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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 29, 2026
Celularity
Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-38914 |
|
83-1702591 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
170
Park Ave
Florham
Park, New Jersey |
|
07932 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (908) 768-2170
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instructions A.2. below):
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Class
A Common Stock, $0.0001 par value per share |
|
CELU |
|
The
Nasdaq Stock Market LLC |
| Warrants,
each exercisable for one-tenth of one share of Class A Common Stock at an exercise price of $11.50 per share |
|
CELUW |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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.
Item
5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of
Certain Officers.
On
May 29, 2026, Celularity Inc. (“Celularity”) appointed Rick Gonzalez as Chief Commercial Officer of Celularity. Mr. Gonzalez
will report directly to Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and Chief Executive Officer.
Celularity
has not entered into a definitive employment agreement with Mr. Gonzalez in connection with his appointment. Celularity will disclose
the material terms of any definitive compensatory arrangement with Mr. Gonzalez in a subsequent filing with the Securities and Exchange
Commission, as required.
There
are no family relationships between Mr. Gonzalez and any director or executive officer of Celularity. There are no arrangements or understandings
between Mr. Gonzalez and any other person pursuant to which he was appointed as Chief Commercial Officer. Mr. Gonzalez is not a party
to any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Item
7.01. Regulation FD Disclosure.
On
June 3, 2026, Celularity issued a press release announcing the appointment of Mr. Gonzalez as Chief Commercial Officer. A copy of the
press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Also
on June 3, 2026, Celularity made available a letter to shareholders from Dr. Hariri, providing an update on Celularity’s strategic
focus, including its focus on longevity, regenerative medicine and the preservation of human performance, its commercial opportunity
for cenplacel-L, its Lifebank cellular banking platform, and the appointment of Mr. Gonzalez as Chief Commercial Officer. A copy of the
shareholder letter is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The
information in this Item 7.01, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall
not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act
of 1934, as amended, except as expressly set forth by specific reference in such filing.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits
| 99.1 |
|
Press release issued by Celularity Inc. on June 3, 2026. |
| 99.2 |
|
Letter to Shareholders from Robert J. Hariri, MD, PhD, Chairman and CEO, dated June 3, 2023 |
| 104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL) |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
CELULARITY
INC. |
| Dated:
June 3, 2026 |
|
| |
By: |
/s/
John Sprague |
| |
Name: |
John
Sprague |
| |
Title: |
Chief
Financial Officer |
Exhibit
99.1
Celularity
Appoints Rick Gonzalez as Chief Commercial Officer
| |
● | Appointment
supports Celularity’s focus on longevity, regenerative medicine and preservation of human performance by advancing
commercialization of cenplacel-L and Lifebank |
FLORHAM
PARK, NJ, June 3, 2026 (GLOBE NEWSWIRE), Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a longevity-focused
regenerative and cellular medicine company pioneering placental-derived cellular and regenerative therapies, today announced the appointment
of Rick Gonzalez as Chief Commercial Officer, effective May 29, 2026. In this role, Mr. Gonzalez will oversee global commercial strategy
and execution for cenplacel-L, Lifebank and the Company’s broader regenerative medicine portfolio, and will report to Robert J.
Hariri, M.D., Ph.D., Celularity’s Chairman, Chief Executive Officer and Founder.
“Rick’s
appointment comes at an important time for Celularity as we continue to advance our revenue-generating strategy and expand the reach
of our regenerative medicine platform,” said Robert J. Hariri. “Celularity was founded on the belief that the placenta represents
a powerful biological resource with the potential to transform medicine at global scale. As physician and patient interest in cellular
medicine continues to grow, we believe Rick’s experience building commercial organizations and executing disciplined growth strategies
across complex healthcare markets will be important as we seek to expand responsible access to cenplacel-L, enhance our Lifebank offering,
and translate Celularity’s science into long-term value for physicians, patients, families and shareholders.
Mr.
Gonzalez brings more than two decades of executive leadership experience across biotechnology, medical technology, precision medicine
and digital health. Most recently, he served as Chief Commercial Officer of Alume Biosciences, where he led global commercialization
strategy for a clinical-stage surgical visualization platform, including pricing, reimbursement, market access and launch readiness.
He previously served as President, Chief Executive Officer and Director of Navidea Biopharmaceuticals, where he led commercialization
of a precision diagnostic platform and drove 2.5x year-over-year revenue growth, and as Senior Vice President, Global Operations at Spectrum
Pharmaceuticals, where he helped scale global revenue from $7.7 million to approximately $300 million through international expansion
and commercialization of specialty therapies. Earlier in his career, Mr. Gonzalez held leadership roles at Abraxis, Genzyme, Corixa,
Ligand and Roche.
Cenplacel-L,
clinically investigated as PDA-001 and PDA-002, is Celularity’s most mature placental-derived allogeneic cell therapy asset. The
program reflects more than two decades of research by Celularity into the unique biological properties of postpartum placental cells.
Celularity believes cenplacel-L has the potential to play an important role in the emerging global market for stem-cell and regenerative
cellular therapies, particularly in jurisdictions where regulatory frameworks permit physician-directed access to such therapies.
