Instil Bio, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
TIL$6.83-2.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001789769-24-000103
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001789769-25-000051
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 162 previous paragraphs and 124 current paragraphs.
57 unchanged; 40 reworded; 25 added; 62 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 3 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 (25)
Current report
ImmuneOnco is also conducting a Phase 1 open label clinical trial of AXN-2510/IMM2510 in combination with chemotherapy in patients with advanced/metastatic NSCLC. In January 2025, ImmuneOnco announced that the first patient had been dosed in the safety run-in and is enrolling patients with first-line advanced/metastatic NSCLC in this trial.
Current report
Our development efforts are focused on advancing AXN-2510/IMM2510 and we expect to continue to pursue additional promising therapeutic in-licensing or acquisition opportunities.
Current report
Restructuring and impairment charges for the three months ended March 31, 2025 primarily consist 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.
Current report
Restructuring and impairment charges for the three months ended March 31, 2024 consist primarily of a loss on contract terminations, impairment loss recognized on long-lived assets held for sale, impairment loss on right-of-use asset and employee termination costs.
Current report
In March 2025, the Board of Directors approved a plan to sell the Tarzana facility and we listed our Tarzana facility for sale.
Current report
As a result of the Plan and the impairment loss related to listing our Tarzana facility for sale, we incurred restructuring and impairment charges of $16.1 million during the three months ended March 31, 2025.
Current report
Other Income (Expense), Net
Current report
Research and development expenses were $5.4 million and $7.3 million for the three months ended March 31, 2025 and 2024, respectively. The net decrease of $1.9 million was primarily due to:
Current report
•$1.5 million increase in costs related to research and clinical development activities from our ImmuneOnco collaboration.
Current report
(1) Other program expenses consist of costs related to our past development of our CoStAR-TIL technology.
Current report
General and administrative expenses were $9.1 million and $12.4 million for the three months ended March 31, 2025 and 2024, respectively. The net decrease of $3.3 million was primarily due to:
Current report
•$14.0 million increase in impairment recognized on long-lived assets held for sale mainly related to impairment recognized on the Tarzana facility; partially offset by
Current report
•$1.0 million decrease in contract termination costs due to a settlement gain of terminated contracts of $0.5 million recognized in 2025, combined with costs associated with termination of contracts recognized in 2024 of $0.5 million;
Current report
•$0.2 million decrease in leased assets impairment charge;
Current report
•$0.3 million decrease in leasehold improvement impairment charge; and
Current report
•$0.7 million decrease in costs consisting of severance and severance related payments.
Current report
Interest Income, Interest Expense, Other Rental Income and Other Income (Expense), Net
Current report
•$0.9 million decrease in interest expense from our note payable;
Current report
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 report
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.
Current report
On November 13, 2024, we filed a shelf registration statement on Form S-3 with the SEC, which the SEC declared effective on November 21, 2024. Pursuant to our shelf registration statement we may, from time to time, sell up to an aggregate of $200 million of our common stock, preferred stock, debt securities or warrants.
Current report
March 2025 ATM Sales Agreement
Current report
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, or ATM Shares, through Jefferies, or the ATM Offering. In March 2025, we filed a sales agreement prospectus to our registration statement on Form S-3 filed with the SEC in November 2024, for the issuance and sale of up to $100.0 million of shares of our common stock under the ATM Sales Agreement. Under the ATM Sales Agreement, Jefferies may sell the ATM Shares by methods deemed to be an “at the market offering,” as defined in Rule 415(a)(4) promulgated under the Securities Exchange Act of 1934, as amended. We may sell the ATM Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the ATM Sales Agreement, but we have no obligation to sell any of the ATM Shares in the ATM Offering.
Current report
As of March 31, 2025, we have not sold any shares of our common stock pursuant to the ATM Offering. We may offer and sell ATM Shares at an aggregate offering price of up to the remaining $100.0 million available under the ATM Offering.
Current report
Cash provided by investing activities for the three months ended March 31, 2024 was $9.2 million related to redemptions from marketable securities.
