Instil Bio, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
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Sep 30, 2025 · Filed Nov 13, 2025
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Notes to Condensed Consolidated Financial Statements
- Organization and Description of Business
Instil Bio, Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. The Company is advancing the development of its lead product candidate, AXN-2510/IMM2510 (“‘2510”), a bispecific antibody targeting both programmed death-ligand 1 (“PD-L1”) and vascular endothelial growth factor (“VEGF”) in solid tumor cancers, and seeks to in-license or acquire and develop additional novel therapeutic candidates in diseases with significant unmet medical need.
In August 2024, the Company’s wholly owned subsidiary, Axion Bio, Inc. (“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. (“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 (the “IO Collaboration Agreement”), Axion Bio has an exclusive license to research, develop, manufacture and commercialize these product candidates globally, including in the United States, Europe and Japan, excluding mainland China, Hong Kong, Macau and Taiwan (“Greater China”). ImmuneOnco retains development and commercialization rights in Greater China.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2025, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024, the condensed consolidated statements of stockholders’ equity for the three and nine months ended September 30, 2025 and 2024, and the results of its cash flows for the nine months ended September 30, 2025 and 2024. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2025 and 2024 are also unaudited. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other periods, or any future year period. The Company has evaluated subsequent events through the date the condensed consolidated financial statements were issued.
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 4, 2025.
Segments
Operating segments are identified as components of an entity for which separate discrete financial information is available and that is regularly reviewed by the chief operating decision-maker, the Company's Chief Executive Officer, in deciding how to allocate resources to an individual segment and in assessing performance. The Company has determined it operates in a single operating segment and hasone operating segment. See Note 3 for further information.
Cash, Cash Equivalents, Restricted Cash, Marketable Securities, and Long-Term Investments
The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents include amounts invested in money market accounts.
Restricted cash consists of a cash reserve which served as collateral for the Loan (as defined in Note 8) on the condensed consolidated balance sheet as of December 31, 2024. As of September 30, 2025 the restricted cash consists of a cash reserve allocated to future tax payments. There was $0.3 million and $1.8 million of restricted cash as of September 30, 2025 and December 31, 2024, respectively, on the condensed consolidated balance sheets.
The Company’s investments in marketable securities and long-term investments have been classified and accounted for as available-for-sale. The Company classifies its maturities as either short-term or long-term based on each instrument’s underlying contractual maturity date, which are carried at their fair values based on the quoted market prices of the securities. Unrealized gains and losses are reported as accumulated other comprehensive income (loss). Realized gains and losses on available-for-sale securities are included in net loss in the period earned or incurred. As of September 30, 2025 and December 31, 2024, marketable securities and long-term investments consisted of U.S. Treasury bills.
The Company periodically reviews whether its securities may be other-than-temporarily impaired, including whether or not (i) the Company has the intent to sell the security or (ii) it is more likely than not that the Company will be required to sell the security before its anticipated recovery. If one of these factors is met, the Company will record an impairment loss associated with its impaired investment. The impairment loss will be recorded as a write-down of investments in the condensed consolidated balance sheets and a realized loss within other expense in the condensed consolidated statements of operations and comprehensive loss. As of September 30, 2025 and December 31, 2024, there were no impairment losses for the investments.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the amounts shown in the condensed consolidated statements of cash flows (in thousands):
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Cash and cash equivalents | $5,801 | $8,805 |
| Restricted cash | 280 | 1,830 |
| Cash, cash equivalents and restricted cash | $6,081 | $10,635 |
Assets Held for Sale
The Company classifies long-lived assets or disposal groups to be sold as held for sale in the period in which all of the following criteria are met: management, having the authority to approve the action, commits to a plan to sell the asset or disposal group; the asset or disposal group is available for immediate sale in its present condition subject only to terms that are usual and customary for sales of such assets or disposal group; the sale of the asset or disposal group is probable, and transfer of the asset or disposal group is expected to qualify for recognition as a completed sale within one year, except if events or circumstances beyond the Company’s control extend the period of time required to sell the asset or disposal group beyond one year, and actions required to complete the plan to sell have been initiated.
