FLORHAM PARK, N.J., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a longevity-focused regenerative and cellular medicine company, today announced receipt of $12.2 Million in net cash proceeds from the sale of approximately $126.3 Million of its unused New Jersey net operating losses (NOLs) and $1.9 Million of unused New Jersey research and development (R&D) tax credits. The NOLs and R&D tax credits sale was administered through New Jersey’s Technology Business Tax Certific ...

As filed with the Securities and Exchange Commission on December 31, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CELULARITY INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 83-1702591 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 170 Park Aven ...

Core Viewpoint - Celularity Inc. welcomes the withdrawal of the Local Coverage Determinations (LCDs) for skin substitute products by the Centers for Medicare & Medicaid Services (CMS), which were set to take effect on January 1, 2026, while ensuring that its Biovance® and Biovance 3L products remain eligible for Medicare coverage [1][2] Group 1: CMS Actions - On December 24, 2025, CMS announced the immediate withdrawal of LCDs for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, which would have affected coverage starting January 1, 2026 [2] - The withdrawn LCDs eliminated Medicare coverage for 158 skin substitute products from other companies, while Celularity's products remained unaffected [2] Group 2: Company Insights - Dr. Robert J. Hariri, CEO of Celularity, highlighted the substantial real-world evidence supporting the effectiveness of Biovance® in treating chronic wounds across diverse patient populations [3] - Biovance® has shown a reduction in steroid use in about 50% of treated patients, which may help decrease pro-inflammatory factors and enhance the body's natural healing process [3] - The new Medicare payment policy, effective January 1, 2026, will reimburse skin substitute applications at a flat rate of $127.28 per square centimeter, which Celularity is prepared to operate under due to its efficient manufacturing process [3] Group 3: Company Overview - Celularity Inc. is focused on developing, manufacturing, and commercializing advanced biomaterial products and cell therapies derived from postpartum placenta, addressing significant unmet needs in regenerative medicine [4] - The company aims to leverage the unique biology of the placenta to create effective and affordable therapies targeting aging mechanisms such as cellular senescence and chronic inflammation [4]

Core Viewpoint - Celularity Inc. has successfully closed a financing transaction, enhancing its financial position and supporting its strategic initiatives in regenerative and cellular medicine [1][4]. Financing Details - Celularity received $10.00 million in gross proceeds from the financing, with the potential for an additional $2.0 million based on specific conditions [2]. - The financing structure includes a senior secured term loan of $7.0 million and secured convertible notes with commitments of up to $5.0 million, convertible at a price of $1.66 per share [3]. - The secured convertible notes are backed by a first-priority lien on proceeds from a qualified financing, and Celularity issued warrants for 3,707,657 shares of Class A Common Stock with an exercise price of $2.00 per share [3]. Strategic Focus - The company aims to leverage its placental-derived platform to address significant unmet medical needs related to healthy aging and performance optimization [4]. - Celularity plans to articulate its corporate strategy in the upcoming year, aligning its scientific capabilities with long-term opportunities in longevity and age-related diseases [5]. Company Overview - Celularity Inc. specializes in developing, manufacturing, and commercializing advanced biomaterial products and cell therapies derived from postpartum placenta, targeting fundamental aging mechanisms [7].

As filed with the Securities and Exchange Commission on December 19, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (State or other jurisdiction of incorporation or organization) Delaware 2834 83-1702591 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 170 Park Avenue Florham Park, New Jersey 07932 (908) 768-2170 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CELULARITY INC. (Exact ...

Core Viewpoint - Celularity Inc. has announced financing transactions that will provide up to $12 million to support its strategic priorities focused on longevity and human performance preservation [1] Financing Details - The financing includes a senior secured term loan of $7 million and secured convertible notes with commitments of up to $5 million, convertible at a price of $1.66 per share [3][4] - Initial proceeds of $10 million are expected, with an additional $2 million available under certain conditions [2] Strategic Focus - The financing is intended to enhance Celularity's mission by advancing its placental-derived technologies and aligning its organizational structure with its strategic priorities [3] - The investment reflects a commitment to support the company's long-term vision and operational alignment [4] Investor Insights - Philip A. Barach, the investor, emphasizes the importance of aligning strategy, operations, and capital structure to realize the company's scientific potential [4] - The investment is seen as a long-term commitment to provide financial support and constructive perspective as Celularity navigates necessary changes [4] Securities Information - The securities involved in the financing will be sold in a private placement exempt from registration requirements under the Securities Act of 1933 [4] - Celularity will file registration statements with the SEC for the resale of shares underlying the convertible notes and warrants [4]

