Prelude Therapeutics(PRLD) - 2025 Q1 - Quarterly Results

Corporate Update and Q1 2025 Highlights The company achieved strong Q1 2025 execution, advancing SMARCA2 degrader programs and presenting initial KAT6A degrader preclinical data, with key clinical updates expected in H2 2025 - The company reported strong execution in Q1 2025, with rapid progress in its SMARCA2 degrader programs and the presentation of first preclinical data for its oral KAT6A degraders[2] - Key clinical updates for PRT3789 (SMARCA2 degrader) and PRT7732 (oral SMARCA2 degrader) are anticipated in the second half of 2025[1] Financial Position and Runway | Metric | Value | | :--- | :--- | | Cash, cash equivalents, restricted cash and marketable securities | $103.1 million (as of March 31, 2025) | | Cash Runway | Into the second quarter of 2026 | Clinical Program Updates and Upcoming Milestones This section details progress in SMARCA2 degrader clinical trials, KAT6A oral degrader development, and precision ADCs, with key milestones anticipated in 2025-2026 PRT3789 (Intravenous SMARCA2 Degrader) PRT3789, an intravenous SMARCA2 degrader, completed monotherapy and docetaxel combination enrollment, established a 500 mg weekly Phase 2 dose, and is enrolling a KEYTRUDA® combination trial, with data expected in H2 2025 - PRT3789 is designed to treat patients with SMARCA4-mutated cancers, which represent approximately 10% of all non-small cell lung cancers (NSCLC) and 5% of all cancers, an area of high unmet medical need[3][4] - Enrollment is complete for the monotherapy dose escalation (665 mg) and the combination with docetaxel. The recommended Phase 2 dose is 500 mg once weekly[5] - A Phase 2 clinical trial is actively enrolling patients to evaluate PRT3789 in combination with KEYTRUDA® (pembrolizumab) under a collaboration with Merck[6] PRT7732 (Oral SMARCA2 Degrader) PRT7732, an oral SMARCA2 degrader, is rapidly advancing in its Phase 1 dose escalation trial, with the fifth cohort (60 mg once daily) currently enrolling, and initial data expected in H2 2025 - PRT7732 is a distinct oral SMARCA2 degrader being evaluated in a Phase 1 trial for biomarker-selected SMARCA4 mutated cancers[8] - Enrollment has progressed quickly, with the trial currently enrolling patients in the fifth dose escalation cohort at 60 mg once daily[8] Highly Selective KAT6A Oral Degrader Program Prelude is developing selective oral KAT6A degraders to improve efficacy and tolerability by avoiding KAT6B inhibition, with a development candidate expected in Q2 2025 and an IND filing in 2026 - The company believes its program is the industry's first to report a selective KAT6A degrader, which could improve the safety profile by avoiding KAT6B inhibition, a driver of hematologic toxicity[9] - A development candidate is expected to be nominated in the second quarter of 2025, with an Investigational New Drug (IND) application filing planned for 2026[9] Precision ADCs with SMARCA2/4 Dual Degrader Payload In partnership with AbCellera, Prelude is developing precision ADCs with SMARCA2/4 dual degrader payloads, showing superior preclinical efficacy and tolerability, with the first development candidate expected in 2025 - The program uses potent SMARCA2/4 dual degraders as payloads for precision ADCs to inhibit cancer cell growth across multiple cancer types[12] - Prelude and its partner AbCellera anticipate nominating the first development candidate from this program in 2025[12] Upcoming Investor Conference Company leadership will participate in a fireside chat at the Citizens 2025 Life Sciences Conference on May 7, 2025 - The company's leadership, including the CEO, President/CMO, and CSO, will participate in a fireside chat at the Citizens 2025 Life Sciences Conference on May 7, 2025[13] First Quarter 2025 Financial Results This section reviews Prelude Therapeutics' Q1 2025 financial performance, covering cash position, operating expenses, and net loss Financial Position and Runway As of March 31, 2025, Prelude Therapeutics held $103.1 million in cash and equivalents, projected to fund operations into Q2 2026 Cash Position | Date | Cash, Cash Equivalents, Restricted Cash & Marketable Securities | | :--- | :--- | | March 31, 2025 | $103.1 million | - The existing cash is anticipated to fund operations into the second quarter of 2026[15] Operating Expenses Total operating expenses for Q1 2025 were $34.6 million, a slight increase driven by higher R&D for SMARCA2 clinical trials, partially offset by lower G&A due to reduced stock-based compensation Research and Development (R&D) Expenses R&D expenses increased to $28.8 million in Q1 2025, primarily due to higher costs associated with SMARCA2 clinical trials R&D Expense Comparison (in millions) | Period | R&D Expense | Non-cash Stock Comp. | Change Driver | | :--- | :--- | :--- | :--- | | Q1 2025 | $28.8 | $2.3 | Increased expense for SMARCA2 clinical trials | | Q1 2024 | $27.4 | $3.0 | - | General and Administrative (G&A) Expenses G&A expenses decreased to $5.8 million in Q1 2025, primarily due to lower non-cash stock-based compensation from reduced grant valuation G&A Expense Comparison (in millions) | Period | G&A Expense | Non-cash Stock Comp. | Change Driver | | :--- | :--- | :--- | :--- | | Q1 2025 | $5.8 | $1.6 | Lower stock-based compensation | | Q1 2024 | $6.9 | $2.5 | - | Net Loss The company reported a net loss of $32.1 million, or $0.42 per share, for Q1 2025, comparable to the prior year Net Loss Comparison | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss | $(32.1) million | $(31.4) million | | Net Loss Per Share | $(0.42) | $(0.42) | Financial Statements This section presents Prelude Therapeutics' unaudited statements of operations and comprehensive loss, and balance sheets for Q1 2025 and comparative periods Statements of Operations and Comprehensive Loss The unaudited Q1 2025 statement of operations shows a net loss of $32.1 million, with total operating expenses slightly increasing to $34.6 million year-over-year Q1 2025 Statement of Operations (Unaudited, in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $28,816 | $27,409 | | General and administrative | $5,790 | $6,934 | | Total operating expenses | $34,606 | $34,343 | | Loss from operations | $(34,606) | $(34,343) | | Other income, net | $2,521 | $2,912 | | Net loss | $(32,085) | $(31,431) | | Net loss per share | $(0.42) | $(0.42) | Balance Sheets The unaudited balance sheet as of March 31, 2025, shows total assets of $141.3 million and liabilities of $38.1 million, a decrease from December 31, 2024, primarily due to reduced cash and marketable securities Balance Sheet Highlights (Unaudited, in thousands) | Line Item | March 31, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $40,269 | $12,474 | | Marketable securities | $58,805 | $121,140 | | Total current assets | $102,403 | $135,895 | | Total assets | $141,260 | $175,515 | | Total current liabilities | $19,787 | $25,641 | | Total liabilities | $38,082 | $44,056 | | Total stockholders' equity | $103,178 | $131,459 |