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]

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]

WALTHAM, Mass., May 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, effective May 1, 2025, the company granted a non-qualified stock option to purchase 5,000 shares of its common stock to one new employee under Xilio Therapeutics’ 2022 Inducement Stock Incentive Plan. The stock options have an exercise price of $0.755 per share, ...