Instil Bio, Inc.
For the period ended Mar 31, 2026. Filed May 15, 2026.
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.
Mar 31, 2026 · Filed May 15, 2026
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 2025-09-30; filed 2025-11-13.
0001789769-25-000094
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001789769-26-000045
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 169 previous paragraphs and 117 current paragraphs.
57 unchanged; 34 reworded; 24 added; 73 removed; 5 previous and 2 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 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 (24)
Current report
We are a biotechnology company focused on identifying and advancing innovative therapeutic opportunities.
Current report
In January 2026, we announced that our wholly owned subsidiary, Axion Bio, Inc., or Axion Bio, was discontinuing development of AXN-2510, our former lead product candidate. We are actively seeking to in-license or acquire and develop additional novel therapeutic candidates in diseases with significant unmet medical need.
Current report
Collectively, the restructuring events from 2023 and 2024 are referred to as the “Plan.”
Current report
In May 2026, we determined that there had been a change to our plan with respect to the Tarzana facility and the Board of Directors approved discontinuing the plan to market the Tarzana facility for sale. As a result, we determined that this asset no longer meets the criteria to be classified as held for sale under ASC 360. Consequently, in the second quarter of 2026, this asset will be reclassified as held and used at the lower of (a) its carrying amount before the asset was classified as held for sale, adjusted for depreciation expenses that would have been recognized had the asset been continuously classified as held and used, and (b) its fair value. We are currently evaluating the financial statement impact of this reclassification. The resulting adjustment will be recognized in the second quarter in the condensed consolidated statement of operations and comprehensive loss as a component of gain (loss) from operations.
Current report
In January 2026, Axion Bio discontinued development of AXN-2510 and terminated certain employees associated with this program, or the 2026 Employee Terminations.
Current report
Gain on Contract Termination
Current report
Gain on contract termination consists of a payment received pursuant to the termination agreement between ImmuneOnco Biopharmaceuticals (Shanghai) Inc., or ImmuneOnco, and Axion Bio related to discontinuing development of AXN-2510.
Current report
Research and Development Expenses
Current report
Research and development expenses were $0.7 million and $5.4 million for the three months ended March 31, 2026 and 2025, respectively. The net decrease of approximately $4.7 million was primarily due to:
Current report
•$3.6 million decrease in costs related to research and clinical development activities primarily due to discontinuing development of AXN-2510; and
Current report
•$1.1 million decrease in employee-related costs from reduced headcount, consisting primarily of a $0.6 million decrease in stock-based compensation expense and a decrease in bonus and severance payments of $0.5 million.
Current report
General and administrative expenses were $5.3 million and $9.1 million for the three months ended March 31, 2026 and 2025, respectively. The net decrease of $3.8 million was primarily due to:
Current report
•$2.3 million decrease in employee-related costs from reduced headcount, consisting primarily of a $1.9 million decrease in stock-based compensation expense and a $0.4 million decrease in bonus and other employee-related expenses;
Current report
•$0.7 million decrease in insurance expense, depreciation, and office expenses.
Current report
Restructuring and impairment charges were approximately $1.0 million and $16.1 million for the three months ended March 31, 2026 and 2025, respectively. The net decrease of approximately $15.1 million was primarily due to:
Current report
•$16.6 million impairment recognized on long-lived assets held for sale mainly related to impairment of the Tarzana facility and as well as charges related to the anticipated cost to sell the facility in the first quarter of 2025; partially offset by
Current report
•$0.5 million increase due to a settlement gain on terminated contracts in 2025.
Current report
Interest Income, Interest Expense, Other Rental Income, Gain on Contract Termination, and Other (Expense) Income, Net
Current report
•$0.1 million decrease in other expenses; partially offset by
Current report
•$0.5 million increase in interest expense related to the 2024 Loan (as defined below);
Current report
•$0.3 million increase in foreign currency transaction losses.
