NASDAQ: CELU

Aging is associated with a progressive degeneration
of tissues, resulting in significant impairment on the structure and function of vital organs. Chronic, low-grade systemic inflammation
often referred to as “inflammaging” is characterized by higher levels of circulating pro-inflammatory cytokines driven
by cellular damage and senescent cell accumulation. Senescent cells contribute to disease progression by limiting the regenerative capacity
of tissue stem cells and inducing the accumulation of cellular damage.

There is a
close relationship between inflammation and cellular senescence, a process in which cells lose
their ability to divide and function properly and cellular senescence has been described as a link between cancer and age-related
degenerative disease. These cells promote inflammation through well-characterized signaling pathways, including NF-κB
activation. In younger organisms, cellular senescence prevents the proliferation of damaged cells. With aging, impaired clearance
leads to accumulation of these cells, contributing to disease and tissue dysfunction. Stem cell exhaustion also contributes to aging
by reducing the regenerative potential of tissues and limits tissue repair capacity. We believe these processes may be modulated by
increasing the number and quality of stem cells in order to restore tissues’ regenerative power. Aging is also associated with
immunosenescence, or the immune dysfunction that occurs with age and contributes to increased susceptibility to infection and
possibly autoimmune disease and cancer. We believe immune function may be improved by increasing the number and the quality of
immune cells like natural killer or NK cells and naive T cells that improve immune rejuvenation and repair function in damaged
tissues.

We believe the development of effective therapies
against the degenerative processes (including aging-ameliorating preventive therapies) that underlie aging-related diseases and disease
complications and susceptibilities will be central to the extension of health longevity. By harnessing the placenta’s unique biology
and ready availability, we may be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible,
and affordable therapeutics to promote health longevity. To this end, we are developing a pipeline of off-the-shelf placental-derived
allogeneic cellular therapy product candidates such as, human placental-derived stems cells and MLASCs, including cenplacel-L. These therapeutic
candidates have the potential to target indications across multiple age-related degenerative diseases and conditions, including immune
and infectious disease and cancer.

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Specifically,
we are developing a differentiated portfolio of off-the-shelf, placental-derived allogeneic cellular therapies and advanced biomaterial
products for the treatment of degenerative disorders and diseases including those associated with aging. Our cellular therapy candidates
are designed to address core biological drivers of aging, including stem cell exhaustion and cellular senescence. In particular, one
of our MLASCs candidates, cenplacel-L, has demonstrated encouraging clinical data in Phase 1 and Phase 2 studies, and we are selectively
advancing programs with a focus on longevity applications. Additionally, we are leveraging the natural senolytic, or “senoblative,”
activity of NK cells to selectively target and eliminate senescent cells, which are known to accumulate with age and contribute to chronic
inflammation and tissue dysfunction.

We
also develop and market commercial-stage, off-the-shelf placental-derived biomaterial products, including allografts and connective tissue
matrices for use in soft tissue repair and reconstructive procedures addressing a broad range of degenerative and surgical indications.
We are actively expanding our biomaterials pipeline and advancing multiple product candidates toward regulatory submission. Our currently
marketed advanced biomaterial products include:

●
Biovance®,
a human amniotic membrane allograft designed to cover or offer protection from the surrounding environment in soft tissue repair
and reconstructive procedure.

●
Biovance®3L, a Tri-Layer
Biovance® human amniotic membrane allograft designed for use as a covering, barrier, or wrap to surgical sites.

●
Biovance® 3L Ocular,
a tri-layer Biovance® human amniotic membrane allograft designed to support the treatment of ocular surface disease and ocular
surgical applications.

●
Interfyl®, a decellularized
human placental connective tissue matrix designed for use to replace or supplement damaged or inadequate integumental tissue.

●
CentaFlex®, a decellularized
human placental matrix allograft derived from human umbilical cord designed for use as a surgical covering, wrap, or barrier to protect
and support the repair of damaged tissues.

●
ReboundTM, a
full thickness, placental derived extracellular matrix that contain amnion and chorion for use as a wound covering or barrier to
protect and support full thickness wounds.

In
addition to our cell therapy candidates, and commercial-stage biomaterial products, we actively pursue revenue-generating opportunities
that leverage our core expertise in cellular therapeutic development and manufacturing by providing contract manufacturing and development
services to third parties. These services are designed to accelerate translational and clinical development while addressing key industry
challenges, including process variability, supply chain constraints and scalability limitations.. Likewise, our biomaterial contract
manufacturing and development services enable scalable production across both early-stage and commercial volumes. Leveraging over three
decades of experience in human tissue procurement and biobanking, we maintain a reliable supply of cryopreserved placental tissue procured
from informed consent donors, enabling on-demand conversion into finished biomaterial products and addressing the structural inefficiencies
inherent to most tissue supply chains.

Our
Celularity IMPACT (IMmunomodulatory Placenta-derived Allogeneic Cellular
Therapy) platform is designed to harness the unique biological advantages of placenta-derived cells to address multiple
disease areas through a fully integrated, end-to-end platform, from biosourcing postpartum placentas from informed consent donors through
manufacturing cryopreserved and packaged allogeneic cells in our purpose-built U.S.-based 147,215 square foot facility. We believe placental-derived
cells offer distinct scientific and economic advantages. First, relative to adult-derived cells, placental-derived cells demonstrate
greater stemness, meaning the ability to expand and persist. Second, placental-derived cells are immunologically naïve, meaning
the cells have never been exposed to a specific antigen, which may translate into improved tolerability and reduced risk of graft-versus-host
disease. Third, our placental-derived cells are allogeneic, meaning they are intended for use in any patient, as compared to autologous
cells, which are derived from an individual patient for that patient’s sole use. We believe this enables readily available, off-the-shelf
therapies that can be delivered more efficiently, consistently and at scale.

