Century Therapeutics (NASDAQ: IPSC) slashes 2025 net loss on $109M revenue
Rhea-AI Filing Summary
Century Therapeutics reported sharply improved 2025 results while remaining loss-making. Collaboration revenue rose to
Total operating expenses declined to
Positive
- Sharp improvement in profitability: 2025 net loss narrowed to
$9.6M from$126.6M , driven by$109.2M in collaboration revenue and lower operating expenses, significantly strengthening the income statement. - Solid liquidity for development: As of
December 31, 2025 , Century held$61.9M in cash and cash equivalents and$55.3M in short-term investments, providing resources to advance its iPSC-derived cell therapy pipeline.
Negative
- None.
Insights
Century shifts from heavy losses to near break-even on collaboration revenue.
Century Therapeutics generated collaboration revenue of
Cash and cash equivalents of
Management is prioritizing CNTY-813 for type 1 diabetes, aiming to file an IND by the fourth quarter of
UNITED STATES
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FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition |
On March 12, 2026, Century Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 7.01 | Regulation FD Disclosure |
On March 12, 2026, the Company updated information reflected in a slide presentation, which is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the updated presentation in various meetings with investors from time to time.
The information contained in this Item 7.01 (including Exhibit 99.2) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section and shall not be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Document | |
| 99.1 | Press Release of Century Therapeutics, Inc., dated March 12, 2026 | |
| 99.2 | Investor Presentation of Century Therapeutics, Inc., dated March 12, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CENTURY THERAPEUTICS, INC. | ||
| By: | /s/ Brent Pfeiffenberger, Pharm.D. | |
| Name: | Brent Pfeiffenberger, Pharm.D. | |
| Title: | President and Chief Executive Officer | |
Date: March 12, 2026
Exhibit 99.1
Century Therapeutics Reports Full Year 2025 Financial Results and Business Updates
| · | CNTY-813, lead beta islet cell therapy program as a potential functional cure for type 1 diabetes, in Investigational New Drug (IND)-enabling studies; IND submission expected in 4Q 2026 to support anticipated initial clinical data in 2H 2027 |
| · | CNTY-308, a CD19-targeted CAR-iT cell therapy engineered with Allo-Evasion™ 5.0, on track to enter the clinic in 2026 |
| · | Strengthened balance sheet and cash runway extended into 1Q 2029 from oversubscribed $135 million private placement in January 2026 |
PHILADELPHIA, March 12, 2026 -- Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases, including type 1 diabetes, and cancer, today reported financial results for the full year ended December 31, 2025, and recent business highlights.
“Century entered 2026 with strong momentum, fueled by the successful completion of our $135 million private placement and continued focus on advancing our prioritized programs closer to patients living with significant unmet medical need,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “We are moving fast and executing with precision on CNTY-813, our top priority and a program we believe has the potential to functionally cure type 1 diabetes. Recent achievements, including compelling preclinical results combined with constructive interactions with the FDA, strengthen our confidence in the clinical path ahead. We plan to submit an IND as early as the fourth quarter of this year and anticipate initial clinical data in the second half of 2027. We are energized by the progress across our pipeline, confident in the road ahead, and focused on advancing our most promising programs into the clinic.”
Fourth Quarter 2025 and Recent Highlights
Pipeline
| · | CNTY-813, priority program for type 1 diabetes, advancing through IND-enabling activities and tracking toward planned IND submission in 2026: Century continues to advance IND-enabling studies for its lead pipeline program, CNTY-813, a beta islet replacement therapy with Allo-Evasion™ 5.0 as a potential functional cure for type 1 diabetes. To date, Century has generated compelling preclinical data for CNTY-813, demonstrating high potency and long duration for functional glucose control and protection against immune rejection via Allo-Evasion™ 5.0 engineering to potentially minimize or eliminate the need for chronic immunosuppression. This data package, which includes the maintenance of normoglycemia in animal models for more than 6 months, completion of the manufacturing of a GMP Master Cell Bank for CNTY-813, along with recent engagement with the U.S. Food and Drug Administration (FDA), has reinforced the company’s belief in an efficient pathway to IND submission for CNTY-813. Century expects to submit an IND for the program in the fourth quarter of 2026 and anticipates initial clinical data in the second half of 2027. |
