Exhibit
99.1
Celularity
and Vesalius Longevity Labs Sign Exclusive Collaboration for Peptual® Peptide APIs Manufactured in the United States
Celularity
to serve as the exclusive partner for the finish manufacturing of Vesalius’s Peptual peptide APIs, supporting Vesalius’s
expansion into pharmaceutical ingredient supply
Collaboration
advances Celularity’s regenerative longevity vision and creates an opportunity to expand revenue through its U.S. manufacturing
infrastructure and technical expertise
FLORHAM
PARK, N.J. and SCOTTSDALE, A.Z., October 29, 2026—Celularity Inc. (Nasdaq: CELU) (“Celularity”), a longevity-focused
regenerative and cellular medicine company, and Vesalius Longevity Labs Inc. (“Vesalius”), a leading, global peptide and
longevity brand, today announced that they have entered into an exclusive manufacturing agreement to establish a dedicated, first-of-its-kind,
U.S. final stage API manufacturing and supply platform for Vesalius’s Peptual-branded active pharmaceutical ingredients (“APIs”).
The
collaboration expands Celularity’s regenerative longevity platform by applying Celularity’s U.S.-based manufacturing infrastructure
and technical capabilities to support the development of Vesalius’s Peptual®-branded peptide APIs at its Florham Park,
New Jersey facility. It builds on Celularity’s experience manufacturing complex biologics to current good manufacturing practice
(“cGMP”) standards, extending those capabilities into peptide API manufacturing while supporting its broader vision of advancing
regenerative longevity.
Under
the collaboration, Celularity will perform downstream purification, processing, analytical testing and manufacturing activities using
supplier-provided bulk peptide material. The work is intended to establish peptide-specific manufacturing processes that satisfy cGMP
requirements, supported by defined product specifications, documented sourcing and lot-level traceability. The collaboration is intended
to position the parties to respond to potential regulatory developments affecting peptide compounding. If and when the U.S. Food and
Drug Administration (“FDA”), following its consideration of recommendations from the Pharmacy Compounding Advisory Committee
(“PCAC”), adds covered peptide substances and forms to its list of bulk drug substances that may be used in compounding under
federal law, the parties intend to supply eligible Peptual-branded APIs to appropriately licensed U.S. compounding pharmacies. The collaboration
will not involve manufacturing GLP-1 receptor agonists or other weight-loss peptides, as these products are excluded from Vesalius’s
business model.
“Peptides
represent an important category of products which can work to augment the clinical utility of conventional therapeutics, and we believe
can complement our regenerative cellular products,” said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer
of Celularity. “We have invested in a purpose-built U.S. facility and assembled a team with experience manufacturing complex medicines.
As such, our collaboration with Vesalius represents an important business opportunity for Celularity and a practical extension of our
regenerative longevity strategy.”
The
collaboration comes amid regulatory scrutiny of the quality and provenance of imported pharmaceutical ingredients. The FDA has highlighted
concerns about peptide APIs from unverified foreign sources and has separately urged compounding pharmacies to verify their ingredient
suppliers, understand the testing performed and identify the original API manufacturer. Celularity and Vesalius believe these concerns
create an imperative for a domestic manufacturing platform to strengthen pharmaceutical supply-chain resilience and U.S. national health
preparedness. By bringing key downstream manufacturing activities onshore, the collaboration is intended to establish a more transparent
path from bulk peptide material through final API release.
“We
selected Celularity because its facility, technical personnel and experience manufacturing complex biological products provide a strong
foundation for our peptide API sourcing plans,” said Pradeep Albert, CEO of Vesalius. “Celularity’s capabilities complement
our Peptual platform and commercialization strategy. Together, we aim to establish a U.S. domestic supply platform supported by documented
manufacturing processes, defined quality specifications and traceability from supplier inputs through final API release.”
For
patients and prescribing physicians, uncertainty about an ingredient’s origin, identity and purity raises practical questions about
what is being supplied and the evidence supporting its quality. Meaningful transparency requires documentation connecting each lot to
its original source, the manufacturing controls applied and the testing supporting its release. The parties intend to build that accountability
into the planned platform, supporting informed sourcing decisions by pharmacies and providing a clearer basis for peptide use from prescribing
physicians and their patients.