The Company initially measures a long-lived asset or disposal group that is held for sale at the lower of its carrying value or fair value less any costs to sell. Fair value is estimated by the Company through evaluations of quoted market prices received for other comparable held for sale assets sold by the Company. Any loss resulting from this measurement is recognized in the period in which the held for sale criteria are met. Conversely, gains are not recognized on the sale of a long-lived asset or disposal group until the date of sale. The Company assesses the fair value of a long-lived asset or disposal group less any costs to sell each reporting period it remains classified as held for sale and reports any subsequent changes as an adjustment to the carrying value of the asset or disposal group, as long as the new carrying value does not exceed the carrying value of the asset at the time it was initially classified as held for sale. Upon determining that a long-lived asset or disposal group meets the criteria to be classified as held for sale, the Company ceases depreciation and reports long-lived assets in the line item “assets held for sale” in its condensed consolidated balance sheet.
In March 2025, the Company’s board of directors(the“Board of Directors”) approved a plan to sell the Tarzana facility. The Company engaged a broker to facilitate the sale of the Tarzana facility and therefore reclassified the land and building as held for sale in the condensed consolidated balance sheet as of September 30, 2025. Refer to Note 4.
The facility is currently leased to AstraZeneca Pharmaceuticals LP (“Tenant”) and Tenant has a right of first offer to purchase it. Refer to Note 8.
Impairment of Long-Lived Assets
The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or that the useful life is shorter than originally estimated. Recoverability of assets is measured by comparing the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset over its remaining useful life. If such assets are impaired, the impairment recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. If the useful life is shorter than originally estimated, the Company depreciates or amortizes the remaining carrying value over the revised shorter useful life. The Company recognized an impairment of long-lived assets held for sale related to the Tarzana facility ofnil and $16.6 million during the three and nine months ended September 30, 2025, respectively.
The Company recognized non-cash impairment charges of $1.5 million and $4.3 million for the three and nine months ended September 30, 2024, respectively, related to impairment of the Company’s Manchester, United Kingdom manufacturing equipment being reclassified as held for sale.
The Company recognized non-cash impairment charges ofnil for each of the three and nine months ended September 30, 2025, and $0.1 million and $0.3 million for the three and nine months ended September 30, 2024, respectively, related to impairment of leasehold improvements.
These non-cash impairment charges were recorded in the condensed consolidated statements of operations and comprehensive loss in the line item “restructuring and impairment charges.” See Note 12 for more information.
Research and development costs are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from its external service providers. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are achieved.
Recent Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topics 740): Improvements to Income Tax Disclosures” to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company does not expect adoption of ASU 2023-09 to have a material impact on its condensed consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU no. 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40). The amendments in this update require disclosure, in the notes to the financial statements, of specific expense categories present within expense captions presented on the face of the income statement within continuing operations of public business entities. The amendments in this update are effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. The Company is currently evaluating the impact of this ASU 2024-03 on its condensed consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-07, Derivatives and Hedging and Revenue from Contracts with Customers - Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract (“ASC 2025-07”) which applies to all entities that enter into non-exchange-traded contracts with underlyings based on operations or activities specific to one of the parties to the contract. The new guidance excludes from derivative accounting non-exchange-traded contracts with underlyings that are based on operations or activities specific to one of the parties to the contract. ASU 2025-07 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. Early adoption is permitted. The Company does not expect adoption of ASU 2025-07 to have a material impact on its condensed consolidated financial statements and related disclosures.
- Segment Reporting
The Company manages its business activities on a consolidated basis and hasone reportable segment relating to the research and development of its novel therapies. The Chief Executive Officer, who serves as the Company’s chief operating decision maker (“CODM”), is responsible for the overall supervision, direction, and management of the business and its officers.
The CODM reviews net loss, as reported in the condensed consolidated statements of operations and comprehensive loss, as well as the progress of the Company’s program(s). The CODM does not review assets in evaluating the results of the segment, and therefore, such information is not presented. The accounting policies of the segment are the same as those described in Note 2.