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Our Strategy

Our goal is to be the leader in
longevity-focused cellular and regenerative medicine by delivering off-the-shelf allogeneic cellular therapies and biomaterials, at
greater scale and quality with attractive economics. We believe achieving this goal will result in placental-derived allogeneic
cellular therapies becoming a standard of care in various indications and enable us to make potentially lifesaving therapies more
readily accessible to more patients throughout the world. We plan to achieve this mission by:

●
Leveraging the inherent advantages of placental-derived cells. Our cells are sourced from the postpartum placenta donated by healthy donors who have signed informed consent, representing a renewable, economical, and highly scalable starting material collected under rigorous controls. We use those cells to produce on-demand, off-the-shelf investigational allogeneic cellular therapy products investigational medicines that are designed to sidestep treatment delays inherent to more costly autologous cellular therapies and other allogeneic cellular therapy approaches, all while offering the potential for greater in vivo expansion, persistence, potency, and acceptance. Further, we believe the immunological naïveté of placental cells may allow for potentially less toxicity.

●
Capturing efficiencies through our integrated Celularity IMPACT platform. Manufacturing allogeneic cell therapeutic candidates involves a series of complex and precise steps. We believe a critical component to our success will be to leverage our rapidly scalable, end-to-end supply chain. Applying proprietary manufacturing know-how, expertise and capacity utilizing our purpose-built U.S.-based cGMP, compliant facility, we believe our fully integrated manufacturing operations and infrastructure will allow us to improve the manufacturing process, eliminate reliance on contract manufacturing organizations, or CMOs, and more rapidly advance therapeutic candidates. We also plan to leverage this core expertise to generate revenues by providing contract manufacturing and development services to third parties.

●
Selectively targeting indications with unmet patient need with potential for accelerated development. Our pipeline reflects our intent to leverage the unique biology of the placenta to develop placental-derived allogeneic cells for indications where the demonstrated properties of such cells could provide an advantage, both in terms of development (sourcing and proliferation) and potential efficacy (affinity). In selecting indications, we evaluate where the biological properties of placental-derived cells position them for success, as well as where there is a clearly defined regulatory pathway providing the potential for accelerated development to address unmet patient need.

●
Growing our existing commercial business and deepening the pipeline of placentally derived biomaterial products. We intend to grow our existing commercial business both through higher volumes of product sold through existing domestic distribution relationships as well as distribution relationships outside of the United States. We plan to continue to invest in new biomaterials programs, some or all of which may require different regulatory pathways than Section 361 HCT/Ps.

●
Advancing longevity-focused therapeutic strategies. We are expanding our focus on health longevity by developing therapies designed to address the underlying biological mechanisms of aging, including cellular senescence, stem cell exhaustion and immune dysfunction. We believe targeting these core pathways has the potential to impact multiple age-related diseases and conditions, positioning our platform across a broad and growing longevity-focused therapeutic landscape.

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Pursuing investigational and ex-U.S. commercialization pathways for cellular therapies. We are evaluating opportunities to generate revenue from our cellular therapy assets through investigational use in jurisdictions that permit such use, as well as through expanded access frameworks, named patient programs and other regulatory pathways outside the United States. We believe these approaches may enable earlier patient access, support real-world data generation and provide a capital-efficient pathway to advance our cellular programs while broader clinical and regulatory strategies evolve.

Celularity IMPACT Platform

Placental-derived cellular
therapies offer potentially lifesaving therapies for patients with unmet medical needs. We have developed and acquired proprietary technology
for collecting, processing, and storing placental stem cells with potentially broad therapeutic applications in the treatment of aging-associated
and other degenerative disorders and diseases. These span various therapeutic areas for which aging is known to be a major risk factor,
including cancer, regenerative medicine, and immune disorders.

Common to all degenerative
disorders and diseases is the progressive loss of function or structure (or both) of affected tissues and organs based on a continuous
process of degenerative cell changes. We use our proprietary Celularity IMPACT platform for the development of allogeneic cellular therapies
that we believe exert immunomodulatory and regenerative effects. Immunomodulation is the regulation and modulation of immunity achieved
by reducing or enhancing the immune response, for example, promoting immune tolerance to cellular therapies. We believe that by harnessing
the placenta’s unique biology and ready availability, we will be able to develop therapeutic solutions that address a significant
unmet global need for effective, accessible, and affordable therapeutics.

Our Celularity IMPACT manufacturing
process is a seamless, fully integrated process that is built to optimize speed and scale, from the sourcing of human full term healthy
postpartum placentas from informed consent donors through proprietary processing methods, cell selection, product-specific CMC, advanced
cell manufacturing, and cryopreservation resulting in allogeneic inventory-ready and on-demand cellular therapy products. The fully integrated
process is housed in our purpose-built manufacturing, translational research, and biobanking facility located in Florham Park, NJ.

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Our Celularity IMPACT platform
capitalizes on our integrated processes and the unique biologic characteristics of placental-derived allogeneic cells to target degenerative
disorders and diseases including those associated with aging that span various therapeutic areas including cancer, regenerative medicine,
and immune disorders, and infectious diseases. The platform is designed to accelerate the speed at which therapies can be provided to
patients while ensuring manufacturing excellence of high quality and pure placental-derived cellular therapy products at a lower cost.
We believe our IMPACT platform enables cellular therapy inventory to be available to physicians on demand to treat patients in need and
to enable repeat dosing regimens that other cellular therapy platforms will not be able to support.

Biomaterials Collection

The initial source material
for our allogeneic cell types is the postpartum human placenta. We source human placental birth material used for the manufacture
of our products from accredited hospitals and birth centers, with collections performed by licensed health care professionals. Eligibility
for donation is determined by a donor screening process that includes education about the donor program, obtaining informed consent from
the donor, and completion of a detailed maternal health questionnaire and family health history. These forms are completed by the donor,
with assistance from trained collection technicians as needed. Donors providing birth materials do not encounter any fees and are not
renumerated.

