Company Overview - Xilio Therapeutics, Inc. is a clinical-stage biotechnology company focused on discovering and developing tumor-activated immuno-oncology therapies aimed at improving outcomes for cancer patients while minimizing systemic side effects [4] Leadership Appointment - Akintunde (Tunde) Bello, Ph.D., has been appointed to the board of directors of Xilio Therapeutics, bringing over 25 years of experience in oncology research and development [1][2] - Dr. Bello has a strong track record in developing novel therapies, including significant contributions to cancer immunotherapies such as anti-CTLA-4 and PD-1 [2][3] Expertise and Background - Dr. Bello previously served as senior vice president at Bristol Myers Squibb, overseeing clinical pharmacology and pharmacometrics across multiple therapeutic areas [3] - His academic credentials include a B.Sc. in biomedical sciences, an M.Sc. in instrumentation and analytical science, and a Ph.D. in pharmaceutical sciences [3] Strategic Goals - The company aims to leverage Dr. Bello's expertise to advance its pipeline, including XTX501, a masked PD-1/IL-2 bi-specific therapy, and other bi-specific and tri-specific T cell engager programs [2][3] - Xilio's innovative approach focuses on optimizing the therapeutic index by localizing anti-tumor activity within the tumor microenvironment [4]

Core Viewpoint - Xilio Therapeutics, Inc. has successfully closed a public offering of pre-funded warrants and common stock warrants, raising approximately $50 million, with potential total gross proceeds of up to $150 million by the end of 2026 if all warrants are exercised for cash [1][5]. Group 1: Offering Details - The offering included pre-funded warrants to purchase 66,676,000 shares of common stock, along with Series A, B, and C warrants, all sold together at a combined public offering price of $0.7499 [2][4]. - The Series B warrants are exercisable at $0.75 per share between November 1, 2025, and December 2, 2025, potentially generating an additional $50 million if fully exercised [4]. - The Series C warrants are also exercisable at $0.75 per share between June 1, 2026, and December 2, 2026, with the same potential additional proceeds of $50 million if fully exercised [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance the development of Xilio's product candidates and for working capital and general corporate purposes [5]. Group 3: 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 [8].

Core Viewpoint - Xilio Therapeutics, Inc. has announced a public offering of pre-funded warrants and various series of warrants to raise approximately $50 million, aimed at advancing its tumor-activated immuno-oncology therapies for cancer treatment [1][3][4]. Group 1: Offering Details - The public offering includes 66,676,000 pre-funded warrants and corresponding Series A, B, and C warrants, with a combined offering price of $0.7499 per unit [1]. - The offering is expected to close around June 5, 2025, pending customary closing conditions [1]. - The initial gross proceeds from the offering are projected to be approximately $50 million before deducting underwriting discounts and commissions [3]. Group 2: Warrant Specifications - Pre-funded warrants are immediately exercisable until fully exercised, while Series A warrants can be exercised starting December 1, 2025, with an exercise price of $0.75 per share [2]. - Series B warrants will be exercisable on or after November 1, 2025, and Series C warrants on or after June 1, 2026, both with an exercise price of $0.75 per share [2]. Group 3: Use of Proceeds - The net proceeds from the offering will be utilized to advance the development of product candidates and for working capital and general corporate purposes [4]. Group 4: Company Overview - Xilio Therapeutics is focused on developing tumor-activated immuno-oncology therapies designed to improve cancer treatment outcomes while minimizing systemic side effects [8].

Core Viewpoint - Xilio Therapeutics, Inc. is initiating an underwritten public offering of pre-funded warrants and various series of warrants to purchase shares of common stock, aimed at advancing its product candidates and supporting general corporate needs [1][2]. Group 1: Offering Details - The public offering includes pre-funded warrants and Series A, B, and C warrants for purchasing common stock, all offered by Xilio [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the specific terms [1]. - Leerink Partners is acting as the sole bookrunner for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to further develop product candidates and for working capital and other corporate purposes [2]. Group 3: Regulatory Information - A shelf registration statement related to the securities was filed with the SEC on March 11, 2025, and was declared effective on May 8, 2025 [3]. - The offering will be conducted through a prospectus supplement and accompanying prospectus, which will be available on the SEC's website [3]. Group 4: Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies to improve cancer treatment outcomes while minimizing systemic side effects [5]. - The company is leveraging a proprietary platform to advance a pipeline of novel, tumor-activated immuno-oncology molecules [5].

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 ...

