NASDAQ: GRMLW

The Company’s Common Stock and Warrants
trade on the Nasdaq under the symbols “GRML” and “GRMLW” respectively.

Our Research Pipeline

We seek to develop essential medicines for the
treatment of chronic diseases — cancer, cardiovascular, and neurodegenerative disorders. Our cell and gene therapy platform consists
of proprietary technology programs (patents issued and pending) that include a gene therapy program that uses a gene therapy approach
to produce a therapeutic protein called “Klotho” inside the body to treat neurodegenerative diseases and other diseases of
aging (in-licensed pending patent applications from UAB). Next, our clinical-stage generic/biosimilar technologies consist of (a) “off-patent”
portfolio of generic drugs (b) and “off-patent” biosimilar biologics (in-licensed from RLS).

The Company may develop all technologies, or it
may decide to sell or partner and out-license certain technologies with other companies.

The gene therapy product candidates are in the
pre-clinical stage of development. The Company plans to seek market approval in countries where we have issued and/or pending patents,
to include the U.S., Canada, Europe, China, and other viable markets.

Our primary focus is the advancement of a sustainable
portfolio of cell and gene therapy product candidates for age-associated neurologic diseases, both rare “orphan diseases”
as well as diseases in larger patient populations. The following table describes our α-Klotho product pipeline.

Cell and Gene Therapy — α-Klotho
gene

We have licensed from the Autonomous University of Barcelona (UAB)
the exclusive, worldwide rights to commercialize the α-Klotho sequence called s-KL and know-how for gene therapy and cell therapy
against all neurodegenerative diseases — a longer-term, higher-risk program, but potential high reward product development
opportunities.

1

The world’s population is aging rapidly
and preserving brain health and body strength have emerged as major biomedical challenges. Without novel interventions, over 80 million
people worldwide will suffer from memory problems or physical disabilities resulting from aging and age-related disease by 2040. Aging
has been proven to be the primary risk factor for failing cognition and the development of Alzheimer’s disease. Biologic or genetic
regulators of aging might be harnessed for the treatment and prevention of cognitive decline, depression, dementia, and sarcopenia (loss
of muscle).

Because aging is the primary risk factor for cognitive
decline, and an emerging health threat to aging societies worldwide, providing medicine like Klotho may, if proven, be able to counteract
cognitive decline and neurodegenerative diseases such as Alzheimer’s disease. Alzheimer’s disease (“AD”) is the
most common type of senile dementia worldwide. Klotho is named after the Greek goddess who “spins the thread of life.”
A decade ago, Dr. Kuro-O et.al. established a transgenic knock-out mouse without the Klotho gene. The mice were normal
at birth but started to show multiple aging-related disorders such as arteriosclerosis, osteoporosis, skin atrophy, loss of cognition,
hyperphosphatemia, pulmonary emphysema, ectopic calcifications in the lung, heart and skin, depletion of Purkinje cells in the brain,
and infertility after 3-4 weeks—the α–kl+ mouse died at around 2 months whereas the normal mouse lives to around
2-3 years.

The Klotho proteins produced by the Klotho
gene is reported to significantly decline with age, especially in the brains of patients with Alzheimer’s and animals genetically
engineered to have AD. The in vitro treatment with Klotho protein of neurons taken from mouse spinal cords can prevent neuronal
death from toxic glutamate and beta-amyloid protein, while other studies have shown clearance of beta-amyloid plaques in animals treated
with the Klotho protein, so the utility of Klotho and s-KL in the treatment and prevention of AD must be explored.

Therapeutic approaches at increasing Klotho protein
levels might theoretically prevent neuronal degeneration if treatment is started at the beginning of disease and advance the outcome for
AD patients. Recently, our investigator discovered a membrane-bound and a circulating secreted form (“secreted-Klotho” or
“s-KL”) of this protein hormone that is naturally found in humans and encoded by the Klotho gene at a human chromosome locus
of 13q12. We intend on investigating whether this hormone can play a role in protecting brain neurons from degeneration, clearing beta-amyloid
plaques, controlling the insulin/insulin-like growth factor signaling pathway, delaying osteoporosis, lowering the incidence of cardiovascular
disease, affecting kidney disease, and generally increasing the life-span of humans and other mammals who have the gene.

The upregulation of cerebral Klotho expression
using a gene therapy approach has been evaluated by several investigators including our Chief Scientific Advisor and inventor, Dr. Miguel
Chillon Rodriguez and by Dr. Jun-Rong Du. In pioneering work, Chillon Rodriguez and Masso et.al. (“α-Klotho Isoforms
Have Different Spatio-Temporal Profiles in the Brain during Aging and Alzheimer’s Disease”, PLOS ONE OI:10.1371/journal.pone.0143623
November 24, 2015) demonstrated an alternative RNA splicing variant of the Klotho gene which produced a stable, truncated isoform
of the hormone (“s-KL”) which, after intracranial, intrathecal, and intravenous administration, can be detected directly as
protein and mRNA in mouse protein tissue extracts. This work also showed a strong correlation (p-value of 0.001) between high expression
levels of the two Klotho transcripts, full-length, membrane-bound protein (“m-KL”) and s-KL, in brain and healthy cognitive
status while aging. Significantly, the secreted s-KL isoform is exclusively (over 90%) found in brain, while m-KL is mostly expressed
in kidney and to a lesser extent in brain. This suggests s-KL may have an important role in the brain and overall brain health. More detailed
studies revealed that the s-KL protein could be detected in different murine brain regions involved in learning and memory processes,
such as prefrontal cortex, motor cortex and hippocampus. They found that the Klotho gene product, particularly the s-KL isoform, is a
neuroprotective protein in mice and we believe that the loss of this gene product leads to the onset and/or progression of cognitive deficits
associated with aging. By modifying and increasing s-KL levels in the brains of adult C57Bl/6J male mice, the AAV9 gene therapy vectors
deliver the Klotho gene construct and the expression of the Klotho protein is increased and cognition is improved. AAV9 vector is a recombinant
adeno-associated virus serotype 9 delivery vector for optimized delivery (“tropism”) to the central nervous system (CNS) tissues.
Dr. Chillon Rodriguez will serve as Co-Chair of the Combined Company’s Scientific Advisory Committee.

Chillon Rodriguez and others have concluded that
naturally occurring Klotho is a gene regulator of aging, increasing life expectancy when Klotho is overexpressed by the gene, and that
inhibition of the gene can accelerate the development of aging phenotypes. In mice, expression levels of the secreted isoform Klotho (s-KL)
are very high in the brain, suggesting that s-KL activity may have an important role in the nervous system. The functional relevance at
the behavioral level of modifying s-KL levels in the aging brain was studied using the AAVrh10 and AAVrh9 vectors with tropism to the
CNS to deliver and sustain expression of Klotho s-KL protein in 6- and 12-month-old normal C57BL/6J mice. Study results demonstrated in
animals that 6 months after a single injection of s-KL into the central nervous system, long-lasting and quantifiable enhancement
of learning and memory capabilities are found. More importantly, cognitive improvement was observed in very elderly, 18-month-old mice
treated once, at 12 months of age. These findings support the therapeutic potential of s-KL as a treatment for cognitive decline
associated with aging.

2

Dr. J-R Du and associates have also successfully
tested the utility of Klotho gene replacement in treatment and prevention of cognitive disorders in mice. As we and many others have studied
one theory of Alzheimer’s disease pathology, Alzheimer’s disease is characterized by the presence of amyloid-beta (“A-β”)
plaques. Du et.al. previously reported that Klotho lowered A-β levels in the brain and protected against cognitive deficits in amyloid
precursor protein/presenilin 1(APP/PS1) transgenic mice models. They induced intracerebral Klotho overexpression in 13-month-old APP/
PS1 mice by injecting lentivirus that carried full-length mouse Klotho cDNA in the lateral ventricle of the brain. They examined the effects
of Klotho protein overexpression in the brain on cognition, A-β burden, A-β-related neuropathology, microglia transformation,
and A-β transport systems in vivo in this animal model. Additionally, they investigated the effects of Klotho protein on A-β
transport at the blood — cerebrospinal fluid barrier by knocking down (inhibiting) Klotho production in primary human
choroid plexus epithelial cells (HCPEpiCs).

Dr. Du found that upregulation of Klotho
levels in the brain and serum significantly ameliorated A-β burden, neuronal and synaptic loss, and cognitive deficits in aged APP/PS1
“AD mice”. Klotho gene therapy treatment significantly inhibited NACHT, LRR, and PYD domain-containing protein 3 (NLRP3) and
the subsequent transformation of microglia to the M2 type that may enhance microglia-mediated A-β clearance. Meanwhile, Klotho overexpression
also regulated A-β transporter expression, which may promote A-β transporter-mediated A-β clearance. Moreover, the ability
of human HCPEpiCs to transport A-β in vitro was also significantly impaired by Klotho gene and protein knockdown. Given the
observed neuroprotective effect of Klotho overexpression, the present findings provide convincing evidence that Klotho gene and cell therapy
should be further investigated as a potential therapeutic for Alzheimer’s disease and other neurologic diseases.

