Instil Bio, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
TIL$6.83-2.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001789769-25-000081
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001789769-25-000094
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 160 previous paragraphs and 169 current paragraphs.
86 unchanged; 61 reworded; 16 added; 12 removed; 1 previous and 6 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (16)
Current report
•23 patients with squamous NSCLC had been treated with monotherapy ‘2510.
Current report
•All patients had failed previous PD-(L)1 inhibitor plus platinum-doublet chemotherapy, and six patients had previously received VEGF-directed therapy.
Current report
•Patients were treated with ‘2510 at different dose levels (3, 6, 10, or 20 mg/kg Q2W), with the majority of patients treated at the 20 mg/kg Q2W dose level.
Current report
•In the 17 efficacy evaluable patients, the objective response rate was 35.3%, with the majority of responses seen in patients with negative and low PD-L1 TPS scores.
Current report
•In general, ‘2510 was well tolerated and had a manageable safety profile in the Phase 1 trial, with mostly manageable low grade infusion reactions in the first cycle, as previously reported. In the squamous subset there were two Grade 3 VEGF-related adverse events of proteinuria and bleeding.
Current report
ImmuneOnco has also announced it is pursuing additional clinical trials in China of ‘2510, including studies of ‘2510 in combination with each of AXN-27M/IMM27M and IMM01 for advanced solid tumors. IMM01 is a recombinant human signal-regulatory protein alpha (SIRPα) immunoglobulin G1 (IgG1) fusion protein targeting CD47, currently in development by ImmuneOnco.
Current report
In January 2023, the Board of Directors approved a restructuring plan, or the 2023 Plan, and we announced the consolidation of the ITIL-306 Phase 1 clinical trial and related manufacturing of CoStAR-TIL to our operations in Manchester, UK and stopped recruiting for the ITIL-306 clinical trial.
Current report
Other (Expense) Income, Net
Current report
In-process research and development expenses were nil and $10.0 millionfor thethree months ended September 30, 2025 and 2024, respectively. The netdecrease of $10.0 million was due to the fact that there was a $10.0 million in-license payment to ImmuneOnco pursuant to the IO Collaboration Agreement in the three months ended September 30, 2024 and no in-license payments in the three months ended September 30, 2025.
Current report
Research and development expenses were $9.1 million and $0.6 million for the three months ended September 30, 2025 and 2024, respectively. The netincrease of approximately $8.6 million was due to:
Current report
Restructuring and impairment charges were nil and $2.4 million for the three months ended September 30, 2025 and 2024, respectively. The net decrease of $2.4 million was due to:
Current report
•$0.6 million decrease in costs from right-of-use asset impairment; and
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
In-process research and development expenses were $10.0 million for each of the nine months ended September 30, 2025 and 2024, reflecting $10.0 million of in-process research and development costs being paid to ImmuneOnco during each of the nine month periods ended September 30, 2025 and 2024.
Current report
Research and development expenses were $21.2 million and $10.7 million for the nine months ended September 30, 2025 and 2024, respectively. The netincrease in research and development expenses of $10.5 millionwas primarily dueto:
Current report
General and administrative expenses were $21.2 million and $33.8 million for the nine months ended September 30, 2025 and 2024, respectively. The net decrease of approximately $12.7 million was primarily due to:
Removed paragraphs (12)
Previous report
Our development efforts are focused on advancing AXN-2510/IMM2510 and we may pursue additional promising therapeutic in-licensing or acquisition opportunities.
Previous report
Other Income (Expense), Net
Previous report
In-process research and development expenses were $10.0 million and nilfor thethree months ended June 30, 2025 and 2024, respectively. The net increase of$10.0 million was due to:
Previous report
•$10.0 million increase in research and development costs related to payments made to ImmuneOnco upon achievement of a development milestone under the collaboration agreement.
Previous report
Research and development expenses were $6.7 million and $2.9 million for the three months ended June 30, 2025 and 2024, respectively. The net increase of $3.8 million was primarily due to:
Previous report
•$0.5 million decrease in costs from reduced headcount, consisting primarily of a decrease of $0.8 million in wages and benefits and a $0.4 million decrease in stock-based compensation expense, partially offset by an increase of $0.7 million in expenses for professional service fees; and
Previous report
Restructuring and impairment charges were approximately $0.5 million and $0.5 million for the three months ended June 30, 2025 and 2024, respectively. The net change of nil was primarily due to:
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
In-process research and development expenses were $10.0 million and nilfor the six months ended June 30, 2025 and 2024, respectively. The net increase of$10.0 million was due to:
Previous report
•$10.0 million increase in research and development costs related to payments made to ImmuneOnco upon achievement of a development milestone under the collaboration agreement.
