Inmune Bio, Inc. (INMB) Business

Item 1. Business

Our Strategy

Company Overview

INmune
Bio is a clinical-stage biotechnology company dedicated to developing and commercializing a pipeline of product candidates designed to
reprogram the innate immune system. Our mission is to address a broad range of diseases where chronic inflammation and immune dysfunction
are primary drivers of pathology.

Lead
Program: CORDStrom™ for RDEB Our primary focus is the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
using CORDStrom, our proprietary, pooled, human umbilical cord-derived mesenchymal stromal cell platform. RDEB is a devastating pediatric
orphan disease caused by mutations in the COL7A1 gene. This genetic deficiency leads to systemic complications, including highly
debilitating skin blistering, chronic non-healing wounds, dysphagia, and failure to thrive. Over time, the chronic inflammatory environment
associated with RDEB often progresses to fatal squamous cell carcinoma. RDEB is a systemic disease with no approved systemic treatments.
The only approved products to date are topical and do not address the systemic issues of the disease, which is the focus of CORDStrom.

CORDStrom has recently completed a pivotal, blinded, randomized cross-over
trial. Based on these data, the Company is transitioning toward regulatory submission and commercialization. We intend to file a Marketing
Authorization Application (MAA) in the United Kingdom in July 2026 and the European Union (EU) in September 2026, followed by a Biologics
License Application (BLA) with the U.S. Food and Drug Administration (FDA) targeted for December 2026.

Neuroinflammation
and Oncology Pipelines In addition to our lead rare
disease program, the Company is advancing two other clinical-stage platforms:

By
targeting the innate immune system across these distinct therapeutic areas, INmune Bio aims to deliver disease-modifying treatments
for patients with high unmet medical needs.

CORDStrom

CORDStrom,
developed by INmune Bio circa 2020, represents a breakthrough in mesenchymal stromal cell technology. The CORDStrom platform
leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled
human umbilical cord - derived mesenchymal stromal cells as medicines to treat complex inflammatory diseases. CORDStrom is
manufactured in the United Kingdom under the direction of Mark Lowdell, the Company’s CSO, using a supply of human umbilical
cords. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP
manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification. Initially developed at
the INKmune manufacturing facilities utilizing United Kingdom academic grant funding, CORDStrom is a product platform that shows
promise as a therapy for RDEB and many other debilitating conditions. While the first generation CORDStrom product is agnostic to
indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory,
immunomodulatory, wound healing, and other characteristics.

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Children with RDEB have skin that is damaged by even the smallest amount of friction which causes severe blistering, deep wounds, and
scars. It is caused by a fault in a gene that makes collagen, a protein that holds the skin layers together. There are limited options
available for treatment, none that adequately meet the needs of patients, and the condition gets worse over time with many children reliant
on a wheelchair as they move into their teenage years. Many of those with an RDEB diagnosis will also go on to develop aggressive life-threatening
skin cancer in adulthood caused by the accumulated damage to their skin. The Company estimates roughly 2,000 people suffer from RDEB in
the US, United Kingdom and EU representing a large unmet opportunity to potentially provide routine clinical care to these children.

From 2020 until mid-2024, the Company supplied CORDStrom as an investigational medical product to the Great Ormond Street Children’s
Hospital (“GOSH”), London, and Birmingham Children’s Hospital in connection with the MissionEB study, which was primarily
funded by a grant from the National Institute for Health and Care Research (“NIHR”) and Cure EB in the United Kingdom. INmune
Bio was compensated for CORDStrom used in the trial and was not a sponsor of the MissionEB study. The investigators recently concluded
the double blinded, randomized, placebo-controlled arm of the study, which evaluated the safety and efficacy of CORDStrom in 30 pediatric
patients (less than 16 years old) in the United Kingdom with intermediate and severe RDEB using a novel cross-over clinical trial design.
Patients were randomized to CORDStrom or placebo arms and received two intravenous infusions two weeks apart and then followed for 9 months.
Each child then crossed over to the other arm and received two doses of placebo or CORDStrom two weeks apart with a further 9-month follow-up.

All
patients were treated as day-cases and no CORDStrom related serious adverse events were reported through the study. Top-line results
showed the treatment was easily administered, well tolerated and there were beneficial effects across all types of patients receiving
CORDStrom with respect to Itch Man Scale, iscorEB clinician score and iscorEB skin involvement.  Most notably, CORDStrom significantly
reduced itch scores as measured by the Itch Man Scale. In patients with the most severe disease activity, CORDStrom reduced itch at 3
months and led to a sustained reduction of over 27% at 6 months. These results demonstrate a clinically meaningful reduction in itch
severity sustained over time. Intermediate group patients showed a broader range of improvements, including reduced skin involvement
and less pain as well as large reduction in itch.  The younger patients (less than 10 years old) showed improvements in skin score,
indicating better skin integrity and reduced disease activity. Interviews with patients and caregivers on completing follow up strongly
support the clinical benefits of the therapy; both caregivers and patients were able to correctly identify which treatment had been CORDStrom
and which had been placebo. Those who completed the study are asking to continue on therapy, which the Company intends to pursue as an
open-label study.

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Further
analysis of the data by the Company noted an improvement in pain of the patients compared to placebo as follows:

In
addition, further analysis of the data by the Company showed an improvement of wellbeing compared to placebo as follows:

The Mission EB data form the basis of a license that was entered into
between INmune Bio and GOSH, whereby the Company gains exclusive access to the clinical study data for commercial uses in exchange for
payment of an initiation milestone of approximately $0.3 million which the Company paid during July 2025 and a single development milestone
of up to 6 million pounds (approximately $8.1 million at December 31, 2025) due on receipt of first marketing authorization from the FDA,
European Medicines Agencies (“EMA”), or the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”),
which has not occurred yet.

After
reviewing results of the Mission EB study, the Company initiated a Type C meeting with the FDA to obtain CMC and regulatory feedback and
submitted information, data and requests for Rare Pediatric Disease and Orphan Drug Designations (RPDD/ODD).

The FDA granted RPDD to the Company’s CORDStrom product on December
13, 2024. CORDStrom remains eligible to receive a Priority Review Voucher (PRV) if approved by the FDA on or prior to September 30, 2029,
assuming the PRV program is not extended. If granted, a PRV can be redeemed to receive priority review for a different product. Alternatively,
a PRV may be transferred or sold to another organization.

The
FDA granted ODD to the Company’s CORDStrom product on January 6, 2025. Benefits of ODD include certain tax credits and eligibility
for select grants, waiver of FDA user fees, including the BLA application fees, access to frequent meetings with the FDA for efficient
drug development, and eligibility for seven (7) years of market exclusivity post approval.

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The
Company plans to prepare for and hold a pre-BLA meeting to discuss particulars of its planned BLA submission, with intent to submit a
BLA this year seeking approval of CORDStrom for treatment of RDEB. Concurrently, the Company will also seek to submit MAAs to the EU and
United Kingdom in 2026.

XPro

We believe our XPro platform can be used as a CNS (“central nervous
system”) therapy to target glial activation to prevent progression of AD along with other inflammatory diseases. The primary focus
of the Company’s development efforts for XPro is AD. In each case, we believe neutralizing soluble Tumor Necrosis Factor (“sTNF”)
is a cornerstone to the treatment of neuroinflammation and immune dysfunction in these diseases.

We believe the dominant negative tumor necrosis factor (“DN-TNF”)
platform can be used to treat selected neurodegenerative diseases by reducing neuroinflammation without immunosuppression. The Company
believes the core pathology of cognitive decline is a combination of neurodegeneration and synaptic dysfunction. Neurodegeneration is
nerve cell death that may include demyelination. Synaptic dysfunction means the connections between nerve cells cease to work efficiently
and may decrease in number. The combination of neurodegeneration and synaptic dysfunction causes cognitive decline and behavioral changes
associated with AD. XPro completed a Phase I trial treating patients with Alzheimer’s disease that was partially funded by a Part-the-Clouds
Award from the Alzheimer’s Association. We believe XPro targets activated microglia and astrocytes of the brain that produce sTNF
that promotes nerve cell loss, synaptic dysfunction and prevents myelin repair - key elements in the development of dementia. In animal
models, elimination of sTNF prevents nerve cell dysfunction, reverses synaptic pruning and promotes myelin repair. The Phase I trial in
patients with biomarkers of inflammation with AD has been completed. The open label, dose escalation trial was designed to demonstrate
that XPro can safely decrease neuroinflammation in patients with AD and biomarkers of inflammation. The goal of the Phase 1 trial was
to demonstrate safety in the target population (patients with AD), demonstrate target engagement by showing XPro got into the brain in
therapeutically relevant concentrations and reduced neuroinflammation) and identify the best dose for phase 2. XPro got into the brain
(Figure 1a) and dose dependently decreased biomarker of neuroinflammation in the CSF (Figure 1b) with patients treated with
the highest dose (1mg/kg/week dose) having the greatest reduction in neuroinflammation. A broad analysis of proteomic changes following
treatment of XPro revealed significant changes in CSF proteins related to CNS neuronal function, immune/inflammatory response, Cytoskeletal,
metabolic processes, and dendritic spine morphogenesis and synaptic plasticity. Of note, XPro reduced neuronal injury markers Visinin-like
protein-1 (91%) and Neurofilament light (84%), improved measures of synaptic function as evinced by a 222% increase in Contactin 2 and
a 56% decrease neurogranin. Finally, XPro significantly reduced CSL levels of p-Tau217 (43%) and pTau181 (2%) after 3 months of therapy
(Figure 1c).

Figure 1: (A) XPro gets into the brain
at therapeutically relevant concentrations. XPro neutralizes 99.9% of sTNF when drug levels exceed two logs. (B) XPro dose dependently
reduces CSF inflammation in the brain. CSF composite – a composite score of change of all cytokines measured in the OLINK Target
48 Cytokine panel. (C) XPro (at 1 mg/kg dose) reduces CSF pTau217 and pTau181 as measure by proteomics.

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The Phase II study, also known
as AD-02 and MINDFuL, was a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability,
and efficacy of XPro in individuals with early Alzheimer’s disease with biomarkers of inflammation. The primary goal of AD02 was
to determine if XPro could affect cognition following 6 months of treatment. Participants with a diagnosis of early AD (mild cognitive
impairment or mild AD) were randomized in a 2:1 (XPro:Placebo) ratio to receive either 1.0 mg/kg of XPro or placebo via weekly subcutaneous
injections for 6 months. An enrichment strategy mirroring to the successful strategy used in the Phase I trial was used to align the mechanism
of the drug with the patients AD pathology. Eligibility required the presence of at least one
inflammatory biomarker—either high-sensitivity C-reactive protein (hsCRP 1.5 mg/L), erythrocyte sedimentation rate (ESR
10 mm/h), hemoglobin A1c (HbA1c 6.0% DCCT), or at least one APOE4 allele. The primary endpoint was the Early and Mild Alzheimer’s
Cognitive Composite (EMACC), with secondary endpoints of Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB), Everyday Cognition
Scale (E-Cog), Neuropsychiatric Inventory (NPI-12), ADCS-ADL, and biomarkers such as pTau-217 and GFAP. MRI-based neuroinflammation and
brain volumetrics are also evaluated. The AD program had sites in Australia, Canada, the United Kingdom, France, Germany, Spain, Czech
Republic and Slovakia.

