Allogene Therapeutics(ALLO) - 2025 Q2 - Quarterly Results

Corporate Updates & Highlights Allogene reported significant progress in Q2 2025, advancing the pivotal ALPHA3 trial for cema-cel, initiating the RESOLUTION trial for ALLO-329 in autoimmune diseases, and aligning with the FDA on a pivotal path for ALLO-316 in solid tumors, ending the quarter with a strong cash position extending its runway into the second half of 2027 - Key strategic advancements include streamlining the ALPHA3 trial, initiating clinical enrollment for ALLO-329 in autoimmune indications, and aligning with the FDA on a pivotal path for ALLO-316 in solid tumors[3] - The company ended Q2 2025 with $302.6 million in cash, cash equivalents, and investments, with a projected cash runway into the second half of 2027[8][10] Program Updates The company provided updates on its key clinical programs, including the pivotal Phase 2 ALPHA3 trial for cema-cel, the initiated Phase 1 RESOLUTION trial for ALLO-329 in autoimmune diseases, and the aligned pivotal trial design for ALLO-316 with the FDA Cema-Cel: Pivotal Phase 2 ALPHA3 Trial in LBCL The ALPHA3 trial for cema-cel in Large B-Cell Lymphoma (LBCL) will now proceed as a two-arm randomized study, comparing cema-cel with standard fludarabine and cyclophosphamide (FC) lymphodepletion against observation, supported by early safety and biomarker data, with a futility analysis scheduled for the first half of 2026 and over 50 clinical sites activated - The ALPHA3 trial is now a randomized two-arm study comparing cema-cel with standard fludarabine and cyclophosphamide (FC) lymphodepletion to observation, the current standard of care[4] - The selection of the FC regimen is based on encouraging preliminary safety, MRD conversion rates, and operational benefits for community cancer centers[5] - A futility analysis comparing MRD conversion rates between the two arms is expected in 1H 2026[6][8] - Over 50 clinical sites are activated across the U.S. and Canada, with international expansion underway[6][8] ALLO-329: Phase 1 RESOLUTION Trial in Autoimmune Disease (AID) The Phase 1 RESOLUTION basket trial for ALLO-329 was initiated in Q2 2025 for rheumatology indications like lupus and systemic sclerosis, featuring a first-in-class dual CAR T product incorporating Dagger® technology with initial proof-of-concept data expected in the first half of 2026 - The Phase 1 RESOLUTION basket trial was launched in Q2 2025 for rheumatology, including conditions such as systemic lupus erythematosus, idiopathic inflammatory myopathies, and systemic sclerosis[7] - The trial features two lymphodepletion arms: one with cyclophosphamide alone and one with no lymphodepletion[7] - ALLO-329 is a first-in-class allogeneic CD19/CD70 dual CAR T product incorporating Dagger® technology to potentially reduce the need for lymphodepletion[9] - First clinical update with biomarker and proof-of-concept data is expected in 1H 2026[7][8] ALLO-316: TRAVERSE Trial in RCC Enrollment in the Phase 1b cohort for ALLO-316 in advanced Renal Cell Carcinoma (RCC) is complete, with updated data presented at ASCO 2025 showing clinical responses and robust cell expansion, leading to alignment with the FDA on a pivotal trial design that supports potential partnership discussions - Enrollment is complete for the Phase 1b cohort evaluating ALLO-316 in heavily pretreated advanced or metastatic Renal Cell Carcinoma (RCC)[9] - Updated Phase 1b results presented at ASCO 2025 highlighted clinical responses and the potential of Dagger® technology[8][9] - The company has aligned with the FDA on a pivotal trial design, setting the stage for potential partnership discussions[3][8][9] Financial Results Summary For the second quarter of 2025, Allogene reported a net loss of $50.9 million, ending the quarter with $302.6 million in cash, cash equivalents, and investments, with a projected cash runway into the second half of 2027 and full-year 2025 GAAP operating expenses expected to be approximately $230 million Key Financial Metrics for Q2 2025 | Metric | Value (USD) | | :--- | :--- | | Cash, Cash Equivalents, and Investments (as of June 30, 2025) | $302.6 million | | Research and Development Expenses | $40.2 million | | General and Administrative Expenses | $14.3 million | | Net Loss | $50.9 million | | Net Loss per Share | $0.23 | - Cash runway is expected to extend into the second half of 2027[10] - 2025 guidance includes an expected decrease in cash of approximately $150 million and GAAP Operating Expenses of approximately $230 million, including about $45 million in non-cash stock-based compensation[10] Selected Financial Data The detailed financial tables show a year-over-year decrease in operating expenses and net loss for Q2 2025, with the balance sheet reflecting a reduction in cash and total assets since the end of 2024, consistent with the company's operational spending Statements of Operations For the three months ended June 30, 2025, Allogene reported total operating expenses of $56.8 million, a decrease from $71.4 million in the same period of 2024, resulting in a net loss of $50.9 million, or $0.23 per share, compared to a net loss of $66.4 million, or $0.35 per share, in Q2 2024 Consolidated Statements of Operations (Unaudited) | | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $40,156 | $50,355 | | General and administrative | $14,281 | $16,087 | | Total operating expenses | $56,819 | $71,431 | | Loss from operations | $(56,819) | $(71,431) | | Net loss | $(50,943) | $(66,358) | | Net loss per share, basic and diluted | $(0.23) | $(0.35) | Selected Balance Sheet Data As of June 30, 2025, Allogene had $302.6 million in cash, cash equivalents, and investments, a decrease from $373.1 million at the end of 2024, with total assets at $470.6 million and total stockholders' equity at $344.6 million Selected Balance Sheet Data (Unaudited) | | As of June 30, 2025 (in thousands) | As of December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash, cash equivalents and investments | $302,630 | $373,149 | | Total assets | $470,593 | $548,710 | | Total liabilities | $126,032 | $126,531 | | Total stockholders' equity | $344,561 | $422,179 |