Previous report
Research and development expenses were $12.1 million and $10.2 million for the six months ended June 30, 2025 and 2024, respectively. The increase in research and development expenses of$1.9 millionwas primarily dueto:
Previous report
General and administrative expenses were $15.3 million and $23.1 million for the six months ended June 30, 2025 and 2024, respectively. The net decrease of $7.9 million was primarily due to:
Reworded paragraphs (61)
Previous wording
We are a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. We are advancing the development of our lead product candidate, AXN-2510/IMM2510, a bispecific antibody targeting both programmed death-ligand 1, or PD-L1, and the family of vascular endothelial growth factors, or VEGFs, in solid tumor cancers, and we seek to in-license or acquire and develop additional novel therapeutic candidates in diseases with significant unmet medical need.
Current wording
We are a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. We are advancing the development of our lead product candidate, AXN-2510/IMM2510, or ‘2510, a bispecific antibody targeting both programmed death-ligand 1, or PD-L1, and the family of vascular endothelial growth factors, or VEGFs, in solid tumor cancers, and we seek to in-license or acquire and develop additional novel therapeutic candidates in diseases with significant unmet medical need.
Previous wording
In August 2024, our wholly owned subsidiary, Axion Bio, Inc., or Axion Bio, in-licensed certain bispecific antibodies, including AXN-2510/IMM2510 and AXN-27M/IMM27M, a monoclonal antibody targeting cytotoxic T-lymphocyte associated antigen 4, or CTLA-4, from ImmuneOnco Biopharmaceuticals (Shanghai) Inc., or ImmuneOnco. AXN-2510/IMM2510, the lead in-licensed product candidate, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. Pursuant to the license and collaboration agreement with ImmuneOnco, or the IO Collaboration Agreement, Axion Bio has an exclusive license to research, develop, manufacture and commercialize these product candidates outside of China, including mainland China, Hong Kong, Macau and Taiwan, or Greater China. ImmuneOnco retains development and commercialization rights in Greater China.
Current wording
In August 2024, our wholly owned subsidiary, Axion Bio, Inc., or Axion Bio, in-licensed certain bispecific antibodies, including ‘2510 and AXN-27M/IMM27M, a monoclonal antibody targeting cytotoxic T-lymphocyte associated antigen 4, from ImmuneOnco Biopharmaceuticals (Shanghai) Inc., or ImmuneOnco. ‘2510, the lead in-licensed product candidate, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. Pursuant to the license and collaboration agreement with ImmuneOnco, or the IO Collaboration Agreement, Axion Bio has an exclusive license to research, develop, manufacture and commercialize these product candidates outside of China, including mainland China, Hong Kong, Macau and Taiwan, or Greater China. ImmuneOnco retains development and commercialization rights in Greater China.
Previous wording
ImmuneOnco is conducting a Phase 1 open label trial in China of AXN-2510/IMM2510 as monotherapy in patients with advanced solid tumors that have failed prior therapies, including triple-negative breast cancer, or TNBC, non-small cell lung cancer, or NSCLC, hepatocellular carcinoma, renal cell carcinoma, and rare solid tumors including soft tissue sarcomas and thymic cancer. As of January 13, 2025, ImmuneOnco announced over 100 patients have been enrolled in this clinical trial.
