WALTHAM, Mass., Oct. 30, 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 will present a late-breaking poster presentation for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 5-9, 2025 in National Harbor, Maryland. The Phase 2 ...

WALTHAM, Mass., Oct. 30, 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 will present a late-breaking poster presentation for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 5-9, 2025 in National Harbor, Maryland. The Phase 2 ...

Core Insights - Xilio Therapeutics, Inc. is set to present multiple clinical and preclinical data at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting from November 6-9, 2025, focusing on tumor-activated immuno-oncology therapies for cancer patients [1][2]. Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing tumor-activated immuno-oncology therapies aimed at improving patient outcomes while minimizing systemic side effects associated with current treatments [2]. Upcoming Presentations - The company will present clinical data for vilastobart, an anti-CTLA-4 therapy, and efarindodekin alfa (XTX301), an IL-12 therapy, along with preclinical data on masked T cell engager programs [2]. - Specific poster presentations include: - "ctDNA as a Potential Surrogate Biomarker for Response to Combination Vilastobart and Atezolizumab in Heavily Pretreated Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)" on November 7, 2025 [4]. - "XTX301, a Tumor-Activated Interleukin-12 (IL-12), Demonstrated IL-12 Pharmacology in Patients with Advanced Solid Tumors: Pharmacodynamic Data from First-in-Human Phase 1 Study" on November 7, 2025 [4]. - "Masked T Cell Engagers Designed to Drive Potent Synthetic Anti-Tumor Immunity with Favorable Tolerability" on November 8, 2025 [4].

Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].

Core Insights - Xilio Therapeutics has initiated patient dosing in Phase 2 of the clinical trial for efarindodekin alfa (XTX301), a tumor-activated IL-12, demonstrating promising anti-tumor activity in patients with advanced solid tumors [1][2] - The company achieved a $17.5 million development milestone under its license agreement with Gilead Sciences, extending its cash runway into the first quarter of 2027 [1][6] Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes while minimizing systemic side effects [11] - The company is leveraging its proprietary platform to advance a pipeline of novel tumor-activated immuno-oncology molecules [11] Clinical Trial Details - Efarindodekin alfa (XTX301) is designed to stimulate anti-tumor immunity and reprogram the tumor microenvironment of poorly immunogenic "cold" tumors to a more inflamed state [3][10] - The ongoing Phase 1/2 clinical trial is evaluating efarindodekin alfa as a monotherapy in patients with advanced solid tumors, with the Phase 2 portion expected to enroll approximately 40 patients [10] Financial Position - As of June 30, 2025, Xilio had cash and cash equivalents of $121.6 million, which, along with the recent milestone payment, is expected to fund operations into the first quarter of 2027 [5][6] Collaboration with Gilead - In March 2024, Xilio entered into an exclusive global license agreement with Gilead for the development and commercialization of efarindodekin alfa [7][10] - If Gilead exercises its option for efarindodekin alfa, Xilio could receive up to $500 million in specified milestones and tiered royalties on global net product sales [9]

Financial Performance - Xilio Therapeutics reported a quarterly loss of $0.16 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.08, and improved from a loss of $0.24 per share a year ago [1] - The company posted revenues of $8.08 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 10.38%, and showing significant growth from year-ago revenues of $2.36 million [2] - Over the last four quarters, Xilio Therapeutics has surpassed consensus EPS estimates two times, but has not beaten consensus revenue estimates [2] Stock Performance - Xilio Therapeutics shares have declined approximately 25.2% since the beginning of the year, contrasting with the S&P 500's gain of 10% [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating expectations of underperformance in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.05 on revenues of $25.56 million, and for the current fiscal year, it is -$0.23 on revenues of $103.74 million [7] - The trend of estimate revisions for Xilio Therapeutics was unfavorable prior to the earnings release, which may impact future stock movements [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Xilio Therapeutics belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, suggesting potential challenges for stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could be a useful metric for investors [5]