Amyotrophic lateral sclerosis (ALS) is a devastating
neurodegenerative disorder of the motor system characterized by the degeneration of motoneurons (MNs) and muscle denervation. This results
in progressive muscle weakness ultimately leading to paralysis and patient death within 2-5 years of diagnosis, often due to respiratory
failure1. Sporadic ALS (sALS) accounts for the majority of the cases, with only 5-10% being familiar forms (fALS) caused by inherited
mutations. Over 30 genes have been linked to ALS and several animal models carrying mutations in these genes have been developed. The
transgenic mouse featuring a high copy number of the human SOD1 gene with a glycine-to-alanine transition at the 93rd codon referred to
as SOD1G93A being the most extensively used.

Multiple pathological mechanisms underlying the
ALS disease process have been identified using ALS animal models. These mechanisms include oxidative stress, inflammation, excitotoxicity,
mitochondrial dysfunction, impaired proteostasis, endoplasmic reticulum stress, and RNA disturbances. The interplay of these factors likely
results in the selective death of motor neurons (MNs). Promising preclinical and clinical trials targeting a single or a limited number
of disease mechanisms have largely failed. A growing viewpoint supports a more integrated approach by targeting multiple mechanisms simultaneously.
We propose the therapeutic exploration of the pleiotropic RNA splice variant called secreted protein α-Klotho (s-KL), which counteracts
several mechanisms involved in neurodegeneration, such as oxidative stress, demyelination, senescence, inflammation, and synaptic dysfunction.
KL and s-KL are also critical for promoting muscle regeneration and avoiding fibrosis.

Results published recently by the Barcelona group
have been promising (reference Bosch et.al., Research Square, titled “Muscle-targeted Klotho Gene Therapy Ameliorates ALS Hallmarks
by Addressing Multiple Disease Mechanisms in SOD1G93A Mice”, DOI: https://org/10.21203/rs.3.rs-4510655/V1), Thus, the
antiaging protein variant of α-Klotho (s-KL) exhibits neuroprotective and myoregenerative properties, mitigating age-related neurodegeneration
and promoting muscle regeneration in this mouse model of ALS. The study showed that s-KL harnesses its multifactorial, pleiotropic properties
in the context of Amyotrophic Lateral Sclerosis (ALS), a motoneuron disease lacking effective treatments due to its diverse pathophysiological
mechanisms. By overexpressing secreted KL in skeletal muscles of SOD1G93A mice with myotropic viral vectors we aimed to directly
protect muscles and exert a paracrine effect on motoneuron (MN) terminals. Secreted KL preserved MNs and neuromuscular junctions, and
mitigated glial reactivity, resulting in maintained muscle mass, improved neuromuscular function, delayed disease onset, and extended
survival. Even when administered during symptomatic stages, s-KL slowed down ALS progression. Transcriptomic and proteomic studies in
muscles revealed significant correction of pathophysiological mechanisms involved in ALS disease, unveiling novel roles for KL. These
findings highlight the potential application of muscle-secreted KL in ALS regardless of its origin and suggest broader therapeutic implications.

3

We are working with UAB scientists to advance
our programs focused on neurodegenerative and age-related disorders — Alzheimer’s and ALS — all
based on the Klotho gene and the s-KL protein. In addition to our product pipeline candidates, we are building a platform of next-generation
gene and cell delivery technologies, to optimize our AAV-based, Lentivirus-based, and lipid-based gene therapies. Much of this work will
be funded by the Sponsored Research Agreement with UAB in Barcelona.

Supplementation of this human Klotho protein by
biologic infusion or by gene therapy may potentially treat many diseases and pathologies. Alzheimer’s disease is extremely important,
and certainly an urgent medical need, however the Klotho protein may be effective in heart disease, blood vessel diseases, kidney diseases,
and other diseases or problems associated with aging. Our plans are focused on these important programs, but new programs may evolve from
this core technology, such as gene-based therapy delivering other proteins of interest. We are developing a gene therapy approach to introduce
genetic material like plasmid DNA or mRNA into the body in order to induce production of a therapeutic protein inside the patient’s
body — we envision either blocking factors causing the disease, replacing human genes that have shut down protein production,
or replacing genes that have mutated to produce aberrant proteins that do not function at all. Through gene therapy, or gene-modified
stem cells, we aim to fix these problems.

In gene therapy, the measurement of the concentration
of the gene-transcribed protein is important. Thus, it is important to measure the decrease or increase in blood and tissue levels of
the Klotho gene-transcribed protein isoforms as part of our gene therapy development program. Of particular importance in our gene therapy
program is the separation and measurement of the three Klotho protein isoforms produced by the Klotho gene and the two Klotho protein
metabolites. The human Klotho-gene encodes a type I transmembrane protein (1012 amino acids, 140 kDa) with a large extracellular
domain and a short intracellular portion (10 amino acids), called “membrane Klotho” or m-KL predominantly expressed
in the renal tubules and in the parathyroid glands. The extracellular domain of Klotho cleaved from the m-KL and is found as a circulating
factor called “plasma Klotho” or p-KL (1002 amino acids, 135 kDa) that circulates and is detectable in blood and
in lesser extent in other biological fluids. The p-KL is further metabolized to two nearly identical monomers (450 amino acids each,
70 kDa) called KL1 and KL2. The Klotho gene also produces a RNA splice variant (550 amino acids, 63 kDa) called “secreted-Klotho”
or s-KL. The s-KL isoform is predominantly produced by cells in the brain and CNS.

Studies addressing Klotho tissue concentrations
used a commercial test kit, an antibody-based ELISA assay sold by IBL Laboratories (IBL Japan and IBL-America), however the ELISA assay
currently available is unable to differentiate the three isoforms, s-KL, m-KL, p-KL, and the KL1 and KL2 metabolites (reference L. Pedersen
et al. / Clinical Biochemistry 46 (2013) 1079 – 1083). The antibody used in IBL’s commercial ELISA assay recognizes
the same epitope sequence in the amino-terminal region of all the protein isoforms, however the key differences of 13 amino acids
are found in the carboxy-terminal end of the proteins. This difference is especially true of the s-KL isoform compared to the p-KL and
KL1 domains, which differ by a 13 amino acid “tail” found on s-KL. The lack of specificity of the current commercial
assays has motivated us to develop a new assay method.

Therefore, as part of the research and development
(R&D) program, we plan to develop and validate an assay to separate and individually measure all Klotho isoforms and metabolites of
p-KL. We will compare our assay to the IBL ELISA assay and establish assay specific reference intervals in healthy and aged adults.
In addition, several other clinical and laboratory characteristics will be determined in the cohorts and compared to the levels of the
circulating Klotho isoforms. The Klotho isoform assay will be used to identify subjects with low total Klotho and evaluate the contribution
of each Klotho isoform in the disease status of each subject. The specific measure of the s-KL isoform produced as a result of the Klotho
gene therapy product candidate will be analyzed and reported. If the assay developed as a research test method (e.g., ELISA, SDS/Western
blot, capillary electrophoresis) becomes a clinical biomarker of disease, the Company will attempt to introduce this test as a commercial
diagnostic. Our scientists will develop isoform-specific monoclonal antibodies and utilize a separation technology such as Western blot
analysis, capillary electrophoresis or high-performance liquid chromatography and mass spectrometry (LC/MS) to bring this assay online.

4

We have in-licensed this key technology from UAB — with
successful and encouraging data from animal models we hope to study and treat these aging-related diseases. In some studies, the
gene therapy that we are researching has shown evidence that it may eliminate the disease-causing factors e.g., clearance of beta-amyloid
plaques and “tau tangles” from the brain in AD or prevention of mitochondrial oxidative stress and neuronal damage in ALS.
We have not yet submitted any IND applications in connection with any gene therapies.

Our two lead gene therapy product candidates are
KLTO-101 (AAV9-CMV-sKL) for the treatment or prevention of Alzheimer’s disease, and KLTO-202 (AAVmyo-Des-sKL) gene therapy product
for treatment and prevention of Lou Gehrig’s disease (amyotrophic lateral sclerosis or “ALS”). Within the next 12 months,
we plan to complete the animal toxicology package for KLTO-202 and the submission of an Investigational New Drug application (IND) to
the FDA in 2025 for permission to start the first-in-human Phase I “Compassionate Use” study of KLTO-202 in late-stage
ALS patients. Likewise, the pre-clinical development program for KLTO-101, similar to that of KLTO-202, will follow behind the development
of KLTO-202 by six to nine months. We plan to find a corporate partner to help in the development of KLTO-101 for the Alzheimer’s
disease indication. We may also bring the recombinant s-KL protein into clinical trials to evaluate the safety and efficacy of infusing
the protein into normal healthy volunteers for pharmacology (“PK/PD”) and safety, and then in select patient populations.
Our KLTO-101 and KLTO-202 product candidate are dependent upon the s-KL variant and the intellectual property position around the RNA
splice variant. We have in-licensed the exclusive rights to patents and patent applications to treat neurodegenerative diseases with patent
approvals in the U.S. (US Patent No. 12,036,268), Europe, China, Hong Kong, and pending in Canada. Patent applications (PCT Application
No. PCT/EP2023/059677) filed in the major markets covering the composition and use of s-KL gene therapies to treat neuromuscular diseases
like ALS are scheduled for review by the examiners in these countries.