Current wording
ImmuneOnco is conducting a Phase 1 open label trial in China of ‘2510 as monotherapy in patients with advanced solid tumors that have failed prior therapies, including triple-negative breast cancer, or TNBC, non-small cell lung cancer, or NSCLC, hepatocellular carcinoma, renal cell carcinoma, and rare solid tumors including soft tissue sarcomas and thymic cancer. ImmuneOnco has announced that 150 patients have been enrolled in this clinical trial as of June 30, 2025. In September 2025, ImmuneOnco presented preliminary efficacy (as of August 6, 2025) and safety (as of June 13, 2025) data from this study in patients with previously treated squamous NSCLC at the 2025 World Conference on Lung Cancer. ImmuneOnco reported that:
Previous wording
ImmuneOnco is also conducting a Phase 2 open label clinical trial of AXN-2510/IMM2510 in combination with chemotherapy in patients with advanced/metastatic NSCLC. On July 31, 2025, ImmuneOnco announced preliminary safety and efficacy data from the ongoing Phase 2 open-label, multicenter study of IMM2510/
Current wording
ImmuneOnco is also conducting a Phase 2 open label, multicenter clinical trial of ‘2510 in combination with chemotherapy in front-line patients with advanced/metastatic NSCLC in China. In July 2025, ImmuneOnco announced the following preliminary safety and efficacy data from the Phase 2 trial (as of July 1, 2025):
Previous wording
AXN-2510 in combination with chemotherapy for first-line patients with advanced/metastatic NSCLC conducted by ImmuneOnco in China. As of July 1, 2025, 33 patients were dosed at 10 mg/kg of AXN-2510/IMM2510, with 21 patients having at least one tumor assessment (efficacy evaluable). Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. No dose-limiting toxicities were observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events, or TRAE, leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade and infusion-related reactions were nearly all low-grade.
Current wording
•33 patients were dosed at 10 mg/kg of ‘2510, with 21 patients having at least one tumor assessment (efficacy evaluable).
Previous wording
On July 2, 2025, we announced the clearance of an Investigational New Drug (IND) application for AXN-2510/IMM2510 by the U.S. Food and Drug Administration, and we expect to initiate a Phase 1 trial of AXN-2510/IMM2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025.
Current wording
In July 2025, we announced the clearance of an Investigational New Drug (IND) application for ‘2510 by the U.S. Food and Drug Administration. Axion Bio has initiated a Phase 1 clinical trial of ‘2510 as monotherapy for adult patients with relapsed/refractory solid tumors, and the first patient was dosed in this study in October 2025.
Previous wording
Since inception, we have had significant operating losses. Our net loss was $21.4 million for the three months ended June 30, 2025 and $49.6 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $704.7 million. As of June 30, 2025, we had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $103.6 million, which consists of $7.7 million in cash and cash equivalents, approximately $0.2 million in restricted cash, $84.1 million in marketable securities and $11.7 million in long-term investments. We expect to continue to incur net losses for the foreseeable future.
Current wording
Since inception, we have had significant operating losses. Our net loss was $13.6 million for the three months ended September 30, 2025 and $63.2 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $718.3 million. As of September 30, 2025, we had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $83.4 million, which consists 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. We expect to continue to incur net losses for the foreseeable future.
Previous wording
We expect our future research and development expenses to change in line with our clinical development activities for AXN-2510/IMM2510 and other potential business development activities. Our expenditures on future nonclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of clinical trials and development of product candidates will depend on a variety of factors, including:
Current wording
We expect our future research and development expenses to change in line with our clinical development activities for ‘2510 and other potential business development activities. Our expenditures on future nonclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of clinical trials and development of product candidates will depend on a variety of factors, including:
Previous wording
Restructuring and impairment charges for the six months ended June 30, 2025 primarily consist of contract fees related to terminated contracts, and an impairment loss recognized on long-lived assets held for sale in connection with listing our Tarzana facility for sale in March 2025.
Current wording
Restructuring and impairment charges for the nine months ended September 30, 2025 consisted primarily of contract fees related to terminated contracts and an impairment loss recognized on long-lived assets held for sale in connection with listing our Tarzana facility for sale in March 2025.
Previous wording
Restructuring and impairment charges for the six months ended June 30, 2024 consist primarily of employee termination costs, contract terminations, and impairment loss recognized on long-lived assets held for sale.
Current wording
Restructuring and impairment charges for the nine months ended September 30, 2024 consisted primarily of employee termination costs, contract terminations, and impairment loss recognized on long-lived assets held for sale, leasehold improvements, and right-of-use assets.
Previous wording
In January 2024, we decided to initiate closure of our UK manufacturing and clinical operations related to our past development of our CoStAR-TIL technology, and in September 2024 we decided to close most of our remaining Manchester, UK operations related to our past development of our CoStAR-TIL technology, which resulted in the elimination of the majority of the remaining UK workforce, with the remaining reduction substantially completed by the end of 2024, which collectively we refer to as the Plan.