Licensed health care professionals
collect donor material utilizing our proprietary collection kits, which include barcode labels for biomaterials (cord blood, placenta,
and maternal blood samples) along with appropriate chain of custody documentation. Once collected, the donated material and a maternal
blood sample are shipped in an insulated container via courier to our Florham Park, New Jersey laboratory and manufacturing facility.

Upon arrival at our facility,
the donated material is reviewed for labeling completeness and accuracy of the barcoded kit and is electronically coded into a validated
software database. If all quality criteria are met, the donated material is then individually evaluated and forwarded to the appropriate
production suite for processing and manufacturing. We believe that our sourcing is rapidly scalable due to numerous established procurement
relationships that provide a constant renewable supply to meet current and future manufacturing needs.

Unique Biology of Placenta-Derived Cells

Placental-derived cells have
unique biology related to immunological naïveté, stemness, persistence and proliferation that makes them a biologically preferred
starting material with the potential for less toxicity and superior biological activity relative to adult bone marrow or peripheral blood-derived
cells.

Research has shown that the
human placenta is a novel and valuable source of multi potential stem/progenitor cells of mesenchymal and hematopoietic origin, which
have multiple therapeutic applications. Our characterization data show that approximately one to five percent of placental-derived cells
are CD34+ hematopoietic stem cells, or HSCs, among which expression of certain markers suggests that such HSCs have more self-renewal
capacity and the potential to facilitate the early engraftment of the placental-derived cells. In addition, further characterization has
shown low T-cell content and immature T subpopulations. This demonstrated immunological naïveté further suggests the potential
for low or no GvHD in transplant. Furthermore, mesenchymal-like cells have been shown to possess other characteristics, capabilities,
and effects (e.g., osteogenic, chondrogenic, adipogenic differentiation capabilities and immunomodulatory effects). The high quantity
of mesenchymal-like cells and Treg cells indicate that placental-derived cells can potentially contribute to prevention of GvHD and host
microenvironment modulation. In summary, we believe the stemness, potential capacity of proliferation and persistence of placental-derived
cells support multiple potential therapeutic applications, including those in development by us.

Overview of NK cells

NK cells are potent effector
cells of the innate immune system responsible for identifying and eliminating abnormal and stressed host cells. They are equipped with
NK cell-specific activating receptors that recognize conserved antigens induced by cellular stress while being simultaneously tuned with
inhibitory receptors to avoid mistakenly targeting healthy cells. NK cells are particularly relevant in combating viral infections and
mediating anti-tumor immunity in which normal cellular processes are stressed for the purposes of perpetuating viral infection and cancer
cell proliferation.

Commercializing NK cellular
therapies has been limited by the difficulty and cost to scale the production of mature NK cells for clinical dosing. Utilizing our Celularity
IMPACT platform, our proprietary process has mitigated these limitations by expanding and differentiating placental-derived stem cells
into NK cells over a period of 35 days. We derive the HSCs from healthy donor placentas, then propagate and differentiate these cells
into NK cells. This process can produce hundreds of doses per donor placenta. We also developed technologies that can achieve high genetic
modification efficiency by transducing placenta HSCs and producing downstream stable gene modified CYNK cells with enhanced cancer killing
activities. These cells are then cryopreserved and available to be shipped upon request.

Overview of MLASCs

Placental-derived MLASCs are
a novel, culture-expanded mesenchymal-like cell population derived from placental tissue. In vivo, we demonstrated that MLASCs’
immune-modulatory properties alleviate autoimmunity and possess anti-inflammatory activity. Cenplacel-L, MLASCs clinically designated
as PDA-001 and PDA-002, have been developed and investigated in clinical studies in Crohn’s Disease, multiple sclerosis, rheumatoid
arthritis, stroke, diabetic foot ulcers and diabetic peripheral neuropathy.

Allogeneic human placental
MLASCs are derived from healthy donor placentas. Our first allogeneic MLASC, cenplacel-L, product begins with the thawing and activation
of the isolated placental-derived MLASCs, followed by genetic modification of tissue factor to reduce potential toxicities and lower risk
of adverse effects. Once modified, we expand the MLASCs to large quantities prior to harvest, final formulation, and cryopreservation
of the cellular therapeutic.

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Allogeneic Cellular therapies — an
“Off-the-Shelf” Approach

There are two primary approaches
to engineered cellular therapies: autologous and allogeneic. Autologous therapies use engineered cells derived from the individual patient,
while allogeneic therapies use cells derived from an unrelated third-party healthy donor. We believe our human placental-derived allogeneic
platform is leading the next evolution of cellular medicine because we aim to deliver off-the-shelf allogeneic cellular therapies, at
greater scale and quality with attractive economics, potentially making lifesaving therapies more readily accessible to more patients
throughout the world. Our human placental-derived allogeneic cryopreserved, off-the-shelf platform currently includes placental NK cells.

CYNK

Autologous NK cells
and genetically modified autologous NK cells have been used in the setting of immuno-oncology. NK cells can directly kill cancer cells
by recognizing signals of cellular stress and carry no risk of GvHD. However, autologous peripheral blood derived NK cells have limited
proliferation capacity and usually require leukemia cell line-based technology to assist production. In addition, autologous CAR-NK was
shown to encounter technical challenges due to low transduction efficiency of CAR vectors in the peripheral NK cells. Our NK platform
propagates human placenta derived HSCs and differentiates these cells into unmodified NK cells (CYNK-001). This process can produce hundreds
of doses per placenta donor. We have also developed technologies that can achieve high genetic modification efficiency by transducing
placenta HSCs and produce downstream stable gene modified CYNK cells with enhanced and selective cytotoxic and senolytic activity for
potential use in age-related diseases, including cancer, and autoimmune diseases. These cells are cryopreserved and can be shipped to
clinical administration immediately upon request. Our CYNK-001 development efforts were previously under IND for cancer and has been discontinued
internally. We are evaluating CYNK-001 as a senolytic/senablatant for age-related conditions and will seek to out-license the technology
or find a development partner.