Current report
The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We evaluated our ability to continue as a going concern for the twelve months following the issuance of the condensed consolidated financial statements. As discussed above and in Note 8 to the accompanying condensed consolidated financial statements, the 2024 Loan is due in January 2027, for total principal of $85.6 million, which is in excess of cash, cash equivalents, and marketable securities on hand as of March 31, 2026, which we concluded is an indicator of substantial doubt about our ability to continue as a going concern.
Current report
We plan to exercise our contractual right to extend the maturity of the 2024 Loan to January 2028. In addition, we may seek to refinance or restructure the 2024 Loan, sell the Tarzana facility to repay the 2024 Loan, or seek additional financing in the form of equity or debt instruments. There can be no assurance that new financing or other forms of funding will be available on favorable terms or at all. We concluded that management's plans, including Complex Therapeutics LLC’s contractual right to exercise the extension option to January 2028, which is within Complex Therapeutics LLC’s control, alleviate the conditions that raise substantial doubt about our ability to continue as a going concern.
Current report
Cash used in investing activities for the three months ended March 31, 2026 was $0.3 million, consisting of $0.3 million related to purchases of marketable securities.
Removed paragraphs (73)
Previous report
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 report
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 report
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 report
•23 patients with squamous NSCLC had been treated with monotherapy ‘2510.
Previous report
•All patients had failed previous PD-(L)1 inhibitor plus platinum-doublet chemotherapy, and six patients had previously received VEGF-directed therapy.
Previous 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.
Previous 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.
Previous 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.
Previous report
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 report
•33 patients were dosed at 10 mg/kg of ‘2510, with 21 patients having at least one tumor assessment (efficacy evaluable).
Previous report
•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.
Previous report
•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.
Previous report
•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.
Previous 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.
Previous report
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 report
In-Process Research and Development
Previous report
In-process research and development (IPR&D) expenses include IPR&D acquired as part of in-license payments made to ImmuneOnco for which there is no alternative future use, and are expensed as incurred.
Previous report
Income Tax Provision
Previous report
We are subject to income taxes in the United States and the United Kingdom. The United Kingdom has statutory tax rates that differ from those in the United States. Accordingly, our effective tax rates will vary depending on the relative proportion of United Kingdom to United States income, the availability of research and development tax credits, changes in the valuation of our deferred tax assets and liabilities and changes in tax laws.
Previous report
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Due to the uncertainty of the business in which we operate, projections of future profitability are difficult and past profitability is not necessarily indicative of future profitability. We maintain full valuation allowance against net deferred tax assets for the United States and the United Kingdom. The valuation allowance has been provided based on the positive and negative evidence relative to our company, including the existence of cumulative net operating losses, or NOLs, since our inception, and the inability to carryback these NOLs to prior periods. Furthermore, we have determined that it is more likely than not that the benefit of these assets would not be realized in the foreseeable future. The timing and the reversal of our valuation allowance will continue to be monitored.
Previous report
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 report
In-process Research and Development Expenses
Previous 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.
Previous 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:
Previous report
•$9.1 million increase in costs primarily related to research and clinical development activities from our ImmuneOnco collaboration; partially offset by
Previous report
•$0.5 million decrease in expenses related to facilities and overhead, depreciation, and other expenses.
Previous report
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 report
•$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 report
•$1.4 million decrease in facility and other office expenses; and
Previous 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:
Previous report
•$1.5 million decrease in costs from impairments of assets held for sale;
Previous report
•$0.6 million decrease in costs from right-of-use asset impairment; and
Previous report
•$0.1 million decrease in costs from leasehold improvement impairments; partially offset by
Previous report
•$1.3 million increase in costs resulting from a termination of a contract.
Previous report
Interest Income, Interest Expense, Other Rental Income and Other Income (Expense), Net
Previous report
•$1.0 million change in fair value from terminated derivative financial instrument;
Previous report
•$0.8 million increase in rental income related to the Tarzana facility; and
Previous report
•$0.4 million decrease in interest expense from our note payable; partially offset by
Previous report
•$0.6 million change in loss on foreign currency transactions.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Showing the first 40 of 73 passages. Open the source sections for the rest.
