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Century Therapeutics(IPSC) - 2024 Q4 - Annual Report
IPSCCentury Therapeutics(IPSC)2025-03-19 20:07

Company Overview - The company is a clinical-stage biotechnology firm focused on developing allogeneic pluripotent stem cell therapies for autoimmune diseases and cancer, utilizing induced pluripotent stem cells (iPSCs) for scalable manufacturing and genetic editing capabilities[563][564]. Product Development - The lead product candidate, CNTY-101, is a CAR-iNK cell therapy currently in a Phase 1 clinical trial for B-cell mediated autoimmune diseases, but its evaluation for lymphoma has been discontinued due to strategic reasons[567]. - The company has re-prioritized its pre-clinical pipeline to focus on three core programs based on its iT cell platform, which are expected to have significant differentiation potential[568]. Financial Position - As of December 31, 2024, the company had cash and cash equivalents of 58.4millionandinvestmentsof58.4 million and investments of 161.7 million[612]. - The accumulated deficit reached 782.3millionasofDecember31,2024[612].−Thecompanyreportedanetlossof782.3 million as of December 31, 2024[612]. - The company reported a net loss of 126.6 million for 2024, compared to a net loss of 136.7millionfor2023,indicatingaslightimprovementinfinancialperformance[620][621].RevenueandExpenses−Thecompanyhasnotgeneratedanyrevenuefromproductsalesanddoesnotexpecttodosointheforeseeablefuture,relyinginsteadoncollaborationagreementsforrevenue[589].−ResearchanddevelopmentexpensesfortheyearsendedDecember31,2024,and2023were136.7 million for 2023, indicating a slight improvement in financial performance[620][621]. Revenue and Expenses - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying instead on collaboration agreements for revenue[589]. - Research and development expenses for the years ended December 31, 2024, and 2023 were 6.3 million and 0.0million,respectively,within−processresearchanddevelopmentexpensesof0.0 million, respectively, with in-process research and development expenses of 0.0 million and 5.0million[585].−Researchanddevelopmentexpensesincreasedto5.0 million[585]. - Research and development expenses increased to 107.2 million in 2024 from 92.7millionin2023,representinga92.7 million in 2023, representing a 14.5 million increase[606]. - Collaboration revenue rose to 6.6millionin2024from6.6 million in 2024 from 2.2 million in 2023, an increase of 4.4million[604].−Thetotaloperatingexpensesdecreasedto4.4 million[604]. - The total operating expenses decreased to 144.7 million in 2024 from 148.8millionin2023,areductionof148.8 million in 2023, a reduction of 4.1 million[603]. Financing and Cash Flow - The company anticipates needing to raise additional financing in the future to support operations, including preclinical studies and clinical trials[575]. - The company issued 4,084,502 shares of common stock at a weighted-average price of 4.50pershare,resultinginapproximately4.50 per share, resulting in approximately 18.4 million in gross proceeds during 2024[613]. - Net cash used in operating activities was 110.1millionfortheyearendedDecember31,2024,comparedto110.1 million for the year ended December 31, 2024, compared to 88.3 million for 2023, primarily due to a net loss of 126.6millionin2024[620].−Cashprovidedbyfinancingactivitieswas126.6 million in 2024[620]. - Cash provided by financing activities was 74.6 million in 2024, a significant increase from cash used of 9.7millionin2023,drivenby9.7 million in 2023, driven by 17.8 million from an at-the-market capital raise and 56.6millionfromPIPEfinancing[624].CollaborationsandAgreements−ThecompanyhasenteredintoacollaborationagreementwithBristol−MyersSquibb,whichincludedanon−refundableupfrontcashpaymentof56.6 million from PIPE financing[624]. Collaborations and Agreements - The company has entered into a collaboration agreement with Bristol-Myers Squibb, which included a non-refundable upfront cash payment of 100 million and stock purchases totaling 50million,butthisagreementwasterminatedeffectiveMarch12,2025[576][578].−Anupfrontpaymentof50 million, but this agreement was terminated effective March 12, 2025[576][578]. - An upfront payment of 4.0 million was recorded in connection with a new autoimmune license agreement with Fujifilm Cellular Dynamics, which also includes milestone payments and low single-digit royalties[584]. - The company expects to recognize 109.2millionofcollaborationrevenueforthequarterendedMarch31,2025,followingtheterminationoftheCollaborationAgreement[604].MarketandRiskFactors−Theprimarymarketriskexposureforthecompanyisinterestincomesensitivity,whichisinfluencedbychangesinU.S.interestrates;however,thelowriskprofileoftheportfoliomeansthatchangesininterestrateswouldnotmateriallyimpactfinancialresults[649].−Thecompanydoesnotcurrentlyhavematerialexposuretoforeigncurrencyfluctuationsanddoesnotengageinhedgingactivities[648].−Futuredisruptionsinfinancialinstitutionscouldadverselyaffectthecompany′saccesstocashandcashequivalents[650].OperationalInsights−ThecompanyhasmadesignificantinvestmentsinmanufacturingcapabilitiesandinfrastructuretoenhanceefficiencyandscalabilityofitsiPSCcelltherapyplatforms[574].−Inflationhasincreasedcostsrelatedtolaborandlaboratoryconsumables,butithasnothadamaterialeffectonthecompany′sfinancialstatements[651].−Thecompanyisclassifiedasan"emerginggrowthcompany"undertheJOBSAct,allowingittotakeadvantageofreducedreportingrequirementsuntilcertainrevenueormarketvaluethresholdsaremet[628][630].Stock−BasedCompensation−Stock−basedcompensationexpensefor2024includednon−cashchargesof109.2 million of collaboration revenue for the quarter ended March 31, 2025, following the termination of the Collaboration Agreement[604]. Market and Risk Factors - The primary market risk exposure for the company is interest income sensitivity, which is influenced by changes in U.S. interest rates; however, the low risk profile of the portfolio means that changes in interest rates would not materially impact financial results[649]. - The company does not currently have material exposure to foreign currency fluctuations and does not engage in hedging activities[648]. - Future disruptions in financial institutions could adversely affect the company's access to cash and cash equivalents[650]. Operational Insights - The company has made significant investments in manufacturing capabilities and infrastructure to enhance efficiency and scalability of its iPSC cell therapy platforms[574]. - Inflation has increased costs related to labor and laboratory consumables, but it has not had a material effect on the company's financial statements[651]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced reporting requirements until certain revenue or market value thresholds are met[628][630]. Stock-Based Compensation - Stock-based compensation expense for 2024 included non-cash charges of 25.7 million, primarily from stock-based compensation and depreciation[620]. - The expected volatility of the company's stock is now based on its own trading history, starting from June 2023, after previously relying on comparable publicly traded entities[646]. - The risk-free interest rate used for stock-based awards is based on U.S. Treasury yields for zero-coupon notes with maturities equal to the expected term of the awards[646]. - The expected term for stock-based awards is determined using a simplified method based on the average time-to-vesting and the contractual life of the options[646]. - The fair value of stock-based awards is determined on the grant date using the closing price of the common stock post-IPO, with input from management and third-party valuations[646].