The following table is a summary of the segment loss, including significant segment expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| In-process research and development | $— | $10,000 | $10,000 | $10,000 |
| AXN-2510/IMM2510 | 9,040 | 437 | 20,351 | 437 |
| Other program expenses(1)(2) | 87 | — | 890 | 9,656 |
| General and administrative(1) | 5,883 | 9,930 | 20,639 | 31,614 |
| Restructuring and impairment charges | — | 2,362 | 16,622 | 7,146 |
| Depreciation | 12 | 902 | 522 | 2,869 |
| Interest income | (893) | (1,654) | (3,112) | (5,635) |
| Interest expense | 1,582 | 2,007 | 4,262 | 5,988 |
| Other (income) expense, net | (2,124) | (963) | (6,993) | 165 |
| Segment and consolidated net loss | $13,587 | $23,021 | $63,181 | $62,240 |
(1) Depreciation expense is removed from both “General and administrative” and “Other program expense” and is disclosed separately.
(2) Other program expenses consist of costs related to the Company’s past development of its CoStAR-TIL technology.
- Balance Sheet Components
Prepaid and other current assets
Prepaid and other current assets consisted of the following (in thousands):
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Prepaid general and administrative | $1,174 | $1,316 |
| Prepaid research and development | 1,608 | 4,146 |
| Tax-related receivable | 843 | 2,622 |
| Prepaid contract research organization expenses | 431 | 282 |
| Other current assets | 164 | 959 |
| Total prepaid and other current assets | $4,220 | $9,325 |
Property, Plant and Equipment, Net
Property, plant and equipment, net consisted of the following (in thousands):
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Land | $— | $31,243 |
| Building | — | 102,433 |
| Office and computer equipment | 509 | 509 |
| Total property, plant and equipment, gross | 509 | 134,185 |
| Less: accumulated depreciation | (371) | (4,779) |
| Total property, plant and equipment, net | $138 | $129,406 |
Depreciation expense was $0.01 million and $0.9 million for the three months ended September 30, 2025 and 2024, respectively, and $0.5 million and $2.9 million for the nine months ended September 30, 2025 and 2024, respectively, in the condensed consolidated statements of operations and comprehensive loss.
As of September 30, 2025, the Company had $112.1 million in assets related to the Tarzana facility on the condensed consolidated balance sheet meeting the criteria of held for sale assets. These assets are recognized at the lower of cost or fair value less costs to sell. The Company estimates the fair value of its Tarzana facility through a combination of an income-based approach and a market-based approach. The income-based approach is dependent on specific assumptions such as market rental rates, capitalization rates and discount rates. The market-based approach utilizes observable data such as comparable building sales. The fair value of these assets are classified as Level 3 in the fair value hierarchy due to a mix of unobservable inputs utilized such as proprietary independent research in the market as well as actual quotes from market participants. The Company recognized impairments ofnil and $16.6 million related to the building and land during the three and nine months ended September 30, 2025, respectively.
The Company recognized non-cash impairment charges of $1.5 million and $4.3 million related to United Kingdom equipment impairments during the three and nine months ended September 30, 2024, respectively.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Accrued compensation and benefits | $2,085 | $2,691 |
| Accrued operational expenses | 869 | 582 |
| Accrued restructuring costs | 155 | 2,073 |
| Accrued research, development and clinical trial expenses | 1,355 | 209 |
| Operating lease liabilities, current | 305 | 1,682 |
| Total accrued expenses and other current liabilities | $4,769 | $7,237 |
- Fair Value Measurement
The fair value of cash and cash equivalents approximates carrying value since cash and cash equivalents consist of short-term highly liquid investments with maturities of less than three months at the time of purchase. Cash and cash equivalents are valued based upon quoted market prices in active markets for identical assets and are therefore classified as Level 1 assets. Money market funds are open-end mutual funds that invest in cash, government securities, and/or repurchase agreements that are collateralized fully. To the extent that these funds are valued based upon the reported net asset value, they are categorized in Level 1 of the fair value hierarchy.