Reworded paragraphs (34)
Previous wording
The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, expectations regarding our collaborations and clinical trials, future financial position, future revenues, projected costs, prospects, and plans and objectives of management. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements.
Current wording
The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, expectations regarding collaborations and clinical trials, future financial position, future revenues, projected costs, prospects, and plans and objectives of management. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements.
Previous 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.
Current wording
Since inception, we have had significant operating losses. Our net loss was $4.2 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of$730.7 million. As of March 31, 2026, we had cash, cash equivalents, restricted cash and marketable securities of approximately $74.7 million, which consists of $5.0 million in cash and cash equivalents, $0.1 million in restricted cash and $69.5 million in marketable securities. 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 ‘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:
Current wording
We expect our future research and development expenses to change in line with our potential business development activities and any nonclinical and clinical development activities. Our expenditures on any 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
The process of conducting the necessary clinical research to obtain regulatory approval from the FDA, Medicines and Healthcare Products Regulatory Agency, or MHRA, European Medicines Agency, or EMA, and comparable foreign authorities is costly and time consuming and the successful development of product candidates is highly uncertain. The risks and uncertainties associated with our research and development projects are discussed more fully in the section of this Quarterly Report titled “Risk Factors.” As a result of these risks and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects, or if, when or to what extent we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates.
Current wording
The process of conducting the necessary clinical research to obtain regulatory approval from the U.S. Food and Drug Administration, or FDA, Medicines and Healthcare Products Regulatory Agency, or MHRA, European Medicines Agency, or EMA, and comparable foreign authorities is costly and time-consuming and the successful development of product candidates is highly uncertain. The risks and uncertainties associated with our research and development projects are discussed more fully in the section of this Quarterly Report titled “Risk Factors.” As a result of these risks and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects, or if, when or to what extent we will generate revenues from the commercialization and sale of any product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any product candidates.
Previous 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.
Current wording
Restructuring and impairment charges for the three months ended March 31, 2026 consisted of employee termination costs. Restructuring and impairment charges for the three months ended March 31, 2025 consisted primarily of an impairment loss recognized on long-lived assets held for sale in connection with listing our Tarzana facility for sale in March 2025, partially offset by a settlement gain on terminated contracts.
Previous wording
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 wording
In January 2023, the Board of Directors approved a restructuring plan and we announced the consolidation of the ITIL-306 Phase 1 clinical trial, which included contract terminations.
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 we refer to as the 2024 Plan, and collectively with the 2023 Plan, 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.
Previous wording
In March 2025, the Board of Directors approved a plan to sell the Tarzana facility and we listed our Tarzana facility for sale.
Current wording
In March 2025, the Board of Directors approved a plan to sell our Tarzana facility, and we listed our Tarzana facility for sale. At such time, we reclassified the facility as a long-lived asset held for sale and incurred impairment charges related thereto, which we refer to as the 2025 Tarzana Charges.
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 nil and $16.6 million during the three and nine months ended September 30, 2025, respectively.
Current wording
As a result of the Plan, the 2025 Tarzana Charges and the 2026 Employee Terminations, we incurred restructuring and impairment charges of $1.0 million and $16.1 million during the three months ended March 31, 2026 and 2025, respectively.
Previous wording
Interest income consists of interest income from funds held in our cash and cash equivalent accounts, marketable securities and long-term investments.
Current wording
Interest income consists of interest income from funds held in our cash and cash equivalent accounts, restricted cash and marketable securities.
Previous wording
Other rental income consists primarily of rental income related to our Tarzana facility.
Current wording
Other rental income consists of rental income related to the Tarzana facility.
Previous 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.
Current wording
Other (expense) income, net consists primarily of foreign exchange remeasurement gain or loss and other expenses and income.
