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●Briquilimab
demonstrated a rapid onset of clinical efficacy with clinical responses seen as early as
1 week post-dose and complete responses observed as early as week 2 post-dose.

●Briquilimab
drove deep and meaningful clinical responses at dose levels of 180mg or higher, most notably
with 100% of patients in the 240mg single dose cohorts achieving complete responses in the
first 8 weeks.

●Briquilimab
was well-tolerated and demonstrated a favorable safety profile:

oKIT-related
adverse events (“AEs”) were generally transient, low-grade events;

oThe
majority of AEs observed were resolved while on study prior to subsequent doses; and

oNo
dose delays, missed doses or discontinuations were reported due to AEs possibly related to
KIT blockade.

1

While the data generated to date in the BEACON
study has generally been positive, in the July 2025 data update, results from the 240mg Q8W and the 240mg/180mg Q8W dose cohorts demonstrated
an atypical absence of UAS7 reduction in 11 of the 13 patients enrolled, and as a result, we launched an investigation into those two
cohorts. Factors examined included clinical site conduct, site dosing procedures, patient selection criteria, as well as potential product
lot variability in one lot of drug product first introduced into the BEACON study in those two cohorts. We also provided new clinical
drug supply from a different lot for ongoing dosing of existing patients and subsequently enrolled an additional 10 patients in aggregate
across those two cohorts. Based on the work conducted during the investigation, we concluded the anomalous efficacy results in these two
cohorts was not the result of any issues with the investigational product used, or from drug substance (“DS”) or drug product
(“DP”) manufacturing or distribution processes, but rather appeared to be an issue resulting from patient selection process/criteria
at certain clinical sites participating in the study. The conclusions reached as a result of the investigation were supported by expert
panels comprised of key opinion leaders in clinical development and antibody manufacturing that reviewed the findings and provided feedback
and recommendations on patient enrollment processes that are being integrated into the planned Phase 2b/3 CSU study to increase the likelihood
that CSU patients enrolled in the study would be more likely to have mast cell driven disease. These recommendations were incorporated
into enrollment of the additional patients in the 240mg Q8W and 240mg/180mg Q8W cohorts. Given the additional data reported in January
2026 for 6 patients dosed with briquilimab in the 240mg/180mgQ8W cohort showed deep and meaningful clinical responses with UAS7 reductions
of as much as 29 points observed and 4 of 6 participants (67%) reporting a complete response at 12 weeks, we believe these recommendations
have been effective and we are integrating them into our planned Phase 2b/3 CSU study.

CIndU
– SPOTLIGHT Study

In
early 2024, we commenced the Phase 1b/2a SPOTLIGHT study in CIndU. The SPOTLIGHT study is a Phase 1b/2a open label clinical trial evaluating
single doses of subcutaneous briquilimab in adult participants with cold urticaria or symptomatic dermographism, the two most prevalent
sub types of CIndU, who are refractory to antihistamines. The study enrolled 27 participants across three single dose cohorts of 40mg,
120mg, and 180mg. In October 2024, we presented positive preliminary data on the 40mg and 120mg cohorts from the study for a 6-week preliminary
analysis period following dosing, and in June 2025, we reported positive preliminary data from the 180mg single dose cohort at the 8-week
preliminary analysis period. Highlights of the data presented were as follows:

●Briquilimab
treatment resulted in deep disease control at all three dose levels with 26 of 27 participants
(96%) enrolled in the study achieving a clinical response within the 8-week preliminary analysis
period following dosing, and 21 of 24 participants (88%) dosed at 120mg or 180mg achieving
a complete response in that period; and

●
Briquilimab
was well-tolerated in the study, with KIT-related AEs being low-grade events,
and no grade 3 or higher AEs possibly related to KIT blockade reported in any of the dose
cohorts.

Open
Label Extension (OLE) Study

In
2025, we commenced an Open Label Extension study (the “OLE”) in which patients in the BEACON study in CSU and the SPOTLIGHT
study in CIndU were eligible to roll over to once they either completed their initial safety follow up period or experienced a return
of disease during the safety follow up period. All patients rolling over to the OLE study were treated with a 180mg Q8W dosing regimen.
In January 2026, we reported preliminary data from the OLE study in both CSU and CIndU patients.

2

Highlights
of the clinical efficacy observed in CSU and CIndU participants for the OLE study released in January 2026 were as follows:

●In
CSU participants, briquilimab treatment resulted in deep and durable disease control in the
OLE study with 27 of 36 participants (75%) achieving complete response or well controlled
disease at the week 12 assessment; and

●In
CIndU participants, briquilimab treatment resulted in deep and durable disease control as
well, with 11 of 17 participants (65%) achieving complete response or partial response at
the week 16 assessment, which was 8 weeks following administration of the second dose.

Across
both CSU and CIndU participants in the OLE study, briquilimab continued to demonstrate a favorable safety profile:

●
KIT-related
AEs were generally transient, low-grade events;

●The
majority of AEs observed were resolved while on study prior to subsequent doses;

●One
patient discontinued therapy due to taste disturbance potentially related to briquilimab;
and

●No
other dose delays, missed doses or discontinuations were reported due to AEs possibly related
to KIT blockade.

Asthma
– ETESIAN Study

In
late 2024, we commenced a Phase 1b study in asthma, the “ETESIAN” study, which is a single dose double-blind, placebo-controlled
challenge study seeking to demonstrate proof-of-concept in asthma utilizing a potential therapeutic dose to inform future trials in the
broader asthma population. The study was conducted utilizing a single 180mg dose of subcutaneous briquilimab and key assessments included
measuring improvements in Forced Expiratory Volume in 1 second (“FEV1”) in both Early Asthmatic Response (“EAR”),
and Late Asthmatic Response (“LAR”) measured at 6 and 12 weeks, changes in airway hyperresponsiveness, mast cell depletion
and recovery, and safety.

In December 2025, we reported preliminary results
from the ETESIAN study in 14 participants (7 receiving a single dose of 180mg briquilimab and 7 receiving placebo) who completed at least
the 6 week allergen challenge assessment following dosing with investigational product or placebo. Highlights of the clinical response
observed in ETESIAN participants reported in December 2025 were as follows:

●Compared
to baseline, briquilimab reduced the allergen induced LAR (measured by the mean maximum percentage
fall in FEV1 (%Max FEV1) and fall in area under the FEV1 time
response curve (“AUC”)) at both 6 and 12 weeks. Patients who received briquilimab
showed an improvement in the LAR %Max FEV1 of 10.4% at 6 weeks and 8.7% at
12 weeks compared to baseline, as well as demonstrating an improvement in the LAR AUC of
25.4% at 6 weeks and 23.3% at 12 weeks.

●Sputum
eosinophils, a potential marker of inflammatory response, were also measured at 7 and 24
hours following allergen challenge at week 6 and week 12. Participants receiving briquilimab
demonstrated notably lower eosinophil levels as compared to those receiving placebo, indicating
a reduction in the inflammatory response to their allergen.

3

The positive proof of concept
data generated in the ETESIAN study supports further development in the broader asthma population, however, advancing any future clinical
studies in asthma would be based on an evaluation of the competitive landscape, the potential for strategic partnerships and capital availability.

Historically,
we have also evaluated briquilimab as a one-time conditioning therapy for severe combined immunodeficiency (“SCID”) patients
undergoing a second stem cell transplant for which we conducted a Phase 1/2 clinical trial as well as via Investigator Sponsored Trials
(“ISTs”) in several other stem cell transplant indications. In July 2025, we re-focused resources on our mast cell disease
development programs.

We
intend to become a fully integrated discovery, development and commercial company in the field of mast cell therapeutics. We are developing
our product candidates to be used individually or, in some cases, in combination with other therapeutics. Our goal is to advance our
product candidates through regulatory approval and bring them to the commercial market based on the data from our clinical trials and
communications with regulatory agencies and payor communities. We expect to continue to broaden our pipeline with additional mast cell
indications.

We
have an exclusive license agreement with Amgen Inc. (“Amgen”) for the development and commercialization of the briquilimab
monoclonal antibody in all indications and territories worldwide. We also have an exclusive license agreement with Stanford University
for the right to use briquilimab in the clearance of diseased stem cells prior to the transplantation of hematopoietic stem cells (“HSCs”).

Briquilimab

We believe briquilimab is a unique, humanized,
monoclonal antibody that targets the underlying biology of mast cell survival to potentially serve as a therapeutic to prevent mast cell
driven diseases. In addition, we believe briquilimab targets a key differentiation pathway for HSCs and may be developed to improve the
efficacy and safety of hematopoietic stem cell transplantation. Briquilimab binds to human KIT, the receptor for SCF, which is expressed
on the surface of various cells, including mast cells. The interaction of SCF and KIT is required for mast cells to survive. By blocking
SCF from binding to KIT and disrupting these critical signals, briquilimab leads to the depletion of mast cells in the skin. Briquilimab
is designed to bind to KIT with a greater affinity than SCF.

The monoclonal antibody isotype and other modifications
of briquilimab were chosen carefully to retain high affinity binding to the KIT receptor and SCF signal blockade without recruiting other
immune cells that could lead to receptor activation, mast cell degranulation or other off-target toxicities. For example, designing briquilimab
as an IgG1 isotype instead of an IgG2 isotype results in more potent inhibition of KIT, potentially increasing the effect on mast cell
depletion. Briquilimab was also designed to be aglycosylated in order to eliminate the recruitment of other immune effector cells that
may bring unwanted effects to any cell that expresses KIT. This finding and other data demonstrate that not all anti-KIT antibodies behave
equally or have the same mechanism of action.

