a patent is terminally disclaimed over an earlier

USPTO in examining and granting a patent or the term of a patent may be shortened if a patent is terminally disclaimed over an earlier

filed patent.

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thereby limiting the protection such patent would afford the respective product and any competitive advantage such patent may provide.

have filed an intent-to-use U.S.

trademark application for “HILLSTREAM

BIOPHARMA” (for “Pharmaceutical preparations for use in cancer treatment and therapies”) in International class 5.

have filed an intent-to-use U.S.

trademark application for “QUATRAMER” and QUATRABODY (both for “Nano particle technologies

and nanoparticle technologies for cancer therapy and treatment, namely, drug delivery agents in the form of nanoparticles that provide

controlled release of active ingredients for a wide variety of pharmaceuticals for the treatment of cancer”) in International class

We also hold a pending U.S.

trademark application for HILLSTREAM BIOPHARMA, claiming use of the mark for “Research and development

in the field of oncology” in International class 42.

Further, the collaborations we have entered into may not result in patentable subject matter or potential licensing agreements may not

be successfully negotiated.

intend to file an intent-to-use U.S.

trademark application for “THARIMMUNE INC” (for “Pharmaceutical preparations for

use in cancer treatment and therapies”) in International class 5.

Research and Collaboration Agreement and Taurus License Agreement

Hillstream has entered into a research collaboration and product license

agreement with Minotaur and a commercial license agreement with Taurus for use of certain technology, including OmniAb antibodies, to

entered into a research collaboration and product license agreement with Minotaur Therapeutics, Inc.

(“Minotaur”) and a commercial

license agreement with Taurus Biosciences, LLC (“Taurus”) for use of certain technology, including OmniAb antibodies, to

advance Picobodies against novel, unreachable and undruggable epitopes in high-value validated targets starting with PD-1.

and collaboration agreement and product license agreement is for the development of proprietary targeted biologics, Knob Quatrabodies™

(HSB-1940), against PD-1.

technologies of Hillstream and Minotaur will be combined under the license

from Taurus to discover, develop and advance biotherapeutics against high-value validated IO targets.

Picobodies are bovine-derived antibody

“knob” domains comprised of cysteine-rich ultralong CDR H3 sequences of 30-40 amino acids weighing ~3-4KDa, which have the

potential to access challenging epitopes better than full size antibodies can.

combining Quatramers with their long half-life coated with a PD-1 Picobody ™

to create HSB-1940, Hillstream believes it could more efficiently target novel epitopes with greater binding affinity than approved

anti-PD-1 antibodies.

We further believe that the development of HSB-1940 is a step toward enabling us to enter the rapidly growing IO

market with additional targets thereafter.

and collaboration agreement and product license agreement are for the development of proprietary targeted biologics, including TH1940,

against PD-1.

research collaboration between us and Minotaur will be executed under the license from Taurus to discover, develop and advance biotherapeutics

against high-value validated IO targets.

Picobodies are bovine-derived antibody “knob” domains comprised of cysteine-rich

ultralong complementary determining region H3 sequences of 30-40 amino acids weighing ~3-4KDa, which have the potential to access challenging

epitopes better than full size antibodies can.

combining non-proprietary half-life extending methods which are linked to a PD-1 Picobody ™ to create TH1940, we believe

we could more efficiently target novel epitopes with greater binding affinity than currently approved anti-PD-1 antibodies.

believe that the development of TH1940 is a step toward enabling us to enter the rapidly growing immune-oncology market with additional

targets thereafter.

Biomedical Research Institute Option Agreement

ABSI has developed technology to target unique functional epitopes of the cancer

targets HER2 and HER3.

Monoclonal antibodies being developed at ABSI are unique from the currently approved anti-HER2 antibodies.

has granted us an exclusive option to license technology to develop HER2 and HER3 antibodies, including multi-specific and Quatramer-based

therapeutics incorporating portions of the antibodies.

These antibodies could be incorporated into proprietary multi-format biologics

(bi- and tri-specific antibodies, ADCs (antibody drug conjugates), CAR-T and CAR-NKs, in Quatramers and Quatrabodies) against drug resistant

cancers including HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer.

The ABSI option terminates on March 24, 2023, unless extended by the parties.

July 5, 2023, the ABSI Effective Date, we entered into the ABSI Agreement with ABSI pursuant to which ABSI granted us an exclusive royalty-bearing,

sublicensable license to the ABSI Patents and a non-exclusive, royalty-bearing, sublicensable license to the ABSI Know-How to Exploit

the ABSI Products for the treatment, diagnosis, prediction, detection or prevention of disease in humans and animals worldwide (each

as defined in the ABSI Agreement).