“The
healthcare community deserves transparency about where the ingredients in medications originate and how their quality has been
evaluated,” said Micheal Roizen, M.D., former head of Wellness at Cleveland
Clinic and Chief Scientific Advisor at Vesalius. “When the original manufacturer is unclear or testing records are
incomplete, physicians and patients are left with questions that should be answered before a product is used. Vesalius’s
collaboration with Celularity is intended to bring greater visibility and accountability to that supply chain. That is an important
foundation for responsible progress in peptide medicine.”
Regulatory
Notice
The
peptides and APIs described in this release are not FDA-approved drug products. Compounded drugs are not FDA-approved and are not reviewed
by FDA for safety, effectiveness or manufacturing quality before marketing. FDA establishment registration, facility inspection, advisory
committee consideration or recommendations, cGMP terminology, a certificate of analysis or domestic manufacture does not constitute FDA
approval or endorsement of a substance, API, compounded drug, manufacturer or pharmacy. Execution of the collaboration agreement and
completion of development or qualification activities do not themselves authorize commercial release, distribution or use of any peptide
API. Availability is subject to applicable law, FDA policy and local jurisdictional requirements.
About
Vesalius Longevity Labs
Vesalius
Longevity Labs is a longevity science and regenerative health platform focused on peptides, biologics, preventative healthcare and performance
optimization. Vesalius operates a scalable B2Doctor2Consumer ecosystem designed to support healthcare providers, telehealth infrastructure,
product fulfillment and advanced longevity therapeutics across global markets. Vesalius’s expanding ecosystem includes peptide
therapeutics, regenerative medicine initiatives, royalty-generating biologics partnerships and advanced provider enablement technologies
designed to support the future of personalized health and wellness.
For
more information, visit: https://www.vesaliuslabs.com/
Vesalius
Media Contacts:
Media
Contact: vesalius@jacktaylorpr.com
About
Celularity
Celularity
Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous
cell therapies and biomaterials. Celularity’s regenerative longevity vision centers on advancing technologies intended to address
aging and age-related conditions and extend healthspan. Its purpose-built facility in Florham Park, New Jersey supports manufacturing,
research and biobanking activities. Celularity also pursues contract development and manufacturing opportunities that apply its infrastructure
and technical expertise to third-party programs.
For
more information, visit www.celularity.com.
Celularity
Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of the U.S. federal securities laws, including statements regarding
the establishment, development and potential growth of Celularity’s peptide API manufacturing business vertical; its alignment
with Celularity’s regenerative longevity strategy; the anticipated scope, implementation and benefits of the collaboration with
Vesalius; the development and qualification of manufacturing processes that satisfy applicable cGMP requirements; potential commercial
supply and revenue generation; utilization of Celularity’s existing infrastructure; and anticipated benefits relating to quality,
traceability and domestic supply-chain resilience. These statements may be identified by words such as “anticipate,” “believe,”
“expect,” “intend,” “may,” “plan,” “potential,” “will” and similar
expressions, although not all forward-looking statements contain these words.
These
forward-looking statements reflect Celularity’s current expectations and assumptions and are subject to substantial risks and uncertainties
that could cause actual results to differ materially. These risks include the parties’ ability to agree upon and fund product-specific
development plans and commercial supply terms; complete technical transfer, process development, analytical-method qualification and
manufacturing qualification; establish peptide-specific processes and quality systems that satisfy applicable cGMP requirements; achieve
required specifications and commercial scale; and obtain and maintain required regulatory authorizations, registrations and licenses.
Additional risks include uncertain customer demand, the costs of establishing the new business vertical, Celularity’s ability to
generate revenue or achieve profitable operations, and changes in laws, regulations, FDA policies or enforcement priorities affecting
peptide manufacture, distribution or compounding. Particular peptide substances or forms may not be eligible for supply or use in the
intended channels. Celularity’s existing facility and manufacturing experience do not assure successful development or commercial
manufacture of any peptide API. Commercial supply may be delayed indefinitely or may not occur.
These
risks and uncertainties should be considered together with the risks described under “Risk Factors” and elsewhere in Celularity’s
most recent Annual Report on Form 10-K, as amended, subsequent Quarterly Reports on Form 10-Q and other filings with the U.S. Securities
and Exchange Commission. The risks described are not exhaustive. Forward-looking statements speak only as of the date of this release,
and readers should not place undue reliance on them. Except as required by law, Celularity undertakes no obligation to update any forward-looking
statement to reflect subsequent events, circumstances or changes in expectations.
Celularity
Investor and Media Contact
info@celularity.com