| · | CNTY-308 advancing in IND-enabling studies for projected clinical entry in 2026: Century continues to make progress in IND-enabling studies with CNTY-308, a CD19-targeted CD4+/CD8+ ab CAR-iT cell therapy with Allo-Evasion™ 5.0 as a potential treatment for B-cell-mediated diseases. In previously presented preclinical studies, CNTY-308 demonstrated functional comparability to primary CAR-T cells, including target-mediated proliferation, cytokine secretion, and long-term persistence. These data, coupled with the growing academic and industry experience with CAR-T treatment supporting its potential to deliver deep and durable responses in patients, reinforce Century’s belief in CNTY-308 to deliver autologous, CAR-T-like clinical benefits in an allogeneic, patient-centric format for enhanced treatment accessibility. Subject to completion of IND-enabling studies and regulatory clearance, Century expects CNTY-308 to enter the clinic in 2026. |
| · | Additional insights from ongoing CARAMEL IST expected in 2026: The company anticipates updated preliminary clinical data this year from the ongoing CARAMEL study, a Phase 1/2 investigator-sponsored trial (IST) led by Professors Georg Schett and Andreas Mackensen and sponsored by the Friedrich-Alexander University Erlangen-Nürnberg. Previously disclosed clinical data from the trial have demonstrated that CNTY-101 was generally well tolerated and exhibits a predictable biologic profile with early signs of clinical response in autoimmune diseases. |
Corporate
| · | Completed oversubscribed $135 million private placement financing: In January 2026, Century entered into a securities purchase agreement led by new investor TCGX with participation from additional new and existing investors, including RA Capital Management, Commodore Capital, Deep Track Capital, RTW Investments, Venrock Healthcare Capital Partners, and the T1D Fund. The gross proceeds were approximately $135 million before placement agent fees and offering expenses. |
| · | Appointed two new members to the Board of Directors: In December 2025, Han Lee, Ph.D., M.B.A., and Martin Murphy, Ph.D., were appointed to Century’s Board of Directors. As part of their appointments, Dr. Lee serves as a member of the Audit and the Compensation Committees and Dr. Murphy serves as Chair of the Compensation and a member of the Nominating and Corporate Governance Committees. |
Full Year 2025 Financial Results
| · | Cash Position: Cash, cash equivalents, and marketable securities were $117.1 million as of December 31, 2025, as compared to $220.1 million as of December 31, 2024. Net cash used in operations was $103.9 million for the year ended December 31, 2025, compared to net cash used in operations of $110.1 million for the year ended December 31, 2024. The company estimates its cash, cash equivalents, and investments as of December 31, 2025, together with the net proceeds raised after year end, will support operations into the first quarter of 2029. |
| · | Collaboration Revenue: Collaboration revenue generated through the company’s collaboration, option, and license agreement with Bristol-Myers Squibb was $109.2 million for the year ended December 31, 2025, compared to $6.6 million for the same period in 2024. |
| · | Research and Development (R&D) Expenses: R&D expenses were $95.7 million for the year ended December 31, 2025, compared to $107.2 million for the same period in 2024. The decrease in R&D expenses was primarily due to a reduction of personnel and manufacturing costs, offset by an increase in research and laboratory costs to progress clinical trials and preclinical programs. |
| · | General and Administrative (G&A) Expenses: G&A expenses were $24.0 million for the year ended December 31, 2025, compared to $33.2 million for the same period in 2024. The decrease was primarily the result of a decrease in legal fees associated with the Clade acquisition in 2024, a gain on lease modification, a gain on reduction of contingent consideration liability, and a decrease in stock-based compensation. |
| · | Net Loss: Net loss was $9.6 million for the year ended December 31, 2025, compared to net loss of $126.6 million for the same period in 2024. |
