Xilio Therapeutics Reports Second Quarter 2026 Financial Results and Provides Pipeline and Business Updates
Rhea-AI Summary
Xilio Therapeutics (Nasdaq:XLO) reported second quarter 2026 results and key pipeline updates. The company received FDA clearance of its IND for XTX501, a bispecific PD‑1 / masked IL‑2, enabling initiation of a first‑in‑human Phase 1/2 trial in metastatic NSCLC and select advanced solid tumors in the second half of 2026, with initial Phase 1 NSCLC data expected in the second half of 2027.
Xilio is advancing IND‑enabling studies for potential first‑in‑class masked T cell engager programs targeting CLDN18.2 and PSMA+STEAP1, with IND submissions planned in the second half of 2027, and continues a Phase 2 trial of masked IL‑12 efarindodekin alfa. For Q2 2026, collaboration and license revenue was $18.7 million versus $8.1 million a year ago, R&D expenses were $14.6 million, G&A expenses were $7.6 million, and net loss was $6.4 million versus $15.8 million. Cash and cash equivalents were $136.0 million as of June 30, 2026, and Xilio expects its cash runway to extend into the first quarter of 2028.
Positive
- FDA IND clearance for XTX501 enabling Phase 1/2 trial initiation in 2H 2026
- Collaboration and license revenue $18.7 million in Q2 2026 vs. $8.1 million in Q2 2025
- Net loss narrowed to $6.4 million in Q2 2026 from $15.8 million in Q2 2025
- Cash and cash equivalents $136.0 million as of June 30, 2026
- Cash runway expected to fund operations into the first quarter of 2028
- Deferred revenue of $35.3 million reflecting existing collaboration obligations
Negative
- Continuing net loss of $6.4 million in Q2 2026
- Common stock warrant liabilities of $30.2 million as of June 30, 2026
- Change in fair value of warrant liabilities negative $3.9 million in Q2 2026
- G&A expenses increased to $7.6 million in Q2 2026 from $7.1 million in Q2 2025
News Explained
On
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 12 | Q1 earnings | Positive | +0.0% | Revenue increased, net loss narrowed, and cash supported operations into early 2028. |
| Mar 23 | Q4 earnings | Positive | +0.0% | Pipeline milestones advanced while year-end cash and runway were disclosed. |
| Nov 13 | Q3 earnings | Positive | -9.3% | Clinical response data and pipeline progress accompanied a negative 24-hour reaction. |
| Aug 14 | Q2 earnings | Positive | -1.7% | Clinical data, financing, and runway updates preceded a negative 24-hour reaction. |
| May 08 | Q1 earnings | Positive | +8.0% | AbbVie collaboration funding and improved quarterly loss accompanied positive clinical data. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific earnings reactions averaged -0.59% across five events, with three aligned reactions and two divergences.
Key Terms
investigational new drug application regulatory
bispecific medical
t cell engager medical
tumor microenvironment medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Received FDA clearance of IND application for XTX501, a potential best-in-class bispecific PD-1 / masked IL-2
Advancing IND-enabling studies for potential first-in-class multi-specific, masked T cell engager programs targeting CLDN18.2 and PSMA+STEAP1; IND applications anticipated in the second half of 2027
Cash runway into the first quarter of 2028 expected to support key milestones across pipeline of next generation multi-specific I-O therapies
WALTHAM, Mass., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the second quarter ended June 30, 2026.
“In the second quarter, we remained focused on disciplined execution across our pipeline as we continued to advance our next generation of masked immuno-oncology therapies toward the clinic. Today, we are excited to announce FDA clearance of our IND for XTX501, a bispecific PD-1 / masked IL-2 that we believe has the potential to become a foundational backbone therapy for solid tumors,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “At the same time, we are advancing IND-enabling studies for our multi-specific, masked T cell engagers targeting CLDN18.2 and PSMA+STEAP1. Together, these programs highlight the potential to leverage our masking technology to unlock the next generation of sophisticated, multi-specific I-O therapies for people living with cancer.”