Short-term marketable securities and long-term investments consisted of U.S. Treasury bills that are classified within Level 2 of the fair value hierarchy are valued based on other observable inputs, including broker or dealer quotations, alternative pricing sources or U.S. Government Treasury yield of appropriate term.
The following tables provide information by level for assets and liabilities that are measured at fair value on a recurring and nonrecurring basis:
| As of September 30, 2025 | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| (In thousands) | ||||
| Financial Assets | ||||
| Money market funds | $3,253 | $— | $— | $3,253 |
| U.S. Treasury bills | — | 77,311 | — | 77,311 |
| Total | $3,253 | $77,311 | $— | $80,564 |
| Financial Liabilities | ||||
| Contingent consideration | $— | $— | $948 | $948 |
| As of December 31, 2024 | ||||
| Level 1 | Level 2 | Level 3 | Total | |
| (In thousands) | ||||
| Financial Assets | ||||
| Money market funds | $5,632 | $— | $— | $5,632 |
| U.S. Treasury bills | — | 104,510 | — | 104,510 |
| Total | $5,632 | $104,510 | $— | $110,142 |
| Financial Liabilities | ||||
| Contingent consideration | $— | $— | $948 | $948 |
There were no transfers in or out of Level 1, 2 and 3 measurements for the nine months ended September 30, 2025 and the year ended December 31, 2024. As of September 30, 2025 and December 31, 2024, there were no securities within Level 3 of the fair value hierarchy.
As of September 30, 2025 and December 31, 2024, the fair value of the Company’s Loan (as defined in Note 8) was $85.4 million and $84.7 million, respectively. The fair value was determined on the basis of its net present value and is considered Level 2 in the fair value hierarchy.
- Financial Instruments
Marketable securities and long-term investments classified as available-for-sale on September 30, 2025 and December 31, 2024 consisted of the following (in thousands):
| September 30, 2025 | |||||
|---|---|---|---|---|---|
| Maturity | Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
| U.S. Treasury bills | Less than one year | $73,829 | $47 | $(9) | $73,867 |
| U.S. Treasury bills | Between one and two years | 3,450 | — | (6) | 3,444 |
| Total | $77,279 | $47 | $(15) | $77,311 | |
| December 31, 2024 | |||||
|---|---|---|---|---|---|
| Maturity | Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | |
| U.S. Treasury bills | Less than one year | $104,445 | $99 | $(34) | $104,510 |
As of September 30, 2025 and December 31, 2024, marketable securities that had contractual maturities less than one year are classified as current because management considers these marketable securities to be available for current operations. As of September 30, 2025 and December 31, 2024, marketable securities that had contractual maturities between one and two years are classified as long-term because management considers these marketable securities to be available for operations beyond one year. The Company does not intend to sell its marketable securities and it is not likely that the Company will be required to sell these securities before recovery of their amortized cost basis. There were $73.9 million of marketable securities and $3.4 million of long-term investments maturing in less than two years classified as available-for-sale as of September 30, 2025. There were $104.5 million of marketable securities maturing in less than one year classified as available-for-sale as of December 31, 2024.
- License and Collaboration Agreement with ImmuneOnco
On August 1, 2024, Axion Bio entered into the IO Collaboration Agreement with ImmuneOnco, under which it in-licensed several bispecific antibodies, including ‘2510 and AXN-27M/IMM27M. As part of this agreement, Axion Bio made a $10.0 million upfront payment to ImmuneOnco during the year ended December 31, 2024. This amount was fully expensed as in-process research and development (IPR&D) in the same year.
ImmuneOnco is eligible to receive additional potential near-term payments of up to $15.0 million, up to $2.1 billion in commercial, development and regulatory milestones (including up to $270.0 million in longer term development and regulatory milestones and up to $1.8 billion in commercial milestones) plus single-digit to low double-digit percentage royalties on global net sales of the licensed products outside of Greater China.