We
are focused on advancing Briquilimab in development as a chronic therapy in mast cell driven diseases such as CSU, CIndU, asthma and
other mast cell driven indications currently under evaluation.

Briquilimab
as a Primary Therapeutic for Disorders of Mast Cells

Mast
cells are primary cells of the immune system derived from HSCs in the bone marrow. Mast cells store a number of different chemical mediators
such as tryptase, histamine, interleukins and heparin in granules found throughout the cell. When a mast cell is triggered, such as by
an allergen specific to membrane-bound Immunoglobulin E (“IgE”) antibodies, the mast cell is activated and releases the content
of the granules into the surrounding tissue. These chemical mediators attract other immune cells to help with any response as well as
produce a local allergic reaction consisting of inflammation, swelling, contraction of smooth muscle and increased mucus secretion. Mast
cells are usually long-lived and found at boundaries to the external environment such as the skin, mucosal surfaces of the gut and lungs
and eye.

4

Dysfunctional
regulation and activation of mast cells is thought to be a significant driver of multiple diseases, including urticarias, asthma, prurigo
nodularis, allergic eye disease and others. Each of these diseases has been shown to have local concentrations of mast cells, cellular
response consistent with mast cell degranulation and disease modification with use of antihistamines. Unfortunately, currently approved
agents targeting mast cells in these diseases are ineffective in many patients, leading to continued high disease burden.

Briquilimab blocks signaling on the KIT receptor
by inhibiting the binding of SCF, the ligand for the KIT receptor. The interaction of SCF/KIT on mast cells is critical for development,
proliferation and survival. Without continued signaling through KIT, mast cells will undergo apoptosis and die. We have shown that a single
subcutaneous dose of briquilimab leads to depletion of mast cells in the skin of healthy human volunteers for at least 29 days. We believe
that depletion of mast cells in the skin of patients with chronic urticaria or other mast cell driven diseases has the potential to lead
to improved disease control for those patients without adequate response to current therapies.

Figure
1 – Healthy volunteers administered single doses of briquilimab 42 mg to 280 mg subcutaneously received punch skin biopsies to
evaluate the decreases in mast cells at 4 weeks after briquilimab was administered compared to the baseline.

(1)
Jasper
internal data (Phase 1a, healthy volunteer study).

Briquilimab
in Chronic Urticaria

Mast
cells are immune cells that play a key role in the inflammatory response to pathogens or injury and are typically found in the skin,
lungs, digestive track, conjunctiva of the eye and the mucosal linings of the mouth and nose. Typically, mast cells are triggered by
a specific antigen or antibody interaction to release histamine, a variety of cytokines and other chemical mediators in order fight
a potential infection and to recruit additional types of immune cells to aid in the body’s response. However, with certain
diseases, such as CSU, CIndU, allergic asthma, prurigo nodularis and eosinophilic esophagitis, the mast cell response is
dysregulated and may lead to unwanted responses such as hives, itching, airway constriction or conjunctivitis. Current therapeutic
approaches to controlling mast cell response include antihistamines to counteract the release of histamine by activated mast cells,
anti-IgE antibody therapy to try to eliminate the antibodies responsible for a trigger of mast cell activation and inhibition of
other signaling pathways such as Bruton’s Tyrosine Kinase (“BTK”) or IL4/IL13 that may suppress mast cell
activation. We believe that new chronic therapies that target mast cells could be beneficial in treating many diseases that are a
function of mast cell dysfunction.

5

In late 2023, we commenced a Phase 1b/2a clinical
trial in patients with CSU. CSU is a disorder of mast cells in the skin in which patients experience swelling, redness and itching of
the skin that lasts at least six weeks due to either an unknown cause, Type I autoimmunity with IgE against self or Type IIb autoimmunity
with activating antibodies directed at mast cells. CSU is thought to affect over five million patients in the United States, France, Germany,
Italy, Spain, and the United Kingdom. The U.S. Food and Drug Administration (the “FDA”)-approved drug therapy for CSU
includes second generation H1-antihistamines for first line use followed by consideration for use of omalizumab, a monoclonal antibody
directed at circulating IgE; dupilumab, a monoclonal antibody directed at the IL-4 and IL-13 signaling pathways; and remibrutinib, a small
molecule inhibitor of BTK. The biologic rationale for these therapies is based on modulating mast cell response. Antihistamines work to
counteract the effects of histamine that is released from activated mast cells and the other agents are thought to remove or suppress
signaling pathways that trigger mast cell activation. Based on human healthy volunteer clinical data showing that briquilimab can deplete
mast cells from the skin and from data in a study of CSU patients showing that an anti-KIT antibody can control disease symptoms, we believe
that briquilimab could be effective therapy for CSU patients. The Phase 1b/2a study is a monotherapy study being conducted in CSU patients
who are refractory to antihistamine therapy and who have had an inadequate response to omalizumab. The study design has three parts. The
first part is an open-label 3+3 dose escalation with two dose cohorts (10mg and 40mg). The second part consists of seven dose cohorts
(80mg Q8W, 120mg Q8W, 120mg Q12W, 180mg Q8W, 180mg Q12W, 240mg Q8W and 240mg/180mg Q8W) in a double-blind placebo controlled format. The
final part is a single dose cohort with two dose levels being explored (240mg single-dose and 360mg single-dose) in a double-blind placebo
controlled format.

Figure
2 – Study design for the Phase 1b/2a BEACON study in CSU.

In
January 2025, we presented positive preliminary data from the first 8 dosing cohorts in this study (10mg, 40mg, 80mg Q8W, 120mg Q8W,
120mg Q12W, 180mg Q8W, 180mg Q12W, and 240mg single-dose). Average patient duration on study as of the cutoff date for the data presented
was approximately 28 weeks. Highlights of the data presented were as follows:

●Briquilimab
demonstrated a rapid onset of clinical efficacy with clinical responses seen as early as
1 week post-dose and complete responses observed as early as week 2 post-dose.

6

●Briquilimab
drove deep and meaningful clinical responses with 100% complete responses through 8 weeks
demonstrated at the 240mg dose level.

●Briquilimab
was well-tolerated and demonstrated a favorable safety profile:

o
KIT-related
AEs were generally transient, low-grade events;

oThe
majority of AEs observed were resolved while on study prior to subsequent doses; and

oNo
dose delays, missed doses or discontinuations were reported due to AEs possibly related to
KIT blockade.

In
July 2025, we reported updated data from the Phase 1b/2a BEACON study in CSU with updates on the 240mg and 360mg single dose cohorts
as well as the 240mg Q8W and the 240mg/180mg Q8W cohorts. Highlights of the data update presented were as follows:

●Briquilimab
administration continued to demonstrate deep and rapid disease control in the 240mg and 360mg
single-dose cohorts with 8 of 9 (89%) of participants enrolled across both cohorts achieving
a complete response, and with 7 of 9 (78%) achieving a clinical response by week 2.

●Results
from the 240mg Q8W and the 240mg/180mg Q8W dose cohorts demonstrated an atypical absence
of UAS7 reduction in 11 of the 13 patients enrolled, and as a result, we launched an investigation
into those two cohorts. Factors examined included clinical site conduct, site dosing procedures,
patient selection criteria, as well as potential product lot variability in one lot of drug
product first introduced into the BEACON study in those two cohorts. We also provided new
clinical drug supply from a different lot for ongoing dosing of existing patients and subsequently
enrolled an additional 10 patients in aggregate across those two cohorts.

In
December 2025, we reported the completion of the investigation into the confounded efficacy results reported in July 2025 from the 240mg
Q8W and the 240mg/180mg Q8W cohorts of the BEACON study in CSU. Based on the work conducted, we concluded the anomalous efficacy results
in these two cohorts was not the result of any issues with the investigational product used, or from DS or DP manufacturing or distribution
processes, but rather appeared to be an issue resulting from patient selection process/criteria at certain clinical sites participating
in the study. This conclusion reflects, among other factors:

●a
comprehensive review of manufacturing and distribution records;

●robust
testing of multiple lots across the manufacturing and clinical supply chain;

●independent,
blinded testing of returned drug product samples from trial sites;

7

●review
of stability samples from the lots used in the two cohorts compared against other lots;

●review
of patient selection and enrollment processes;

●review
of investigational product handling and administration at the site level;

●review
of drug delivery methods (for example, injection site, needle and injection media); and

●review
of additional patient- and site-level data.

The conclusions reached as a result of the investigation were supported
by expert panels comprised of key opinion leaders in clinical development and antibody manufacturing that reviewed the findings and provided
feedback and recommendations that are being integrated into the planned Phase 2b/3 CSU study to increase the likelihood that CSU patients
enrolled in the study would be more likely to have mast cell driven disease.

In
January 2026, we reported updated data from the Phase 1b/2a BEACON study in CSU with updates on an additional 8 patients enrolled in
the 240mg/180mg Q8W cohort (6 on briquilimab and 2 on placebo). Highlights of the data update were as follows:

●
Briquilimab
demonstrated a rapid onset of clinical efficacy with clinical responses achieved by 5 of
6 participants (83%) by week 3.

●
Briquilimab
drove deep and meaningful clinical responses with UAS7 reductions of as much as 29 points
noted, and 4 of 6 participants (67%) reporting a complete response at 12 weeks.

