UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 10-K
(Mark One)
For the fiscal year ended December 31, 2025
OR
For the transition period from
to
Commission file number 001-38914
Celularity Inc.
(Exact name of registrant as specified in its
charter)
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including
area code: (908)768-2170
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Securities registered pursuant to Section 12(g)
of the Act: None
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No☒
Indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐No☒
Indicate by check mark whether the registrant:
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes☒ No ☐
Indicate by check mark whether
the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit
such files). Yes☒ No ☐
Indicate by check mark whether
the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company,
indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether
the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that
prepared or issued its audit report. ☐
If securities are registered
pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing
reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether
any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether
the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
The aggregate market value
of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of the shares of Class
A common stock on the Nasdaq Stock Market on June 30, 2025, was $28.4 million.
The number of shares of the
registrant’s Class A common stock outstanding as of April 28, 2026 was 28,945,961.
DOCUMENTS INCORPORATED BY REFERENCE
None
Table of Contents
Page
PART I
Item 1. Business 1
Item 1A. Risk Factors 16
Item 1B. Unresolved Staff Comments 59
Item 1C. Cybersecurity 59
Item 2. Properties 60
Item 3. Legal Proceedings 60
Item 4. Mine Safety Disclosures 60
PART II
Item 6. [Reserved] 61
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 73
Item 8. Financial Statements and Supplementary Data 73
Item 9A. Controls and Procedures 130
Item 9B. Other Information 130
Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevents Inspections 130
PART III
Item 10. Directors, Executive Officers and Corporate Governance 131
Item 11. Executive Compensation 131
Item 14. Principal Accounting Fees and Services 131
PART IV
Item 15. Exhibits, Financial Statement Schedules 131
Unless the context indicates
otherwise, references in this annual report on Form 10-K to the “Company,” “Celularity,” “we,” “us,”
“our” and similar terms refer to Celularity Inc. (f/k/a GX Acquisition Corp.) and its consolidated subsidiaries (including
Celularity LLC, or Legacy Celularity).
The Celularity logo, Celularity
IMPACT, Biovance, Biovance 3L, Rebound, Interfyl, Lifebank, CentaFlex and other trademarks or service marks of Celularity Inc. appearing
in this annual report on Form 10-K are exclusively licensed by Celularity Inc. This annual report on Form 10-K also contains registered
marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing herein are the
property of their respective holders. Solely for convenience, trademarks and trade names referred to, including logos, artwork and other
visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that their
respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
On February 28, 2024, we effected
a 1-for-10 reverse stock split of our outstanding shares of Class A common stock. Unless specifically provided otherwise herein, all share
and per share information in this annual report on Form 10-K has been adjusted to reflect the reverse stock split.
i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements contained
in this annual report on form 10-K constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. Forward-looking statements
relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning
matters that are not historical facts. These statements relate to our future events, including our anticipated operations, research, development
and commercialization activities, clinical trials, operating results and financial condition. These forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially
different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking
statements may include, but are not limited to, statements about:
● our use of cash and other resources;
In some cases, you can identify
these forward-looking statements by the use of terminology such as “anticipate,” “believe,” “can,”
“contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,”
“intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,”
“predict,” “project,” “seek,” “should,” “strive,” “target,” “will,”
“would” and the negative version of these words or other comparable words or phrases, but the absence of these words does
not mean that a statement is not forward-looking. These statements reflect our current views with respect to future events, are based
on assumptions and are subject to risks and uncertainties. Given these risks and uncertainties, you should not place undue reliance on
these forward-looking statements. We discuss many of these risks in greater detail under the headings “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” in this annual report on Form 10-K. Because forward-looking
statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond
our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected
in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the
forward-looking statements.
Moreover, we operate in a
very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict
all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks,
uncertainties and assumptions, the forward-looking events and circumstances discussed in this annual report may not occur and actual results
could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You should not rely upon
forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected
in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes
responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any
forward-looking statements for any reason after the date of this annual report on Form 10-K to conform these statements to actual results
or to changes in our expectations.
You should read this annual
report on Form 10-K and the documents that we reference in this annual report on Form 10-K completely and with the understanding that
our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary
statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained
herein, whether as a result of any new information, future events, changed circumstances, or otherwise. Readers are cautioned not to place
undue reliance on the forward-looking statements, which speak only as of the date of this annual report on Form 10-K.
ii
PART I
Item 1. Business.
We are a cellular and regenerative medicine
company focused on advancing health longevity and redefining the standard of care for age-related disease using novel therapies
derived from the post-partum human placenta. The objective of extending health longevity is to meaningfully reduce the duration and
severity in which an individual experiences aging-related degenerative diseases and disorders associated with increased mortality
towards the end of life. Aging is known to be a major risk factor for many degenerative disorders and diseases across multiple
high-value therapeutic areas, including immunology and regenerative medicine. Common to all degenerative disorders and diseases is
the progressive loss of function or structure (or both) of affected tissues and organs driven by underlying cellular dysfunction.
These processes directly impact regenerative capacity, healthspan and overall lifespan. Likewise, age-associated immunosenescence
and other physiological changes contribute to increased vulnerability to infections. Infections further exacerbate aging-related
decline and are increasingly associated with frailty and adverse clinical outcomes.
Aging and longevity are determined by a complex
combination of genetic, nongenetic, and environmental factors. While aging is not itself a disease, it increases vulnerability to disease
and is among the most important known risk factors for most chronic diseases. For example, aging is a primary driver of cancer and other
chronic conditions. The accumulation of senescent cells in aged tissues is suggested to be a key factor underlying age related cancer.
Likewise, age is a key risk factor for autoimmune disease, and many autoimmune diseases preferentially occur in the second half of adulthood
as immune function declines. These processes are increasingly linked to age-related immune dysregulation.
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.
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:
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.
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:
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.
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.
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.
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.
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.
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 MLASC therapies: Mesoblast Limited and, Longeveron.
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.
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.
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.
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