During the year ended December 31, 2024, Axion Bio made a $5.0 million prepayment to ImmuneOnco for development costs, which was fully expensed in research and development as of March 31, 2025. A second $5.0 million prepayment for development costs was made to ImmuneOnco in April 2025, which was fully expensed in research and development as of September 30, 2025. A third $5.0 million prepayment to ImmuneOnco for development costs was made in August 2025. This amount was partially expensed under research and development, with a remaining prepaid balance of $1.6 million recorded as of September 30, 2025.
In June 2025, Axion Bio achieved Investigational New Drug (IND) clearance in the United States for a Phase 1 trial of ‘2510 in relapsed/refractory solid tumors. This milestone triggered a $10.0 million development payment to ImmuneOnco, which was paid in July 2025. This amount was fully expensed as IPR&D during the second quarter of 2025.
The expenses recognized in connection with the IO Collaboration Agreement were $4.1 million and $10.0 million for the three months ended September 30, 2025 and 2024, respectively, and $22.5 million and $10.0 million for the nine months ended September 30, 2025 and 2024, respectively, and were recorded as a component of research and development expense on the condensed consolidated statements of operations and comprehensive loss.
- Commitments and Contingencies
Leases
Company as a Lessee: Operating Lease Obligations
The Company currently leases office spaces and laboratory spaces located in Dallas, Texas and Alderley Park in the United Kingdom. During April 2025, the Company terminated its prior lease in Thousand Oaks, California. The Company’s leased facilities have original lease terms ranging from 2 to 5 years that in general require the Company to provide a security deposit. Certain leases provide the right for the Company to renew the lease upon the expiration of the initial lease term, and various leases have scheduled rent increases on an annual basis. The exercise of lease renewal options for the Company’s existing leases is at the Company’s sole discretion, and not included in the measurement of right-of-use asset or lease liability as they are not reasonably certain to be exercised. Certain leases have leasehold improvements that are being amortized over the shorter of the estimated useful life of the improvements or the remaining life of the lease. Such improvements incurred by the Company will revert to the landlord at the expiration of the lease and will be removed from Company’s condensed consolidated balance sheets.
The Company’s lease costs consisted of the following (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Operating lease cost | $290 | $172 | $1,108 | $1,097 |
| Variable lease cost | 24 | 283 | 652 | 649 |
| Total lease cost | $314 | $455 | $1,760 | $1,746 |
The following table summarizes cash flow information related to the Company’s lease obligations (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Cash paid for operating lease liabilities | $265 | $494 | $1,080 | $1,756 |
The following table summarizes the Company’s lease assets and liabilities (in thousands):
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Operating lease right-of-use assets | $415 | $934 |
| Current operating lease liabilities | $305 | $1,682 |
| Non-current operating lease liabilities | $— | $1,017 |
The following table summarizes other supplemental information related to the Company’s lease obligations:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Weighted-average remaining lease term (in years) | 0.63 | 1.70 |
| Weighted-average discount rate | 6.75% | 6.75% |
Future minimum lease payments under operating lease liabilities were (in thousands):
| September 30, 2025 | |
|---|---|
| 2025 (remaining three months) | $145 |
| 2026 | 170 |
| Total future lease payments | 315 |
| Less: imputed interest | 10 |
| Total lease liability balance | 305 |
| Less: current portion of operating lease liabilities | 305 |
| Total operating lease liabilities, non-current | $— |
During the nine months ended September 30, 2025 and 2024, the Company evaluated its remaining right-of-use assets for impairment, as the Plan (as defined below in Note 12) has resulted in a cessation of use for several locations. The Company determined these assets were impaired and recognized an impairment loss ofnil and $0.6 million for the three months ended September 30, 2025 and 2024, andnil and $0.8 million for the nine months ended September 30, 2025 and 2024, respectively, which are recorded in the line item “restructuring and impairment charges” in the condensed consolidated statements of operations and comprehensive loss.