Financial Performance - Net loss for Q1 2025 was $13.3 million, compared to a net loss of $17.2 million in Q1 2024[12]. - Net loss narrowed to $13.265 million in Q1 2025, compared to a net loss of $17.203 million in Q1 2024, reflecting an improvement of approximately 23%[20]. - Net loss per share improved to $0.18 in Q1 2025 from $0.62 in Q1 2024[20]. - Total operating expenses decreased to $16.781 million in Q1 2025 from $17.487 million in Q1 2024, a reduction of about 4%[20]. Revenue and Collaboration - Collaboration and license revenue for Q1 2025 was $2.9 million, with no revenue recognized in Q1 2024[12]. - Collaboration and license revenue for the three months ended March 31, 2025, was $2.930 million, compared to $0 for the same period in 2024[20]. - Xilio entered into a collaboration agreement with AbbVie, receiving $52.0 million in upfront payments and is eligible for up to $2.1 billion in contingent payments[8]. Expenses - Research and development expenses decreased to $8.3 million in Q1 2025 from $10.4 million in Q1 2024, primarily due to reduced clinical development activities for XTX202[12]. - Research and development expenses decreased to $8.266 million in Q1 2025 from $10.400 million in Q1 2024, a decline of about 21%[20]. - General and administrative expenses rose to $8.5 million in Q1 2025 from $6.1 million in Q1 2024, driven by increased legal fees and personnel-related costs[12]. - General and administrative expenses increased to $8.515 million in Q1 2025 from $6.139 million in Q1 2024, an increase of approximately 39%[20]. Cash and Assets - Cash and cash equivalents increased to $89.1 million as of March 31, 2025, up from $55.3 million as of December 31, 2024[12]. - Cash and cash equivalents increased significantly to $89.073 million as of March 31, 2025, compared to $55.291 million at the end of 2024, marking a rise of about 61%[19]. - Total assets increased to $103.716 million as of March 31, 2025, up from $71.075 million on December 31, 2024, representing a growth of approximately 46%[19]. - Deferred revenue surged to $78.994 million as of March 31, 2025, up from $32.780 million on December 31, 2024, indicating a growth of approximately 141%[19]. Clinical Development - Xilio reported a preliminary 27% objective response rate for vilastobart in combination with atezolizumab in late-line MSS CRC patients without liver metastases[2]. - Xilio plans to report updated Phase 2 data for vilastobart at the ASCO Annual Meeting from May 30 to June 3, 2025[3]. - Xilio anticipates nominating a development candidate for its PSMA program in the ATACR format in Q3 2025[7]. - XTX501 is currently advancing in IND-enabling studies, with an IND application planned for mid-2026[5]. Shareholder Information - The weighted average common shares outstanding increased to 74,700,364 in Q1 2025 from 27,912,584 in Q1 2024, reflecting a significant increase in share count[20].

Core Insights - Xilio Therapeutics announced progress in its pipeline, particularly highlighting the Phase 2 data for vilastobart, a tumor-activated anti-CTLA-4 monoclonal antibody, in combination with atezolizumab for treating metastatic microsatellite stable colorectal cancer (MSS CRC) [1][2][5] - The company is advancing multiple masked T cell engager programs and anticipates the first development candidates in the second half of 2025 [1][2] Pipeline and Business Updates - Vilastobart is designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment, currently evaluated in Phase 1C and Phase 2 trials [3][14] - Initial Phase 2 data showed a 27% objective response rate in late-line MSS CRC patients without liver metastases, with a favorable safety profile [2][5] - XTX301, a tumor-activated IL-12, is in Phase 1 trials, with a partnership established with Gilead for its development [6][15] - XTX501, a masked PD-1/IL-2 bispecific, is in IND-enabling studies, with an IND application planned for mid-2026 [7][9] Corporate Updates - Xilio entered a collaboration agreement with AbbVie, receiving $52 million upfront and potential total payments of approximately $2.1 billion [10] - The company reported cash and cash equivalents of $89.1 million as of March 31, 2025, an increase from $55.3 million at the end of 2024 [11][20] Financial Results - Collaboration and license revenue for Q1 2025 was $2.9 million, with R&D expenses at $8.3 million, down from $10.4 million in Q1 2024 [17][22] - General and administrative expenses increased to $8.5 million from $6.1 million year-over-year [17][22] - The net loss for Q1 2025 was $13.3 million, compared to $17.2 million in the same quarter of 2024 [17][22]

Company Overview - Xilio Therapeutics, Inc. is a clinical-stage biotechnology company focused on discovering and developing tumor-activated immuno-oncology therapies aimed at improving outcomes for cancer patients without the systemic side effects associated with current treatments [4]. Stock Option Grant - On May 1, 2025, the company granted a non-qualified stock option to purchase 5,000 shares of its common stock to a new employee under its 2022 Inducement Stock Incentive Plan [1]. - The exercise price for the stock options is set at $0.755 per share, which matches the closing price of the company's common stock on the grant date [2]. - The stock options have a ten-year term, with 25% of the shares vesting on the first anniversary of employment and the remaining 75% vesting in 36 equal monthly installments, contingent on continued service with the company [2][3]. Compliance and Inducement - The stock options are granted in accordance with Nasdaq Listing Rule 5635(c)(4) as an inducement material to the individual entering employment with the company [3].

Core Insights - Xilio Therapeutics, Inc. is set to present updated data from its Phase 2 clinical trial of vilastobart, an anti-CTLA-4 therapy, in combination with atezolizumab for metastatic microsatellite stable colorectal cancer at the 2025 ASCO Annual Meeting [1] - The presentation will take place on May 31, 2025, during a poster session focused on gastrointestinal cancer [2] 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 [3] - The company utilizes a proprietary platform to create novel tumor-activated immuno-oncology molecules that enhance localized anti-tumor activity within the tumor microenvironment [3] Clinical Trial Details - Vilastobart is designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment [2] - In 2023, Xilio entered a collaboration with Roche to co-fund a clinical trial evaluating vilastobart in combination with atezolizumab in a multi-center, open-label Phase 1/2 trial [2] - The ongoing trials include a Phase 1C dose escalation for advanced solid tumors and a Phase 2 trial for metastatic microsatellite stable colorectal cancer, with and without liver metastases [2]