●Briquilimab
continued to be well-tolerated and demonstrated a favorable safety profile:

o
KIT-related
AEs were generally transient, low-grade events;

oThe
majority of AEs observed were resolved while on study prior to subsequent doses; and

oNo
dose delays, missed doses or discontinuations were reported due to AEs possibly related to
KIT blockade.

8

We
are also conducting a Phase 1b/2a clinical trial in patients with CIndU. Similar to CSU, CIndU is a disorder of mast cells in the skin
in which patients experience swelling, redness and itching of the skin that lasts at least six weeks, but CIndU is induced by specific
physical or environmental stimuli, including cold, heat, exercise, pressure, sunlight and others. CIndU includes physical urticarias,
such as symptomatic dermographism and cold urticaria, as well as non-physical urticarias caused by exposure to specific stimuli, such
as cholinergic urticaria and aquagenic urticaria.

The
FDA-approved drug therapy for CIndU consists solely of second generation H1-antihistamines. The biologic rationale for this therapy is
based on modulating mast cell response. Antihistamines work to counteract the effects of histamine that is released from activated mast
cells. CIndU is thought to affect over two million patients in the United States, France, Germany, Italy, Spain and the United Kingdom.
Approximately 40% of these patients’ CIndU is not controlled by first line antihistamines and these patients could be eligible
for biologic therapy depending on disease severity. Based on preclinical and human healthy volunteer clinical data showing that briquilimab
can deplete mast cells from the skin, we believe that briquilimab could be an effective therapeutic for CIndU patients. The Phase 1b/2a
study is a monotherapy study being conducted in CIndU patients who are refractory to antihistamine therapy. The study design contains
a single dose in three dosing cohorts (40mg, 120mg and 180mg) with a provocation test measured at various timepoints through 12 weeks
post-dosing.

Figure
3 – Study Design for the Phase 1b/2a SPOTLIGHT Study in CIndU

In
early 2024, we commenced the Phase 1b/2a SPOTLIGHT study in CIndU. In October 2024, we presented positive preliminary data on the 40mg
and 120mg cohorts from the study showing the following for the 6-week preliminary analysis period following dosing, as follows:

●Across
the 40mg and 120mg dosing cohorts in the study, 14 of the 15 participants (93%) achieved
a clinical response;

●In
the 120mg dose cohort, 10 of 12 participants (83%) experienced a complete response, and 1
participant experienced a partial response; and

●Briquilimab
has been well-tolerated in the study, with no serious adverse events (“SAEs”)
and no grade 3 or higher AEs reported.

9

In
late 2024, we added a 180mg single dose cohort to the SPOTLIGHT study in CIndU. In June 2025, we reported positive preliminary data from
the 180mg single dose cohort, the highlights of which were as follows:

●Briquilimab
treatment resulted in deep disease control at 180mg, with 12 of 12 participants (100%) enrolled
in the cohort achieving a clinical response within the preliminary analysis period;

●The
efficacy observed was rapid and durable, with 8 of 12 participants (66%) achieving clinical
response by week 2, and 7 of 12 participants (58%) maintaining clinical response through
week 8; and

●
Briquilimab
continued to be well-tolerated in the study, with KIT-related AEs being low-grade
events, and no grade 3 or higher AEs possibly related to KIT blockade reported in any of
the dose cohorts.

In
addition to the BEACON and SPOTLIGHT studies, we also commenced an Open Label Extension study (the “OLE”) in which patients
in the BEACON study in CSU and the SPOTLIGHT study in CIndU are eligible to roll over to once they have completed their initial safety
follow up period or experienced return of disease during the safety follow up period. All patients rolling over to the OLE study are
treated with a 180mg Q8W dosing regimen.

Figure
4 – Study Design for the OLE Study in CSU and CIndU

In January 2026, we reported preliminary
data from the OLE study in both CSU and CIndU patients. Highlights of the clinical efficacy observed in CSU and CIndU participants for
the OLE study released in January 2026 were as follows:

●In
CSU participants, briquilimab treatment resulted in deep and durable disease control in the
OLE study with 27 of 36 participants (75%) achieving complete response or well controlled
disease at the week 12 assessment; and

●In
CIndU participants, briquilimab treatment resulted in deep and durable disease control as
well, with 11 of 17 participants (65%) achieving complete response or partial response at
the week 16 assessment, which was 8 weeks following administration of the second dose.

10

Across
both CSU and CIndU participants in the OLE study, briquilimab continued to demonstrate a favorable safety profile:

●
KIT-related
AEs were generally transient, low-grade events;

●
The
majority of AEs observed were resolved while on study prior to subsequent doses;

●
One
patient discontinued therapy due to taste disturbance potentially related to briquilimab;
and

●No
other dose delays, missed doses or discontinuations were reported due to AEs possibly related
to KIT blockade.

Briquilimab
in Asthma

Allergic
asthma is a form of asthma triggered by specific allergens that leads to constriction of smooth muscles in the airways, cellular infiltration
of various immune mediators and excess production of mucus. Patients with allergic asthma may have an increased number of mast cells
in the bronchi and mast cells are believed to not only be a direct driver of inflammation the asthmatic response, but to also be recruiters
of other cell types that contribute to that inflammation. Given these factors, we believe that asthma may be responsive to agents that
modulate mast cell response, including antihistamines and anti-IgE monoclonal antibody therapy.

In
late 2024, we commenced a Phase 1b clinical trial in patients with allergic asthma (the ETESIAN study). The Phase 1b study is a double-blind
placebo controlled single-dose monotherapy allergen challenge study being conducted in allergic asthma patients. Patients enrolled in
the study will either receive placebo, or a single 180mg dose of briquilimab. Endpoints evaluated will include both early and late asthmatic
response, as measured by % decrease in FEV1 relative to baseline, and change in airway hyperresponsiveness from baseline,
and both will be measured at 6 weeks post-dose and 12 weeks post-dose.

Figure
5 – Study Design for the Phase 1b ETESIAN study in Asthma

In December 2025, we reported preliminary results from the ETESIAN
study in 14 participants (7 receiving a single dose of 180mg briquilimab and 7 receiving placebo) who completed at least 6 weeks of allergen
challenge testing following dosing with investigational product. Highlights of the clinical response observed in ETESIAN participants
reported in December 2025 were as follows:

●Compared
to baseline, briquilimab reduced the allergen induced LAR (measured by the mean maximum percentage
fall in FEV1 (%Max FEV1) and fall in area under the FEV1 time
response curve (“AUC”)) at both 6 and 12 weeks with patients who received briquilimab
showing an improvement in the LAR %Max FEV1 of 10.4% at 6 weeks and 8.7%
at 12 weeks compared to baseline and an improvement in the LAR AUC of 25.4% at 6 weeks and
23.3% at 12 weeks.

11

Figure
6 – Change in FEV1 observed in ETESIAN study

●Patient
airway hyperresponsiveness was also assessed pre- and post-allergen challenge by methacholine
PD20. At baseline, prior to administration of briquilimab, patients randomized to both the
placebo group and the briquilimab group had similar drops in the ratio of post- to pre-allergen
challenge methacholine PD20 (dose of methacholine required to drive a 20% decrease in FEV1)
following allergen challenge of 0.50 and 0.46, respectively. At the week 6 challenge the
shift in the methacholine PD20 response was 0.40 for placebo and 0.63 for briquilimab and
at the week 12 challenge the shift was 0.60 for placebo and 1.58 for briquilimab indicating
an increased resistance to methacholine following allergen in patients dosed with briquilimab.

●Sputum
eosinophils, a potential marker of inflammatory response, were also measured at pre-challenge,
7 and 24 hours following allergen challenge at week 6 and week 12. Participants receiving
briquilimab demonstrated notably lower eosinophil levels as compared to those receiving placebo,
indicating a reduction in the inflammatory response to their allergen.

Figure
7 –Reduced eosinophil levels observed in participants receiving briquilimab in the ETESIAN study

The positive proof of concept
data generated in the ETESIAN study supports further development in the broader asthma population, however, advancing any future clinical
studies in asthma would be based on an evaluation of the competitive landscape, the potential for strategic partnerships and capital availability.

12

Briquilimab
in Other Mast Cell Disorders

Mast cells may also be the key cellular target
for a number of other inflammatory or autoimmune diseases outside of the chronic urticarias and asthma, such as atopic dermatitis, prurigo
nodularis and food allergies.

Atopic
dermatitis is a chronic disease that causes inflammation, redness, and irritation of the skin. It is a common condition that usually
begins in childhood; however, anyone can get the disease at any age. Atopic dermatitis causes the skin to become extremely itchy. In
most cases, there are periods of time when the disease is worse, called flares, followed by periods when the skin improves or clears
up entirely, called remissions. Treatments include moisturizers, topical steroids, immunomodulators (tacrolimus and pimecrolimus) and
biologic therapies (dupilumab). Mast cells may play an important role in the disease and agents that modulate mast cells may provide
benefit to patients.

Prurigo
Nodularis is also a disease that manifests in the skin. Patients develop severe itch and firm bumps on the skin, called nodules, that
may lead to loss of sleep and bleeding due to scratching. Degranulation of mast cells in the skin is thought to trigger peripheral sensory
neurons in the skin leading to itch. Various medications are used to treat Prurigo Nodularis including anti-itch creams and topical steroids.
For cases that remain uncontrolled physicians may prescribe antihistamines or biologics such as dupilumab.