Full enrollment in the Phase
II AD trial occurred in late 2024 with 208 patients enrolled and top-line data was received during June 2025. In the Phase 2 MINDFuL trial
of XPro in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT)
population (n=200) did not meet the primary and key secondary endpoints (figure 1). Efficacy, Demographics and Safety data are
shown below.

Figure 1: Phase 2 Study Results – mITT population Primary
and Key Secondary Endpoints, Change From Baseline

Figure 1: As these graphs depict, the primary
and secondary endpoints in this trial were not met as no decline in the placebo groups were observed. A trend was observed in NPI that
favored XPro over placebo. For reference, A higher EMACC score =better, A lower CDR and NPI score is better. EMACC: LS Mean Diff (SE):
-0.018 (0.0414), 90% CI: -0.0860, 0.0509, p-value: 0.672. CDR-SB: LS Mean Diff (SE): -0.11 (0.185), 90% CI: -0.417, 0.195, p-value: 0.5491.
NPI: LS Mean Diff (SE): -0.9 (0.78), 90% CI: -2.18, 0.39, p-value: 0.2499

Prespecified subgroups analyses
suggested a signal that favored XPro in a predetermined population of patients that were both amyloid positive and had a higher burden
of inflammation defined by 2 or more biomarkers of inflammation (from hereon referred to as enriched group). As shown in figure 2, the
mITT placebo group did not decline whereas patients in the enriched group did decline. Decline in the placebo group is required to test
the ability of a treatment to prevent or slow decline.

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Figure 2: Phase 2 Study Results – Placebo group decline in
the mITT and enriched population

Figure 2: Placebo patients in the mITT
did not show decline on the EMACC over the 24 week study. In the enriched group, placebo patients did decline over 24 weeks.

To evaluate a subgroup after
missing the primary endpoint, we used effect size as the primary metric due to the smaller sample size (n=100). Effect size, measured
by Cohen’s D, is well-suited for small samples and allows comparisons across different measures (e.g., cognitive tests and biomarkers).
Unlike p-values, which indicate the likelihood of results being due to chance, effect size reflects clinical relevance and is commonly
used for signal detection in Phase 2 studies.

We defined a promising signal
as a minimum effect size of 0.2, where XPro outperformed placebo on multiple endpoints aligned with our hypothesis and the drug’s
mechanism of action. Results must also be appropriate for the trial’s parameters, meaning the observed effects should align with
the trial’s duration and endpoints. For example, if a clinical measure typically requires a longer time to show meaningful change
than the trial’s 6-month timeframe, an observed effect on that endpoint would not be considered supportive. Signal detection was
based on the effect size difference in LS mean change from baseline (MMRM model) between XPro and placebo at 6 months, ensuring results
were meaningful, relevant, and appropriate for the trial’s design and objectives.

Using this method, the enriched
population (50% of the total sample, n=100) showed trends toward improvement with XPro on the primary endpoint (EMACC) and a key secondary
endpoint (NPI) (Figure 3a). With the placebo group showing the expected decline on EMACC over six months, a beneficial effect of
XPro became evident. EMACC, which measures cognition (higher scores are better), showed an effect size of 0.27, exceeding the company’s
threshold of 0.2, though the p-value of 0.16 fell short of the 0.1 target. For neuropsychiatric symptoms (NPI), the enriched population
showed a stronger beneficial effect compared to the overall population, with an effect size of -0.23 and a p-value of 0.2. There was no
effect on CDR-SB, which measures cognition and function (lower scores are better). Within the dose compliant group of patients, there
was an increased benefit seen corresponding to the amount of XPro received during the trial (Figure 3b). We also evaluated the effect
size of additional endpoints (Figure 4). Across most endpoints, XPro showed favorable trends, with effect sizes approaching the
0.2 threshold for clinical relevance.

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Figure 3a: Phase 2 Study Results – Enriched population primary
and key secondary endpoints, change from baseline

Figure 3: The enriched population show
effect size 0.2 favoring XPro on the EMACC and NPI. , A higher EMACC score =better, A lower CDR and NPI score is better. EMACC: LS
Mean Diff (SE): 0.086 (0.0603), 90% CI: -0.0146, 0.1857, p-value: 0.1594. CDR-SB: LS Mean Diff (SE): -0.08 (0.307), 90% CI: -0.593, 0.426,
p-value: 0.7859. NPI: LS Mean Diff (SE): -1.6 (1.25), 90% CI: -3.71, 0.47, p-value: 0.2003

Figure 3b: Phase 2 Study Results – XPro had greater impact
on dose compliant patients

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Figure 4: Effect size of XPro across multiple endpoints described
as absolute effect sizes (cohen’s D).

Demographics

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Safety

Safety: Treatment Emergent Adverse Events (TEAEs): Safety Analyses Set

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The Company believes these findings from the Phase 2 results indicate
that XPro may offer benefits to a readily identified subgroup of Alzheimer’s patients across all ages with biomarker-defined neuroinflammation,
regardless of comorbidities or ApoE4 status and potentially lays the foundation for advancing XPro as a promising treatment for AD. The
Company participated in an end-of-phase 2 meeting with the FDA during January 2026. The minutes from the end-of phase 2 meeting confirmed
regulatory alignment on the Company’s proposed integrated Phase 2b/3 clinical development strategy for XPro in early AD.

The Company intends to pursue
strategic partnership opportunities to support the further development of XPro in neurodegenerative and/or other indications. The Company
does not currently plan to independently advance XPro into later-stage development.

INKmune

We have demonstrated that INKmune improves the ability of the patient’s
own NK cells to attack their tumor. INKmune interacts with the patient’s NK cells to convert them from inert resting NK cells into
memory-like NK cells that kill the patient’s cancer cells. INKmune is designed to be given to patients after their immune system
has recovered after cytotoxic chemotherapy to target the residual disease that remains after treatment with cytotoxic therapy. We believe
INKmune can be used to treat numerous hematologic malignancies and solid tumors including leukemia, multiple myeloma, lymphoma, lung,
ovary, breast, renal and prostate cancer. The Company sponsored a Phase I trial using INKmune to treat patients with high risk MDS/AML,
a form of leukemia in the UK. Due to Covid restrictions only one patient completed treatment and follow-up in the Phase I trial for MDS;
a further three AML patients were treated compassionately. Due to the post-Covid recruitment problems, the Company decided to terminate
further enrollment in the MDS/AML trial in March 2024. Nonetheless, from the four patients treated and completing follow-up it was determined
that INKmune therapy is safe and promotes development of cancer killing memory-like NK cells that are activated and can kill NK-resistant
cancer cells which can be found in the patient’s circulation for up to 4 months after completion of treatment. The Company initiated
a separate multicenter Phase I/II trial of INKmune in a metastatic castrate resistant prostate cancer in the US and enrolled the first patient in December 2023.

The Company’s Phase
I/II trial using INKmune to treat patients with metastatic castrate resistant prostate cancer (mCPRC) is an open label trial. Biomarker
data from the patients will be visible as patients are treated. The Company plans to report data from each cohort as it becomes available.
The trial was completely enrolled during the fourth quarter of 2025 and top-line data is anticipated approximately 6 months thereafter.
Topline data are divided into immunologic and tumor response variables. The most important immunologic response variable is related to
memory-like NK cell persistence. There are 3 important variables to tumor response: i) blood PSA changes; ii) change in PSMA-PET scan
and iii) change in circulating tumor DNA (ctDNA). INKmune is not a hormone-targeting treatment and will not directly reduce PSA levels
but tumor load measured by PSMA-PET and/or ctDNA are expected to decrease with treatment. We do not expect this 6-month trial to provide
survival data.

Due to capital constraints, the Company does not intend to move INKmune further into development at this time.

Intellectual Property

We seek to protect our therapeutic
programs by continuously developing patent properties covering novel compositions, formulations, purpose-limited compositions, combination
treatments, methods of medical treatment, and other inventions, whether created internally or in-licensed, in the United States Patent
& Trademark Office (the “USPTO”), the World Intellectual Property Organization (“WIPO”) under the Patent Cooperation
Treaty (“PCT”), and in patent offices for various foreign jurisdictions. While each invention is unique and territories for
protection are decided on a case-by-case basis, we generally pursue patents in Australia, Canada, Europe, Japan, and the United States,
and sometimes in Brazil, China and/or Korea. We currently have in our portfolio thirteen (13) issued patents and twenty-seven (27) pending
patent applications, including both company-owned and in-licensed properties. The following sections and corresponding tables summarize,
for each of our current therapeutic programs, our pending and granted patent positions, to the extent publicly available, as of the time
of preparing this document:

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CORDStrom (MSCs)

CORDStrom is a cell suspension
for intravenous infusion or injection comprising aseptic, allogeneic, pooled human umbilical cord derived mesenchymal stromal cells (hucMSCs).
CORDStrom solves certain manufacturing and CMC limitations known to affect mesenchymal stem/stromal cell products, namely, improved batch-to-batch
consistency and scalable manufacturing. The following table summarizes current IP covering our CORDStrom platform technology:

DN-TNF Platform Technology

The DN-TNF Platform Technology covers a variety of dominant negative
tumor necrosis factor variant proteins, including the pegylated DN-TNF protein variants known as XPro and INB03. The following table summarizes
current IP covering our DN-TNF platform technology:

INB-16 / INKmune (Oncology)

INKmune is a replication-incompetent
derivative of our proprietary INB-16 cell line. One commercial application of INKmune includes use as a therapeutic composition designed
to enhance the ability of a patient’s own NK cells to seek, recognize and eliminate cancer. Another commercial application of INKmune
includes use as a cytokine-like agent for enhancing NK cell killing specificity, potency, and efficacy of NK cell -based therapeutics.
The following table summarizes current IP covering INB-16 / INKmune:

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General IP Disclosures

Our commercial success
depends in part on obtaining and maintaining patent and trade secret protections, where applicable, of our current and future product
candidates and the methods used to manufacture them, as well as successfully defending our patents against third-party challenges.

Our ability to stop third
parties from making, using, selling, offering to sell or importing our products depends on the extent to which we have rights under valid
and enforceable patents or trade secrets that cover these activities, and whether we are able to enforce such rights. We cannot assure
you that our pending patent applications will result in issued patents, or that any or all rights will be enforceable in every jurisdiction
whether or not patent rights are sought.

International PCT patent applications
cover all 152 nations which are signatories of the PCT. However, our global IP strategy generally targets Australia, Canada, Europe, Japan,
and the United States, and sometimes Brazil, China and/or Korea, as targets for extending patent protection under the PCT. Decisions regarding
which countries to extend patent coverage under the PCT is taken on a case-by-case basis, subject to normal business considerations such
as value and return on investment. Given the markets for products we are developing, we consider the foregoing jurisdictions to amount
to “global” coverage as used herein as it relates to IP.

The above disclosures related
to patents and patent applications are subject to change based on strategic patent portfolio building decisions, which may include refiling
and reissue, certain abandonments, including those in favor of continuing patent applications, maturations from provisional to non-provisional
filings, and other regular patent prosecution activities.