Part I Financial Information [Financial Statements](index=9&type=section&id=Item%201.%20Financial%20Statements) Xilio's June 30, 2025, financials show increased cash and liabilities, a $29.1 million net loss, and significant going concern doubts [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $121,551 | $55,291 | | Total current assets | $123,716 | $60,234 | | Total assets | $133,813 | $71,075 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $53,260 | $27,261 | | Common stock warrant liabilities | $38,550 | $0 | | Total liabilities | $126,744 | $53,477 | | Accumulated deficit | $(412,862) | $(383,753) | | Total stockholders' equity | $7,069 | $17,598 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | $11,014 | $2,357 | | Research and development | $15,330 | $11,216 | $23,596 | $21,616 | | General and administrative | $7,120 | $5,815 | $15,635 | $11,954 | | Total operating expenses | $22,450 | $17,061 | $39,231 | $34,548 | | Loss from operations | $(14,366) | $(14,704) | $(28,217) | $(32,191) | | Net loss | $(15,844) | $(13,925) | $(29,109) | $(31,128) | | Net loss per share, basic and diluted | $(0.16) | $(0.24) | $(0.34) | $(0.73) | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $14,501 | $9,451 | | Net cash used in investing activities | $(423) | $(21) | | Net cash provided by financing activities | $52,194 | $20,997 | | **Increase in cash, cash equivalents and restricted cash** | **$66,272** | **$30,427** | [Notes to Condensed Consolidated Financial Statements](index=15&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company has incurred significant operating losses, with a **net loss of $29.1 million** for the six months ended June 30, 2025, and an **accumulated deficit of $412.9 million**, raising substantial doubt about its ability to continue as a going concern[33](index=33&type=chunk) - To fund operations, the company will need to raise additional capital through warrant exercises, milestone payments from Gilead and AbbVie, equity/debt financings, or other collaborations, with potential cost reduction strategies if capital is not secured[34](index=34&type=chunk) - In February 2025, the company entered a collaboration with AbbVie for up to four programs, receiving an initial **$52.0 million** ($42.0 million upfront cash and $10.0 million from a private placement) and is eligible for up to approximately **$2.1 billion** in additional contingent payments[55](index=55&type=chunk)[61](index=61&type=chunk) - In March 2024, the company entered a license agreement with Gilead for its XTX301 (IL-12) program, receiving **$55.0 million** ($30.0 million upfront cash and $25.0 million from private placements) and is eligible for up to **$592.5 million** in additional contingent payments, including a **$75.0 million** transition fee[72](index=72&type=chunk)[74](index=74&type=chunk) - In June 2025, the company closed a follow-on public offering of prefunded warrants and accompanying common stock warrants, receiving initial gross proceeds of **$50.0 million**, with potential for an additional **$100.0 million** if certain warrants are exercised for cash by the second half of 2026[32](index=32&type=chunk)[89](index=89&type=chunk)[96](index=96&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reports Xilio, a clinical-stage biotech, has $121.6 million cash, funding through Q3 2026, but faces going concern doubts and needs more capital [Overview](index=43&type=section&id=Overview) - Xilio is a clinical-stage biotechnology company developing tumor-activated immuno-oncology (I-O) therapies to improve outcomes for cancer patients while minimizing systemic side effects[123](index=123&type=chunk) - The company's most advanced product candidates are vilastobart (anti-CTLA-4 mAb) and XTX301 (engineered IL-12), with vilastobart in a Phase 2 trial and XTX301 in a Phase 1 trial under a license agreement with Gilead[123](index=123&type=chunk) - The company is also advancing preclinical programs, including XTX501 (masked PD-1/IL-2 bispecific) and masked T cell engagers, partly in collaboration with AbbVie[123](index=123&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) Comparison of Results for the Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | $5,727 | | Research and development | $15,330 | $11,216 | $4,114 | | General and administrative | $7,120 | $5,815 | $1,305 | | **Net loss** | **$(15,844)** | **$(13,925)** | **$(1,919)** | Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $11,014 | $2,357 | $8,657 | | Research and development | $23,596 | $21,616 | $1,980 | | General and administrative | $15,635 | $11,954 | $3,681 | | **Net loss** | **$(29,109)** | **$(31,128)** | **$2,019** | - The increase in collaboration revenue for both the three and six-month periods in 2025 was primarily due to revenue recognized under the new agreement with AbbVie and increased revenue from the Gilead agreement[147](index=147&type=chunk)[155](index=155&type=chunk) - R&D expenses increased in Q2 2025 due to higher clinical development costs for vilastobart and manufacturing activities for XTX501, partially offset by the discontinuation of the XTX202 program[148](index=148&type=chunk) [Liquidity and Capital Resources](index=60&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **cash and cash equivalents of $121.6 million**[165](index=165&type=chunk)[178](index=178&type=chunk) - Management anticipates that existing cash will be sufficient to fund operating expenses and capital expenditure requirements through the end of the **third quarter of 2026**[178](index=178&type=chunk) - The company's recurring operating losses and negative cash flows raise substantial doubt about its ability to continue as a going concern, with future operations dependent on raising additional capital through warrant exercises, milestone payments, or other financing activities[178](index=178&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $14,501 | $9,451 | | Net cash used in investing activities | $(423) | $(21) | | Net cash provided by financing activities | $52,194 | $20,997 | [Quantitative and Qualitative Disclosures About Market Risk](index=70&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide this information - As a smaller reporting company defined by Rule 12b-2 of the Exchange Act, Xilio Therapeutics is not required to provide the information under this item[191](index=191&type=chunk) [Controls and Procedures](index=70&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2025, with no material changes to internal control - The company's principal executive officer and principal financial officer evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and concluded they were effective at a reasonable assurance level[193](index=193&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[194](index=194&type=chunk) Part II Other Information [Risk Factors](index=71&type=section&id=Item%201A.%20Risk%20Factors) Xilio faces substantial risks including going concern doubts, potential delisting, unproven early-stage products, clinical/manufacturing challenges, third-party reliance, and IP/regulatory hurdles [Risks Related to Financial Position and Capital Requirements](index=71&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Position%20and%20Capital%20Requirements) - Recurring losses from operations raise substantial doubt about the company's ability to continue as a going concern, potentially requiring cost reduction strategies like delaying or reducing R&D programs without additional capital[198](index=198&type=chunk)[199](index=199&type=chunk) - The company's common stock may be delisted from Nasdaq for failing to meet the minimum bid price requirement of **$1.00 per share**, which could negatively impact its ability to access capital markets[206](index=206&type=chunk) - The company has a history of significant operating losses, with an **accumulated deficit of $412.9 million** as of June 30, 2025, and expects these losses to continue for the foreseeable future[212](index=212&type=chunk) [Risks Related to Product Discovery and Development](index=81&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) - The company's business is highly dependent on the success of its current product candidates (vilastobart and XTX301), which are in early stages of development and require significant additional clinical work[224](index=224&type=chunk) - The company's technological approach to discovering and developing tumor-activated product candidates is unproven, with no guarantee it will lead to commercially valuable products[265](index=265&type=chunk) - Clinical trials may be substantially delayed, suspended, or terminated due to numerous unforeseen events, including regulatory hurdles, patient enrollment difficulties, and unfavorable results[239](index=239&type=chunk) - Interim and preliminary data from clinical trials may change as more patient data becomes available, and final data could be materially different[253](index=253&type=chunk) [Risks Related to Manufacturing and Supply](index=100&type=section&id=Risks%20Relating%20to%20Manufacturing%20and%20Supply) - Manufacturing biologics is complex and subject to problems like contamination or lot failures, which could delay development and commercialization programs[273](index=273&type=chunk)[276](index=276&type=chunk) - The company relies on a single CDMO, WuXi Biologics, based in China, exposing it to risks related to supply interruptions, regulatory compliance, and geopolitical tensions, including potential U.S. trade restrictions or sanctions[280](index=280&type=chunk)[285](index=285&type=chunk)[516](index=516&type=chunk) [Risks Related to Dependence on Third Parties](index=108&type=section&id=Risks%20Related%20to%20our%20Dependence%20on%20Third%20Parties) - The company relies on third-party CROs to conduct clinical trials, and their unsatisfactory performance could harm the business and delay programs[291](index=291&type=chunk)[292](index=292&type=chunk) - Success is dependent on collaborations with Gilead and AbbVie, where partners have significant discretion over development and commercialization, with no guarantee of success or future payments[295](index=295&type=chunk)[297](index=297&type=chunk) [Risks Related to Intellectual Property](index=124&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success depends on its ability to obtain and maintain patent protection, as insufficient scope could allow competitors to develop similar products, adversely affecting commercialization[338](index=338&type=chunk)[339](index=339&type=chunk) - The company relies on in-licensed patent rights for its product candidates (e.g., from City of Hope and WuXi Biologics) and faces risks of losing these rights if it fails to comply with license obligations[359](index=359&type=chunk)[360](index=360&type=chunk) - The company may face third-party claims of intellectual property infringement, which could be expensive, time-consuming, and prevent or delay development efforts[384](index=384&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=152&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) - The regulatory approval process for biologics is expensive, lengthy, and uncertain, and the company, lacking experience in filing for marketing approval, may be unable to obtain it for its product candidates[411](index=411&type=chunk)[412](index=412&type=chunk) - Disruptions at the FDA and other government agencies due to funding cuts, shutdowns, or other events could hinder their ability to provide guidance and review submissions in a timely manner[423](index=423&type=chunk) - Current and future healthcare legislation, such as the Inflation Reduction Act (IRA), may increase the difficulty and cost of obtaining reimbursement and limit the prices for the company's products if approved[464](index=464&type=chunk)[476](index=476&type=chunk) - The company is subject to stringent and evolving data privacy laws (e.g., GDPR, CCPA), and failure to comply could result in significant fines and penalties[492](index=492&type=chunk)[498](index=498&type=chunk) [Other Information](index=211&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[582](index=582&type=chunk) [Exhibits](index=212&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including corporate documents and officer certifications - The Exhibit Index lists key corporate and financial documents filed with the report, such as the Restated Certificate of Incorporation, Warrant Agreements, and Officer Certifications pursuant to the Sarbanes-Oxley Act[585](index=585&type=chunk)