Also, our team will pursue new innovations in
vector design and delivery to optimize our investigational gene therapy products for safety, potency, durability, and clinical response.
We will continue to build integrated internal development capabilities from product development through commercialization and focus on
accelerating the pace of product development in the clinic. As part of our ongoing business strategy, we continue to explore potential
opportunities to acquire or license new product candidates as well as opportunities for partnership or collaboration on our existing products
in development.

Intellectual Property — Our
Licenses and Technology

We have entered into other license agreements,
some exclusive, covering the key technologies upon which our research and product development efforts will be based as outlined in the
programs below.

Gene and Cell Therapy Programs

UAB Agreements:

1) On January 20, 2022, we entered into
an exclusive, worldwide, royalty-bearing license with Universitat Autònoma de Barcelona (“UAB”) and
Institució Catalana De Recerca I Estudis Avançats (“ICREA”) to develop and commercialize certain
patent rights, technology and know-how in the field of secreted-Klotho splicing variant diagnostics and therapeutics to prevent or
treat neurodegenerative diseases and other age-related pathologies of the central nervous system. The patents (issued in the US,
Europe and China) and pending patent applications support our KLTO-101 and KLTO-202 product candidates with claims directed to
methods of treatment and compositions of matter. The issued patents and any applications granted on a pending application would be
enforceable until 11/21/2036, absent any patent term adjustment or extension. The patent family includes:

Country

Application/Publication

Status

US

12,036,268

Issued

EU

EP3377091B1

Issued

Canada

CA3005398A

Pending

China

CN108289933B

Issued

China (DIV)

CN 117126829 A

Pending

Hong Kong (based upon China DIV)

42024089833.8

Pending

Hong Kong

HK1259628A1

Issued

Japan

JP2019501643A

Pending

US (CON)

18/773,164

Pending

US (DIV)

18/773,181

Pending

5

The license includes the right to sublicense.
The term of the license extends until the expiration of the last to expire Royalty Term, on a product-by-product, country-by-country basis,
unless terminated earlier pursuant to the terms of the agreement. “Royalty term” means the period of time, product-by-product,
country-by-country, beginning on the first commercial sale and extending to the later of (i) last patent to expire such Product in
such country, or (ii) indefinitely (if no patent right covers such Product in such country), provided that no generic equivalent
or biosimilar product is commercialized in such country. UAB and ICREA reserve the rights to use the licensed rights for internal non-commercial
research and to allow other academic institutions to use the licensed rights for internal non-commercial research.

As set forth in the agreement, we are responsible
for all costs associated with the research, development, and commercialization of the Products, including entering into a Sponsored Research
agreement with Dr. Chillon’s and Dr. Bosch’s laboratory at UAB (discussed below).

As consideration for the license, we paid an upfront
fee corresponding to prior patent costs. We are also required to pay an annual patent maintenance fee of 10,000€ as well as certain
milestone payments and a royalty of 3% of Net Sales, as that term is defined in the agreement, in countries wherein patent rights exist,
otherwise the royalty is 1.5% of Net Sales. Separate royalty amounts exist in the event we sublicense any rights granted. The milestone
payments are 35,000 euro upon IND achievement, 250,000 euro upon completion of Phase 1 study, 500,000 euro upon completion of Phase 2
study, 1,200,000 euro upon completion of Phase 3 study and 2,000,000 euro upon first commercial product approval in the U.S., EU
or Japan. We are also responsible for all ongoing patent maintenance, protection, and management costs.

The parties may terminate the agreement in the
event of a material default by the other party of any terms, conditions, obligations, and undertakings upon written notice which is not
cured within three months from such notice. UAB/ ICREA may terminate if we (1) abandon or discontinue use of the licensed rights
for more than one year, (2) illegally use the licensed rights, including violations of the Universal Declaration of Human Rights,
(3) fail to make royalty payments or underreporting such payments in excess of 15% in two different years; (4) challenge
the validity or enforceability of the licensed patent rights; or (5) fail to achieve product development stages set forth in the
agreement. We may terminate the agreement at any time with 90 days’ notice.

2) On December 20, 2022, we entered into
an exclusive, worldwide royalty-bearing license with UAB ICREA, Consorcio Centro de Investigación Biomédica en Red (“CIBER”),
and Fundació Hospital Universitari Vall D’hebron — Institut de Recerca (“VHIR”) to develop and
commercialize certain patent rights, technology and know-how in the field of Neuronal (central nervous system) or Neuromuscular (peripheral
nervous system) Diseases or Disorders. The pending patent application supports our KLTO-202 product candidate with claims directed to
methods of treatment and compositions of matter. If granted, such patent would be enforceable until 4/16/2043, absent any patent term
adjustment or extension. The patent family includes:

Country

Application Number

Filing date

Status

US

63/330,684

April 26, 2022

Expired

US

18/299,989

April 13, 2023

Pending

PCT

PCT/EP2023/059677

April 13, 2023

Pending

Korea

10-2024-7036732

April 13, 2023

Pending

China

202380035280.7

April 13, 2023

Pending

India

202427083283

April 13, 2023

Pending

Japan

2024-560761

April 13, 2023

Pending

EU

23720252.8

April 13, 2023

Pending

Hong Kong

62025104793.7

April 13, 2023

Pending

Canada

3246384

April 13, 2023

Pending

The license includes the right to sublicense.
The term of the license extends until the expiration of the last to expire Royalty Term, on a product-by-product, country-by-country basis,
unless terminated earlier pursuant to the terms of the agreement. “Royalty term” means the period of time, product-by-product,
country-by-country, beginning on the first commercial sale and extending to the later of (i) last patent to expire such Product in
such country, or (ii) indefinitely (if no patent right covers such Product in such country), provided that no generic equivalent
or biosimilar product is commercialized in such country. UAB/ICREA/CIBER/VHIR reserve rights to use the licensed rights for internal non-commercial
research and to allow other academic institutions to use the licensed rights for internal non-commercial research.

As set forth in the agreement, we are responsible
for all costs associated with the research, development, and commercialization of the Products, including entering into a Sponsored Research
agreement with Dr. Bosch and/or Dr. Chillon’s laboratory at UAB to perform R&D activities (discussed below).

6

As consideration for the license and in the event
that our January 20, 2022 license discussed above is terminated, then we must pay an annual patent maintenance fee of 10.000€. We
will also be obligated to pay certain milestone payments and a royalty of 3% of Net Sales, as that term is defined in the agreement, in
countries wherein patent rights exist, otherwise the royalty is 1.5% of Net Sales. Separate royalties exist in the event we sublicense
any rights granted. The milestone payments are 35,000 euro upon IND achievement, 250,000 euro upon completion of Phase 1 study, 500,000
euro upon completion of Phase 2 study, 1,200,000 euro upon completion of Phase 3 study and 2,000,000 euro upon first commercial
product approval in the U.S., EU or Japan. The agreement has an anti-stacking clause in the event that Products are covered by patents
or technology from both this agreement and our 1/20/2022 license discussed above, then we are only obligated to pay royalties of such
Product pursuant to this agreement. We are also responsible for all ongoing patent maintenance, protection, and management costs.

The parties may terminate the agreement in the
event of a material default by the other party of any terms, conditions, obligations, and undertakings upon written notice which is not
cured within three months from such notice. UAB/ICREA/CIBER/VHIR may terminate if we (1) abandon or discontinue use of the licensed
rights for more than one year, (2) illegally use the licensed rights, including violations of the Universal Declaration of Human
Rights, (3) fail to make royalty payments or underreporting such payments in excess of 15% in two different years; (4) challenge
the validity or enforceability of the licensed patent rights; or (5) fail to achieve product development stages set forth in the
agreement. We may terminate the agreement at any time with 90 days’ notice.

3. As mentioned above, and in accordance with
our UAB licenses, we entered into a Sponsored Research Agreement with UAB on January 24, 2022, under which the research will be directed
and supervised by the Principal Investigators, Dr. Assumpcio Bosch and Dr. Miguel Chillon having a two year budget of 623,100
euros.

