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]

Financial Performance - The company incurred a net loss of $15.4 million for the quarter, compared to a net loss of $14.1 million in the previous quarter[17]. - Total net revenues for the three months ended September 30, 2024, were $9,296,000, a significant increase from $3,786,000 in the same period of 2023, representing a growth of 145%[18]. - Product sales, net for the three months ended September 30, 2024, reached $3,393,000, compared to $1,684,000 in the prior year, marking an increase of 102%[18]. - Total operating expenses for the three months ended September 30, 2024, were $20,823,000, down from $103,042,000 in the same period of 2023, reflecting a decrease of 80%[18]. - Loss from operations for the three months ended September 30, 2024, was $(11,527,000), a significant improvement compared to $(99,256,000) in the same period of 2023[18]. - Net loss for the three months ended September 30, 2024, was $(16,098,000), compared to $(93,876,000) in the same period of 2023, indicating a reduction of 83%[18]. - The company reported a comprehensive loss of $(16,100,000) for the three months ended September 30, 2024, compared to $(93,876,000) in the same period of 2023[18]. - Research and development expenses for the three months ended September 30, 2024, were $3,915,000, down from $5,182,000 in the same period of 2023, a decrease of 24%[18]. - Selling, general and administrative expenses increased to $12,650,000 for the three months ended September 30, 2024, from $10,748,000 in the same period of 2023, an increase of 19%[18]. - The company reported a net loss per share of $(0.73) for the three months ended September 30, 2024, compared to $(4.98) in the same period of 2023[18]. Assets and Equity - As of September 30, 2024, the company reported total assets of $133 million, a decrease from $227 million as of December 31, 2023[17]. - As of March 31, 2024, total stockholders' equity decreased to $31,245,000 from $40,960,000 at the beginning of the year, reflecting a net loss of $22,013,000 for the quarter[21]. - As of September 30, 2023, total stockholders' equity stood at $30,247,000, with an accumulated deficit of $(851,338,000)[21]. - The company reported an accumulated deficit of $886,390 thousand as of September 30, 2024[30]. - The total common stock shares increased to 21,933,861 by June 30, 2024, up from 19,378,192 at the beginning of the year[21]. Cash Flow and Liquidity - Cash flow from operating activities showed a significant improvement, with net cash used decreasing from $34,344 thousand in 2023 to $7,995 thousand in 2024[30]. - The company had cash, cash equivalents, and restricted cash of $10,296 thousand at the end of the period, down from $15,098 thousand in the previous year[30]. - The company must raise additional capital to support operations, with potential liquidity issues if funding is not secured[9]. - The company is actively seeking to secure additional outside capital to fund operations, but as of the issuance date, no additional capital was secured[33]. Debt and Financing - The company had approximately $46,050 thousand of debt outstanding, all due within one year of the issuance date[33]. - The total debt increased to $42,610 as of September 30, 2024, compared to $39,240 as of December 31, 2023, reflecting an increase of about 6.0%[74]. - The company entered into a loan agreement for $3,000 with its CEO, bearing interest at 15.0% per year, maturing on August 21, 2024[81]. - The Company entered into a senior secured loan agreement with Resorts World Inc Pte Ltd for an initial loan of $6,000, net of a $120 original issue discount, bearing interest at 12.5% per year[85]. - The Company recorded a total discount of $2,151 from the Amended RWI Loan, which was recognized as a loss within other income (expense)[85]. Regulatory and Operational Challenges - The company has no cellular therapeutic candidates approved for commercial sale and anticipates substantial net losses in the future, raising concerns about its ability to continue as a going concern[9]. - Regulatory challenges have arisen, including the Center for Medicare & Medicaid Services rejecting claims for one of the company's products, Interfyl, which remains unresolved[11]. - The company operates its own manufacturing facility, which requires significant resources and poses risks to clinical trials and commercial viability[11]. - The company faces significant competition from other biotechnology and pharmaceutical companies, which may affect its operating results[11]. Stock and Equity Transactions - The company issued 2,141,098 common stock shares in a PIPE offering, netting $6,000,000 in additional paid-in capital[21]. - The Company entered into a Pre-Paid Advance (PPA) agreement with Yorkville, receiving an initial advance of $40,000 gross, with a maturity of 12 months[77]. - The Company entered into an At-the-Market Sales Agreement allowing for the sale of up to $150 million in common stock, with gross proceeds of $141,000 from 13,296 shares sold at an average price of $10.60 per share during the nine months ended September 30, 2023[111]. - The Company has issued 21,984,614 shares of Class A common stock as of September 30, 2024, an increase from 19,378,192 shares as of December 31, 2023[104]. Legal and Compliance Issues - The company is engaged in ongoing legal proceedings, including a complaint against Evolution Biologyx, LLC for approximately $2,350 million in unpaid invoices[102]. - The company has not incurred any material costs related to indemnification agreements as of September 30, 2024[95]. - The company has regained compliance with Nasdaq listing requirements after filing its Form 10-Q for the period ended June 30, 2024, but is currently not in compliance for the period ended September 30, 2024[33]. Research and Development - The company plans to leverage its expertise in cellular therapeutic development and manufacturing to generate revenues through contract manufacturing services[9]. - The company has not achieved any milestones or earned royalties under the Sirion License during the nine months ended September 30, 2024 and 2023[97]. - The company recorded stock-based compensation expense of $2,400 for selling, general, and administrative expenses for the three months ended September 30, 2024, compared to $3,053 for the same period in 2023, a decrease of 21.4%[144].