[Overview and Highlights](index=1&type=section&id=Xilio%20Therapeutics%20Announces%20Pipeline%20and%20Business%20Updates%20and%20Second%20Quarter%202025%20Financial%20Results) 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](index=1&type=chunk) - 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](index=1&type=chunk) 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](index=1&type=section&id=Pipeline%20and%20Business%20Updates) The company reports progress across its key pipeline assets, including vilastobart, XTX301, XTX501, and masked T cell engagers [Vilastobart (anti-CTLA-4)](index=1&type=section&id=Vilastobart%3A%20tumor-activated%2C%20Fc-enhanced%2C%20high%20af%20inity%20binding%20anti-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](index=3&type=chunk) - The therapy showed a **differentiated and well-tolerated safety profile**, with a low incidence of colitis and other immune-related adverse events[3](index=3&type=chunk) - Xilio is actively engaging with strategic partners for potential opportunities to **accelerate and expand the development** of vilastobart[3](index=3&type=chunk) [XTX301 (IL-12)](index=2&type=section&id=XTX301%3A%20tumor-activated%20IL-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](index=4&type=chunk) - **Enrollment in the Phase 1A monotherapy dose escalation** portion of the clinical trial has been completed, with patient evaluation ongoing[4](index=4&type=chunk) [XTX501 (PD-1/IL-2 bispecific)](index=2&type=section&id=XTX501%3A%20masked%20PD-1%2FIL-2%20bispecific) 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](index=5&type=chunk) - The company plans to **submit an IND application for XTX501 in the middle of 2026**[5](index=5&type=chunk) [Masked T Cell Engager Programs](index=2&type=section&id=Masked%20T%20Cell%20Engager%20Programs) 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](index=6&type=chunk) - The programs utilize two proprietary formats: the bispecific **ATACR** (activated cell engager) and the tri-specific **SEECR** (selective effector-enhanced cell engager)[7](index=7&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) 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](index=9&type=chunk) - Akintunde (Tunde) Bello, Ph.D., was appointed to the company's board of directors in June 2025[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported increased revenue and operating expenses for Q2 2025 and provided financial guidance through Q3 2026 [Q2 2025 Financial Highlights](index=3&type=section&id=Q2%202025%20Financial%20Highlights) 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](index=3&type=section&id=Financial%20Guidance) 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](index=11&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) The report includes condensed consolidated balance sheets and statements of operations for the period ending June 30, 2025 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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) |

