Century Therapeutics(IPSC)
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Century Therapeutics(IPSC) - 2025 Q3 - Quarterly Report
2025-11-13 12:35
Development Programs - The company is developing CNTY-813 for Type 1 diabetes, with plans to move into IND-enabling studies by the end of 2025 and anticipate IND submission as early as 2026[140] - CNTY-308, a CD19-targeted CAR-iT cell therapy, is progressing towards clinical studies expected to start in 2026 following successful IND-enabling studies[141] Financial Performance - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying on future collaborations for revenue[158] - Collaboration revenue for the nine months ended September 30, 2025, was $109.2 million, a significant increase from $2.4 million in 2024[176] - Total operating expenses for the three months ended September 30, 2025, were $36.1 million, slightly higher than $35.6 million in 2024[168] - Research and development expenses decreased to $22.5 million for the three months ended September 30, 2025, from $27.2 million in 2024, a reduction of $4.7 million[170] - General and administrative expenses were $6.8 million for the three months ended September 30, 2025, down from $8.4 million in 2024[171] - Interest income decreased to $1.6 million for the three months ended September 30, 2025, compared to $3.3 million in 2024[173] - The accumulated deficit as of September 30, 2025, was $772.7 million[183] Cash Flow and Financing - As of September 30, 2025, the company had cash and cash equivalents of $55.5 million and investments of $77.2 million[183] - The company anticipates needing to raise additional financing in the future to support ongoing operations and clinical trials[146] - Net cash used in operating activities was $87.8 million for the nine months ended September 30, 2025, compared to $85.9 million for the same period in 2024, reflecting a net income of $9.6 million and non-cash charges of $23.1 million[190] - Net cash provided by investing activities increased significantly to $85.1 million for the nine months ended September 30, 2025, from $16.9 million in the same period of 2024, primarily due to the sale of fixed maturity securities of $121.7 million[192] - Net cash provided by financing activities decreased to $0.1 million for the nine months ended September 30, 2025, down from $75.2 million in 2024, which included $17.8 million from an at-the-market capital raise and $56.6 million from PIPE financing[194] - The company reported a net decrease in cash, cash equivalents, and restricted cash of $2.5 million for the nine months ended September 30, 2025, compared to an increase of $6.1 million in 2024[189] - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $58.7 million, along with investments of $77.2 million[206] Operational Changes - The company completed a workforce reduction of approximately 51% to focus on key clinical programs[143] - Bristol-Myers Squibb terminated its collaboration agreement effective March 12, 2025, which included a $100 million upfront payment and stock purchase[149] - The company is investing in manufacturing capabilities to improve efficiency and scalability of its iPSC cell therapy products[145] - Future capital requirements will depend on various factors, including the costs of clinical trials and regulatory approvals for current and future product candidates[187] - The company has significant contractual obligations totaling $66.4 million, with $7.99 million due within one year and $14.8 million due in the next one to three years[196] - The company experienced a $120.5 million decrease in net operating assets and liabilities during the nine months ended September 30, 2025, primarily due to a decrease in deferred revenue from the termination of a collaboration agreement[190] Economic Factors - Inflation has not had a material effect on the company's financial statements, although it has increased costs related to labor and laboratory consumables[208] - Future disruptions in financial institutions could adversely affect the company's ability to access cash and cash equivalents[207] - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced reporting requirements[198]
Century Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-13 12:30
Core Insights - Century Therapeutics is advancing its iPSC-derived cell therapies targeting autoimmune diseases and cancer, with a focus on Type 1 diabetes (T1D) and B-cell-mediated diseases [2][5][6] Business Update - The company announced its lead iPSC-derived beta islet program for T1D, with plans to initiate IND-enabling studies by the end of 2025 and submit an IND as early as 2026 [2][5][6] - CNTY-308 is progressing through IND-enabling studies, aiming for clinical study initiation in 2026 [5][6] - CNTY-101 is continuing in a Phase 1/2 investigator-sponsored trial, with initial clinical data expected in December 2025 [6] Financial Results - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $132.7 million, down from $220.1 million at the end of 2024, with an estimated cash runway into Q4 2027 [6][10] - R&D expenses for Q3 2025 were $22.5 million, a decrease from $27.2 million in Q3 2024, primarily due to reduced personnel and manufacturing costs [6][10] - G&A expenses were $6.8 million for Q3 2025, down from $8.4 million in Q3 2024, attributed to a gain on lease modification [10] - The net loss for Q3 2025 was $34.4 million, compared to a net loss of $31.2 million for the same period in 2024 [10][13]