MLASCs

Both autologous and allogeneic
bone marrow or adipose tissue derived MLASCs have been used in human clinical trials. Autologous MLASC therapies have advantages including
the absence of donor cell related adverse events and fewer regulatory hurdles since cell products are derived from a donor’s own
cells. However, autologous MLASC products carry the inherited or aging-related biological defects of the donor, which may impair therapeutic
value. Furthermore, in most cases, autologous cells still require cultivation before patient administration and there is a risk of manufacturing
failure.

Conversely, allogeneic MLASCs
can provide an off-the-shelf product with high quality and flexibility of dosing. MLASCs are regarded as immune-privileged due to their
relative low-level major histocompatibility complex class I and II protein expression. Our placenta tissue derived MLASCs are potentially
more immune privileged due to their fetal origin. In addition, because MLASCs have higher proliferative capability, they are expected
to be more suitable for genetic manipulations to engineer the cells to have specific features to enhance their functions or to mitigate
risk factors.

Therapeutic Candidate Pipeline and Development
Strategy

We are researching and developing
multiple placental-derived allogeneic cellular therapeutic candidates for the treatment of indications across aging-related and degenerative
diseases. From a single source material, the placenta, we focus on two allogeneic cell types: unmodified NK cells and MLASCs.

Future Pipeline Opportunities

We plan to utilize our Celularity
IMPACT platform to pursue additional targets of interest. These may include the additional indications for the allogeneic cell types currently
in the pipeline as well as other targets that might be validated in the future. In addition, we regularly survey the scientific and industry
landscape for opportunities to license, partner or acquire technologies that may help us advance current or new cellular therapies for
the benefit of patients.

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Our ability to prosecute future
opportunities, including those with scientific and potential commercial merit may be influenced by our ability to raise sufficient capital
to pursue those opportunities or to find commercial partners that are willing and able to fund portions of their development. Co-developed
or partnered programs may have longer term economics that are less favorable than internally funded programs, but those programs also
may have higher odds of success with a well-capitalized development partner with specific expertise in the disease state under investigation.

We are continuing to invest
in new biomaterials programs to expand our pipeline of placenta-derived advanced biomaterial products. We are currently developing a
tendon wrap indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue;
a bone void filler product for use in orthopedic surgical markets; and a placenta-derived extracellular matrix, or PECM, for use as a
passive temporary wound covering. We have preliminary data from a knee osteoarthritis animal model that our PECM may decrease joint pain
and promote chondrogenesis in damaged cartilage.

We continue to invest in creating
new or differentiated products for the Degenerative Disease segment to supplement sales of our mature commercial products, Biovance and
Interfyl. For example, we are developing three investigational advanced biomaterial products: Celularity Tendon Wrap, or CTW; Fuse Bone
Void Filler, and Celularity Placental Matrix, or CPM. We are developing our CTW investigational product for the management and protection
of tendon injuries in which there has been no substantial loss of tendon tissue as a structural barrier for injured tendon tissue and
does not depend on chemical action (pharmacological activity) to mediate this effect, to be classified as a surgical mesh. Based on the
FDA Office of Combination Products’, or OCP, preliminary assessment we now intend to submit a 510(k) notification for CTW in the
first half of 2025. We are developing our Fuse Bone Void Filler investigational product for use as a passive osteoconductive bone filler
in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects that are not dependent on
chemical action to mediate an effect. Based on OCP’s preliminary assessment, we now intend to submit a 510(k) notification for
FUSE in the second half of 2025. We are developing our CPM investigational product for use as a passive temporary wound covering which
is not meant to achieve its primary intended purpose through chemical action (pharmacological activity) and is not dependent on being
metabolized for the achievement of its intended purpose. CPM is a fully resorbable device composed of extracellular matrix (ECM) derived
from decellularized human placental tissue. Its wound management
indications include partial and full-thickness wounds; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undermined
wounds; surgical wounds; trauma wounds; and draining wounds.

Advanced
Biomaterial Products for Degenerative Diseases

We
report sales of advanced biomaterial products within the Degenerative Disease operating segment, which includes products for use in wound
care and the treatment of degenerative disease. The National Cancer Institute defines “degenerative disease” as a disease
in which the function or structure of the affected tissues or organs changes for the worse over time. Our advanced biomaterials business
today is comprised primarily of the sale of our Biovance 3L and Rebound products, directly or through our distribution network. Biovance
3L is a tri-layer decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. It
is an intact, natural extracellular matrix that provides a foundation for the wound regeneration process and acts as a scaffold for restoration
of functional tissue. Rebound is a full thickness extracellular matrix that contains amnion and chorion. We are developing new placental
biomaterial products to deepen the biomaterials commercial pipeline. We also market our Biovance and Interfyl products, directly or through
our distribution network. Biovance is decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term
pregnancy. It is an intact, natural extracellular matrix that provides a foundation for the wound regeneration process and acts as a
scaffold for restoration of functional tissue. Interfyl is human connective tissue matrix derived from the placenta of a healthy, full-term
pregnancy. It is used by a variety of medical specialists to fill soft tissue deficits resulting from wounds, trauma, or surgery.

We
have focused our marketing and sales strategy within the Advanced Biomaterial Products segment on developing strong distribution partners
for our products rather than building out our own direct sales force.

In
December 2025, we entered into an amended Sublicense and Marketing Agreement with BioCellgraft, Inc., to develop and commercialize certain
of our advanced biomaterial products under private label formulations, including Biovance®, Biovance® 3L, and Interfyl, in the
dental and oral healthcare field worldwide (subject to customary territorial exclusions).

