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

Rhea-AI Summary

Instil Bio (NASDAQ: TIL) reported its Q1 2025 financial results and provided corporate updates. The company's key clinical trial of AXN-2510/IMM2510 in combination with chemotherapy for first-line NSCLC patients is progressing in China, with initial data expected in H2 2025. A U.S. clinical study is planned to begin by end of 2025, pending regulatory approvals. Financial highlights show $111.8 million in total cash and investments as of March 31, 2025, expected to fund operations beyond 2026. Q1 2025 saw reduced operating expenses with R&D at $5.4 million (vs $7.3M in Q1 2024) and G&A at $9.1 million (vs $12.4M in Q1 2024). However, restructuring charges increased to $16.1 million (vs $4.3M in Q1 2024). The company reported a basic and diluted net loss per share of $4.32, compared to $3.74 in Q1 2024.

Positive

• Cash runway extended beyond 2026 with $111.8 million in total cash and investments
• Reduced operating expenses: R&D down 26% and G&A down 27% year-over-year
• Progress in clinical trials with expected data readout in H2 2025

Negative

• Increased restructuring charges to $16.1 million, up 274% year-over-year
• Wider net loss per share of $4.32 compared to $3.74 in Q1 2024
• U.S. clinical study still pending regulatory approvals

Insights

Oncology Clinical Trials Expert

Instil Bio reports disappointing Q1 results with increased losses despite advancing NSCLC trials and maintaining cash runway through 2026.

Instil Bio's pipeline development for AXN-2510/IMM2510 shows measured progress with ongoing enrollment in China for the Phase 1b/2 trial in first-line Non-Small Cell Lung Cancer (NSCLC) patients. The company expects initial clinical data from this trial in the second half of 2025, which represents a critical milestone. Additionally, Instil plans to expand their clinical program by initiating a U.S. trial for the same combination therapy before year-end 2025, pending regulatory approvals.

The staggered global development approach - starting with China trials through ImmuneOnco before expanding to the U.S. - represents a prudent strategy to minimize investment risk while gathering preliminary efficacy data. First-line NSCLC represents a substantial market opportunity, though Instil will face intense competition from established players.

Concerning is the significant increase in restructuring and impairment charges, which jumped from $4.3 million to $16.1 million year-over-year. This 270% increase suggests substantial organizational changes and potential write-downs of assets. While research and development spending decreased by 26%, possibly reflecting completion of earlier development stages, the magnitude of restructuring charges raises questions about operational stability.

The company maintains a reasonable cash position of $111.8 million, projecting runway beyond 2026, providing approximately 18+ months of operational capacity at current burn rates. However, the widening GAAP net loss per share from $3.74 to $4.32 indicates increasing financial pressure despite cost-cutting efforts.

Biotech Financial Analyst

Despite $111.8M cash position and runway beyond 2026, Instil Bio's significant restructuring charges and widening losses signal fundamental challenges.

Instil Bio's Q1 2025 financials reveal concerning trends despite cost-cutting efforts. The company's cash position stands at $111.8 million (comprising $15.4 million in cash/equivalents, $1.0 million restricted cash, $88.3 million in marketable securities, and $7.2 million in long-term investments). While this represents only a modest 2.9% decline from the $115.1 million reported at year-end 2024, deeper examination reveals concerning patterns.

The dramatic threefold increase in restructuring and impairment charges to $16.1 million (versus $4.3 million in Q1 2024) signals significant organizational upheaval. Despite reducing R&D expenses by 26% to $5.4 million and G&A expenses by 26.6% to $9.1 million, the basic and diluted net loss per share worsened by 15.5% to $4.32.

The substantial divergence between GAAP and non-GAAP metrics (non-GAAP loss of $1.32 vs. GAAP loss of $4.32) indicates that a significant portion of losses stems from non-cash impairments and restructuring — suggesting potential asset write-downs or facility closures. This aligns with biotech companies rationalizing operations when facing development challenges.

While management emphasizes cash runway extending beyond 2026, the expanding loss profile raises questions about long-term sustainability without additional financing or strategic partnerships. The reduced R&D spending could indicate either improved operational efficiency or concerning deprioritization of innovation activities. Instil's focus on advancing AXN-2510/IMM2510 through partnership with ImmuneOnco in China before U.S. expansion appears to be a capital-preservation strategy while awaiting clinical validation.

Enrollment of 1L NSCLC patients in China trial of AXN-2510/IMM2510 in combination with chemotherapy is ongoing with initial clinical data by ImmuneOnco expected in 2H 2025

Initiation of U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated before the end of 2025, assuming receipt of necessary regulatory approvals

DALLAS, May 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 first quarter 2025 financial results and provided a corporate update.

Recent Highlights:

• ImmuneOnco’s Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC in China is ongoing and ImmuneOnco anticipates initial clinical data from first-line NSCLC patients in 2H 2025.

