CELU.NASDAQCelularity INC

S-1: Celularity Files S-1 for Resale, Citing Going Concern Doubts

Sentiment:

Registration Statement for Resale


Celularity Inc. filed an S-1 registration statement for the resale of up to 15.9 million Class A Common Stock shares by existing stockholders, while disclosing substantial doubt about its ability to continue as a going concern.

Delay expectedThe company failed to timely file a registration statement with the SEC registering the resale of shares underlying the Series A Preferred Stock and warrants from the October 2025 private placement, leading to the issuance of additional warrants as compensation on December 16, 2025.
Capital raiseThe company will receive gross proceeds of approximately $31.9 million if 8,875,329 warrants offered for resale are exercised in cash, though this is not guaranteed.In October 2025, the company entered into a securities purchase agreement for a private placement of Series A Convertible Preferred Stock and warrants, with an initial tranche closing for approximately $2 million.In July 2025, the company entered into a securities purchase agreement for the issuance and sale of 1,230,769 shares of Class A Common Stock and warrants for $1.625 per share/warrant.In June 2025, the company sold 739,284 shares of Class A Common Stock at $1.40 per share in a private placement.In July 2025, the company issued a promissory note for $6,812,230 and a warrant to purchase 3,700,000 shares of Class A Common Stock.In March 2024, the company entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville, giving it the right to sell up to $10.0 million of Class A Common Stock, and issued a $3.15 million convertible promissory note for $2.99 million in cash.In November 2024, the company sold unsecured senior convertible notes and warrants for an aggregate of $750,000 (out of a potential $1,000,000).
Worse than expectedThe filing explicitly states that 'historical operating results indicate substantial doubt exists related to our ability to continue as a going concern,' which is a severe negative indicator.The company has 'incurred net losses in every period since our inception' and 'anticipate that we will incur substantial net losses in the future,' demonstrating a persistent lack of profitability.There are 'no cellular therapeutic candidates approved for commercial sale,' meaning the company lacks a primary revenue source from its core therapeutic development efforts.The company has 'substantial indebtedness, which is secured by all of our assets,' indicating a high level of financial leverage and risk.

Summary

  • Celularity Inc. is registering up to 15,945,039 shares of Class A Common Stock for resale by existing Selling Stockholders.
  • The company will not receive any proceeds from the sale of shares by Selling Stockholders, but may receive approximately $31.9 million if 8,875,329 warrants are exercised for cash.
  • Celularity is a regenerative and cellular medicines company focused on aging-related diseases, developing placental-derived biomaterial products and cell therapies.
  • Key biomaterial product candidates include Celularity Tendon Wrap (CTW) (510(k) application submitted August 2025), FUSE Bone Void Filler (FUSE) (510(k) objective H2 2026), and Celularity Placental Matrix (CPM) (510(k) objective H2 2027).
  • The company is assessing opportunities to supply MLASCs cell therapy product candidates PDA 001 and PDA 002 to physicians in states with expanded access, such as Florida.
  • Celularity operates a commercial biobanking business, offering collection, processing, and cryogenic storage of birth byproducts for a one-time fee and annual storage fees.
  • The company has a robust global intellectual property portfolio with over 290 patents and patent applications.
  • As of December 18, 2025, the closing price of Celularity's Class A Common Stock on Nasdaq was $1.25 per share.
  • As of December 16, 2025, there were 28,478,880 shares of Class A Common Stock outstanding, with 21,966,918 warrants outstanding at a weighted average exercise price of $15.12.

Sentiment

Score: 2

Explanation: The filing presents a highly negative financial outlook, explicitly stating 'substantial doubt exists related to our ability to continue as a going concern,' a history of net losses, substantial indebtedness, and a continuous need for additional financing. While there are some positive development milestones, the overwhelming financial risks and lack of commercialized products overshadow them, indicating a very weak position.

Positives

  • Submitted a 510(k) application for Celularity Tendon Wrap (CTW) in August 2025, advancing its biomaterial product pipeline.
  • Actively assessing opportunities to supply MLASCs cell therapy product candidates (PDA 001 and PDA 002) to physicians in states like Florida, which have expanded access to stem cell therapies.
  • Possesses a robust global intellectual property portfolio with over 290 patents and patent applications, protecting its platform, processes, technologies, and cell therapy programs.
  • Has a seasoned and experienced management team with over two decades of cumulative background and effort in placental-derived technology.