Trademarks

The designations INMUNE BIOTM,
CORDStromTM, INB16TM, INKmuneTM, XPro1595TM and XProTM are trademarks of INmune
Bio Inc. Some or all these trademarks may be protected by registrations or applications pending at the USPTO and other trademark registration
authorities globally. As part of the trademark registration process, we may be required to submit a statement of use evidencing bona
fide use of each mark in commerce. By nature of being in the biopharmaceutical business, certain regulatory requirements must be met
in connection with certain products and/or services prior to receiving marketing authorization from a regulatory agency, and thus it may
take some time before products and/or services are offered for sale and a statement of use can be submitted for perfecting trademark registration.
For these reasons, we may be required to obtain extensions of time, or to refile applications, seeking registration of trademarks. We
cannot guarantee that a given trademark application will be allowed or issued in a respective office for each jurisdiction.

IP License Agreements

Immune Ventures, LLC License Agreement

On October 29, 2015, the Company
entered into an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”).
Pursuant to the INKmune License Agreement, we were granted an exclusive worldwide, sub-licensable, royalty-bearing license to commercialize
INKmune (the “INKmune License”). In consideration for the INKmune License, we are obligated to pay Immune Ventures certain
milestone and royalty payments.

The term of the Immune Ventures
Agreement began on October 29, 2015, and, if not terminated sooner pursuant to the agreement, ends on a country-by-country basis on the
date of the expiration of the last to expire patent rights where patent rights exist. Subject to granting, prosecution-related patent
term adjustments, and requirements for maintenance and renewals, the latest to expire patent is scheduled to expire on March 15, 2038
(“Natural Expiration”). Upon Natural Expiration of the Immune Ventures Agreement, we shall have a fully paid up, perpetual,
royalty-free license without further obligation to Immune Ventures. The Immune Ventures Agreement can be terminated by Immune Ventures
if, after 60 days from our receipt of notice that we have not made a payment under the Immune Ventures Agreement we still do not make
this payment. On July 20, 2018 and October 30, 2020, the parties amended the agreement under which the Company was required to achieve
milestones pursuant to the agreement.

On April 17, 2023, the parties
executed an additional amendment to the agreement under which the Company removed the due diligence requirements to achieve reasonable
commercial efforts to bring INKmune to market. This removed all requirements of clinical trial timelines and the filing timelines of an
NDA or equivalent. All other provisions in the INKmune License Agreement shall continue in full force and effect.

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University of Pittsburg License Agreement

On October 3, 2017, the Company
entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University
of Pittsburgh. Pursuant to the Assignment and Assumption Agreement (the “Assignment Agreement”), Immune Ventures assigned
all its rights, obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth
System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”).

As consideration under the
PITT Agreement, we are obligated to pay: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of
the licensed technology, and (iii) milestone payments.

The PITT Agreement expires
upon the earlier of: (i) expiration of the last claim of the Patent Rights forming the subject matter of the PITT Agreement; or (ii) the
date that is 20 years from the effective date of the agreement (June 26, 2037).

The Company may terminate
the PITT Agreement upon 3 months prior written notice provided all payments under the license are current. Licensor may terminate the
PITT Agreement upon written notice if: (i) the Company defaults as to performance of material obligations which have not been cured within
60 days after receiving written notice; or (ii) the Company ceases to carry out its business, becomes bankrupt or insolvent, applies for
or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.

Xencor License Agreement

On October 3, 2017, the Company
entered into a license agreement with Xencor, Inc. (“Xencor”), which has discovered and developed a proprietary biological
molecule that inhibits soluble tumor necrosis factor (the “Xencor Agreement”). During June 2021, the Company entered into
the First Amendment to License Agreement with Xencor. Pursuant to the Xencor Agreement, Xencor granted the Company an exclusive worldwide,
royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the Xencor Agreement) to make,
develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein
known as “XPro” that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed
protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage
or formulation. The Xencor Agreement expires upon the later of: (a) the expiration of the last to expire valid claim covering any pharmaceutical
product that contains, comprises, or incorporates Xencor’s proprietary protein known as XPro alone or in combination with one or
more active ingredients, in any dosage or formulation. (“Licensed Product”) in such country or (b) ten years following the
first sale to a third party of the licensed product in such country. Net Sales with respect to any Licensed Product is the gross amounts
invoiced by us for sales of the Licensed Products less deductions actually incurred. A valid claim is an issued, unexpired or pending
claim with the patent rights that Xencor controls as of October 3, 2017 which patent rights are necessary to make, develop, use, sell,
have sold, offer for sale and import a Licensed Product in the Field (the Field means all applications for the treatment of diseases in
humans) or the Product Patent Rights, which claim has not lapsed, been abandoned, been revoked or been held to be unpatentable, invalid
or unenforceable by a final judgment of a court or other governmental agency or competent jurisdiction from which no appeal can be or
is taken within the time allowed for appeal and which has not been admitted to be invalid or unenforceable through reissue, re-examination,
disclaimer or otherwise. Product Patent Rights shall mean any and all our patent rights that are necessary to make, develop, use, sell,
have sold, offer for sale and import a Licensed Product in the Field, including any improvements or patent rights directed to the Licensed
Product. Either party may terminate the Xencor Agreement upon 60 days’ (10 days for any payment default) prior written notice to
the other party after the breach of any material provision of the agreement by the other party if the breaching party has not cured the
breach within the 60-day period (10-day period for any payment default) following written notice of termination by the non-breaching party.
We can terminate the Xencor Agreement upon 180 days prior written notice to Xencor. Xencor may terminate the Xencor Agreement in its entirety
or with respect to any specific Licensed Product upon written notice in the event that we contest, oppose or challenge or assist any party
in contesting, opposing or challenging, Xencor’s ownership of, or the enforceability or validity of the Patent Rights that Xencor
controls as of October 3, 2017 which Patent Rights are necessary to make develop, use, sell, have sold, offered for sale and import a
Licensed Product in the Field. Either party may terminate the Xencor Agreement upon written notice to the other party upon or after the
insolvency, bankruptcy, dissolution or winding up of such other party or the making or seeking to make or arrange an assignment for the
benefit of creditors of such other party or the initiation of proceedings in voluntary or involuntary bankruptcy which proceeding, or
action remains undismissed or unstayed for a period of more than 60 days.

In consideration of the Xencor
Agreement, we agreed to royalty payments and a percentage of any payments received in exchange for a sub-license.

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CORDStrom License Agreement – Clinical
Trial Data

On February 6, 2025, the
Company and Great Ormond Street Hospital NHS Foundation Trust (“GOSH”) executed an exclusive commercial use license to clinical
trial data associated with the MissionEB trial (ISRCTN14409785). The Company owns the intellectual property covering the CORDStrom product,
the investigational medicinal product (“IMP”) used in the MissionEB trial. In addition, the Company owns IP and maintains
trade secret protections covering the manufacturing of CORDStrom. With this license to the clinical trial data, the Company intends to
prepare applications seeking marketing authorization of CORDStrom for treatment of pediatric recessive dystrophic epidermolysis bullosa
(“RDEB”) in each of the FDA, EMA, and MHRA. Terms of the GOSH license include an upfront payment of £250,000 (approximately
$0.3 million) which the Company paid during 2025 and a single milestone payment of up to £6,000,000 (approximately $8.1 million
at December 31, 2025) due on the first to occur marketing authorization to be granted by the FDA, EMA or MHRA. Under the license agreement,
the Company was previously obligated to provide CORDStrom for use in the MissionEB clinical study at no cost. During February 2026, the
MissionEB study was formally closed, and the Company’s obligation to supply CORDStrom in connection with that study has terminated
in accordance with the terms of the license agreement. As a result, the Company has no remaining contractual product supply obligations
related to the MissionEB study under the license agreement. The Company intends to provide CORDStrom at no cost for use in a contemplated
follow-on clinical study referred to as “MissionEB II” however, no definitive agreement governing such study has been executed,
and the Company has no present contractual obligation to supply product for MissionEB II.

Government Regulation

The
FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among
other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,
storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting
of biologics such as those we are developing. We, along with third-party contractors, will be required to navigate the various preclinical,
clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies
or seek approval or licensure of our product candidates. Generally, before a new therapeutic product can be marketed, considerable data
demonstrating a biological product candidate’s quality, safety, purity and potency, or a small molecule drug candidate’s quality,
safety and efficacy, must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved
by the regulatory authority. For biological product candidates, potency is similar to efficacy and is interpreted to mean the specific
ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through
the administration of the product in the manner intended to effect a given result.

Failure
to comply with the applicable U.S. requirements at any time during the product development process, approval process or post-marketing
may subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions, the FDA’s
refusal to approve pending applications from the sponsor, withdrawal of an approval, a clinical hold, untitled or warning letters, product
recalls or market withdrawals, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals
of government contracts, restitution, disgorgement and civil or criminal penalties. Any agency or judicial enforcement action could have
a material adverse effect on our company and our products or product candidates.

U.S. Biologics Regulation

In
the United States, biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the “FDCA”),
the Public Health Service Act (“PHSA”), and other federal, state, local, and foreign statutes and regulations. The process
of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations requires
the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during
the product development process, approval process or following approval may subject an applicant to administrative action and judicial
sanctions. The process required by the FDA before biologic product candidates may be marketed in the United States generally involves
the following:

14

Preclinical
and Clinical Development

Prior
to beginning any clinical trial with a product candidate in the United States, we must submit an IND to the FDA. An IND is a request for
authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on the
general investigational plan and the protocol or protocols for preclinical studies and clinical trials. The IND also includes results
of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology and pharmacodynamic characteristics of the product,
chemistry, manufacturing and controls information, and any available human data or literature to support the use of the investigational
product. In April 2025, the FDA published a roadmap to reduce animal testing in preclinical safety studies, including those required in
INDs, with scientifically validated new approach methodologies. An IND must become effective before human clinical trials may begin. The
IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises safety concerns
or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA
must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not
result in FDA authorization to begin a clinical trial.

In
addition to the IND submission process, supervision of human gene transfer trials includes evaluation and assessment by an institutional
biosafety committee (“IBC”), a local institutional committee that reviews and oversees research utilizing recombinant or synthetic
nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health
or the environment and such review may result in some delay before initiation of a clinical trial.

Clinical
trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters
to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made
for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independent
IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent
form before the clinical trial begins at that site, and must monitor the study until completed. Regulatory authorities, the IRB or the
sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable
health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of
qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether
or not a study may move forward at designated check points based on access to certain data from the study and may halt the clinical trial
if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There
are also requirements governing the reporting of ongoing preclinical studies and clinical trials and clinical study results to public
registries.

15

For
purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

In
some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more
information about the product. These so-called Phase 4 studies may be made a condition to approval of the BLA. Concurrent with clinical
trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the
product candidate, and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things,
must develop methods for testing the identity, strength, quality and purity of the final product, or for biologics, the safety, purity
and potency. 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.

A
sponsor may choose, but is not required, to conduct a foreign clinical study under an IND. When a foreign clinical study is conducted
under an IND, all IND requirements must be met unless waived. When the foreign clinical study is not conducted under an IND, the sponsor
must ensure that the study complies with certain FDA regulatory requirements in order to use the study as support for an IND or application
for marketing approval or licensure, including that the study was conducted in accordance with GCP, including review and approval by an
independent ethics committee and use of proper procedures for obtaining informed consent from subjects, and the FDA is able to validate
the data from the study through an onsite inspection if the FDA deems such inspection necessary. The GCP requirements encompass both ethical
and data integrity standards for clinical studies.