University of Heidelberg Agreement:

On March 5, 2023, we entered into a non-exclusive,
worldwide license with University of Heidelberg, Germany for innovations related to certain modified AAV capsid polypeptides in the field
of neuromuscular disorders. The pending patent applications support our KLTO-202 product candidate with claims directed to methods of
treatment and compositions of matter. If granted, such patent would be enforceable until 4/26/2039, absent any patent term adjustment
or extension. The patent family includes:

Country

Application Number

Status

PCT

PCT/EP2019/060790

Nationalized

CA

3,097,375

Pending

US

17/051,123

Pending

EP

3784288

Pending

AU

2019258830

Pending

JP

2020-560127

Pending

CN

201980028398

Pending

The license includes the right to sublicense.
The term of the license extends until the expiration or cancelation of each patent in each licensed jurisdiction.

As consideration for the license, we are required
to pay the licensor certain milestone payments and a royalty of 2% of Net Sales, as that term is defined in the agreement. The milestone
payments are 150,000 euro upon execution of the license, 150,000 euro within 60 days of start of Phase 1 clinical trial, and
200,000 euro within 60 days of start of Phase 3 trial.

The University of Heidelberg may terminate the
agreement (1) in the event of a material default by us upon written notice which is not cured within 60 days from such notice,
(2) with 10 days’ notice if we cease operations, file for bankruptcy, dissolution or make an assignment to creditors,
or (3) if we challenge the licensed patents. We may terminate the agreement at any time with 120 days’ notice.

7

Biosimilars Program

Reliance Life Science Agreements:

On November 27, 2014, we entered into an
exclusive, royalty bearing License Agreement with Reliance Life Sciences Private Limited (“RLS”) to develop, manufacture finished
Product(s) based on an API for a finished biosimilar to Roche’s rituximab (MabThera®/Rituxan®),
trastuzumab (Herceptin®), and bevacizumab (Avastin®) in the Field of the treatment of cancer, autoimmune
diseases, neovascularization diseases, and other diseases or conditions that may be treated by the Products or derivatives (e.g. antibody-drug
conjugates) of the Products. The license permits our exclusive use in the Territory of RLS’s technology (including RLS’s Know-how
concerning manufacturing and RLS regulatory data, including RLS’s dossier for India). The licensed Territory is limited to North
America, Europe, and Israel. Future patents related to the Product would be included in the agreement, however there were no RLS patents
in existence as of the execution of the agreement.

As consideration we previously paid RLS upfront
license fees of $300,000 and are required to pay the licensor certain milestone payments and a royalty of 5% of Net Sales, as that term
is defined in the agreement. The milestone payments are per Product of: $250,000 upon submission to the FDA, $100,000 upon submission
of Market Authorization to European Medicines Agency (“EMA”), $3,000,000 upon receipt of Marketing Authorization from US Food
and Drugs Administration, $2,000,000 upon approval in Europe by EMA, $500,000 upon market authorization in Canada, $300,000 upon market
authorization in Mexico, $200,000 upon market authorization in Israel, $2,000,000 upon Net Sales of $20 million or more in US, $1,000,000
upon Net Sales of $10 million or more in Europe, and $10,000,000 upon achieving Net Sales in any country of over $100 million.
The license includes the right to sublicense. In the event we sublicense rights under this agreement will subject us to alternate sublicense
milestone fees.

The term of the license is for a period of 10 years
after Market Authorization on a country-by-country basis, which automatically extends for another 10 years unless notice not to extend
is received 180 days prior to the end of the term.

The parties may also terminate the agreement at
any time if (1) the other party breaches the agreement and fails to cure the breach within 60 days of notice of such breach,
(2) bankruptcy of the other party, or (3) a change in the law so that performance by a party becomes onerous or inexpedient.
We may also terminate this agreement on a product-by-product basis upon 60 days written notice. In the event that we fail to make
any payment, RLS may terminate the agreement by giving 30 days prior written notice.

Pursuant to the license, RLS will exclusively
provide us with the API pursuant to a separate manufacturing and supply agreement that the parties executed on November 27, 2014.

On November 27, 2014 the parties executed
amendments to the above license and manufacturing and supply agreements to include development and manufacture of cetuximab (Erbitux®,
BMS/Lilly/Imclone) under the same terms, exclusive rights and territories. As consideration for the additional rights set forth in the
amendment, we paid RLS upfront license fees of $150,000 and are required to pay the licensor certain milestone payments and a royalty
of 5% of Net Sales, as that term is defined in the agreement. The milestone payments are: $250,000 upon submission to the FDA, $100,000
upon submission of Market Authorization to EMA, $3,000,000 upon receipt of Marketing Authorization from US Food and Drugs Administration,
$2,000,000 upon approval in Europe by EMA, $500,000 upon market authorization in Canada, $300,000 upon market authorization in Mexico,
$200,000 upon market authorization in Israel, $2,000,000 upon Net Sales of $20 million or more in US, $1,000,000 upon Net Sales of
$10 million or more in Europe, and $10,000,000 upon achieving Net Sales in any country of over $100 million. The license includes
the right to sublicense. In the event we sublicense rights under this agreement will subject us to alternate sublicense milestone fees.

Avastin® and Rituxan®/Mabthera®
are the brand names of bevacizumab and rituximab. Both Genentech in the U.S. and Roche in Switzerland manufacture these antibodies.
Rituximab is marketed as Rituxan® in the US and Japan, and branded as Mabthera® outside the US and Japan.

The approved indications for these antibodies
are as follows:

Rituxan® (rituximab) is indicated
for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL) — Relapsed or refractory, low-grade or follicular,
CD20-positive, B-cell NHL as a single agent, Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line
chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent
maintenance therapy, Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line
CVP chemotherapy, Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy
regimens. Rituxan is indicated for the treatment of pediatric patients aged 6 months and older with mature B-cell NHL and mature
B-cell acute leukemia (B-AL), Previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma
(BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. Rituxan is indicated for the
treatment of adult patients with previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination
with fludarabine and cyclophosphamide (FC).

Rituxan, in combination with methotrexate, is
also indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate
response to one or more TNF antagonist therapies. Rituxan is also indicated in combination with glucocorticoids, is indicated for the
treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis)
and Microscopic Polyangiitis (MPA). Rituxan is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris
(PV).

8

Bevacizumab (Avastin®) is indicated
for the treatment of the following indications: Stage III or IV ovarian cancer (OC) after primary surgery — Avastin, in
combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III
or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. Recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer (rOC) -Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin,
or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary
peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or
with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive
recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Persistent, recurrent, or metastatic cervical cancer (CC)
— Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients
with persistent, recurrent, or metastatic cervical cancer.

Metastatic renal cell carcinoma (mRCC) —
Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma.

Recurrent glioblastoma (rGBM) — Avastin
is indicated for the treatment of recurrent glioblastoma in adults.

First-line non-squamous non-small cell lung cancer
(NSCLC) — Avastin, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable,
locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer.

Metastatic colorectal cancer (MCRC) — Avastin,
in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with
metastatic colorectal cancer. Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy,
is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line bevacizumab
product-containing regimen. Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer.

Hepatocellular carcinoma (HCC) — Avastin,
in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma
who have not received prior systemic therapy.

Competition

There are three classes of drugs that are used
to help with the physiologic effects of advancing cognitive disorders and dementia, (1) Cholinesterase inhibitors — donepezil
(Aricept), rivastigmine (Elexon) and galantamine (Razadyne), (2) the Glutamate regulators — memantine (Namenda) and (3) the
combination of cholinesterase inhibitor and glutamate regulator called Namzaric) donepezil plus memantine. Companies selling these generic
and branded drugs include Allergan, Eisai Co., LTD, Novartis AG, Daiichi Sankyo Company, Limited., Merz Pharma, Pfizer Inc., Johnson &
Johnson Services, Inc., H. Lundbeck A/S, Biogen, AstraZeneca, F. Hoffmann-La Roche Ltd, VTV Therapeutics, TauRx, Eli Lilly and
Company, Teva Pharmaceutical Industries LTD, Ono Pharmaceutical Co., LTD, AC Immune, AB Science, AbbVie Inc., Bristol-Myers Squibb Company,
Takeda Pharmaceutical Company Limited., Bayer AG, and among others.

