Xilio Therapeutics Reports Third Quarter 2026 Financial Results and Provides Pipeline and Business Updates

Third-quarter warrant remeasurement produced $4.820 million of income, compared with a $15.380 million expense a year earlier.

Rhea-AI Summary

Xilio Therapeutics (Nasdaq: XLO) reported third-quarter 2026 results and dosed the first patient in its Phase 1/2 XTX501 cancer trial. Collaboration and license revenue fell to $9.984 million from $19.066 million a year earlier. Net loss narrowed to $5.948 million from $16.287 million, while operating loss widened to $11.749 million from $1.929 million.

Cash and cash equivalents totaled $122.182 million at September 30, versus $137.531 million at December 31, 2025. Xilio expects existing cash to fund operations and capital expenditures into the first quarter of 2028. It plans initial XTX501 Phase 1 data in metastatic non-small cell lung cancer and investigational new drug applications for XTX602 and XTX701 in the fourth quarter of 2027. It expects to deliver an efarindodekin alfa option data package to Gilead in the first half of 2027. Yariv Houvras became chief medical officer in September 2026.

15 points · 0 major

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0 major · 8 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Cash runway is expected to cover operating expenses and capital expenditures into the first quarter of 2028.
• Moderate pointThird-quarter net loss narrowed to $5.948 million from $16.287 million; loss per share fell to $0.30 from $1.58.
• Moderate pointNine-month collaboration and license revenue rose to $41.324 million from $30.080 million in 2025.
• Moderate pointNine-month net loss narrowed to $21.850 million from $45.396 million; loss per share fell to $1.18 from $6.03.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Up to $31.0 million in AbbVie milestones and option extension fees could be achieved through first-half 2027. 52% of market cap

10 minor points

• Minor pointXTX501 first patient dosed in Phase 1 of the Phase 1/2 trial for metastatic NSCLC and select advanced solid tumors.
• Minor point. Forward-looking: it has not happened yet and may not happen.XTX501 initial Phase 1 data in metastatic NSCLC are planned for the fourth quarter of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.XTX602 studies supporting a clinical-trial application are ongoing; Xilio plans submission in the fourth quarter of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.XTX701 studies supporting a clinical-trial application are ongoing; Xilio plans submission in the fourth quarter of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Efarindodekin alfa remains in Phase 2; Xilio expects a Gilead option data package in the first half of 2027.
• Minor pointThird-quarter warrant fair-value change generated $4.820 million income versus $15.380 million expense a year earlier.
• Minor pointNine-month operating loss narrowed to $29.352 million from $30.146 million in 2025.
• Minor pointNine-month G&A expenses declined to $21.480 million from $22.309 million in 2025.
• Minor pointNine-month warrant fair-value change generated $4.180 million income versus $15.430 million expense in 2025.
• Minor pointNine-month other income, net rose to $3.322 million from $0.180 million in 2025.

Negative

• Moderate pointThird-quarter collaboration and license revenue declined to $9.984 million from $19.066 million a year earlier.
• Moderate pointThird-quarter operating loss widened to $11.749 million from $1.929 million a year earlier.
• Moderate pointNine-month R&D expenses increased to $49.196 million from $37.917 million in 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Series C warrant proceeds of up to $36.2 million depend on all outstanding warrants being exercised at current prices. 61% of market cap
• Minor pointCash and cash equivalents fell to $122.182 million at September 30, 2026, from $137.531 million at December 31, 2025.

3 minor points

• Minor pointThird-quarter R&D expenses increased to $14.805 million from $14.321 million a year earlier.
• Minor pointThird-quarter G&A expenses increased to $6.928 million from $6.674 million a year earlier.
• Minor pointThird-quarter other income, net declined to $0.981 million from $1.022 million a year earlier.

News Explained

Xilio’s stated runway into the first quarter of 2028 is based on existing cash and excludes contingent proceeds: up to $36.2 million in fourth-quarter warrant proceeds if all outstanding Series C warrants are exercised at their current price, and potential collaboration payments including up to $31.0 million in near-term AbbVie milestones and option-extension fees through the first half of 2027.

