Core Points - Celularity Inc. has been notified by Nasdaq for not timely filing its Quarterly Report on Form 10-Q for the period ended March 31, 2025, resulting in non-compliance with Listing Rule 5250 (c)(1) [1] - The notice from Nasdaq does not have an immediate effect on the listing or trading of the Company's shares, and the Company has 60 calendar days to submit a compliance plan [2] - The Company is actively working to complete its Form 10-Q and anticipates maintaining compliance with SEC reporting obligations [3] Company Overview - Celularity Inc. is a regenerative and cellular medicine company focused on developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, utilizing the postpartum placenta [4]

[Management Commentary](index=1&type=section&id=Management%20Commentary) Management highlights strong 2024 performance with Biovance® revenue growth and positive FDA feedback, anticipating continued momentum - Net revenue growth was primarily driven by the strong performance of commercial-stage advanced biomaterial products, particularly the Biovance® product line[2](index=2&type=chunk) - The company received favorable recommendation letters from the U.S. FDA's Tissue Reference Group for new additions to its portfolio of human placental-derived biomaterial products[2](index=2&type=chunk) - Management anticipates continued momentum in 2025, leveraging its unique business model, technical infrastructure, and human capital[2](index=2&type=chunk) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) Celularity reported **138.1% net revenue growth to $54.2 million** and **57.0% reduced operating expenses**, significantly narrowing loss from operations Key Financial Metrics (FY 2024 vs. FY 2023) | Metric | FY 2024 (million USD) | FY 2023 (million USD) | Change (million USD) | % Change | | :--- | :--- | :--- | :--- | :--- | | Net Revenues | $54.2 | $22.8 | +$31.4 | +138.1% | | Total Operating Expenses | $92.6 | $215.1 | -$122.5 | -57.0% | | Loss from Operations | $38.4 | $192.3 | -$153.9 | -80.1% | - The primary driver of revenue growth was a **$22.2 million (168.7%) increase** in product sales within wound care applications[3](index=3&type=chunk) - The significant decrease in operating expenses is mainly attributable to the non-recurrence of goodwill and in-process research and development (IPR&D) impairments, which were major expenses in 2023[4](index=4&type=chunk) [Detailed Financial Results](index=2&type=section&id=Detailed%20Financial%20Results) Detailed financial results show significant revenue growth and reduced operating expenses due to no impairment charges, impacting balance sheet assets, liabilities, and equity [Results of Operations (Income Statement)](index=2&type=section&id=Results%20of%20Operations) Consolidated Statement of Operations (in thousand USD) | Line Item | 2024 (thousand USD) | 2023 (thousand USD) | % Change | | :--- | :--- | :--- | :--- | | **Total revenues** | **$54,220** | **$22,771** | **138.1%** | | Product sales, net | $35,336 | $13,149 | 168.7% | | License, royalty and other | $13,744 | $4,181 | 228.7% | | **Total operating expenses** | **$92,578** | **$215,058** | **(57.0)%** | | R&D | $17,386 | $30,465 | (42.9)% | | SG&A | $58,643 | $50,576 | 16.0% | | Goodwill impairment | $0 | $112,347 | (100.0)% | | IPR&D impairment | $0 | $107,800 | (100.0)% | | **Loss from operations** | **$(38,358)** | **$(192,287)** | **(80.1)%** | - No goodwill or IPR&D impairment charges were recorded in 2024, compared to a combined **$220.1 million** in such charges in 2023, which was the primary reason for the large decrease in total operating expenses[5](index=5&type=chunk) [Financial Position (Balance Sheet)](index=3&type=section&id=Financial%20Position) Consolidated Balance Sheet Highlights (in thousand USD) | Line Item | Dec 31, 2024 (thousand USD) | Dec 31, 2023 (thousand USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $738 | $227 | | Total current assets | $20,561 | $19,793 | | **Total assets** | **$132,682** | **$143,889** | | Total current liabilities | $53,680 | $67,298 | | **Total liabilities** | **$123,845** | **$102,929** | | **Total stockholders' equity** | **$8,837** | **$40,960** | - Total liabilities increased from **$102.9 million to $123.8 million**, while stockholders' equity decreased sharply from **$41.0 million to $8.8 million** year-over-year[7](index=7&type=chunk) - The company's debt structure shifted, with short-term debt decreasing significantly while long-term debt from related parties increased to **$35.9 million**[7](index=7&type=chunk) [Company Overview](index=4&type=section&id=About%20Celularity) Celularity is a regenerative and cellular medicine company developing advanced biomaterial products and cell therapies from postpartum placenta for global health needs - The company's focus is on developing therapeutic solutions from the postpartum placenta[8](index=8&type=chunk) - Celularity aims to address significant unmet global needs with effective, accessible, and affordable therapies[8](index=8&type=chunk)