In
August 2025, we entered into an agreement with Defeye, Inc. for which we received shares of preferred stock in Defeye, Inc. in exchange
for product purchase credits. In October 2025, we entered into a collaboration and license agreement with Defeye, Inc. to develop, manufacture,
and commercialize certain of our advanced biomaterial products for ophthalmic applications in a specified territory in Florida.

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Biobanking

We provide a fee-based biobanking
service to expectant parents who contract with us to collect, process, cryogenically preserve and store certain biomaterial, including
umbilical cord blood and placenta derived cells and tissue. We receive a one-time fee for the collection, processing, and cryogenic preservation
of the biomaterials, and a storage fee to maintain the biomaterials in our biobank payable annually generally over a period of 18 to 25
years. We acquired our biobanking business in May 2017 from HLI, which HLI operated as LifebankUSA, along with the degenerative disease
products Biovance and Interfyl, and in October 2018, we acquired CariCord Inc., or CariCord, a family cord blood bank.

Manufacturing

We have a 147,215 square foot
purpose-built facility located in Florham Park, New Jersey, which includes a cGMP-ready manufacturing center, along with dedicated research
and office spaces and space for shared services. Our facility includes nine Grade C/ISO-7 and six Grade D/ISO-8 manufacturing suites designed
for commercial production of cellular therapies and advanced biomaterials. We manufacture all finished products in-house

We may sell contract manufacturing
and development services to third parties. We believe that we will be able to provide a flexible and cost-effective alternative to the
larger contract manufacturing organizations currently serving this market.

Licensing Agreements

We enter into license agreements
in the ordinary course of our business.

Intellectual Property

Our commercial success depends
in part on our ability to obtain and maintain proprietary protection for the technologies supporting our Celularity IMPACT platform, our
future therapeutic candidates, as well as novel discoveries, product development technologies, and know-how. Our success also depends
on our ability to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary
rights. We seek to protect our proprietary position by filing or in-licensing U.S. and foreign patents and applications covering our technologies,
inventions, and improvements that are important to the development and implementation of our business.

We also rely on trademarks
and copyright law, trade secrets, know-how, continuing technological innovation, confidentiality agreements, and invention assignment
agreements to maintain our proprietary position. Confidentiality agreements are designed to protect our proprietary information, and invention
assignment agreements are designed to grant us ownership of technologies developed for us by employees, consultants, or third parties.
While we have confidence in our agreements and security measures, either may be breached, and we may not have adequate remedies. In addition,
our trade secrets may otherwise become known or independently discovered by competitors.

With respect to both licensed and Company-owned
intellectual property, including intellectual property that we have transferred and licensed back from Celeniv, we cannot be sure that
patents will be granted with respect to pending applications or future filings, nor can we be sure that any existing patents or future
patents will be commercially useful in protecting our therapeutics and methods of use and manufacturing. Our patents and applications
could also face challenges, such as interference proceedings, opposition proceedings, re-examinations, or other forms of post-grant review,
which could result in narrowing or invalidation of patents and applications, requiring significant time and resources to resolve.

We are actively building
our intellectual property portfolio around our Celularity IMPACT platform, our allogeneic cell types, and our therapeutic candidates
based on both Company-owned and licensed intellectual property. As of the date of this prospectus, our vast global intellectual
property portfolio, which protects our platform, processes, technologies, and
therapy programs. Our patent portfolio and filing strategy are designed to provide multiple layers of protection, including claims
directed to composition of matter, methods of making, and methods of use.

The term of individual patents
generally depends on the legal term in the country of filing, typically 20 years from the first non-provisional filing. In the United
States, patent terms may be adjusted for USPTO delays or extended under the Hatch-Waxman Act to compensate for regulatory review periods,
subject to limitations. Similar provisions are available in Europe and other jurisdictions to extend patent terms covering approved products.

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In August 2025, we sold certain
intellectual property assets to Celeniv Pte. Ltd. (“Celeniv”) and retained rights to such assets pursuant to a license agreement.
Our ability to develop, manufacture, and commercialize certain products and technologies now depends in part on our rights under that
license and our continued compliance with its terms.

Competition

Our products will compete
with novel therapies developed by biopharmaceutical companies, academic research institutions, governmental agencies, and public and private
research institutions, in addition to existing standard of care treatments.

Due to the promising therapeutic
effect of cellular therapies in other companies’ clinical trials, we anticipate increasing competition from existing and new companies
developing these therapies, as well as in the development of allogeneic cellular therapies.

Potential cellular therapy
and biomaterials competitors include:

●
allogeneic NK cellular therapies: Fate Therapeutics Inc., Century Therapeutics, Inc., Nkarta, Inc., Artiva Biotherapeutics, Wugen, and Shoreline Biosciences.

●
allogeneic MLASC therapies: Mesoblast Limited and, Longeveron.

●
Cellular therapy competition: Allogene Therapeutics, Inc., Atara Biotherapeutics, Inc., Adaptimmune Therapeutics PLC, Celyad S.A., CRISPR Therapeutics AG, Intellia Therapeutics, Inc., Gilead Sciences, Inc., Poseida Therapeutics, Inc., Precision Biosciences, Inc., Sangamo Therapeutics, Inc., Fate Therapeutics, Sana Biotechnology, Caribou Bio, and Artiva Biotherapeutics

●
Biomaterials competition: Mimedx Group, Inc., Organogenesis Holdings Inc., Skye Biologics Holdings LLC, Regenerative Labs, and Legacy Medical Consultants.

Competition will also arise
from non-cell-based therapies pursued by small-cap biotechnology and large-cap pharmaceutical companies including Amgen Inc., AstraZeneca
plc, Bristol Myers Squibb Company, Incyte Corporation, Merck & Co., Inc., and F. Hoffmann-La Roche AG.

