WALTHAM, Mass. – Xilio Therapeutics Inc. (NASDAQ: XLO), a biotechnology firm focused on immuno-oncology therapies, has announced upcoming presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, along with a business update and third-quarter financial results. The company is set to showcase initial Phase 1C dose escalation data for its investigational drug vilastobart (XTX101) in combination with atezolizumab.
Vilastobart is a tumor-activated, Fc-enhanced anti-CTLA-4 antibody intended to block CTLA-4 and deplete regulatory T cells within the tumor microenvironment. Xilio is currently enrolling patients in a Phase 2 clinical trial to assess the efficacy of vilastobart combined with atezolizumab in metastatic microsatellite stable colorectal cancer (MSS CRC), including those with liver metastases. Initial Phase 2 data is expected in the fourth quarter of 2024 for about 20 patients, with further results anticipated in the first quarter of 2025.
In addition to vilastobart, Xilio is advancing XTX301, a tumor-activated IL-12, through Phase 1A and 1B trials. The company plans to report Phase 1 safety, pharmacokinetic, and pharmacodynamic data in the fourth quarter of 2024.
Research into tumor-activated bispecific and immune cell engager molecules continues with preclinical data on the company's SELECTIVE EFFECTOR-ENHANCED CELL ENGAGER (SEECR) format to be presented at the SITC meeting. Xilio is also progressing with investigational new drug (IND)-enabling activities for XTX501, a tumor-activated bispecific PD-1/IL-2.
Financially, Xilio reported an increase in cash and cash equivalents to $61.3 million as of September 30, 2024, from $44.7 million at the end of 2023. License revenue for the quarter was $2.3 million, attributed to a license agreement and stock purchase agreement with Gilead (NASDAQ:GILD). R&D expenses saw a slight decrease from the previous year's quarter, while G&A expenses remained stable. The net loss for the quarter was reported at $14.0 million, an improvement from the $16.7 million loss in the same quarter of 2023.
Xilio anticipates that its current cash reserves will fund operations through the end of the second quarter of 2025. The company's strategic focus remains on developing therapies that localize anti-tumor activity within the tumor microenvironment to improve patient outcomes.
This article is based on a press release statement from Xilio Therapeutics.
In other recent news, Xilio Therapeutics has reported promising initial clinical data from its ongoing Phase 1C trial evaluating a new combination of cancer treatments, vilastobart and atezolizumab, particularly for difficult-to-treat, microsatellite stable colorectal cancer (MSS CRC). The company has also received a deficiency notice from Nasdaq regarding its share price falling below the required $1.00, and has until March 10, 2025, to regain compliance. In addition, TD Cowen has reaffirmed its Buy rating on Xilio, indicating confidence in the company's clinical direction.
In financial reports, Xilio announced a second-quarter net loss of $14 million, with cash reserves of $75 million projected to last until 2025. The company continues to focus its efforts on two significant clinical trials, XTX101 and XTX301, with results anticipated later this year.
Furthermore, Xilio has announced the addition of Aoife Brennan, M.D., and James Shannon, M.D., to its board of directors. The company also secured approximately $11.3 million through a private investment involving Bain Capital Life Sciences and Rock Springs Capital. As a recent development, Xilio is reducing its workforce by approximately 21%, expected to incur one-time costs of around $1 million. These are the latest developments in Xilio's ongoing operations and strategic efforts.
InvestingPro Insights
Xilio Therapeutics Inc. (NASDAQ: XLO) is showing some intriguing financial dynamics that align with its recent announcements and strategic focus. According to InvestingPro data, the company's market capitalization stands at $56.7 million, reflecting its current position in the biotech sector.
An InvestingPro Tip indicates that Xilio holds more cash than debt on its balance sheet, which corroborates the company's reported increase in cash and cash equivalents to $61.3 million as of September 30, 2024. This strong cash position supports Xilio's projection of funding operations through the end of the second quarter of 2025, crucial for its ongoing clinical trials and research activities.
Another relevant InvestingPro Tip reveals that Xilio is quickly burning through cash, which is typical for biotech companies in the research and development phase. This aligns with the company's reported R&D expenses and ongoing clinical trials for vilastobart and XTX301.
The company's stock has shown a strong return over the last month and three months, with InvestingPro data indicating a 61.25% and 49.74% price total return, respectively. This recent performance may reflect investor optimism about Xilio's upcoming presentations and anticipated clinical data releases.
It's worth noting that analysts do not anticipate the company to be profitable this year, which is consistent with Xilio's reported net loss and its focus on long-term drug development rather than immediate profitability.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Xilio Therapeutics, providing deeper insights into the company's financial health and market position.
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