Negatives

  • Incurred net losses in every period since inception and anticipates substantial net losses in the future.
  • Has no cellular therapeutic candidates approved for commercial sale.
  • Historical operating results indicate substantial doubt about the company's ability to continue as a going concern, as noted by the independent registered public accounting firm.
  • Requires substantial additional financing to develop therapeutics and implement operating plans, with failure to obtain it potentially halting development and commercialization.
  • Carries substantial indebtedness secured by all company assets, which could impact liquidity and potentially lead to bankruptcy.
  • The company will not receive any proceeds from the current resale offering by Selling Stockholders, limiting direct capital infusion from this filing.
  • Failed to timely file a registration statement for the October 2025 private placement, resulting in the issuance of additional warrants to the investor.

Risks

  • There may not be an active trading market for Class A Common Stock, making it difficult to sell shares.
  • The market price of securities may be volatile, causing investment value to decline.
  • Class A Common Stock may be delisted from Nasdaq if compliance standards are not maintained.
  • Future sales and issuances of Class A Common Stock or rights to purchase will result in additional dilution and could cause the stock price to fall.
  • The company does not intend to pay cash dividends for the foreseeable future.
  • Incurred net losses since inception and anticipates substantial net losses in the future, with no cellular therapeutic candidates approved for commercial sale.
  • Historical operating results indicate substantial doubt about the company's ability to continue as a going concern.
  • Requires substantial additional financing; failure to obtain it may prevent completion of therapeutic development and commercialization.
  • Substantial indebtedness secured by all assets could impact liquidity, require operational modifications, or force bankruptcy protection.
  • Significant decline in sales of currently commercialized biomaterial products without alternative products would seriously harm the business.
  • Placental-derived cellular therapy candidates represent a novel approach with significant development challenges.
  • Reliance on distribution arrangements for biomaterials carries risks of unmet demand or costs for unmaterialized forecasts.
  • Operating its own manufacturing and storage facility requires significant resources, and failures could adversely affect clinical trials, commercial viability, and biobanking.
  • Faces significant competition from other biotechnology and pharmaceutical companies.
  • Strategic alliances or licensing arrangements may not realize anticipated benefits.
  • Health pandemics or epidemics could materially adversely affect business operations.
  • Identified material weaknesses in internal control over financial reporting, which if unremediated, could harm investor confidence.
  • The U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services' CY 2026 Medicare Physician Fee Schedule (effective January 1, 2026) may materially adversely affect reimbursement rates for skin substitute products.
  • Commercial biomaterials business may be impacted if CMS and Medicare Administrative Contractors do not reverse their Local Coverage Determination (LCD) for skin substitute grafts before January 1, 2026.
  • The FDA regulatory approval process is lengthy and time-consuming, potentially leading to significant delays.
  • Reliance on donors for healthy human full-term post-partum placentas; inadequate supply could adversely impact development.
  • Reliance on third parties to conduct future clinical trials; failure to perform could prevent regulatory approval or commercialization.
  • Inadequate protection of intellectual property could hinder effective competition in the market.

Future Outlook

Celularity expects to advance the development of its FUSE Bone Void Filler with an objective of a 510(k) filing in the second half of 2026, and its Celularity Placental Matrix (CPM) with an objective of a 510(k) filing in the second half of 2027. The company plans to complete safety and efficacy assessments for its MLASCs cell therapy product candidates, PDA 002 (diabetic foot ulcer) and PDA 001 (Crohn's disease), to determine progress to Phase III clinical trials, contingent on sufficient capitalization. It also intends to explore opportunities to diversify its biobanking business, including adult cell banking.

Management Comments

  • Our goal is to ensure all individuals have the opportunity to live healthier longer.
  • 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 current science is the product of the cumulative background and effort over two decades of our seasoned and experienced management team.
  • We believe this know-how, expertise and intellectual property will drive the rapid development and, if approved, the commercialization of these potentially lifesaving therapies for patients with unmet medical needs.