Many of our competitors, either
alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development,
preclinical testing, clinical trials, manufacturing, and marketing than we do. Future collaborations and mergers and acquisitions may
result in further resource concentration among a smaller number of competitors.

Our commercial potential could
be reduced or eliminated if our competitors develop and commercialize therapeutics that are safer, more effective, have fewer or less
severe side effects, are more convenient or are less expensive than cellular therapeutics that we may develop. Our competitors also may
obtain FDA or other regulatory approval for their therapies more rapidly than we may obtain approval for ours, which could result in our
competitors establishing a strong market position before we are able to enter the market or make development efforts more complicated.
The key competitive factors affecting the success of all of our programs are likely to be efficacy, safety, and convenience.

These competitors may also
vie for a similar pool of qualified scientific and management talent, sites, and patient populations for clinical trials, as well as for
technologies complementary to, or necessary for, our programs.

Government Regulation and Product Approval

As a company developing and
commercializing products across multiple categories, including cellular therapeutics, biomaterials and related technologies, we operate
in a complex and evolving regulatory environment. The degree and scope of regulation applicable to our products vary significantly depending
on the product type, intended use, jurisdiction and applicable regulatory framework.

Certain product candidates,
including our cellular therapeutics, are expected to be subject to extensive regulatory oversight in jurisdictions where such products
are regulated as biological or advanced therapy products. However, other products and technologies within our portfolio, including certain
biomaterials and regenerative products, may be commercialized in markets or for uses that are subject to reduced regulatory requirements
or alternative regulatory pathways, including jurisdictions outside the United States. In these markets, products may be subject to varying
levels of oversight, including general product safety, manufacturing, labeling and marketing requirements, rather than premarket approval
or clearance.

We may pursue commercialization
strategies in jurisdictions where regulatory pathways are more streamlined or where certain products may be marketed without prior approval,
subject to compliance with applicable local laws and regulations. These regulatory frameworks may differ significantly from those applicable
in more highly regulated markets and may evolve over time. As a result, we may be able to generate revenue from certain products in these
markets prior to obtaining approvals in other jurisdictions, or without seeking such approvals.

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At the same time, operating
in markets with less prescriptive regulatory requirements presents additional risks. Regulatory standards in such jurisdictions may be
less defined, subject to interpretation or change, or inconsistently enforced. In addition, regulators in these jurisdictions may modify
applicable requirements, increase enforcement activities or impose new restrictions, which could adversely affect our ability to commercialize
products or continue operations in those markets.

Our activities, including
research, development, manufacturing, distribution, marketing and commercialization, are also subject to a range of other laws and regulations,
including those relating to product safety, advertising, consumer protection, data privacy, import and export controls and anti-corruption.
Compliance with these requirements may require the expenditure of significant time and resources, and failure to comply could result in
penalties, restrictions on our operations or other adverse consequences.

In addition, the classification
of our products, including whether a product is subject to regulation and the extent of such regulation, may not always be clear and may
be subject to differing interpretations by regulatory authorities. Changes in the regulatory classification of our products or in applicable
regulatory frameworks could require us to modify our development, manufacturing or commercialization strategies, incur additional costs
or delay or limit our ability to bring products to market.

Because we operate across
multiple jurisdictions, we are subject to regulatory regimes that differ in scope, complexity and enforcement. Our ability to successfully
commercialize our products depends, in part, on our ability to navigate these varying regulatory environments and to adapt to changes
in applicable laws and regulations.

Orphan Drug Designation

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

If a therapeutic that has
orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the therapeutic
is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market
the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority
to the therapeutic with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different drug or biologic
for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan
drug designation are tax credits for certain research and a waiver of the BLA application user fee.

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

In April 2021, the FDA granted
orphan drug designation to our non-genetically modified cryopreserved human placental hematopoietic stem cell-derived NK cell therapy,
CYNK-001, for the treatment of patients with malignant gliomas. However, we have discontinued development as to this indication.

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Expedited Development and Review Programs

In March 2021, we received
fast track designation from the FDA for our non-genetically modified cryopreserved human placental hematopoietic stem cell-derived NK
cell therapy. This program is currently not active.

Coverage, Pricing and Reimbursement

Significant uncertainty exists
as to the coverage and reimbursement status of any therapeutic candidates for which we obtain regulatory approval. In the United States
and certain markets in other countries, sales of any therapeutics for which we receive regulatory approval for commercial sale will depend,
in part, on the extent to which third-party payors provide coverage, and establish adequate reimbursement levels for such products. No
uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from
payor to payor. As a result, the coverage determination process is often time-consuming and costly. In the United States, third-party
payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations. The process
for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price
of a product or from establishing the reimbursement rate that such a payor will pay for the product. Third-party payors may limit coverage
to specific products on an approved list, also known as a formulary, which might not include all the FDA-approved products for a particular
indication. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness
of medical products, therapies and services, in addition to questioning their safety and efficacy. We may need to conduct expensive pharmaco-economic
studies to demonstrate the medical necessity and cost-effectiveness of our therapeutics, in addition to the costs required to
obtain FDA approvals. Our therapeutic candidates may not be considered medically necessary or cost-effective. A payor’s decision
to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Net prices for our therapeutics
may also be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation
of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Further,
one payor’s determination to provide coverage for a therapeutic does not ensure that other payors will also provide coverage for
the therapeutic. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to make an
appropriate return on our investment in therapeutic development.

