Total gross proceeds of up to $150.0 million before the end of 2026 if all Series B warrants and Series C warrants are exercised for cash Xilio may elect to cancel unexercised Series B or Series C warrants proportionately to the amount of non-dilutive capital received, under certain circumstances Financing co-led by new investors Coastlands Capital and Frazier Life Sciences and included participation from Gilead Sciences, Inc., Logos Capital, Samsara BioCapital and other new and existing investors WALTHAM, ...

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].