The
Company is seeing demand from physicians seeking access to high-quality, responsibly manufactured stem-cell therapies for appropriate
patients in permissive markets. Since making cenplacel-L available to qualified physicians for investigational use in such jurisdictions,
Celularity believes this early commercial traction supports the Company’s decision to strengthen its commercial leadership with
the appointment of Mr. Gonzalez and the continued build-out of commercial capabilities designed to support appropriate physician engagement,
education and market development.
Mr.
Gonzalez will also lead expansion of Celularity’s Lifebank product offering for expectant parents and adults who wish to bank their
own cells for potential future use. Lifebank generated sales in 2025 that reflected continued interest in cellular banking and its role
in Celularity’s broader longevity and regenerative medicine strategy. Celularity believes Lifebank is a natural extension of that
strategy, providing individuals and families with an opportunity to preserve valuable cellular material at a time when interest in proactive
health, cellular medicine and future therapeutic optionality continues to grow. Under Mr. Gonzalez’s leadership, Celularity intends
to strengthen commercial education around Lifebank, expand engagement with physicians and other healthcare providers, and broaden awareness
among consumers seeking to preserve biological resources that may support future advances in regenerative medicine and human performance.
“I
am honored to join Celularity at such a pivotal point in the Company’s evolution,” said Mr. Gonzalez. “Celularity has
a differentiated foundation in placental-derived cellular therapy, a near-term commercial opportunity with cenplacel-L, the Lifebank
cellular banking platform, and a broader mission that aligns with the growing demand for longevity and regenerative medicine. My focus
will be on building disciplined commercial infrastructure, strengthening physician engagement, aligning cross-functional execution, and
helping translate Celularity’s scientific and manufacturing capabilities into sustainable commercial growth. I look forward to
working with the team to expand access responsibly, support physicians and patients, and create long-term value for the Company and its
stakeholders.”
Celularity
believes the next phase of regenerative medicine will be defined not only by demand for innovative cellular therapies, but also by manufacturing
rigor, quality systems, regulatory discipline and clinically responsible access. The Company’s current manufacturing infrastructure
and existing inventory position it to support anticipated demand for cenplacel-L while maintaining the quality standards and manufacturing
discipline central to Celularity’s platform.
About
Celularity
Celularity
Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous
cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties
and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease.
For
more information, please visit www.celularity.com.
Forward
Looking Statements
This
press release contains “forward-looking statements” within the meaning of the federal securities laws, including statements
regarding Celularity’s commercial strategy, leadership appointments, longevity strategy, product opportunities, physician demand,
responsible access, market expansion, Lifebank, cellular banking, future therapeutic optionality, revenue generation, growth prospects,
manufacturing capabilities, anticipated demand, participating centers, repeat physician utilization, patient cohorts, and anticipated
value creation. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that
could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include,
among others, risks described in Celularity’s filings with the Securities and Exchange Commission, including its most recent Annual
Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Celularity undertakes no obligation
to update any forward-looking statements, except as required by law.
Carlos
Ramirez
SVP,
Investor Relations
Celularity
Inc.
Carlos.ramirez@celularity.com
Exhibit
99.2
Dear
Fellow Shareholders,
I
want to take this opportunity to provide an important update on the developments at Celularity over the past several months particularly
in the context of evolving clinical and regulatory progress. At the same time, we recognize that the broader biotechnology sector, and
cellular therapy companies in particular, continue to operate in a highly selective and challenging capital markets environment. Celularity’s
leadership has taken important steps to sharpen our strategic focus, strengthen our financial position and enable Celularity to pursue
the opportunities we believe are most closely aligned with our founding vision. These actions are intended to streamline our business
and concentrate resources where we believe we can create durable long-term value.
As
previously announced, we completed a transaction with NexGel, Inc. to out-license the commercial assets of our biomaterials business
for consideration of up to $30 million, whereupon through strategic structuring, we eliminated certain of our recorded liabilities by
nearly $13 million. The rationale for the transaction was straightforward. The biomaterials business generated meaningful revenue during
our ownership and supported the treatment of thousands of patients, but these assets no longer represent the central focus of our long-term
strategy. In short, the transaction enabled us to simplify our operating structure and redirect attention and resources toward our core
placental-derived cellular therapy programs in the field of longevity and age-related disease.
Celularity
was founded on the belief that the placenta represents a powerful and ethical biological resource with the potential to transform medicine
on a global scale. Together with Peter Diamandis, M.D., one of the leading voices in the global longevity and exponential technology
movements, I launched Celularity around a shared conviction: that placental-derived cellular therapies could play an anchoring role in
extending human health span, addressing age-related disease and improving human performance. That vision continues to guide our strategy
today.
Celularity
sits at a unique intersection of regenerative medicine, immunology and aging biology. Our technologies are designed to harness the intrinsic
biological properties of placental cells to address inflammation and the degenerative changes associated with aging. As global interest
in longevity, cellular medicine, and regenerative therapies continues to expand, we believe Celularity is uniquely positioned to be a
leader in this exciting area of medical innovation.