Century Therapeutics Announces New Beta Islet Program for Type 1 Diabetes
Globenewswire· 2025-11-13 12:00
Core Insights - Century Therapeutics has announced its first program for Type 1 diabetes (T1D), CNTY-813, utilizing iPSC-derived beta islets engineered with Allo-Evasion™ 5.0 technology to achieve durable glycemic control without systemic immunosuppression [1][2][5] Company Overview - Century Therapeutics is a biotechnology company focused on developing induced pluripotent stem cell (iPSC)-derived cell therapies aimed at addressing autoimmune diseases and cancer [7] - The company leverages its proprietary Allo-Evasion™ technology to create off-the-shelf cell therapies that enhance patient access and offer advantages over existing treatments [7] Product Development - The CNTY-813 program aims to provide a scalable, immune-evasive beta islet therapy that could significantly improve the treatment landscape for T1D, which affects approximately 9 million people globally, including 2 million in the U.S. [4][5] - Century has generated compelling preclinical data demonstrating rapid and sustained normalization of glucose levels in diabetic mouse models, along with significant glucose-stimulated insulin secretion and engineered resistance to immune rejection [2][6] - The company plans to initiate IND-enabling studies by the end of 2025 and aims to submit an IND application to the FDA as early as 2026 [3][5] Market Opportunity - The current treatment for T1D imposes a significant financial burden on the healthcare system, with annual insulin costs in the U.S. estimated between $6 billion and $8 billion [4] - An off-the-shelf, immune-evasive beta islet therapy could provide a paradigm shift in T1D management, addressing the challenges of unpredictable glucose swings and the need for lifelong insulin [2][4]
Century Therapeutics (NasdaqGS:IPSC) FY Conference Transcript
2025-10-21 17:22
Century Therapeutics Conference Call Summary Company Overview - **Company Name**: Century Therapeutics (Ticker: IPSC) - **Industry**: Biotechnology, specifically focused on induced pluripotent stem cells (iPSCs) and cell therapies Key Points and Arguments Clinical Programs - **CNTY-101**: An NK cell-based therapy with a CD19 CAR, currently in clinical trials in the U.S. and EU, targeting autoimmune diseases [3][20] - **CNTY-308**: A preclinical program targeting B-cell-mediated diseases, expected to enter clinical trials mid-next year [4] - **Non-Immune Cell Program**: A highly anticipated program that is not disclosed for competitive reasons but is believed to have significant potential [4] Scientific Advancements - **Cell Foundry**: Century's capability to produce adult functional cells from iPSCs, including CD4 and CD8 T cells, which are crucial for treating B-cell malignancies and autoimmune diseases [5][6] - **Alloevasion Technology**: Century is a leader in immune evasion strategies, with advancements from alloevasion 1.0 to 5.0, allowing for better protection of allogeneic cells from the patient's immune system [6][7][9] Pipeline and Efficacy - **Efficacy of T Cells**: The company claims that their iPSC-derived T cells can perform comparably to autologous T cells, with the ability to engage targets and proliferate effectively [15][16] - **Long-term Durability**: The combination of CD4 and CD8 T cells enhances long-term durability and effectiveness in tumor control [17][18] Clinical Trials and Results - **Calypso Trial**: A company-sponsored trial for CNTY-101, allowing for re-dosing without lymphodepletion, showing promise in autoimmune diseases [20][21] - **B Cell Malignancy Trial**: Previous trials demonstrated deep and sustained B cell depletion, indicating the potential for effective treatment in autoimmune diseases [23][24] Financial and Operational Updates - **Cash Runway**: The company has extended its cash runway through 2027, allowing for continued development and data collection from ongoing trials [7] - **Restructuring**: A recent restructuring has focused the company on key assets and streamlined operations [7] Additional Important Information - **Cost-Effectiveness**: The company aims to produce therapies at costs comparable to antibody treatments, which could enhance accessibility [22] - **Safety Profile**: NK cell therapies are noted for their favorable safety profile compared to T cell therapies, which can have severe side effects [22] - **Future Directions**: The company is exploring the possibility of reducing or eliminating lymphodepletion in trial designs, which could further enhance treatment options [28][29] This summary encapsulates the key insights from the conference call, highlighting Century Therapeutics' innovative approaches in the biotechnology sector, particularly in cell therapy and immune evasion strategies.