Financial Performance - Total net revenues for Q3 2025 were $5.284 million, a decrease of 43.3% compared to $9.296 million in Q3 2024[17] - Product sales, net for Q3 2025 were $894 thousand, down 73.7% from $3.393 million in Q3 2024[17] - Total operating expenses for Q3 2025 were $18.184 million, a decrease of 8.0% compared to $20.823 million in Q3 2024[17] - Net loss for Q3 2025 was $23.076 million, compared to a net loss of $16.098 million in Q3 2024, representing a 43.5% increase in losses[17] - The company reported a comprehensive loss of $23.073 million for Q3 2025, compared to a comprehensive loss of $16.100 million in Q3 2024[17] - For the nine months ended September 30, 2025, the company reported a net loss of $67,354,000 compared to a net loss of $44,599,000 for the same period in 2024[22] Cash and Liquidity - Cash and cash equivalents decreased to $120 thousand as of September 30, 2025, down from $738 thousand as of December 31, 2024[16] - The company incurred an operating loss of $39,250,000 and net cash used in operating activities of $8,151,000 for the nine months ending September 30, 2025[32] - Cash paid for interest increased to $1,771,000 for the nine months ended September 30, 2025, compared to $144,000 for the same period in 2024[23] - The company reported net cash provided by financing activities of $7,429,000 for the nine months ended September 30, 2025[22] - The company is actively seeking to secure additional outside capital to fund its operations[32] Assets and Liabilities - Total current liabilities increased to $65.314 million as of September 30, 2025, compared to $53.680 million as of December 31, 2024, reflecting a 21.7% increase[16] - Total assets decreased to $114.239 million as of September 30, 2025, down from $132.682 million as of December 31, 2024[16] - As of September 30, 2025, the company had an accumulated deficit of $967,101,000[32] - The company's total debt stood at $4,284 as of September 30, 2025, down from $42,288 on December 31, 2024, indicating a significant reduction in liabilities[90] Stock and Equity - The weighted average shares outstanding for Q3 2025 were 26,347,818, compared to 21,976,339 in Q3 2024[17] - As of September 30, 2025, the total number of common stock shares increased to 28,216,485, reflecting a growth of approximately 14.5% from the previous quarter[19] - The total common stock shares increased from 19,378,192 on January 1, 2024, to 21,984,614 by September 30, 2024, reflecting an increase of approximately 13.5%[18] Research and Development - Research and development expenses for Q3 2025 were $4.598 million, an increase of 17.4% from $3.915 million in Q3 2024[17] Legal and Regulatory Matters - The Company is currently involved in multiple legal proceedings, including a complaint against Evolution Biologyx for approximately $2,350 in unpaid invoices[157] - The Company has accrued $668 for amounts owed to Hackensack Meridian Health related to clinical trial costs, with ongoing disputes regarding improper charges[159] - The Company has not achieved any clinical or regulatory milestones under the Sirion License as of the reporting date[154] Financing Activities - Celularity Inc. issued 2,141,098 shares in a PIPE offering, raising $6,000,000 net of offering expenses[18] - The Company completed a registered direct offering on April 10, 2023, raising approximately $6,000 in gross proceeds from the sale of 923,076 shares and warrants, with net proceeds of $5,505 used to repay obligations[172] - The Company also completed a registered direct offering on July 31, 2023, generating approximately $3,000 in gross proceeds from 857,142 shares, with net proceeds of $2,740 allocated for working capital[174] Asset Acquisitions - The Company entered into an asset purchase agreement to acquire Sequence LifeScience's Rebound™ product for up to $5.5 million, including an upfront payment of $1 million and milestone payments based on net sales[53] - As of September 30, 2025, the Company accrued $3.045 million for milestone payments due to Sequence, including $2.395 million accrued during the nine months ended September 30, 2025[53] Stock-Based Compensation - The company recognized stock-based compensation expenses of $2,966,000 for the quarter ending March 31, 2024, and $2,672,000 for the quarter ending June 30, 2024[18] - The company incurred stock-based compensation expense of $7,126,000 for the nine months ended September 30, 2025[22] Debt and Interest - The Company entered into a loan agreement for $3,000 with a 15.0% interest rate, which was extended to December 31, 2025[105][107] - The Starr Bridge Loan of $5,000 has an interest rate of 12.0%, increasing to 15.0% in the event of default, and was set to mature on March 17, 2025[109] - The Company recognized a loss on extinguishment of debt of $233 due to a substantial modification of the convertible promissory note[96] Inventory and Expenses - As of September 30, 2025, the company's net inventory was $9,515, a decrease of 47% from $17,996 on December 31, 2024[77] - The total prepaid expenses and other current assets increased to $1,208 as of September 30, 2025, from $857 on December 31, 2024, marking a 41% increase[80] - The Company recognized write-offs of capitalized bulk material costs amounting to $1,387 and $3,903 for the three and nine months ended September 30, 2025, respectively[78] Accounting and Fair Value - The Company is currently evaluating the impact of recently issued accounting pronouncements on its consolidated financial statements[49] - The fair value measurement of the warrant liabilities utilizes Level 3 inputs, including expected volatility based on historical data of comparable public companies[72]