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases, including type 1 diabetes, and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion™. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care. For more information on Century Therapeutics, please visit www.centurytx.com and connect with us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements our timing and expectations regarding our preclinical and clinical development programs, including their planned development, therapeutic potential and market opportunity, ongoing and planned regulatory interactions, the achievement of developmental milestones, corporate strategies, and our financial resources and expected cash runway are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; our ability to obtain clearance of our future IND or CTA submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, trade disputes and tariffs, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
For More Information:
Century Therapeutics
Douglas Carr
Senior Vice President, Finance
investor.relations@centurytx.com
JPA Health
Sarah McCabe
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Century Therapeutics, Inc
Condensed Balance Sheets
(unaudited, in thousands)
| December 31, | December 31, | |||||||
| Assets | 2025 | 2024 | ||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 61,853 | $ | 58,441 | ||||
| Short-term investments | 55,261 | 130,851 | ||||||
| Prepaid expenses and other current assets | 3,655 | 4,759 | ||||||
| Total current assets | 120,769 | 194,051 | ||||||
| Property and equipment, net | 50,026 | 62,141 | ||||||
| Operating lease right-of-use assets, net | 16,139 | 28,706 | ||||||
| Long-term investments | - | 30,818 | ||||||
| Intangible assets | 34,200 | 34,200 | ||||||
| Other long-term assets | 2,570 | 3,300 | ||||||
| Total assets | $ | 223,704 | $ | 353,216 | ||||
| Liabilities, convertible preferred stock, and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,773 | $ | 3,075 | ||||
| Accrued expenses and other liabilities | 11,696 | 17,543 | ||||||
| Contingent consideration liability, short term | 3,757 | - | ||||||
| Deferred revenue, current | - | 109,164 | ||||||
| Total current liabilities | 20,226 | 129,782 | ||||||
| Operating lease liability, noncurrent | 40,241 | 48,960 | ||||||
| Contingent consideration liability, long term | - | 8,738 | ||||||
| Deferred tax liability | 4,301 | 4,374 | ||||||
| Total liabilities | 64,768 | 191,854 | ||||||
| Stockholders' equity | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 9 | 9 | ||||||
| Additional paid-in capital | 950,814 | 943,366 | ||||||
| Accumulated deficit | (791,917 | ) | (782,337 | ) | ||||
| Accumulated other comprehensive loss | 30 | 324 | ||||||
| Total stockholders' equity | 158,936 | 161,362 | ||||||
| Total liabilities and stockholders' equity | $ | 223,704 | $ | 353,216 | ||||
Century Therapeutics, Inc
Condensed consolidated statements of operations
(unaudited, in thousands, except share and per share amounts)
| Year Ended | Year Ended | |||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Collaboration Revenue | $ | 109,164 | $ | 6,589 | ||||
| Operating Expenses | ||||||||
| Research and development | 95,667 | 107,244 | ||||||
| General and administrative | 24,003 | 33,155 | ||||||
| Impairment of long-lived assets | 6,763 | - | ||||||
| Impairment of goodwill | - | 4,327 | ||||||
| Total operating expenses | 126,433 | 144,726 | ||||||
| Income (loss) from operations | (17,269 | ) | (138,137 | ) | ||||
| Interest income | 7,346 | 13,007 | ||||||
| Other income, net | 275 | 354 | ||||||
| Loss before (benefit) provision for income taxes | (9,648 | ) | (124,776 | ) | ||||
| (Benefit) provision for income taxes | (68 | ) | 1,790 | |||||
| Net Loss | $ | (9,580 | ) | $ | (126,566 | ) | ||
| Unrealized gain (loss) on investments | (294 | ) | 153 | |||||
| Foreign currency translation adjustment gain (loss) | - | 63 | ||||||
| Comprehensive loss | $ | (9,874 | ) | $ | (126,350 | ) | ||
| Net loss per common share Basic and Diluted | (0.14 | ) | (1.61 | ) | ||||
| Weighted average common shares outstanding Basic and Diluted | 86,556,515 | 78,648,958 | ||||||
Exhibit 99.2
| Unlocking the Value of our Pipeline for T1D March 2026 |
| 2 Forward-looking statements This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this presentation, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding the initial safety and efficacy profiles of our product candidates, statements regarding our preclinical development programs, including initial preclinical data and development plans and timelines, and statements regarding cash runway are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this presentation are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this presentation and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our ability to progress our product candidates through clinical development; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; our ability to obtain clearance of our future IND or CTA submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, trade disputes and tariffs, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. |