Previous wording
•$0.9 million decrease in consulting and professional services costs.
Current wording
•$0.8 million decrease in consulting and professional services costs; and
Previous wording
•$1.5 million decrease in severance payments and benefits continuation costs;
Current wording
•$1.0 million increase in severance payments; and
Previous 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:
Current wording
Interest income, interest expense, other rental income, gain on contract termination and other (expense) income, net were $2.8 million and $2.4 million of income for the three months ended March 31, 2026 and 2025, respectively. The net increase of approximately $0.4 million was primarily due to:
Previous wording
•$0.1 million increase in gain on foreign currency transactions; partially offset by
Current wording
•$1.6 million increase in gain on contract termination;
Previous wording
•$0.8 million decrease in interest income related to our investments; and
Current wording
•$0.5 million decrease in interest income related to our investments; and
Previous wording
Since our inception, we have not generated any revenue from product sales and we have incurred significant operating losses. We do not have any products that have achieved regulatory marketing approval and we do not expect to generate revenue from commercial sales of any product candidates for at least several years, if ever.
Current wording
Since our inception, we have not generated any revenue from product sales and we have incurred significant operating losses. We do not have any products that have achieved regulatory marketing approval and we do not expect to generate revenue from commercial sales of any product candidate for at least several years, if ever.
Previous wording
In June 2022, our wholly owned subsidiaries, Complex Therapeutics Mezzanine LLC, and Complex Therapeutics LLC, entered into a mortgage construction loan and mezzanine construction loan, or together, the Construction Loans, secured by Complex Therapeutics LLC's Tarzana, California land and building. Construction of the Tarzana facility was completed and the facility has been leased to AstraZeneca Pharmaceuticals LP, or Tenant. The initial principal amount of the Construction Loans was $52.1 million, with additional future principal of up to $32.9 million to fund then ongoing construction costs. During the year ended December 31, 2024, Complex Therapeutics LLC refinanced the outstanding principal amount under the Construction Loans and we treated it as an extinguishment for accounting purposes. On December 20, 2024, or the Closing Date, Complex Therapeutics LLC entered into a Term Loan Agreement and related loan documents with Midland National Life Insurance Company, or Lender, pursuant to which Lender loaned Complex Therapeutics LLC a term loan in the principal amount of $85.6 million, or the Loan, to refinance the Construction Loans secured by the facility in Tarzana, California. Substantially all of the Loan proceeds were used to repay in full the Construction Loans. As of September 30, 2025, the outstanding principal amount under the Loan was $85.6 million and unamortized debt issuance costs were $1.0 million.
Current wording
In June 2022, our wholly owned subsidiaries, Complex Therapeutics Mezzanine LLC and Complex Therapeutics LLC, entered into a mortgage construction loan and mezzanine construction loan, or together, the Construction Loans, secured by Complex Therapeutics LLC’s Tarzana, California land and building. Construction of the Tarzana facility was subsequently completed and in 2024 the facility was leased to AstraZeneca
Previous wording
In March 2025, we entered into an Open Market Sale Agreement SM, or the ATM Sales Agreement, with Jefferies LLC, or Jefferies, as sales agent, under which we may offer and sell, from time to time, shares of our common stock through Jefferies, with an aggregate offering price of up to $100.0 million by methods deemed to be an “at the market offering,” or the ATM Program.
Current wording
In March 2025, we entered into an Open Market Sale Agreement SM, with Jefferies LLC, or Jefferies, as sales agent, under which we may offer and sell, from time to time, shares of our common stock, through Jefferies, with an aggregate offering price of up to $100 million by methods deemed to be an“at the market offering,” or the ATM Program.
Previous wording
During the nine months ended September 30, 2025, we sold an aggregate of 185,837 shares of our common stock under the ATM Program for net proceeds of $6.6 million after deducting commissions and expenses of approximately $0.3 million. The remaining availability under the ATM Program as of September 30, 2025 was approximately $93.1 million.