Food
allergy is an immune-mediated disease characterized by an IgE-mediated response to specific dietary antigens, which leads to
allergic hypersensitivity reactions. In IgE-mediated food allergies, allergic reactions from exposure to the food result from receptor-bound
allergen-specific IgE antibodies binding to the food proteins, leading to the cross-linking of IgE receptors on mast cells and subsequently
mast cell activation and degranulation; resulting in the release of chemical mediators of inflammation. Symptoms of food allergy
can range from mild symptoms, such as hives and itching to potentially fatal systemic allergic reactions including anaphylaxis. Treatments
include antihistamines and steroids for mild to moderate reactions, epinephrine for severe reactions and anaphylaxis, as well as preventative
therapies such as oral immunotherapy or biologic therapies (omalizumab).

We
have performed pre-clinical evaluation of briquilimab as a potential therapeutic in these and a number of other mast cell driven diseases
and expect to continue to expand our portfolio of mast cell indications in clinical development in the future.

Briquilimab
in Non-Mast Cell Driven Disorders

Briquilimab
as a Conditioning Agent for SCID Patients Undergoing Re-Transplantation

We
historically funded a program developing briquilimab as a conditioning agent for SCID patients undergoing a stem cell re-transplantation.
Due to genetic errors at birth, SCID patients do not possess fully functional immune systems, which results in chronic infections, failure
to thrive and significantly decreased lifespans. If available, these patients are typically given a transplant from a close relative
with the goal of allowing healthy donor stem cells to establish in the patient’s bone marrow, leading to production of normal immune
cells. However, stem cell transplants are not universally successful. SCID patients with poor transplant outcomes are typically dependent
on external therapies such as intravenous immunoglobin (“IVIG”) and often have poor immunity, leading to chronic infections
and decreased lifespans. SCID patients who fail transplant are not usually given a second transplant due to their fragile health and
the significant toxicities of current conditioning agents.

We
conducted a Phase 1/2 dose escalation open label clinical trial to evaluate briquilimab as the sole conditioning agent to achieve HSC
engraftment in SCID patients undergoing stem cell re-transplantation. The primary endpoint in Phase 1 was to assess the safety and tolerability
of briquilimab as a conditioning agent in SCID patients. The two primary efficacy endpoints defined in the Phase 2 study are
the proportion of patients achieving adequate donor HSC engraftment and the proportion of patients achieving naïve CD4+ T cell production
greater than or equal to 85 cells/uL, a level expected to provide immune reconstitution, during weeks 36 to 104 post-transplant. Secondary
endpoints include durability of naïve T cell production, incidence and severity of GvHD, hematopoietic recovery and pharmacokinetic
properties of briquilimab. Patients received a single intravenous infusion of briquilimab on study day 0 in one of four dose cohorts:
0.1 mg/kg, 0.3 mg/kg, 0.6mg/kg or 1.0 mg/kg. Patients were to potentially be followed for up to five years following transplant.

13

We
believe briquilimab has enabled immune reconstitution for patients based on naïve CD4+ T-cell levels and has shown clinical benefit
in T-B-SCID patients in a re-transplant setting. Patients have shown resolution of chronic infections, independence from or reduction
of IVIG therapy and antibody response to vaccine challenge. Through December 31, 2024, in this open label clinical trial, eleven T-B-SCID
re-transplant patients have been treated in the ongoing SCID Phase 1/2 study. Seven of the eleven transplanted patients with 1-
5 years of follow-up have shown engraftment of donor cells and production of functional immune cells. No briquilimab treatment-related
“SAEs” have been reported through December 31, 2023 in this clinical trial. In July 2025, the SCID program was discontinued
to focus resources exclusively on our mast cell disease development programs.

The
FDA has granted rare pediatric disease designation to briquilimab as a conditioning treatment for patients with SCID. In addition, both
the FDA and the European Medicines Agency (“EMA”) have granted orphan drug designation to briquilimab for conditioning treatment
prior to hematopoietic stem cell transplantation.

Stem
Cell Transplant Indications

We
have historically evaluated briquilimab in a number of stem cell transplant indications, including patients with Fanconi Anemia (“FA”),
Sickle Cell Disease (“SCD”), Chronic Granulomatous Disease (“CGD”), GATA-2 MDS and others through ISTs run by
partners including the National Institute of Health (“NIH”), the National Heart, Lung, and Blood Institute, the National
Institute of Allergy and Infectious Diseases, the National Cancer Institute and Stanford University.

While
promising data has been generated to date in FA, SCD, CGD and GATA-2 MDS, given our corporate focus on mast cell driven diseases, we
have discontinued these ISTs and we have no plans to pursue additional clinical development in these indications.

Our
Strategy

Our
goal is to develop and commercialize briquilimab as a safe and efficacious therapeutic to address the significant unmet medical need
for patients suffering from mast cell driven diseases such as CSU, CIndU and asthma. As part of our strategy, we aim to:

Build
a leading biotechnology company to enable cures via immune modulation. We are bringing together a team of biotech veterans, leading
academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision of developing and commercializing
therapeutics with a focus on mast cell driven diseases.

Advance the development of briquilimab as
a chronic therapeutic in mast cell driven diseases. We are focused on developing briquilimab as a repeat dose therapy for disorders
of mast cells, such as CSU, CIndU, asthma and additional potential mast cell driven indications.

Commercialize
our product candidates to expand the use of effective and safe mast cell therapies for patients and physicians in our target markets.
If approved, we plan to bring our product candidates to the American, European and Japanese markets, focusing on the top physicians
who administer the majority of mast cell therapies.

Form
and strengthen strategic collaborations with leading industry and academic organizations to further develop our pipeline, unlock the
commercial potential of our portfolio and provide enabling technologies for collaborators. We intend to continue collaborations
with our existing partners and enter new strategic partnerships to develop additional candidates, generate evidence, and commercialize
new products in the field of mast cell therapies.

14

Agreements
with Amgen

In November 2019, we entered into a worldwide exclusive
license agreement with Amgen for briquilimab (formerly AMG-191 and JSP191) in all indications and territories worldwide, which also includes
translational science and materials from Stanford University. We were assigned and accepted Amgen’s rights and obligations, effective
November 21, 2019, for the Investigator Sponsored Research Agreement (“ISRA”), entered into in June 2013, between Amgen
and The Board of Trustees of the Leland Stanford Junior University (“Stanford”) and Quality Agreement between Amgen and Stanford,
effective as of October 7, 2015. Under the ISRA, we received an option to negotiate a definitive license with Stanford for rights to certain
Stanford intellectual property related to the study of briquilimab in exchange for an option exercise fee of $1.0 million, payable over
a two-year period (the “Option”). We exercised the Option to Stanford docket S06-265 “Antibody-based clearance of endogenous
stem cell niches prior to transplantation of bone marrow or HSCs (KIT)” granted by Stanford under the ISRA on June 2, 2020. As a
result, we have worldwide exclusive rights to develop and commercialize briquilimab in all indications, including stem cell transplants.
The issued U.S. patents would be expected to expire in 2027, absent any applicable patent term extensions.

License
Agreement with Stanford

In
March 2021, we entered into an exclusive license agreement with respect to the use of briquilimab from the Stanford Office of Technology
Licensing to license U.S. Patent Application Serial Number 60/856,435, filed Nov. 3, 2006, and U.S. Patent Application Serial Number
12/447,634 (publication number US 2010/0226927 Al) and know-how for the purpose of depleting endogenous blood stem cells in patients
for whom hematopoietic cell transplantation is indicated.

Intellectual
Property

Our
success depends in part on our ability to obtain and maintain proprietary protection for our product candidates and other discoveries,
inventions, trade secrets and know-how that are critical to our business operations. It also depends in part on our ability to operate
without infringing the proprietary rights of others, and in part, on our ability to prevent others from infringing our proprietary rights.
We have a series of in-licensed patents outlined below with an additional pending patent application in the United States.

In-licensed
Amgen Portfolio

We have exclusively licensed a patent family from
Amgen applicable to our clinical development programs that contains patents and applications directed to a humanized KIT antibody. As
of March 25, 2026, this patent portfolio includes three issued U.S. patents and one European patent, as well as granted patents in Australia,
Canada, Japan, and Mexico, and pending patent applications in Europe and Hong Kong. The issued U.S. and European patents would be expected
to expire in 2027, absent any applicable patent term extensions.

In-licensed
Stanford Portfolio

We have an exclusive license in the field of use
of briquilimab for the purpose of depleting endogenous blood stem cells in patients for whom hematopoietic cell transplantation is indicated
to a patent family from Stanford University applicable to targeted conditioning that contains patents and applications directed to immunodepletion
of endogenous stem cell niche prior to hematopoietic stem cell transplantation. As of March 25, 2026, this patent portfolio includes two
issued U.S. patents and one European patent, as well as pending European and Hong Kong patent applications. The issued U.S. and European
patents would be expected to expire in 2027, absent any applicable patent term extensions.

15

Jasper
Portfolio

As of March 25, 2026, we own two patent families
directed to compositions and/or methods for hematopoietic stem cell transplantation, one patent family directed to other methods of treating
certain hematopoietic malignancies, three patent families directed to treating mast cell-driven disease, and one patent family directed
to therapeutic efficacy testing models. These patent families include one pending U.S. provisional applications, three pending U.S. utility
applications, two pending Patent Cooperation Treaty applications, and applications pending certain other jurisdictions. Any patents that
grant from these applications would be expected to expire in 2042 to 2046, absent any applicable patent term extensions.