Removed paragraphs (62)
Previous report
•As of December 21, 2023, 33 patients had received IMM2510 at 9 dose levels (0.007-20.0 mg/kg), the median age was 57 years (range 36-74), the median prior line of therapy was 3 (range 1-13), and 27.3% patients received prior anti PD-1/PD-L1 inhibitor therapies.
Previous report
•Treatment-related adverse events (TRAEs) occurred in 32 patients (97.0%). Most TRAEs were grade 1 or 2. The most common TRAEs (≥ 20%) of all grades were infusion related reaction (IRR) (72.7%), platelet count decreased (39.4%), anemia (33.3%) and diarrhea (21.2%). Grade ≥3 TRAEs occurred in 11 patients (33.3%). Grade ≥3 TRAEs (≥5%) were IRR (9.1%), platelet count decreased (6.1%), lymphocyte count decreased (6.1%) and diarrhea (6.1%). TRAEs leading to treatment discontinuation occurred in 3 patients (9.1%) which were IRR, hypersensitivity and pyrexia, respectively. No dose limiting toxicities (DLT) occurred.
Previous report
•In 25 response evaluable patients, 3 patients had confirmed partial response (PR): 1 patient with sq-NSCLC (onco-driver gene negative, previous IO treatment failure) at 3 mg/kg with tumor shrinkage 46% and still on the treatment with treatment duration over 20 months; 1 patient with sq-NSCLC at 10 mg/kg with tumor shrinkage about 32% along with treatment duration 9.4 months; 1 patient with thymus adeno-squamous carcinoma (PD-L1 CPS 80) at 20 mg/kg with tumor shrinkage over 53% and still remains on the treatment along with treatment duration 8.1 months. In addition, 7 patients with best objective response stable disease (BOR SD) and 4 of them had over 15% decreased tumor burden (1 cervical cancer at 3 mg/kg, 2 non-sq NSCLC at 10 and 20 mg/kg respectively, 1 ovarian cancer at 20 mg/kg).
Previous report
•The half-life of IMM2510 in 20.0mg/kg dose group was around 6.8 days. The recommended phase 2 dose (RP2D) was determined by ImmuneOnco to be 20.0 mg/kg.
Previous report
SYN-27M is an antibody-dependent cellular cytotoxicity-enhanced monoclonal antibody targeting CTLA-4, which has been designed to promote intratumoral regulatory T cell depletion to enhance the efficacy and reduce the toxicity associated with first-generation anti-CTLA-4 antibodies. By end of 2023, ImmuneOnco completed a first-in-human dose escalation study of SYN-27M/IMM27M in patients with solid tumor cancers in China with 25 subjects dosed. ImmuneOnco is currently pursing cohort expansions of the RP2D in this Phase I trial in patients with hormone receptor-positive breast cancer and hepatocellular carcinoma who have failed prior therapy.
Previous report
We also have a proprietary folate receptor alpha (FRα) co-stimulatory antigen receptor, or CoStAR, tumor infiltrating lymphocyte, or TIL, cell therapy for the treatment of cancer, which we are seeking to advance via collaboration. In December 2023, we entered into an agreement with a third-party collaborator to develop an autologous folate receptor alpha (FRα) CoStAR-TIL, or the CoStAR-TIL Collaboration Product, for a potential investigator-initiated trial, or IIT, in non-small cell lung cancer, or NSCLC, in China. The collaborator has an option to exclusively license the CoStAR-TIL Collaboration Product in China and Taiwan.
Previous report
Recent Developments
Previous report
In July 2024, Complex Therapeutics LLC entered into a lease, or the Lease with AstraZeneca Pharmaceuticals LP pursuant to which AstraZeneca Pharmaceuticals LP is leasing Complex Therapeutic LLC’s manufacturing facility located in Tarzana, CA. The Lease has an initial term of approximately 15 years and the initial base rent is $0.6 million per month ($7.5 million annually), the base rent will escalate by 3% per annum and AstraZeneca
Previous report
Pharmaceuticals LP is required to pay certain operating expenses and tax expenses as additional rent. There is rent abatement during the first year of the Lease such that AstraZeneca Pharmaceuticals LP will initially pay no rent or reduced rent.