Pipeline Progress and Business Updates
XTX501: bispecific PD-1 / masked IL-2
XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational backbone therapy for solid tumors, including in combination with other agents. XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents.
- Xilio received clearance from the U.S. Food and Drug Administration (FDA) for the company’s investigational new drug application (IND) to proceed to a Phase 1/2 clinical trial for XTX501.
- Xilio expects to initiate dosing in the Phase 1 portion of the trial in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors in the second half of 2026. Xilio plans to report initial Phase 1 data in patients with metastatic NSCLC in the second half of 2027.
Masked T Cell Engager Programs
Xilio is leveraging its proprietary, clinically-validated masking technology and modular T cell engager (TCE) architectures to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie Group Holdings Limited (AbbVie).
The company’s masked TCEs are designed with a masked CD3 targeting domain and one or more tumor-associated antigen (TAA) binding domains as part of the core molecule design. In addition, the company’s modular architecture enables the incorporation of a co-stimulatory domain designed to further enhance potency and durability of T cell response, as well as the potential to mask the TAA binding domain(s) and/or mask the co-stimulatory signaling domain. Upon tumor-selective activation, Xilio’s TCE molecules are designed to release a potent, short half-life TCE in the tumor microenvironment.
- Xilio is advancing IND-enabling studies for a potential first-in-class masked TCE program targeting CLDN18.2 and a potential first-in-class multi-specific, masked TCE program targeting PSMA and STEAP1 with built-in co-stimulatory signaling. CLDN18.2 is a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal), and PSMA and STEAP1 are TAAs expressed in prostate cancer.
- Xilio plans to submit INDs for its CLDN18.2 and PSMA+STEAP1 programs in the second half of 2027.
Efarindodekin alfa: masked IL-12
- Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. (Gilead) in the first half of 2027.
Recent Corporate Updates
- Xilio appointed Ben Harshbarger as its chief legal officer in June 2026. Ben has over 20 years of executive leadership and legal expertise within the biopharmaceutical industry. Read more here.
Second Quarter 2026 Financial Results
- Cash Position: Cash and cash equivalents were
$136.0 million as of June 30, 2026, compared to$137.5 million as of December 31, 2025. - Collaboration and License Revenue: Collaboration and license revenue was
$18.7 million for the quarter ended June 30, 2026, compared to$8.1 million for the quarter ended June 30, 2025. The increase was driven by an increase in collaboration and license revenue recognized under the collaboration and license agreements with AbbVie and Gilead. - Research & Development (R&D) Expenses: R&D expenses were
$14.6 million for the quarter ended June 30, 2026, compared to$15.3 million for the quarter ended June 30, 2025. The decrease was primarily driven by decreased clinical development activities related to vilastobart and decreased manufacturing activities for XTX501, partially offset by increased costs related to masked TCE programs and indirect research and development and increased personnel-related costs. - General & Administrative (G&A) Expenses: G&A expenses were
$7.6 million for the quarter ended June 30, 2026, compared to$7.1 million for the quarter ended June 30, 2025. The increase was primarily driven by an increase in personnel-related costs. - Net Loss: Net loss was
$6.4 million for the quarter ended June 30, 2026, compared to a net loss of$15.8 million for the quarter ended June 30, 2025.
Cash Runway
Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2028.