Core Insights - Xilio Therapeutics announced updated Phase 2 data for vilastobart, showing deep and durable responses with a differentiated safety profile for anti-CTLA-4 combination therapy [1][5] - The company is on track to nominate its first development candidates for masked T cell engager programs in the second half of 2025 [1][12] - As of June 30, 2025, Xilio reported $121.6 million in cash and cash equivalents, providing a cash runway through the end of the third quarter of 2026 [1][13] Pipeline and Business Updates - Vilastobart is a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody currently evaluated in combination with atezolizumab for advanced solid tumors and metastatic microsatellite stable colorectal cancer [3][14] - XTX301, a tumor-activated IL-12, is designed to stimulate anti-tumor immunity and is being evaluated as a monotherapy in a Phase 1 clinical trial [4][15] - Xilio's masked T cell engager programs include bispecific and tri-specific molecules designed to enhance T cell activation and are advancing through IND-enabling studies [7][9] Financial Results - Collaboration and license revenue for the quarter ended June 30, 2025, was $8.1 million, up from $2.4 million in the same quarter of 2024 [17] - Research and development expenses increased to $15.3 million in Q2 2025 from $11.2 million in Q2 2024, driven by clinical development activities [17] - The net loss for the quarter ended June 30, 2025, was $15.8 million, compared to a net loss of $13.9 million for the same period in 2024 [17][23]