Industry Context

Celularity operates in the highly competitive and regulated regenerative and cellular medicines industry, focusing on placental-derived therapies. The industry is characterized by significant R&D investment, lengthy FDA approval processes, and intense competition from established biotechnology and pharmaceutical companies. Recent state legislation, such as Florida's law expanding access to stem cell therapies, presents new market opportunities for companies like Celularity, though regulatory and reimbursement changes (e.g., proposed CMS Medicare Physician Fee Schedule) pose significant challenges to commercialization and profitability.

Comparison to Industry Standards

  • The company's disclosure of 'substantial doubt exists related to our ability to continue as a going concern' is a critical indicator that places it significantly below industry standards for financial stability and operational viability, where such warnings are typically associated with distressed companies.
  • The reliance on continuous private placements and warrant exercises for capital, coupled with a history of net losses since inception and no approved cellular therapeutic candidates, contrasts sharply with more mature biotechnology companies that have established revenue streams from approved products or robust pipelines with clear paths to commercialization.
  • The weighted average exercise price of outstanding warrants at $15.12 per share, compared to the current stock price of $1.25, indicates a significant disconnect between past investor expectations (or warrant terms) and current market valuation, suggesting a substantial decline in perceived value relative to industry peers with stable or growing stock prices.
  • The company's need for 'substantial additional financing' and 'substantial indebtedness, which is secured by all of our assets' suggests a higher financial risk profile compared to industry benchmarks for companies at similar development stages, which might have stronger balance sheets or less dilutive financing options.

Corporate Governance

Change TypeDescriptionEffective DateImpact Assessment
Board StructureThe board of directors is divided into three classes (Class I, Class II, and Class III), with only one class elected each year, and each class serving a three-year term.N/AThis staggered board structure can make it more difficult for stockholders to change a majority of the board, potentially hindering activist investors or hostile takeovers.
Voting RightsHolders of Class A Common Stock are entitled to one vote per share, with no cumulative voting for the election of directors.N/AThe absence of cumulative voting means that holders of more than 50% of the shares voted can elect all directors, potentially limiting minority shareholder representation on the board.
Stockholder Meeting ProceduresBylaws require stockholders to provide timely notice (90-120 days prior to the annual meeting anniversary) for bringing business or nominating directors.N/AThese advance notice requirements can preclude stockholders from introducing matters or nominations without sufficient planning, potentially limiting stockholder influence.
Authorized CapitalAuthorized capital includes 730,000,000 shares of Class A Common Stock and 10,000,000 shares of preferred stock (6,000,000 designated as Series A Convertible Preferred Stock).N/AThe existence of authorized but unissued shares allows for future issuances without stockholder approval, which could be used for capital raises, acquisitions, or employee plans, but also potentially for anti-takeover measures or dilution.
Exclusive Forum SelectionCertificate of Incorporation designates the Delaware Court of Chancery as the exclusive forum for certain corporate claims and federal district courts for Securities Act claims.N/AAims to provide consistency in legal interpretations and potentially discourage lawsuits against directors and officers, but may limit stockholders' choice of forum and could be challenged for enforceability.
Anti-Takeover ProvisionsSubject to Section 203 of the DGCL, which prevents certain Delaware corporations from engaging in business combinations with interested stockholders for three years.N/AThis provision can make it more difficult for a person to acquire the company without board approval, potentially protecting the company from hostile takeovers but also limiting opportunities for stockholders to realize a premium.

Related Party Transactions

  • Dr. Robert J. Hariri, the company's Chairman and Chief Executive Officer, subscribed for $2.0 million in the March 2023 private placement of Class A Common Stock and warrants.
  • Dragasac Limited, an indirect wholly-owned subsidiary of Genting Berhad (whose CEO/Chairman Tan Sri Lim Kok Thay is an indirect beneficial owner of the largest stockholder), participated in the January 2024 private placement, acquiring 2,141,098 shares of Class A Common Stock and warrants.