The anti-amyloid antibodies, aducanumab (Biogen:Aduhelm)
and lecanumab (Lilly:Leqembi) were FDA approved and will potentially compete with Roche, Bristol-Myers/Celgene, and others developing
anti-amyloid antibodies. Recently, aducanumab (Biogen:Aduhelm) was removed from the market due to lack of effectiveness and serious side
effects. The long-term prognosis of anti-amyloid antibodies is still questionable based on the failure of so many anti-amyloid product
candidates. There remains multiple large and early-stage pharma companies pursuing therapeutics against Alzheimer’s disease. Very
few companies mention the use of Klotho or Klotho gene therapy on their websites and/or in press releases. ADvantage Therapeutics mentions
Klotho in the website, but they appear to be working on AD04™ and suggest it may act as an immunomodulator, stimulating and/or regulating
the immune system to reduce AD pathology. There is mention of mRNA therapies, but this vaccine adjuvant AD04 appears to be their main
product candidate, and no description of their Klotho program. They may be testing Klotho as an immunomodulator. Another company, Bioviva,
says on their website that “Klotho has been shown to reverse beta- amyloid plaques” but gives no details on their stage of
product development. One of their team members, George Church, published an article on full-length Klotho m-KL about 10 years ago,
so it may be full-length Klotho. Bioviva does not mention Klotho or Klotho product stage of development at their website.

To the best of our knowledge, there is no direct
competition in ALS, AD, PD, or other neurodegenerative disorders involving the human s-KL Klotho gene or the s-KL protein. Two companies,
Klotho Therapeutics and Klogenix, were formed many years ago but the management teams could not raise capital and they are now defunct.
Klothea BIO is a preclinical stage biotechnology company developing mRNA solutions to enhance the secretion of Klotho.

Biosimilar Competition

We will face competition in the US, European and
other markets from the innovator brand in that market, from biosimilars already approved in those markets, and from biosimilars still
in development in those markets. Major players in the rituximab biosimilars market are Pfizer Inc., Mylan Inc., Amgen Inc., Teva Pharmaceutical
Industries LTD, and Celltrion Healthcare Co. LTD, Sandoz International GmbH, Reliance Life Sciences, C.H. Boehringer Sohn AG & Co.
KG, BioXpress Therapeutics SA, and Intas Biopharmaceuticals LTD There are two other Avastin biosimilars, Mvasi (bevacizumab-awwb), co-developed
by Amgen and Allergan, and Pfizer’s Zirabev (bevacizumab-bvzr).

In Europe, due to immediate acceptance by physicians
and government agencies of potential savings due to the price competition of biosimilars, the prices of the innovator’s products
came down by 30%-40% or more because of the lower retail prices of the biosimilar product once approved by EMA, whereas in the U.S., biosimilar
products approved by FDA are priced at nearly the same price of the innovator’s product. With improving acceptance of biosimilar
products in the U.S., the prices of both the biosimilar and innovator’s products are decreasing, and significant savings are realized
by the insurance companies and other payors in the U.S.

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Cell and Gene Therapy Competition — Configured
for specific rare diseases

Gene Therapy of Alzheimer’s

Researchers at University of California San Diego
School of Medicine have launched a first-in-human Phase I clinical trial (March 2021) to assess the safety and efficacy of a
gene therapy to deliver a key protein into the brains of persons with Alzheimer’s disease (AD) or Mild Cognitive Impairment (MCI),
a condition that often precedes full-blown dementia. The protein, called brain-derived neurotrophic factor (BDNF), is part of a family
of growth factors found in the brain and central nervous system that support the survival of existing neurons and promote growth and differentiation
of new neurons and synapses. BDNF is particularly important in brain regions susceptible to degeneration in AD. In previous
published research, principal investigator Mark Tuszynski, MD, PhD, professor of neuroscience and director of the Translational Neuroscience
Institute at UC San Diego School of Medicine has helped to bring this approach forward. No one else to our knowledge is actively pursuing
this approach for AD or ADAD.

The leading competitor in Klotho gene therapy
is Unity Biotechnology, a San Francisco Bay area startup biotechnology company that develops drugs which target senescent cells. Their
website claims the company’s products in development include UBX1325 that targets Bcl-xL, a mechanism to eliminate senescent cells
in age-related eye diseases, and UBX1967, a preclinical product targeting ophthalmologic diseases. They claim to be in “lead optimization”
of a Klotho product candidate, but they have not reported any data and no pre-clinical or clinical trials data published to date. Unity
recently licensed the Dubal Klotho technology to two of their publication authors who formed Jocasta Therapeutics, Inc. and a hedge fund
in Northbrook, IL, and no press releases have been published. They would be pursuing full-length protein therapy, m-KL or p-KL, and not
s-KL. Jocasta Therapeutics expects to file an IND in 2026.

Gene Therapy and Other Approaches to ALS

Gene therapy approaches to ALS are being pursued
using anti-sense oligonucleotides to block ataxin-2 (Biogen), and to try to produce Caveolin-1 (Eikonoklastes Therapeutics), which are
believed to be involved with innervation of muscles cells. Neurosense Therapeutics is conducting a clinical trial of a combination of
two pharmaceuticals, ciprofloxacin and celecoxib, an antibiotic and an anti-inflammatory, to try to reduce inflammatory reactions in the
muscles. Amylyx received approval by FDA of Relyvrio®, a combination of sodium phenylbutyrate (an aromatic fatty acid salt
used in urea cycle disorders) and taurursodiol (a bile acid used in treatment of gall stones and several other diseases including ALS).
Recently, Amylyx removed Relyvrio® from the market for lack of efficacy in follow-on studies. None of these potential agents
have shown significant clinical benefit and muscle-saving activity in human studies to date.

Gene Therapy for Parkinson’s Disease

Parkinson’s disease is a progressive neurodegenerative
disorder that is caused by the loss of dopamine signaling in the brain and results in the continual decline of motor control and quality
of life. While there is currently no cure for the disease, through dopaminergic strategies that temporarily increase dopamine levels in
the brain, patients see a short-term improvement in symptoms which wane with disease progression. AXO-Lenti-PD is the only investigational
gene therapy for Parkinson’s disease that delivers the three key genes (TH, CH1, and AADC) required for endogenous dopamine synthesis
in a single lentiviral vector. The goal of this one-time infusion is to restore steady, tonic levels of dopamine, potentially reducing
the need for daily L-dopa medication while stabilizing the disease to provide long-lasting benefits. Initial clinical data demonstrate
that a single dose of AXO-Lenti-PD “turns back the clock” for patients by improving motor function and activities of daily
living. AXO-Lenti-PD has been optimized from ProSavin, an earlier gene therapy for the treatment of Parkinson’s disease. The company
is currently evaluating AXO-Lenti-PD in a Phase 2 clinical trial (SUNRISE-PD) in patients with moderate to advanced Parkinson’s
disease. These companies have declared bankruptcy and none are in business.

Government Regulations

Regulations by governmental authorities in the
U.S. and other countries are a significant factor in developing manufacturing and marketing of our pharmaceutical products. The nature
and extent to which such regulation applies to us may vary depending on the nature of our product candidates. We anticipate that all of
our product candidates will require regulatory approval by governmental agencies prior to commercialization. Our product candidates are
subject to rigorous pre-clinical testing and clinical trials and other approval procedures of the FDA, and similar regulatory authorities
in Europe, Japan, and other countries. Various governmental statutes and regulations also govern or influence clinical trials, Chemistry,
Manufacture and Control (CMC) related to such product candidates and their marketing. The approval process and subsequent compliance with
related statutes and regulations require substantial time and capital commitment, and there can be no guarantee that approvals will be
granted.

In the United States, the FDA regulates pharmaceutical
and biological products under the Federal Food, Drug, and Cosmetic Act, or the FDCA, the PHSA, and regulations and guidance documents
implementing these laws. The FDCA, PHSA and their corresponding regulations govern, among other things, the testing, manufacturing, safety,
purity, potency, labeling, packaging, storage, record keeping, distribution, reporting, advertising, and other promotional practices involving
pharmaceutical products. Consent from the FDA is required before conducting human clinical testing of drug products. FDA approval of a
new drug application (NDA) or a biologics license application (BLA) also must be obtained before marketing a new drug or biological product.
The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes
and regulations require the expenditure of substantial time and financial resources.

10

U.S. New Drug Product Development Process

Any new drug or therapeutic biologic product must
be approved by the FDA before it may be legally marketed in the United States. FDA approval is also required before marketing an approved
drug product for a new indication or condition of use. The process required by the FDA before a new drug product candidate may be marketed
in the United States generally involves the following:

●
Completion of preclinical laboratory tests and in vivo studies in accordance with the FDA’s Good Laboratory Practice (GLP) regulations and applicable requirements for the humane use of laboratory animals or other applicable regulations;

●
Submission to the FDA of an investigational new drug (IND) application, which allows human clinical trials to begin unless FDA objects (issues a “clinical hold”) within 30 calendar days;

●
Approval by an independent institutional review board (IRB), reviewing each proposed clinical trial and clinical site before each clinical trial may be initiated;

●
Performance of adequate and well-controlled human clinical trials in accordance with the protocol contained in the approved IND and in accordance with the FDA’s Good Clinical Practice (GCP) regulations, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed product candidate for its intended use;

●
Preparation and submission to the FDA of a new drug application (NDA) for marketing approval that includes substantial evidence of safety and efficacy from results of nonclinical testing and clinical trials;

●
Review of the product by an FDA advisory committee, if applicable;

●
Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product candidate is produced to assess compliance with current Good Manufacturing Practice (cGMP) requirements and to assure that the facilities, methods and controls are adequate to preserve the product candidate’s identity, safety, strength, quality, potency and purity;

●
Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the NDA; and

●
Payment of user fees and FDA review and approval of the NDA.

