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Century Therapeutics(IPSC) - 2024 Q3 - Quarterly Report
2024-11-05 14:05
Financial Position - The company reported an accumulated deficit of $746.3 million as of September 30, 2024, primarily due to research and development expenses and general administrative costs [149]. - The company has raised approximately $666 million in net proceeds from equity securities sales since inception, with cash and cash equivalents of $52.6 million and investments of $192.1 million as of September 30, 2024 [150]. - The company anticipates needing to raise additional financing in the future to fund operations, including preclinical studies and clinical trials for various product candidates [159]. - The company expects to extend its cash runway into the second half of 2026 based on current business plans and available resources [157]. - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash totaling $52.6 million, along with investments amounting to $192.1 million [216]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates below $700.0 million and annual revenue under $100.0 million [212]. - The company will remain an emerging growth company until the earliest of December 31, 2026, or achieving total annual gross revenue of at least $1.235 billion [211]. - Future disruptions in financial institutions could adversely affect the company's access to cash and cash equivalents [217]. Research and Development - The ongoing ELiPSE-1 clinical trial for CNTY-101 has treated a total of 20 participants, with 19 evaluable for preliminary efficacy as of October 15, 2024 [151]. - The company plans to expand the clinical development of CNTY-101 into additional autoimmune disease indications, with multiple clinical sites activated in the U.S. and plans to expand to select European countries [152]. - A strategic internal portfolio prioritization in January 2023 led to the deprioritization of CNTY-103 and a focus on CNTY-102 and CNTY-107, which are believed to have higher market potential [153]. - The company completed a private placement offering in April 2024, raising $60 million in gross proceeds to support increased research and development activities [154]. - The company incurred $42.6 million in expenses under the FCDI Collaboration Agreement from inception through September 30, 2024 [170]. - The company expects to incur additional losses in the foreseeable future as it expands research and development efforts [197]. Revenue and Expenses - Collaboration revenue for the three months ended September 30, 2024, was $0.8 million, an increase from $0.1 million in the same period of 2023, reflecting a change of $0.7 million [180]. - For the nine months ended September 30, 2024, collaboration revenue was $2.4 million, compared to $2.0 million in 2023, indicating a change of $0.4 million [188]. - Research and development expenses for the three months ended September 30, 2024, were $27.2 million, up from $22.8 million in 2023, representing an increase of $4.4 million [182]. - Research and development expenses for the nine months ended September 30, 2024, totaled $77.9 million, an increase of $7.5 million from $70.4 million in 2023 [189]. - Total operating expenses for the nine months ended September 30, 2024, were $103.3 million, a slight decrease from $104.8 million in 2023, showing a reduction of $1.5 million [187]. - General and administrative expenses were $25.4 million for the nine months ended September 30, 2024, down from $26.1 million for the same period in 2023 [191]. - Personnel-related expenses decreased by $0.8 million, including a $0.3 million decrease in salary and benefits, and a $0.5 million decrease in stock compensation [190]. - The net loss for the three months ended September 30, 2024, was $31.2 million, an improvement from a net loss of $32.7 million in the same period of 2023, reflecting a change of $1.5 million [180]. - Interest income increased to $10.1 million for the nine months ended September 30, 2024, compared to $9.2 million for the same period in 2023, due to higher interest rates [193]. - The company recognized interest income of $3.3 million for the three months ended September 30, 2024, compared to $3.5 million in 2023 [185]. Investments and Acquisitions - The acquisition of Clade Therapeutics is expected to enhance the company's Allo-Evasion technology and expand its pipeline with three additional preclinical-stage programs [154]. - The company raised approximately $60 million from a private placement of 15,873,011 shares at $3.78 per share in April 2024 [196]. - Cash provided by investing activities was $16.9 million for the nine months ended September 30, 2024, down from $42.5 million for the same period in 2023 [201]. Market and Economic Conditions - The company has no material exposure to foreign currency fluctuations and does not engage in hedging activities [215]. - Inflation has not had a material effect on the company's financial statements, although it has increased costs related to labor and laboratory consumables [218]. - The company’s primary market risk exposure is interest income sensitivity, which is influenced by changes in U.S. interest rates [216]. - The company reported no material changes to its critical accounting policies during the nine months ended September 30, 2024 [214]. - The company has opted to use the extended transition period for complying with new or revised accounting standards [210].
