Xilio Therapeutics Provides Pipeline, Business, and Q2 2024 Financial Updates

Xilio Therapeutics, Inc., a clinical-stage biotechnology firm based in Waltham, Massachusetts, has recently made significant advancements in its immuno-oncology treatments targeting cancer patients. The company's latest pipeline progress and financial performance for the second quarter ending June 30, 2024, demonstrate promising developments.

Xilio has initiated enrollment in several critical clinical trials. One of the key trials is a Phase 2 study of XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 in combination with atezolizumab, aimed at treating patients with microsatellite stable colorectal cancer (MSS CRC). This study is particularly focused on evaluating both the safety and efficacy of this combination at specific dosage intervals. Initial results from this trial are anticipated by the fourth quarter of 2024.

Another notable trial involves XTX301, a tumor-activated IL-12 designed to enhance anti-tumor immunity. Xilio has begun the Phase 1B monotherapy dose expansion for XTX301 in patients with advanced solid tumors. Concurrently, the Phase 1A monotherapy dose escalation is still ongoing, with dosages being assessed for safety and tolerability. Encouragingly, no dose-limiting toxicities have been observed thus far, and related data is expected to be reported by the end of 2024.

In addition to these clinical trials, Xilio is also advancing several research-stage programs focused on tumor-activated bispecifics and immune cell engagers, leveraging its innovative masking technology. These programs aim to develop new therapeutic options that target and activate immune cells within the tumor microenvironment, potentially leading to more effective cancer treatments.

On the corporate front, Xilio has announced the promotion of Chris Frankenfield to the position of chief financial officer. His extensive experience in strategic, financial, and operational roles is expected to be instrumental in progressing Xilio's pipeline of novel therapies.

From a financial perspective, Xilio reported significant improvements. As of June 30, 2024, the company had $74.9 million in cash and cash equivalents, an increase from $44.7 million at the end of 2023. This boost was partly due to a $30 million upfront payment under a license agreement with Gilead Sciences for XTX301, as well as proceeds from the sale of common stock and prefunded warrants.

For the quarter ending June 30, 2024, Xilio's license revenue stood at $2.4 million, a new revenue stream associated with its agreement with Gilead. Research and development (R&D) expenses decreased to $11.2 million compared to $13.2 million in the same quarter last year, primarily due to reduced manufacturing activities for XTX301 and lower clinical development costs for other programs. General and administrative (G&A) expenses also saw a reduction, amounting to $5.8 million, down from $6.9 million the previous year. This decrease was largely attributed to lower personnel-related costs and consulting fees.

Despite these reductions, Xilio reported a net loss of $13.9 million for the quarter, an improvement from the $19.4 million loss reported for the same period in 2023. The company remains optimistic about its financial outlook, anticipating that its current cash reserves will be sufficient to fund operations into the second quarter of 2025.

Xilio's recent strategic moves and clinical progress underscore its commitment to developing innovative cancer therapies. With several key data milestones expected in the coming year, the company is poised to make significant strides in the field of immuno-oncology.

In summary, Xilio Therapeutics continues to advance its clinical-stage pipeline, focusing on tumor-activated therapies designed to improve the efficacy and safety of cancer treatments. The company's robust financial position and strategic leadership changes further position it for potential growth and success in the biopharmaceutical industry.

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