Additional
Intellectual Property

We
also rely on trade secrets, including know-how, confidential information, unpatented technologies and other proprietary information,
to strengthen or enhance our competitive position, and prevent competitors from reverse engineering or copying our technologies. We maintain,
as trade secrets, information relating our product candidates currently in development, as well as information related to our business
strategy and business methods. However, trade secrets and confidential know-how are difficult to protect. To avoid inadvertent and improper
disclosure of trade secrets, and to avoid the risks of former employees using these trade secrets to gain future employment, it is our
policy to require employees, consultants and independent contractors to assign to us all rights to intellectual property they develop
in connection with their employment with or services for us. We also protect our existing and developing intellectual property expressly
through confidentiality provisions in agreements with third parties. There can be no assurance, however, that these agreements will be
self-executing or otherwise provide meaningful protection for our trade secrets or other intellectual property or proprietary information,
or adequate remedies in the event of unauthorized use or disclosure of such trade secrets or other intellectual property or proprietary
information. We also seek to preserve the integrity and confidentiality of our trade secrets and other confidential information by maintaining
physical security of our premises and physical and electronic security of our information technology systems. While we have confidence
in the measures we take to protect and preserve our trade secrets, such measures can be breached, and we may not have adequate remedies
for any such breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors.

We
intend to pursue additional intellectual property protection to the extent we believe it would advance our business objectives, which
may include objectives within and outside the United States. Despite our efforts to protect our intellectual property rights these rights
may not be respected in the future or may be circumvented or challenged (and potentially invalidated) in a legal proceeding in any jurisdiction
where we have intellectual property rights. In addition, the laws of various foreign countries may not afford the same protections or
assurances to the same extent as the laws in the United States. See the section titled “Risk Factors — Risks Related to Our
Intellectual Property” for additional information regarding these and other risks related to intellectual property.

Competition

The
industry we operate in is highly competitive and dynamic, subject to rapid technological change. We have competition in the market for
both our product candidates and may face competition from large pharmaceutical and biotechnology companies, smaller pharmaceutical and
biotechnology companies, specialty pharmaceutical companies, generic drug companies, academic institutions, government agencies, research
institutions and others.

We
believe that our intellectual property, proprietary scientific knowledge, development experience and partnerships will provide us with
competitive advantages in the market we operate in.

16

We
are aware of competing products and adjacent therapies, not limited to small molecules, biologics and cell therapies, that address the
same domain of conditions we are targeting. The following list of competitors indicate companies that are directly competing with our
product candidate.

Competitors
for our briquilimab KIT targeted therapeutic program include the following:

●
Celldex
Therapeutics, Inc., which is developing an antibody to KIT that is being studied in mast cell diseases;

●
Blueprint
Medicines, which is developing a small molecule KIT inhibitor for mast cell diseases;

●
Novartis,
Inc., which is developing a small molecule inhibitor to Bruton’s Tyrosine Kinase for mast cell diseases;

●
Sanofi
Aventis, Inc., which is developing an antibody to the Interleukin 4 receptor alpha for mast cell diseases;

●
Evommune,
Inc., which is developing a small-molecule antagonist of MRGPRX2 in mast cell driven diseases.

Sales
and Marketing

We
do not currently have sales and marketing infrastructure to support commercial launch of our product candidates, if approved. We may
build such capabilities in North America prior to potential launch of briquilimab. Outside of North America, we may rely on licensing,
co-sale and co-promotion agreements with strategic partners for the commercialization of our product candidates. If we build a commercial
infrastructure to support marketing in North America, such commercial infrastructure could be expected to include a targeted sales force
supported by sales management, internal sales support, an internal marketing group and distribution support. To develop the appropriate
commercial infrastructure internally, we would have to invest financial and management resources, some of which would have to be deployed
prior to any confirmation that briquilimab will be approved.

Research
and Development

We invest significantly in our research and development
efforts, to discover and validate therapeutics while improving our processes and approach to drug making. We strive to progress candidates
that can address unmet or underserved clinical needs and favor programs with well-validated targets and defined regulatory approval paths.
Our R&D team has played key roles in discovering and developing a number of promising candidates over the past 20 plus years. They
have leveraged experience, insights and capabilities to optimize development, along with fostering collaboration with external partners
to innovate and expand into potential additional indications. Our current development-stage portfolio consists of briquilimab in mast
cell driven diseases.

Manufacturing

We
do not currently own or operate any manufacturing facility. We rely on contract manufacturing organizations to produce our drug candidates
in accordance with current good manufacturing practice (“cGMP”) regulations for use in our clinical trials. The manufacture
of pharmaceuticals is subject to extensive cGMP regulations, which impose various procedural and documentation requirements and govern
all areas of record keeping, production processes and controls, personnel and quality control. Under our license agreement with Amgen,
we have received a substantial amount of drug product to support initiation of our planned clinical trials of briquilimab. In November
2019, we entered into development and manufacturing agreements with Lonza Sales AG (“Lonza”) relating to the manufacturing
of briquilimab and product quality testing. The facility of Lonza in Slough, United Kingdom is responsible for production and testing
of drug substance. The facility of Lonza in Stein, Switzerland is responsible for production and testing of drug product. Labelling,
packaging and storage of finished drug product is provided by PCI Pharma Services, in San Diego, California. Our agreement with Lonza
includes certain limitations that may impact our ability to enter into supply arrangements with any other supplier without Lonza’s
consent. In addition, Lonza has the right to increase the prices it charges us for certain supplies depending on a number of factors,
some of which are outside of our control.

17

Government
Regulation

Government
authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European
Union, extensively regulate, among other things, the research, development, testing, manufacture, pricing, reimbursement, sales, quality
control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring
and reporting, and import and export of pharmaceutical products, including biological products. The processes for obtaining marketing
approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes
and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.

Licensure
and Regulation of Biologics in the United States

In
the United States, our product candidates are regulated as biological products, or biologics, under the Public Health Service Act (“PHSA”)
and the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations and guidance. The failure to comply
with the applicable U.S. requirements at any time during the product development process, including preclinical testing, clinical testing,
the approval process, or post-approval process, may subject an applicant to delays in the conduct of the study, regulatory review, and
approval, and/or administrative or judicial sanctions.

An
applicant seeking approval to market and distribute a new biologic in the United States generally must satisfactorily complete each of
the following steps:

●
preclinical
laboratory tests, animal studies, and formulation studies all performed in accordance with the FDA’s good laboratory practice
(“GLP”) regulations;

●
completion
of the manufacture, under cGMP conditions, of the drug substance and drug product that the sponsor intends to use in human clinical
trials along with required analytical and stability testing;

●

submission
to the FDA of an investigational new drug (“IND”) application for human clinical
testing, which must become effective before human clinical trials may begin;

●
approval
by an institutional review board (“IRB”) representing each clinical site before each clinical trial may be initiated;

●
performance
of adequate and well-controlled human clinical trials to establish the safety, potency, and purity of the product candidate for each
proposed indication, in accordance with good clinical practices (“GCPs”);

●
preparation
and submission to the FDA of a biologics license application (“BLA”) for a biologic product requesting marketing for
one or more proposed indications, including submission of detailed information on the manufacture and composition of the product
in clinical development and proposed labelling;

●
review
of the product by an FDA advisory committee, where appropriate or if applicable;

18

●
satisfactory
completion of one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which
the product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the facilities, methods,
and controls are adequate to preserve the product’s identity, strength, quality, and purity;

●
satisfactory
completion of any FDA audits of the preclinical studies and clinical trial sites to assure compliance with GLP, as applicable, and
GCP and the integrity of clinical data in support of the BLA;

●
payment
of user fees under the Prescription Drug User Fee Act (“PDUFA”);

●
securing
FDA approval of the BLA and licensure of the new biologic product; and

●
compliance
with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”)
and any post-approval studies or other post-marketing commitments required by the FDA.

Preclinical
Studies and Investigational New Drug Application

Before
testing any biologic product candidate in humans, the product candidate must undergo preclinical testing. Preclinical tests include laboratory
evaluations of product chemistry, formulation and stability, as well as studies to evaluate the potential for efficacy and toxicity in
animal studies. The conduct of the preclinical tests and formulation of the compounds for testing must comply with federal regulations
and requirements. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to
the FDA as part of an IND application.

An
IND is an exemption from the FDCA that allows an unapproved product candidate to be shipped in interstate commerce for use in an investigational
clinical trial and a request for FDA authorization to administer such investigational product to humans. The IND automatically becomes
effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about the product or conduct
of the proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In that
case, the IND sponsor and the FDA must resolve any outstanding FDA concerns before the clinical trials can begin or recommence.

As
a result, submission of the IND may result in the FDA not allowing the trials to commence or allowing the trial to commence on the terms
originally specified by the sponsor in the IND. If the FDA raises concerns or questions either during this initial 30-day period, or
at any time during the IND review process, it may choose to impose a partial or complete clinical hold. Clinical holds are imposed by
the FDA whenever there is concern for patient safety, may be a result of new data, findings, or developments in clinical, preclinical,
and/or chemistry, manufacturing, and controls or where there is non-compliance with regulatory requirements. A clinical hold issued by
the FDA would delay either a proposed clinical trial or cause suspension of an ongoing trial, until all outstanding concerns have been
adequately addressed and the FDA has notified the company that investigations may proceed. This could cause significant delays or difficulties
in completing our planned clinical trial or future clinical trials in a timely manner.