Key Figures

Cash and cash equivalents: $122.2 million Collaboration and license revenue: $10.0 million vs. $19.1 million Net loss: $5.9 million vs. $16.3 million +5 more

Cash and cash equivalents

$122.2 million

As of September 30, 2026

Collaboration and license revenue

$10.0 million vs. $19.1 million

Third quarter 2026 vs. third quarter 2025

Net loss

$5.9 million vs. $16.3 million

Third quarter 2026 vs. third quarter 2025

Cash runway

Into the first quarter of 2028

Based on current operating plans

Potential Series C warrant proceeds

Up to $36.2 million

Fourth quarter of 2026, if all outstanding warrants are exercised

Potential AbbVie milestones and option extension fees

Up to $31.0 million

Could be achieved through the first half of 2027

Initial Phase 1 data

Fourth quarter of 2027

XTX501 in patients with metastatic NSCLC

Planned IND submissions

Fourth quarter of 2027

XTX602 and XTX701

Previous Earnings Reports

1 past event · Latest: Aug 12

Same Type 1 event

1. Aug 12

   Q2 2026 earnings

   24h Move

   -1.4%

   FDA cleared XTX501's IND, enabling initiation of the Phase 1/2 trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

bispecific antibody, non-small cell lung cancer, investigational new drug application, t cell engager

4 terms

bispecific antibody medical

"a novel, investigational PD-1/masked IL-2 (alpha-optimized) bispecific antibody fusion protein"

A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.

non-small cell lung cancer medical

"patients with metastatic non-small cell lung cancer (NSCLC)"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

investigational new drug application regulatory

"Investigational new drug application (IND)-enabling studies for XTX602 are ongoing"

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

t cell engager medical

"Xilio’s TCEs incorporate a masked CD3 binding domain"

A T cell engager is an engineered protein drug that physically links a patient’s T cell — the immune system’s attack cell — to a diseased cell so the T cell will recognize and kill it. For investors it matters because clinical trial results, manufacturing success and safety profiles determine whether the therapy becomes a widely adopted, high-value treatment or a costly failure; think of it like a matchmaker that must reliably bring soldiers to the right target without triggering friendly fire.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Dosed first patient in Phase 1/2 clinical trial for XTX501, a potential best-in-class PD-1/masked IL-2 bispecific, for patients with metastatic NSCLC, and plan to report initial Phase 1 data in the fourth quarter of 2027

Advancing XTX602, a dual-masked CLDN18.2-targeting multi-specific TCE with co-stimulation, and XTX701, a masked PSMAxSTEAP1-targeting multi-specific TCE with co-stimulation, toward planned IND applications in the fourth quarter of 2027

WALTHAM, Mass., Nov. 10, 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 third quarter ended September 30, 2026.

“In the third quarter, we initiated our Phase 1/2 clinical trial for XTX501, a PD-1/masked IL-2 bispecific that we believe has the potential to become a foundational backbone immunotherapy regimen for solid tumors,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “By incorporating masking and tumor-selective activation of a high potency, alpha-optimized IL-2 with inhibition of PD-1/PD-L1 in a single molecule, XTX501 is designed to simultaneously leverage these two validated mechanisms, while overcoming the toxicity and rapid clearance that have limited non-masked IL-2 therapies. We also continued to execute across our preclinical pipeline, advancing our programs for masked, multi-specific TCEs with built-in co-stimulation toward planned IND filings next year.”

Pipeline Progress and Business Updates

XTX501: PD-1/masked IL-2 bispecific

XTX501 is a novel, investigational PD-1/masked IL-2 (alpha-optimized) bispecific antibody fusion protein that combines two complementary mechanisms in a single molecule: selective inhibition of the PD-1/PD-L1 pathway and potent IL-2-driven expansion of T cells. The PD-1 binding arm is designed to selectively direct IL-2 activity to PD-1 positive, antigen-experienced T cells and enhance their function. The IL-2 binding arm incorporates a masked, high potency IL-2 variant with an alpha-optimized receptor binding profile. By leveraging Xilio’s proprietary masking technology, XTX501 aims to overcome IL-2 receptor-mediated clearance, peripheral activity and tolerability challenges associated with non-masked IL-2 therapies.