Core Viewpoint - Celularity Inc. reported significant growth in net revenues for the year ending December 31, 2024, totaling $54.2 million, which represents an increase of $31.4 million or 138.1% compared to the previous year, driven primarily by strong sales in wound care applications [1][3]. Financial Performance - Net revenues for 2024 were $54.2 million, an increase of $31.4 million or 138.1% from the prior year, with product sales in wound care applications rising by $22.2 million, reflecting a growth of 168.7% [1][3]. - Total operating expenses decreased to $92.6 million, down by $122.5 million or 57.0% compared to 2023, mainly due to the absence of goodwill and in-process research and development impairments [4][6]. - Loss from operations for 2024 was $38.4 million, a decrease of $153.9 million or 80.1% from the previous year, attributed to higher revenues and lower operating expenses, which improved gross margin [4][6]. Product and Market Development - The company experienced strong sales growth in its Biovance® product line, which is expected to continue contributing positively to revenue in the upcoming quarters [2]. - Celularity received recommendation letters from the U.S. FDA Tissue Reference Group for new additions to its portfolio of human placental-derived advanced biomaterial products, indicating a commitment to innovation in the wound care sector [2]. Balance Sheet Overview - As of December 31, 2024, total assets were $132.7 million, a decrease from $143.9 million in 2023, with current assets amounting to $20.6 million [8][9]. - Total liabilities increased to $123.8 million from $102.9 million in the previous year, with current liabilities at $53.7 million [8][9]. Company Background - Celularity Inc. is focused on developing and commercializing advanced biomaterial products and placental-derived cell therapies, aiming to address significant unmet global needs for effective and affordable therapies [10].