The testing and approval process of product candidates
requires substantial time, effort, and financial resources. Satisfaction of the FDA’s pre-market approval requirements typically
takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease.
Before testing any product candidate in humans, the product candidate must undergo preclinical testing. Preclinical tests, also referred
to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity, and formulation, as well as in vivo animal studies
to assess the potential safety and activity of the product candidate and to establish a rationale for therapeutic use. The conduct of
the preclinical tests must comply with federal regulations and requirements including GLPs.

Concurrently with clinical trials, companies usually
must complete some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and must also
develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the
drug in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing
quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength,
quality and purity of the final drug product. Additionally, appropriate packaging must be selected and tested and stability studies must
be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

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A clinical trial sponsor must submit the results
of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed
clinical protocol, to the FDA as part of the IND. Some preclinical testing may continue even after the IND is submitted. The IND automatically
becomes active 30 calendar days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to a proposed
clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks, and places the clinical
trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial
can begin. The FDA also may impose partial or full clinical holds on a product candidate at any time before or during clinical trials
due to safety concerns or non-compliance. If the FDA imposes a clinical hold, trials may not begin or recommence without FDA authorization
and then only under terms authorized by the FDA. Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing
clinical trials to begin, or that, once begun, that issues arise that partially or fully suspend or terminate such studies.

Human Clinical Trials Under an IND

Clinical trials involve the administration of
the investigational product to healthy volunteers or patients under the supervision of qualified investigators which are generally physicians
not employed by, or under, the control of the trial sponsor. Clinical trials must be conducted under written study protocols detailing,
among other things, the objectives of the trial, subject selection and exclusion, the trial procedures, the parameters to be used in monitoring
safety, the criteria to be evaluated, and a statistical analysis plan. Each protocol and any amendments to the protocol must be submitted
to the FDA as part of the IND.

Further, clinical trials must be conducted in
accordance with federal regulations and GCP requirements, which include the requirements that all research subjects provide their informed
consent in writing for their participation in any clinical trial, as well as review and approval by an IRB at each study site participating
in the clinical trial or a central IRB. An IRB is charged with protecting the welfare and rights of trial participants and considers items
such as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated
benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject, or their
legal representative, reviews and approves the study protocol, and must monitor the clinical trial until completed.

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

●
Phase 1. The product candidate initially is introduced into a small number of healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early understanding of its value in treating patients. In the case of some product candidates for severe or life-threatening diseases, especially when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

●
Phase 2. The product candidate is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases and to determine dosage tolerance, optimal dosage, and dosing schedule.

●
Phase 3. Phase 3 clinical trials are commonly referred to as “pivotal” or “registrational” studies, which typically denotes a study which presents the data that the FDA or other relevant regulatory agency will use to determine whether to approve a product. In Phase 3 studies, the product candidate is administered to an expanded patient population, generally at multiple geographically dispersed clinical trial sites in adequate and well-controlled clinical trials to generate sufficient data to statistically demonstrate the efficacy and safety of the product for approval. These clinical trials are intended to establish the overall risk/benefit ratio of the product candidate and provide an adequate basis for product labeling.

Post-approval clinical trials, sometimes referred
to as Phase 4 clinical trials, may be required by FDA, or may be voluntarily conducted after initial approval. These clinical trials are
used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety
follow-up.

12

During all phases of clinical development, regulatory
agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators. Annual
progress reports detailing the results of the clinical trials must be submitted to the FDA.

Written IND safety reports must be promptly submitted
to the FDA and the investigators for: serious and unexpected adverse events; any findings from other studies, in vivo laboratory tests
or in vitro testing that suggest a significant risk for human subjects; or any clinically important increase in the rate of a serious
suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within
15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any
unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of
the information. Relevant additional information obtained by the sponsor that pertains to a previously submitted IND safety report must
be submitted as a follow-up IND safety report. Such report should be submitted within 15 calendar days after the sponsor receives the
information.

Information about certain clinical trials, including
a description of the study and, in some cases, study results, must be submitted within specific timeframes to the National Institutes
of Health, or NIH, for public dissemination on their clinicaltrials.gov website. Manufacturers or distributors of investigational products
for the diagnosis, monitoring, or treatment of one or more serious or life-threatening diseases or conditions where no other comparable
or satisfactory therapeutic options exist must also have a publicly available policy on evaluating and responding to requests for expanded
access, sometimes called “compassionate use,” requests.

Additionally, some clinical trials are overseen
by an independent group of qualified experts organized by the clinical trial sponsor that regularly reviews accumulated data and advises
the study sponsor regarding the continuing safety of the trial. This group, known as a Data and Safety Monitoring Board (DSMB) or Data
and Safety Monitoring Committee (DSMC), may also review interim data to assess the continuing validity and scientific merit of the clinical
trial. This group receives special access to unblinded data during the clinical trial and may advise the sponsor to halt the clinical
trial if it is determined there is an unacceptable safety risk for subjects or on other grounds, such as no demonstration of efficacy.

The FDA may order the temporary, or permanent,
discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being
conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. An IRB may also require
the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements
or if the trial poses an unexpected serious harm to subjects. The FDA or an IRB may also impose conditions on the conduct of a clinical
trial. Clinical trial sponsors may also choose to discontinue clinical trials as a result of risks to subjects, a lack of favorable results,
or changing business priorities.

Compliance with current Good Manufacturing
Practices (cGMP) Requirements

Manufacturers of pharmaceutical and biological
products must comply with applicable cGMP regulations, including quality control and quality assurance and maintenance of records and
documentation. Manufacturers and others involved in the manufacture and distribution of such products also must register their establishments
with the FDA and certain state agencies. Both domestic and foreign manufacturing establishments must register and provide additional information
to the FDA upon their initial participation in the manufacturing process. Establishments may be subject to periodic, unannounced inspections
by government authorities to ensure compliance with cGMP requirements and other laws. Discovery of problems may result in a government
entity placing restrictions on a product, manufacturer, or holder of an approved NDA, and may extend to requiring withdrawal of the product
from the market. The FDA will not approve an NDA unless it determines that the manufacturing processes and facilities are in compliance
with cGMP requirements and adequate to assure consistent production of the product within required specification.

13

Concurrently with clinical trials, companies usually
complete additional preclinical studies and must also develop additional information about the physical characteristics of the product
candidate as well as finalize a process for manufacturing the product candidate in commercial quantities in accordance with cGMP requirements.
To help reduce the risk of the introduction of adventitious agents or of causing other adverse events with the use of small molecule products,
the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing
process must be capable of consistently producing quality batches of the product candidate and, among other requirements, the sponsor
must develop methods for testing the identity, strength, quality, potency and purity of the final product. Additionally, appropriate packaging
must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable
deterioration over its shelf life.

In relation to the clinical trials that may be
conducted in other countries with a view to obtaining a marketing authorization, there are comparable cGMP requirements and other regulatory
rules that are implemented nationally.

U.S. FDA Review and Approval Process

Assuming successful completion of the required
clinical and preclinical testing, the results of the preclinical tests and clinical trials together with detailed information relating
to the product’s CMC, including negative or ambiguous results as well as positive findings, and proposed labeling, among other things,
are submitted to the FDA for NDA or BLA approval to market the product for one or more indications.

Under the Prescription Drug User Fee Act (PDUFA),
as amended, each NDA or BLA must be accompanied by a significant user fee. The FDA adjusts the PDUFA user fees on an annual basis. The
PDUFA also imposes an annual program fee for approved therapeutic products. Fee waivers or reductions are available in certain circumstances,
including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed
on NDAs for product candidates designated as orphan drugs, unless the product candidate also includes a non-orphan indication.

In addition, under the Pediatric Research Equity
Act (PREA), an NDA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration, must contain data
that are adequate to assess the safety and potential of the product for the claimed indications in all relevant pediatric subpopulations,
and to support dosing and administration for each pediatric subpopulation for which the product is safe. Also, applications for product
candidates intended for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially
relevant to the growth or progression of pediatric cancer, in place of the PREA investigations, sponsors must submit, with the application,
reports from molecularly targeted pediatric cancer investigations designed to yield clinically meaningful pediatric study data, using
appropriate formulations, to inform potential pediatric labeling. The FDA may, on its own initiative or at the request of the applicant,
grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial
waivers from the pediatric data requirements. Orphan products are also exempt from the PREA requirements.