Core Insights - Celularity Inc. has formed a strategic partnership with DefEYE, Inc., focusing on regenerative therapies in eye care through an exclusive license and pricing arrangement [1][3] - DefEYE aims to leverage Celularity's expertise and biologics portfolio to enhance its offerings in the ophthalmic market, with a significant sales growth of nearly 70% in 2024 compared to the previous year [2][3] - The partnership is expected to facilitate the launch and scaling of decellularized biologic solutions for eye care, with Celularity serving as the exclusive contract manufacturer for DefEYE's products [2][5] Company Overview - Celularity Inc. specializes in regenerative and aging-related cellular medicine, developing advanced biomaterial products and cell therapies derived from postpartum placenta [5] - DefEYE, Inc. is focused on transforming therapeutic approaches in eye care, delivering innovative decellularized biologic solutions for various ocular conditions [6] Strategic Implications - The collaboration is seen as a strategic opportunity for both companies, aligning their capabilities to drive innovation in the eye care sector [3][5] - Celularity's investment and licensing agreement reflect its commitment to expanding into new markets and enhancing its portfolio of commercial products [3][5]

Core Insights - Celularity Inc. announced the publication of its Phase 2 study on PDA-002, a placenta-derived cell therapy for diabetic foot ulcers (DFUs) complicated by peripheral artery disease (PAD), demonstrating safety and efficacy in treating serious wounds [1][6] - The study involved 159 adult patients and was conducted across 35 clinical sites in the U.S., showing that PDA-002 achieved higher rates of wound closure compared to placebo [3][4] Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on developing therapies derived from postpartum placenta to address age-related and degenerative diseases [10] - The company aims to provide effective, accessible, and affordable therapies targeting fundamental aging mechanisms [10] Study Details - The Phase 2 study included patients with chronic DFUs, with a primary efficacy endpoint of complete wound closure within three months, maintaining healing for at least four additional weeks [3] - PDA-002 was administered in three dosage levels (3×10⁶, 10×10⁶, or 30×10⁶ cells) or as a placebo, with the lowest dose showing the highest healing rates in patients with PAD [4] Economic Context - Approximately two million individuals in the U.S. are affected by DFUs annually, with an estimated economic burden of over $9 billion for treating DFUs alone [2] - There are currently no FDA-approved therapies specifically for DFUs complicated by PAD, highlighting the need for innovative treatments [2] Clinical Findings - In patients with PAD, 38.5% of ulcers healed completely with the lowest PDA-002 dose compared to 22.6% in the placebo group, indicating a significant improvement in healing rates [4] - PDA-002 demonstrated a favorable safety profile, with no serious side effects reported during the two-year follow-up [4][5] Future Implications - The positive results from the Phase 2 study position Celularity for a confirmatory Phase 3 trial, aiming to deliver the first FDA-approved targeted therapy for DFU/PAD patients [6] - The recent Florida law allows for expanded access to stem cell therapies like PDA-002, potentially providing new treatment options for patients in the state [7][8]

Core Insights - Celularity Inc. has filed its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025, and June 30, 2025, regaining compliance with Nasdaq Listing Rule 5250(c)(1) [2][6] - The company has successfully retired all $32.0 million of senior secured debt along with $9.6 million in unpaid interest, which alleviates previous financial pressures [2][3] - Celularity is focusing on advancing its late-stage 510(k) pipeline products and exploring new opportunities in stem cell product sales [3] Financial Performance - The company faced challenges in the first half of 2025, including a significant secured debt overhang and uncertainties regarding wound care product reimbursement policies [3] - Despite these challenges, the company experienced substantial growth in wound care-related commercial product sales in the second half of 2024, which contributed to working capital pressures in early 2025 [3] Business Strategy - Celularity is restructuring its operations by establishing subsidiaries for each functional business unit to enhance operational efficiency [2] - The company aims to leverage traditional working capital facilities to support renewed sales growth in wound care products and advance its product pipeline [3] Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on developing therapies derived from postpartum placenta to address age-related and degenerative diseases [4]