Workflow
Century Therapeutics(IPSC)
icon
Search documents
Century Therapeutics(IPSC) - 2025 Q1 - Quarterly Results
2025-05-15 20:15
[Company Overview and Strategy](index=3&type=section&id=Company%20Overview%20and%20Strategy) Century Therapeutics focuses on iPSC-derived cell therapies, prioritizing CNTY-101 for autoimmune disorders and advancing its preclinical pipeline with a cash runway into late 2026 [Strategic Focus and Financial Position](index=3&type=section&id=Strategic%20Focus%20and%20Financial%20Position) Century Therapeutics is concentrating its clinical efforts on CNTY-101 for autoimmune disorders, leveraging its unique iPSC-derived cell therapy platform. The company is advancing an enhanced preclinical pipeline featuring Allo-Evasion™ 5.0 technology and has secured a cash runway into the fourth quarter of 2026 to support key development milestones, including expected clinical data for CNTY-101 in 2025 - The company is concentrating its clinical focus on CNTY-101 for autoimmune disorders, highlighting its potential as a unique CD19-targeting iNK cell product[3](index=3&type=chunk) - Century is enhancing its preclinical pipeline with programs engineered with Allo-Evasion™ 5.0, focusing on iPSC-derived 'tunable' CD4+/CD8+ aß T cells[3](index=3&type=chunk) Financial Position and Key Milestones | Metric | Value / Milestone | | :--- | :--- | | **Cash Position (End Q1 2025)** | $185.8M (cash, cash equivalents, and investments) | | **Estimated Cash Runway** | Into 4Q 2026 | | **CNTY-101 Autoimmune Data** | Expected in 2025 | | **CNTY-308 Program** | Expected to enter IND-enabling stage in mid-2025 | [Technology Platform](index=4&type=section&id=Technology%20Platform) Century's technology platform leverages an iPSC foundation for scalable, reproducible cell therapy production, featuring proprietary Allo-Evasion™ engineering to enable immune evasion and potential repeat dosing [iPSC Platform and Allo-Evasion™ Engineering](index=4&type=section&id=iPSC%20Platform%20and%20Allo-Evasion%E2%84%A2%20Engineering) Century's core technology is built on an induced pluripotent stem cell (iPSC) platform, which allows for the creation of multiple, genetically engineered cell types from a single-cell clone master cell bank. This enables scalability, reproducibility, and consistency. A key feature is the proprietary Allo-Evasion™ engineering, which is designed to protect the allogeneic cell therapies from the patient's immune system (T-cells, NK-cells, and antibodies), potentially allowing for repeat dosing without the need for continuous lymphodepletion and driving durable responses - The iPSC platform enables the creation of multiple cell types from a fully characterized single-cell clone, ensuring reproducibility and large batch sizes for scalability[4](index=4&type=chunk) - Allo-Evasion™ engineering is designed to protect therapy cells from the host's native T-cells, NK-cells, and antibody immunity, enabling potential re-dosing[4](index=4&type=chunk)[5](index=5&type=chunk) - The technology has evolved, with CNTY-101 using Allo-Evasion™ 1.0 and newer programs like CNTY-308 incorporating Allo-Evasion™ 5.0, which adds protection from humoral immunity via an IgG degrading enzyme (IDP)[9](index=9&type=chunk)[13](index=13&type=chunk)[14](index=14&type=chunk) - Preclinical studies show the CD300a TASR ligand provides broad protection from host NK cells, and the IDP enzyme protects cells from complement-dependent (CDC) and antibody-dependent cellular cytotoxicity (ADCC)[11](index=11&type=chunk)[15](index=15&type=chunk)[16](index=16&type=chunk) [Clinical Pipeline](index=9&type=section&id=Clinical%20Pipeline) Century's clinical pipeline focuses on iPSC-derived cell therapies for autoimmune diseases and cancer, led by CNTY-101 in Phase 1 and advanced preclinical αβ iT cell programs [Pipeline Overview](index=9&type=section&id=Pipeline%20Overview) Century Therapeutics is advancing a focused pipeline of iPSC-derived cell therapies targeting autoimmune diseases and cancer. The lead clinical candidate, CNTY-101, is in a Phase 1 trial for B-cell-mediated autoimmune diseases. The preclinical pipeline includes next-generation αβ iT cell programs like CNTY-308 and CNTY-341, which utilize enhanced Allo-Evasion™ 5.0 technology for autoimmune and malignancy indications, alongside programs for solid tumors Century Therapeutics Product Pipeline | Product | Targets | Indications | Research | IND-enabling | Phase 1 | | :--- | :--- | :--- | :--- | :--- | :--- | | **CNTY-101** (iNK) | CD19 | B-cell-mediated autoimmune