Part I [Business](index=8&type=section&id=Item%201.%20Business) Celularity is a regenerative and cellular medicines company with three core business lines: advanced biomaterials, cell therapy pipeline, and biobanking services - The company's business is structured around three core areas: 1) Advanced biomaterials (e.g., Biovance 3L, Rebound) for wound care, 2) Development of off-the-shelf placental-derived cell therapies (MLASCs, NK cells), and 3) A commercial biobanking service for storing birth byproducts[24](index=24&type=chunk)[26](index=26&type=chunk) - Celularity is developing new biomaterial products requiring 510(k) clearance, including Celularity Tendon Wrap (CTW), FUSE Bone Void Filler (FUSE), and Celularity Placental Matrix (CPM), with expected filings in 2025, 2026, and 2027, respectively[25](index=25&type=chunk)[37](index=37&type=chunk) - The company has refocused its cell therapy pipeline, prioritizing advanced-stage programs for MLASCs in Diabetic Foot Ulcer (DFU) and Crohn's Disease (CD) It has discontinued internal development for oncology indications like CYNK-001 (AML, GBM) and CYCART-19, now seeking collaboration partners for these assets[32](index=32&type=chunk)[35](index=35&type=chunk) - The company operates a **147,215 sq. ft.** cGMP-ready manufacturing, research, and biobanking facility in Florham Park, NJ, which underpins its Celularity IMPACT platform and supports plans to offer contract manufacturing services[51](index=51&type=chunk)[90](index=90&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including significant net losses, an accumulated deficit, low cash, and material weaknesses in internal controls, raising going concern doubts - The company has a history of net losses, reporting a net loss of **$57.9 million** for FY 2024 and an accumulated deficit of **$899.7 million** as of December 31, 2024[193](index=193&type=chunk) - Historical operating results and a cash balance of **$0.7 million** at year-end indicate substantial doubt about the company's ability to continue as a going concern The independent auditor's report includes an explanatory paragraph regarding this uncertainty[195](index=195&type=chunk) - The company has substantial indebtedness of **$36.4 million** as of December 31, 2024, which is secured by all of its assets, posing a risk to liquidity and operations[269](index=269&type=chunk) - The company is at risk of being delisted from Nasdaq for failing to meet continued listing standards, including the timely filing of its 10-K report An appeal has been filed[366](index=366&type=chunk) - Material weaknesses in internal control over financial reporting have been identified, which could lead to inaccurate financial reporting and loss of investor confidence[268](index=268&type=chunk)[384](index=384&type=chunk) - The business is highly dependent on key personnel, including CEO Robert Hariri Recent reductions-in-force and attrition, particularly in finance and legal, have created operational challenges[229](index=229&type=chunk)[240](index=240&type=chunk) [Unresolved Staff Comments](index=91&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[385](index=385&type=chunk) [Cybersecurity](index=91&type=section&id=Item%201C.%20Cybersecurity) Celularity maintains a cybersecurity program managed by a VP reporting to the CEO, with no material incidents reported for FY 2024 - The company's cybersecurity program is managed by a vice president who reports to the CEO, with ultimate oversight by the Board of Directors[387](index=387&type=chunk) - For the year ended December 31, 2024, the company is not aware of any material cybersecurity incidents[388](index=388&type=chunk) [Properties](index=92&type=section&id=Item%202.%20Properties) The company's primary operations are conducted from a 150,000 sq. ft. facility in Florham Park, New Jersey, leased until 2036 - Celularity occupies a **~150,000 sq. ft.** facility in Florham Park, New Jersey, under a lease that expires in 2036[389](index=389&type=chunk) [Legal Proceedings](index=92&type=section&id=Item%203.%20Legal%20Proceedings) Celularity is involved in multiple legal matters, including a settled dispute with Palantir, claims against Evolution Biologyx, and a Civil Investigative Demand - The company is cooperating with a Civil Investigative Demand from the U.S. Attorney's Office for the Eastern District of Pennsylvania related to its Interfyl product and claims submitted to federal insurers[393](index=393&type=chunk) - Celularity filed a complaint against Evolution Biologyx to recover approximately **$2.35 million** in unpaid invoices and is defending against counterclaims from Evolution[392](index=392&type=chunk) - A settlement with Palantir Technologies was finalized in June 2024, with Celularity making payments of **$3.5 million** and issuing **60,584 shares** of Class A common stock[391](index=391&type=chunk) - Hackensack Meridian Health (HUMC) filed a complaint seeking **$947,576** for alleged unpaid clinical trial costs[395](index=395&type=chunk) [Mine Safety Disclosures](index=93&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[396](index=396&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=94&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's Class A common stock and warrants trade on Nasdaq, with approximately 96 stockholders of record as of May 7, 2025 - Class A common stock trades on Nasdaq under the symbol 'CELU' Warrants trade under 'CELUW'[398](index=398&type=chunk) - As of May 7, 2025, there were approximately **96 stockholders** of record of Class A common stock[399](index=399&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=95&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenues increased significantly in FY 2024, while net loss