Century Therapeutics(IPSC) - 2024 Q2 - Quarterly Results

Second Quarter 2024 Highlights Century Therapeutics reported significant progress in Q2 2024, highlighted by the strategic expansion into autoimmune diseases with the initiation of the CALiPSO-1 trial. The company also presented encouraging interim data from its ELiPSE-1 trial in B-cell lymphomas and maintained a strong financial position with a cash runway expected into 2026 - Initiated the Phase 1 CALiPSO-1 trial of CNTY-101 in Systemic Lupus Erythematosus (SLE), marking a strategic expansion into autoimmune diseases. The protocol was also amended to include a cohort of Lupus Nephritis patients[1] - Presented encouraging preliminary efficacy and tolerability data from the Phase 1 ELiPSE-1 trial in relapsed/refractory (R/R) CD19-positive B-cell lymphomas at ASCO[1] - Completed dose escalation for the ELiPSE-1 trial and is advancing into the dose expansion phase in the second half of 2024[1] | Metric | Value | | :--- | :--- | | Cash, cash equivalents, and investments | $269.6 million (as of June 30, 2024) | | Expected Cash Runway | Into 2026 | Research & Development Highlights The company advanced its clinical programs by initiating the Phase 1 CALiPSO-1 trial for SLE and LN, with initial data anticipated by year-end 2024. It also presented positive interim data for the ELiPSE-1 trial in B-cell lymphomas, demonstrating a manageable tolerability profile, and has now completed dose escalation for that trial - Initiated the Phase 1 CALiPSO-1 trial for CNTY-101 in Systemic Lupus Erythematosus (SLE) and amended the protocol to add a cohort for Lupus Nephritis (LN) patients. Initial clinical data is expected by year-end 2024[3] - Presented encouraging interim data from the Phase 1 ELiPSE-1 trial at the ASCO Annual Meeting, showing a manageable tolerability profile with no observed dose-limiting toxicities (DLT) or graft-versus-host disease (GvHD) in heavily pre-treated B-cell lymphoma patients[5] - Completed dose escalation for both single-dose and multi-dose schedules in the ELiPSE-1 trial and is currently enrolling in the dose confirmation portion, with progression to dose expansion expected in 2H 2024[6] - Presented new preclinical data at the ASGCT Annual Meeting on CNTY-101's potential for B-Cell driven autoimmune diseases and a novel strategy using a synthetic ligand targeting CD300a to prevent NK cell-mediated rejection[4] Corporate Highlights In April 2024, the company bolstered its financial position and pipeline by completing a $60 million private placement and acquiring Clade Therapeutics. This acquisition enhances its Allo-Evasion™ platform and adds three preclinical stage αβ iT programs to its portfolio - Completed a private placement of common stock in April 2024, raising gross proceeds of $60 million from new and existing investors[7] - Acquired Clade Therapeutics, enhancing the Allo-Evasion™ platform and adding three preclinical αβ iT programs for cancer and autoimmune diseases to its pipeline[7] Second Quarter 2024 Financial Results For Q2 2024, the company reported a cash position of $269.6 million. R&D expenses rose to $27.2 million, primarily due to increased manufacturing for CNTY-101 and the Clade Therapeutics acquisition. The net loss for the quarter narrowed to $31.2 million from $33.3 million in the prior-year period | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Cash, Cash Equivalents & Marketable Securities | $269.6M | N/A | | Collaboration Revenue | $0.8M | $0.1M | | R&D Expenses | $27.2M | $22.7M | | G&A Expenses | $8.3M | $8.2M | | Net Loss | $31.2M | $33.3M | - The increase in R&D expenses was primarily due to increased manufacturing activity for CNTY-101 and the acquisition of Clade Therapeutics[8] - Net cash used in operations for the six months ended June 30, 2024, was $57.6 million, compared to $48.5 million for the same period in 2023[8] Financial Guidance The company projects full-year 2024 GAAP operating expenses to be between $150 million and $160 million. It also confirms that its current cash, cash equivalents, and investments are sufficient to fund operations into 2026 - The company expects full-year GAAP operating expenses to be between $150 million and $160 million[10] - The company's cash, cash equivalents, and investments are estimated to support operations into 2026[10] Financial Statements The unaudited financial statements detail the company's financial position as of June 30, 2024, and its operational results for the three and six months then ended. Total assets increased to $416.4 million, and the net loss for the second quarter improved to $31.2 million compared to the prior year Condensed Balance Sheets As of June 30, 2024, total assets stood at $416.4 million and total liabilities were $194.3 million, resulting in total stockholders' equity of $222.1 million. This reflects an increase in both assets and equity compared to December 31, 2023, partly due to the acquisition of Clade Therapeutics and a private placement | | June 30, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $41,457 | $47,324 | | Total current assets | $203,478 | $176,994 | | Total assets | $416,446 | $360,691 | | Liabilities & Equity | | | | Total current liabilities | $19,163 | $17,846 | | Total liabilities | $194,342 | $175,941 | | Total stockholders' equity | $222,104 | $184,750 | Condensed Consolidated Statements of Operations For the three months ended June 30, 2024, the company reported a net loss of $31.2 million, or ($0.38) per share, an improvement from a net loss of $33.3 million, or ($0.56) per share, for the same period in 2023. For the six-month period, the net loss was $59.3 million in 2024 compared to $64.6 million in 2023 Statement of Operations (Three Months Ended June 30, in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Collaboration Revenue | $771 | $99 | | Research and development | $27,220 | $22,727 | | Loss from operations | $(34,755) | $(35,077) | | Net Loss | $(31,207) | $(33,291) | | Net loss per common share | $(0.38) | $(0.56) | Statement of Operations (Six Months Ended June 30, in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Collaboration Revenue | $1,625 | $1,819 | | Research and development | $50,641 | $47,626 | | Loss from operations | $(66,068) | $(67,158) | | Net Loss | $(59,269) | $(64,555) |