diseases | | | CALiPSO-1 | | **CNTY-308** (αβ iT) | CD19 | B-cell-mediated autoimmune diseases, B-cell malignancies | ✓ | | | | **CNTY-341** (αβ iT) | CD19 + CD22 | B-cell malignancies | ✓ | | | | **Solid Tumors** (iT) | Nectin-4/other | Solid tumors | ✓ | | | [CNTY-101 Program](index=10&type=section&id=CNTY-101%20Program) CNTY-101 is an off-the-shelf, CD19-targeted CAR-iNK cell therapy candidate featuring Allo-Evasion™ 1.0. It is currently in the CALiPSO-1 Phase 1 trial for moderate to severe autoimmune diseases (SLE, LN, IIM, dcSSc). Supporting data from the ELiPSE-1 study in B-cell lymphoma demonstrated a favorable safety profile, deep B-cell depletion, and sustained exposure, reinforcing its potential for autoimmune applications - CNTY-101 is an allogeneic CAR-iNK cell therapy with six gene edits, including a CD19 CAR, Allo-Evasion™ technology, secreted IL-15 for persistence, and a safety switch[22](index=22&type=chunk)[24](index=24&type=chunk) - The CALiPSO-1 Phase 1 study is enrolling up to 48 patients with moderate to severe SLE, LN, IIM, or dcSSc, with a dosing schedule of 1e9 cells per infusion[34](index=34&type=chunk)[35](index=35&type=chunk) - In vitro studies show CNTY-101 eliminates B-cells from SLE patients with greater potency than primary CAR-T cells[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) Key Findings from ELiPSE-1 Study (R/R B-cell Lymphoma) | Finding | Detail | | :--- | :--- | | **Safety Profile (n=23)** | Favorable; no DLTs, no GvHD. Majority of infusions in outpatient setting | | **Efficacy (DL 3B & 4B, n=9)** | 77% ORR, 22% CR | | **B-cell Depletion** | Demonstrated deep and rapid B-cell depletion | | **Pharmacokinetics (PK)** | Sustained exposure at dose levels intended for autoimmune study; similar PK with or without endogenous lymphocytes | [Next-Generation iT Cell Platform (CNTY-308, CNTY-341)](index=23&type=section&id=Next-Generation%20iT%20Cell%20Platform%20%28CNTY-308%2C%20CNTY-341%29) Century is developing a next-generation platform of iPSC-derived αβ T cells (iT) to address the ~$4.5B CAR-T market. The lead candidate, CNTY-308, is a CD19-targeted CAR-iT with Allo-Evasion™ 5.0, designed for B-cell mediated diseases. Preclinical data show it has functional characteristics similar to primary CAR-T cells, including high proliferation, cytokine secretion, and long-term persistence. CNTY-341 is a dual-targeting (CD19/CD22) candidate for B-cell malignancies, and the platform is also being applied to solid tumors - The platform aims to replace and expand the current **~$4.5B** autologous CAR-T market with an off-the-shelf product, addressing challenges like manufacturing time and patient access[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) - CNTY-308 is a CD19-targeted CD4+/CD8+ αβ iT-cell product with Allo-Evasion™ 5.0, which includes edits to evade T cell, NK cell, and humoral responses[62](index=62&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk) - Preclinical studies demonstrate that Century's iPSC-derived CAR-αβT cells (CNTY-308) show comparable characteristics to primary CAR-T cells, including IL-2 secretion, repeat killing ability, and in vivo tumor control after rechallenge[68](index=68&type=chunk)[70](index=70&type=chunk)[75](index=75&type=chunk) - CNTY-341 is a dual-targeting (CD19/CD22) CAR-iT designed to reduce potential antigen escape in B-cell malignancies. The platform is also being developed for solid tumors with targets like Nectin-4, GPC3, and CD70[76](index=76&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) [Platform and Manufacturing](index=32&type=section&id=Platform%20and%20Manufacturing) Century's integrated platform enables the generation of diverse iPSC-derived immune effector cells through precise gene editing, supported by robust in-house cGMP manufacturing for scalability and consistency [iPSC Cell Foundry and Engineering](index=32&type=section&id=iPSC%20Cell%20Foundry%20and%20Engineering) Century's platform leverages the ability to generate multiple iPSC-derived immune effector cells (iNK, γδ iT, αβ iT) to match the optimal cell type to a specific disease. The company uses a precise, sequential CRISPR MAD7-mediated gene editing process on iPSCs. This creates a uniform, well-characterized engineered Master Cell Bank (MCB), which serves as the starting point for manufacturing, ensuring product consistency and avoiding issues from genetic aberrations - The platform can generate various cell types (CAR iNK, CAR γδ iT, CAR αβ iT), allowing the selection of the right cell for the right