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
Restructuring and impairment charges consist primarily of:
Previous report
•for the nine months ended September 30, 2023, asset impairment charges related to our facility in Tarzana;
Previous report
•for the nine months ended September 30, 2024, asset impairment charges related to our former manufacturing facility in Manchester;
Previous report
•contract terminations, including contract terminations related to the Tarzana, Thousand Oaks and Manchester facilities; and
Previous report
•severance and other employee termination related costs.
Previous report
Other Expense, Net
Previous report
In-process Research and Development Expenses
Previous report
In-process research and development expenses were $10.0 million andnil forthree months ended September 30, 2024 and 2023, respectively. The net increase of$10.0 million was primarily due to:
Previous report
•$10.0 million increase in research and development costs related to payments made to ImmuneOnco.
Previous report
Research and development expenses were $0.6 million and$8.5 million for the three months ended September 30, 2024 and 2023, respectively. The net decreaseof $7.9 millionwas primarily due to:
Previous report
•$3.9 million decrease in costs mainly related to our discontinuation of our ITIL-168 clinical manufacturing activities;
Previous report
General and administrative expenses were $10.7 million and $11.9 million for the three months ended September 30, 2024 and 2023, respectively. The net decrease of $1.2 million was primarily due to:
Previous report
•$0.9 million decrease in costs from reduced headcount, consisting of decreases in wages and benefits of $0.4 million and stock-based compensation expense of $0.5 million;
Previous report
•$3.1 million decrease in costs from impairments of assets held for sale;
Previous report
•$41.5 million decrease in costs related to the impairment of the Tarzana manufacturing facility; and
Previous report
•$1.3 million decrease in costs resulting from termination of contracts; offset by
Previous report
•$0.5 million increase in costs from impairments of right-of-use assets;
Previous report
•$0.1 million increase in leasehold improvement impairments; and
Previous report
•$1.4 million increase in severance payments and benefits continuation costs.
Previous report
We expect to incur additional restructuring and impairment charges in 2024 as result of reducing our UK workforce and other actions related to our 2024 Plan.
Previous report
Interest Income, Interest Expense, Other Rental Income and Other Expense, Net
Previous report
•$0.5 million increase in other losses, including loss from our derivative financial instrument;
Previous report
•$0.7 million decrease of interest income related to our investments; offset by
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report
In-process Research and Development Expenses
Previous report
In-process research and development expenses were $10.0 million andnil forthree months ended September 30, 2024 and 2023, respectively. The net increase of$10.0 million was primarily due to:
Previous report
•$10.0 million increase in research and development costs related to payments made to ImmuneOnco.
Previous report
Research and Development Expenses
Previous report
Research and development expenses were $10.7 million and$37.6 millionfor the nine months ended September 30, 2024 and 2023, respectively. The decrease in research and development expenses of$26.9 millionwas primarily due to:
Showing the first 40 of 62 passages. Open the source sections for the rest.
Reworded paragraphs (40)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us” and “our” refer to Instil Bio, Inc. and our consolidated subsidiaries.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 4, 2025. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us” and “our” refer to Instil Bio, Inc. and our consolidated subsidiaries.
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, our 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 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.
Previous wording
We are a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. In particular, we seek to in-license or acquire and develop additional novel therapeutic candidates in diseases with significant unmet medical need.
Current wording
We are a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. We are advancing the development of our lead product candidate, AXN-2510/IMM2510, a bispecific antibody targeting both programmed death-ligand 1, or PD-L1, and the family of vascular endothelial growth factors, or VEGFs, in solid tumor cancers, and we seek to in-license or acquire and develop additional novel therapeutic candidates in diseases with significant unmet medical need.