Human
Clinical Trials in Support of a BLA

Clinical
trials involve the administration of the investigational product candidate to healthy volunteers or patients with the disease or condition
to be treated under the supervision of a qualified principal investigator in accordance with GCP requirements. Clinical trials are conducted
under protocols detailing, among other things, the objectives of the trial, inclusion and exclusion criteria, the parameters to be used
in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol
amendments must be submitted to the FDA as part of the IND.

19

A
sponsor who wishes to conduct a clinical trial outside the United States may, but need not, obtain FDA authorization to conduct the clinical
trial under an IND. When a foreign clinical trial is conducted under an IND, all FDA IND requirements must be met unless waived. When
a foreign clinical trial is not conducted under an IND, the sponsor must ensure that the trial complies with certain regulatory requirements
of the FDA in order to use the trial as support for an IND or application for marketing approval. Specifically, the FDA requires that
such trials be conducted in accordance with GCP, including review and approval by an independent ethics committee and informed consent
from participants. The GCP requirements encompass both ethical and data integrity standards for clinical trials. The FDA’s regulations
are intended to help ensure the protection of human subjects enrolled in non-IND foreign clinical trials, as well as the quality and
integrity of the resulting data. They further help ensure that non-IND foreign trials are conducted in a manner comparable to that required
for clinical trials in the United States.

Further,
each clinical trial must be reviewed and approved by an IRB either centrally or individually at each institution at which the clinical
trial will be conducted. The IRB will consider, among other things, clinical trial design, patient informed consent, ethical factors,
the safety of human subjects, and the possible liability of the institution. An IRB must operate in compliance with FDA regulations.
The FDA, IRB, or the clinical trial sponsor may suspend or discontinue a clinical trial at any time for various reasons, including a
finding that the clinical trial is not being conducted in accordance with FDA requirements or that the participants are being exposed
to an unacceptable health risk. Clinical testing also must satisfy extensive GCP rules and the requirements for informed consent.

Additionally,
some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data
safety monitoring board (“DSMB”) or Independent Data Safety Monitoring Committee (“IDMC”). This group may recommend
continuation of the trial as planned, changes in trial conduct, or cessation of the trial at designated check points based on certain
available data from the trial to which only the DSMB or IDMC has access.

Clinical
trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Additional studies may be required
after approval.

●
Phase
1 clinical trials are initially conducted in a limited population to test the product candidate for safety, including adverse effects,
dose tolerance, absorption, metabolism, distribution, excretion, and pharmacodynamics in healthy humans or, on occasion, in patients,
such as cancer patients.

●
Phase
2 clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks,
evaluate the efficacy of the product candidate for specific targeted indications and determine dose tolerance and optimal dosage.
Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more costly
Phase 3 clinical trials.

●
Phase
3 clinical trials proceed if the Phase 2 clinical trials demonstrate that a dose range of the product candidate is potentially effective
and has an acceptable safety profile. Phase 3 clinical trials are undertaken within an expanded patient population to further evaluate
dosage, provide substantial evidence of clinical efficacy, and further test for safety in an expanded and diverse patient population
at multiple, geographically dispersed clinical trial sites. A well-controlled, statistically robust Phase 3 trial may be designed
to deliver the data that regulatory authorities will use to decide whether or not to approve, and, if approved, how to appropriately
label a biologic; such Phase 3 studies are referred to as “pivotal.”

In
some cases, the FDA may approve a BLA for a product but require the sponsor to conduct additional clinical trials to further assess the
product’s safety and effectiveness after licensure. Such post-approval studies are typically referred to as Phase 4 clinical trials.
These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication and to document
a clinical benefit in the case of biologics approved under accelerated approval regulations. The FDA may require a post-approval study
to be underway prior to approval or within a specified time period following approval, and the submission of progress reports for the
study. The FDA is authorized to initiate enforcement action for the failure to conduct with due diligence a required post-approval study,
including a failure to meet any required conditions specified by the FDA or to submit timely reports. If the FDA approves a product while
a company has ongoing clinical trials that were not necessary for approval, a company may be able to use the data from these clinical
trials to meet all or part of any Phase 4 clinical trial requirement or to request a change in the product labeling. The failure to exercise
due diligence with regard to conducting Phase 4 clinical trials could result in withdrawal of approval for products.

20

Information
about applicable clinical trials must be submitted within specific timeframes to the NIH for public dissemination on its ClinicalTrials.gov
website.

Compliance
with cGMP Requirements

Before
approving a BLA, the FDA typically will 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 comply with cGMP requirements and adequate to assure
consistent production of the product within required specifications. The PHSA emphasizes the importance of manufacturing control for
products like biologics whose attributes cannot be precisely defined.

Manufacturers
and others involved in the manufacture and distribution of products must also register their establishments with the FDA and certain
state agencies. Both domestic and foreign manufacturing establishments must register and provide additional information to the FDA upon
their initial participation in the manufacturing process. Any product manufactured by or imported from a facility that has not registered,
whether foreign or domestic, is deemed misbranded under the FDCA. Establishments may be subject to periodic unannounced inspections by
government authorities to ensure compliance with cGMPs and other laws. Inspections must follow a “risk-based schedule” that
may result in certain establishments being inspected more frequently. Manufacturers may also have to provide, on request, electronic
or physical records regarding their establishments. Delaying, denying, limiting, or refusing inspection by the FDA may lead to a product
being deemed to be adulterated.

Review
and Approval of a BLA

The
results of product candidate development, preclinical testing, and clinical trials, including negative or ambiguous results as well as
positive findings, are submitted to the FDA as part of a BLA requesting a license to market the product. The BLA must contain extensive
manufacturing information and detailed information on the composition of the product and proposed labeling as well as payment of a user
fee. Under the Prescription Drug User Fee Act, as amended (“PDUFA”), each BLA must be accompanied by a significant user fee,
which is adjusted on an annual basis. The sponsor of a licensed BLA is also subject to an annual program fee. Certain exceptions and
waivers are available for some of these fees, such as an exception from the application fee for products with orphan designation and
a waiver for certain small businesses.

The
FDA has 60 days after submission of the application to conduct an initial review to determine whether it is sufficient to accept for
filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission
has been accepted for filing, the FDA begins an in-depth review of the application. Under the goals and policies agreed to by the FDA
under PDUFA, the FDA has ten months in which to complete its initial review of a standard application and respond to the applicant, and
six months for a priority review of the application. The FDA does not always meet its PDUFA goal dates for standard and priority BLAs.
Products are eligible for priority review (a status assigned by the FDA at filing) if the application is for a product intended to treat
a serious or life-threatening condition and the product, if approved, would provide a significant improvement in safety or effectiveness
compared to any existing licensed products for the same intended use. The FDA has substantial discretion in the approval process and
may refuse to file any application or not approve an BLA if the FDA determines that the data are insufficient for approval. The review
process may often be significantly extended by FDA requests for additional information or clarification. The review process and the PDUFA
goal date may be extended by three months if the FDA requests or if the applicant otherwise provides additional information or clarification
regarding information already provided in the submission within the last three months before the PDUFA goal date.

Under
the PHSA, the FDA may approve a BLA if it determines that the product is safe, pure, and potent, and the facility where the product will
be manufactured meets standards designed to ensure that it continues to be safe, pure, and potent. On the basis of the FDA’s evaluation
of the application and accompanying information, including the results of the inspection of the manufacturing facilities and any FDA
audits of preclinical and clinical trial sites to assure compliance with GCPs, 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.
If the application is not approved, the FDA will issue a complete response letter, or CRL, which will contain the conditions that must
be met in order to secure final approval of the application, and when possible will outline recommended actions the sponsor might take
to obtain approval of the application. Sponsors that receive a CRL may submit to the FDA information that represents a complete response
to the issues identified by the FDA.

21

The
FDA may also refer the application to an advisory committee for review, evaluation, and recommendation as to whether the application
should be approved. In particular, the FDA may refer applications for novel biologic products or biologic products that present difficult
questions of safety or efficacy to an advisory committee. Typically, an advisory committee is a panel of independent experts, including
clinicians and other scientific experts, that reviews, evaluates, and provides a recommendation as to whether the application should
be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations
carefully when making decisions.

If
the FDA approves a new product, it may limit the approved indication(s) for use of the product. It may also require that contraindications,
warnings, or precautions be included in the product labeling. In addition, the FDA may call for post-approval studies, including Phase
4 clinical trials, to further assess the product’s efficacy and/or safety after approval. The agency may also require testing and
surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions
or other risk management mechanisms, including a Risk Evaluation and Mitigation Strategy (“REMS”), to help ensure that the
benefits of the product outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals,
and elements to assure safe use. Additionally, post-approval, many types of changes to the approved product, such as adding new indications,
changing manufacturing processes and adding labeling claims, are subject to further testing requirements and FDA review and approval.

Expedited
Review Programs

The
FDA is authorized to expedite the review of BLAs in several ways. Under the Fast Track program, the sponsor of a product candidate may
request the FDA to designate the product for a specific indication as a Fast Track product concurrent with or after the filing of the
IND. Candidate products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition
and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the combination of
the product candidate and the specific indication for which it is being studied. In addition to other benefits, such as the ability to
have greater interactions with the FDA, the FDA may initiate review of sections of a Fast Track application before the application is
complete, a process known as rolling review.