Current wording
In January 2024, we decided to initiate closure of our UK manufacturing and clinical operations related to our past development of our CoStAR-TIL technology, and in September 2024 we decided to close most of our remaining Manchester, UK operations related to our past development of our CoStAR-TIL technology, which resulted in the elimination of the majority of the remaining UK workforce, with the remaining reduction substantially completed by the end of 2024, which we refer to as the 2024 Plan, and collectively with the 2023 Plan, as the Plan.
Previous wording
As a result of the Plan and the impairment loss related to listing our Tarzana facility for sale, we incurred restructuring and impairment charges of $16.6 million during the six months ended June 30, 2024.
Current wording
As a result of the Plan and the impairment loss related to listing our Tarzana facility for sale, we incurred restructuring and impairment charges of nil and $16.6 million during the three and nine months ended September 30, 2025, respectively.
Previous wording
Other income (expense), net consists primarily of derivative financial instrument fair value gain or loss, foreign exchange remeasurement gain or loss and other expenses and income.
Current wording
Other (expense) income, net consists primarily of derivative financial instrument fair value gain or loss, foreign exchange remeasurement gain or loss and other expenses and income.
Previous wording
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted. The OBBBA includes an elective deduction for domestic research and development (R&D) and a reinstatement of elective 100% first-year bonus depreciation, among other provisions. We are currently evaluating the impact of OBBBA on our consolidated financial statements.
Current wording
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into the law. The OBBBA includes an elective deduction for domestic research and development (R&D) and a reinstatement of elective 100% first-year bonus depreciation, among other provisions. We do not expect the OBBBA to have a material impact on our 2025 condensed consolidated financial statements.
Previous wording
•$5.3 million increase in costs primarily related to research and clinical development activities from our ImmuneOnco collaboration; partially offset by
Current wording
•$9.1 million increase in costs primarily related to research and clinical development activities from our ImmuneOnco collaboration; partially offset by
Previous wording
•$1.0 million decrease in expenses related to facilities and overhead, depreciation, and other expenses.
Current wording
•$0.5 million decrease in expenses related to facilities and overhead, depreciation, and other expenses.
Previous wording
General and administrative expenses were $6.2 million and $10.7 million for the three months ended June 30, 2025 and 2024, respectively. The net decrease of $4.5 million was primarily due to:
Current wording
General and administrative expenses were $5.9 million and $10.7 million for the three months ended September 30, 2025 and 2024, respectively. The net decrease of $4.8 million was primarily due to:
Previous wording
•$2.3 million decrease in costs from reduced headcount, consisting of decreases in wages, benefits, and other employee related expenses of $0.3 million and stock-based compensation expense of $2.0 million;
Current wording
•$2.5 million decrease in costs from reduced headcount, consisting of a decrease in wages, benefits, and other employee related expenses of $0.4 million and stock-based compensation expense of $2.1 million;
Previous wording
•$0.8 million decrease in consulting and professional services costs.
Current wording
•$0.9 million decrease in consulting and professional services costs.
Previous wording
•$0.3 million decrease in costs from impairments of assets held for sale;
Current wording
•$1.5 million decrease in costs from impairments of assets held for sale;
Previous wording
•$1.0 million decrease in severance payments and benefits continuation costs;
Current wording
•$1.5 million decrease in severance payments and benefits continuation costs;
Previous wording
•$0.5 million increase in costs resulting from a termination of a contract.
Current wording
•$1.3 million increase in costs resulting from a termination of a contract.
Previous wording
Interest income, interest expense, other rental income and other income (expense), net was $2.0 million of income and $0.8 million of expense for the three months ended June 30, 2025 and 2024, respectively. The increase of $2.8 million was primarily due to:
Current wording
Interest income, interest expense, other rental income and other income (expense), net was $1.4 million and $0.6 million of income for the three months ended September 30, 2025 and 2024, respectively. The net increase of $0.8 million was primarily due to:
Previous wording
•$0.7 million change in fair value from terminated derivative financial instrument;
Current wording
•$1.0 million change in fair value from terminated derivative financial instrument;
Previous wording
•$2.2 million increase in rental income related to the Tarzana facility;
Current wording
•$0.8 million increase in rental income related to the Tarzana facility; and
Previous wording
•$0.9 million decrease in interest income related to our investments.
