Century Therapeutics(IPSC) - 2025 Q2 - Quarterly Results

Introduction & Executive Summary CEO's Strategic Overview 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] - Continued clinical execution of CNTY-101 in autoimmune disease and acceleration of core preclinical programs[3] - IND-enabling studies are underway for CNTY-308, with rapid progress toward drug candidacy for the non-immune cell program[3] - Brent Pfeiffenberger, CEO, assumed the role of Board Chair, succeeding Joe Jimenez[3] Key Highlights 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] - CNTY-308, a CAR-iT cell therapy, is now in IND-enabling studies and is expected to progress into the clinic in 2026[4] - CEO Brent Pfeiffenberger has been appointed to Board Chair[4] - Cash runway has been extended into the fourth quarter of 2027[4] Pipeline and Program Updates CNTY-101 in Autoimmune Diseases 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] - Clinical data for CNTY-101 in B-cell-mediated autoimmune diseases is on track to be reported by the end of 2025[7] - CARAMEL IIT study activated in July, with initial patient enrollment and dosing expected in Q3 2025[7] - Preclinical data presented at EULAR 2025 Congress demonstrated CNTY-101's ability to exhibit B cell depletion[7] CNTY-308 and Other Preclinical Programs 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] - Rapid progress towards drug candidacy has been made for Century's first non-immune cell therapy program engineered with Allo-Evasion™ 5.0[7] - 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] Corporate Updates Leadership Changes 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] - Joe Jimenez, who served as Board Chair since 2021, transitioned to a new role as a special advisor[12] Cash Runway and Strategic Focus 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] - 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] Summary of Financial Results Cash Position 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] Operating Expenses 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] Net Income (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 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] - The pipeline includes programs designed to address autoimmune diseases and cancers[13] - Commitment to developing off-the-shelf cell therapies to expand patient access and advance care[13] Forward-Looking Statements Disclaimer and Risk Factors 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] - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to differ materially[15] - The company does not plan to publicly update or revise any forward-looking statements unless required by applicable law[15] Financial Statements (Detailed) Condensed Balance Sheets 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 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) |