| Cell Foundry and Allo-Evasion Technology High Impact Programs Focused on Execution Century Therapeutics Today © 2026 3 Cell foundry generates fully functional cells at scale • Key developmental insights allow directed differentiation of cells that function like primary cells, such as beta Islet cells and CD4+/CD8+ αβ T cells Leaders in immune evasion engineering • Allo-Evasion allows cells to co-exist with a patient’s immune system • Enables enhanced persistence and potential for re-dosing of therapy Advancing lead iPSC derived cell therapies with Allo-Evasion 5.0 toward the clinic • CNTY-813 in IND-enabling studies with potential for functional cure in Type 1 Diabetes • CNTY-308 in IND-enabling studies for treatment of B-cell-mediated diseases • Patient enrollment ongoing for CNTY-101 in Phase 1/2 CARAMEL IST in autoimmune disease Cash runway extended beyond planned key clinical milestones • CNTY-813 IND submission planned for fourth quarter of 2026 with initial clinical data expected in the second half of 2027 • CNTY-308 αβ T cell program expected to enter the clinic in 2026 • CNTY-101 preliminary clinical data from Phase 1/2 CARAMEL IST expected in 2026 |
| 4 Century pipeline focus on Type 1 Diabetes and other autoimmune disease Allo-Evasion engineered in all programs infusions in outpatient setting 1. Agreement in place for an investigator sponsored trial (IST) by Professors Georg Schett and Andreas Mackensen at Friedrich-Alexander University Erlangen-Nürnberg. Product Targets Indications Research IND-enabling Clinical Phase 1 Phase 2 Phase 3 Priority Program CNTY-813 Beta Islet cells (Allo-Evasion 5.0) Beta Islet Transplantation Type 1 Diabetes Additional Programs CNTY-308 αβ iT (Allo-Evasion 5.0) CD19 B-cell-mediated autoimmune diseases CNTY-101 iNK (Allo-Evasion 1.0) CD19 B-cell-mediated autoimmune diseases Multiple iT (Allo-Evasion 5.0) Multiple B-cell mediated autoimmune diseases, solid tumors, others CARAMEL IST1 1. Agreement in place for an investigator sponsored trial (IST) by Professors Georg Schett and Andreas Mackensen at Friedrich-Alexander University Erlangen-Nürnberg. |
| 5 Century Executive Team Experienced leadership with a track record of driving innovation and success in cell therapy Chad Cowan, PhD Chief Scientific Officer Brent Pfeiffenberger, PharmD, MBA Chairman and Chief Executive Officer Greg Russotti, PhD Chief Technology and Manufacturing Officer Megan Bilson Chief People Officer Douglas Carr, CPA Head of Finance Principal Financial Officer Elizabeth Devlin Head of Development |
| Allo-Evasion |
| 7 Continued evolution to enhance holistic protection from major immunity pathways Century is a leader in immune evasion engineering Allo-Evasion 1.0 Deletion of HLA-I Deletion of HLA-II Insertion of HLA-E Protection from: Native T-cells Native NK-cells Humoral immunity CNTY-101 Deletion of HLA-I Deletion of HLA-II Insertion of CD300a TASR pan-NK inhibitory ligand1, 2 Insertion of cell-surface enzyme to degrade IgG antibodies3 b2M KO (HLA-I) CIITA KO (HLA-II) CD8+ T Cell CD4+ T Cell Pan NK Inhibitory ligand Fc NK cell Allo-Evasion 5.0 CNTY-308 CNTY-813 Solid tumors CNTY-341 1. https://www.centurytx.com/wp-content/uploads/ASH_Welstead_Universal-Protection-of-Allogenic-T-Cells-Final.pdf 2. https://ashpublications.org/bloodadvances/article/doi/10.1182/bloodadvances.2024013436/518079/Universal-Protection-of-Allogeneic-T-Cell 3. Peraro et al, Mol. Therapy 2021, 29(12), 3398-3409; https://pmc.ncbi.nlm.nih.gov/articles/PMC8636170 |
| 8 Allo-EvasionTM 5.0: The CD300a TASR ligand has been shown to provide broad protection from host NK cells Male Female <50 >50 Gender Age Ethni-city CMV Caucasian Other African American Hispanic Negative Positive N = 45 PBMC Donors 0.01 0.1 1 0 0 .0 1 0 .1 1 0 25 50 75 100 0 E:T Ratio T Cell Survival (%) 0 0.01 0.1 1 No Cloak CD300a TASR CD47 HLA-I+ 20 hours Target (T) T Cell NK Effector (E) CD300a was expressed broadly CD300a detects disordered membrane lipids TASR mimics signaling of dead or dying cells Drug Product (live) Inhibit NK Cell TASR CD300a Dead/dying cell NK Cell Inhibit CD300a TASR shown to provide protection from NK cells in vitro NK Donor 2 (2Cdom NK Donor 1 (2A ) dom) NK Donor 3 (2Adom) TASR KI B2M KO CD300a NKG2A KIR 0 20 40 60 80 100 Inhibitory Receptor Expression on NK Cells (n = 46 donors) % of NK Cells https://ashpublications.org/bloodadvances/article/doi/10.1182/bloodadvances.2024013436/518079/Universal-Protection-of-Allogeneic-T-Cell; https://www.centurytx.com/wp-content/uploads/ASH_Welstead_Universal-Protection-of-Allogenic-T-Cells-Final.pdf |