Pursuant to the ABSI Agreement, the parties shall form a committee to manage the preclinical, IND-

enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product.

will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against such Target with a view to identifying

or generating suitable Products (as defined in the ABSI Agreement) for our Company to Exploit.

“Target” means ErB2 (Her2)

and ErbB3 (HER3).

Upon completion of the Discovery Timeline (as defined in the ABSI Agreement) for a Target, subject to the terms and

conditions of ABSI Agreement, we shall exclusively own any ABSI Products against such Target.

In the event the committee determines that

the discovery activities are unsuccessful with respect to a Target, we may propose an additional target, which, upon approval by ABSI,

shall replace a failed Target.

authorities in the U.S.

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

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

In the U.S., the

FDA regulates such products under the Federal Food, Drug, and Cosmetic Act (“FsDCA”) and its implementing 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 or untitled letters, product

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

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

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

In the U.S., the FDA regulates

such products under the FDCA and its implementing 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 or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution,

injunctions and/or criminal prosecution.

Food and Drug Administration Regulation

States Drug Development

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

the FDCA and its implementing regulations.

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

FDCA and its implementing regulations.

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

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.

of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations

requires the expenditure of substantial time and financial resources.

Failure to comply with the applicable U.S.

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

administrative or judicial sanctions.

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

applications, withdrawal of an approval, a clinical hold, untitled or warning or untitled 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.

requirements at any

time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial

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 or untitled 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

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

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of adequate and well-controlled human clinical trials in accordance with an applicable IND and 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 a new drug application (“NDA”);

referred to as GCP, to establish the safety and efficacy of the proposed drug for its proposed indication;

to the FDA of an NDA;

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

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clinical trial.

Further, an institutional review board (“IRB”) must review and approve the plan for any clinical trial before

it commences at any institution, and the IRB must conduct continuing review and reapprove the study at least annually.

An IRB considers,

among other things, whether the risks to individuals participating in the clinical trial are minimized and are reasonable in relation

to anticipated benefits.

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

to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.

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

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

An IRB considers, among other things, whether the risks

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

approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his

or her legal representative and must monitor the clinical trial until completed.

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

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subject to extensive and increasing regulation by numerous federal, state, and local government agencies including the FDA, the Office

of Inspector General (“OIG”), the Department of Justice (“DOJ”), the CMS, the Office of Civil Rights, and various

state authorities.

of Inspector General (“OIG”), the DOJ, the CMS, the Office of Civil Rights, and various state authorities.

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

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against Medicare and state healthcare programs.

The federal government, including as a result of the passage of the Affordable Care Act

(“ACA”), and a number of courts have taken the position that claims presented in violation of certain other statutes, including

the federal Anti-Kickback Statute (“AKS”) or the federal physician referral law, 42 U.S.C.

1395nn (the “Stark Law”),

can also be considered a violation of the False Claims Act.

The federal government, including as a result of the passage of the ACA, and a number

of courts have taken the position that claims presented in violation of certain other statutes, including the federal Anti-Kickback Statute

(“AKS”) or the federal physician referral law, 42 U.S.C.

1395nn (the “Stark Law”), can also be considered a violation

of the False Claims Act.

number of states have enacted laws that are similar to the federal False Claims Act.

Under Section 6031 of the Deficit Reduction Act

of 2005, as amended, if a state enacts a false claims act that is at least as stringent as the federal statute and that also meets

certain other requirements, the state will be eligible to receive a greater share of any monetary recovery obtained pursuant to

certain actions brought under the state’s false claims act.

As a result, many states have enacted laws that are similar to the

federal False Claims Act and there has been a concomitant increase in state false claims enforcement efforts.

Violations of federal

and state fraud and abuse laws may be punishable by criminal and/or civil sanctions, including significant penalties, fines,

disgorgement, additional reporting requirements and oversight under a corporate integrity agreement or similar agreement to resolve

allegations of noncompliance with these laws, and/or exclusion or suspension from federal healthcare programs, such as Medicare, and

debarment from contracting with the U.S.

Penalties for False Claims Act violations include fines ranging from $13,508 to

$27,018 for each false claim adjusted each year for inflation, plus up to three times the amount of damages sustained by the government.

In addition to the

provisions of the False Claims Act, which provide for civil enforcement, the federal government also can use several criminal

statutes to prosecute persons who are alleged to have submitted false or fraudulent claims to the government for payments.

