WALTHAM, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced the pricing of an underwritten public offering of pre-funded warrants to purchase 66,676,000 shares of common stock (the “pre-funded warrants”), accompanied by Series A warrants to purchase 66,676,000 shares of common stock (or, in certain circumstances, pre-funded w ...

WALTHAM, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that it is commencing an underwritten public offering of pre-funded warrants to purchase shares of common stock accompanied by Series A warrants to purchase shares of common stock (or, in certain circumstances, pre-funded warrants), Series B warrants to purchase shar ...

Core Insights - Xilio Therapeutics announced a preliminary objective response rate (ORR) of 26% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases, demonstrating deep and durable responses lasting up to 37 weeks [1][4][10] - The combination therapy of vilastobart and atezolizumab showed a differentiated safety profile with a low incidence of immune-related adverse events, particularly colitis [2][7][11] - The ongoing Phase 2 trial is evaluating vilastobart in combination with atezolizumab, with plans to expand the study to include a higher dose level [9][13] Patient Data - As of May 12, 2025, 44 patients with metastatic MSS CRC were treated with vilastobart at 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3][5] - 80% of patients had previously received three or more lines of anti-cancer therapy, indicating a heavily pre-treated population [3] Anti-Tumor Activity - The preliminary ORR of 26% included seven partial responses, with six confirmed responses, and substantial decreases in tumor biomarkers such as circulating tumor DNA [4][10] - In patients without liver metastases, responses were deep and durable, with reductions in target lesions of up to 71% from baseline [10] Safety Profile - The combination therapy exhibited a low incidence of immune-mediated adverse events, with only 7% of patients experiencing colitis [7][11] - Common treatment-related adverse events included fatigue (30%), infusion-related reactions (23%), and diarrhea (18%) [11] Future Development Plans - Xilio is enrolling a cohort of patients at a higher dose level of 150 mg Q6W for vilastobart in the ongoing Phase 2 trial, with additional data expected in the first half of 2026 [9][12] - The company is seeking partnership opportunities to accelerate the development of the vilastobart program [12]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40925 Xilio Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...

Exhibit 99.1 "In the first quarter, we presented encouraging initial Phase 2 data for vilastobart, our tumor-activated anti- CTLA-4, in combination with atezolizumab in patients with late-line MSS CRC. These data included a preliminary 27% objective response rate in late-line MSS CRC patients without liver metastases accompanied by a differentiated safety profile with a low incidence of colitis and other immune-related adverse events, which are common dose-limiting adverse events for other CTLA-4 agents," s ...

Updated Phase 2 data to be presented at ASCO for vilastobart, a tumor-activated, Fc-enhanced, anti-CTLA-4, in combination with atezolizumab in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) Advancing multiple masked T cell engager programs utilizing Xilio’s novel ATACR and SEECR formats, with first development candidates anticipated in second half of 2025 WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology compan ...

WALTHAM, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced plans to present updated data from its ongoing Phase 2 clinical trial investigating vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at ...

Company Performance - Xilio Therapeutics reported a quarterly loss of $0.20 per share, better than the Zacks Consensus Estimate of a loss of $0.22, and an improvement from a loss of $0.64 per share a year ago, indicating an earnings surprise of 9.09% [1] - The company posted revenues of $1.72 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 23.72%, compared to zero revenues a year ago [2] - Xilio Therapeutics shares have declined approximately 11.5% since the beginning of the year, while the S&P 500 has decreased by 4.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.34 on revenues of $42 million, and for the current fiscal year, it is -$0.40 on revenues of $64.25 million [7] - The estimate revisions trend for Xilio Therapeutics is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Xilio Therapeutics belongs, is currently in the top 29% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor decisions [5]