Century Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates
GlobeNewswire News Room· 2024-11-05 14:05
Core Insights - Century Therapeutics is expanding its Phase 1 CALiPSO-1 trial of CNTY-101 to include idiopathic inflammatory myopathy and diffuse cutaneous systemic sclerosis, aiming to explore its potential in underserved autoimmune disease categories [1][3] - The Phase 1 ELiPSE-1 study of CNTY-101 in r/r B-cell lymphomas has shown an overall response rate (ORR) of 83% at Dose Level 3B, indicating a favorable safety profile [1][4] - The company ended Q3 2024 with cash and equivalents of $244.7 million, extending its cash runway into the second half of 2026 due to organizational efficiencies [1][10] Research & Development Highlights - The CALiPSO-1 trial has been amended to evaluate CNTY-101 in additional autoimmune diseases, with a basket protocol design to assess safety and preliminary efficacy [3] - Updated interim data from the ELiPSE-1 study shows increased ORR at higher doses, with no dose-limiting toxicities reported [4][5] - CNTY-101 demonstrated persistence upon repeated dosing, supporting the efficacy of Century's Allo-Evasion™ technology [5][6] Business Highlights - Following the integration of Clade Therapeutics, the company is conducting a strategic review of its preclinical pipeline, with results expected in Q1 2025 [9] - Organizational changes have been implemented to enhance efficiencies, extending the expected cash runway into the second half of 2026 [9][12] - New appointments include Morgan Conn as CFO and Chad Cowan as CSO, with Hy Levitsky transitioning to an advisory role [9] Financial Results - As of September 30, 2024, the company reported cash, cash equivalents, and marketable securities of $244.7 million, down from $261.8 million at the end of 2023 [10] - R&D expenses increased to $27.2 million for Q3 2024, primarily due to the progression of clinical trials and increased manufacturing activity [11] - The net loss for Q3 2024 was $31.2 million, slightly improved from a net loss of $32.7 million in Q3 2023 [11][19]
Century Therapeutics to Present at Guggenheim's Inaugural Healthcare Innovation Conference
GlobeNewswire News Room· 2024-11-04 12:00
PHILADELPHIA, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune disease, today announced that Brent Pfeiffenberger, Pharm.D., Chief Executive Officer, and Chad Cowan, Ph.D., Chief Scientific Officer, will participate in a fireside chat at Guggenheim’s Inaugural Healthcare Innovation Conference on Tuesday, November 12, 2024 at 9:30am ET. A live webc ...
Century Therapeutics, Inc. (IPSC) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-08 13:50
Century Therapeutics, Inc. (IPSC) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $0.56 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 24%. A quarter ago, it was expected that this company would post a loss of $0.50 per share when it actually produced a loss of $0.45, delivering a surprise of 10%. Over the last four quarters, the company has s ...
Century Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates
GlobeNewswire News Room· 2024-08-08 11:30
– Initiation of Phase 1 CALiPSO-1 Trial of CNTY-101 in Systemic Lupus Erythematosus, marking strategic expansion into autoimmune disease; protocol amended to include additional cohort of Lupus Nephritis patients – – Presented interim results from Phase 1 ELiPSE-1 trial of CNTY-101 demonstrating encouraging preliminary efficacy and tolerability data in heavily pretreated relapsed/refractory – – Completed dose escalation for ELiPSE-1 and advancing into dose expansion in 2H 2024 – – Ended second quarter 2024 w ...
Century Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates
Newsfilter· 2024-08-08 11:30
– Initiation of Phase 1 CALiPSO-1 Trial of CNTY-101 in Systemic Lupus Erythematosus, marking strategic expansion into autoimmune disease; protocol amended to include additional cohort of Lupus Nephritis patients – – Presented interim results from Phase 1 ELiPSE-1 trial of CNTY-101 demonstrating encouraging preliminary efficacy and tolerability data in heavily pretreated relapsed/refractory – – Completed dose escalation for ELiPSE-1 and advancing into dose expansion in 2H 2024 – – Ended second quarter 2024 w ...
Century Therapeutics (IPSC) Moves to Buy: Rationale Behind the Upgrade
ZACKS· 2024-07-09 17:01
The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system. As such, the Zacks rating upgrade for Century Therapeutics is essentially a positive comment on its earnings outlook that could have a favorable impact on its stock price. The change in a company's future earnings potential, as reflected in earnings esti ...
Century Therapeutics Presents Interim Results from Phase 1 ELiPSE-1 Study at ASCO 2024 Annual Meeting
Newsfilter· 2024-06-03 11:00
Enrollment continues in dose escalation phase of ELiPSE-1 at dose levels 3B (three weekly infusions of 1 billion cells) and 4A (single infusion of 3 billion cells) per cycle PHILADELPHIA, June 03, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced a poster presentation highlighting interim results from the ongoing Ph ...
Century Therapeutics Presents Interim Results from Phase 1 ELiPSE-1 Study at ASCO 2024 Annual Meeting
GlobeNewswire News Room· 2024-06-03 11:00
In ongoing dose escalation, CNTY-101 has demonstrated a manageable safety profile with no observed DLTs or GvHD and with majority of patients treated in outpatient setting Encouraging preliminary efficacy in heavily pretreated R/R NHL at initial dose levels Novel cell-free DNA method for detecting total body PK suggests CNTY-101 persists outside the bloodstream Enrollment continues in dose escalation phase of ELiPSE-1 at dose levels 3B (three weekly infusions of 1 billion cells) and 4A (single infusion of 3 ...
Century Therapeutics, Inc. (IPSC) Reports Q1 Loss, Tops Revenue Estimates
Zacks Investment Research· 2024-05-09 13:40
Century Therapeutics, Inc. (IPSC) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $0.53 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 10%. A quarter ago, it was expected that this company would post a loss of $0.56 per share when it actually produced a loss of $0.49, delivering a surprise of 12.50%.Over the last four quarters, the company has ...