BLA
Submission and Review

Assuming
successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development,
nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or
more indications. The BLA must include all relevant data available from pertinent preclinical studies and clinical trials, including negative
or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing,
controls, and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to test the safety
and effectiveness of the product, or from a number of alternative sources, including studies initiated and sponsored by investigators.
The submission of a BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

16

In
addition, under the Pediatric Research Equity Act (“PREA”), a BLA or supplement to a BLA must contain data to assess the safety
and effectiveness of the biological product candidate 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 and effective. The Food and Drug Administration
Safety and Innovation Act requires that a sponsor who is planning to submit a marketing application for a biological product that includes
a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial pediatric
study plan within sixty days after an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA. Unless otherwise required
by regulation, PREA does not apply to any biological product for an indication for which orphan designation has been granted, except that
the PREA will apply to an original BLA for a new active ingredient that is orphan-designated if the biologic is a molecularly targeted
cancer product intended for the treatment of an adult cancer and is directed at a molecular target that the FDA determines to be substantially
relevant to the growth or progression of a pediatric cancer.

Within
60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the
agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not
properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with
the additional information. Once a BLA has been accepted for filing, the FDA’s goal is to review standard applications within ten
months after the filing date, or, if the application qualifies for priority review, six months after the FDA accepts the application for
filing. In both standard and priority reviews, the review process may also be extended by FDA requests for additional information or clarification.
The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured,
processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may convene
an advisory committee to provide clinical insight on application review questions. The FDA is not bound by the recommendations of an advisory
committee, but it considers such recommendations carefully when making decisions.

Before
approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve
an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate
to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically
inspect one or more clinical sites to assure compliance with GCPs. If the FDA determines that the application, manufacturing process or
manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing
or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application
does not satisfy the regulatory criteria for approval.

After
the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance
will be produced, 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 will describe all of the deficiencies
that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to
support approval, the FDA may issue the Complete Response letter without first conducting required inspections, testing submitted product
lots and/or reviewing proposed labeling. In issuing the Complete Response letter, the FDA may recommend actions that the applicant might
take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay or
refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require
post-marketing testing and surveillance to monitor safety or efficacy of a product.

If
regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the
indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation
Strategy (“REMS”) to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known
or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their
safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to
proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval
if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace.
The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety
and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing
studies.

17

Expedited
Development and Review Programs

The
FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program is intended
to expedite or facilitate the process for reviewing new products that meet certain criteria. Specifically, new products are eligible for
fast track designation if they are intended to treat a serious or life-threatening disease or condition and data demonstrate the potential
to address unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product and the
specific indication for which it is being studied. The sponsor of a fast track product has opportunities for more frequent interactions
with the review team during product development and, once a BLA is submitted, the product may be
eligible for priority review. A fast track product may also be eligible for rolling review, where the FDA may consider for review sections
of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the
sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays
any required user fees upon submission of the first section of the BLA.

Additionally,
products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated
approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit,
or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict
an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of
the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require
the sponsor to perform adequate and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible
morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022, the FDA may require, as appropriate,
that such studies be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated
approval. Products receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the
required post-marketing studies or if such studies fail to verify the predicted clinical benefit. In addition, the FDA currently requires
as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial
launch of the product.

In
2017, the FDA established a new regenerative medicine advanced therapy (“RMAT”) designation as part of its implementation
of the 21st Century Cures Act (the “Cures Act”). The RMAT designation program is intended to fulfill the Cures Act requirement
that the FDA facilitate an efficient development program for, and expedite review of, any drug that meets the following criteria: (i)
the drug qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product,
or any combination product using such therapies or products, with limited exceptions; (ii) the drug is intended to treat, modify, reverse,
or cure a serious or life-threatening disease or condition; and (iii) preliminary clinical evidence indicates that the drug has the potential
to address unmet medical needs for such a disease or condition. RMAT designation provides all the benefits of breakthrough therapy designation,
including more frequent meetings with the FDA to discuss the development plan for the product candidate and eligibility for rolling review
and priority review.

Products
granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably
likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion
to additional sites. When appropriate, the FDA can permit fulfillment of post-approval requirements for an RMAT that has received accelerated
approval through: the submission of clinical evidence, preclinical studies, clinical trials, patient registries or other sources of real
world evidence such as electronic health records; the collection of larger confirmatory datasets; or post-approval monitoring of all patients
treated with the therapy prior to approval.

18

A
product intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation
to expedite its development and review. A product can receive breakthrough therapy designation if preliminary clinical evidence indicates
that the product, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early
as Phase 1 and an organizational commitment to expedite the development and review of the product, including involvement of senior managers.

Any
marketing application for a biologic submitted to the FDA for approval, including a product with a fast track designation and/or breakthrough
therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval process, such as
priority review and accelerated approval. A product is eligible for priority review if there is evidence it has the potential to provide
a significant improvement in the treatment, diagnosis or prevention of a serious disease or condition. For original BLAs, priority review
designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (as
compared to ten months under standard review).

Fast
track designation, breakthrough therapy designation, RMAT designation and priority review do not change the standards for approval but
may expedite the development or approval process. Even if a product qualifies for one or more of these programs, the FDA may later decide
that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be
shortened.

Orphan
Drug Designation and Exclusivity

Under
the Orphan Drug Act of 1983, the FDA may grant orphan drug designation to a product candidate intended to treat a rare disease or condition,
which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or 200,000 or more individuals
in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States
a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that product candidate.
Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the identity of the therapeutic
agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or
shorten the duration of, the regulatory review or approval process.

If
a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has
such designation, the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve
any other applications, including a full BLA, to market the same product for the same approved use or indication for seven years, except
in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity by means of greater effectiveness,
greater safety or providing a major contribution to patient care or if the holder of the orphan drug exclusivity cannot assure the availability
of sufficient quantities of the orphan drug to meet the needs of patients with the same use or indication for which the already-approved
or licensed product was approved or licensed. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic
for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan
drug designation are tax credits for certain research and a waiver of the BLA application fee.

A
designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which
it received orphan drug designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines
that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product
to meet the needs of patients with the rare disease or condition.

There
is some uncertainty with respect to the FDA’s interpretation of the scope of orphan drug exclusivity. Historically, exclusivity
was specific to the orphan indication for which the drug was approved. As a result, the scope of exclusivity was interpreted as preventing
approval of a competing product. However, in 2021, the federal court in Catalyst Pharmaceuticals, Inc. v. Becerra suggested that orphan
drug exclusivity covers the full scope of the orphan-designated “disease or condition” regardless of whether a drug obtained
approval for a narrower use.

19

Post-Approval
Requirements

Any
products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including,
among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and
distribution, and advertising and promotion of the product. As part of the manufacturing process, the manufacturer is required to perform
certain tests on each lot of the product before it is released for distribution. After a BLA is approved for a biological product, the
product also may be subject to official lot release. If the product is subject to official release by the FDA, the manufacturer submits
samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot
and the results of all of the manufacturer’s tests performed on the lot. The FDA also may perform certain confirmatory tests on
lots of some products before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research
related to the regulatory standards on the safety, purity, and potency or effectiveness of biologics. After approval, most changes to
the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also
are continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved BLA.
Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies,
and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain
procedural and documentation requirements upon us and our third-party manufacturers. Changes to the manufacturing
process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented.
FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting requirements upon us and any
third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the
area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

The
FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product
reaches the market. 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 revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition
of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

The
FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating to
safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The
FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these
requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal
penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that
differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe
that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians
in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of
their products.

20

Biosimilars
and Reference Product Exclusivity

The
Affordable Care Act (“ACA”) includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”),
which created an abbreviated approval pathway for biological products that are highly similar, or “biosimilar”, to or interchangeable
with an FDA-approved reference biological product. The FDA has issued several guidance documents outlining an approach to review and approval
of biosimilars.

Biosimilarity,
which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of
safety, purity, and potency, is generally shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability
requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the
same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual,
the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety
risks or risks of diminished efficacy relative to exclusive use of the reference biologic. A product shown to be biosimilar or interchangeable
with an FDA-approved reference biological product may rely in part on the FDA’s previous determination of safety and effectiveness
for the reference product for approval, which can potentially reduce the cost and time required to obtain approval to market the product.
Complexities associated with the larger, and often more complex, structures of biological products,
as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval
pathway that are still being worked out by the FDA.

The
FDA has issued guidance documents intended to inform prospective applicants and facilitate the development of proposed biosimilars and
interchangeable biosimilars, as well as to describe the FDA’s interpretation of certain statutory requirements added by the BPCIA.

Under
the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference
product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12
years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may
still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s
own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product.
The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it is unclear
whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed
by state pharmacy law.

A
reference biologic is granted twelve years of exclusivity from the time of first licensure of the reference product. The first biologic
product submitted under the abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity
against other biologics submitted under the abbreviated approval pathway for the lesser of (i) one year after the first commercial marketing,
(ii) 18 months after approval if there is no legal challenge, (iii) 18 months after the resolution in the applicant’s favor of a
lawsuit challenging the biologics’ patents if an application has been submitted, or (iv) 42 months after the application has been
approved if a lawsuit is ongoing within the 42-month period.

A
biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months
to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection
or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written
Request” for such a study.

The
BPCIA is complex and continues to be interpreted and implemented by the FDA. On December 20, 2020, Congress amended the PHSA as part of
the COVID-19 relief bill to further simplify the biosimilar review process by making it optional to show that conditions of use proposed
in labeling have been previously approved for the reference product, which used to be a requirement of the application. In addition, government
proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact
the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and
impact of the BPCIA is subject to significant uncertainty. As discussed below, the Inflation Reduction Act of 2022 (“IRA”)
is a significant new law that intends to foster generic and biosimilar competition and to lower drug and biologic costs.

21

Patent
Term Extension

In
the United States, after a BLA is approved, owners of relevant drug patents may apply for up to a five-year patent extension, which permits
patent term restoration as compensation for the patent term lost during the FDA regulatory process. The allowable patent term extension
is typically calculated as one-half the time between, the latter of the effective date of an IND and issue date of the patent for which
extension is sought, and the submission date of a BLA, plus the time between BLA submission date and the BLA approval date up to a maximum
of five years. The time can be shortened if the FDA determines that the applicant did not pursue licensure with due diligence. The total
patent term after the extension may not exceed 14 years from the date of product licensure. Only one patent applicable to a licensed biological
product is eligible for extension and only those claims covering the product, a method for using it, or a method for manufacturing it
may be extended and the application for the extension must be submitted prior to the expiration of the patent in question. However, we
may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review
process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to
satisfy applicable requirements.

Some,
but not all, foreign jurisdictions possess patent term extension or other additional patent exclusivity mechanisms that may be more or
less stringent and comprehensive than those of the United States.

Other
Healthcare Laws and Compliance Requirements

Pharmaceutical
companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and
foreign jurisdictions in which they conduct their business. Such laws include, without limitation: the federal Anti-Kickback Statute (“AKS”);
the federal False Claims Act (“FCA”); the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)
and similar foreign, federal and state fraud, abuse and transparency laws.