Stakeholder Impact

  • **Shareholders**: Face significant dilution risk from future equity issuances and warrant exercises. The 'going concern' doubt and history of losses pose substantial risk to investment value. No cash dividends are expected in the foreseeable future. The current resale offering by selling stockholders could put downward pressure on the stock price.
  • **Employees**: The company's financial instability and need for additional financing could impact job security, compensation, and the long-term viability of employee stock options/units.
  • **Customers**: Continued product development (e.g., CTW, FUSE, CPM) and exploration of cell therapy opportunities could benefit customers seeking advanced biomaterial and regenerative medicine solutions. However, financial instability could pose risks to long-term product availability and support.
  • **Suppliers/Creditors**: The 'substantial indebtedness' and 'going concern' warning indicate elevated credit risk. Suppliers may face payment delays or increased scrutiny of payment terms. The promissory note issued in July 2025 is secured by all company assets, potentially limiting recovery for other unsecured creditors.
  • **Regulatory Authorities**: The company is subject to ongoing FDA regulatory processes for its therapeutic candidates and faces potential adverse impacts from changes in Medicare reimbursement policies (CY 2026 Medicare Physician Fee Schedule, LCDs).

Next Steps

  • Advance the development of FUSE Bone Void Filler with the objective of a 510(k) filing in the second half of 2026.
  • Advance the development of Celularity Placental Matrix (CPM) with the objective of a 510(k) filing in the second half of 2027.
  • Actively assess opportunities in Florida and elsewhere to supply MLASCs cell therapy product candidates PDA 001 and PDA 002 to physicians in accordance with state law.
  • When sufficiently capitalized, complete safety and efficacy assessment to determine progress to a Phase III clinical trial of PDA 002 in diabetic foot ulcer (DFU) and PDA 001 in Crohn's disease.
  • Explore opportunities to diversify the biobanking business, including adult cell banking.
  • Use commercially reasonable efforts to cause registration statements for previous private placements to become effective within 60 calendar days following their closing dates and keep them effective.

