Instil Bio, Inc. Progresses with Ongoing NSCLC Trials for AXN-2510/IMM2510 and Reports Q1 2025 Financial Results

Instil Bio reports ongoing trials for AXN-2510/IMM2510 in NSCLC; financial results show cash reserves enabling operations beyond 2026.

Quiver AI Summary

Instil Bio, Inc. announced ongoing enrollment for a clinical trial in China evaluating AXN-2510/IMM2510 in combination with chemotherapy for first-line non-small cell lung cancer (NSCLC), with initial results expected in the second half of 2025. The company also plans to launch a U.S. clinical study of the same treatment before the end of 2025, pending regulatory approval. Financially, as of March 31, 2025, Instil reported $111.8 million in cash and marketable securities, sufficient to fund operations beyond 2026. The first quarter of 2025 saw a net loss of $28.2 million, with operating expenses including higher restructuring costs compared to the previous year. Instil's primary focus remains on advancing its novel therapies for solid tumors, particularly through the development of AXN-2510.

Potential Positives

• Enrollment of 1L NSCLC patients in a trial for AXN-2510/IMM2510 in China is ongoing, with initial clinical data expected in 2H 2025, indicating progress in developing a potential treatment for lung cancer.
• Instil Bio plans to initiate a U.S. clinical study for AXN-2510/IMM2510, anticipated before the end of 2025, which could expand the drug's market presence and therapeutic options for patients.
• As of March 31, 2025, Instil maintains a strong financial position with $111.8 million in cash, cash equivalents, and marketable securities, enabling it to fund its operations beyond 2026.
• Research and development expenses decreased to $5.4 million for the first quarter of 2025 compared to $7.3 million in the same period of 2024, indicating improved cost management in R&D efforts.

Potential Negatives

• Instil reported an increase in restructuring and impairment charges from $4.3 million in Q1 2024 to $16.1 million in Q1 2025, indicating potential operational challenges or inefficiencies.
• The net loss per share increased from $3.74 in Q1 2024 to $4.32 in Q1 2025, suggesting deteriorating financial performance year-over-year.
• Despite a slight decrease in overall operating expenses, the company is still operating at a significant net loss, raising concerns about long-term financial sustainability and the effectiveness of cost management strategies.

FAQ

What is the status of the AXN-2510/IMM2510 trial in China?

The enrollment of 1L NSCLC patients in the China trial is ongoing, with initial data expected in 2H 2025.

When will the U.S. trial for AXN-2510/IMM2510 begin?

The U.S. clinical study is anticipated to start before the end of 2025, pending regulatory approvals.

What were Instil Bio's financial results for Q1 2025?

Instil reported a net loss of $28.2 million for Q1 2025, with total cash resources at $111.8 million.

What significant expenses did Instil incur during Q1 2025?

Research and development expenses were $5.4 million, while general and administrative expenses were $9.1 million.

What are non-GAAP financial measures used by Instil Bio?

Non-GAAP measures exclude non-cash stock-based compensation and restructuring charges, providing insight into operational performance.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$TIL Hedge Fund Activity

We have seen 26 institutional investors add shares of $TIL stock to their portfolio, and 23 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• PERCEPTIVE ADVISORS LLC removed 345,545 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $6,596,454
• COMMODORE CAPITAL LP removed 150,929 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $2,881,234
• INVESCO LTD. removed 145,118 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $2,770,302
• POINT72 ASSET MANAGEMENT, L.P. removed 95,450 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $1,822,140
• UBS GROUP AG added 90,955 shares (+69431.3%) to their portfolio in Q4 2024, for an estimated $1,736,330
• ORBIMED ADVISORS LLC added 83,085 shares (+246.5%) to their portfolio in Q4 2024, for an estimated $1,586,092
• MILLENNIUM MANAGEMENT LLC added 53,253 shares (+inf%) to their portfolio in Q4 2024, for an estimated $1,016,599

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

Full Release

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

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

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.