Celularity Inc. (Nasdaq: CELU) (“Celularity”) a biotechnology
company developing allogeneic cell therapies and advanced
biomaterial products, today announced that its abstract “Tri-layer
decellularized, dehydrated human amniotic membrane supports
proliferation and stemness of limbal stem cells derived from
induced pluripotent stem cells” has been accepted as a poster
presentation at WBC 2024, the 12th World Biomaterials Congress
which will be held on 26-31 May 2024 in Daegu, Republic of Korea,
and hosted by the Korean Society for Biomaterials (KSBM). The theme
of WBC 2024 is “Convergence in Biomaterials: a vision for the
future of healthcare.”
The study described in the poster presentation
investigated Celularity’s tri-layer decellularized, dehydrated
human amniotic membrane technology product as a carrier of induced
pluripotent stem cell derived-limbal stem cells (iPSC-LSC) which
were investigated for the treatment of limbal stem cell deficiency
(LSCD). LSCD is a debilitating ocular surface disorder that occurs
due to loss or dysfunction of limbal stem cells (LSCs) that are
vital for the re-population of the corneal epithelium and to the
barrier function of the limbus. Limbal Stem Cell (LSC) transplant
is a recognized method to restore the ocular surface in advanced
stem cell deficient corneas.
Robert J. Hariri, M.D., Ph.D., Celularity
Chairman, CEO and Founder, noted, “LSCD is characterized by
cellular invasion onto the cornea by conjunctival epithelium,
leading to impaired epithelial wound healing and resulting in
chronic ocular surface inflammation, neovascularization, and
eventually opacification. The causes of LSCD include trauma and
contact lens wear as well as infection and inflammation and this
represents a significant clinical opportunity for Celularity’s
regenerative medicine technologies.” According to data published by
Delve Insight, the United States had the highest number of
diagnosed prevalent cases of LSCD.
Anna Gosiewska, PhD., Vice President of Research
and Development for Degenerative Diseases, leading Celularity’s
development of advanced biomaterials and cell technologies, stated,
“The investigation into the integration of placental biomaterials
into regenerative cellular medicine protocols may enhance the
efficacy of stem cell therapies expanding the scope of potential
applications, from treating degenerative diseases to repairing
damaged tissues and organs. As our research continues to explore
the remarkable capabilities of placental biomaterials combined with
cell-based technologies, we believe we can accelerate the
translation of discoveries from the laboratory to the clinic,
bringing our innovative solutions to patients.”
The Gluck Tissue Engineering Laboratory is part
of the Wilson College of Textiles at North Carolina State
University and is focused on understanding how the microenvironment
contributes to stem cell differentiation and function. Its Tissue
Engineering Lab Team is particularly interested in corneal tissue
engineering, focusing primarily on ocular surface regeneration. As
noted by Dr Jessica M. Gluck, Principal Investigator of the Gluck
Lab, “Working with Celularity provides a collaborative effort of
moving ocular regenerative medicine closer to the clinic.”
The study described in the poster presentation
concluded that tri-layer decellularized, dehydrated human amniotic
membranes have the potential to be a viable carrier for iPSC-LSCs
for the treatment of LSCD and other ocular surface disorders. The
off-the-shelf availability of existing commercial tri-layer
decellularized, dehydrated human amniotic membrane products, in
combination with iPSC-LSCs, may improve patient access to LSCD
treatment and the therapeutic management of LSCD.
The abstract authors are Nasif Mahmood
(principal author), Daxian Zha, Dr. Brain C. Gilger, and Dr.
Jessica M. Gluck, all of North Carolina State University; and Dr.
Anna Gosiewska, Dr. Stephen A. Brigido, Dr. Robert J. Hariri, all
of Celularity.
About Celularity
Celularity is a cellular and regenerative
medicine company developing “off-the-shelf” placental-derived
allogeneic cellular therapy product candidates, including T cells
engineered with a chimeric antigen receptor (“CAR”), unmodified
natural killer (“NK”) cells and genetically modified CAR NK cells,
and mesenchymal-like adherent stromal cells (“MLASCs”). These
therapeutic candidates target indications across a range of
degenerative disorders and diseases including those associated with
aging, which is known to be a major risk factor across multiple
therapeutic areas including cancer, regenerative medicine, and
immune disorders. Celularity also develops, manufactures, and
markets advanced biomaterial products derived from the postpartum
placenta and the umbilical cord and operates a commercial
biobanking service. Celularity believes that by harnessing the
placenta’s unique biology and ready availability, it is able to
develop solutions that address a significant unmet global need for
effective, accessible, and affordable therapeutics.
For more information, visit www.celularity.com.
Forward-Looking Statements
This press release includes “forward-looking
statements” within the meaning of The Private Securities Litigation
Reform Act of 1995, as well as within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These forward-looking
statements include statements regarding: (i) the efficacy of a
combination product which includes tri-layer decellularized,
dehydrated human amniotic membrane and iPSC-LSCs; and (ii) the
potential for Celularity’s tri-layer decellularized, dehydrated
human amniotic membrane to be a viable carrier for iPSC-LSCs for
the treatment of LSCD and other ocular surface disorders .
Forward-looking statements include all
statements that are not historical facts and all statements
relating to future events, including expectations regarding our
operational and efficiency initiatives, our strategy, expected net
revenue per unit, forecasted results, and expectations regarding
the effect of our actions to improve performance. These
forward-looking statements reflect our current expectations and
projections with respect to, among other things, the Company’s
financial condition, results of operations, plans, objectives,
strategy, future performance, and business. In some cases, you can
identify forward-looking statements by terminology that may
precede, follow or include the words “aim,” "anticipate,"
"believe," “can,” “contemplate,” “continue,” “could,” "estimate,"
"expect," "forecast," "intend," "likely," “may,” “might,”
"outlook," "plan," “possible,” "potential," "project,"
"projection," "seek," "should," “strive,” “target,” “will,”
"would," "will," and the negative of terms like these or other
comparable terminology, and other words or terms of similar
meaning.
The forward-looking statements in this press
release are subject to risks and uncertainties and we caution
against placing undue reliance on such statements. Many factors
could cause actual results to differ materially from those
described in these forward-looking statements, including but not
limited to: statements regarding our ability to develop a
combination product which includes tri-layer decellularized,
dehydrated human amniotic membrane and iPSC-LSCs; regulatory
uncertainties associated with the use of tri-layer decellularized,
dehydrated human amniotic membrane in combination with iPSC-LSCs;
our ability to expand the scope of potential applications of stem
cell therapies; and the risks associated with our current
liquidity, along with those risk factors set forth under the
caption “Risk Factors” in the Company’s annual report on Form 10-K
filed with the Securities and Exchange Commission (SEC) on March
31, 2023, and other filings with the SEC.
If any of these risks materialize or underlying
assumptions prove incorrect, actual results could differ materially
from the results implied by these forward-looking statements. There
may be additional risks that we do not presently know, or that we
currently believe are immaterial, that could also cause actual
results to differ from those contained in the forward-looking
statements. In addition, these forward-looking statements reflect
our current expectations, plans, or forecasts of future events and
views as of the date of this communication. Subsequent events and
developments could cause assessments to change. Accordingly,
forward-looking statements should not be relied upon as
representing our views as of any subsequent date, and we undertake
no obligation to update forward-looking statements to reflect
events or circumstances after the date hereof, whether as a result
of new information, future events or otherwise, except as may be
required under applicable securities laws.
Celularity Investor
Contact:
Carlos Ramirez SVP, Investor RelationsCelularity
Inc.carlos.ramirez@celularity.com
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