| 9 Immunoglobulin degrading protease As a result, Century’s T cells have been shown to be protected from rejection in preclinical CDC, ADCC and ADCP assays Century T cells have been shown to stably express IDP, an enzyme that cleaves off IgGs below the hinge, releasing the Fc fragment Allo-EvasionTM 5.0: Century’s IgG degrading enzyme (IDP) protected cells from multiple pathways of humoral immunity Complement Dependent Cytotoxicity Antibody-Dependent Cellular Cytotoxicity Antibody-Dependent Cellular Phagocytosis Measure of Phagocytosis (Area under the curve) Cells expressing IDP showed less phagocytosis in the presence of an antibody trigger Cells WT Century WT Condition +Ab +Ab - Cells expressing IDP showed greater survival GFP IdeStm 0 20 40 60 80 100 % Specific Lysis ✱✱✱✱ WT Century Cells expressing IDP showed less lysis WT Gen 2.3 0 25 50 75 100 % Survival ✱ WT Century Source: Company data on file |
| Type 1 Diabetes Program |
| 11 Century is uniquely positioned to deliver a successful T1D cell replacement therapy • T1D is a significant global market (9M pts WW) with high unmet medical need1 • Beta islet cell replacement for T1D has clear, validated clinical Proof-of-Concept (POC) over 20+ years2 • Transformational outcomes for patients BUT adoption is very limited due to 1) Cell source and 2) Chronic immunosuppression • Recent clinical data with stem cells demonstrate similar outcomes and potential solution to cell source/scale3 1. Diabetes Res Clin Pract.2025 Jul: 225:112277.doi: 10.1016/j.diabres.2025.112277.Epub 2025 May 22 2. Approximately 1500 patients reported in https://www.citregistry.org/system/files/CITR%2012th%20Allograft%20Report_2025_Final.pdf 3. https://www.nejm.org/doi/10.1056/NEJMoa2506549?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed CNTY-813 is an iPSC derived beta islet cell replacement therapy engineered with Allo-EvasionTM 5.0 CNTY-813 has comprehensive pre-clinical data demonstrating unique potential for functional cure • Highly potent/pure iPSC derived beta islet cells functional glucose control • Allo-EvasionTM 5.0 engineering reduce/eliminate need for chronic immunosuppression • Highly scalable manufacturing (bioreactors) ensure broad patient access and supply Unique Company know-how and experience with iPSC development and supply (research, clinical, regulatory, manufacturing) CNTY-813 Scalable Generation of Beta Islets with Allo-Evasion 5.0 |
| 12 Significant unmet need in Type 1 Diabetes (T1D) Despite insulin therapy, people living with T1D face a high risk of life-limiting complications ~9 million people worldwide living with T1D1 Lifetime economic burden of T1D (US) estimated at~$813 billion2 T1D is associated with serious comorbidities and complications3 1. Diabetes Res Clin Pract. 2025 Jul: 225:112277.doi: 10.1016/j.diabres.2025.112277. Epub 2025 May 22 2. https://www.liebertpub.com/doi/10.1089/dia.2019.0398 3. van den Boom L, Buchal G, Kaiser M, Kostev K. Multimorbidity among adult outpatients with type 1 diabetes in Germany. J Diabetes Sci Technol. 2022;16(1):152-160. doi:https://doi.org/10.1177/1932296820965261 |
| 13 Beta Islet cell transplantation provides a potentially curative therapy in T1D Cell supply and chronic immunosuppression are major limitations In T1D, beta cells are destroyed Healthy islet beta cells produce insulin (green) In T1D, beta cells are destroyed Insulin independence achieved for one year in ~70% of patients receiving allogeneic cadaveric Islet transplantation1 Islet transplantation provides a potentially curative therapy for T1D Insulin Independence following pancreatic islet transplantation 1. Approximately 1500 patients reported in https://www.citregistry.org/system/files/CITR%2012th%20Allograft%20Report_2025_Final.pdf Source: Marfil-Garza et al. 2022; Pancreatic islet transplantation in type 1 diabetes: 20-year experience from a single-centre cohort in Canada Supply and logistics limits scalability of cadaveric islet therapy |
| 14 Stem-cell (SC) derived islets have demonstrated the ability to restore physiologic islet function Demonstrates function and scale, but still requires chronic immunosuppression Zimislecel (VX-880) is a SC-derived insulin producing islet cell therapy3 10/12 patients receiving SC-derived islets were exogenous insulin free at 12 months after a single dose1 1. https://www.nejm.org/doi/10.1056/NEJMoa2506549?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed 2. ADA IR Presentation_v FINAL – Vertex Corporate website 3. Based on publicly available information VX-880 provides POC for iPSC-derived islet therapies but need for immunosuppression remains a challenge Total Daily Insulin Dose (units/day) Zimislecel is delivered by infusion into the hepatic portal vein Steroid free immunosuppression is used to protect the islet grafts 1 2 |