Company as a Lessor: Tarzana Facility Lease with AstraZeneca
On July 10, 2024, Complex Therapeutics LLC, a wholly owned subsidiary of the Company, entered into a lease with AstraZeneca Pharmaceuticals LP pursuant to which Tenant is leasing the facility located in Tarzana, California (the "Lease"). The Lease has an initial term of approximately 15 years, beginning on July 10, 2024 and ending on July 31, 2039, with Tenant havingtwo consecutive options to extend the term for afive-year period each and a one-time option to terminate the Lease on the tenth anniversary of the commencement of the Lease, which, if exercised, obligates Tenant to pay Complex Therapeutics LLC a termination fee. The initial base rent was approximately $0.6 million per month (approximately $7.5 million annually) and the base rent escalates by 3% per annum. Tenant is also required to pay certain operating expenses and tax expenses as additional rent. There was rent abatement during the first year of the Lease such that Tenant paid no rent or reduced rent during this period. Tenant also has a right of first offer to purchase the premises that are subject to the Lease.
The Lease is classified as an operating lease and revenue is recognized on a straight-line basis and is recorded within the consolidated statements of operations and comprehensive loss in the line item “Other rental income” as this is not a part of the Company’s core operations. Rental income related to the Lease was as follows (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Rental income related to fixed lease income | $2,242 | $1,493 | $6,726 | $1,493 |
Approximate future straight-lined contractual lease income to be recognized under the Lease in effect as of September 30, 2025, are as follows (in thousands):
| September 30, 2025 | |
|---|---|
| 2025 (remaining three months) | $2,242 |
| 2026 | 8,968 |
| 2027 | 8,968 |
| 2028 | 8,968 |
| 2029 | 8,968 |
| 2030 and thereafter | 85,941 |
| Total | $124,055 |
Differences between rental income earned and amounts due per the Lease is capitalized or charged, as applicable, to accrued rent receivable. As of September 30, 2025 and December 31, 2024, the Company had accrued rent receivable of $7.4 million and $4.3 million, respectively.
Legal Proceedings
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position, results of operations or cash flows.
Debt
In June 2022, the Company’s wholly owned subsidiaries Complex Therapeutics Mezzanine LLC and Complex Therapeutics LLC entered into a mortgage construction loan and mezzanine construction loan (together, the “Construction Loans”) secured by Complex Therapeutic LLC’s Tarzana, California land and building. The initial principal amount of the Construction Loans was $52.1 million, with additional future principal of up to $32.9 million to fund ongoing construction costs. The Construction Loans were guaranteed by the Company and bore interest at the one-month Secured Overnight Financing Rate, plus 5.25% per annum. The Company discontinued capitalizing interest in June 2023 as the building was substantially complete at such time. On July 10, 2024, Complex Therapeutics LLC entered into the Lease. On December 20, 2024, Complex Therapeutics LLC refinanced the outstanding principal amount under the Construction Loans and the Company treated it as a loan extinguishment for accounting purposes and recorded the $0.4 million of unamortized debt issuance costs associated with the Construction Loans as a loss on debt extinguishment recognized in other expense, net in the condensed consolidated statements of operations and comprehensive loss for the year ended December 31, 2024.
On December 20, 2024 (the “Closing Date”), Complex Therapeutics LLC entered into a Term Loan Agreement (the “Loan”) and related loan documents with Midland National Life Insurance Company (“Lender”), pursuant to which Lender loaned Complex Therapeutics LLC a term loan in the principal amount of $85.6 million to refinance the Construction Loans. Substantially all of the Loan proceeds were used to repay in full the Construction Loans. As of both September 30, 2025 and December 31, 2024, the outstanding principal amount under the Loan was $85.6 million and unamortized debt issuance costs were $1.0 million and $1.4 million, respectively.
The Loan has a term oftwo years with aone-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.
The Loan may be prepaid in whole but not in part. If the Loan is prepaid on or prior to the 12-month anniversary of the Closing Date, a prepayment fee is required (other than in connection with a casualty or condemnation event) to make Lender whole for the interest it would have otherwise earned on the Loan during the first 12 months. There is no prepayment fee due if the Loan is prepaid after the 12-month anniversary of the Closing Date.