Pipeline and Programs - Vilastobart (tumor-activated anti-CTLA-4) reported a preliminary Objective Response Rate (ORR) of 26% in Phase 2 for heavily pre-treated patients with microsatellite stable colorectal cancer (MSS CRC) without liver metastases[35, 41] - XTX301 (tumor-activated IL-12) is advancing in partnership with Gilead, with a potential $75 million option fee at Phase 1/2 data package[67, 69] - XTX501 (tumor-activated PD-1/IL-2 bispecific) IND submission is anticipated in mid-2026[74] - The company plans to nominate development candidates for PSMA, CLDN182, and STEAP1 masked T cell engager programs in Q3 2025, Q4 2025, and 1H 2026, respectively[24, 101] Financials and Partnerships - The company had $89.1 million in cash and cash equivalents as of March 31, 2025[120] - The company received approximately $47.2 million in estimated net proceeds from equity financing in June 2025[120] - The company anticipates a cash runway through the end of Q3 2026[21, 120] - The company is eligible to receive up to $100 million in additional gross proceeds from equity financing by 2H 2026[21, 120] - The company has a collaboration, license, and option agreement with AbbVie for tumor-activated immunotherapies, including masked T cell engagers, with up to ~$2.1 billion in total contingent payments[20, 113] Technology and Approach - The company's platform exploits dysregulated matrix metalloprotease (MMP) activity in tumors to activate molecules[12] - The company's masked T cell engagers are designed to optimize the therapeutic index by maximizing tumor exposure and minimizing peripheral activity and off-tumor cytotoxicity[98]