Different pricing and reimbursement
schemes exist in other countries. In the European Union, or EU, governments influence the price of pharmaceutical products through their
pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers.
Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has
been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare
the cost-effectiveness of a particular therapeutic candidate to currently available therapies. Other member states allow companies to
fix their own prices for medicines but monitor and control company profits. The downward pressure on health care costs has become very
intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border
imports from low-priced markets exert commercial pressure on pricing within a country. Accordingly, in markets outside the United States,
the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable
revenue and profits. Pricing and rebate programs must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation
Act of 1990 and more recent requirements in the Patient Protection Affordable Care Act of 2010, as amended by the Health Care and Education
Reconciliation Act of 2010, collectively, the Affordable Care Act. If products are made available to authorized users of the Federal Supply
Schedule of the General Services Administration, additional laws and requirements apply.

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The marketability of any
therapeutic candidates for which we receive regulatory approval for commercial sales may suffer if the government and third-party payors
fail to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased and we expect
will continue to increase the pressure on healthcare pricing. For example, actions by federal and state governments and health plans may
put additional downward pressure on pharmaceutical pricing and health care costs, which could negatively impact coverage and reimbursement
for our products if approved, our revenue, and our ability to compete with other marketed products and to recoup the costs of our research
and development. 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 therapeutics for which we receive regulatory approval, less favorable coverage policies and reimbursement
rates may be implemented in the future.

Healthcare Reform

In the United States and
some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of therapeutic candidates, restrict or regulate post-approval activities,
and affect the ability to profitably sell therapeutic candidates for which marketing approval is obtained. Among policy makers and payors
in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of
containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular
focus of these efforts and has been significantly affected by major legislative initiatives.

For example, the Affordable
Care Act has substantially changed healthcare financing and delivery by both governmental and private insurers. Among the Affordable Care
Act provisions of importance to the pharmaceutical and biotechnology industries, in addition to those otherwise described above, are the
following:

●
an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs that began in 2011;

●
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, retroactive to January 1, 2010, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively, and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price (AMP);

●
a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D;

●
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

●
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;

●
expansion of the entities eligible for discounts under the 340B Drug Discount Program;

●
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

●
expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;

●
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected;

●
requirements to report certain financial arrangements with physicians and teaching hospitals;

●
a requirement to annually report certain information regarding drug samples that manufacturers and distributors provide to physicians;

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●
establishment of a Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; and

●
a licensure framework for follow on biologic products.

There remain executive, legal
and political challenges to certain aspects of the Affordable Care Act. For example, in December 2019, the Further Consolidated Appropriations
Act (H.R. 1865), which repealed the Cadillac tax, the health insurance provider tax, and the medical device excise tax, was signed into
law. Moreover, the Bipartisan Budget Act of 2018, effective January 2019, among other things, amended the Affordable Care Act to close
the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole”. In June 2021, the U.S. Supreme Court
dismissed the most recent judicial challenge to the Affordable Care Act brought by several states without specifically ruling on the constitutionality
of the Affordable Care Act. Prior to the Supreme Court’s decision an Executive Order was issued to initiate a special enrollment
period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the Affordable Care
Act marketplace. The Executive Order also instructed certain governmental agencies to review and reconsider their existing policies and
rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include
work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or
the Affordable Care Act. The ultimate content, timing or effect of any healthcare reform legislation on the United States healthcare industry
is unclear.

Previously, in October 2017,
an Executive Order was signed terminating the cost-sharing subsidies that reimburse insurers under the Affordable Care Act. The former
administration concluded that cost-sharing reduction, or CSR, payments to insurance companies required under the Affordable Care Act have
not received necessary appropriations from Congress and announced that it will discontinue these payments immediately until those appropriations
are made. Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their request for
a restraining order was denied by a federal judge in California in October 2017. In August 2020, the U.S. Court of Appeals for the Federal
Circuit ruled in two separate cases that the federal government is liable for the full amount of unpaid CSRs for the years preceding and
including 2017. For CSR claims made by health insurance companies for years 2018 and later, further litigation will be required to determine
the amounts due, if any. Further, in June 2018, the U.S. Court of Appeals for the Federal Circuit ruled that the federal government was
not required to pay more than $12 billion in Affordable Care Act risk corridor payments to third-party payors who argued the payments
were owed to them. In April 2020, the United States Supreme Court reversed the U.S. Court of Appeals for the Federal Circuit’s decision
and remanded the case to the U.S. Court of Federal Claims, concluding the government has an obligation to pay these risk corridor payments
under the relevant formula.

We anticipate that the Affordable
Care Act, if substantially maintained in its current form, will continue to result in additional downward pressure on coverage and the
price that we receive for any approved therapeutic, and could seriously harm our business. Any reduction in reimbursement from Medicare
and other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment
measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our therapeutics.
Such reforms could have an adverse effect on anticipated revenue from therapeutic candidates that we may successfully develop and for
which we may obtain regulatory approval and may affect our overall financial condition and ability to develop therapeutic candidates.

Further legislation or regulation
could be passed that could harm our business, financial condition and results of operations. Other legislative changes have been proposed
and adopted since the Affordable Care Act was enacted. For example, in August 2011, the Budget Control Act of 2011 was signed into law,
which, among other things, created the Joint Select Committee on Deficit Reduction to recommend Congress proposals in spending reductions.
The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years
2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions
to Medicare payments to providers of up to 2% per fiscal year. These reductions went into effect in April 2013 and, due to subsequent
legislative amendments to the statute, will remain in effect through 2030, except for a temporary suspension from May 1, 2020,
through March 31, 2022. Then, a 1% payment reduction occurred beginning April 1, 2022 through June 30, 2022, and the 2% payment reduction
resumed on July 1, 2022. Further, in January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things,
further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and
increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

In addition, on May 30, 2018,
the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain
investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval.
Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission
under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to
eligible patients because of the Right to Try Act.