The net carrying amount of the liability component of the Loan was as follows (in thousands):
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Principal amount | $85,600 | $85,600 |
| Unamortized debt issuance cost | (987) | (1,413) |
| Net carrying amount | $84,613 | $84,187 |
The following table sets forth the interest expense recognized related to the Loan (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Contractual interest expense | $1,389 | $1,758 | $3,664 | $5,241 |
| Amortization of debt issuance cost | 193 | 249 | 598 | 747 |
| Total interest expense related to the Loan | $1,582 | $2,007 | $4,262 | $5,988 |
Other Commitments
In the normal course of business, the Company enters into contracts and various purchase agreements and commitments with third-party vendors for clinical research services, products and other services for operating purposes. These agreements generally provide for termination or cancellation at the Company's option, other than for costs already incurred.
As of September 30, 2025 and December 31, 2024, the Company hadnil and $0.1 million outstanding liabilities, respectively, in commitments for employee benefits as part of the Plan (see Note 12). As of September 30, 2025 and December 31, 2024, the Company had $0.2 million and $1.9 million, respectively, in commitments for contract terminations as part of the Plan (see Note 12).
The Company entered into an agreement in 2023 with a third-party collaborator related to the development of the Company's CoStAR-TIL technology; this agreement was subsequently terminated on September 26, 2025. Milestone payments ofnil and $2.6 million were made during the nine months ended September 30, 2025 and 2024, respectively, and were recorded within research and development expense in the consolidated statements of operations and comprehensive loss.
- Equity
Common Stock
Each share of common stock has the right toone vote. The holders of common stock are also entitled to receive dividends out of legally available funds when and if declared by the Company’s Board of Directors, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. No cash dividends have been declared by the Board of Directors from inception.
As of September 30, 2025 and December 31, 2024, the Company had 6,781,976 and 6,525,887 shares of common stock outstanding, respectively.
At-the-Market Offering (ATM Program)
In March 2025, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC (“Jefferies”) pursuant to which the Company may, subject to the terms and conditions set forth in the agreement, offer and sell, from time to time, through or to Jefferies, acting as agent or principal, shares of common stock having an aggregate offering price of up to $100.0 million in one or more “at the market offerings” (the “ATM Program”).
During the nine months ended September 30, 2025, the Company sold 185,837 shares of common stock under the ATM Program at a weighted-average price of $37.13 per share, 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 is approximately $93.1 million.
Preferred Stock
The Company’s current amended and restated certificate of incorporation authorizes the Company to issue up to 10,000,000 shares of preferred stock at $0.000001 par value per share. The Board of Directors is authorized to provide for the issuance of the preferred stock in one or more series, and to fix the number of shares and to determine or alter for each such series, such voting powers, full or limited, or no voting powers, and such designation, preferences, and relative, participating, optional, or other rights and such qualifications, limitations, or restrictions thereof, as shall be stated and expressed in subsequent resolution or resolutions adopted by the board providing for the issuance of such shares. As of September 30, 2025 and December 31, 2024, there wereno shares of preferred stock issued or outstanding.
- Stock-Based Compensation
2021 Equity Incentive Plan
In March 2021, the Company adopted the 2021 Equity Incentive Plan (the “2021 Plan”), which became effective in connection with the Company’s initial public offering (“IPO”). The 2021 Plan was approved by the Board of Directors and stockholders in March 2021. The 2021 Plan is an equity incentive plan pursuant to which the Company may grant the following awards: (i) incentive stock options; (ii) nonstatutory stock options; (iii) stock appreciation rights; (iv) restricted stock awards; (v) restricted stock unit awards; (vi) performance awards; and (vii) other forms of stock awards to employees, directors, and consultants, including employees and consultants of the Company’s affiliates. The 2021 Plan is a successor to the Company’s 2018 Stock Incentive Plan (the “2018 Plan”). Following the effectiveness of the 2021 Plan, no further grants may be made under the 2018 Plan; however, any outstanding equity awards granted under the 2018 Plan will continue to be governed by the terms of the 2018 Plan.