This estimate excludes up to
About XTX501 and the Phase 1/2 Clinical Trial
XTX501 is an investigational bispecific PD-1 / masked IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. Xilio is evaluating the safety and tolerability of XTX501 as a monotherapy in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors in the Phase 1 portion of a first-in-human, multi-center, open-label Phase 1/2 clinical trial at multiple sites in the United States. Please refer to NCT07688577 on www.clinicaltrials.gov for additional details.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing masked immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. Leveraging our clinically-validated masking technology and capabilities, Xilio is developing I-O therapies designed to selectively activate within the tumor microenvironment to achieve durable efficacy without the severe side effects associated with systemically active I-O agents. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, expectations, development timelines and anticipated milestones for Xilio’s programs; the timing of clinical development, data releases, regulatory submissions, delivery of option data packages or other program updates; the promise or potential success of Xilio’s programs, including the best-in-class potential of XTX501 and the potential for XTX501 to be a foundational backbone therapy for solid tumors and the first-in-class potential of Xilio’s masked TCE programs targeting CLDN18.2 and PSMA+STEAP1; the timing and receipt of future contingent payments under Xilio’s collaboration and license agreements with AbbVie and Gilead; the potential receipt of up to
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Investor Contact
Alex Lobo, Precision AQ
alex.lobo@precisionaq.com
Media Contact
Josie Butler, 1AB
josie@1abmedia.com
| XILIO THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (In thousands) (Unaudited) | ||||||
| June 30, 2026 | December 31, 2025 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 136,040 | $ | 137,531 | ||
| Other assets | 18,214 | 17,154 | ||||
| Total assets | $ | 154,254 | $ | 154,685 | ||
| Liabilities and Stockholders’ Equity | ||||||
| Liabilities | ||||||
| Deferred revenue | $ | 35,318 | $ | 60,658 | ||
| Common stock warrant liabilities | 30,200 | 29,560 | ||||
| Other liabilities | 16,472 | 29,194 | ||||
| Total liabilities | $ | 81,990 | $ | 119,412 | ||
| Stockholders’ equity | 72,264 | 35,273 | ||||
| Total liabilities and stockholders’ equity | $ | 154,254 | $ | 154,685 | ||
| XILIO THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data)(1) (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Collaboration and license revenue | $ | 18,692 | $ | 8,084 | $ | 31,340 | $ | 11,014 | ||||||||
| Operating expenses(2) | ||||||||||||||||
| Research and development | $ | 14,559 | $ | 15,330 | $ | 34,391 | $ | 23,596 | ||||||||
| General and administrative | 7,624 | 7,120 | 14,552 | 15,635 | ||||||||||||
| Total operating expenses | 22,183 | 22,450 | 48,943 | 39,231 | ||||||||||||
| Loss from operations | (3,491 | ) | (14,366 | ) | (17,603 | ) | (28,217 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Change in fair value of common stock warrant liabilities | (3,940 | ) | (50 | ) | (640 | ) | (50 | ) | ||||||||
| Other income (expense), net | 1,058 | (1,428 | ) | 2,341 | (842 | ) | ||||||||||
| Total other income (expense), net | (2,882 | ) | (1,478 | ) | 1,701 | (892 | ) | |||||||||
| Net loss and comprehensive loss | $ | (6,373 | ) | $ | (15,844 | ) | $ | (15,902 | ) | $ | (29,109 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.33 | ) | (2.30 | ) | $ | (0.89 | ) | $ | (4.76 | ) | |||||
| Weighted average common shares outstanding, basic and diluted(3) | 19,404,688 | 6,889,119 | 17,884,542 | 6,116,721 | ||||||||||||
(1) On March 13, 2026, the company effected a 1-for-14 reverse stock split of its common stock. All share amounts and per share amounts in this press release have been adjusted retroactively to reflect the reverse stock split for the periods presented.
(2) Operating expenses include the following amounts of non-cash stock-based compensation expense:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||
| Research and development | $ | 524 | $ | 346 | $ | 1,316 | $ | 735 | ||||
| General and administrative | 1,074 | 1,005 | 2,493 | 2,151 | ||||||||
| Total stock-based compensation expense | $ | 1,598 | $ | 1,351 | $ | 3,809 | $ | 2,886 | ||||
(3) Weighted average common shares outstanding, basic and diluted, includes prefunded warrants to purchase common stock, as the prefunded warrants are exercisable at any time for nominal cash consideration.
