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of Diabetic Foot Ulcers and Venous Leg Ulcers, which would have affected coverage starting January 1, 2026 [2] - The withdrawn LCDs eliminated Medicare coverage for 158 skin substitute products from other companies, while Celularity's products remained unaffected [2] Group 2: Company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].

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]

Core Viewpoint - A new Florida law effective July 1, 2025, allows physicians to provide investigational stem cell therapies for orthopedics, wound care, and pain management, with strict safety and ethical standards in place [1][2]. Group 1: New Legislation - The law permits the use of stem cell therapies not yet approved by the FDA, with strict limits on the sources of stem cells, which must come from FDA-registered facilities [2][4]. - Physicians are required to obtain informed consent from patients before administering these therapies [2]. Group 2: Company Positioning - Celularity Inc. is prepared to supply ethically sourced stem cells for these treatments and has a facility that complies with the new law's requirements [2][4]. - The company has extensive knowledge and real-world data from clinical trials related to the therapies authorized under the new law [3][4]. Group 3: Industry Impact - The Florida Medical Association was involved in crafting the legislation to balance public protection against ineffective therapies and avoid overregulation of physicians [4]. - The law is seen as a potential model for other states, emphasizing the role of physicians in assessing the best therapeutic approaches for patients [4]. Group 4: Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on placental-derived cell therapies and advanced biomaterial products [5]. - The company aims to address significant unmet global needs for effective and affordable therapies by utilizing the unique biology of the placenta [5].

Core Points - Celularity Inc. has terminated its Chief Financial Officer, David Beers, effective immediately, without cause, and this decision is not related to the company's financial performance or reporting practices [1] - Joseph DosSantos, the current Senior Vice President of Finance, has been appointed as the interim CFO while the company searches for a new CFO [2] - The company has retained CFO Squad, a financial and business advisory firm, to provide outsourced accounting and consulting services during this transition period, focusing on SEC and financial reporting support [3] Company Overview - Celularity Inc. is a regenerative and cellular medicine company that develops and commercializes advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, utilizing the postpartum placenta [4]

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].

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]