Current wording
As of March 31, 2026, we had sold an aggregate of 185,837 shares of our common stock under the ATM Program for net proceeds of $6.6 million after deducting commissions and expenses of approximately $0.3 million. The remaining availability under the ATM Program as of March 31, 2026 was approximately $93.1 million.
Previous wording
As of September 30, 2025, we had cash and 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. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
Current wording
As of March 31, 2026, we had cash, cash equivalents, restricted cash and marketable securities of approximately $74.7 million, which consisted of $5.0 million in cash and cash equivalents, $0.1 million in restricted cash and $69.5 million in marketable securities. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
Previous wording
The Loan has a term of two years with a one-year extension option. The extension option is subject to certain conditions being met, including: (a) no potential default or event of default, (b) payment of a 0.35% extension fee and the costs and expenses of Lender incurred in connection with the extension, (c) replenishing of all reserve funds as reasonably determined by Lender, and (d) compliance with minimum debt yield and debt service coverage ratio requirements. The Loan bears interest at a fixed rate of 6.35% per annum, with interest-only payments during the term of the Loan and the principal balance due in full at maturity.
Current wording
In December 2024, Complex Therapeutics LLC entered into the 2024 Loan to refinance the Construction Loans secured by the Tarzana facility. As of March 31, 2026, the outstanding principal amount under the 2024 Loan was $85.6 million and unamortized debt issuance costs were $0.6 million. The 2024 Loan bears interest at a fixed rate of 6.35% per annum, with interest-only payments during the term of the 2024 Loan and the principal balance due in full at maturity. The 2024 Loan may be prepaid in whole but not in part. There is no prepayment fee due if the 2024 Loan is prepaid after the 12-month anniversary of the Closing Date. The 2024 Loan has a term of two years with a one-year extension option. The extension option is subject to certain conditions being met, including: (a) no potential default or event of default, (b) payment of a 0.35% extension fee and the costs and expenses of Midland incurred in connection with the extension, (c) replenishing of all reserve funds as reasonably determined by Midland, and (d) compliance with minimum debt yield and debt service coverage ratio requirements. We expect Complex Therapeutics LLC to meet all requirements necessary to exercise the extension to extend the maturity by one year to January 2028, and we expect that written notice to extend the loan will be provided as early as the 2024 Loan permits, which is no sooner than one hundred twenty days from its maturity date and no later than thirty days before its maturity date.
Previous wording
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 wording
Based on our current operating plan, we believe our existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements beyond 2027.
Previous wording
We use our cash to fund operations, primarily to fund our business development, research and development expenditures and related personnel costs. We expect our expenses to continue to be significant as we invest in research and development activities, particularly as we in-license or acquire product candidates, advance product candidates into later stages of development and conduct clinical trials, seek regulatory approvals for and commercialize any product candidates that successfully complete clinical trials, hire personnel and invest in and grow our business, expand and protect our intellectual property portfolio, and operate as a public company. Because of the numerous risks and uncertainties associated with acquiring product candidates, and the research, development and commercialization of product candidates, we are unable to estimate the exact timing and amount of our funding requirements. Our future operating expenditures will depend on many factors, including:
Current wording
We use our cash to fund operations, primarily to fund our business development, research and development expenditures and related personnel costs. We expect our expenses to continue to be significant as we invest in research and development activities, particularly if we in-license or acquire product candidates, advance one or more product candidates into later stages of development and conduct clinical trials, seek regulatory approvals for and commercialize any product candidates that successfully complete clinical trials, hire personnel and invest in and grow our business, expand and protect our intellectual property portfolio, and operate as a public company. Because of the numerous risks and uncertainties associated with acquiring product candidates, and the research, development and commercialization of product candidates, we are unable to estimate the exact timing and amount of our funding requirements. Our future operating expenditures will depend on many factors, including:
Previous wording
•the cost of commercialization activities of our product candidates, if approved for sale, including marketing, sales and distribution costs;
Current wording
•the cost of commercialization activities of any product candidates, if approved for sale, including marketing, sales and distribution costs;
Previous wording
•the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing our intellectual property portfolio; and
Current wording
•the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing any intellectual property portfolio we may acquire;
Previous wording
Until we can generate substantial revenue from sales of our product candidates, if that occurs, we plan to fund our operations through equity offerings, debt financings, or other capital sources. This may include leasing income, strategic collaborations or other arrangements with third parties. Additional funds may not be available to us on acceptable terms or at all. If we raise additional funds by issuing equity or convertible debt securities, our stockholders will suffer dilution, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities receive any distribution of our corporate assets. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to technologies, future revenue streams, product candidates or research programs or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our ability to raise additional funds may be adversely impacted by worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from, among other things, heightened inflation, fluctuations in interest rates, conflicts in Ukraine and the Middle East, tariffs and recent and potential trade wars. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. See “Risk Factors.”
