Instil Bio Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Rhea-AI Summary

Instil Bio (Nasdaq: TIL) reported Q3 2025 results and a corporate update on Nov 13, 2025.

Key points: $83.4 million in cash, cash equivalents, restricted cash, marketable securities and long-term investments as of Sep 30, 2025 versus $115.1 million as of Dec 31, 2024; company expects these resources to fund operations beyond 2026. Axion Bio, a subsidiary, dosed the first patient in a Phase 1 monotherapy trial of AXN-2510/IMM2510 in Oct 2025; collaborator ImmuneOnco presented updated relapsed/refractory squamous NSCLC data at WCLC 2025.

Selected financials: Q3 2025 net loss per share was $2.01 (GAAP) and non-GAAP net loss per share was $1.75; nine-month GAAP net loss per share was $9.53.

Positive

• Total liquidity of $83.4M as of Sep 30, 2025
• Company expects funding runway beyond 2026
• First patient dosed in Phase 1 AXN-2510 monotherapy trial (Oct 2025)
• Updated relapsed/refractory squamous NSCLC data presented at WCLC 2025

Negative

• Total liquidity declined from $115.1M on Dec 31, 2024
• Nine-month restructuring and impairment charges of $16.6M
• Q3 2025 GAAP net loss per share of $2.01

Insights

Clinical and Financial Analyst

Instil reports a Phase 1 first‑patient dose for ‘2510 and a cash runway stated to extend beyond 2026, with mixed quarters.

Instil achieved a clinical milestone when Axion Bio dosed the first patient in the Phase 1 monotherapy trial of AXN-2510/IMM2510 in October, and collaborator ImmuneOnco presented additional patient data in September. On the financial side, cash, equivalents, restricted cash, marketable securities and long‑term investments totalled $83.4 million as of September 30, 2025, and management states these resources should fund operations beyond 2026.

Risks and dependencies include continued trial enrollment and data readouts from the Phase 1 program and the absence of explicit forward guidance beyond the stated runway. Reported results show elevated R&D of $9.1 million for the quarter and a GAAP net loss per share of $2.01 for the quarter (non‑GAAP $1.75), with restructuring and impairment charges of $16.6 million year‑to‑date; these are material inputs to near‑term cash use.

Key items to watch: additional clinical data from the ongoing Phase 1 program, any enrollment or safety updates, and quarterly cash consumption relative to the stated runway (next near‑term checkpoints: upcoming trial data releases and the company’s next quarterly report covering operations after September 30, 2025). Expect relevant milestones and cash updates within the next 6–12 months.

First patient dosed in Phase 1 clinical trial evaluating AXN-2510/IMM2510 (“’2510”) monotherapy in adult patients with advanced solid tumors

DALLAS, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today reported its third quarter 2025 financial results and provided a corporate update.

Recent Highlights:

• In September, ImmuneOnco, Instil’s collaborator, presented updated data from additional patients with relapsed/refractory squamous non-small cell lung cancer treated with ‘2510 as monotherapy in a poster presentation at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer.
• In October, Axion Bio, Instil’s subsidiary, dosed the first patient in its Phase 1 clinical trial of ‘2510 as monotherapy in patients with relapsed or refractory solid tumors.

Third Quarter 2025 Financial and Operating Results:

As of September 30, 2025, Instil had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $83.4 million, which consisted of $5.8 million in cash and cash equivalents, $0.3 million in restricted cash, $73.9 million in marketable securities, and $3.4 million in long-term investments, compared to $115.1 million in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024, consisting of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities. Instil expects that its cash, cash equivalents, restricted cash, marketable securities and long-term investments as of September 30, 2025 will enable it to fund its operating plan beyond 2026.

In-process research and development expenses were nil and $10.0 million for the three and nine months ended September 30, 2025, respectively, compared to $10.0 million for both the three and nine months ended September 30, 2024.

Research and development expenses were $9.1 million and $21.2 million for the three and nine months ended September 30, 2025, respectively, compared to $0.6 million and $10.7 million for the three and nine months ended September 30, 2024, respectively.

General and administrative expenses were $5.9 million and $21.2 million for the three and nine months ended September 30, 2025, respectively, compared to $10.7 million and $33.8 million for the three and nine months ended September 30, 2024, respectively.

Restructuring and impairment charges were nil and $16.6 million for the three and nine months ended September 30, 2025, respectively, compared to $2.4 million and $7.1 million for three and nine months ended September 30, 2024, respectively.

Net loss per share, basic and diluted were $2.01 and $9.53 for the three and nine months ended September 30, 2025, respectively, compared to $3.54 and $9.57 for the three and nine months ended September 30, 2024, respectively. Non-GAAP net loss per share, basic and diluted, were $1.75 and $5.95 for the three and nine months ended September 30, 2025, respectively, compared to $2.55 and $6.51 for the three and nine months ended September 30, 2024, respectively.