Core Viewpoint - Celularity Inc. has received a notification from Nasdaq regarding non-compliance with continued listing requirements due to the delay in filing its Quarterly Report on Form 10-Q for Q3 2024, but the company's stock continues to trade on Nasdaq [1][2]. Compliance and Reporting - The company is required to submit a plan to Nasdaq to regain compliance by January 20, 2025, and if accepted, has until May 13, 2025, to implement the plan [2]. - The delay in filing the Q3 Form 10-Q is attributed to a backlog from previous filings, including the Forms 10-Q for the first and second quarters of 2024, which have been filed recently [3]. Management Commitment - The CEO of Celularity has acknowledged the challenges posed by the filing delays but emphasized the company's commitment to robust and timely financial reporting, stating that the Q3 Form 10-Q is nearing completion [4]. Company Overview - Celularity Inc. focuses on developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, targeting aging-related diseases, cancer, and immune disorders [5].

Core Insights - Celularity is collaborating with Genting Berhad to introduce placenta-derived allogeneic stem cell therapeutics in the Asia Pacific region [1][4] - Genting Berhad has commenced construction of Fontaine Vitale, a wellness and health center in Bali, Indonesia, which will utilize Celularity's products [1][2] - The Asia Pacific stem cell market is projected to grow from USD 3.0 billion in 2024 to USD 7.2 billion by 2030, with a CAGR of 16.4% [3] Company Overview - Celularity Inc. specializes in regenerative medicine, focusing on advanced biomaterial products and placenta-derived cell therapies targeting aging-related diseases, cancer, and immune disorders [5] - The company utilizes mesenchymal-like adherent stromal cells (MLASCs), CAR T-cells, and natural killer (NK) cells in its therapeutic programs [5] Market Context - The Asia Pacific region accounts for 16.8% of the global stem cell market and is expected to experience the highest growth rate globally [3] - Increased investment in stem cell technologies and therapies is driven by a growing emphasis on research and development in regenerative medicine within the region [3]

Core Viewpoint - Celularity Inc. has resolved its compliance issues with Nasdaq, allowing its stock to continue trading on the Nasdaq Stock Market after curing its filing delinquency [1][2][3] Group 1: Compliance Resolution - The Nasdaq Listing Qualifications Hearings Panel cancelled the scheduled hearing regarding Celularity's non-compliance with Nasdaq Listing Rule 5250(c)(1) after the company filed its overdue quarterly reports [1][2] - Celularity filed its Form 10-Q for the period ended March 31, 2024, on October 16, 2024, and its Form 10-Q for the period ended June 30, 2024, on November 7, 2024, achieving compliance with Nasdaq requirements [2] Group 2: Company Statements and Challenges - Robert J. Hariri, CEO of Celularity, expressed satisfaction in meeting Nasdaq's requirements and emphasized the company's commitment to transparency and regulatory compliance [3] - The delays in filing were attributed to significant financial challenges in the biotechnology sector, which limited access to capital and affected the company's ability to secure essential audit and financial advisory services [3] Group 3: Company Overview - Celularity Inc. is focused on developing and commercializing advanced biomaterial products and placental-derived cell therapies targeting aging-related diseases, cancer, and immune disorders [4] - The company aims to leverage the unique biology of the placenta to create effective, accessible, and affordable therapeutic solutions for significant unmet global needs [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 one-tenth of one share CELUW The Nasdaq Stock Market LLC FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Repo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38914 Celularity Inc. (Exact name of registrant as specified in its charter) Delaware 83-1702591 (State or other jurisdiction of ...

FLORHAM PARK, N.J., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company, today announced that it has requested a hearing before the Nasdaq Hearings Panel (the “Hearings Panel”) the Nasdaq Listing Qualifications Department’s determination regarding Celularity’s non-compliance with Nasdaq Listing Rule 5250(c)(1) (the “Rule”) and to seek an additional extension to regain compliance. As previously announced, Celularity received formal not ...

FLORHAM PARK, N.J., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (the "Company"), a regenerative medicine company developing and commercializing placental-derived technologies, today announced that it has received a formal notice from the Listing Qualifications department of the Nasdaq Stock Market LLC ("Nasdaq") on October 16, 2024, indicating that the Company is subject to delisting due to its inability to timely file its Forms 10-Q for the the periods ended March 31, 2024, and June 30 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38914 Celularity Inc. (Exact name of registrant as specified in its charter) Delaware 83-1702591 (State or other jurisdiction o ...