Prelude Therapeutics(PRLD) - 2025 Q2 - Quarterly Results

Prelude Therapeutics Second Quarter 2025 Update Prelude Therapeutics reports significant clinical pipeline advancements and a strong financial position for Q2 2025, with a focus on oral SMARCA2 degrader PRT7732 and a cash runway into Q2 2026 Corporate and Pipeline Highlights Prelude Therapeutics highlights advancements in its oral SMARCA2 degrader PRT7732, strategic pipeline prioritization, and a strong cash position for Q2 2025 - The oral SMARCA2 degrader, PRT7732, is currently enrolling its seventh dosing cohort at 125 mg, with preliminary clinical data anticipated by the end of 2025[1] - The company has completed the Phase 1 study of its intravenous SMARCA2 degrader, PRT3789, but has paused further development to focus solely on the oral PRT7732 program[1][2] - A development candidate for the oral KAT6A degrader program has been selected, with an Investigational New Drug (IND) application filing planned for the first half of 2026[1][3][7] - As of June 30, 2025, the company has $77.3 million in cash, cash equivalents, restricted cash, and marketable securities, which is expected to fund operations into the second quarter of 2026[1][10] Clinical Program Updates and Upcoming Milestones Prelude strategically prioritizes its oral SMARCA2 degrader, advances its KAT6A program, and develops novel precision ADCs SMARCA2 Degrader Development Program Prelude halts intravenous SMARCA2 degrader PRT3789 development to focus resources on the more promising oral PRT7732 due to its favorable clinical profile - The company is pausing further development of PRT3789 (IV) to focus solely on PRT7732 (oral) as the go-forward strategy for the SMARCA2 Program[2] - The decision was influenced by the potential need for higher target coverage and capital requirements to advance both agents simultaneously[2] - PRT7732 has shown a favorable clinical profile to date, including oral once-daily dosing, good safety and tolerability, and over 90% target degradation[2][3] PRT3789 (Intravenous SMARCA2 Degrader) Phase 1 clinical development for PRT3789 is complete, with further advancement contingent on partnership and final data expected by year-end 2025 - Phase 1 clinical development in patients with biomarker-selected SMARCA4-mutated cancers is complete[5] - Further advancement of the program is contingent on securing a partnership; internal resources are being redirected to PRT7732[5] - The company plans to provide updated data from the Phase 1 study by the end of 2025[5] PRT7732 (Oral SMARCA2 Degrader) PRT7732, an oral SMARCA2 degrader, is rapidly advancing in its Phase 1 trial, with initial data expected by year-end 2025 - Enrollment is advancing rapidly, with the seventh dose escalation cohort (125 mg once daily) currently enrolling patients[6] - An initial first-in-human data update, including PK/PD, safety, and initial clinical activity, is expected by year-end 2025[6] KAT6A Oral Degrader Program Prelude is advancing a highly selective oral KAT6A degrader, targeting an IND filing in H1 2026, anticipating improved efficacy and tolerability - The company is advancing a development candidate and is on track to file an IND in the first half of 2026[7] - This program is developing what is believed to be the industry's first highly potent, selective, and orally bioavailable KAT6A selective degraders[7] - The selective degradation of KAT6A is hypothesized to offer improved efficacy, tolerability, and combinability compared to non-selective inhibitors[7] Other Pipeline Programs Prelude is developing next-generation cancer therapies, including precision ADCs with novel SMARCA2/4 dual degrader payloads and mCALR-targeted ADCs - Developing potent SMARCA2/4 dual degraders as payloads for precision ADCs, which have shown significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs in preclinical models[8] - Developing mCALR-targeted precision ADCs for myelofibrosis (MF) and essential thrombocythemia (ET), targeting a neoantigen found in 25-35% of patients[9] Second Quarter 2025 Financial Results Prelude Therapeutics reported a narrowed net loss of $31.2 million for Q2 2025, driven by reduced operating expenses, ending the quarter with $77.3 million in cash Summary of Key Financial Metrics | Financial Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $25.8M | $29.5M | -12.5% | | G&A Expenses | $6.4M | $7.7M | -16.9% | | Net Loss | $31.2M | $34.7M | -10.1% | | Net Loss Per Share | $0.41 | $0.46 | -10.9% | Financial Position As of June 30, 2025, Prelude Therapeutics held $77.3 million in cash and equivalents, projected to fund operations into Q2 2026 - Total cash, cash equivalents, restricted cash, and marketable securities were $77.3 million as of June 30, 2025[10] - The existing cash runway is anticipated to fund operations into the second quarter of 2026[10] Operating Expenses Total operating expenses decreased in Q2 2025, with R&D expenses falling to $25.8 million and G&A expenses to $6.4 million Operating Expenses Summary | Expense Category | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research & Development | $25.8M | $29.5M | | General & Administrative | $6.4M | $7.7M | - The decrease in R&D expenses was primarily due to a decrease in expenses related to the company's SMARCA2 clinical trials[11] - The decrease in G&A expenses was primarily due to lower stock-based compensation, resulting from a lower valuation on recent grants[12] Net Loss Prelude's net loss for Q2 2025 narrowed to $31.2 million ($0.41 per share), an improvement from $34.7 million in Q2 2024 Net Loss Summary | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $31.2M | $34.7M | | Net Loss Per Share | $0.41 | $0.46 | - Included in the Q2 2025 net loss was $3.8 million of non-cash expenses related to share-based payments, down from $6.1 million in Q2 2024[14] Financial Statements This section presents Prelude Therapeutics' unaudited consolidated financial statements, including Statements of Operations and Balance Sheets for Q2 2025 Statements of Operations and Comprehensive Loss For Q2 2025, Prelude reported total operating expenses of $32.2 million and a net loss of $31.2 million, an improvement from Q2 2024 Consolidated Statements of Operations and Comprehensive Loss | (in thousands, except per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Operating expenses | | | | Research and development | $25,784 | $29,509 | | General and administrative | $6,410 | $7,655 | | Total operating expenses | $32,194 | $37,164 | | Loss from operations | ($32,194) | ($37,164) | | Other income, net | $963 | $2,424 | | Net loss | ($31,231) | ($34,740) | | Net loss per share, basic and diluted | ($0.41) | ($0.46) | Balance Sheets As of June 30, 2025, Prelude Therapeutics reported total assets of $114.9 million, total liabilities of $39.1 million, and stockholders' equity of $75.8 million Consolidated Balance Sheets | (in thousands) | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $25,752 | $12,474 | | Marketable securities | $47,464 | $121,140 | | Total current assets | $76,876 | $135,895 | | Total assets | $114,918 | $175,515 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $20,908 | $25,641 | | Total liabilities | $39,080 | $44,056 | | Total stockholders' equity | $75,838 | $131,459 | | Total liabilities and stockholders' equity | $114,918 | $175,515 |