indication based on functional attributes like cytolytic capacity and proliferative potential[86](index=86&type=chunk)[87](index=87&type=chunk) - Century utilizes precise CRISPR MAD7-mediated sequential gene editing to create engineered iPSC Master Cell Banks (MCBs), ensuring a uniform and quality-controlled starting material for all products[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) [In-House Manufacturing and Scalability](index=36&type=section&id=In-House%20Manufacturing%20and%20Scalability) Century has established significant in-house manufacturing capabilities with a 53,000 sq. ft. cGMP facility, led by an experienced team. This vertical integration is designed to ensure product quality, consistency, and speed. The company is developing scalable production systems with the goal of achieving antibody-like scale and cost of goods, which would be disruptive for the cell therapy field - The company operates a **53,000 ft²** purpose-built cGMP facility with an experienced in-house team, providing control over priorities, learning, and proprietary know-how[92](index=92&type=chunk) - The manufacturing process, starting from a single-cell clonal master bank, is designed for consistency, batch-to-batch reproducibility, and high cell fitness[92](index=92&type=chunk) - Development shows progress in scalable, dynamic cell production systems, aiming for antibody-like cost and scale[94](index=94&type=chunk)[95](index=95&type=chunk) [Conclusion and Outlook](index=38&type=section&id=Conclusion%20and%20Outlook) Century Therapeutics maintains a clear strategic focus on advancing iPSC-derived cell therapies, prioritizing CNTY-101 clinical development and supported by a strong preclinical pipeline and financial runway [Summary of Strategy and Milestones](index=38&type=section&id=Summary%20of%20Strategy%20and%20Milestones) Century Therapeutics reiterates its clear strategic focus on advancing its unique iPSC-derived cell therapies. The company is prioritizing the clinical development of CNTY-101 in autoimmune diseases, with initial data expected in 2025. Supported by a strong preclinical pipeline featuring Allo-Evasion™ 5.0 and a cash runway into late 2026, Century is positioned to achieve key value-driving milestones - The company's core strategy is to concentrate clinical development on CNTY-101 for autoimmune disorders while advancing an enhanced preclinical pipeline with next-generation technologies[97](index=97&type=chunk) Forward-Looking Milestones and Financials | Item | Detail | | :--- | :--- | | **Clinical Focus** | CNTY-101 in autoimmune disorders (Phase 1 CALiPSO-1) | | **Key Data Readout** | CNTY-101 autoimmune clinical data expected in 2025 | | **Pipeline Advancement** | CNTY-308 (αβ T cell) program to enter IND-enabling stage in mid-2025 | | **Financial Runway** | Estimated into 4Q 2026, with $185.8M in cash at end of Q1 2025 |
Century Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-15 20:01
Core Insights - Century Therapeutics is advancing its pipeline of induced pluripotent stem cell (iPSC)-derived therapies for autoimmune diseases and cancer, with significant progress reported in the first quarter of 2025 [1][2]. Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $185.8 million, down from $220.1 million at the end of 2024, which is expected to support operations into Q4 2026 [11]. - Collaboration revenue for the first quarter of 2025 was $109.2 million, a substantial increase from $0.9 million in the same period of 2024, attributed to a collaboration agreement with Bristol-Myers Squibb, which was terminated on March 12, 2025 [11]. - Research and Development (R&D) expenses rose to $26.6 million in Q1 2025 from $23.4 million in Q1 2024, primarily due to increased clinical trial costs [11]. - General and Administrative (G&A) expenses decreased slightly to $8.4 million from $8.7 million year-over-year [11]. - The company reported a net income of $76.6 million for Q1 2025, compared to a net loss of $28.1 million in Q1 2024 [11]. Pipeline Developments - The company is on track to initiate Investigational New Drug (IND)-enabling studies for its lead preclinical program, CNTY-308, in mid-2025 [2][11]. - Patient dosing has commenced in the Phase 1 CALiPSO-1 trial for CNTY-101, with plans to expand into additional U.S. and European sites [5][6]. - Presentations at the ASGCT 28th Annual Meeting highlighted advancements in the preclinical pipeline, including improvements in anti-tumor activity of iPSC-derived immunotherapies [4][5]. Strategic Focus - Century Therapeutics is committed to developing off-the-shelf cell therapies to enhance patient access and improve treatment outcomes for autoimmune diseases and cancers [9]. - The company is leveraging its expertise in cellular reprogramming and genetic engineering to create scalable and accessible CAR-T cell therapies [7][11].