Century Therapeutics to Present at Chardan's 9th Annual Genetic Medicines Conference
Globenewswire· 2025-10-14 20:01
Core Insights - Century Therapeutics, Inc. is focused on developing induced pluripotent stem cell (iPSC)-derived cell therapies targeting autoimmune diseases and cancer [1][3] - Chad Cowan, Ph.D., the Chief Scientific Officer, will present at Chardan's 9th Annual Genetic Medicines Conference on October 21, 2025 [1] - The company utilizes its proprietary Allo-Evasion™ technology to enhance immune evasion in its therapies, aiming to improve patient access and treatment outcomes [3] Company Overview - Century Therapeutics is a clinical-stage biotechnology firm listed on NASDAQ under the ticker IPSC [3] - The company is advancing a pipeline of iPSC-derived cell therapies, which are designed to address significant medical needs in autoimmune diseases and cancer [3] - The therapies are produced from the company's iPSC cell foundry, indicating a focus on innovative and scalable treatment solutions [3] Presentation Details - The presentation by Chad Cowan will take place at 12:20 p.m. ET in New York, NY [1] - A live webcast of the presentation will be accessible on the company's Investors page, with an archived replay available for at least 30 days [2]
Century Therapeutics to Present at Chardan’s 9th Annual Genetic Medicines Conference
Globenewswire· 2025-10-14 20:01
Core Insights - Century Therapeutics is a biotechnology company focused on developing induced pluripotent stem cell (iPSC)-derived cell therapies targeting autoimmune diseases and cancer [3]. Company Overview - Century Therapeutics (NASDAQ: IPSC) is in the clinical stage of developing a pipeline of iPSC-derived cell therapies [3]. - The company utilizes its iPSC cell foundry and a unique immune evasion engineering technology called Allo-Evasion™ to enhance its therapies [3]. - Century aims to create off-the-shelf cell therapies to improve patient access and offer advantages over existing cell therapies, thereby advancing treatment options [3]. Upcoming Events - Chad Cowan, Ph.D., Chief Scientific Officer of Century Therapeutics, will present at Chardan's 9th Annual Genetic Medicines Conference on October 21, 2025, at 12:20 p.m. ET in New York, NY [1]. - A live webcast of the presentation will be available on the company's Investors page, with an archived replay accessible for at least 30 days [2].
Century Therapeutics (IPSC) FY Conference Transcript
2025-09-05 12:00
Summary of Century Therapeutics Conference Call Company Overview - **Company**: Century Therapeutics - **Ticker**: IPSC (NASDAQ) - **Focus**: Development of next-generation allogeneic cell therapies from programmable induced pluripotent stem cells (iPSCs) for autoimmune diseases and cancer [1][2] Core Technology and Pipeline - **Core Technology**: AlloVision technology, which enables the engineering of iPSC-derived cell therapies [2][5] - **Key Programs**: - **Century 308**: CD19 targeting CD4/CD8 alpha-beta CARiT cell therapy, currently in IND-enabling studies for B-cell-mediated diseases [3][5] - **Century 101**: CAR INK therapy targeting CD19, currently in clinical trials for autoimmune diseases [18][19] Clinical Development and Milestones - **Cash Runway**: Estimated to extend into Q4 2027, covering key clinical milestones [5] - **Clinical Trials**: - **Century 101**: In two Phase I trials for systemic lupus erythematosus (SLE), lupus nephritis, myositis, and systemic sclerosis [18][19] - **Century 308**: Expected to enter the clinic next year [5][18] Market Opportunity - **Autoimmune Disease Market**: Significant unmet medical need with tens of thousands of addressable patients in the U.S. for B-cell-mediated diseases [20][21] - **CAR T Therapy Market**: Current approved CAR T therapies have close to $5 billion in worldwide sales, but access remains a challenge with fewer than 30% of eligible patients receiving treatment [11][20] AlloVision Technology - **Immune Evasion**: AlloVision technology involves genetic edits to enhance the persistence of allogeneic cells and reduce rejection by the immune system [6][7] - **Holistic Protection**: AlloVision 5.0 includes multiple genetic modifications to protect against various immune rejection mechanisms [8][9] Preclinical and Clinical Data - **Century 308**: Demonstrated comparable functionality to primary T cells in preclinical studies, including IL-2 secretion and tumor control in mouse models [13][17] - **Century 101**: Established a safe and well-tolerated dose with effective B-cell depletion observed in clinical trials [22][23] Conclusion - **Future Outlook**: Century Therapeutics aims to leverage its iPSC platform and AlloVision technology to create impactful therapies for patients with severe diseases, with a focus on delivering clinical data throughout 2025 [24]
Century Therapeutics to Present at H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-08-22 12:00
Group 1 - Century Therapeutics, Inc. is a biotechnology company focused on developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancer [1][3] - The CEO, Brent Pfeiffenberger, will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 9-10, 2025, in New York [1] - The company aims to provide off-the-shelf cell therapies to enhance patient access and improve treatment outcomes in autoimmune disease and cancer care [3] Group 2 - An on-demand webcast of the company presentation will be available starting at 7:00 a.m. ET on September 5, 2025, on Century's website [2] - The webcast will be archived for at least 30 days for investor access [2] Group 3 - Century Therapeutics utilizes expertise in cellular reprogramming, genetic engineering, and manufacturing to develop its cell therapy pipeline [3] - The company is in the clinical stage and is committed to advancing the field of cell therapies [3]
Century Therapeutics(IPSC) - 2025 Q2 - Quarterly Report
2025-08-14 20:21
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-40498 Century Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware ...