Previous wording
In August 2024, our wholly owned subsidiary, SynBioTx, Inc. or SynBioTx, in-licensed certain bispecific antibodies, including SYN-2510/IMM2510, a bispecific antibody targeting both programmed death-ligand 1, or PD-L1, and vascular endothelial growth factor, or VEGF, and SYN-27M/IMM27M, a monoclonal antibody targeting cytotoxic T-lymphocyte associated antigen 4, or CTLA-4, from ImmuneOnco Biopharmaceuticals (Shanghai) Inc., or ImmuneOnco. SYN-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, SynBioTx has an exclusive license to research, develop, manufacture and commercialize these product candidates outside of China, including mainland China, Hong Kong, Macau and Taiwan, or Greater China. ImmuneOnco retains development and commercialization rights in Greater China.
Current wording
In August 2024, our wholly owned subsidiary, Axion Bio, Inc., or Axion Bio, in-licensed certain bispecific antibodies, including AXN-2510/IMM2510 and AXN-27M/IMM27M, a monoclonal antibody targeting cytotoxic T-lymphocyte associated antigen 4, or CTLA-4, from ImmuneOnco Biopharmaceuticals (Shanghai) Inc., or ImmuneOnco. AXN-2510/IMM2510, the lead in-licensed product candidate, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. Pursuant to the license and collaboration agreement with ImmuneOnco, or the IO Collaboration Agreement, Axion Bio has an exclusive license to research, develop, manufacture and commercialize these product candidates outside of China, including mainland China, Hong Kong, Macau and Taiwan, or Greater China. ImmuneOnco retains development and commercialization rights in Greater China.
Previous wording
SYN-2510, our lead product candidate, is a potentially best-in-class PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. ImmuneOnco is conducting a Phase I open label trial in China of SYN-2510/IMM2510 as monotherapy in patients with advanced solid tumors that have failed prior therapies, including triple-negative breast cancer, or TNBC, squamous non-small cell lung cancer, or NSCLC, hepatocellular carcinoma, renal cell carcinoma, and rare solid tumors including soft tissue sarcomas and thymic cancer. Approximately 65 additional patients have been dosed with SYN-2510/IMM2510 monotherapy in addition to the initial 33 patients reported in ImmuneOnco’s ASCO 2024 publication. The preliminary data showed:
Current wording
ImmuneOnco is conducting a Phase I open label trial in China of AXN-2510/IMM2510 as monotherapy in patients with advanced solid tumors that have failed prior therapies, including triple-negative breast cancer, or TNBC, squamous non-small cell lung cancer, or NSCLC, hepatocellular carcinoma, renal cell carcinoma, and rare solid tumors including soft tissue sarcomas and thymic cancer. As of January 13, 2025, ImmuneOnco announced over 100 patients have been enrolled in this clinical trial.
Previous wording
Since inception, we have had significant operating losses. Our net loss was $23.0 million for the three months ended September 30, 2024 and$62.2 million for the nine months ended September 30, 2024. As of September 30, 2024, we had an accumulated deficit of$643.2 million. As of September 30, 2024, we had cash, cash equivalents, marketable securities and long-term investments of $122.9 million, which consists of $6.7 million in cash and cash equivalents, $113.7 million in marketable securities and $2.6 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 $28.2 million for the three months ended March 31, 2025. As of March 31, 2025, we had an accumulated deficit of $683.3 million. As of March 31, 2025, we had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $111.8 million, which consists of $15.4 million in cash and cash equivalents, $1.0 million in restricted cash, $88.3 million in marketable securities and $7.2 million in long-term investments. We expect to continue to incur net losses for the foreseeable future.
Previous wording
Research and development expenses consist primarily of research and development, manufacturing, monitoring and other services payments and, to a lesser extent, salaries, benefits and other personnel-related costs, including stock-based compensation, professional service fees, and facility and other related costs. In addition, research and development expense is presented net of reimbursements from reimbursable tax and expenditure credits and grants from the UK government. For the three and nine months ended September 30, 2024 and 2023, we did not allocate our research and development expenses by program.