The FDA initially reviews an NDA or BLA submission
to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any NDA or BLA that it
deems incomplete or not properly reviewable at the time of submission and may request additional information. In that event, the NDA or
BLA must be resubmitted with additional information. The resubmitted application also is subject to review before the FDA accepts it for
filing. Once the submission is accepted for filing, the FDA begins an in-depth, substantive review of the application.

The FDA reviews the application to determine,
among other things, whether the proposed product candidate is safe and effective ( or pure and potent for BLAs) for its intended use,
has an acceptable purity profile and whether the product candidate is being manufactured in accordance with cGMP to assure and preserve
the product candidate’s identity, safety, strength, quality, potency and purity. The FDA may refer applications for novel therapeutic
products or therapeutic products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that
includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and
under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully
when making decisions. During the product approval process, the FDA also will determine whether a risk evaluation and mitigation strategy,
(REMS) is necessary to assure the safe use of the product candidate. REMS use risk minimization strategies beyond the professional labeling
to ensure that the benefits of the product outweigh the potential risks. To determine whether a REMS is needed, the FDA will consider
the size of the population likely to use the product, seriousness of the disease, expected benefit of the product, expected duration of
treatment, seriousness of known or potential adverse events, and whether the product is a new molecular entity. A REMS could include medication
guides, physician communication plans and elements to assure safe use, such as restricted distribution methods, patient registries and
other risk minimization tools. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS; the FDA will
not approve the application without a REMS, if required.

14

Before approving an application, the FDA will
inspect the facilities at which the product candidate is manufactured. The FDA will not approve the product candidate if it determines
that the manufacturing processes and facilities are not in compliance with cGMP requirements or otherwise are not adequate to assure consistent
production of the product candidate within required specifications. Additionally, before approving an application, the FDA typically will
inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP
requirements.

Based on the application and accompanying information,
including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter.
An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A complete
response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in
order for the FDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in
a resubmission of the application, the FDA will issue an approval letter.

If a product candidate receives regulatory approval,
the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited. Further,
the FDA may require that certain contraindications, warnings, or precautions be included in the product labeling. The FDA may impose restrictions
and conditions on product distribution, prescribing or dispensing in the form of a REMS, or otherwise limit the scope of any approval.
The FDA may also require post-marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess
a product’s safety, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.

Every five years, the FDA agrees to specified
performance goals in the review of NDAs under the PDUFA. One such current goal is to review standard NDAs in ten months after the FDA
accepts the NDA for filing, and priority NDAs in six months, whereupon a review decision is to be made. The FDA does not always meet its
PDUFA goal dates for standard and priority NDAs and its review goals are subject to change from time to time. The review process and the
PDUFA goal date may be extended by three months if the FDA requests or the NDA sponsor otherwise provides additional information or clarification
regarding information already provided in the submission within the last three months before the PDUFA goal date.

Post-Approval Requirements

After approval, there also are continuing annual
program user fee requirements for approved products, excluding, under certain circumstances, orphan products.

Rigorous and extensive FDA regulation of pharmaceutical
and biological products continues after approval, particularly with respect to cGMP requirements. Manufacturers are required to comply
with applicable requirements in the cGMP regulations, including quality control and quality assurance and maintenance of records and documentation.
To help reduce the increased risk of the introduction of adventitious agents, the PHSA emphasizes the importance of manufacturing controls
for products whose attributes cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses
in situations where there exists a danger to public health, to prepare or procure products in the event of shortages and critical public
health needs, and to authorize the creation and enforcement of regulations to prevent the introduction or spread of communicable diseases
in the United States and between states.

Other post-approval requirements applicable to
pharmaceutical products include reporting of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed
product, record-keeping requirements, reporting of adverse effects, reporting updated safety and efficacy information, and complying with
electronic record and signature requirements. In addition, the FDA conducts laboratory research related to the regulatory standards on
the safety, purity, and potency of pharmacological products.

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In addition, manufacturers and other entities
involved in the manufacture and distribution of approved pharmaceuticals are required to register their establishments with the FDA and
certain state agencies, list their products, and are subject to periodic announced and unannounced inspections by the FDA and these state
agencies for compliance with current cGMP and other requirements, which impose certain procedural and documentation requirements upon
us and third-party manufacturers. Manufacturers must continue to expend time, money, and effort in the areas of production and quality
control to maintain compliance with current cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if
a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized
problems are subsequently discovered. In addition, changes to the manufacturing process or facility generally require prior FDA approval
or notification before being implemented, and other types of changes to the approved product, such as adding new indications and additional
labeling claims, are also subject to further FDA review and approval.

Moreover, the Drug Quality and Security Act imposes
obligations on manufacturers of pharmaceutical products related to product tracking and tracing.

Adverse event reporting and submission of periodic
reports, including annual reports and deviation reports, are required following FDA approval of an NDA or BLA. Later discovery of previously
unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or
failure to comply with regulatory requirements, may result in significant regulatory actions. Such actions may include refusal to approve
pending applications, license suspension or revocation, imposition of a partial or full clinical hold or termination of clinical trials,
warning letters, untitled letters, modification of promotional materials or labeling, provision of corrective information, imposition
of post-market requirements including the need for additional testing, imposition of distribution or other restrictions under a REMS,
product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution,
FDA debarment, injunctions, fines, consent decrees, corporate integrity agreements, suspension and debarment from government contracts,
and refusal of orders under existing government contracts, exclusion from participation in federal and state healthcare programs, restitution,
disgorgement, or civil or criminal penalties, including fines and imprisonment, and result in adverse publicity, among other adverse consequences.

A sponsor also must comply with the FDA’s
advertising and promotion requirements, such as the prohibition on promoting products for uses or inpatient populations that are inconsistent
with the product’s approved labeling (known as “off-label use”). The FDA and other agencies actively enforce the laws
and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may
be subject to significant liability. Violations relating to the promotion of off-label uses may lead to investigations alleging violations
of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws. Companies, however, may generally
share truthful and non-misleading information that is otherwise consistent with a product’s FDA approved labeling. Discovery of
previously unknown problems or the failure to comply with the applicable regulatory requirements may result in restrictions on the marketing
of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions.

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 or manufacturer to administrative
or judicial civil or criminal actions and adverse publicity. These actions could include refusal to approve pending applications or supplemental
applications, withdrawal of an approval, clinical hold, suspension or termination of a clinical trial by an IRB, warning or untitled letters,
product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines or other monetary penalties,
refusals of government contracts, mandated corrective advertising or communications with healthcare providers, debarment, restitution,
disgorgement of profits or other civil or criminal penalties.

Broadly equivalent requirements and controls typically
apply in other countries to the submission of marketing authorization applications and, post-approval, to the holding of such marketing
authorizations.

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Other Healthcare Laws and Regulations

Our business activities, including but not limited
to, research, sales, promotion, distribution, medical education, and other activities following product approval will be subject to regulation
by numerous federal and state regulatory and law enforcement authorities in the United States in addition to the FDA, including potentially
the Department of Justice, the Department of Health and Human Services (HHS) and its various divisions, including the Office of Inspector
General, the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration, the Department of
Veterans Affairs, the Department of Defense, and state and local governments. Healthcare providers and third-party payors play a primary
role in the recommendation and use of pharmaceutical products that are granted marketing approval. Arrangements with third-party payors,
existing or potential customers and referral sources, including healthcare providers, are subject to broadly applicable fraud and abuse
laws and regulations, and these laws and regulations may constrain the business or financial arrangements and relationships through which
manufacturers conduct clinical research, market, sell and distribute the products for which they obtain marketing approval. Such restrictions
under applicable federal and state healthcare laws and regulations include the following:

●
The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or kind, in exchange for, or to induce, either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers, on the one hand, and prescribers, purchasers, formulary managers and other individuals and entities on the other. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the ACA) amended the intent requirement of the federal Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to commit a violation;

●
The federal civil and criminal false claims, including the civil FCA, and Civil Monetary Penalties Laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent, or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. Certain marketing practices, including off-label promotion, also may implicate the FCA. In addition, the ACA codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA;

●
The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, therapeutic products and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or the CMS, information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members;

●
Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, a healthcare benefit program, regardless of whether the payor is public or private, in connection with the delivery or payment for health care benefits, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items, or services relating to healthcare matters. Additionally, the ACA amended the intent requirement of certain of these criminal statutes under HIPAA so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to violate it, to have committed a violation; and

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●
State and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers and drug pricing and/or marketing expenditures; and state and local laws requiring the registration of pharmaceutical sales representatives and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Further, we may be subject to data privacy and
security regulation by both the federal government and the states and foreign jurisdictions in which we conduct our business. HIPAA, as
amended by the Health Information Technology for Clinical Health Act of 2009 (HITECH), and its respective implementing regulations imposes
certain requirements, including mandatory contractual terms, on covered entities, business associates and their covered subcontractors
relating to the privacy, security, and transmission of certain individually identifiable health information known as protected health
information. Among other things, HITECH, through its implementing regulations, makes HIPAA’s security standards and certain privacy
standards directly applicable to business associates, defined as a person or organization, other than a member of a covered entity’s
workforce, that creates, receives, maintains, or transmits protected health information on behalf of a covered entity for a function or
activity regulated by HIPAA. HITECH also strengthened the civil and criminal penalties that may be imposed against covered entities, business
associates, subcontractors, and individuals, and gave state attorneys general new authority to file civil actions for damages or injunctions
in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
In addition, other federal and state laws may govern the privacy and security of health and other information in certain circumstances,
many of which differ from each other in significant ways and may not be pre-empted by HIPAA, thus complicating compliance efforts.