narrowed due to lower impairment charges, but liquidity remains critical Comparison of Operations (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Total net revenues** | $54,220 | $22,771 | $31,449 | 138.1% | | Product sales, net | $35,336 | $13,149 | $22,187 | 168.7% | | License, royalty and other | $13,744 | $4,181 | $9,563 | 228.7% | | **Loss from operations** | $(38,358) | $(192,287) | $153,929 | (80.1)% | | Research and development | $17,386 | $30,465 | $(13,079) | (42.9)% | | Goodwill impairment | $0 | $112,347 | $(112,347) | (100.0)% | | IPR&D impairment | $0 | $107,800 | $(107,800) | (100.0)% | | **Net loss** | $(57,892) | $(196,295) | $138,403 | (70.5)% | - The company had **$0.7 million** in cash and cash equivalents and an accumulated deficit of **$899.7 million** as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[442](index=442&type=chunk)[422](index=422&type=chunk) - The significant decrease in operating loss was primarily due to the absence of goodwill (**$112.3 million**) and IPR&D (**$107.8 million**) impairment charges that were recorded in 2023[440](index=440&type=chunk) - R&D expenses decreased by **42.9%** to **$17.4 million**, driven by a reduction in outside services and clinical trial costs following the discontinuation of certain cell therapy trials[437](index=437&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=111&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure is primarily to interest rates, but it is not significant due to short-term cash and no variable interest debt - The company's exposure to interest rate risk is considered not significant as its investments are primarily short-term and it has no variable interest debt[471](index=471&type=chunk) [Financial Statements and Supplementary Data](index=111&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited financial statements for FY 2024 and 2023, with the auditor's report highlighting going concern doubts - The independent auditor's report for FY 2024, issued by EisnerAmper LLP, contains a 'Going Concern' paragraph, citing recurring losses, net cash outflows, and outstanding due debt as factors that raise substantial doubt about the company's ability to continue[476](index=476&type=chunk) Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $738 | $227 | | Total Assets | $132,682 | $143,889 | | Total Liabilities | $123,845 | $102,929 | | Total Stockholders' Equity | $8,837 | $40,960 | Consolidated Cash Flow Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,401) | $(38,685) | | Net cash provided by (used in) investing activities | $514 | $(4,048) | | Net cash provided by financing activities | $6,701 | $24,094 | - As of December 31, 2024, the company had total debt of **$42.3 million**, with significant portions related to loans from C.V. Starr and RWI that are subject to forbearance agreements[621](index=621&type=chunk)[643](index=643&type=chunk)[654](index=654&type=chunk) - For FY 2024, the Degenerative Disease segment generated **$48.4 million** in revenue with a segment contribution of **$13.7 million**, while the Cell Therapy segment had a negative contribution of **$15.1 million**[750](index=750&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=180&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting and financial disclosure - None[766](index=766&type=chunk) [Controls and Procedures](index=180&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of December 31, 2024, due to five material weaknesses, with a remediation plan underway - Management concluded that disclosure controls and procedures were not effective as of December 31, 2024[768](index=768&type=chunk) - **Five material weaknesses** in internal control over financial reporting were identified, relating to: Control Environment, Risk Assessment, Control Activities, Information and Communication, and Monitoring[770](index=770&type=chunk) - The company is implementing a remediation plan that includes hiring more accounting staff and engaging an external firm to help document and implement a stronger internal control environment[771](index=771&type=chunk)[774](index=774&type=chunk) [Other Information](index=182&type=section&id=Item%209B.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the fourth quarter of 2024 - No directors or executive officers adopted or terminated Rule 10b5-1 trading plans in the three months ended December 31, 2024[773](index=773&type=chunk) Part III Part III incorporates information by reference from the company's Definitive Proxy Statement, covering directors, executive compensation, security ownership, and related transactions [Directors, Executive Officers and Corporate Governance](index=183&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the company's Definitive Proxy Statement [Executive Compensation](index=183&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the company's Definitive Proxy Statement [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=183&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the company's Definitive Proxy Statement [Certain Relationships and Related Transactions, and Director Independence](index=183&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item is incorporated by reference from the company's Definitive Proxy Statement [Principal Accounting Fees and Services](index=183&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is incorporated by reference from the company's Definitive Proxy Statement Part IV [Exhibits, Financial Statement Schedules](index=183&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits, including key corporate documents and officer certifications [Form 10-K Summary](index=189&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - Not applicable[792](index=792&type=chunk)