Any
product candidate submitted to the FDA for marketing, including under a Fast Track program, may be eligible for other types of FDA programs
intended to expedite development and review, such as breakthrough therapy designation, priority review and accelerated approval.

●
Breakthrough
therapy designation. To qualify for the breakthrough therapy program, product candidates must be intended to treat a serious or life-threatening
disease or condition and preliminary clinical evidence must indicate that such product candidates may demonstrate substantial improvement
on one or more clinically significant endpoints over existing therapies. The FDA will seek to ensure the sponsor of a breakthrough
therapy product candidate receives intensive guidance on an efficient drug development program, intensive involvement of senior managers
and experienced staff on a proactive, collaborative and cross-disciplinary review and rolling review.

●
Priority
review. A product candidate is eligible for priority review if it treats a serious condition and, if approved, it would be a significant
improvement in the safety or effectiveness of the treatment, diagnosis or prevention compared to marketed products. The FDA aims
to complete its review of priority review applications within six months as opposed to 10 months for standard review.

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●
Accelerated
approval. Drug or biologic products studied for their safety and effectiveness in treating serious or life-threatening illnesses
and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval. Accelerated approval means
that a product candidate may be approved on the basis of adequate and well controlled clinical trials establishing that the product
candidate has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect
on a clinical endpoint other than survival or irreversible morbidity or mortality or other clinical benefit, taking into account
the severity, rarity and prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval,
the FDA may require that a sponsor of a drug or biologic product candidate receiving accelerated approval perform adequate and well
controlled post-marketing clinical trials. In addition, the FDA currently requires as a condition for accelerated approval pre-approval
of promotional materials.

●
Regenerative
advanced therapy. With passage of the 21st Century Cures Act (the “Cures Act”) in December 2016, Congress authorized
the FDA to accelerate review and approval of products designated as regenerative advanced therapies. A product is eligible for this
designation if it is a regenerative medicine therapy that is intended to treat, modify, reverse or cure a serious or life-threatening
disease or condition and preliminary clinical evidence indicates that the product candidate has the potential to address unmet medical
needs for such disease or condition. The benefits of a regenerative advanced therapy designation include early interactions with
the FDA to expedite development and review, benefits available to breakthrough therapies, potential eligibility for priority review
and accelerated approval based on surrogate or intermediate endpoints.

None
of these expedited programs change the standards for approval but they may help expedite the development or approval process of product
candidates.

Post-Approval
Regulation

If
regulatory approval for marketing of a product or new indication for an existing product is obtained, the sponsor will be required to
comply with all regular post-approval regulatory requirements as well as any post-approval requirements that the FDA have imposed as
part of the approval process. The sponsor will be required to report certain safety and other postmarketing information and submissions,
provide updated safety and efficacy information, implement product tracking and tracing requirements, and comply with requirements concerning
advertising and promotional labeling requirements. Manufacturers and certain of 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 ongoing regulatory requirements, including cGMP regulations, which impose certain procedural and documentation requirements
upon manufacturers. BLA holders using contract manufacturers, laboratories, or packagers are responsible for the selection and monitoring
of qualified firms, and, in certain circumstances, qualified suppliers to these firms. These firms and, where applicable, their suppliers
are subject to inspections by the FDA at any time, and the discovery of violative conditions, including failure to conform to cGMP, could
result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured,
processed or tested by them. Accordingly, the sponsor and its third-party manufacturers must continue to expend time, money, and effort
in the areas of production and quality control to maintain compliance with cGMP regulations and other regulatory requirements.

A
product may also be subject to official lot release, meaning that the manufacturer is required to perform certain tests on each lot of
the product before it is released for distribution. If the product is subject to official lot release, the manufacturer must submit samples
of each lot, 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, to the FDA. The FDA may in addition perform certain confirmatory tests on lots of some
products before releasing the lots for distribution. Finally, the FDA will conduct laboratory research related to the safety, purity,
potency, and effectiveness of pharmaceutical products.

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Once
an approval is granted, the FDA may withdraw the 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 trials to assess
new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among
other things:

●
investigation
or additional study obligations;

●
adverse
publicity or communications to prescribers or patients about specific information or issues;

●
restrictions
on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

●
fines,
warning or untitled letters or holds on post-approval clinical trials;

●
refusal
of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license
approvals;

●
product
recall, seizure or detention, or refusal to permit the import or export of products; or

●
injunctions,
consent decrees or the imposition of civil or criminal penalties.

Pharmaceutical
products may be promoted only for the approved indications and in accordance with the provisions of the approved label. Although healthcare
providers may prescribe products for uses not described in the drug’s labeling, known as off-label uses, in their professional
judgment, drug manufacturers are prohibited from soliciting, encouraging or promoting unapproved uses of a product. The FDA and other
agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly
promoted off-label uses may be subject to significant liability.

The
FDA strictly regulates the marketing, labeling, advertising, and promotion of prescription drug products placed on the market. This regulation
includes, among other things, standards and regulations for direct-to-consumer advertising, communications regarding unapproved uses,
industry-sponsored scientific and educational activities, and promotional activities involving the Internet and social media. Promotional
claims about a drug’s safety or effectiveness are prohibited before the drug is approved. After approval, a drug product generally
may not be promoted for uses that are not approved by the FDA, as reflected in the product’s prescribing information.

If
a company is found to have promoted off-label uses, it may become subject to adverse public relations and administrative and judicial
enforcement by the FDA, the Department of Justice or the Office of the Inspector General of the Department of Health and Human Services,
as well as state authorities. This could subject a company to a range of penalties that could have a significant commercial impact, including
civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes drug products.
The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has also requested
that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

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Regulation
and Procedures Governing Approval of Medicinal Products in the European Union

In
order to market any product outside of the United States, a company must also comply with numerous and varying regulatory requirements
of other countries and jurisdictions regarding quality, safety, and efficacy, and governing, among other things, clinical trials, marketing
authorization, commercial sales, and distribution of drug products. Whether or not it obtains FDA approval for a product, an applicant
will need to obtain the necessary approvals by the comparable foreign regulatory authorities before it can commence clinical trials or
marketing of the product in those countries or jurisdictions. Specifically, the process governing approval of medicinal products in the
European Union generally follows the same lines as in the United States. It entails satisfactory completion of preclinical studies and
adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication. It also
requires the submission to the relevant competent authorities of a marketing authorization application (“MAA”) and granting
of a marketing authorization by these authorities before the product can be marketed and sold in the European Union.

Clinical
Trial Approval

Pursuant
to Clinical Trials Directive 2001/20/EC and the Directive 2005/28/EC on GCP, a system for the approval of clinical trials in the European
Union was implemented through national legislation of the member states. Under this system, an applicant must obtain approval from the
competent national authority of a European Union member state in which the clinical trial is to be conducted, or in multiple member states
if the clinical trial is to be conducted in a number of member states. Furthermore, the applicant may only start a clinical trial at
a specific site after the competent ethics committee has issued a favorable opinion. The clinical trial application must be accompanied
by an investigational medicinal product dossier with supporting information prescribed by Directive 2001/20/EC and Directive 2005/28/EC
and corresponding national laws of the member states and further detailed in applicable guidance documents.

In
April 2014, the European Union adopted a new Clinical Trials Regulation (EU) No 536/2014, which became effective on January 31, 2022.
It overhauled the current system of approvals for clinical trials in the European Union. Specifically, the new legislation, which is
directly applicable in all member states, is aimed at simplifying and streamlining the approval of clinical trials in the European Union.
For instance, the new Clinical Trials Regulation provides for a streamlined application procedure via a single-entry point, the Clinical
Trials Information System (“CTIS”), and strictly defined deadlines for the assessment of clinical trial applications.

The
conduct of all clinical trials commenced in the European Union prior to January 31, 2022 will continue to be bound by the previously
applicable provisions. However, if a clinical trial continues for more than three years after January 31, 2022, the Clinical Trials Regulation
will at that time begin to apply to the clinical trial. As of January 31, 2023, all new trial authorizations must be applied for under
the Clinical Trials Regulation and utilize CTIS.

Marketing
Authorization

To
obtain a marketing authorization for a product under the European Union regulatory system, an applicant must submit an MAA, either under
a centralized procedure administered by the EMA or one of the procedures administered by competent authorities in European Union Member
States (decentralized procedure, national procedure, or mutual recognition procedure). A marketing authorization may be granted only
to an applicant established in the European Union. Regulation (EC) No 1901/2006 provides that prior to obtaining a marketing authorization
in the European Union, an applicant must demonstrate compliance with all measures included in an EMA approved Pediatric Investigation
Plan (“PIP”) covering all subsets of the pediatric population, unless the EMA has granted a product specific waiver, class
waiver, or a deferral for one or more of the measures included in the PIP.

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The
centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all European
Union member states. Pursuant to Regulation (EC) No. 726/2004, the centralized procedure is compulsory for specific products, including
for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy products
and products with a new active substance indicated for the treatment of certain diseases, including products for the treatment of cancer.
For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for
which a centralized process is in the interest of patients, the centralized procedure may be optional. Manufacturers must demonstrate
the quality, safety, and efficacy of their products to the EMA, which provides an opinion regarding the MAA. The European Commission
grants or refuses marketing authorization in light of the opinion delivered by the EMA.