Additionally, private parties may initiate qui tam whistleblower lawsuits against any person or entity under the False Claims

Act in the name of the federal government, as well as under the false claims laws of several states, and may share in the proceeds

of a successful suit.

Generally, federal and state governments have made investigating and prosecuting healthcare fraud and abuse a

of 2005, as amended, if a state enacts a false claims act that is at least as stringent as the federal statute and that also meets certain

other requirements, the state will be eligible to receive a greater share of any monetary recovery obtained pursuant to certain actions

brought under the state’s false claims act.

As a result, many states have enacted laws that are similar to the federal False Claims

Act and there has been a concomitant increase in state false claims enforcement efforts.

Violations of federal and state fraud and abuse

laws may be punishable by criminal and/or civil sanctions, including significant penalties, fines, disgorgement, additional reporting

requirements and oversight under a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these

laws, and/or exclusion or suspension from federal healthcare programs, such as Medicare, and debarment from contracting with the U.S.

Penalties for False Claims Act violations include fines ranging from $13,508 to $27,018 for each false claim adjusted each

year for inflation, plus up to three times the amount of damages sustained by the government.

In addition to the provisions of the False

Claims Act, which provide for civil enforcement, the federal government also can use several criminal statutes to prosecute persons who

are alleged to have submitted false or fraudulent claims to the government for payments.

Additionally, private parties may initiate qui

tam whistleblower lawsuits against any person or entity under the False Claims Act in the name of the federal government, as well

as under the false claims laws of several states, and may share in the proceeds of a successful suit.

Generally, federal and state governments

have made investigating and prosecuting healthcare fraud and abuse a priority.

Federal “Stark” Law

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Monetary Penalties Statute

Civil Monetary Penalties Law (“CMPL”), 42 U.S.C.

§ 1320a-7a, authorizes the imposition of civil monetary penalties,

assessments, and exclusions against an individual or entity based on a variety of prohibited conduct, including, but not limited to:

(i) presenting, or causing to be presented, claims for payment to Medicare, Medicaid, or other third-party payors that the individual

or entity knows or should know are for an item or service that was not provided as claimed or is false or fraudulent;

(ii) offering remuneration

to a federal healthcare program beneficiary that the individual or entity knows or should know is likely to influence the beneficiary

to order or receive healthcare items or services from a particular provider;

(iii) arranging contracts with an entity or individual excluded

from participation in a federal healthcare program;

CMPL, 42 U.S.C.

§ 1320a-7a, authorizes the imposition of civil monetary penalties, assessments, and exclusions against an individual

or entity based on a variety of prohibited conduct, including, but not limited to:

(i) presenting, or causing to be presented, claims

for payment to Medicare, Medicaid, or other third-party payors that the individual or entity knows or should know are for an item or

service that was not provided as claimed or is false or fraudulent;

(ii) offering remuneration to a federal healthcare program beneficiary

that the individual or entity knows or should know is likely to influence the beneficiary to order or receive healthcare items or services

from a particular provider;

(iii) arranging contracts with an entity or individual excluded from participation in a federal healthcare

(iv) violating the federal AKS;

(v) making, using, or causing to be made or used,

a false record or statement material to a false or fraudulent claim for payment for items and services furnished under a federal healthcare

(vi) making, using, or causing to be made any false statement, omission, or misrepresentation of a material fact in any application,

bid, or contract to participate or enroll as a provider of services or a supplier under a federal healthcare program;

and (vii) failing

to report and return an overpayment owed to the federal government.

We could be exposed to a wide range of allegations to which the federal

CMPL would apply.

We cannot foreclose the possibility that we will face allegations subject to the CMPL with the potential for a material

adverse impact on our business, results of operations and financial condition.

Substantial civil monetary penalties may be imposed under

the federal Civil Monetary Penalty Statute and may vary, depending on the underlying violation.

In addition, an assessment of not more

than three times the total amount claimed for each item or service may also apply, and a violator may be subject to exclusion from federal

and state healthcare programs.

(v) making, using, or causing to be made or used, a false record or statement material to a

false or fraudulent claim for payment for items and services furnished under a federal healthcare program;

(vi) making, using, or causing

to be made any false statement, omission, or misrepresentation of a material fact in any application, bid, or contract to participate

or enroll as a provider of services or a supplier under a federal healthcare program;

and (vii) failing to report and return an overpayment

owed to the federal government.

We could be exposed to a wide range of allegations to which the federal CMPL would apply.

We cannot foreclose

the possibility that we will face allegations subject to the CMPL with the potential for a material adverse impact on our business, results

of operations and financial condition.