• Xilio recently dosed the first patient in the Phase 1 portion of the trial for XTX501 in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors. For more information, read the press release here.
• Xilio recently presented a trial-in-progress poster highlighting the design of the Phase 1/2 clinical trial of XTX501 at the Society for Immunotherapy of Cancer (SITC) 41^st Annual Meeting.
• Xilio plans to report initial Phase 1 data in patients with metastatic NSCLC in the fourth quarter of 2027.
  

Masked T Cell Engager (TCE) Programs

Xilio is leveraging its proprietary, clinically-validated masking technology and modular TCE architecture to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie Group Holdings Limited (AbbVie).

As part of the core design, Xilio’s TCEs incorporate a masked CD3 binding domain, a tumor-associated antigen (TAA) binding domain and built-in co-stimulation. The company’s modular architecture enables the flexibility to incorporate additional TAA binding domains and mask the TAA binding domain(s) and/or co-stimulatory signaling domain. Upon tumor-selective activation, the molecules are designed to release the mask(s) and deliver a potent TCE with a short half-life in the tumor microenvironment.

XTX602: dual-masked CLDN18.2-targeting multi-specific TCE with co-stimulation

XTX602 is a potential first-in-class, dual-masked CLDN18.2-targeting multi-specific TCE with built-in CD2 co-stimulation. CLDN18.2 is a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal). By incorporating masks for both the CLDN18.2 and the CD3 binding domains, XTX602 is designed to overcome potential gastrointestinal toxicity associated with non-masked CLDN18.2-targeting molecules. In addition, the CD2 co-stimulatory domain is built directly into the molecule to enable enhanced T cell activation, expansion and durability of T cell response.

• Investigational new drug application (IND)-enabling studies for XTX602 are ongoing, and Xilio plans to submit an IND for XTX602 in the fourth quarter of 2027.
  

XTX701: masked PSMAxSTEAP1-targeting multi-specific TCE with co-stimulation

XTX701 is a potential first-in-class, masked PSMAxSTEAP1-targeting multi-specific TCE with built-in CD2 co-stimulation. PSMA and STEAP1 are TAAs collectively expressed in approximately 95% of metastatic castration-resistant prostate cancer. Targeting these two TAAs is intended to address heterogeneity of expression of PSMA and STEAP1 across prostate tumors and limit resistance and lack of durability of response due to antigen escape. By incorporating a mask for the CD3 binding domain, XTX701 is designed to minimize toxicity due to peripheral T cell activation and on-target, off-tumor engagement associated with non-masked molecules. In addition, the CD2 co-stimulatory domain is built directly into the molecule to enable enhanced T cell activation, expansion and durability of T cell response.

• IND-enabling studies for XTX701 are ongoing, and Xilio plans to submit an IND for XTX701 in the fourth quarter 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 Yariv Houvras, M.D., Ph.D., as its chief medical officer in September 2026. Dr. Houvras has over 20 years of executive leadership across premier industry and academic research institutions in clinical development, translational medicine and immuno-oncology. Read more here.
  

Third Quarter 2026 Financial Results

• Cash Position: Cash and cash equivalents were $122.2 million as of September 30, 2026, compared to $137.5 million as of December 31, 2025.
• Collaboration and License Revenue: Collaboration and license revenue was $10.0 million for the quarter ended September 30, 2026, compared to $19.1 million for the quarter ended September 30, 2025. The decrease was driven by a decrease in collaboration and license revenue recognized under the company’s collaboration and license agreements with AbbVie and Gilead.
• Research & Development (R&D) Expenses: R&D expenses were $14.8 million for the quarter ended September 30, 2026, compared to $14.3 million for the quarter ended September 30, 2025. The increase was primarily driven by an increase in preclinical research and development activities related to the company’s wholly-owned masked TCE programs, an increase in clinical trial startup activities related to the company’s Phase 1/2 clinical trial for XTX501 and an increase in personnel-related costs due to higher research and development headcount, partially offset by a decrease in preclinical development activities and manufacturing activities related to IND-enabling studies for XTX501 and a decrease in clinical development activities for efarindodekin alfa and vilastobart.
• General & Administrative (G&A) Expenses: G&A expenses were $6.9 million for the quarter ended September 30, 2026, compared to $6.7 million for the quarter ended September 30, 2025. The increase was primarily driven by an increase in stock-based compensation expense.
• Net Loss: Net loss was $5.9 million for the quarter ended September 30, 2026, compared to a net loss of $16.3 million for the quarter ended September 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 $36.2 million in additional gross proceeds in the fourth quarter of 2026 if all outstanding Series C warrants are exercised at their current exercise price and any potential additional milestone payments, option-related fees or other contingent payments under Xilio’s collaboration and license agreements with AbbVie and Gilead, including up to $31.0 million in near-term milestones and option extension fees that could be achieved under the AbbVie collaboration through the first half of 2027.