Core Points - Celularity Inc. has been notified by Nasdaq regarding non-payment of fees and potential delisting unless an appeal is made [1] - The company has a past due fee balance of $70,000, which was paid in full on April 25, 2025 [1] - Nasdaq also indicated that Celularity is delinquent in filing its Form 10-K for the year ended December 31, 2024, which could lead to additional delisting actions [2] - The company is actively working to file the 2024 Form 10-K and expects to do so imminently [3] Company Overview - Celularity Inc. is a regenerative and cellular medicine company focused on developing and commercializing advanced biomaterial products and placental-derived cell therapies [4] - The company aims to leverage the unique biology of the placenta to create therapeutic solutions that meet significant global healthcare needs [4]

Core Points - The Centers for Medicare & Medicaid Services (CMS) has revised the effective date of the Medicare Local Coverage Determination (LCD) for skin substitute products to January 1, 2026, which is used to treat diabetic foot ulcers and venous leg ulcers [1][3] - This action follows a January 2025 executive order by President Trump that froze all regulatory guidance not yet in effect, leading to a previous delay of the LCD's effective date by sixty days [3] - Celularity Inc. expressed support for CMS's decision, highlighting the importance of access to skin substitute products for Medicare patients to avoid serious health complications [4] Company Overview - Celularity Inc. is a regenerative and cellular medicine company focused on developing and commercializing advanced biomaterial products and placental-derived cell therapies [5] - The company aims to leverage the unique biology of the placenta to create effective, accessible, and affordable therapeutic solutions for significant unmet global health needs [5]

Core Insights - Celularity Inc. has highlighted the therapeutic potential of its clinical-stage candidate CYNK-001 in addressing age-related diseases, as discussed in a recent publication in Frontiers in Immunology [1][2]. Group 1: Research Findings - The publication titled "Senescence, NK cells, and cancer: navigating the crossroads of aging and disease" explores the impact of aging on the immune system's ability to combat cancer, emphasizing the importance of maintaining Natural Killer (NK) cell function for healthy aging and longevity [2]. - The concept of "senoablation" is introduced, which involves the elimination of senescent cells that contribute to inflammation and malignant transformation, thereby rejuvenating the aging immune system [3]. Group 2: Clinical Development - CYNK-001, a placental-derived allogeneic NK cell therapy, has been studied in over 70 subjects with acceptable safety, indicating its potential as a treatment for conditions associated with cellular senescence, such as age-related frailty and sarcopenia [3]. - The company aims to leverage the unique biology of the placenta to develop effective and accessible therapies for significant unmet medical needs [4].

Core Insights - Celularity Inc. has received recommendation letters from the FDA's Tissue Reference Group for its products Natalin and Acelagraft™, confirming they meet the criteria for regulation under section 361 of the PHS Act [1][5] - Natalin is a tri-layer graft and Acelagraft™ is a bi-layer graft, both indicated for treating partial and full thickness acute and chronic wounds [2] - The global Biological Skin Substitutes market was valued at $347.75 million in 2024 and is projected to grow at a CAGR of 8.83% to reach $810.50 million by 2034, with the chronic wounds segment expected to grow at a 9.13% CAGR [3] Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on advanced biomaterial products and placental-derived cell therapies [6] - The company aims to leverage the unique biology of the placenta to develop effective and affordable therapeutic solutions for unmet global health needs [6] Market Context - North America accounted for 42.0% of the global Biological Skin Substitutes market in 2024, indicating a significant market presence [3]

Core Insights - Celularity Inc. has entered into a Master Services Collaboration Agreement with BlueSphere Bio, Inc. to manufacture certain cell therapy products, showcasing its advanced cGMP manufacturing capabilities [1][2] - The collaboration will focus on producing BlueSphere's novel T cell receptor (TCR) therapies, including a product for treating Acute Myelogenous Leukemia (AML) [2][3] - Celularity aims to leverage its manufacturing infrastructure to attract clients and generate revenue, while BlueSphere emphasizes the importance of reliable manufacturing for its clinical programs [3][5] Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, developing placental-derived cell therapies and biomaterial products [4] - The company utilizes postpartum placenta to create therapeutic solutions addressing unmet global healthcare needs [4] BlueSphere Bio Overview - BlueSphere Bio is focused on drug development, particularly in AML, with its lead product BSB-1001 targeting specific antigens in high-risk patients [5][6] - The company is advancing its clinical programs, including TCX-101 and TCX-102, with plans to dose its first patient in 1H2025 [5][6]

Core Points - The MASS Coalition supports President Trump's Freeze Order, which halts the implementation of Medicare Local Coverage Determinations (LCDs) for skin substitute products until at least April 13, 2025 [1][2] - The Freeze Order is seen as a necessary action to prevent a healthcare crisis for diabetic patients who rely on skin substitutes for treatment [2] - The MASS Coalition consists of wound care companies dedicated to ensuring access to essential wound care products for Medicare beneficiaries [3] Company Overview - Celularity Inc. is a regenerative medicine company focused on developing advanced biomaterial products and placental-derived cell therapies targeting aging-related diseases, cancer, and immune disorders [4] - The company utilizes mesenchymal-like adherent stromal cells (MLASCs), CAR T-cells, and natural killer (NK) cells in its therapeutic programs [4] - Celularity aims to address significant unmet global needs for effective and affordable therapies by leveraging the unique biology of the placenta [4]