Century Therapeutics, Inc. (IPSC) May Report Negative Earnings: Know the Trend Ahead of Q1 Release
ZACKS· 2025-05-01 15:07
Core Viewpoint - Wall Street anticipates a year-over-year increase in earnings for Century Therapeutics, Inc. due to higher revenues, but actual results compared to estimates will significantly influence the stock price [1][2]. Earnings Expectations - The upcoming earnings report is expected to show a quarterly loss of $0.31 per share, reflecting a year-over-year change of +31.1% [3]. - Revenues are projected to be $45.52 million, representing a substantial increase of 5193% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 2.86% higher in the last 30 days, indicating a reassessment by analysts [4]. - The Most Accurate Estimate for Century Therapeutics is lower than the Zacks Consensus Estimate, leading to an Earnings ESP of -30.43% [10][11]. Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from consensus estimates, with positive readings being more predictive of earnings beats [6][7]. - Stocks with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have shown a nearly 70% success rate in delivering positive surprises [8]. Historical Performance - In the last reported quarter, Century Therapeutics was expected to post a loss of $0.45 per share but delivered a loss of $0.43, resulting in a surprise of +4.44% [12]. - The company has beaten consensus EPS estimates in the last four quarters [13]. Conclusion - Century Therapeutics does not currently appear to be a strong candidate for an earnings beat, and investors should consider other factors when making decisions regarding the stock ahead of the earnings release [16].
Century Therapeutics Announces Two Upcoming Presentations at the ASGCT 28th Annual Meeting
Globenewswire· 2025-04-28 20:30
Core Insights - Century Therapeutics, Inc. is set to present at the ASGCT 28th Annual Meeting, showcasing its preclinical cell therapy pipeline targeting autoimmune diseases and cancer [1][2] Presentation Details - The first presentation will focus on enhancing solid tumor elimination using a TGF-b neutralizing synthetic receptor in iPSC-derived allogeneic therapies, scheduled for May 13, 2025 [2] - The second presentation will discuss the generation of iPSC-derived CD4+ and CD8+ CD19 CAR ab T cells, demonstrating in vivo tumor control and cell expansion comparable to healthy donor T cells, set for May 17, 2025 [2] Company Overview - Century Therapeutics is a clinical-stage biotechnology company specializing in iPSC-derived cell therapies, aiming to provide significant advantages over existing therapies [3] - The company is committed to developing off-the-shelf cell therapies to enhance patient access and improve treatment outcomes for autoimmune diseases and cancers [3]
Century Therapeutics to Host Live Fireside Chat Focused on Newly Prioritized Preclinical Cell Therapy Programs for Autoimmune Diseases and Cancer on Tuesday, April 22, 2025
Newsfilter· 2025-04-15 20:01
Core Viewpoint - Century Therapeutics, Inc. is advancing its preclinical cell therapy programs targeting autoimmune diseases and cancer, with a live event scheduled to discuss these developments [1][2]. Group 1: Company Overview - Century Therapeutics is a clinical-stage biotechnology company focused on developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancers [4]. - The company aims to create off-the-shelf cell therapies to enhance patient access and improve treatment outcomes in autoimmune disease and cancer care [4]. Group 2: Upcoming Event Details - A live fireside chat will take place on April 22, 2025, at 10:00 a.m. EDT, where management will present details and data on prioritized preclinical programs [1]. - The event will cover investigational cell therapies including CNTY-308, a CD19-targeted CAR-iT therapy, and CNTY-341, a dual-targeted CAR-iT therapy, as well as a solid tumor CAR iT program [2]. - The discussion will highlight the proprietary immune evasion technology, Allo-Evasion™ 5.0, which aims to enable comprehensive evasion of various immune responses [2]. Group 3: Accessing Information - The live event can be accessed via the Investors page on Century's website, with a replay available for at least 30 days post-event [3].