Current wording
Until we can generate substantial revenue from sales of a product candidate, if that occurs, we plan to fund our operations through equity offerings, debt financings, leasing income, or other capital sources. This may include strategic collaborations or other arrangements with third parties. Additional funds may not be available to us on acceptable terms or at all. If we raise additional funds by issuing equity or convertible debt securities, our stockholders will suffer dilution, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities receive any distribution of our corporate assets. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to technologies, future revenue streams, product candidates or research programs or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our ability to raise additional funds may be adversely impacted by worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from, among other things, heightened inflation, fluctuations in interest rates, military conflicts, including in Ukraine and the Middle East, tariffs and recent and potential trade wars. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. See“Risk Factors.”
Previous wording
Cash used in operating activities for the nine months ended September 30, 2024 was $45.1 million, which consisted of the net loss of $62.2 million and a $8.5 million net change to our net operating assets and liabilities, offset by $25.6 million in non-cash charges and other adjustments to reconcile net loss to net cash used in operating activities. The net change in our operating assets and liabilities was primarily due to a decrease of $0.4 million in accrued expenses and other current liabilities, a decrease of $1.0 million in operating lease liabilities, an increase of $2.5 million in prepaid expenses and other current assets, an increase of $1.5 million in accrued rent receivable, and an increase of $3.1 million in other long-term assets. The non-cash charges primarily consisted of stock-based compensation expense of $12.8 million, in-process research and development expenses of $10.0 million, impairment of fixed assets and right-of-use assets, and loss on disposal of property and equipment of $5.5 million, change in fair value of interest cap derivative instrument and non-cash interest expense of $1.0 million, and depreciation expense of $2.9 million, partially offset by accretion on invested securities of $3.9 million and change in fair value of contingent consideration of $2.5 million.
Current wording
Cash used in operating activities for the three months ended March 31, 2026 was $1.3 million, which consisted of the net loss of $4.2 million, partially offset by a $1.3 million net change to our net operating assets and liabilities and $1.6 million in non-cash charges and other adjustments to reconcile net loss to net cash used in operating activities. The net change in our operating assets and liabilities was primarily due to a decrease of $1.5 million in prepaid expenses and other current assets, a decrease of $0.1 million in other long-term assets, and an increase of $0.1 million in accrued expenses and other current liabilities, partially offset by an increase of $0.3 million in accrued rent receivable and a decrease of $0.1 million in operating lease liabilities. The non-cash charges primarily consisted of stock-based compensation expense of $1.0 million, non-cash interest expense of $0.2 million, accretion on invested securities of $0.2 million and change in foreign exchange remeasurement of $0.1 million.