Century Therapeutics(IPSC) - 2025 Q2 - Quarterly Results
2025-08-14 20:17
Introduction & Executive Summary [CEO's Strategic Overview](index=1&type=section&id=CEO's%20Strategic%20Overview) The CEO outlined strategic priorities to focus capital on transformative cell therapy candidates and accelerate key programs - Strategic focus on potentially transformational cell therapy candidates and technologies[3](index=3&type=chunk) - Continued clinical execution of **CNTY-101** in autoimmune disease and acceleration of core preclinical programs[3](index=3&type=chunk) - IND-enabling studies are underway for **CNTY-308**, with rapid progress toward drug candidacy for the non-immune cell program[3](index=3&type=chunk) - **Brent Pfeiffenberger**, CEO, assumed the role of Board Chair, succeeding Joe Jimenez[3](index=3&type=chunk) [Key Highlights](index=1&type=section&id=Key%20Highlights) Q2 2025 highlights include ongoing CNTY-101 patient dosing, CNTY-308's advancement, a CEO leadership change, and an extended cash runway - Patient dosing is ongoing in the **CALiPSO-1 trial** for CNTY-101, with clinical data expected by **year-end 2025**[4](index=4&type=chunk) - **CNTY-308**, a CAR-iT cell therapy, is now in IND-enabling studies and is expected to progress into the clinic in **2026**[4](index=4&type=chunk) - CEO **Brent Pfeiffenberger** has been appointed to Board Chair[4](index=4&type=chunk) - Cash runway has been extended into the **fourth quarter of 2027**[4](index=4&type=chunk) Pipeline and Program Updates [CNTY-101 in Autoimmune Diseases](index=2&type=section&id=CNTY-101%20in%20Autoimmune%20Diseases) The CALiPSO-1 trial for CNTY-101 is actively enrolling patients, with initial data expected by year-end 2025 - **CALiPSO-1 trial** for CNTY-101 is progressing with continued patient enrollment and clinical trial site activations; **two patients dosed**[7](index=7&type=chunk) - Clinical data for CNTY-101 in B-cell-mediated autoimmune diseases is on track to be reported by the **end of 2025**[7](index=7&type=chunk) - **CARAMEL IIT study** activated in July, with initial patient enrollment and dosing expected in **Q3 2025**[7](index=7&type=chunk) - Preclinical data presented at EULAR 2025 Congress demonstrated CNTY-101's ability to exhibit **B cell depletion**[7](index=7&type=chunk) [CNTY-308 and Other Preclinical Programs](index=2&type=section&id=CNTY-308%20and%20Other%20Preclinical%20Program) CNTY-308 has initiated IND-enabling studies for B-cell-mediated diseases, with clinical studies planned for 2026 - **CNTY-308** initiated Investigational New Drug (IND)-enabling studies for B-cell-mediated diseases; clinical studies planned for **2026**[7](index=7&type=chunk) - Rapid progress towards drug candidacy has been made for Century's first non-immune cell therapy program engineered with **Allo-Evasion™ 5.0**[7](index=7&type=chunk) - EULAR 2025 Congress presentation supported CNTY-308's ability to deliver rapid ablation of primary B cells and **Allo-Evasion™ 5.0's** protection from allogeneic immune cells[8](index=8&type=chunk) Corporate Updates [Leadership Changes](index=3&type=section&id=Leadership%20Changes) CEO Brent Pfeiffenberger was elected Board Chair, succeeding Joe Jimenez, who transitioned to a special advisor role - **Brent Pfeiffenberger**, PharmD, Chief Executive Officer, was unanimously elected to serve as Board Chair[12](index=12&type=chunk) - **Joe Jimenez**, who served as Board Chair since 2021, transitioned to a new role as a special advisor[12](index=12&type=chunk) [Cash Runway and Strategic Focus](index=3&type=section&id=Cash%20runway%20extended) The company extended its cash runway into Q4 2027 through a workforce reduction and strategic pipeline prioritization - Cash runway extended into the **fourth quarter of 2027**[12](index=12&type=chunk) - Extension achieved through a workforce reduction in July 2025 and prioritization of pipeline development for **CNTY-101**, **CNTY-308**, and the non-immune cell program[12](index=12&type=chunk) Summary of