Xilio Therapeutics(XLO) - 2025 Q2 - Quarterly Results

Overview and Highlights The company announced positive Phase 2 data, progress in its T cell engager programs, and a cash runway through Q3 2026 - Announced updated Phase 2 data for vilastobart at ASCO, demonstrating deep, durable responses and a differentiated safety profile for an anti-CTLA-4 combination therapy[1] - The company is on track to nominate its first development candidates for wholly owned masked T cell engager programs in the second half of 2025[1] Financial Position and Runway | Metric | Value | | :--- | :--- | | Cash and cash equivalents (as of June 30, 2025) | $121.6 million | | Anticipated cash runway | Through end of Q3 2026 | Pipeline and Business Updates The company reports progress across its key pipeline assets, including vilastobart, XTX301, XTX501, and masked T cell engagers Vilastobart (anti-CTLA-4) Phase 2 data for vilastobart showed a 26% objective response rate in certain CRC patients with a well-tolerated safety profile - Updated Phase 2 data presented at ASCO 2025 demonstrated a preliminary 26% objective response rate (ORR) in heavily pre-treated metastatic MSS CRC patients without liver metastases[3] - The therapy showed a differentiated and well-tolerated safety profile, with a low incidence of colitis and other immune-related adverse events[3] - Xilio is actively engaging with strategic partners for potential opportunities to accelerate and expand the development of vilastobart[3] XTX301 (IL-12) The company is advancing its tumor-activated IL-12, XTX301, under an exclusive license agreement with Gilead - Xilio has an exclusive license agreement with Gilead Sciences for its tumor-activated IL-12 program, including XTX301[4] - Enrollment in the Phase 1A monotherapy dose escalation portion of the clinical trial has been completed, with patient evaluation ongoing[4] XTX501 (PD-1/IL-2 bispecific) The novel tumor-activated bispecific XTX501 is progressing through IND-enabling studies, with an IND submission planned for mid-2026 - XTX501 is currently advancing in investigational new drug (IND)-enabling studies[5] - The company plans to submit an IND application for XTX501 in the middle of 2026[5] Masked T Cell Engager Programs The company is developing multiple preclinical masked T cell engager programs using its proprietary ATACR and SEECR formats - The pipeline includes wholly owned programs targeting PSMA, CLDN18.2, and STEAP1, plus a collaboration with AbbVie[6] - The programs utilize two proprietary formats: the bispecific ATACR (activated cell engager) and the tri-specific SEECR (selective effector-enhanced cell engager)[7] Corporate Updates The company provided a development candidate timeline, closed a public offering, and appointed a new board member Development Candidate Nomination Timeline | Program | Format | Anticipated Nomination | | :--- | :--- | :--- | | PSMA | ATACR | Q3 2025 | | CLDN18.2 | ATACR | Q4 2025 | | STEAP1 | SEECR | H1 2026 | - In June 2025, Xilio closed a follow-on public offering, receiving initial gross proceeds of approximately $50.0 million, with potential for up to an additional $100.0 million if all associated warrants are exercised[9] - Akintunde (Tunde) Bello, Ph.D., was appointed to the company's board of directors in June 2025[9] Second Quarter 2025 Financial Results The company reported increased revenue and operating expenses for Q2 2025 and provided financial guidance through Q3 2026 Q2 2025 Financial Highlights Collaboration revenue grew to $8.1 million while net loss increased to $15.8 million, with a strengthened cash position of $121.6 million Q2 2025 Financial Performance (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration & License Revenue | $8.1M | $2.4M | +238% | | R&D Expenses | $15.3M | $11.2M | +37% | | G&A Expenses | $7.1M | $5.8M | +22% | | Net Loss | $15.8M | $13.9M | +14% | | Net Loss per Share | $(0.16) | $(0.24) | N/A | | Cash & Cash Equivalents (period end) | $121.6M | N/A | N/A | Financial Guidance The company's current cash position is expected to fund operations and capital expenditures through the end of Q3 2026 - The company expects its cash and cash equivalents as of June 30, 2025, to fund operating expenses and capital expenditure requirements through the end of Q3 2026[11] Financial Statements The report includes condensed consolidated balance sheets and statements of operations for the period ending June 30, 2025 Condensed Consolidated Balance Sheets Total assets increased to $133.8 million driven by a rise in cash, while total liabilities grew to $126.7 million Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $121,551 | $55,291 | | Total assets | $133,813 | $71,075 | | Liabilities & Equity | | | | Deferred revenue | $70,910 | $32,780 | | Common stock warrant liabilities | $38,550 | $0 | | Total liabilities | $126,744 | $53,477 | | Stockholders' equity | $7,069 | $17,598 | Condensed Consolidated Statements of Operations The company reported a net loss of $15.8 million for the three months ended June 30, 2025, on revenues of $8.1 million Statement of Operations Summary (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | | Research and development | $15,330 | $11,216 | | General and administrative | $7,120 | $5,815 | | Total operating expenses | $22,450 | $17,061 | | Loss from operations | $(14,366) | $(14,704) | | Net loss | $(15,844) | $(13,925) | | Net loss per share | $(0.16) | $(0.24) |