Current wording
Research and development expenses consist primarily of research and development, manufacturing, monitoring and other services payments and, to a lesser extent, salaries, benefits and other personnel-related costs, including stock-based compensation, professional service fees, and facility and other related costs. In addition, research and development expense is presented net of reimbursements from reimbursable tax and expenditure credits and grants from the UK government.
Previous wording
We expect our future research and development expenses to change in line with our clinical development activities for SYN-2510 and SYN-27M, our CoStAR-TIL Collaboration Product or other next-generation TIL technologies and other potential business development activities. Our expenditures on future nonclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of clinical trials and development of product candidates will depend on a variety of factors, including:
Current wording
We expect our future research and development expenses to change in line with our clinical development activities for AXN-2510/IMM2510 and other potential business development activities. Our expenditures on future nonclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of clinical trials and development of product candidates will depend on a variety of factors, including:
Previous wording
Additionally, we expect to continue to incur expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, director and officer insurance expenses, and any investor relations related expenses, as well as other administrative and professional services.
Current wording
We expect to continue to incur expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, director and officer insurance expenses, and any investor relations related expenses, as well as other administrative and professional services.
Previous wording
As part of a restructuring plan adopted in January 2023, we transitioned clinical manufacturing and trial operations of ITIL-306 to the United Kingdom, and as a result, in 2023 we reduced our U.S. workforce by approximately 96% and our UK workforce by approximately 42%. Subsequently, in January 2024, we decided to close our UK manufacturing and clinical operations, and in September 2024 we decided to close most of our remaining Manchester, UK operations, which resulted in the elimination of the majority of the UK workforce, with the remaining reduction anticipated to be largely completed by the end of 2024, which collectively we refer to as the 2024 Plan. As a result of the 2024 Plan, we incurred charges of $7.1 million during the nine months ended September 30, 2024 and we estimate we will incur additional charges of up to $0.5 million in 2024 related to the 2024 Plan.
Current wording
In January 2024, we decided to initiate closure of our UK manufacturing and clinical operations related to our past development of our CoStAR-TIL technology, and in September 2024 we decided to close most of our remaining Manchester, UK operations related to our past development of our CoStAR-TIL technology, which resulted in the elimination of the majority of the remaining UK workforce, with the remaining reduction substantially completed by the end of 2024, which collectively we refer to as the Plan.
Previous wording
Interest expense consists of interest expense on our Loan and amortization of loan origination costs.
Current wording
Interest expense consists of interest expense on our debt and amortization of loan origination costs.
Previous wording
Other rental income consists primarily of straight-lined rental income related to the Tarzana manufacturing facility.
Current wording
Other rental income consists primarily of rental income related to our Tarzana facility.
Previous wording
Other expense, net consists primarily of interest cap derivative instrument fair value gain or loss, foreign exchange remeasurement gain or loss and other expenses and income.
Current wording
Other income (expense), net consists primarily of derivative financial instrument fair value gain or loss, foreign exchange remeasurement gain or loss and other expenses and income.
Previous wording
•$11.9 million decrease in costs from reduced headcount, consisting primarily of a decrease of $11.9 millionin wages and benefits, $0.2 million decrease in other employee-related expenses in relation to our research and development personnel and $0.4 million decrease in professional services; offset by an increase of $0.6 million in stock-based compensation expense;
Current wording
•$2.6 million decrease in employee-related costs from reduced headcount, consisting primarily of a decrease of $2.3 million in wages, benefits and other employee-related expenses in relation to our research and development personnel and a $0.3 million decrease in stock-based compensation expense; and
Previous wording
•$1.9 million decrease in expenses related to facilities and overhead, depreciation, and other expenses due to reductions made in these areas.
Current wording
•$0.8 million decrease in expenses related to facilities and overhead, depreciation, and other expenses due to strategic reductions made in these areas; partially offset by
Previous wording
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):
Current wording
The following table shows our research and development expenses by program for the three months ended March 31, 2025 and 2024 (in thousands):
Previous wording
•$2.1 million decrease in costs from reduced headcount, consisting primarily of a decrease of $2.0 million in wages and benefits and a $0.1 million decrease in stock-based compensation expense; and
Current wording
•$2.6 million decrease in employee-related costs from reduced headcount, consisting primarily of a $1.9 million decrease in wages, benefits and other employee-related expenses and a $0.7 million decrease in stock-based compensation expense; and
Previous wording
•$0.2 million decrease in facility and other office expenses.