Current wording
•$0.8 million decrease in interest income related to our investments; and
Previous wording
•$0.4 million increase in gain on foreign currency transactions; and
Current wording
•$0.6 million change in loss on foreign currency transactions.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
•$6.3 million increase in costs related to research and clinical development activities from our ImmuneOnco collaboration; partially offset by,
Current wording
•$15.4 million increase in costs related to research and clinical development activities from our ImmuneOnco collaboration; partially offset by
Previous wording
•$3.0 million decrease in costs from reduced headcount, consisting primarily of a decrease of $3.0 million in wages and benefits, $0.7 million decrease in stock-based compensation expense; partially offset by $0.7 million increase in expenses for professional services; and
Current wording
•$3.1 million decrease in costs from reduced headcount, consisting primarily of a decrease of $2.9 million in wages and benefits, $1.0 million decrease in stock-based compensation expense, and $0.1 million decrease for other employee-related expenses in relation to our research and development personnel; partially offset by $0.9 million increase in expenses for professional services; and
Previous wording
•$1.4 million decrease in expenses related to facilities and overhead, depreciation, and other expenses.
Current wording
•$1.8 million decrease in expenses related to facilities and overhead, depreciation, and other expenses.
Previous wording
The following table shows our research and development expenses by program for the six months ended June 30, 2025 and 2024 (in thousands)
Current wording
The following table shows our research and development expenses by program for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
•$5.0 million decrease in costs from reduced headcount, mainly due to a decrease in wages of $2.1 million, a decrease in stock-based compensation expense of $2.7 million and a decrease in other employee-related expenses of $0.2 million;
Current wording
•$7.4 million decrease in costs from reduced headcount, mainly due to a decrease in wages of $2.4 million, a decrease in stock-based compensation expense of $4.7 million and a decrease in other employee-related expenses of $0.3 million;
Previous wording
•$2.3 million decrease in depreciation, facility costs, and insurance expenses; and
Current wording
•$3.8 million decrease in depreciation, facility costs, and insurance expenses; and
Previous wording
•$0.6 million decrease in consulting and professional services costs.
Current wording
•$1.5 million decrease in consulting and professional services costs.
Previous wording
Restructuring and impairment charges were $16.6 million and $4.8 million for the six months ended June 30, 2025 and 2024, respectively. The net increase of $11.8 million was primarily due to:
Current wording
Restructuring and impairment charges were $16.6 million and $7.1 million for the nine months ended September 30, 2025 and 2024, respectively. The net increase of $9.5 million was primarily due to:
Previous wording
•$13.8 million increase in costs from impairments of assets held for sale, primarily an impairment of the Tarzana facility; partially offset by,
Current wording
•$12.3 million increase in costs from impairments of assets held for sale, primarily an impairment of the Tarzana facility; and
Previous wording
•$0.5 million decrease in costs resulting from termination of contracts;
Current wording
•$0.8 million increase in costs resulting from termination of contracts; partially offset by
Previous wording
•$0.2 million decrease in severance payments and benefits continuation costs; partially offset by
Current wording
•$2.4 million decrease in severance payments and benefits continuation costs;
Previous wording
•$0.2 million decrease in costs from impairments of right-of-use assets.
Current wording
•$0.8 million decrease in costs from impairments of right-of-use assets; and
Showing the first 40 of 61 pairs. Open the source sections for the rest.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
•Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off.
Current report — wording carried from elsewhere
•No dose-limiting toxicities were observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events, or TRAEs, leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae.
Current report — wording carried from elsewhere
•Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade and infusion-related reactions were nearly all low-grade.
Current report — wording carried from elsewhere
•$0.1 million decrease in costs from leasehold improvement impairments; partially offset by
Current report — wording carried from elsewhere
Based on our current operating plan, we believe our existing cash, cash equivalents, restricted cash, marketable securities and long-term investments will be sufficient to fund our operating expenses and capital expenditure requirements beyond 2026.
Current report — wording carried from elsewhere
Cash provided by financing activities for the nine months ended September 30, 2024 was $0.2 million, which primarily consisted of proceeds from the exercise of stock options.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Cash provided by financing activities for the six months ended June 30, 2024 was nil.