| 15 CNTY-813: Century’s Beta Islets with Allo-Evasion 5.0 Uniquely positioned to potentially deliver a successful T1D cell replacement therapy • Glucose control in patients is important for resolving disease and reducing consequences of uncontrolled glucose • A scalable drug product enables broader patient access, reduced COGs, and product consistency • Immune suppression has significant long-term side effects for patients; a therapy with reduced or free of immune suppression is desired Glucose Control Scalable Drug Product Free of Immune Suppression Cadaveric Islets (+/- device) YES NO NO Stem-cell Beta Islets YES YES NO Allo-Engineered Cadaveric Islets - NO YES CNTY-813 iPSC Beta Islets* YES YES YES J Clin Invest. 2004 Oct 1;114(7):877–883 N Engl J Med 2025;393:887-894 N Engl J Med 2025;393:858-868 *Based on pre-clinical data |
| 16 A fully scalable, bioreactor-enabled differentiation process yields mature, functional beta Islets from engineered iPSCs Clinical candidate selected with Century’s Allo-Evasion 5.0 to protect cells from immune rejection In vitro and in vivo data support potential to provide functional cure without systemic immunosuppression CNTY-813 Scalable Generation of Beta Islets with Allo-Evasion 5.0 |
| 17 iPSC Definitive Endoderm Primitive Gut Tube Pancreatic Progenitor I Pancreatic Progenitor II Endocrine β Cell Generation of Beta Islets with a 29 day, Defined, Multi-stage Process Adapted to a Scalable Bioreactor Suspension System iPSC DE PGT PP1 PP2 EN β Stage 1 Stage 2 Stage 3 Stage 4 Stage 5 Stage 6 Beta: >1M cells/mL >90% CHGA, >30% INS+NKX6.1 >2 GSIS Index PP: >90% PDX1+ >40% PDX1+NKX6.1+ DE: >90% FOXA2+SOX17+ Source: Company data on file |
| 18 Century beta-islet differentiation process is reproducible across batches High Purity Throughout the Differentiation Stage 1: Definitive Endoderm Stage 4: Pancreatic Endoderm Stage 6: Islet Endocrine Stage 6: Beta Cell Success Criteria: set by literature review of necessary purity to ensure a safe, potent drug product Mean (n) 97.3 (20) 98.2 (24) 95.9 (32) 60.2 (32) Illustrated are all control process runs from R26 unedited and Allo 5.0 performed in a bioreactor since establishment of the baseline process (V1.2), with no data exclusions. Ns may differ due to experimental or analytical reasons, not targeted exclusions. Data points represent independent differentiation batches conducted in their own bioreactor. Success criteria is set by a literature review of expected purities necessary for a safe and potent product Source: Company data on file |
| 19 CNTY-813 Beta Islets are highly potent Potency Total Insulin Content Glucose-Stimulated Insulin Secretion Stimulation Index iPSC-Beta Islets Primary Islets 0 10000 20000 30000 40000 uIU Insulin/ 1E6 Cells 2mM Glucose 20mM Glucose iPSC-Beta Islets Primary Islets 0 5 10 15 Glucose Stimualtion Index (20mM glucose/ 2mM glucose) Source: Company data on file Mean +/- SD is shown in graphs |
| 20 CNTY-813 comprises terminally differentiated endocrine cells Cell Cycle Analysis of Stage 6 CNTY-813 cells Cell Cycle Progression Analysis by Differentiation Stage Diff. Stage: iPSC 1 2 3 4 5 6 Post-mitotic β-islets with no cell proliferation MKI67 gene expression Cell cycle stage Source: Company data on file |
| 21 CNTY-813 Beta Islets rapidly restored normoglycemia in STZ-rendered T1D mice Century Beta Islets Persisted and Controlled Glucose for >6 Months Non-Fasted Blood Glucose Century iPSC Beta Islets (unedited) Century iPSC Beta Islets with Allo-Evasion 5.0 -20 0 20 40 60 80 100120140160180200220 0 100 200 300 400 500 600 Days Post Treatment Blood Glucose (mg/dL) No Treatment Allo 5.0 Beta Islets (SRC) (5M or 3.2K IEQ) Control STZ = Streptozotocin | SRC = Sub renal capsule implantation | Source: Company data on file Mean +/- SD is shown in graphs -20 0 20 40 60 80 100 120 140 160 180 200 220 0 100 200 300 400 500 600 Days Post Treatment Blood Glucose (mg/dL) No Treatment iPSC Beta Islets (SRC) (5M or 3.2K IEQ) Control |
| 22 CNTY-813 observed to restore normoglycemia upon a Glucose Tolerance Test (GTT) Upon a GTT, normoglycemia is rescued within 60 minutes in both Unedited and Allo 5.0 Beta islet txp mice 12-week 0 10,000 20,000 30,000 40,000 AUC Diabetic Control: n=5 Unedited CNTY Beta Islets: n=3 Allo 5.0 CNTY Beta islets: n=4 CNTY-813 Shapiro et al. 2025 0 20 40 60 80 100 120 0 200 400 600 Time (min) Blood Glucose (mg/dL) Diabetic Control Unedited CNTY Beta Islets Allo 5.0 Beta Islets Millman et al. 2025 Source: Company data on file Mean +/- SD is shown in graphs |