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, including data releases, regulatory submissions, delivery of option data packages and other potential program milestones; 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 I-O regimen for solid tumors and the first-in-class potential of Xilio’s masked TCE programs targeting CLDN18.2 and PSMAxSTEAP1; 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 $36.2 million in additional gross proceeds in the fourth quarter of 2026 if all outstanding Series C warrants are exercised at their current exercise price; the sufficiency of, and the period in which Xilio expects to have, cash to fund its operations and capital expenditure requirements; and Xilio’s strategy, goals and anticipated financial performance (including anticipated cash runway), milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target,” “design,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to general market conditions and geopolitical uncertainties; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; initial, preliminary, interim or retrospective preclinical or clinical data or results may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates may not support further development of such product candidates; actions of regulatory agencies may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s need to obtain additional cash resources to advance its pipeline of masked I-O molecules; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; and Xilio’s ability to maintain its collaboration and license agreements with AbbVie and Gilead. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (SEC), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.

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)
		September 30, 2026			December 31, 2025
Assets
Cash and cash equivalents		$	122,182		$	137,531
Other assets			12,650			17,154
Total assets		$	134,832		$	154,685
Liabilities and Stockholders’ Equity
Liabilities
Deferred revenue		$	25,334		$	60,658
Common stock warrant liabilities			25,380			29,560
Other liabilities			15,884			29,194
Total liabilities		$	66,598		$	119,412
Stockholders’ equity			68,234			35,273
Total liabilities and stockholders’ equity		$	134,832		$	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 September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Collaboration and license revenue		$	9,984			$	19,066			$	41,324			$		30,080
Operating expenses (2)
Research and development		$	14,805			$	14,321			$	49,196			$		37,917
General and administrative			6,928				6,674				21,480					22,309
Total operating expenses			21,733				20,995				70,676					60,226
Loss from operations			(11,749	)			(1,929	)			(29,352	)				(30,146	)
Other income (expense), net
Change in fair value of common stock warrant liabilities			4,820				(15,380	)			4,180					(15,430	)
Other income, net			981				1,022				3,322					180
Total other income (expense), net			5,801				(14,358	)			7,502					(15,250	)
Net loss and comprehensive loss		$	(5,948	)		$	(16,287	)		$	(21,850	)		$		(45,396	)
Net loss per share, basic and diluted		$	(0.30	)			(1.58	)		$	(1.18	)		$		(6.03	)
Weighted average common shares outstanding, basic and diluted (3)			19,687,818				10,293,347				18,492,240					7,524,228

(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 September 30,						Nine Months Ended September 30,
		2026			2025			2026			2025
Research and development		$	632		$	319		$	1,947		$	1,054
General and administrative			1,286			804			3,780			2,955
Total stock-based compensation expense		$	1,918		$	1,123		$	5,727		$	4,009

(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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Xilio expect initial XTX501 clinical trial data?

Xilio plans to report initial Phase 1 data in metastatic non-small cell lung cancer in the fourth quarter of 2027. The first patient has been dosed in the Phase 1 portion of its Phase 1/2 trial, which includes patients with metastatic non-small cell lung cancer and select advanced solid tumors.

How long does Xilio expect its September 2026 cash to last?

Xilio expects its existing cash and cash equivalents to fund operating expenses and capital expenditures into the first quarter of 2028, based on current operating plans. Cash and cash equivalents totaled $122.182 million at September 30, 2026.

What potential funding does Xilio exclude from its cash runway estimate?

The runway estimate excludes up to $36.2 million in additional fourth-quarter 2026 gross proceeds if all outstanding Series C warrants are exercised at their current exercise price, plus potential contingent collaboration payments. Those include up to $31.0 million in AbbVie milestones and option extension fees that could be achieved through the first half of 2027.