Century Therapeutics (IPSC) Upgraded to Buy: What Does It Mean for the Stock?
ZACKS· 2025-03-25 17:01
Century Therapeutics, Inc. (IPSC) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual inve ...
Century Therapeutics, Inc. (IPSC) Reports Q4 Loss, Misses Revenue Estimates
ZACKS· 2025-03-19 22:15
Century Therapeutics, Inc. (IPSC) came out with a quarterly loss of $0.43 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 4.44%. A quarter ago, it was expected that this company would post a loss of $0.46 per share when it actually produced a loss of $0.37, delivering a surprise of 19.57%.Over the last four quarters, the company ha ...
Century Therapeutics(IPSC) - 2024 Q4 - Annual Results
2025-03-19 20:08
Clinical Trials and Efficacy - CNTY-101 is currently in Phase 1 trials targeting CD19 for B-cell malignancies and autoimmune disorders, with a focus on repeat dosing enabled by Allo-Evasion™ technology[22]. - The ELiPSE-1 study shows a median overall response rate (ORR) of 83% with a median follow-up of 2.9 months, indicating promising efficacy for CNTY-101[32]. - CNTY-101 demonstrated increased exposure and dose-responsive efficacy, with higher doses correlating with improved outcomes[29][33]. - The study enrolled heavily pre-treated patients, with a median of 4 prior therapies and 60% classified as refractory[28]. - CNTY-101 demonstrated an 83% overall response rate (ORR) at dose level 3B in a heavily pretreated patient population[43]. - The Phase 1 study ELiPSE-1 showed increased CNTY-101 exposure with multiple infusions, indicating extended persistence in circulation beyond day 15[36]. - CNTY-101 treatment resulted in rapid B-cell depletion observed in the first cycle, with a naive non-class switched profile of re-emergent B-cells[39]. - The Phase 1 ELiPSE-1 trial of CNTY-101 is ongoing, with updated clinical data expected for multiple malignancies[78]. - The CALiPSO-1 trial has been initiated for participants with systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathies (IIM), and diffuse cutaneous systemic sclerosis (dcSSc)[80]. Safety Profile - CNTY-101's safety profile includes no instances of Graft vs Host Disease (GvHD) and manageable adverse events, such as Grade 1 and 2 cytokine release syndrome (CRS)[32]. - The study included 11 patients in Schedule A and 8 patients in Schedule B, with favorable initial safety profiles allowing outpatient delivery[43]. - CNTY-101's pharmacokinetics and pharmacodynamics are characterized by short-lived, predictable profiles, contributing to manageable safety[48]. Product Development and Pipeline - CNTY-101 incorporates six precision gene edits, including CD19-targeted CAR and safety switches, enhancing its therapeutic profile[22]. - The product pipeline includes multiple candidates, with CNTY-308 and CNTY-361 also targeting autoimmune diseases and B-cell malignancies, respectively[15]. - CNTY-308, another product in development, is an iPSC-derived CD19-targeted CAR-iT cell therapy showing comparable preclinical activity to autologous CAR-T cells[59]. - Century Therapeutics is focusing on expanding its pipeline into additional autoimmune indications, leveraging its Allo-Evasion™ technology[77]. - The differentiated pipeline includes multiple opportunities in autoimmune diseases, supported by promising preclinical data[80]. Manufacturing and Technology - The company is advancing its iPSC-derived cell types, focusing on scalable and reproducible manufacturing processes to reduce costs[5]. - The company has established in-house manufacturing capabilities, including a 53,000 ft² cGMP facility, to ensure efficient and scalable production[76]. - The iPSC Precision Engineering platform allows for precise CRISPR-mediated gene editing, reducing off-target integration and enhancing product quality[75]. - The platform enables lower cost of goods sold (COGs) compared to donor-derived or autologous therapies, enhancing batch-to-batch consistency[48]. - The company aims to manufacture at antibody-like scale, optimizing processes to maximize yield and reduce costs[76]. Financials and Future Plans - The company ended FY24 with cash and investments of approximately $2 million, noting that this estimate is unaudited and preliminary[79]. - Future development plans include progressing CNTY-101 through clinical trials and obtaining FDA clearance for IND submissions[3]. - The company is expanding clinical trial sites to the EU in 2025, following the initial enrollment in the USA[53]. - Century Therapeutics is advancing next-generation iPSC-derived NK and T cell therapy candidates for cancer treatment, with encouraging preliminary clinical data from Phase 1 trial of CNTY-101 in R/R B-cell lymphomas[77].