The
AKS prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration,
to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which payment
may be made under any federal healthcare program. The term remuneration has been interpreted broadly to include anything of value. The
AKS has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand, and prescribers and purchasers on
the other. The government often takes the position that to violate the AKS, only one purpose of the remuneration need be to induce referrals,
even if there are other legitimate purposes for the remuneration. There are a number of statutory exceptions and regulatory safe harbors
protecting some common commercial activities from AKS prosecution, but they are drawn narrowly and practices that involve remuneration,
such as consulting agreements, for persons in a position to refer or recommend federally reimbursable healthcare business may be alleged
to be intended to induce prescribing, purchasing or recommending, and may be subject to scrutiny if they do not qualify for an exception
or regulatory safe harbor. Qualifying for a statutory exception or regulatory safe harbor requires satisfying all of the criteria for
the exception or safe harbor. Our practices may not in all cases meet all of the criteria for protection under a statutory exception or
regulatory safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor
does not make the conduct per se illegal under the AKS, but it does increase the risk of regulatory scrutiny. Ultimately, the legality
of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. A person
or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

The
FCA, which can be enforced through civil whistleblower or qui tam actions, prohibits, among other things, individuals or entities from
knowingly presenting, or causing to be presented, claims for payment of federal government funds, including in federal healthcare programs,
that are false or fraudulent. Pharmaceutical and other healthcare companies have been prosecuted under these laws for engaging in a variety
of different types of conduct that caused the submission of false claims to federal healthcare programs. Under the AKS, for example, a
claim resulting from a violation of the AKS is deemed to be a false or fraudulent claim for purposes of the FCA.

22

HIPAA
created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program,
including private third-party payors, and making false statements relating to healthcare matters. A person or entity does not need to
have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate the statute in order to have
committed a violation.

The
FDCA addresses, among other things, the design, production, labeling, promotion, manufacturing, and testing of drugs, biologics and medical
devices, and prohibits such acts as the introduction into interstate commerce of adulterated or misbranded drugs or devices. The PHSA
also prohibits the introduction into interstate commerce of unlicensed or mislabeled biological products.

The
U.S. federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which
payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually
report to the Centers for Medicaid & Medicare Services (“CMS”) information related to payments or other transfers of value
to various healthcare professionals including physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified
nurse anesthetists, certified nurse-midwives, and teaching hospitals, as well as ownership and investment interests held by physicians
and their immediate family members. Beginning on January 1, 2023, California Assembly Bill 1278 requires California physicians and surgeons
to notify patients of the Open Payments database established under the federal Physician Payments Sunshine Act.

We
are also subject to federal price reporting laws and federal consumer protection and unfair competition laws. Federal price reporting
laws require manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be used
in the calculation of reimbursement and/ or discounts on approved products. Federal consumer protection and unfair competition laws broadly
regulate marketplace activities and activities that potentially harm consumers.

We
are also subject to additional similar U.S. state and foreign law equivalents of each of the above federal laws, which, in some cases,
differ from each other in significant ways, and may not have the same effect, thus complicating compliance efforts. If our operations
are found to be in violation of any of such laws or any other governmental regulations that apply, we may be subject to penalties, including,
without limitation, civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare programs,
such as Medicare and Medicaid or similar programs in other countries or jurisdictions, integrity oversight and reporting obligations to
resolve allegations of non-compliance, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits
and the curtailment or restructuring of our operations.

Data
Privacy and Security

Numerous
state, federal, and foreign laws govern the collection, dissemination, use, access to, confidentiality and security of personal information,
including health-related information. In the United States, numerous federal and state laws and regulations, including state data breach
notification laws, state health information privacy laws, and federal and state consumer protection laws and regulations, that govern
the collection, use, disclosure, and protection of health-related and other personal information and could apply to our operations or
the operations of our partners. For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act
(“HITECH”), and their respective implementing regulations impose data privacy, security, and breach notification obligations
on certain health care providers, health plans, and health care clearinghouses, known as covered entities, as well as their business associates
and their covered subcontractors that perform certain services that involve using, disclosing, creating, receiving, maintaining, or transmitting
individually identifiable protected health information (“PHI”) for or on behalf of such covered entities. These requirements
imposed by HIPAA and HITECH on covered entities and business associates include entering into agreements that require business associates
protect PHI provided by the covered entity against improper use or disclosure, among other things; following certain standards for the
privacy of PHI, which limit the disclosure of a patient’s past, present, or future physical or mental health or condition or information
about a patient’s receipt of health care if the information identifies, or could reasonably be used to identify, the individual;
ensuring the confidentiality, integrity, and availability of all PHI created, received, maintained, or transmitted in electronic form,
to identify and protect against reasonably anticipated threats or impermissible uses or disclosures to the security and integrity of such
PHI; and reporting of breaches of PHI to individuals and regulators.

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Entities
that are found to be in violation of HIPAA may be subject to significant civil, criminal, and administrative fines and penalties and/or
additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to
settle allegations of HIPAA non-compliance. A covered entity or business associate is also liable for civil money penalties for a violation
that is based on an act or omission of any of its agents, which may include a downstream business associate, as determined according to
the federal common law of agency. HITECH also increased the civil and criminal penalties applicable to covered entities and business associates
and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and
seek attorneys’ fees and costs associated with pursuing federal civil actions. To the extent that we submit electronic healthcare
claims and payment transactions that do not comply with the electronic data transmission standards established under HIPAA and HITECH,
payments to us may be delayed or denied.

In
addition, state health information privacy laws, such as California’s Confidentiality of Medical Information Act and Washington’s
My Health My Data Act, govern the privacy and security of health-related information, specifically, may apply even when HIPAA does not
and impose additional requirements.

Even
when HIPAA and state health information privacy laws do not apply, according to the FTC and state attorneys general, violating consumers’
privacy rights or failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or
practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act and state consumer protection laws.

In
addition, certain state laws, such as the California Consumer Privacy Act of 2018 (“CCPA”), as amended by the California Privacy
Rights Act of 2020, govern the privacy and security of personal information, including health-related information in certain circumstances,
some of which are more stringent than HIPAA in various ways. Numerous other states have passed similar laws, but many differ from each
other in significant ways and may not have the same effect, thus complicating compliance efforts. The CCPA applies to personal data of
consumers, business representatives, and employees, and imposes obligations on certain businesses that do business in California, including
to provide specific disclosures in privacy notices, and affords rights to California residents in relation to their personal information.
Health information falls under the CCPA’s definition of personal information where it identifies, relates to, describes, or is reasonably
capable of being associated with or could reasonably be linked, directly or indirectly, with a particular consumer or household and is
included under a new category of personal information, “sensitive personal information,” which is offered greater protection.
The CCPA and numerous other comprehensive privacy laws that have passed or are being considered in other states, as well as at the federal
and local levels, exempt PHI that is subject to HIPAA; and others exempt covered entities and business associates subject to HIPAA altogether,
further complicating compliance efforts, and increasing legal risk and compliance costs for us and the third parties upon whom we rely.

Additionally, our use of artificial intelligence, or AI, and machine
learning may be subject to laws and evolving regulations regarding the use of AI and machine learning, controlling for data bias, and
antidiscrimination.

Failure
to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation.
Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance
efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions
on data processing.

Coverage
and Reimbursement

In
the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs
associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid,
and commercial payors is critical to new product acceptance. Our ability to successfully commercialize our product candidates will depend
in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government
health administration authorities, private health insurers and other organizations. Even if coverage is provided, the approved reimbursement
amount may not be high enough to allow it to establish or maintain pricing sufficient to realize a sufficient return on its investment.
Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications
they will pay for and establish reimbursement levels.

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Significant
uncertainty exists as to the coverage and reimbursement status of any pharmaceutical or biological product for which we obtain regulatory
approval. Sales of any product, if approved, depend, in part, on the extent to which such product will be covered by third-party payors,
such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the
level of reimbursement, if any, for such product by third-party payors. Decisions regarding whether to cover any of our product candidates,
if approved, the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. Further, no uniform policy
for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor.
Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also
have their own methods and approval process apart from Medicare determinations.

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 product candidates to each payor separately, with no assurance that coverage and adequate reimbursement
will be applied consistently or obtained in the first instance. Factors payors consider in determining reimbursement are based on whether
the product is:

Third-party
payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing
the cost effectiveness of pharmaceutical or biological products, medical devices and medical services, in addition to questioning safety
and efficacy. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with
existing controls and measures, could further limit sales of any product that receives approval. Decreases in third-party reimbursement
for any product or a decision by a third-party not to cover a product could reduce physician usage and patient demand for the product.

For
products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult
because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment
or procedure in which the product is used may not be available, which may impact physician utilization. In addition, companion diagnostic
tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or
biological products. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products,
will apply to companion diagnostics.

In
addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including
price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. The IRA provides CMS
with significant new authorities intended to curb drug costs and to encourage market competition. For the first time, CMS will be able
to directly negotiate prescription drug prices and to cap out-of-pocket costs. Each year, CMS will select and negotiate a preset number
of high-spend drugs and biologics that are covered under Medicare Part B and Part D that do not have generic or biosimilar competition.
On August 29, 2023, HHS announced the list of the first ten drugs subject to price negotiations. These price negotiations occurred in
2024. In January 2025, CMS announced a list of 15 additional Medicare Part D drugs that will be subject to price negotiations. The IRA
also provides a new “inflation rebate” covering Medicare patients that took effect in 2023 and is intended to counter certain
price increases in prescriptions drugs. The inflation rebate provision requires drug manufacturers to pay a rebate to the federal government
if the price for a drug or biologic under Medicare Part B and Part D increases faster than the rate of inflation. To support biosimilar
competition, beginning in October 2022, qualifying biosimilars may receive a Medicare Part B payment increase for a period of five years.
Separately, if a biologic drug for which no biosimilar exists delays a biosimilar’s market entry beyond two years, CMS will be authorized
to subject the biologics manufacturer to price negotiations intended to ensure fair competition. Notwithstanding these provisions, the
IRA’s impact on commercialization and competition remains largely uncertain.

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In
addition, net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private
payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices
than in the United States. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts
from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available for
any product candidate that we may commercialize and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical
manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price, and best price.
Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices for drugs may be reduced
by mandatory discounts or rebates required by government healthcare programs.

Finally,
in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing
drug pricing vary widely from country to country. For example, the EU provides options for its member states to restrict the range of
medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products
for human use. To obtain reimbursement or pricing approval, some of these countries may require
the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies.
A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls
on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price
controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any
of our product candidates. Historically, products launched in the EU do not follow price structures of the United States and generally
prices tend to be significantly lower.

Healthcare
Reform

The
United States and some foreign jurisdictions are considering or have enacted a number of reform proposals to change the healthcare system.
There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving
quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been
significantly affected by federal and state initiatives, including those designed to limit the pricing, coverage, and reimbursement of
pharmaceutical and biopharmaceutical products, especially under government-funded health care programs, and increased governmental control
of drug pricing.

The
ACA, which was enacted in March 2010, substantially changed the way healthcare is financed by both governmental and private insurers in
the United States, and significantly affected the pharmaceutical industry. The ACA contains a number of provisions of particular import
to the pharmaceutical and biotechnology industries, including, but not limited to, those governing enrollment in federal healthcare programs,
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled,
infused, instilled, implanted or injected, and annual fees based on pharmaceutical companies’ share of sales to federal health care
programs. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there
will be additional challenges and amendments to the ACA in the future. For example, the IRA, among other things, extends enhanced subsidies
for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut
hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and
creating a new manufacturer discount program.