Central
to our renewed focus is our most mature cell therapy product, cenplacel-L. Cenplacel-L is a placental-derived allogeneic cell therapy
in the broader category of stem-cell and regenerative medicine, developed from postpartum placental tissue and designed to deliver the
regenerative, immunomodulatory and anti-inflammatory potential of placental cells and reflects more than two decades of research by Celularity
and its predecessor company, Celgene Cellular Therapeutics.
We
believe cenplacel-L has the potential to play an important role in the emerging global market for stem-cell and regenerative cellular
therapies, particularly in jurisdictions where regulatory frameworks permit physician-directed access to such therapies. These markets
offer Celularity the opportunity to generate early commercial activity and build real-world clinical experience while continuing to evaluate
opportunities to advance cenplacel-L through traditional regulatory pathways.
We
are excited that physician interest in cenplacel-L has been strong. We are seeing demand from physicians seeking access to high-quality,
responsibly manufactured placental-derived cellular therapies for appropriate patients in permissive markets. This demand includes interest
from our affiliate partners at Fountain Life, whose physician network, focused on longevity, performance, and proactive health, has a
mission closely aligned with Celularity. We believe the next phase of regenerative medicine will be defined not only by physician demand,
but by manufacturing rigor, quality systems, regulatory discipline, and clinically responsible access. We believe these are areas where
Celularity is well-positioned to differentiate.
Since
emerging as a spin-off from Celgene at the end of 2017, Celularity has distinguished itself from other cellular medicine companies through
our ability to generate revenues from placental biomaterials, CDMO and biobanking services, and the sale of cenplacel-L. While still
early in the commercialization process, we believe growth in cenplacel-L revenues in 2026 will be driven principally by increasing physician
participation and patient adoption in Florida, where the evolving regulatory framework and our collaboration with Fountain Life are helping
to create an important initial market for placental-derived cellular therapies. We believe this market can provide a meaningful foundation
for early commercial growth while also contributing valuable real-world clinical experience. Importantly, our current manufacturing infrastructure
and existing inventory position us well to support anticipated demand, and we believe we have abundant capacity to meet expected growth
while maintaining the quality standards and manufacturing discipline central to Celularity’s platform. As we scale, we intend to
report on key metrics such as the number of participating centers, repeat physician utilization, and patient cohorts to provide greater
transparency into the trajectory of this emerging commercial opportunity.
As
Celularity enters this next phase, we are pleased to welcome Rick Gonzalez as Chief Commercial Officer. Rick will be responsible for
leading Celularity’s commercial strategy, with a focus on expanding physician access to cenplacel-L and related Celularity products.
His leadership will be critical as we seek to translate growing physician interest into a disciplined and scalable commercial model.
One that broadens access while maintaining the quality, manufacturing rigor, and scientific integrity central to Celularity’s platform.
Cenplacel-L
also remains an important part of Celularity’s longer-term clinical strategy. Previously investigated as PDA-001 and PDA-002, cenplacel-L
has been studied across multiple indications, and we continue to evaluate opportunities to return this program to the clinic in the United
States in areas where placental-derived cellular therapy may address significant unmet medical need.
We
are also continuing to explore the potential of our natural killer cell program, CYNK-001, including its potential application as a senoblative
therapy. Senescent cells accumulate with age and contribute to tissue dysfunction, degenerative disease and declining physiological performance.
The ability to selectively eliminate these cells represents an emerging approach to addressing biological mechanisms that influence aging
and health span. Together, we believe cenplacel-L and CYNK-001 represent complementary pillars of a differentiated, placenta-derived
longevity platform designed to address both the consequences and underlying biological drivers of age-related decline.
While
we are encouraged by the opportunities ahead, we remain realistic about the challenges facing Celularity. Like many companies advancing
novel cellular therapies, we operate in a demanding capital environment. Our existing residual debt obligations and capital constraints
require discipline and careful execution. In parallel, we are actively evaluating opportunities to support the business through strategic
partnerships, non-dilutive sources of capital, and disciplined geographic expansion in markets where the regulatory environment and physician
demand may enable responsible near-term commercialization. The actions we are taking, including the NexGel transaction and our renewed
focus on cell therapy in longevity, are intended to strengthen Celularity’s financial position and concentrate our resources on
the programs where we believe our science, manufacturing capabilities and strategic relationships can create the greatest long-term value.
Celularity
is entering a new phase of focused execution. With a more streamlined operating structure, a differentiated placental-derived cellular
therapy platform, growing physician interest in cenplacel-L, and the addition of experienced commercial leadership to expand physician
access, we believe Celularity is well-positioned to pursue meaningful near-term commercial opportunities while continuing to advance
its broader mission in longevity, regenerative medicine, and cellular therapy to preserve human performance. Thank you for your continued
support and confidence in Celularity.
Sincerely,
Robert
J. Hariri, M.D., Ph.D.
Founder,
Chairman and Chief Executive Officer
Celularity
Inc.