• U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated to commence before the end of 2025: Instil anticipates initiating a U.S. clinical trial of AXN-2510/IMM2510 in combination with chemotherapy for 1L NSCLC patients before the end of 2025, assuming the necessary regulatory approvals are obtained.

First Quarter 2025 Financial and Operating Results:

As of March 31, 2025, Instil had $111.8 million in total cash, cash equivalents, restricted cash, marketable securities and long-term investments, which consisted of $15.4 million in cash and cash equivalents, approximately $1.0 million in restricted cash, $88.3 million in marketable securities and $7.2 million in long-term investments, compared to $115.1 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities, as of December 31, 2024. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of March 31, 2025 will enable it to fund its current operating plan beyond 2026.

Research and development expenses were $5.4 million for the three months ended March 31, 2025, compared to $7.3 million for the three months ended March 31, 2024.

General and administrative expenses were $9.1 million for the three months ended March 31, 2025, compared to $12.4 million for the three months ended March 31, 2024.

Restructuring and impairment charges were $16.1 million for the three months ended March 31, 2025, compared to $4.3 million for the three months ended March 31, 2024.

Net loss per share, basic and diluted were $4.32 for the three months ended March 31, 2025, compared to $3.74 for the three months ended March 31, 2024. Non-GAAP net loss per share, basic and diluted were $1.32 for the three months ended March 31, 2025, compared to $2.39 for the three months ended March 31, 2024.

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,” “expected,” “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 our expectations with respect to the therapeutic potential of AXN-2510/IMM2510; clinical development of AXN-2510/IMM2510, including the initiation of clinical trials for AXN-2510/IMM2510 and the generation of clinical data for AXN-2510/IMM2510 and the timing thereof; research, development, regulatory and clinical plans for AXN-2510/IMM2510; Instil's expectations regarding its capital position, resources, and balance sheet, including 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 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 March 31, 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

INSTIL BIO, INC. SELECTED FINANCIAL DATA (Unaudited; in thousands, except share and per share amounts) Selected Condensed Consolidated Balance Sheet Data
	March 31, 2025				December 31, 2024
Cash, cash equivalents, restricted cash, marketable securities and long-term investments	$	111,802			$	115,145
Total assets	$	237,449			$	263,567
Total liabilities	$	92,537			$	94,131
Stockholders’ equity	$	144,912			$	169,436

Condensed Consolidated Statements of Operations
	Three Months Ended March 31,
		2025				2024
Operating expenses:
Research and development	$	5,371			$	7,256
General and administrative		9,109				12,424
Restructuring and impairment charges		16,082				4,275
Total operating expenses		30,562				23,955
Loss from operations		(30,562	)			(23,955	)
Interest income		1,175				2,062
Interest expense		(1,098	)			(1,981	)
Other rental income		2,242				—
Other income (expense), net		43				(428	)
Net loss	$	(28,200	)		$	(24,302	)
Net loss per share, basic and diluted	$	(4.32	)		$	(3.74	)
Weighted-average shares used in computing net loss per share, basic and diluted		6,532,658				6,503,913

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 March 31,
		2025				2024
Net loss	$	(28,200	)		$	(24,302	)
Adjustments:
Non-cash stock-based compensation expense		3,495				4,515
Restructuring and impairment charges		16,082				4,275
Non-GAAP net loss	$	(8,623	)		$	(15,512	)
Net loss per share, basic and diluted	$	(4.32	)		$	(3.74	)
Adjustments:
Non-cash stock-based compensation expense per share		0.54				0.69
Restructuring and impairment charges per share		2.46				0.66
Non-GAAP net loss per share, basic and diluted*	$	(1.32	)		$	(2.39	)
Weighted-average shares outstanding, basic and diluted		6,532,658				6,503,913

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

FAQ

What were Instil Bio's (TIL) key financial results for Q1 2025?

Instil Bio reported $111.8M in total cash and investments, R&D expenses of $5.4M, G&A expenses of $9.1M, and a net loss per share of $4.32. The company's cash position is expected to fund operations beyond 2026.

What is the status of Instil Bio's AXN-2510/IMM2510 clinical trials?

The Phase 1b/2 trial in China for first-line NSCLC is ongoing with initial data expected in H2 2025. A U.S. clinical study is planned to begin by end of 2025, subject to regulatory approvals.

How much did Instil Bio's restructuring charges increase in Q1 2025?

Restructuring charges increased to $16.1 million in Q1 2025, compared to $4.3 million in Q1 2024, representing a 274% increase year-over-year.

How long can Instil Bio's current cash position fund its operations?

Based on the current operating plan, Instil Bio's $111.8 million in cash and investments as of March 31, 2025, is expected to fund operations beyond 2026.