As of September 30, 2025,424,288 shares of common stock remained available for issuance under the 2021 Plan.
The following table sets forth stock-based compensation included in the Company’s condensed consolidated statements of operations and comprehensive loss (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Research and development expense | $263 | $506 | $633 | $1,587 |
| General and administrative expense | 1,505 | 3,562 | 6,454 | 11,169 |
| Total stock-based compensation expense | $1,768 | $4,068 | $7,087 | $12,756 |
As of September 30, 2025, there was $15.2 million of total unrecognized compensation cost related to unvested stock options granted under the 2018 Plan and 2021 Plan, which is expected to be recognized over a weighted average period of 2.5 years.
Employee Stock Purchase Plan
In March 2021, the Company adopted the Employee Stock Purchase Plan (the “ESPP”), which became effective in connection with the IPO. The ESPP was adopted by the Board of Directors and stockholders in March 2021, but the Company has not yet commenced offerings to employees under the ESPP. The ESPP provides participating employees with the opportunity to purchase up to an aggregate of 192,148 shares of common stock as of September 30, 2025.
- Net Loss Per Share
The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect:
| September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options to purchase common stock | 1,594,174 | 1,251,394 |
- Corporate Restructuring Plan
In January 2023, the Board of Directors approved a restructuring plan (referred to as the “2023 Plan”) and the Company announced the consolidation of the ITIL-306 Phase 1 clinical trial and related manufacturing of CoStAR-TIL to its operations in Manchester, UK and stopped recruiting for the ITIL-306 clinical trial.
In January 2024, the Board of Directors approved a comprehensive restructuring plan, which included the closure of the Company’s UK manufacturing facility and clinical trial operations. In September 2024, the Board of Directors approved additional UK restructuring actions, which resulted in the elimination of the majority of the remaining UK workforce in the fall of 2024, with the remaining reduction and restructuring activities substantially completed by the end of 2024. Collectively, these actions are referred to as the “2024 Plan.”
The 2023 Plan and 2024 Plan are collectively referred to as the “Plan”.
As a result of the Plan and listing the Tarzana facility for sale, the Company recorded charges ofnil and $16.6 million within the condensed consolidated statements of operations and comprehensive loss in the line item “restructuring and impairment charges” for the three and nine months ended September 30, 2025, respectively, and $2.4 million and $7.1 million for the three and nine months ended September 30, 2024, respectively.
These charges relate to asset impairments, contract terminations, severance payments, employee-related costs and other gains incurred. The following table summarizes the restructuring and impairment (gain) loss by category (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Asset impairment for leasehold improvements | $— | $51 | $— | $343 |
| One-time employee termination benefits | — | 1,449 | — | 2,427 |
| Contract terminations | — | (1,282) | 53 | (736) |
| Right-of-use asset impairment | — | 640 | — | 827 |
| Impairment of long-lived assets held for sale | — | 1,504 | 16,569 | 4,285 |
| Total restructuring and impairment charges | $— | $2,362 | $16,622 | $7,146 |
Restructuring Liability
As a result of the Plan, a restructuring liability was recorded in the condensed consolidated balance sheets under “Accrued expenses and other current liabilities” and was measured at the amount expected to be paid, or that was paid. During the three and nine months ended September 30, 2025, the Company paidnil and $1.4 million of restructuring costs, respectively, and expects to pay the remainder of the restructuring costs by December 31, 2026.
The following table shows the liability related to the Plan (in thousands):
| Employee Benefits | Contract Terminations | Total | |
|---|---|---|---|
| Restructuring liability as of December 31, 2024 | $131 | $1,942 | $2,073 |
| Payments | (131) | (1,300) | (1,431) |
| Adjustments | — | (487) | (487) |
| Total restructuring liability as of September 30, 2025 | $— | $155 | $155 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.