Financial Reporting and Compliance - The company is permitted to provide only two years of audited financial statements and reduced disclosures under the JOBS Act [646]. - The company may continue to qualify as a smaller reporting company with less than $100 million in annual revenue, allowing it to avoid certain auditor attestation requirements [649]. - The company has incurred substantial costs due to compliance with public company regulations, including the Sarbanes-Oxley Act and Dodd-Frank Act [652]. - The company is engaged in a process to document and evaluate its internal control over financial reporting, which is both costly and challenging [654]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [791]. Taxation and Financial Impact - Changes in tax laws, including a reduction of the corporate tax rate from 35% to 21%, may adversely affect the company's financial condition [661]. - The Tax Act requires corporations to capitalize and amortize research and development expenditures over five years starting in 2022 [663]. Corporate Governance and Legal Matters - Provisions in the company's corporate charter may discourage or prevent beneficial acquisitions and limit stockholder actions [665]. - The company is governed by Section 203 of the Delaware General Corporation Law, which restricts mergers with stockholders owning over 15% of voting stock for three years [669]. - The company’s restated certificate of incorporation designates Delaware courts as the exclusive forum for certain disputes, potentially increasing litigation costs [670].

Financial Performance - The net loss for Q4 2024 was $13.1 million, compared to $17.7 million in Q4 2023, and the full-year net loss was $58.2 million, down from $76.4 million in 2023[15]. - Net loss for Q4 2024 was $13.093 million, an improvement from a net loss of $17.655 million in Q4 2023, representing a reduction of approximately 25.5%[23]. - Total assets increased to $71.075 million in December 2024, up from $60.926 million in December 2023, reflecting a growth of approximately 16.7%[21]. - Total liabilities rose to $53.477 million in December 2024, compared to $24.099 million in December 2023, indicating a substantial increase of 121.5%[21]. - The company reported total operating expenses of $15.353 million for Q4 2024, down from $18.130 million in Q4 2023, a decrease of approximately 15.5%[23]. - Stock-based compensation expense for the year ended December 31, 2024, was $6.434 million, down from $7.382 million in 2023, a decrease of about 12.8%[23]. - General and administrative expenses for the year ended December 31, 2024, totaled $24.778 million, a decrease from $26.997 million in 2023, reflecting a reduction of approximately 8.1%[23]. - Research and development expenses for the year ended December 31, 2024, were $41.211 million, down from $52.136 million in 2023, a decrease of about 21.0%[23]. - General & Administrative (G&A) expenses were $6.5 million for Q4 2024, slightly up from $6.4 million in Q4 2023, and totaled $24.8 million for the full year, down from $27.0 million in 2023[15]. Revenue and Payments - The company received $52.0 million in upfront payments from AbbVie as part of a collaboration agreement, with potential total contingent payments of approximately $2.1 billion[10]. - License revenue for Q4 2024 was $1.7 million, and $6.3 million for the full year, compared to no license revenue in 2023[10]. - License revenue for Q4 2024 reached $1.724 million, compared to $0 in Q4 2023, marking a significant increase[23]. - The company has deferred revenue of $32.780 million as of December 31, 2024, indicating a new revenue stream[21]. Cash Position - Cash and cash equivalents were $55.3 million as of December 31, 2024, an increase from $44.7 million as of December 31, 2023[10]. - Xilio expects its current cash position, along with the recent upfront payments, to fund operations into Q1 2026[11]. Clinical Development - Xilio reported a preliminary 27% objective response rate for vilastobart in patients without liver metastases during the Phase 2 trial, with a low incidence of immune-related adverse events, including only 5% reporting colitis[2][3]. - Xilio plans to submit an IND application for XTX501 in the middle of 2026, following promising preclinical studies[5][8]. - The company anticipates nominating a development candidate for its PSMA program in the ATACR format in Q3 2025 and submitting an IND application in Q1 2027[10]. Shareholder Information - The weighted average common shares outstanding increased to 64,675,807 in Q4 2024, compared to 27,557,021 in Q4 2023, indicating a significant increase of 134.5%[23].