Other
legislative changes have been proposed and adopted since the ACA was enacted, including automatic aggregate reductions of Medicare payments
to providers of on average 2% per fiscal year as part of the federal budget sequestration under the Budget Control Act of 2011. These
reductions went into effect in April 2013 and, due to subsequent legislative amendments, will remain in effect until 2032 unless additional
action is taken by Congress. In addition, the Bipartisan Budget Act of 2018, among other things, amended the Medicare Act (as amended
by the ACA) to increase the point-of-sale discounts that manufacturers must agree to offer under the Medicare Part D coverage discount
program from 50% to 70% off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as
a condition for the manufacturer’s outpatient drugs being covered under Medicare Part D.

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Moreover,
there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products,
which has resulted in several Congressional inquiries and proposed and enacted federal and state measures designed to, among other things,
reduce the cost of prescription drugs, bring more transparency to product pricing, review the relationship between pricing and manufacturer
patient programs, and reform government program reimbursement methodologies for drug products. For example, in May 2019, CMS adopted a
final rule allowing Medicare Advantage Plans the option to use step therapy for Part B drugs, permitting Medicare Part D plans to apply
certain utilization controls to new starts of five of the six protected class drugs, and requiring the Explanation of Benefits for Part
D beneficiaries to disclose drug price increases and lower cost therapeutic alternatives, which went into effect on January 1, 2021. In
May 2025, the Trump Administration renewed the idea of international reference pricing through an executive order entitled “Delivering
Most-Favored-Nation Prescription Drug Pricing to American Patients,” which, among other things, directs the HHS and other agencies
to communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for U.S. patients in line with comparably
developed nations and to facilitate direct-to-consumer purchasing programs. The HHS subsequently issued guidance indicating the MFN target
price will be the lowest price paid in an Organization for Economic Co-operation and Development country with a gross domestic product
(“GDP”) per capita of at least 60% of the U.S. GDP per capital. In addition, in December 2025, CMS proposed new drug payment
models to lower drug prices for Medicare beneficiaries; under the models, CMS would explore potential adjustments to Medicare drug inflation
rebate calculations by comparison to international drug pricing information. It is currently unclear whether and to what extent these
measures will be implemented and what impact any such implementation would have on our business.

Notwithstanding
the IRA, continued legislative and enforcement interest exists in the United States with respect to specialty drug pricing practices.
Specifically, we expect government authorities to continue pushing for transparency to drug pricing, reducing the cost of prescription
drugs under Medicare, reviewing the relationship between pricing and manufacturer patient programs, and reforming government program reimbursement
methodologies for drugs. Individual states in the United States have also become increasingly active in passing legislation and implementing
regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts,
restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from
other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could
harm our business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual
hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in
their prescription drug and other healthcare programs. This could reduce the ultimate demand for its drugs or put pressure on its drug
pricing, which could negatively affect our business, financial condition, results of operations and prospects.

Other Government Regulation Outside
of the United States

In
addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing, among other
things, research and development, clinical trials, testing, manufacturing, safety, efficacy, quality control, labeling, packaging, storage,
record keeping, distribution, reporting, export and import, advertising, marketing and other promotional practices involving biological
products as well as authorization, approval as well as post-approval monitoring and reporting of our products. Because biologically sourced
raw materials are subject to unique contamination risks, their use may be restricted in some countries.

Whether
or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior
to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States
have a similar process that requires the submission of a clinical trial application much like the IND prior to the commencement of human
clinical trials.

The
requirements and process governing the conduct of clinical trials, including requirements to conduct additional clinical trials, product
licensing, safety reporting, post-authorization requirements, marketing and promotion, interactions with healthcare professionals, pricing
and reimbursement may vary widely from country to country. No action can be taken to market any product in a country until an appropriate
approval application has been approved by the regulatory authorities in that country. The current approval process varies from country
to country, and the time spent in gaining approval varies from that required for FDA approval. In certain countries, the sales price of
a product must also be approved. The pricing review period often begins after market approval is granted. Even if a product is approved
by a regulatory authority, satisfactory prices may not be approved for such product, which would make launch of such products commercially
unfeasible in such countries.

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Regulation in the European Union

European Data Laws

The
processing of personal data, including health-related personal data in the European Economic Area (“EEA”) is mainly governed
by the provisions of the European General Data Protection Regulation (EU) 2016/679 (“GDPR”), and related data protection laws
in individual EEA countries. In the United Kingdom (“UK”), the processing of personal data is mainly governed by the GDPR
as incorporated into UK law pursuant to the European Union (Withdrawal) Act 2018 (the “UK GDPR”). The GDPR and UK GDPR impose
a number of strict obligations and requirements for the processing, including collecting, analyzing and transferring, of personal data
of individuals in the EEA or in the UK, in particular with respect to health data from clinical trials and adverse event reporting. The
GDPR and UK GDPR include requirements relating to the legal basis of the processing (such as consent of the individuals to whom the personal
data relates), the information provided to the individuals prior to processing their personal data, the personal data breaches which may
have to be notified to the national data protection authorities and data subjects, the measures to be taken when engaging processors,
and obligations relating to the security and confidentiality of the personal data. EEA countries may also impose additional requirements
in relation to the processing of health, genetic and biometric data through their national legislation.

In
addition, the GDPR imposes specific restrictions on the transfer of personal data to countries outside of the EEA that are not considered
by the European Commission (“EC”) to provide an adequate level of data protection. Appropriate safeguards are required to
enable such transfers. Among the appropriate safeguards that can be used, the data exporter may use the standard contractual clauses (“SCCs”).
When relying on the appropriate safeguards, data exporters, with the assistance of the data importers, are also required to conduct a
transfer risk assessment to verify if anything in the law and/or practices of the third country may impinge on the effectiveness of the
safeguards in the context of the transfer at stake and, if so, to identify and adopt supplementary measures that are necessary to bring
the level of protection of the data transferred to the EU standard of essential equivalence. Where no supplementary measure is suitable,
the data exporter should avoid, suspend or terminate the transfer. With regard to the transfer of data from the EEA to the United States,
on July 10, 2023, the EC adopted its adequacy decision for the EU-US Data Privacy Framework. On the basis of the new adequacy decision,
personal data can flow from the EEA to U.S. companies participating in the framework.

With
regard to the transfer of data from the EEA to the UK, based on the EC’s adequacy decision of June 28, 2021 and subsequent renewals, personal
data may continue to flow freely from the EEA to the UK on the basis that the UK is deemed to provide an adequate level of data protection
until December 27, 2031. The adequacy decisions will automatically expire unless renewed.

With
respect to transfers from the UK to other countries, these transfers are also subject to specific transfer rules under the UK regime.
These UK international transfer rules broadly mirror the EU GDPR rules.

On
February 2, 2022, the UK Secretary of State laid before the UK Parliament the international data transfer agreement (“IDTA”)
and the international data transfer addendum to the EC’s standard contractual clauses for international data transfers (“UK
Addendum”) and a document setting out transitional provisions. The IDTA and UK Addendum came into force on March 21, 2022 and are
the primary UK-approved mechanisms for putting in place appropriate safeguards for UK restricted transfers, subject to transitional arrangements
for legacy SCCs. Regarding transfers from the UK to the EEA, the UK Information Commissioner’s Office (“ICO”) guidance
indicates that organizations do not need new arrangements. With regard to the transfer of personal data from the UK to the United States,
the UK government has adopted an adequacy decision for the UK Extension to the EU-US Data Privacy Framework, the UK-US Data Bridge, which
came into force on October 12, 2023. The UK-US Data Bridge recognizes the United States as offering an adequate level of data protection
where the recipient is a U.S. organization certified to the EU-US Data Privacy Framework and participating in the UK Extension to the
EU-US Data Privacy Framework.

Failure
to comply with the requirements of the GDPR or UK GDPR and the related national data protection laws of the EEA countries may result in
significant monetary fines for noncompliance of up to €20 million or £17.5 million (as applicable), 4% of the total worldwide
annual turnover (for higher-tier infringements). This is enforced by ICO and is entirely separate from fines under EU GDPR. In addition,
violations of national laws can trigger additional, administrative penalties, investigations, corrective orders, temporary or definitive
bans, and, in some jurisdictions, a number of criminal offenses for organizations and, in certain cases, their directors and officers,
as well as civil liability claims from individuals whose personal data was processed.

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Drug
Marketing Authorization

In the EEA, after completion of all required clinical testing, pharmaceutical
products may only be placed on the market after obtaining a marketing authorization (“MA”). To obtain an MA of a drug under
EU regulatory systems, an applicant can submit an MAA through, amongst others, a centralized or decentralized procedure.

Data
protection authorities from the different EEA countries may still implement certain variations, enforce the GDPR and national data protection
laws differently, and introduce additional national regulations and guidelines, which adds to the complexity of processing personal data
in the EEA.

To be used or sold in the UK, a drug must have an effective MA granted
by the MHRA under the Human Medicines Regulations 2012 (SI 2012/1916), as amended. MA applications are submitted electronically via the
MHRA Submissions Portal. Under the MHRA’s national assessment procedure, the MHRA generally aims to reach a decision within 210
“clock-on” days, excluding any “clock-stops” while the applicant prepares responses to MHRA questions.

On
August 30, 2023, the MHRA published detailed guidance on its recently announced new International Recognition Procedure (“IRP”)
for MAAs. The IRP applies since January 1, 2024, and replaces existing EU reliance procedures to apply for authorizations from seven international
regulators (e.g. Health Canada, Swiss Medic, FDA, EMA, among others). The IRP allows medicinal products approved in other jurisdictions
that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update a MA in the UK. Applicants can submit initial
MAAs to the IRP but the procedure can also be used throughout the lifecycle of a product for post-authorization procedures including line
extensions, variations and renewals.

Centralized
Authorization Procedure

The
centralized procedure provides for the grant of a single MA that is issued by the EC following the scientific assessment of the application
by the EMA that is valid for all EU member states as well as in the three additional EEA member states (Norway, Iceland, and Liechtenstein).
The centralized procedure is compulsory for specific medicinal products, including for medicines developed by means of certain biotechnological
processes, products designated as orphan medicinal products, advanced therapy medicinal products (gene therapy, somatic cell therapy,
or tissue engineered medicines) and medicinal products with a new active substance indicated for the treatment of certain diseases (HIV/AIDS,
cancer, neurodegenerative disorders, diabetes, auto-immune diseases and other immune dysfunctions, and viral diseases). For medicinal
products containing a new active substance not yet authorized in the EEA before May 20, 2004 and indicated for the treatment of other
diseases, medicinal products that constitute significant therapeutic, scientific or technical innovations or for which the grant of a
MA through the centralized procedure would be in the interest of public health at EU level, an applicant may voluntarily submit an application
for a MA through the centralized procedure.

Under the centralized procedure, the Committee for Medicinal Products
for Human Use (“CHMP”) is responsible for conducting the initial assessment of a drug. The CHMP is also responsible for several
post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing MA. Under the centralized
procedure, the timeframe for the evaluation of an MAA by the EMA’s CHMP is, in principle, 210 days from receipt of a valid MAA.
However, this timeline excludes clock stops, when additional written or oral information is to be provided by the applicant in response
to questions asked by the CHMP, so the overall process typically takes a year or more, unless the application is eligible for an accelerated
assessment. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a
major public health interest, particularly from the point of view of therapeutic innovation. Upon request, the CHMP can reduce the time
frame to 150 days if the applicant provides sufficient justification for an accelerated assessment. The CHMP will provide a positive opinion
regarding the application only if it meets certain quality, safety and efficacy requirements. This opinion is then transmitted to the
EC, which has the ultimate authority for granting MA within 67 days after receipt of the CHMP opinion.