Century Therapeutics(IPSC) - 2024 Q4 - Annual Report
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 $58.4 million and investments of $161.7 million[612]. - The accumulated deficit reached $782.3 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 $136.7 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 $0.0 million, respectively, with in-process research and development expenses of $0.0 million and $5.0 million[585]. - Research and development expenses increased to $107.2 million in 2024 from $92.7 million in 2023, representing a $14.5 million increase[606]. - Collaboration revenue rose to $6.6 million in 2024 from $2.2 million in 2023, an increase of $4.4 million[604]. - The total operating expenses decreased to $144.7 million in 2024 from $148.8 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 $4.50 per share, resulting in approximately $18.4 million in gross proceeds during 2024[613]. - Net cash used in operating activities was $110.1 million for the year ended December 31, 2024, compared to $88.3 million for 2023, primarily due to a net loss of $126.6 million in 2024[620]. - Cash provided by financing activities was $74.6 million in 2024, a significant increase from cash used of $9.7 million in 2023, driven by $17.8 million from an at-the-market capital raise and $56.6 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 $50 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 $109.2 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].
Century Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-03-19 20:01
Core Insights - Century Therapeutics, Inc. reported financial results and business highlights for the full year 2024, emphasizing a pipeline re-prioritization to focus on transformative candidates in high unmet need diseases [1][2] Financial Performance - Cash, cash equivalents, and marketable securities were $220.1 million as of December 31, 2024, down from $261.8 million as of December 31, 2023 [8] - Net cash used in operations was $110.1 million for the year ended December 31, 2024, compared to $88.3 million for the same period in 2023 [8] - Collaboration revenue was $6.6 million, an increase from $2.2 million in 2023 [8] - Research and Development (R&D) expenses rose to $107.2 million from $92.7 million in 2023, primarily due to increased research and laboratory costs [8] - General and Administrative (G&A) expenses decreased to $33.2 million from $34.7 million in 2023 [8] - The net loss for 2024 was $126.6 million, compared to a net loss of $136.7 million in 2023 [8] Clinical Pipeline Developments - The company has decided to discontinue the Phase 1 ELiPSE-1 trial early, focusing instead on CNTY-101, which is positioned to impact B-cell-mediated autoimmune diseases [2][6] - The CALiPSO-1 Phase 1 trial is set to expand in the U.S. and Europe, with the first patient enrolled and scheduled for dosing in March 2025 [6] - The CARAMEL Phase 1 investigator-initiated trial is expected to commence in mid-2025, focusing on CNTY-101 for B-cell mediated autoimmune diseases [6] Strategic Focus - The company is prioritizing four transformative programs, including CNTY-308, which targets B-cell mediated autoimmune diseases and malignancies [5][9] - CNTY-308 is engineered with Allo-Evasion™ 5.0 technology, aiming for comparable or better performance than approved autologous CAR-T therapies [7][9] - The company aims to launch allogeneic cell therapies at antibody-like scale and cost, expanding access to cell therapies [7][9]