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]

Financial Performance - The company reported a net loss of $13.3 million for the three months ended March 31, 2025, compared to a net loss of $17.2 million for the same period in 2024[110]. - As of March 31, 2025, the company had an accumulated deficit of $397.0 million[110]. - The company has not generated any revenue from product sales since inception and does not expect to do so for at least the next several years[114]. - The company has incurred significant operating losses and expects to continue incurring substantial expenses for the foreseeable future[110]. - The company anticipates incurring substantial operating losses and negative operating cash flows for the foreseeable future[147]. Cash and Liquidity - As of March 31, 2025, the company had cash and cash equivalents of $89.1 million, which is expected to fund operations into the first quarter of 2026[110]. - The company has raised a total of $491.8 million in gross proceeds through various financing activities up to March 31, 2025[134]. - During the three months ended March 31, 2025, net cash provided by financing activities was $4.832 million, primarily from the sale of common stock to AbbVie and through ATM offerings[145]. - The cash flows from operating activities were influenced by changes in operating assets and liabilities, including $49.1 million recorded as deferred revenue from collaboration agreements[141]. - The company faces substantial doubt about its ability to continue as a going concern without securing additional capital[149]. Collaboration and Revenue - The company has received $52.0 million in total upfront payments from AbbVie, including a cash payment of $42.0 million and an equity investment of $10.0 million[104]. - The collaboration agreement with AbbVie could yield up to approximately $2.1 billion in additional contingent payments, including $305.0 million in program nomination fees and up to $1.8 billion in development and sales-based milestones[104]. - Collaboration and license revenue for the three months ended March 31, 2025, was $2.9 million, compared to $0 for the same period in 2024[129]. Research and Development - The company is advancing vilastobart in a Phase 2 clinical trial in combination with atezolizumab for metastatic microsatellite stable colorectal cancer[98]. - XTX301 is currently in a Phase 1 clinical trial for advanced solid tumors under a license agreement with Gilead Sciences[98]. - The company plans to report additional data from the Phase 2 clinical trial at the 2025 American Society of Clinical Oncology Annual Meeting[98]. - Research and development expenses decreased by $2.1 million from $10.4 million in Q1 2024 to $8.3 million in Q1 2025[130]. - Research and development expenses for the vilastobart program increased by $0.3 million due to increased clinical development activities[130]. Operating Expenses - General and administrative expenses increased by $2.4 million from $6.1 million in Q1 2024 to $8.5 million in Q1 2025[131]. - Personnel-related costs in general and administrative expenses increased by $0.9 million, driven by higher salaries and recruiting costs[135]. - The company incurred no restructuring expenses in Q1 2025, compared to $0.9 million in Q1 2024[132]. Workforce and Strategic Changes - The company reduced its workforce by 15 employees, representing approximately 21% of its workforce, as part of a strategic restructuring in March 2024[126].

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].

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].