Financial Results [Cash Position](index=3&type=section&id=Cash%20Position) The company's cash, cash equivalents, and marketable securities totaled $158.5 million as of June 30, 2025 Cash Position (in millions) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $158.5 | $220.1 | - The company estimates its cash, cash equivalents, and investments will support operations into the **fourth quarter of 2027**[11](index=11&type=chunk) [Operating Expenses](index=4&type=section&id=Operating%20Expenses) Operating expenses for Q2 2025 saw slight decreases in both R&D and G&A compared to the prior year period Operating Expenses (Three Months Ended June 30, in millions) | Expense Type | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $26.9 | $27.2 | $(0.3) | | G&A Expenses | $7.8 | $8.3 | $(0.5) | - Decrease in R&D expenses primarily due to a reduction of personnel and manufacturing costs, offset by an increase in research and laboratory costs[14](index=14&type=chunk) [Net Income (Loss)](index=4&type=section&id=Net%20Income%20(Loss)) The company reported a net loss of $32.5 million for Q2 2025, a slight increase from the $31.2 million loss in Q2 2024 Net Income (Loss) (Three Months Ended June 30, in millions) | Metric | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Loss | $(32.5) | $(31.2) | $(1.3) | About Century Therapeutics [Company Overview](index=4&type=section&id=Company%20Overview) Century Therapeutics is a clinical-stage biotechnology company developing iPSC-derived cell therapies for autoimmune diseases and cancer - Century Therapeutics is a clinical-stage biotechnology company developing **iPSC-derived cell therapies**[13](index=13&type=chunk) - The pipeline includes programs designed to address **autoimmune diseases and cancers**[13](index=13&type=chunk) - Commitment to developing **off-the-shelf cell therapies** to expand patient access and advance care[13](index=13&type=chunk) Forward-Looking Statements [Disclaimer and Risk Factors](index=5&type=section&id=Disclaimer%20and%20Risk%20Factors) This report contains forward-looking statements subject to significant risks and uncertainties that could cause actual results to differ - The press release contains forward-looking statements regarding clinical development plans and timelines[15](index=15&type=chunk) - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to differ materially[15](index=15&type=chunk) - The company does not plan to publicly update or revise any forward-looking statements unless required by applicable law[15](index=15&type=chunk) Financial Statements (Detailed) [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $284.7 million while total liabilities fell significantly to $74.8 million as of June 30, 2025 Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change (vs. Dec 31, 2024) | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $56,878 | $58,441 | $(1,563) | | Short-term investments | $98,965 | $130,851 | $(31,886) | | Total current assets | $160,169 | $194,051 | $(33,882) | | Long-term investments | $2,690 | $30,818 | $(28,128) | | Total assets | $284,692 | $353,216 | $(68,524) | | Deferred revenue, current | $- | $109,164 | $(109,164) | | Total current liabilities | $14,948 | $129,782 | $(114,834) | | Total liabilities | $74,794 | $191,854 | $(117,060) | | Total stockholders' equity | $209,898 | $161,362 | $48,536 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20consolidated%20statements%20of%20operations) The company reported a net income of $44.0 million for the first six months of 2025, driven by significant collaboration revenue Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $- | $771 | $109,164 | $1,625 | | Research and development | $26,859 | $27,220 | $53,439 | $50,641 | | General and administrative | $7,805 | $8,306 | $16,212 | $17,052 | | Total operating expenses | $34,664 | $35,526 | $69,651 | $67,693 | | Net income (loss) | $(32,541) | $(31,207) | $44,019 | $(59,269) | | Net income (loss) per common share Basic | $(0.38) | $(0.38) | $0.51 | $(0.82) |