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense and restructuring and impairment charges. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

About Instil Bio

Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil’s lead asset, AXN-2510, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors. For more information visit www.instilbio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “exploring,” “future,” “intends,” “may,” “plans,” “potential,” “projects,” “targets” and “will” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include express or implied statements regarding Instil's expectations regarding its cash runway and other statements that are not historical fact. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements, including risks and uncertainties associated with the costly and time-consuming drug product development process and the uncertainty of clinical success; the risks inherent in relying on collaborators and other third parties, including for manufacturing and generating clinical data, and the ability to rely on any such data from clinical trials in China in regulatory filings submitted to regulatory authorities outside of China; the risks and uncertainties related to successfully making regulatory submissions and initiating, enrolling, completing and reporting data from clinical trials, particularly collaborator-led clinical trials, as well as the risks that results obtained in any clinical trials to date may not be indicative of results obtained in ongoing or future trials and that product candidates may have undesirable side effects or otherwise not be effective treatments in their planned indications; risks related to macroeconomic conditions, including as a result of international conflicts and U.S.-China trade and political tensions, as well as interest rates, inflation, tariffs and other factors, which could materially and adversely affect our business and operations and those of our collaborators; the risks and uncertainties associated with the time-consuming and uncertain regulatory approval process and the sufficiency of Instil's cash resources; and other risks and uncertainties affecting Instil's plans and development programs, including those discussed in the section titled “Risk Factors” in Instil's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 to be filed with the SEC, as well as Instil's other filings with the SEC. These forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as the date hereof, and Instil disclaims any obligation to update these statements except as may be required by law.

Contacts:

Investor Relations:
1-972-499-3350
investorrelations@instilbio.com
www.instilbio.com

Kimberly Ha 
KKH Advisors 
CEO & Founder
917-291-5744
kkhadvisors.com

INSTIL BIO, INC.
SELECTED FINANCIAL DATA
(Unaudited; in thousands, except share and per share amounts)
Selected Condensed Consolidated Balance Sheet Data
	September 30, 2025			December 31, 2024
Cash, cash equivalents, restricted cash, marketable securities and long-term investments	$	83,392		$	115,145
Total assets	$	211,768		$	263,567
Total liabilities	$	91,346		$	94,131
Total stockholders’ equity	$	120,422		$	169,436

Condensed Consolidated Statements of Operations
	Three Months Ended								Nine Months Ended
	September 30,								September 30,
		2025				2024				2025				2024
Operating expenses:
In-process research and development	$	—			$	10,000			$	10,000			$	10,000
Research and development		9,127				562				21,241				10,739
General and administrative		5,895				10,707				21,161				33,837
Restructuring and impairment charges		—				2,362				16,622				7,146
Total operating expenses		15,022				23,631				69,024				61,722
Loss from operations		(15,022	)			(23,631	)			(69,024	)			(61,722	)
Interest income		893				1,654				3,112				5,635
Interest expense		(1,582	)			(2,007	)			(4,262	)			(5,988	)
Other rental income		2,242				1,493				6,726				1,493
Other (expense) income, net		(118	)			(530	)			267				(1,658	)
Net loss	$	(13,587	)		$	(23,021	)		$	(63,181	)		$	(62,240	)
Net loss per share, basic and diluted	$	(2.01	)		$	(3.54	)		$	(9.53	)		$	(9.57	)
Weighted-average shares used in computing net loss per share, basic and diluted		6,757,742				6,506,681				6,629,949				6,504,842

INSTIL BIO, INC.
Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss per Share
(Unaudited; in thousands, except share and per share amounts)
	Three Months Ended								Nine Months Ended
	September 30,								September 30,
		2025				2024				2025				2024
Net loss	$	(13,587	)		$	(23,021	)		$	(63,181	)		$	(62,240	)
Adjustments:
Non-cash stock-based compensation expense		1,768				4,068				7,087				12,756
Restructuring and impairment charges		—				2,362				16,622				7,146
Non-GAAP net loss	$	(11,819	)		$	(16,591	)		$	(39,472	)		$	(42,338	)
Net loss per share, basic and diluted	$	(2.01	)		$	(3.54	)		$	(9.53	)		$	(9.57	)
Adjustments:
Non-cash stock-based compensation expense per share		0.26				0.63				1.07				1.96
Restructuring and impairment charges per share		—				0.36				2.51				1.10
Non-GAAP net loss per share, basic and diluted*	$	(1.75	)		$	(2.55	)		$	(5.95	)		$	(6.51	)
Weighted-average shares outstanding, basic and diluted		6,757,742				6,506,681				6,629,949				6,504,842

* Non-GAAP net loss per share, basic and diluted may not total due to rounding.

FAQ

How much cash did Instil Bio (TIL) report on Sep 30, 2025?

Instil reported combined cash, restricted cash, marketable securities and long-term investments of $83.4 million as of Sep 30, 2025.

Does Instil Bio (TIL) have a funding runway beyond 2026?

Yes; Instil stated its cash and investments as of Sep 30, 2025 are expected to fund operations beyond 2026.

When was the first patient dosed in the Phase 1 AXN-2510 monotherapy trial for TIL?

The first patient was dosed in Oct 2025 by Axion Bio, Instil's subsidiary.

What were Instil Bio's (TIL) Q3 2025 net loss per share figures?

Q3 2025 GAAP net loss per share was $2.01; non-GAAP net loss per share was $1.75.

What material non-recurring charges did Instil report in the first nine months of 2025?

Instil recorded $16.6 million of restructuring and impairment charges for the nine months ended Sep 30, 2025.

Did Instil present clinical data at a major conference in 2025?

Yes; ImmuneOnco presented updated '2510 monotherapy' data in relapsed/refractory squamous NSCLC at WCLC 2025.