Financial Performance - The company incurred a net loss of 15.4millionforthequarter,comparedtoanetlossof14.1 million in the previous quarter[17]. - Total net revenues for the three months ended September 30, 2024, were 9,296,000,asignificantincreasefrom3,786,000 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,comparedto1,684,000 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,downfrom103,042,000 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),asignificantimprovementcomparedto(99,256,000) in the same period of 2023[18]. - Net loss for the three months ended September 30, 2024, was (16,098,000),comparedto(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)forthethreemonthsendedSeptember30,2024,comparedto(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,downfrom5,182,000 in the same period of 2023, a decrease of 24%[18]. - Selling, general and administrative expenses increased to 12,650,000forthethreemonthsendedSeptember30,2024,from10,748,000 in the same period of 2023, an increase of 19%[18]. - The company reported a net loss per share of (0.73)forthethreemonthsendedSeptember30,2024,comparedto(4.98) in the same period of 2023[18]. Assets and Equity - As of September 30, 2024, the company reported total assets of 133million,adecreasefrom227 million as of December 31, 2023[17]. - As of March 31, 2024, total stockholders' equity decreased to 31,245,000from40,960,000 at the beginning of the year, reflecting a net loss of 22,013,000forthequarter[21].−AsofSeptember30,2023,totalstockholders′equitystoodat30,247,000, with an accumulated deficit of (851,338,000)[21].−Thecompanyreportedanaccumulateddeficitof886,390 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 34,344thousandin2023to7,995 thousand in 2024[30]. - The company had cash, cash equivalents, and restricted cash of 10,296thousandattheendoftheperiod,downfrom15,098 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 46,050thousandofdebtoutstanding,allduewithinoneyearoftheissuancedate[33].−Thetotaldebtincreasedto42,610 as of September 30, 2024, compared to 39,240asofDecember31,2023,reflectinganincreaseofabout6.03,000 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,netofa120 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 40,000gross,withamaturityof12months[77].−TheCompanyenteredintoanAt−the−MarketSalesAgreementallowingforthesaleofupto150 million in common stock, with gross proceeds of 141,000from13,296sharessoldatanaveragepriceof10.60 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 2,350millioninunpaidinvoices[102].−ThecompanyhasnotincurredanymaterialcostsrelatedtoindemnificationagreementsasofSeptember30,2024[95].−ThecompanyhasregainedcompliancewithNasdaqlistingrequirementsafterfilingitsForm10−QfortheperiodendedJune30,2024,butiscurrentlynotincompliancefortheperiodendedSeptember30,2024[33].ResearchandDevelopment−Thecompanyplanstoleverageitsexpertiseincellulartherapeuticdevelopmentandmanufacturingtogeneraterevenuesthroughcontractmanufacturingservices[9].−ThecompanyhasnotachievedanymilestonesorearnedroyaltiesundertheSirionLicenseduringtheninemonthsendedSeptember30,2024and2023[97].−Thecompanyrecordedstock−basedcompensationexpenseof2,400 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].
Celularity (CELU)2024-12-06 00:45