To the extent that any of our products are sold
in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing
requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting
of payments or transfers of value to healthcare professionals.

In the EU, the data privacy laws are generally
perceived to be stricter than those which apply in the United States and include specific requirements for the transfer of personal data
outside the EU to the United States to ensure that EU standards of data privacy will be applied to such data.

Violation of the laws described above or any other
governmental laws and regulations may result in significant penalties, including administrative, civil and criminal penalties, damages,
fines, the curtailment or restructuring of operations, the exclusion from participation in federal and state healthcare programs, disgorgement,
contractual damages, reputational harm, diminished profits and future earnings, imprisonment, and additional reporting requirements and
oversight if a person becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance
with these laws. Furthermore, efforts to ensure that business activities and business arrangements comply with applicable healthcare laws
and regulations can be costly for manufacturers of branded prescription products.

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Coverage and Reimbursement

Significant uncertainty exists as to the coverage
and reimbursement status of any products for which we may obtain regulatory approval. In the United States, sales of any product candidates
for which regulatory approval for commercial sale is obtained will depend in part on the availability of coverage and adequate reimbursement
from third-party payors. Third-party payors include government authorities and health programs in the United States such as Medicare and
Medicaid, managed care providers, private health insurers and other organizations. These third-party payors are increasingly reducing
reimbursements for medical products and services. The process for determining whether a payor will provide coverage for a drug product
may be separate from the process for setting the reimbursement rate that the payor will pay for the drug product. Third-party payors may
limit coverage to specific drug products on an approved list, or formulary, which might not include all of FDA-approved drugs for a particular
indication. Additionally, the containment of healthcare costs has become a priority of federal and state governments, and the prices of
drugs have been a focus in this effort. The U.S. government, state legislatures and foreign governments have shown significant interest
in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of
generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions
with existing controls and measures, could further limit our net revenue and results.

A payor’s decision to provide coverage for
a drug product does not imply that an adequate reimbursement rate will be approved. Further, coverage and reimbursement for drug products
can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process
that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance
that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Third-party payors are increasingly challenging
the price and examining the medical necessity and cost of medical products and services, in addition to their safety and efficacy. New
metrics frequently are used as the basis for reimbursement rates, such as average sales price, average manufacturer price and actual acquisition
cost. In order to obtain coverage and reimbursement for any product that might be approved for sale, it may be necessary to conduct expensive
pharmacoeconomic studies in order to demonstrate the medical necessity and rational of the cost of the products, in addition to the costs
required to obtain regulatory approvals. If third-party payors do not consider a product to be cost saving when compared to other available
therapies, they may not cover the product after approval as a benefit under their plans or, if they do, the level of payment may not be
sufficient to allow a company to sell its products at a profit.

The marketability of any product candidates for
which we or our collaborators receive regulatory approval for commercial sale may suffer if the government and third-party payors fail
to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased and we expect
will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at
any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we or our collaborators receive
regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. The cost containment measures
that healthcare payors and providers are instituting and any healthcare reform could significantly reduce our revenues from the sale of
any approved product candidates. We cannot provide any assurances that we will be able to obtain and maintain third-party coverage or
adequate reimbursement for our product candidates in whole or in part.

In the EU, pricing and reimbursement schemes vary
widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed.
Some countries may require the completion of additional studies that compare the cost of a particular product candidate to currently available
therapies. EU member states may approve a specific price for a product, or it may instead adopt a system of direct or indirect controls
on the profitability of the company placing the product on the market. Other member states allow companies to fix their own prices for
products but monitor and control company profits. The downward pressure on health care costs has become intense. As a result, increasingly
high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets
exert competitive pressure that may reduce pricing within a country. Any country that has price controls or reimbursement limitations
may not allow favorable reimbursement and pricing arrangements.

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European and Other Regulatory Approval

Whether or not FDA approval has been obtained,
approval of a product by comparable regulatory authorities in Europe, Japan and other countries will likely be necessary prior to commencement
of marketing such product in such countries. The regulatory authorities in each country may impose their own requirements and may refuse
to grant an approval, or may require additional data before approving it, even though the relevant product has been approved by the FDA
or another authority. The regulatory authorities in the European Union (“EU”), Australia and other developed countries have
lengthy approval processes for pharmaceutical products. The process for gaining approval in a particular country may vary from the process
in another country but generally follows a similar sequence to that described for FDA approval. The EU has established a European agency
for the evaluation of medical products, with both a centralized community procedure and a decentralized procedure, the latter being based
on the principle of licensing within one member country followed by mutual recognition by the other member countries.

The process of obtaining approval for a new drug
in Japan resembles U.S. and EU procedures in both substance and scope. All NDAs are collected and reviewed by the Japanese Pharmaceuticals
and Medical Devices Agency, or PMDA. PMDA review typically involves at least two formal evaluations to establish the safety and efficacy
of the drug candidate, as well as one cGMP facility inspection. Consultations to correct outstanding issues are conducted as needed. Assuming
satisfactory results, these reports are communicated to the Ministry of Health, Labour, and Welfare, or MHLW, which then issues final
approval of the drug.

Approval of Biosimilars

The pathway for approval of biosimilar products
was established by the Biologics Price Competition and Innovation Act of 2009, or BPCIA, enacted on March 23, 2010, as part of the Patient
Protection and Affordable Care Act. The BPCIA established this abbreviated pathway under section 351(k) of the Public Health Service Act,
or PHSA. Subsequent to the enactment of the BPCIA, the FDA issued draft guidance regarding the demonstration of biosimilarity as well
as the submission and review of biosimilar applications. Biosimilars are to be compared for biosimilarity to “Reference Products”
already licensed by the FDA. Market success of biosimilar products will depend on demonstrating to patients, physicians, payors, and relevant
authorities that such products are similar in quality, safety and efficacy as compared to the reference product. The BPCIA requires a
biosimilar applicant to demonstrate biochemical and biologic biosimilarity using clinical studies with respect to the reference product
that has been approved by FDA in the United States. Biosimilars approved in the EU and other non-U.S. jurisdictions may not be approved
in the United States without additional studies demonstrating biosimilarity to an FDA-approved reference product. Biosimilars approved
in the United States may also not be approved in foreign jurisdictions without additional bridging studies. We will continue to analyze
and incorporate into our biosimilar development plans all final regulations and guidance issued by the FDA, pharmacy substitution policies
enacted by state governments and other applicable requirements established by relevant authorities.

A biosimilars approval pathway has been in place
in the E.U. since 2003. The EMA has issued a number of scientific and product specific biosimilar guidelines, including requirements for
approving biosimilars containing monoclonal antibodies. In the E.U., biosimilars are generally approved under the centralized procedure.
The approval pathway allows sponsors of a biosimilar to seek and obtain regulatory approval based in part on reliance on the clinical
trial data of an innovator product to which the biosimilar has been demonstrated, through comprehensive comparability studies, to be “similar.”
In many cases, this allows biosimilars to be brought to market without conducting the full complement of clinical trials typically required
for novel biologic drugs.

Employees

As of March 30, 2026, the Company has two (2)
full-time employees and utilizes the services of consultants. As a result of the recent acquisition of Greenland Mines Corp., the Company
also has three (3) additional employees based in Europe.

Properties

The Company is currently using two (2) offices in Omaha, NE and Charlotte,
NC., each consisting of approximately 400 sq ft square feet. The Omaha, NE office is provided for the Company’s use rent-free by
the Company’s CEO. We rent the Charlotte, NC office for $700 a month, or $8,400 annually.

Website

The Company maintains a website at the following
address: https://greenlandmines.com/. The information on the Company’s website is not incorporated by reference in this Annual Report.

The Company makes available on or through the
website reports and amendments to those reports that are filed with or furnished to the SEC in accordance with the Securities Exchange
Act, as amended. These include our Annual Reports on website Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form
8-K and amendments to these reports, if applicable. We make this information available on our website free of charge as soon as reasonably
practicable after we electronically file the information available with, or furnish it to, the SEC. The SEC also maintains a website at
the following address, through which this information is available: http://www.sec.gov.

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