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There has also been increasing
legislative and enforcement interest in the United States with respect to specialty drug pricing practices. At the federal level, an Executive
Order was signed in July 2021 affirming the administration’s policy to (i) support legislative reforms that would lower the prices
of prescription drug and biologics, including by allowing Medicare to negotiate drug prices, imposing inflation caps and supporting the
development and market entry of lower-cost generic drugs and biosimilars; and (ii) support the enactment of a public health insurance
option. Among other things, the Executive Order also directs the Department of Health and Human Services, or HHS to provide a report on
actions to combat excessive pricing of prescription drugs, to enhance the domestic drug supply chain, to reduce the price that the Federal
government pays for drugs, and to address price gouging in the industry; and directs the FDA to work with states and Indian Tribes that
propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003, and the FDA’s implementing regulations. FDA released such implementing regulations in September 2020, which went into
effect in November 2020, providing guidance for states to build and submit importation plans for drugs from Canada. Further, in November
2020, CMS issued an Interim Final Rule implementing the Most Favored Nation Model under which Medicare Part B reimbursement rates will
be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation
and Development countries with a similar gross domestic product per capita. In December 2021, CMS rescinded the Most Favored Nation rule.
Further, authorities in Canada have passed rules designed to safeguard the Canadian drug supply from shortages. If implemented, importation
of drugs from Canada may materially and adversely affect the price we receive for any of our therapeutic candidates. Additionally, in
December 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan
sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also
creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements
between pharmacy benefit managers and manufacturers. In December 2020, HHS published a regulation removing safe harbor protection for
price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers,
unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale,
as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. Pursuant to court order,
the removal and addition of the safe harbors were delayed, and recent legislation imposed a moratorium on implementation
of the rule until January 2026. The Inflation Reduction Act of 2022, or the IRA, further delayed implementation of this rule to January
2032.

In August 2022, the IRA was
signed into law. The IRA includes several provisions that will impact our business to varying degrees, including provisions that create
a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs in Medicare Part
D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic
or biosimilar competition, require companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay
the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries. The effect of IRA on our business
and the healthcare industry in general is not yet known.

Although a number of these
and other proposed measures may require authorization through additional legislation to become effective, and the Executive branch may
reverse or otherwise change these measures, both the current administration and Congress have indicated that they will continue to seek
new legislative measures to control drug costs. Individual states in the United States have also become increasingly active in passing
legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient
reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures,
and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Additional Regulation

In addition to the foregoing,
state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act,
the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect our business. These and other laws govern our use,
handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If
our operations result in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages
and governmental fines.

We believe that we are
in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse
effect on our business. We cannot predict, however, how changes in these laws may affect our future operations. Recent proposed
federal legislative and regulatory initiatives, including those focused on strengthening domestic manufacturing, supply chain
resiliency, environmental permitting and chemical safety oversight, may result in changes to permitting requirements, reporting
obligations, environmental standards, or enforcement priorities. These developments could increase our compliance costs, require
modifications to our manufacturing processes or facilities, or impact on the timing and location of our operations. In addition,
such initiatives may impose new obligations on the sourcing, use or disposal of certain materials or expand regulatory scrutiny of
facilities involved in biotechnology and advanced manufacturing.

Europe/Rest of World Government Regulation

In addition to regulations
in the United States, we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials
and any commercial sales and distribution of our therapeutics. Whether or not we obtain FDA approval of a therapeutic, we must obtain
the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of
the therapeutic in those countries. Certain countries outside of the United States have a similar process that requires the submission
of a clinical trial application much like the IND prior to the commencement of human clinical trials. In the EU, for example, a clinical
trial application must be submitted to each country’s national health authority and an independent ethics committee, much like the
FDA and IRB, respectively. Once the clinical trial application is approved in accordance with a country’s requirements, clinical
trial development may proceed. Because biologically sourced raw materials are subject to unique contamination risks, their use may be
restricted in some countries.

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The requirements and process
governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, the
clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have
their origin in the Declaration of Helsinki.

To obtain regulatory
approval of an investigational drug or biological product under EU regulatory systems, we must submit a Market Authorization
Application. The application used to file the BLA in the United States is like that required in the EU, with the exception of, among
other things, country-specific document requirements.

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

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

Employees and Human Capital Resources

As of December 31, 2025, we
had 115 full-time employees and 1 non-employee leased worker, most of whom are located at our Florham Park facility. Our employees are
not represented by labor unions or covered by collective bargaining agreements, and we consider our relationship with our employees to
be good.

Legal Proceedings

For a discussion of our current legal proceedings,
including certain settlements, arbitration matters, civil investigative demands, and other ongoing litigation, please refer to Item
3, “Legal Proceedings” of this Form 10-K.

Available Information

We post our annual report
on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports filed or furnished pursuant
to Section 13(a) or 15(d) of the Exchange Act, free of charge, on the Investors section of our public website (www.celularity.com) as
soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. In addition, you can read our
SEC filings over the Internet at the SEC’s website at www.sec.gov. The contents of these websites are not incorporated into this
annual report on Form 10-K. Further, our references to the URLs for these websites are intended to be inactive textual references only.

Implications for Being a Smaller Reporting Company

As a “smaller reporting
company,” as such term is defined in Rule 12b-2 under the Exchange Act, we may take advantage of accommodations afforded to smaller
reporting companies including: (i) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes
Oxley Act of 2002, so long as we also qualify as a “non-accelerated filer” as defined in the Exchange Act; (ii) scaled executive
compensation disclosure requirements; and (iii) providing only two years of audited financial statements, instead of three years. We will
qualify as a smaller reporting company: (i) until the fiscal year following the determination that the market value of our voting and
non-voting common stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter,
or (ii) if our annual revenues are less than $100 million during the most recently completed fiscal year, until the fiscal year following
the determination that the market value of our voting and non-voting common stock held by non-affiliates is more than $700 million measured
on the last business day of our second fiscal quarter.

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