| 23 CNTY-813 grafts observed to be comprised of endocrine cells with no evidence of outgrowths Blood Sugar Regulation Cell Division Glucagon Insulin Ki67 • 5M islets injected into murine kidney capsule – STZ treatment abrogated mouse insulin production – Mouse was normoglycemic within 30 days post-infusion • Treated kidney harvested at post-infusion day 90 • CNTY-308 grafts were: – Positive for pancreatic hormones – Negative for cell cycle Islet graft Source: Company data on file |
| 24 Allo-Evasion 5.0 protects CNTY-813 Beta Islets Protection of Beta Islets • NK protection • ADCC protection Allo-Evasion 5.0 on Beta Islets • Elimination of HLA-I and II expression • Confirmed expression of Transgenes Count Normalized to Mode HLA Class I HLA Class II IdeS CD300a-TASR T Cell Evasion Humoral Evasion NK Cell Evasion NK Tox Assay WT Allo 5.0 ADCC = Antibody dependent Cellular Cytotoxicity | WT = unedited (parental line) | DKO = B2M and CIITA KO | Allo 5.0 = fully engineered Allo-Evasion 5.0 | Source:Company data on file IgG Cleavage By IdeS Donor 1 Donor 2 0 25 50 75 100 125 NK Cell Donor Percent Survival (%) DKO Allo 5.0 |
| 25 Scalable manufacturing of cryopreserved Beta Islets Suspension-Based iPSC Differentiation to Cryopreserved Beta Islets Permit Scalable Clinical Manufacturing Scalable iPSC Differentiation Platform Cryopreserved Century Beta Islets Single Dose Clinical Administration 3-80L+ PBS (or Stirred Tank) Bioreactor Cryopreserved & QC’d Lots Potentially Curative T1D Treatment Average Diameter 299.1 ± 63.5 μm Beta Islet Aggregates 4X 300um 100 125 150 (mg/dL) Fasting blood glucose 100 125 150 (mg/dL) *Dithizone is a zinc-specific dye that stains zinc ions present in the beta cells; Company data on file hyperglycemia normogylcemia |
| Autoimmune Disease Programs |
| 27 Addressing significant unmet need in autoimmunity with allogeneic CAR iT and CAR iNK cells • Limited but encouraging POC data2 with CAR-NK therapy support continued development in autoimmune disease • CARAMEL IST with CNTY-101 currently enrolling patients across four indications • Autologous CAR T cell therapies are showing compelling safety and efficacy across a broad range of autoimmune diseases1 • Emerging positive CAR-T data supports advancing the development of more accessible CAR iT cells • CNTY-308 expected to enter clinic in 2026 Clinical data from B-cell-targeted cell therapies in autoimmune disease support the MoA and development of CAR iT and CAR iNK therapies CNTY-308 (CAR iT) CNTY-101 (CAR iNK) 1. Muller 2024 doi/full/10.1056/NEJMoa2308917; Nordmann-Gomes 2025 doi.org/10.1016/j.semarthrit.2025.152786 2. Gao 2025 EULAR Abstract DOI: 10.1016/j.ard.2025.05.396; Wang 2025 doi.org/10.1016/j.cell.2025.05.038 |
| CNTY-308 CD4+/CD8+ αβ iT-cell with Allo-Evasion 5.0 |
| 29 CNTY-308 is an iPSC-derived CD19-targeted CAR-iT intended for B-cell-mediated disease CNTY-308 CD4+/CD8+ αβ iT-cell • CD19-targeted CAR to target B-cells for cytotoxic depletion – 4-1BB and CD3z co-stim domain to stimulate expansion on target engagement • Allo-Evasion 5.0 edits designed to include protection from host T cell, NK cell, and humoral response • Native ab TCR knock-out to eliminate the risk of GvHD • Displays characteristics of autologous CAR-T cells1 – Highly proliferative upon target engagement – Secretes cytokines (e.g., IL-2, IFNg, and TNFa) – Cytotoxic effector function rapidly eliminates tumor cells – Long-term persistence in vivo – Eliminates CD19+ B-cells from healthy donors in vitro2 1. www.centurytx.com/wp-content/uploads/ASH_Heinze_iPSC-Derived-CD4-CD8-Final.pdf 2. Company data on file 3. IDP = IgG degrading enzyme |
| 30 Function 1’ CAR-T CNTY-308 IL-2 secretion (pg/mL) ~3,000 ~2,000 Requires exogenous IL-2/IL-15 No No Repeat killing (rounds) >10 >10 Persistence in blood (days) 32 32 Tumor control after rechallenge (in vivo) Yes Yes CNTY–308 and 1’ CAR-T • Self-supports with own target-mediated IL-2 • High functional persistence: kills for >10 rounds, persists in blood for 32+ days, controls tumor after in vivo rechallenge In preclinical studies, Century’s iPSC-derived CAR- αβT cells are comparable to primary CAR-T cells Source: Company data on file |
| 31 In preclinical animal studies, Century iPSC-CAR-T cells controlled tumors, persisted for ≥1 month, and retained cytotoxic capacity upon rechallenge • Disseminated Nalm6 model (1e5 cells infused) • Effectors added 3 days post-tumor infusion • 1’ CAR-T dose: 5e6 cells • iPSC-CAR-T dose: 30e6 cells • No added cytokine or small molecule support Complete tumor control Measurable long-term persistence ≥1 mo Cytotoxicity maintained upon re-challenge with engrafted cells Tumor challenge Tumor challenge Tumor challenge Tumor challenge Tumor challenge • iPSC-CAR-T persist 21 days post-infusion, • iPSC-CAR-T detectable at day 35, 7 days post-tumor rechallenge (at day 28) Group joined by lines d7 d21 d35 Key d27 tumor rechallenge Source: Company data on file In vivo experimental details |