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Decentralized
Authorization Procedure

Medicines
that fall outside the mandatory scope of the centralized procedure have three routes to authorization: (i) they can be authorized under
the centralized procedure if they concern a significant therapeutic, scientific or technical innovation, or if their authorization would
be in the interest of public health; (ii) they can be authorized under a decentralized procedure where an applicant applies for simultaneous
authorization in more than one EU member state; or (iii) they can be authorized in an EU member state in accordance with that state’s
national procedures and then be authorized in other EU countries by a procedure whereby the countries concerned agree to recognize the
validity of the original, national MA (mutual recognition procedure).

The decentralized procedure permits companies to file identical MAAs
for a medicinal product to the competent authorities in various EU member states simultaneously if such medicinal product has not received
marketing approval in any EU member state before. This procedure is available for pharmaceutical products not falling within the mandatory
scope of the centralized procedure. The competent authority of a single EU member state, the reference member state, is appointed to review
the application and provide an assessment report. The competent authorities of the other EU member states, the concerned member states,
are subsequently required to grant a MA for their territories on the basis of this assessment. The only exception to this is where the
competent authority of an EU member state considers that there are concerns of potential serious risk to public health, the disputed points
are subject to a dispute resolution mechanism and may eventually be referred to the EC, whose decision is binding for all EU member states.

Risk
Management Plan

All
new MAAs must include a Risk Management Plan (“RMP”) describing the risk management system that the company will put in place
and documenting measures to prevent or minimize the risks associated with the product. RMPs are continually modified and updated throughout
the lifetime of the medicine as new information becomes available. An updated RMP must be submitted: (i) at the request of EMA or a national
competent authority, or (ii) whenever the risk-management system is modified, especially as the result of new information being received
that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimization
milestone being reached. The regulatory authorities may also impose specific obligations as a condition of the MA. Since October 20, 2023,
all RMPs for centrally authorized products are published by the EMA, subject only to limited redactions.

MA
Validity Period

MAs
have an initial duration of five years. After these five years, the authorization may subsequently be renewed on the basis of a reevaluation
of the risk-benefit balance. Once renewed, the MA is valid for an unlimited period unless the EC or the national competent authority decides,
on justified grounds relating to pharmacovigilance, to proceed with only one additional five-year renewal. Applications for renewal must
be made to the EMA at least nine months before the five-year period expires.

Any
authorization which is not followed by the actual placing of the drug on the EU market (in case of centralized procedure) or on the market
of the authorizing member state within three years after authorization ceases to be valid.

For
the UK, the period of three years during which the drug has not been marketed in Great Britain will be restarted from the date of conversion
to a Great Britain MA. Following Windsor Framework changes, which became effective January 1, 2025, European Commission Union authorizations
are no longer valid in Northern Ireland and centrally authorized products are instead authorized by the MHRA under UK-wide marketing authorizations;
existing licenses for product licensed by the MHRA that covers Great Britain only become geographically valid UK-wide while retaining
their license number/prefix.

On
the other hand, for the EU, in the case the drug has been marketed in the UK, the placing on the UK market before the end of the period
starting when the UK left the EU on January 31, 2020 and ending on December 31, 2020 (the “Brexit Transition Period”) will
be taken into account. If, after the end of the Brexit Transition Period, the drug is not placed on any other market of the remaining
member states of the EU, the three year period will start running from the last date the drug was placed on the UK market before the end
of the Brexit Transition Period.

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Advanced
Therapy Medicinal Products

In
the EU, medicinal products, including advanced therapy medicinal products (“ATMPs”) are subject to extensive pre-and post-market
regulation by regulatory authorities at both the EU and national levels. ATMPs comprise gene therapy products, somatic cell therapy products
and tissue engineered products, which are genes, cells or tissues that have undergone substantial manipulation and that are administered
to human beings in order to cure, diagnose or prevent diseases or regenerate, repair or replace a human tissue. Pursuant to Regulation
(EC) No 1394/2007, the Committee for Advanced Therapies (“CAT”) is responsible in conjunction
with the CHMP for the evaluation of ATMPs. The CHMP and CAT are also responsible for providing guidelines on ATMPs. These guidelines provide
additional guidance on the factors that the EMA will consider in relation to the development and evaluation of ATMPs and include, among
other things, the preclinical studies required to characterize ATMPs. Although such guidelines are not legally binding, compliance with
them is often necessary to gain and maintain approval for product candidates.

In
addition to the mandatory RMP, the holder of a MA for an ATMP must put in place and maintain a system to ensure that each individual product
and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced
through the sourcing, manufacturing, packaging, storage, transport and delivery to the relevant healthcare institution where the product
is used.

Data
and Market Exclusivity

As
in the United States, it may be possible to obtain a period of market and / or data exclusivity in the EU that would have the effect of
postponing the entry into the marketplace of a competitor’s generic, hybrid or biosimilar product (even if the pharmaceutical product
has already received a MA) and prohibiting another applicant from relying on the MA holder’s pharmacological, toxicological and
clinical data in support of another MA for the purposes of submitting an application, obtaining MA or placing the product on the market.
Innovative medicinal products, referred to as New Chemical Entities (“NCEs”) approved in the EU qualify for eight years of
data exclusivity and 10 years of marketing exclusivity.

An
additional non-cumulative one-year period of marketing exclusivity is possible if during the data exclusivity period (the first eight
years of the 10-year marketing exclusivity period), the MA holder obtains an authorization for one or more new therapeutic indications
that are deemed to bring a significant clinical benefit compared to existing therapies.

The
data exclusivity period begins on the date of the product’s first MA in the EU. After eight years, a generic product application
may be submitted, and generic companies may rely on the MA holder’s data. However, a generic product cannot launch until two years
later (or a total of 10 years after the first MA in the EU of the innovator product), or three years later (or a total of 11 years after
the first MA in the EU of the innovator product) if the MA holder obtains MA for a new indication with significant clinical benefit within
the eight-year data exclusivity period. Additionally, another noncumulative one-year period of data exclusivity can be added to the eight
years of data exclusivity where an application is made for a new indication for a well-established substance, provided that significant
pre-clinical or clinical studies were carried out in relation to the new indication. Another year of data exclusivity may be added to
the eight years, where a change of classification of a pharmaceutical product has been authorized on the basis of significant pre-trial
tests or clinical trials (when examining an application by another applicant for or holder of market authorization for a change of classification
of the same substance the competent authority will not refer to the results of those tests or trials for one year after the initial change
was authorized).

Products
may not be granted data exclusivity since there is no guarantee that a product will be considered by the EU’s regulatory authorities
to include a NCE. Even if a compound is considered to be a NCE and the MA applicant is able to gain the prescribed period of data exclusivity,
another company nevertheless could also market another version of the medicinal product if such company can complete a full MAA with their
own complete database of pharmaceutical tests, preclinical studies and clinical trials and obtain MA of its product.

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On
April 26, 2023, the EC submitted a proposal for the reform of the European pharmaceutical legislation and negotiations are still ongoing.
The timing for finalization of these negotiations and entry into force are unclear.

The
current drafts envisage:

Orphan
Designation and Exclusivity

The
criteria for designating an orphan medicinal product in the EU are similar in principle to those in the United States. The EMA grants
orphan drug designation if the medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically
debilitating condition affecting no more than five in 10,000 persons in the EU (prevalence criterion). In addition, orphan drug designation
can be granted if, for economic reasons, the medicinal product would be unlikely to be developed without incentives and if there is no
other satisfactory method approved in the EU of diagnosing, preventing, or treating the condition, or if such a method exists, the proposed
medicinal product is a significant benefit to patients affected by the condition. An application for orphan drug designation (which is
not a MA, as not all orphan-designated medicines reach the authorization application stage) must be submitted first before an application
for MA of the medicinal product is submitted. The applicant will receive a fee reduction for the MAA if the orphan drug designation has
been granted, but not if the designation is still pending at the time the MA is submitted, and sponsors must submit an annual report to
EMA summarizing the status of development of the medicine. Orphan drug designation does not convey any advantage in, or shorten the duration
of, the regulatory review and approval process. Designated orphan medicines are eligible for conditional MA.

The
EMA’s Committee for Orphan Medicinal Products (“COMP”) reassesses the orphan drug designation of a product in parallel
with the review for a MA; for a product to benefit from market exclusivity it must maintain its orphan drug designation at the time of
MA review by the EMA and approval by the EC. Additionally, any MA granted for an orphan medicinal product must only cover the therapeutic
indication(s) that are covered by the orphan drug designation. Upon the grant of a MA, orphan drug designation provides up to ten years
of market exclusivity in the orphan indication.

During
the 10-year period of market exclusivity, with a limited number of exceptions, the regulatory authorities of the EU member states and
the EMA may not accept applications for MA, accept an application to extend an existing MA or grant a MA for other similar medicinal products
for the same therapeutic indication. A similar medicinal product is defined as a medicinal product containing a similar active substance
or substances as contained in a currently authorized orphan medicinal product, and which is intended for the same therapeutic indication.
An orphan medicinal product can also obtain an additional two years of market exclusivity for an orphan-designated condition when the
results of specific studies are reflected in the Summary of Product Characteristics (“SmPC”) addressing the pediatric population
and completed in accordance with a fully compliant Pediatric Investigation Plan (“PIP”). No extension to any supplementary
protection certificate can be granted on the basis of pediatric studies for orphan indications.

The
10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer
meets the criteria for orphan designation, i.e. the condition prevalence or financial returns criteria under Article 3 of Regulation (EC)
No. 141/2000 on orphan medicinal products. When the period of orphan market exclusivity for an indication ends, the orphan drug designation
for that indication expires as well. Orphan exclusivity runs in parallel with normal rules on data exclusivity and market protection.
Additionally, a MA may be granted to a similar medicinal product (orphan or not) for the same or overlapping indication subject to certain
requirements.

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In
the UK, following the post-Brexit transition period, a system for incentivizing the development of orphan medicines was introduced. Overall,
the requirements for orphan designation largely replicate the requirements in the EU and the benefit of market exclusivity has been retained.
Products with an orphan designation in the EU can be considered for an orphan MA in Great Britain, and marketing authorizations granted
for products that fulfil UK orphan criteria are valid UK-wide regardless of whether there is an EU orphan designation. The MHRA will review
applications for orphan designation at the time of a MA, and will offer incentives, such as market exclusivity and full or partial refunds
for MA fees to encourage the development of medicines in rare diseases. Separately, the MHRA has
stated that it is considering updating its licensing framework for orphan medicines, with a draft framework expected by spring 2026.