Substantial civil monetary penalties may be imposed under the federal Civil Monetary Penalty Statute

and may vary, depending on the underlying violation.

In addition, an assessment of not more than three times the total amount claimed

for each item or service may also apply, and a violator may be subject to exclusion from federal and state healthcare programs.

Additionally,

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

of March 10, 2023, we employed 1 full-time employee and 1 part-time employee.

of February 20, 2024, we employed 2 full-time employees and 1 part-time employee.

We are not a party to any collective bargaining agreements,

and we believe that we maintain good relations with our employee.

and we believe that we maintain good relations with our employees.

human capital resources objectives include identifying, recruiting, retaining and incentivizing our existing and future employees.

principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through

granting of equity-based compensation awards and cash-based compensation awards, in order to increase stockholder value and support success

of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

corporate headquarters are located at 1200 Route 22 East, Suite 2000, Bridgewater, NJ 08807 pursuant to a monthly rental agreement.

believe this to be sufficient to meet our needs for the foreseeable future and that any additional space we may require will be available

on commercially reasonable terms.

time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business.

is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.

We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse

effect on our business, financial condition or operating results.

Corporate History

BioPharma Inc.

(“HBI”) was incorporated on March 28, 2017, as a Delaware C-corporation.

On July 16, 2019, Hillstream BioPharma

Holdings, Inc.

were incorporated under the laws of the State of Delaware on March 28, 2017 under the name Hillstream BioPharma Inc.

On July 16, 2019, Hillstream BioPharma Holdings, Inc.

(“Holdco”) was formed as a Delaware C-corporation.

On July 24, 2019, Holdco entered into a Contribution and

Exchange Agreement with Nanoproteagen LLC (“Nanoproteagen”) whereby the members of Nanoproteagen exchanged 100% of their

membership interests in Nanoproteagen for shares of Holdco common stock.

Also on July 24, 2019, the stockholders of HBI exchanged 100%

of their shares of common stock for shares of common stock of Holdco.

HBI and Nanoproteagen became wholly-owned subsidiaries of Holdco.

On August 7, 2019, pursuant to a certificate of amendment, Holdco’s name was changed to Hillstream BioPharma, Inc.

name was changed to HB Pharma Corp.

On July 24, 2019,

Holdco entered into a Contribution and Exchange Agreement with Nanoproteagen LLC (“Nanoproteagen”) whereby the members of

Nanoproteagen exchanged 100% of their membership interests in Nanoproteagen for shares of Holdco common stock.

Also on July 24, 2019,

the stockholders of HBI exchanged 100% of their shares of common stock for shares of common stock of Holdco.

HBI and Nanoproteagen became

wholly-owned subsidiaries of Holdco.

On August 7, 2019, pursuant to a certificate of amendment, Holdco’s name was changed to Hillstream

BioPharma, Inc.

and HBI’s name was changed to HB Pharma Corp.

On November 12, 2020, Hillstream BioPharma, Inc.

entered into a Share Exchange Agreement with Farrington

Therapeutics LLC (“Farrington”), whereby the members of Farrington exchanged their membership interest in Farrington for

shares of common stock of Hillstream BioPharma, Inc., and Farrington became a wholly-owned subsidiary of Hillstream BioPharma, Inc.

December 31, 2022, Hillstream BioPharma, Inc.

has two wholly-owned subsidiaries:

HB Pharma Corp.

and Farrington.

At February 27, 2023, Hillstream BioPharma, Inc.

has one wholly-owned subsidiary, HB Pharma Corp.

website address is www.hillstreambio.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.

entered into a Share

Exchange Agreement with Farrington Therapeutics LLC (“Farrington”), whereby the members of Farrington exchanged their membership

interest in Farrington for shares of common stock of Hillstream BioPharma, Inc., and Farrington became a wholly-owned subsidiary of Hillstream

BioPharma, Inc.

On September 21, 2023, the Company filed a Certificate of Amendment to its Certificate of Incorporation with the Secretary

of State of the State of Delaware pursuant to which it changed its name to Tharimmune, Inc.

effective as of September 25, 2023.

On November 17, 2023, we

filed a Certificate of Amendment to our Certificate of Incorporation, as amended, with the Delaware Secretary of State to effectuate a

1-for-25 reverse stock split of our issued and outstanding shares of common stock.

The reverse stock split became effective at 4:01 p.m.

Eastern time on November 20, 2023.

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 split.

December 31, 2023, the Company had one wholly-owned subsidiary, HB Pharma Corp.

website address is www.tharimmune.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.

We make our filings

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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