| CNTY-101 CAR-iNK cell therapy with Allo-Evasion |
| 33 CNTY-101 clinical program progressing in CARAMEL Phase 1/2 IST Key Inclusion Criteria: • Participants with moderate to severe SLE, LN, IIM, or dcSSc with treatment-resistant and active disease, after 2+ standard immunosuppressive therapies Key Endpoints: • Safety and tolerability, disease activity measures per clinical and laboratory assessments • Translational endpoints: PK, B-cell depletion, autoantibody decline CARAMEL IST Patient enrollment 30-day DLT Period Schedule: • Evaluating dose levels established in BCM trial (ELiPSE-1) • Single cycle: Initial Dose 1e9 cell, given on Day 0, 7 and 14 – Ability to escalate dose to 3e9 cells, adjust LDC • Efficacy measured at weeks 12, 24, 38 and 52 Status: • Currently enrolling patients CNTY-101 infusion IL-2 LDC D0 D4 D7 D11 D14 D18 IST – Investigator-Sponsored Trial; SLE – Systemic Lupus Erythematosus; LN – Lupus Nephritis; IIM – Idiopathic inflammatory Myopathy; dcSSc – Diffuse Cutaneous Systemic Sclerosis DLT – Dose Limiting Toxicity; LDC – lymphodepleting chemotherapy CARAMEL: single cohort with CNTY-101 (blue circles) supplemented with IL-2 1.5e6 IU daily for 5 days after each dose of CNTY-101 (green bars) |
| 34 Preliminary Data from the Erlangen CARAMEL Basket Trial Preliminary Data Summary 0 20 40 60 0.0 0.5 1.0 1.5 0 20 40 60 0.00 0.05 0.10 0.15 CD19 Pre-CNTY-101 Day 19 Summary N=4 pts dosed Peripheral Blood Lymph Node • 4 patients dosed with CNTY-101 and IL-2 (SLE, IIM, SSc; failed median 7 treatments) • Safety: Generally well-tolerated, one Grade 1 CRS, no ICANS Pt #1 (SSc) data • Early efficacy: Improved mRSS, patient & physician global assessments at 1-3 months • Deep B cell depletion in blood and lymph nodes with day 56 naïve B cell reconstitution Plasmablasts CD19+ B Cells CD20 Days after CNTY-101 % of Lymphocytes % of Lymphocytes Preliminary data from patient with systemic sclerosis, M. Hagen, G. Schett, R. Grieshaber Bouyer, A. Mackensen, F. Muller, Universitatsklinikum. Friedrich-Alexander Universitate Erlangen-Nurnberg Pt #1 (SSc) B-Cell Depletion in Blood & Tissue |
| Corporate Summary |
| 36 Established in-house manufacturing from development to launch Quality product at disruptive scale and cost of goods • Built-for-purpose 53,000 ft2 cGMP facility • Produced and released clinical product for US and EU • Key leaders each with 1–2 decades of cell therapy manufacturing expertise, from leading commercial cell therapies • In-house team facilitates aligned priorities, learnings, faster product iteration for efficiency, speed, and product quality • Builds and protects proprietary know-how • Optionality with redundant sites (in-house, active CDMO) • Consistency: Control of manufacturing and single-donor master-cell-bank over product lifetime for batch-to-batch reproducibility • Increased cell fitness: Differentiated immune cells do not undergo excessive expansion cycles which often result in cell exhaustion • Product homogeneity: Clonal origin enables a well-characterized product • Potential to manufacture at antibody-like scale: Scalable platforms and optimized processes to maximize yield, reduce COGs, and meet demand Century platform and in-house manufacturing: Pathway to scalable, profitable cell therapy |
| Cell Foundry and Allo-Evasion Technology High Impact Programs Focused on Execution Century Therapeutics Today © 2026 37 Cell foundry generates fully functional cells at scale • Key developmental insights allow directed differentiation of cells that function like primary cells, such as beta Islet cells and CD4+/CD8+ αβ T cells Leaders in immune evasion engineering • Allo-Evasion allows cells to co-exist with a patient’s immune system • Enables enhanced persistence and potential for re-dosing of therapy Advancing lead iPSC derived cell therapies with Allo-Evasion 5.0 toward the clinic • CNTY-813 in IND-enabling studies with potential for functional cure in Type 1 Diabetes • CNTY-308 in IND-enabling studies for treatment of B-cell-mediated diseases • Patient enrollment ongoing for CNTY-101 in Phase 1/2 CARAMEL IST in autoimmune disease Cash runway extended beyond planned key clinical milestones • CNTY-813 IND submission planned for fourth quarter of 2026 with initial clinical data expected in the second half of 2027 • CNTY-308 αβ T cell program expected to enter the clinic in 2026 • CNTY-101 preliminary clinical data from Phase 1/2 CARAMEL IST expected in 2026 |
| www.centurytx.com |
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