Celularity (CELU)2024-12-06 00:45Financial 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].