Instil Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Rhea-AI Summary
Instil Bio (TIL) has reported its Q4 and full year 2024 financial results. The company ended 2024 with $115.1 million in total cash and equivalents, down from $175.0 million in 2023. Their cash runway is expected to extend beyond 2026.
Key clinical developments include anticipated data for AXN-2510/IMM2510 monotherapy in relapsed/refractory NSCLC in China during 1H 2025, with additional safety data expected from approximately 100 patients across multiple solid tumors. ImmuneOnco plans to begin enrolling first-line NSCLC patients in Q2 2025 for a combination therapy trial with chemotherapy, with initial data expected in 2H 2025.
Financial highlights show reduced losses, with full-year 2024 net loss per share at $11.39, improved from $24.00 in 2023. R&D expenses decreased to $11.8 million in 2024 from $39.6 million in 2023, while G&A expenses slightly decreased to $44.2 million from $47.6 million.
Positive
- Cash runway extended beyond 2026
- Net loss per share improved by 52.5% to $11.39
- R&D expenses reduced by 70% to $11.8M
- G&A expenses decreased by 7% to $44.2M
Negative
- Cash position declined 34% YoY to $115.1M
- Incurred $7.5M in restructuring charges
- $10M in-process R&D expenses vs nil in 2023
Insights
Instil Bio's financial position shows both encouraging and concerning signals. With
R&D expenses decreased substantially to
However, these expense reductions must be evaluated carefully - while improving the bottom line, they may also signal a narrowed development pipeline. The
Instil Bio's strategy centers on AXN-2510/IMM2510, primarily developed with partner ImmuneOnco targeting non-small cell lung cancer (NSCLC). The planned clinical data readouts create a potential catalyst-rich 2025 with three key milestones:
- 1H 2025: Monotherapy data in relapsed/refractory NSCLC from China, alongside safety data from approximately 100 patients across multiple solid tumors
- 2H 2025: Initial combination data with chemotherapy in first-line NSCLC from ImmuneOnco's China trial
- Late 2025: Initiation of US clinical studies combining AXN-2510/IMM2510 with chemotherapy in first-line NSCLC
The company's approach follows a logical development pathway - first establishing monotherapy activity in later-line patients while gathering comprehensive safety data, then moving to first-line settings in combination with standard chemotherapy. Pursuing parallel development in China and the US is strategically sound, potentially accelerating the overall timeline.
However, investors should note the complete absence of preliminary efficacy signals in this update. While the predefined milestones provide clear development progress markers, without early efficacy indicators, it's impossible to assess the therapy's potential competitive position in the crowded immuno-oncology landscape. The success of these upcoming readouts will be critical in determining whether Instil's focused development approach will ultimately deliver value.
Clinical data for AXN-2510/IMM2510 monotherapy in relapsed/refractory NSCLC in China by ImmuneOnco, as well as additional safety data in other solid tumors, anticipated in 1H 2025
Enrollment of 1L NSCLC patients in trial of AXN-2510/IMM2510 and chemotherapy by ImmuneOnco in China anticipated to begin in Q2 2025 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, March 04, 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 fourth quarter and full year 2024 financial results and provided a corporate update.
Recent Highlights:
- Clinical data for AXN-2510 (formerly SYN-2510) /IMM2510 anticipated in 1H 2025: Instil announced today that ImmuneOnco anticipates providing a clinical data update for AXN-2510/IMM2510 monotherapy in relapsed or refractory (R/R) non-small cell lung cancer (“NSCLC”) in the first half of 2025. Instil anticipates that ImmuneOnco will also release safety data from a total of approximately 100 patients treated with AXN-2510/IMM2510 as monotherapy across multiple solid tumors.
- Initiation by ImmuneOnco of Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in China: ImmuneOnco announced enrollment of the first patient in the safety run-in of a Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in NSCLC in China in January 2025. ImmuneOnco anticipates enrollment of first-line NSCLC patients in this study to initiate in Q2 2025, with initial clinical data anticipated 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.