Under
the centralized procedure, the CHMP established at the EMA is responsible for conducting an initial assessment of a product. Under the
centralized procedure in the European Union, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops when
additional information or written or oral explanation is to be provided by the applicant in response to questions of the CHMP. Accelerated
evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public
health and, in particular, from the viewpoint of therapeutic innovation. If the CHMP accepts such a request, the time limit of 210 days
will be reduced to 150 days, but it is possible that the CHMP may revert to the standard time limit for the centralized procedure if
it determines that it is no longer appropriate to conduct an accelerated assessment.

Coverage,
Pricing, and Reimbursement

Significant
uncertainty exists as to the coverage and reimbursement status of any product candidates for which we may seek regulatory approval by
the FDA or other government authorities. In the United States and markets in other countries, patients who are prescribed treatments
for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of
the associated healthcare costs. Patients are unlikely to use any product candidates we may develop unless coverage is provided and reimbursement
is adequate to cover a significant portion of the cost of such product candidates. Even if any product candidates we may develop are
approved, sales of such product candidates will depend, in part, on the extent to which third-party payors, including government health
programs in the United States such as Medicare and Medicaid, commercial health insurers, and managed care organizations, provide coverage,
and establish adequate reimbursement levels for, such product candidates. The process for determining whether a payor will provide coverage
for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once
coverage is approved. Third-party payors are increasingly challenging the prices charged, examining the medical necessity, and reviewing
the cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party payors may limit coverage
to specific products on an approved list, also known as a formulary, which might not include all of the approved products for a particular
indication.

In
order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic
studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain
FDA or other comparable marketing approvals. Nonetheless, product candidates may not be considered medically necessary or cost-effective.
A decision by a third-party payor not to cover any product candidates we may develop could reduce physician utilization of such product
candidates once approved and have a material adverse effect on our sales, results of operations and financial condition. Additionally,
a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further,
one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and reimbursement
for the product, and the level of coverage and reimbursement can differ significantly from payor to payor. Third-party reimbursement
and coverage may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment
in product development. In addition, any 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 any companion diagnostics.

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The
containment of healthcare costs also has become a priority of federal, state and foreign governments and the prices of pharmaceuticals
have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs, including price
controls, restrictions on reimbursement, and requirements for substitution of generic products. Adoption of price controls and cost-containment
measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit a company’s
revenue generated from the sale of any approved products. Coverage policies and third-party reimbursement rates may change at any time.
Even if favorable coverage and reimbursement status is attained for one or more products for which a company or its collaborators receive
marketing approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

If
we obtain approval in the future to market in the United States any product candidates we may develop, we may be required to provide
discounts or rebates under government healthcare programs or to certain government and private purchasers in order to obtain coverage
under federal healthcare programs such as Medicaid. Participation in such programs may require us to track and report certain drug prices.
We may be subject to fines and other penalties if we fail to report such prices accurately.

Outside
the United States, ensuring adequate coverage and payment for any product candidates we may develop will face challenges. Pricing of
prescription pharmaceuticals is subject to governmental control in many countries. Pricing negotiations with governmental authorities
can extend well beyond the receipt of regulatory marketing approval for a product and may require us to conduct a clinical trial that
compares the cost-effectiveness of any product candidates we may develop to other available therapies. The conduct of such a clinical
trial could be expensive and result in delays in our commercialization efforts.

In
the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be
marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare
the cost-effectiveness of a particular product candidate to currently available therapies (so called health technology assessments) in
order to obtain reimbursement or pricing approval. For example, the European Union provides options for its member states to restrict
the range of products for which their national health insurance systems provide reimbursement and to control the prices of medicinal
products for human use. European Union member states may approve a specific price for a product, or they may instead adopt a system of
direct or indirect controls on the profitability of the company placing the product on the market. Other member states allow companies
to fix their own prices for products but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions.
Recently, many countries in the European Union have increased the amount of discounts required on pharmaceuticals and these efforts could
continue as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crises experienced
by many countries in the European Union. The downward pressure on healthcare costs in general, particularly prescription products, has
become intense. As a result, increasingly high barriers are being erected to the entry of new products. Political, economic, and regulatory
developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.
Reference pricing used by various European Union member states, and parallel trade (arbitrage between low-priced and high-priced member
states), can further reduce prices. 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 products, if approved in those countries.

Healthcare
Law and Regulation

Healthcare
providers and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing
approval. Arrangements with providers, consultants, third-party payors, and customers are subject to broadly applicable fraud and abuse,
anti-kickback, false claims laws, patient privacy laws and regulations and other healthcare laws and regulations that may constrain our
business and/or financial arrangements. Restrictions under applicable federal and state healthcare laws and regulations, include the
following:

●
the
U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting,
offering, paying, receiving, or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the
referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in
whole or in part, under a federal healthcare program such as Medicare and Medicaid;

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●
the
federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit
individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims
for payment that are false, fictitious, or fraudulent or knowingly making, using, or causing to made or used a false record or statement
to avoid, decrease, or conceal an obligation to pay money to the federal government;

●
the
FCPA, which prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S.
officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment; and

●
the
federal transparency requirements known as the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs,
devices, biologics and medical supplies to report annually to the CMS within the U.S. Department of Health and Human Services, information
related to payments and other transfers of value made by that entity to physicians and certain other licensed health care practitioners,
as defined by such law, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate
family members.

Similar
federal, state and foreign fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, may apply to sales
or marketing arrangements and claims involving healthcare items or services. Such laws are generally broad and are enforced by various
state agencies and private actions. Also, many states have similar fraud and abuse statutes or regulations that may be broader in scope
and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Further, some
state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the
relevant compliance guidance promulgated by the federal government in addition to requiring pharmaceutical manufacturers to report information
related to payments to physicians and other healthcare providers or marketing expenditures. In addition, certain state and local laws
require the registration of pharmaceutical sales representatives in the jurisdiction. State and foreign laws also govern the privacy
and security of health information in some circumstances, many of which differ from each other in significant ways and often are not
preempted by the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), thus complicating compliance
efforts.

The
scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform,
especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies regularly scrutinize interactions
between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements
in the healthcare industry. Failure to comply with these laws described above or any other governmental regulations that apply to us,
may subject us to, without limitation, civil, criminal, and administrative penalties, damages, monetary fines, disgorgement, 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, imprisonment, contractual damages, reputational harm, diminished
profits and future earnings and curtailment or restructuring of our operations, any of which could adversely affect our business, financial
condition and results of operations.

Employees
and Human Capital

As
of December 31, 2025, we employed 22 full-time employees. The 22 full-time employees were engaged in research and development, operations,
finance, and business development. Five employees held Ph.D. degrees and one held an M.D. degree. Our employees are not represented by
labor unions or covered under any collective bargaining agreements. We consider our relationship with our employees to be good.

Our
human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing
and additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees
and directors through the granting of stock-based compensation awards.

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Facilities

We
lease a total of approximately 25,900 square feet of space across two buildings for our headquarters in Redwood City, California under
a single lease agreement that expires in August 2026. Thereafter, at our option, we may extend the term for an additional five years
to August 2031. In February 2026, we sublet approximately 13,400 square feet of the space under a short-term sublease agreement
that runs through June 2026. We believe that our existing facilities are adequate to meet our current needs, and that suitable additional alternative
spaces will be available in the future on commercially reasonable terms.

Indemnification
and Insurance

Our
business exposes us to potential liability including, but not limited to, potential liability for (i) non-compliance with applicable
laws and regulations, and (ii) employment-related claims. In certain circumstances, we may also be liable for the acts or omissions of
others, such as suppliers of goods or services.

We
attempt to manage our potential liability to third parties through contractual protection (such as indemnification and limitation of
liability provisions) in our contracts and through insurance. The contractual indemnification provisions vary in scope and generally
do not protect us against all potential liabilities. In addition, in the event that we seek to enforce such an indemnification provision,
the indemnifying party may not have sufficient resources to fully satisfy its indemnification obligations or may otherwise not comply
with its contractual obligations.

We
currently maintain insurance coverage with limits we believe to be appropriate. The coverage provided by such insurance may not be adequate
for all claims made, and such claims may be contested by applicable insurance carriers.

Organization

We
were organized as a corporation under the laws of the State of Delaware on August 13, 2019 under the name “Amplitude Healthcare
Acquisition Corporation”. On September 24, 2021, we consummated the previously announced business combination (the “Business
Combination”) among us, Ample Merger Sub, Inc. (“Merger Sub”) and a private Delaware corporation that is now our wholly-owned subsidiary
and named Jasper Tx Corp. (formerly known as Jasper Therapeutics) (“Old Jasper”). Pursuant to the terms of the Business Combination,
a Business Combination or Reverse Recapitalization for accounting purposes between AMHC and Old Jasper was effected through the merger
of Merger Sub with and into Old Jasper with Old Jasper surviving as AMHC’s wholly-owned subsidiary. In connection with the Business
Combination, AMHC changed its name from Amplitude Healthcare Acquisition Corporation to Jasper Therapeutics, Inc.

Website
Access to SEC Filings

We
file annual, quarterly and special reports, proxy statements and other information with the Securities and Exchange Commission (the “SEC”).
The SEC maintains an Internet website at http://www.sec.gov that contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC, including Jasper. We maintain an Internet website at www.jaspertx.com. The information
contained on our website or that can be accessed through our website does not constitute a part of this report. We make available, free
of charge through our Internet website, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), as soon as reasonably practicable after we electronically file or furnish this
information to the SEC.

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