Xilio Therapeutics, Inc. filings document the regulatory record of a clinical-stage biotechnology company developing masked immuno-oncology therapies. Its 8-K reports cover financial results, pipeline and business updates, investor presentations, material agreements, capital-structure matters, and clinical or regulatory disclosures tied to its masked I-O programs.
Proxy statements and related 8-K filings describe stockholder votes, director elections, board and committee changes, auditor ratification, equity incentive plans, and amendments affecting common stock. The filing record also includes disclosures related to reverse stock split matters, security-holder rights, director compensation, and governance arrangements for the company’s Delaware corporate structure.
Xilio Therapeutics, Inc. is moving its common stock listing from the Nasdaq Global Select Market to the Nasdaq Capital Market, effective at the open of business on October 6, 2025, while continuing to trade under the symbol XLO. This change follows a prior notice from Nasdaq on April 8, 2025 that the company no longer met the $1.00 minimum bid price requirement for the Global Select tier. In connection with the transfer, Nasdaq granted Xilio an additional 180 calendar days, until March 30, 2026, for its stock to close at or above $1.00 for at least 10 consecutive business days to regain compliance. The company states that it is continuing to evaluate options to restore compliance with the minimum bid price rule.
Xilio Therapeutics disclosed that it has begun dosing patients in Phase 2 of an ongoing Phase 1/2 trial of efarindodekin alfa (XTX301), a tumor-activated IL-12 being tested as a monotherapy in certain advanced solid tumors. The company also reported achieving a $17.5 million development milestone under its license agreement with Gilead Sciences tied to this program and referenced updated data from the ongoing Phase 1 trial.
As of June 30, 2025, Xilio had $121.6 million in cash and cash equivalents. It now expects that this balance, together with the $17.5 million milestone, will fund operating and capital needs into the first quarter of 2027. Xilio expects to receive the milestone payment by the fourth quarter of 2025.
Xilio Therapeutics, Inc. reports that Nasdaq has notified the company it no longer meets the Nasdaq Global Select Market requirement to maintain at least $10.0 million in stockholders’ equity, after reporting stockholders’ equity of $7,069,000 in its Form 10-Q for the quarter ended June 30, 2025. The notice does not immediately affect trading of Xilio’s common stock. Xilio has 45 days, until October 6, 2025, to submit a plan to regain compliance, and Nasdaq may grant up to 180 additional days to show it meets the equity standard or allow a transfer to the Nasdaq Capital Market if that market’s listing criteria are satisfied.
The company also reminds investors that it previously received a Nasdaq notice on April 4, 2025 for failing to maintain the $1.00 minimum bid price, with an initial 180‑day cure period expiring on October 1, 2025, and that it remains out of compliance with this bid price requirement. Xilio states that it is evaluating options to regain compliance with Nasdaq listing rules.
Gilead Sciences, Inc. reports beneficial ownership of 10,613,944 shares of Xilio Therapeutics, representing 19.9% of the outstanding common stock based on 51,827,910 shares outstanding. The filing states Gilead has sole voting and dispositive power over these shares. The holdings consist of 6,860,223 shares issued March 28, 2024; 485,250 shares issued April 3, 2024; 1,759,978 shares issued December 18, 2024; and 1,508,493 shares issuable upon exercise of pre-funded warrants. The statement certifies the shares were not acquired to change or influence control of the issuer.
Frazier-affiliated investment vehicles reported ownership of pre-funded warrants exercisable into Xilio Therapeutics (XLO) common stock. Several Frazier funds each directly hold warrants to acquire specific share amounts: Frazier Life Sciences Public Fund (reported cover-page amount 8,141,017 shares), Frazier Life Sciences Public Overage Fund (2,401,633), Frazier Life Sciences X (336,042), Frazier Life Sciences XI (894,779) and Frazier Life Sciences XII (1,561,529). Collectively these positions amount to 13,335,000 shares issuable upon exercise of the reported warrants (sum of the reported quantities). The filing explains that the percentages are calculated using 51,782,273 shares outstanding (as reported by the issuer), and notes that FLSPF’s exercisability is subject to a 9.99% beneficial ownership limitation (the cover pages show FLSPF at 9.9% due to rounding). The statement also corrects prior attributions and clarifies which committee members are not attributed beneficial ownership; certain individuals (e.g., James Topper and Patrick Heron) are reported as sharing voting and dispositive power over 336,042 shares held through FLS X.
Xilio Therapeutics (XLO) reported a mixed quarter with strengthened liquidity but continued operating losses that raise going concern questions. The company held $121.6 million of cash and cash equivalents and $1.8 million of restricted cash at June 30, 2025 (total $123.3 million including restricted cash). Xilio recognized $11.0 million of collaboration and license revenue in the six months ended June 30, 2025 and recorded $70.9 million of total deferred revenue related to agreements with Gilead and AbbVie.
Operating results show a $29.1 million net loss for the six months ended June 30, 2025 and an $412.9 million accumulated deficit. Management discloses that these losses and cash needs create substantial doubt about the company’s ability to continue as a going concern within twelve months. The company closed a June 2025 follow-on offering that produced $50.0 million of initial gross proceeds and issued prefunded warrants and detachable common stock warrants that could yield up to $100.0 million more if exercised. Xilio is also eligible for material contingent payments under collaborations: up to $2.1 billion from AbbVie and $592.5 million from Gilead, subject to achievement of milestones.
Xilio Therapeutics, Inc. furnished an update on its business by announcing financial results for the quarter ended June 30, 2025 and related business highlights. The company did this through a press release dated August 14, 2025, which is attached as Exhibit 99.1.
The press release and related information are furnished, not filed, meaning they are not subject to certain Exchange Act liabilities and are only incorporated into other filings if specifically referenced.