Fourth Quarter and Full Year 2024 Financial and Operating Results:
As of December 31, 2024, Instil had
In-process research and development expenses were nil and
Research and development expenses were
General and administrative expenses were
Restructuring and impairment charges were
Net loss per share, basic and diluted was
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 our expectations with respect to the license and collaboration agreement with ImmuneOnco; 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; our research, development, regulatory and clinical plans for AXN-2510/IMM2510; our expectations regarding our capital position, resources, and balance sheet, including our 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 studies, 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 our 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, 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 our cash resources; and other risks and uncertainties affecting us and our plans and development programs, including those discussed in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 to be filed with the SEC, as well as our 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 we disclaim 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 Consolidated Balance Sheet Data | |||||||
| December 31, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents, restricted cash, marketable securities and long-term investments | $ | 115,145 | $ | 175,018 | |||
| Total assets | $ | 263,567 | $ | 325,630 | |||
| Total liabilities | $ | 94,131 | $ | 99,801 | |||
| Total stockholders’ equity | $ | 169,436 | $ | 225,829 | |||
| Consolidated Statements of Operations | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| In-process research and development | $ | — | $ | — | $ | 10,000 | $ | — | |||||||
| Research and development | 1,099 | 1,983 | 11,838 | 39,604 | |||||||||||
| General and administrative | 10,373 | 10,872 | 44,210 | 47,553 | |||||||||||
| Restructuring and impairment charges | 348 | 165 | 7,493 | 72,012 | |||||||||||
| Total operating expenses | 11,820 | 13,020 | 73,541 | 159,169 | |||||||||||
| Loss from operations | (11,820 | ) | (13,020 | ) | (73,541 | ) | (159,169 | ) | |||||||
| Interest income | 1,352 | 2,195 | 6,987 | 8,866 | |||||||||||
| Interest expense | (3,005 | ) | (1,980 | ) | (8,992 | ) | (5,209 | ) | |||||||
| Other rental income | 2,774 | — | 4,267 | — | |||||||||||
| Other expense, net | (1,196 | ) | (120 | ) | (2,856 | ) | (575 | ) | |||||||
| Net loss | $ | (11,895 | ) | $ | (12,925 | ) | $ | (74,135 | ) | $ | (156,087 | ) | |||
| Net loss per share, basic and diluted | $ | (1.82 | ) | $ | (1.99 | ) | $ | (11.39 | ) | $ | (24.00 | ) | |||
| Weighted-average shares used in computing net loss per share, basic and diluted | 6,525,885 | 6,503,913 | 6,510,138 | 6,503,913 | |||||||||||
| 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 December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net loss | $ | (11,895 | ) | $ | (12,925 | ) | $ | (74,135 | ) | $ | (156,087 | ) | |||
| Adjustments: | |||||||||||||||
| Non-cash stock-based compensation expense | 4,501 | 4,553 | 17,257 | 18,166 | |||||||||||
| Restructuring and impairment charges | 348 | 165 | 7,493 | 72,012 | |||||||||||
| Non-GAAP net loss | $ | (7,046 | ) | $ | (8,207 | ) | $ | (49,385 | ) | $ | (65,909 | ) | |||
| Net loss per share, basic and diluted | $ | (1.82 | ) | $ | (1.99 | ) | $ | (11.39 | ) | $ | (24.00 | ) | |||
| Adjustments: | |||||||||||||||
| Non-cash stock-based compensation expense per share | 0.69 | 0.70 | 2.65 | 2.79 | |||||||||||
| Restructuring and impairment charges | 0.05 | 0.03 | 1.15 | 11.07 | |||||||||||
| Non-GAAP net loss per share, basic and diluted* | $ | (1.08 | ) | $ | (1.26 | ) | $ | (7.59 | ) | $ | (10.14 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 6,525,885 | 6,503,913 | 6,510,138 | 6,503,913 | |||||||||||
______________________________________________________________
* Non-GAAP net loss per share, basic and diluted may not total due to rounding.
FAQ
What is Instil Bio's (TIL) cash position as of December 2024?
When will AXN-2510/IMM2510 clinical data for NSCLC be released?
How did Instil Bio's (TIL) R&D expenses change in 2024 compared to 2023?
What is Instil Bio's (TIL) expected cash runway?
How much did Instil Bio's (TIL) net loss per share improve in 2024?