Key Dates

DateDescription
January 9, 2020Issued warrants to Dragasac Limited to purchase 652,981 shares of Class A Common Stock.
January 8, 2021Merger Agreement and Plan of Reorganization dated.
July 16, 2021Consummated merger with GX Acquisition Corp., changing name to Celularity Inc.
March 17, 2023Issued warrants to C.V. Starr & Co. Inc. to acquire 75,000 shares of Class A Common Stock.
March 20, 2023Entered into a securities purchase agreement for a private placement of 938,183 shares of Class A Common Stock and warrants, including participation from Dr. Robert J. Hariri.
May 18, 2023Issued 581,394 shares of Class A Common Stock and accompanying warrants in a private placement.
June 20, 2023Granted C.V. Starr additional warrants to acquire 50,000 shares and RWI warrants to acquire 300,000 shares in connection with an amended and restated senior secured loan agreement.
September 14, 2023Amended March 2023 PIPE Warrants with an unaffiliated investor to reduce the exercise price from $30.00 to $10.00 per share for 729,698 shares.
September 18, 2023Issued 270,731 shares of Class A Common Stock in connection with a letter agreement with YA II PN, Ltd.
December 21, 2023Confidential Letter Amendment to the Palantir Settlement Agreement dated.
January 3, 2025Issued 21,739 shares of Class A Common Stock to a former employee pursuant to a settlement agreement.
January 10, 2024Issued 20,000 shares of Class A Common Stock to Palantir Technologies Inc. pursuant to a Confidential Letter Agreement.
January 12, 2024Entered into a securities purchase agreement with Dragasac Limited for a private placement of 2,141,098 shares of Class A Common Stock and warrants.
January 16, 2024Closing of the private placement with Dragasac Limited. Amended and restated warrants held by Dragasac to reduce exercise price to $2.4898 per share.
January 24, 2025Issued 1,188,255 shares of Class A Common Stock upon the exercise of warrants.
February 12, 2025Entered into binding term sheets with RWI and C.V. Starr & Co., Inc. for warrants.
February 26, 2024Entered into a letter agreement with KCSA Strategic Communications and issued 12,000 shares of Class A Common Stock.
February 29, 2025Issued 100,000 shares of Class A Common Stock to Yorkville in connection with a maturity date extension and forbearance.
March 13, 2024Entered into a SEPA with YA II PN, LTD (Yorkville) for up to $10.0 million of Class A Common Stock and issued a $3.15 million convertible promissory note. Issued RWI a warrant for 300,000 shares. Amended exercise price of certain C.V. Starr warrants.
May 6, 2024Issued 40,584 shares of Class A Common Stock to Palantir Technologies, Inc. pursuant to a Confidential Letter Amendment.
May 8, 2025Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC.
May 19, 2025Entered into a strategic advisory agreement and issued 50,000 shares of Class A Common Stock and warrants to a consulting firm.
May 20, 2025Issued 100,000 shares of restricted Class A Common Stock to Yorkville.
June 20, 2025Issued 12,000 shares of Class A Common Stock to a consultant.
June 23, 2025Entered into a securities purchase agreement for the issuance and sale of 739,284 shares of Class A Common Stock in a private placement.
June 25, 2025Issued 490,632 shares of Class A Common Stock to holders of unsecured senior convertible notes upon conversion.
July 1, 2025Florida law expanding access to stem cell and other cell therapies went into effect.
July 14, 2025Entered into a securities purchase agreement with an institutional investor for the issuance and sale of 1,230,769 shares of Class A Common Stock and warrants.
July 16, 2025The Centers for Medicare & Medicaid Services published its CY 2026 Medicare Physician Fee Schedule Proposed Rule.
July 21, 2025Issued a promissory note for $6,812,230 and a warrant to purchase 3,700,000 shares of Class A Common Stock to an investor.
August 2025Submitted a 510(k) application for Celularity Tendon Wrap (CTW).
September 13, 2024Conversion price for Yorkville's convertible promissory note reset to $2.7546.
October 9, 2025Entered into a consulting agreement and issued 100,000 shares of Class A Common Stock and warrants to purchase 4,500,000 shares.
October 24, 2025Entered into a securities purchase agreement for a private placement of Series A Convertible Preferred Stock and warrants; initial tranche closed for approximately $2 million.
November 11-14, 2024Issued Yorkville a total of 478,881 shares of Class A Common Stock in connection with the conversion of $1.3 million in notes.
November 18, 2024Issued 59,176 shares of Class A Common Stock to a former employee pursuant to a settlement agreement.
November 25, 2024Entered into a securities purchase agreement for the sale of unsecured senior convertible notes and warrants for up to $1,000,000.
December 16, 2025Issued additional warrants to purchase 50,000 shares of Class A Common Stock to an investor for failure to timely file a registration statement. Issued warrants to purchase 50,000 shares of Class A Common Stock to Helena Global Investment Opportunities 1 Ltd.
December 18, 2025Closing price of Class A Common Stock on Nasdaq was $1.25 per share.
December 19, 2025Date of the preliminary prospectus and filing of the S-1 Registration Statement.
January 1, 2026Effective date for the CY 2026 Medicare Physician Fee Schedule and Local Coverage Determination (LCD) for skin substitute grafts.
Second half of 2026Objective for 510(k) filing for FUSE Bone Void Filler.
Second half of 2027Objective for 510(k) filing for Celularity Placental Matrix (CPM).

Recommendation

strong sell

The filing explicitly states 'substantial doubt exists related to our ability to continue as a going concern,' which is the most severe warning a company can issue about its financial viability. This, coupled with a consistent history of net losses since inception, no approved commercial therapeutic products, substantial indebtedness secured by all assets, and a continuous need for additional financing, paints a dire financial picture. The current S-1 is for the resale of shares by existing stockholders, indicating a desire by current holders to exit, rather than a primary offering to raise capital for the company (except for potential warrant exercises, which are uncertain). These factors collectively suggest extreme financial risk and a high probability of further value erosion for investors.

Keywords

Celularity Inc., CELU, S-1, resale, Class A Common Stock, warrants, private placement, regenerative medicine, cellular therapy, biomaterials, placental-derived, Biovance 3L, Celularity Tendon Wrap, FUSE Bone Void Filler, Celularity Placental Matrix, MLASCs, PDA 001, PDA 002, diabetic foot ulcer, Crohn's disease, biobanking, Nasdaq, SEC filing, going concern, dilution, risk factors

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