Pediatric
Development

In
the EU, companies developing a new medicinal product are obligated to study their product in children and must therefore submit a PIP,
together with a request for agreement to the EMA. The EMA issues a decision on the PIP based on an opinion of the EMA’s Pediatric
Committee. Companies must conduct pediatric clinical trials in accordance with the PIP approved by the EMA, unless a deferral (e.g. until
enough information to demonstrate its effectiveness and safety in adults is available) or waiver (e.g. because the relevant disease or
condition occurs only in adults) has been granted by the EMA. The MAA for the medicinal product must include the results of all pediatric
clinical trials performed and details of all information collected in compliance with the approved PIP, unless a waiver or a deferral
has been granted, in which case the pediatric clinical trials may be completed at a later date. Medicinal products that are granted a
MA on the basis of the pediatric clinical trials conducted in accordance with the approved PIP are eligible for a six month extension
of the protection under a supplementary protection certificate (if any is in effect at the time of approval) or, in the case of orphan
medicinal products, a two year extension of the orphan market exclusivity. This pediatric reward is subject to specific conditions and
is not automatically available when data in compliance with the approved PIP are developed and submitted. An approved PIP is also required
when a MA holder wants to add a new indication, medicinal form or route of administration for a medicine that is already authorized and
covered by intellectual property rights.

In
the UK, the MHRA has published guidance on the procedures for UK Pediatric Investigation Plans which, where possible, mirror the submission
format and requirements of the EU system. From January 1, 2025, EU pediatric requirements are addressed via Windsor Framework categorization:
for Category 2 products, both UK and EU pediatric requirements apply, and an EU-agreed PIP must also be in place (unless waived).

PRIME
Designation

In
March 2016, the EMA launched an initiative to facilitate development of product candidates in indications, often rare, for which few or
no therapies currently exist. The Priority Medicines (“PRIME”) scheme is intended to encourage drug development in areas of
unmet medical need and provides accelerated assessment of products representing substantial innovation reviewed under the centralized
procedure. Products from small-and medium-sized enterprises may qualify for earlier entry into the PRIME scheme than larger companies
on the basis of compelling non-clinical data and tolerability data from initial clinical trials. Many benefits accrue to sponsors of product
candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions
on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted.
Importantly, once a candidate medicine has been selected for the PRIME scheme, a dedicated contact point and rapporteur from the CHMP
or from CAT are appointed facilitating increased understanding of the product at EMA’s Committee level. A kick-off meeting with
the CHMP/CAT rapporteur initiates these relationships and includes a team of multidisciplinary experts to provide guidance on the overall
development plan and regulatory strategy. PRIME eligibility does not change the standards for product approval, and there is no assurance
that any such designation or eligibility will result in expedited review or approval.

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Post-Approval
Regulation

Similar
to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the
EMA, the EC and/or the competent regulatory authorities of the EU member states. This oversight applies both before and after grant of
manufacturing licenses and MAs. It includes control of compliance with EU good manufacturing practices rules, manufacturing authorizations,
pharmacovigilance rules and requirements governing advertising, promotion, sale, and distribution, recordkeeping, importing and exporting
of medicinal products.

Failure
by us or by any of our third-party partners, including suppliers, manufacturers and distributors to comply with EU laws and the related
national laws of individual EU member states governing the conduct of clinical trials, manufacturing approval, MA of medicinal products
and marketing of such products, both before and after grant of MA, statutory health insurance, bribery and anti-corruption or other applicable
regulatory requirements may result in administrative, civil or criminal penalties.

These
penalties could include delays or refusal to authorize the conduct of clinical trials or to grant MA, product withdrawals and recalls,
product seizures, suspension, withdrawal or variation of the MA, total or partial suspension of production, distribution, manufacturing
or clinical trials, operating restrictions, injunctions, suspension of licenses, fines and criminal penalties.

The
holder of a MA for a medicinal product must also comply with EU pharmacovigilance legislation and its related regulations and guidelines,
which entail many requirements for conducting pharmacovigilance, or the assessment and monitoring of the safety of medicinal products.

These
pharmacovigilance rules can impose on holders of MAs the obligation to conduct a labor intensive collection of data regarding the risks
and benefits of marketed medicinal products and to engage in ongoing assessments of those risks and benefits, including the possible requirement
to conduct additional clinical studies or post-authorization safety studies to obtain further information on a medicine’s safety,
or to measure the effectiveness of risk-management measures, which may be time consuming and expensive and could impact our profitability.
MA holders must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance, who
is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission
of Periodic Safety Update Reports (“PSURs”), in relation to medicinal products for which they hold MAs. The EMA reviews PSURs
for medicinal products authorized through the centralized procedure. If the EMA has concerns that the risk benefit profile of a product
has varied, it can adopt an opinion advising that the existing MA for the product be suspended, withdrawn or varied. The agency can advise
that the MA holder be obliged to conduct post-authorization Phase IV safety studies. If the EC agrees with the opinion, it can adopt a
decision varying the existing MA. Failure by the MA holder to fulfill the obligations for which the EC’s decision provides can undermine
the ongoing validity of the MA.

More
generally, non-compliance with pharmacovigilance obligations can lead to the variation, suspension or withdrawal of the MA for the product
or imposition of financial penalties or other enforcement measures.

The
manufacturing process for pharmaceutical products in the EU is highly regulated and regulators may shut down manufacturing facilities
that they believe do not comply with regulations.

Manufacturing
requires a manufacturing authorization, and the manufacturing authorization holder must comply with various requirements set out in the
applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC (repealed by Directive 2017/1572 on
January 31, 2022), Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice (“GMP”).
These requirements include compliance with EU GMP standards when manufacturing pharmaceutical products and active pharmaceutical ingredients,
including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical
ingredients into the EU. Amendments or replacements of at least Directive 2001/83/EC and Regulation (EC) No 726/2004 are part of the reform
proposal for European pharmaceutical legislation. Similarly, the distribution of pharmaceutical products into and within the EU is subject
to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for
distribution granted by the competent authorities of the EU member states. The manufacturer or importer must have a qualified person who
is responsible for certifying that each batch of product has been manufactured in accordance with GMP, before releasing the product for
commercial distribution in the EU or for use in a clinical trial. Manufacturing facilities are subject to periodic inspections by the
competent authorities for compliance with GMP.

On
October 27, 2025, the Council of the European Union approved a framework for compulsory licensing of crisis-relevant products (including
medicinal products) in crisis situations. While the proposal focuses on voluntary agreements with intellectual property rights holders,
it includes rules on compulsory licensing as a measure of last resort upon activation / declaration of a crisis or emergency mode. The
European Parliament has not yet voted on the proposal.

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Sales
and Marketing Regulations

The
advertising and promotion of our products is also subject to EU laws concerning promotion of medicinal products, interactions with physicians,
misleading and comparative advertising and unfair commercial practices. In addition, other national legislation of individual EU member
states may apply to the advertising and promotion of medicinal products and may differ from one country to another. These laws require
that promotional materials and advertising in relation to medicinal products comply with the product’s SmPC as approved by the competent
regulatory authorities. The SmPC is the document that provides information to physicians concerning the safe and effective use of the
medicinal product. It forms an intrinsic and integral part of the MA granted for the medicinal product. Promotion of a medicinal product
that does not comply with the SmPC is considered to constitute off-label promotion. All advertising and promotional activities for the
product must be consistent with the approved SmPC and therefore all off-label promotion is prohibited. Direct-to-consumer advertising
of prescription-only medicines is also prohibited in the EU. Violations of the rules governing the promotion of medicinal products in
the EU could be penalized by administrative measures, fines and imprisonment. These laws may further limit or restrict the advertising
and promotion of our products to the general public and may also impose limitations on its promotional activities with healthcare professionals.
EU regulation with regards to dispensing, sale and purchase of medicines has generally been preserved in the UK following Brexit, through
the Human Medicines Regulations. However, organizations wishing to sell medicines online need to register with the MHRA. Following Brexit,
the requirements to display the common logo no longer apply to UK-based online sellers, except for those established in Northern Ireland.

Anti-Corruption
Legislation

In
the EU, interactions between pharmaceutical companies and physicians are also governed by strict laws, regulations, industry self-regulation
codes of conduct and physicians’ codes of professional conduct both at EU level and in the individual EU member states. The provision
of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order
or use of medicinal products is prohibited in the EU. The provision of benefits or advantages to physicians is also governed by the national
anti-bribery laws of the EU member states. Violation of these laws could result in substantial fines and imprisonment.

Payments
made to physicians in certain EU member states also must be publicly disclosed. Moreover, agreements with physicians must often be the
subject of prior notification and approval by the physician’s employer, his/her regulatory professional organization, and/or the
competent authorities of the individual EU member states. These requirements are provided in the national laws, industry codes, or professional
codes of conduct, applicable in the individual EU member states. Failure to comply with these requirements could result in reputational
risk, public reprimands, administrative penalties, fines or imprisonment. In the UK, the pharmaceutical sector is recognized as being
particularly vulnerable to corrupt practices, some of which fall within the scope of the Bribery Act 2010. Due to the Bribery Act 2010’s
far-reaching territorial application, the potential penalized act does not have to occur in the UK to become within its scope. If the
act or omission does not take place in the UK, but the person’s act or omission would constitute an offense if carried out there
and the person has a close connection with the UK, an offense will still have been committed. The Bribery Act 2010 is comprised of four
offenses that cover (i) individuals, companies and partnerships that give, promise or offer bribes, (ii) individuals, companies and partnerships
that request, agree to receive or accept bribes,(iii) individuals, companies and partnerships that bribe foreign public officials and
(iv) companies and partnerships that fail to prevent persons acting on their behalf from paying bribes. The penalties imposed under the
Bribery Act 2010 depend on the offence committed, harm and culpability and penalties range from unlimited fines to imprisonment for a
maximum term of ten years and in some cases both.

Regulations
in the UK and Other Markets

The
UK formally left the EU on January 31, 2020 and EU laws now only apply to the UK in respect of Northern Ireland as laid out in the protocol
on Ireland and Northern Ireland and as amended by the Windsor Framework sets out a long-term set of arrangements for the supply of medicines
into Northern Ireland.

The
EU and the UK agreed on a trade and cooperation agreement (“TCA”), which includes provisions affecting the life sciences
sector (including on customs and tariffs). There are some specific provisions concerning pharmaceuticals, including the mutual recognition
of GMP, inspections of manufacturing facilities for medicinal products and GMP issued documents. The TCA does not, however, contain wholesale
mutual recognition of UK and EU pharmaceutical regulations and product standards.

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The
UK government has adopted the Medicines and Medical Devices Act 2021 (the “MMDA”) to enable the UK’s regulatory frameworks
to be updated following the UK’s departure from the EU. The MMDA introduces regulation-making, delegated powers covering the fields
of human medicines, clinical trials of human medicines, veterinary medicines and medical devices. The MHRA has since been consulting on
future regulations for medicines and medical devices in the UK.

For
other countries outside of the EU, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct
of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials
must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin
in the Declaration of Helsinki.

If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical
trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Human Capital Resources

As of December 31, 2025, we
had 6 full-time employees in the United States and 15 full-time employees in the United Kingdom. We consider the intellectual capital
of our employees to be an important driver of our business and key to our future prospects. We monitor our compensation programs closely
and provide what we consider to be a very competitive mix of compensation and insurance benefits for all our employees, as well as participation
in our equity programs. None of our employees is subject to a collective bargaining agreement or represented by a trade or labor union.
We consider our relations with our employees to be good.

Corporate Information

We were incorporated under
the laws of the State of Nevada on September 25, 2015. Our principal executive office is located at 225 NE Mizner Blvd, Suite 640, Boca
Raton FL 33432 and our telephone number is (561) 710-0512.