Previous wording
Cash used in operating activities for the nine months ended September 30, 2025 was $29.5 million, which consisted of the net loss of $63.2 million and an approximately $0.6 million net change to our net operating assets and liabilities, partially offset by $34.3 million in non-cash charges and other adjustments to reconcile net loss to net cash used in operating activities. The non-cash charges primarily consisted of impairment of property, plant and equipment of $16.6 million, in-process research and development expenses of $10.0 million, stock-based compensation expense of $7.1 million, depreciation expense of $0.5 million, non-cash lease expense of $0.2 million, and non-cash interest expense of $0.6 million, partially offset by a change in foreign exchange remeasurement of $0.5 million, $0.1 million in restructuring costs, and accretion on invested securities of $0.1 million. The net change in our operating assets and liabilities was primarily due to a decrease of approximately $1.6 million in accrued expenses and other current liabilities, an increase of $3.1 million in accrued rent receivable, and a decrease of $1.6 million in operating lease liabilities, partially offset by an increase of $0.3 million in accounts payable, a decrease of $0.3 million in other long-term assets, and a decrease of $4.9 million in prepaid expenses and other current assets.
Current wording
Cash used in operating activities for the three months ended March 31, 2025 was $4.2 million, which consisted of the net loss of $28.2 million, partially offset by a $3.6 million net change to our net operating assets and liabilities and $20.4 million in non-cash charges and other adjustments to reconcile net loss to net cash used in operating activities. The net change in our operating assets and liabilities was primarily due to an increase of $6.5 million in prepaid expenses and other current assets, an increase of $1.3 million in accrued rent receivable and other long-term assets, a decrease of $0.2 million in operating lease liabilities, a decrease of $0.4 million in accounts payable, and a decrease of $1.0 million in accrued restructuring liabilities, accrued expenses and other current liabilities. The non-cash charges primarily consisted of stock-based compensation expense of $3.5 million, depreciation expense of $0.5 million, impairment of property, plant and equipment of $16.6 million, and non-cash interest expense of $0.2 million, offset by accretion on invested securities of $0.2 million and change in foreign exchange remeasurement of $0.2 million.
Previous wording
Cash provided by investing activities for the nine months ended September 30, 2025 was $17.7 million, consisting primarily of approximately $27.3 million of cash provided by marketable securities investments and $0.4 million of cash received from held for sale assets, offset by $10.0 million of acquired in-process research and development.
Current wording
Cash provided by investing activities for the three months ended March 31, 2025 was $9.6 million, consisting of $9.2 million related to redemptions from marketable securities and $0.4 million of cash received from the sale of assets classified as held for sale.
Previous wording
Cash provided by financing activities for the nine months ended September 30, 2025 was $7.3 million, and primarily consisted of net proceeds from our ATM Program of $6.6 million and net proceeds from the exercise of stock options of $0.9 million, partially offset by loan agreement closing costs of $0.2 million.
Current wording
Cash provided by financing activities for the three months ended March 31, 2026 was nil.
Previous wording
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.
Current wording
Cash provided by financing activities for the three months ended March 31, 2025 was $0.2 million, which was related to proceeds from the exercise of stock options of $0.4 million, offset by loan agreement closing costs of $0.2 million.
Previous wording
We are an “emerging growth company” as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.
Current wording
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Pharmaceuticals LP, or Tenant. The initial base rent under the lease to Tenant was approximately $0.6 million per month (approximately $7.5 million annually) and the base rent escalates by 3% per annum. On December 20, 2024, or the Closing Date, Complex Therapeutics LLC entered into a Term Loan Agreement and related loan documents with Midland National Life Insurance Company, or Midland, pursuant to which Midland loaned Complex Therapeutics LLC a term loan in the principal amount of $85.6 million, or the 2024 Loan, to refinance the Construction Loans secured by the Tarzana facility. Substantially all of the 2024 Loan proceeds were used to repay in full the Construction Loans.
Current report — wording carried from elsewhere
•costs related to the Tarzana facility; and
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
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 report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report — wording carried elsewhere
The following table shows our research and development expenses by program for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report — wording carried elsewhere
(1) Other program expenses consist of costs related to our past development of our CoStAR-TIL technology.
Previous report — wording carried elsewhere
•$1.5 million decrease in consulting and professional services costs.