LAVA Therapeutics(LVTX) - 2024 Q4 - Annual Results

Corporate and Strategic Highlights LAVA Therapeutics will prioritize evaluating strategic options and advancing the LAVA-1266 Phase 1 trial in 2025, supported by a 30% workforce reduction and a strong $76.6 million cash balance projected to fund operations into 2027 - The company's primary focus for 2025 is to evaluate strategic options to maximize shareholder value[3] - A restructuring plan was adopted, resulting in a 30% reduction in the global workforce to extend capital resources[5][10] - The cash balance was $76.6 million as of December 31, 2024, projected to fund operations into 2027[5][10] - Achieved and received a $5.0 million development milestone from Johnson & Johnson in Q4 2024[5][7] Portfolio Highlights LAVA's clinical pipeline is advancing with its proprietary LAVA-1266 program and two Phase 1 partnered programs with Johnson & Johnson and Pfizer, both yielding significant milestone payments in 2024 LAVA-1266 Program LAVA-1266, an internally developed candidate targeting CD123+ tumor cells for AML and MDS, is actively enrolling patients in a Phase 1 study in Australia, currently in its second dose escalation level - Targets CD123+ tumor cells for treating hematological malignancies, specifically Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)[4][6] - Currently enrolling patients in a Phase 1 study in Australia, progressing to the second dose level of 300 µg[6] Johnson & Johnson (J&J) Partnered Program (JNJ-89853413) The J&J partnered program, JNJ-89853413, targets CD33 for hematological cancers, with J&J conducting a Phase 1 study in Canada and Spain, and LAVA receiving a $5.0 million milestone payment in Q4 2024 - Targets CD33 for hematological cancers, including relapsed/refractory AML and moderate or higher risk MDS[7][9] - J&J is actively enrolling patients in a Phase 1, open-label, multi-center study in Canada and Spain[9] - LAVA received a $5.0 million development milestone payment from J&J in Q4 2024[7] Pfizer Partnered Program (PF-08046052) The Pfizer partnered program, PF-08046052, targets EGFR in solid tumors, with Pfizer enrolling patients in a Phase 1 study in the U.S. and UK, and LAVA receiving a $7.0 million milestone payment in Q1 2024 - A potential first-in-class therapy targeting EGFR for solid tumors like CRC, NSCLC, HNSCC, and PDAC[8][10] - Pfizer is enrolling patients in a Phase 1, open-label, multi-center study in the U.S. and UK[10] - LAVA received a $7.0 million clinical development milestone payment from Pfizer in Q1 2024[10] Fourth Quarter and Year-End 2024 Financial Results LAVA's full-year 2024 revenue increased to $12.0 million due to milestone payments, while the net loss significantly decreased to $25.1 million from $41.9 million in 2023, driven by reduced R&D and G&A expenses Key Financial Highlights | Financial Metric | Q4 2024 | Q4 2023 | FY 2024 | FY 2023 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $5.0M | $0.4M | $12.0M | $6.8M | | R&D Expenses | $8.6M | $2.3M | $28.5M | $32.6M | | G&A Expenses | $3.3M | $3.3M | $13.2M | $14.1M | | Net Loss | $3.8M | $6.4M | $25.1M | $41.9M | | Net Loss Per Share | $0.14 | $0.24 | $0.94 | $1.57 | - The increase in full-year revenue was driven by a $7.0 million milestone from Pfizer and a $5.0 million milestone from J&J[11] - The decrease in full-year R&D expenses was mainly due to reduced manufacturing scale-up costs and headcount reductions from the second half of 2023[11] Financial Statements The condensed consolidated financial statements show a full-year 2024 net loss of $25.1 million, with total assets at $80.8 million and shareholders' equity at $27.7 million as of December 31, 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss This statement details revenues, costs, and expenses, showing a decreased net loss for both Q4 and full-year 2024, with the annual net loss at $25.1 million compared to $41.9 million in 2023 | (in thousands, except per share data) | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Total revenue | $11,982 | $6,769 | | Total cost and expenses | ($41,675) | ($50,163) | | Operating loss | ($29,693) | ($43,394) | | Net loss | ($25,114) | ($41,871) | | Net loss per share, basic and diluted | ($0.94) | ($1.57) | Condensed Consolidated Balance Sheets This statement presents the financial position as of December 31, 2024, showing total assets decreased to $80.8 million, liabilities increased to $53.1 million, and shareholders' equity decreased to $27.7 million | (in thousands) | As of Dec 31, 2024 | As of Dec 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $76,576 | $95,571 | | Total assets | $80,831 | $101,673 | | Total liabilities | $53,086 | $50,309 | | Total shareholders' equity | $27,745 | $51,364 |