Current wording
•$0.9 million decrease in insurance expense, depreciation, and other office expenses; partially offset by
Previous wording
•$0.1 million decrease in consulting and professional services costs, mainly consisting of a decrease in costs of legal consultants and executive service fees; and
Current wording
•$0.2 million increase in consulting and professional services costs.
Previous wording
Restructuring and impairment charges were approximately $2.4 million and $46.3 million for the three months ended September 30, 2024 and 2023, respectively. The net decrease of $43.9 million was primarily due to:
Current wording
Restructuring and impairment charges were approximately $16.1 million and $4.3 million for the three months ended March 31, 2025 and 2024, respectively. The net increase of approximately $11.8 million was primarily due to:
Previous wording
Interest income, interest expense, other rental income and other expense, net was $0.6 million of income and $0.7 million of expense for the three months ended September 30, 2024 and 2023, respectively. The increase in income of $1.3 million was primarily due to:
Current wording
Interest income, interest expense, other rental income and other income (expense), net were $2.4 million of income and $0.3 million of expense for the three months ended March 31, 2025 and 2024, respectively. The increase of approximately $2.7 million was primarily due to:
Previous wording
•$1.5 million increase in rental income related to the Tarzana manufacturing facility.
Current wording
•$2.2 million increase in rental income related to our Tarzana facility;
Previous wording
•$1.0 million increase in gain on foreign currency transactions; and
Current wording
•$0.3 million increase in gain on foreign currency transactions; partially offset by
Previous wording
•$1.0 million decrease of interest income related to our investments;
Current wording
•$0.9 million decrease in interest income related to our investments.
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 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 candidates for several years, if ever.
Previous wording
As of September 30, 2024, we had cash, cash equivalents, marketable securities and long-term investments of $122.9 million, which consisted of $6.7 million in cash and cash equivalents, $113.7 million in marketable securities and $2.6 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, 2025, we had cash, cash equivalents, restricted cash, marketable securities, and long-term investments of $111.8 million, which consisted of $15.4 million in cash and cash equivalents, approximately $1.0 million in restricted cash, $88.3 million in marketable securities and $7.2 million in long-term investments. 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
Prior to our initial public offering, or IPO, we funded our operations primarily through the issuance and sale of convertible preferred stock. From our inception through March 2021, we raised net cash proceeds of $380.1 million from the issuance and sale of our convertible preferred stock.
Current wording
Prior to our initial public offering, or IPO, we funded our operations primarily through the issuance and sale of convertible preferred stock. From our inception through March 2021, prior to our IPO, we raised net cash proceeds of $380.1 million from the issuance and sale of our convertible preferred stock.
Previous wording
In June 2022, our wholly owned subsidiary, Complex Therapeutics Mezzanine LLC, and our wholly owned indirect subsidiary, Complex Therapeutics LLC, entered into a mortgage construction loan and mezzanine construction loan, or together, the Loan, secured by our Tarzana, California land and building. Construction of the Tarzana facility has been completed and the facility has been leased to AstraZeneca Pharmaceuticals LP. The initial principal amount of the Loan was $52.1 million, with additional future principal of up to $32.9 million to fund then ongoing construction costs. As of September 30, 2024, the outstanding principal amount under the Loan was $82.8 million and unamortized debt issuance costs were $0.7 million. We have agreed with the lender to terminate commitments in respect of any unadvanced amounts and, accordingly, do not have additional borrowing capacity under the Loan.
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 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 March 31, 2025, the outstanding principal amount under the Loan was $85.6 million and unamortized debt issuance costs were $1.4 million.
Previous 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 2026. We are evaluating opportunities for a potential sale of our Tarzana manufacturing site, as well as subleases of other facilities under lease. If we are successful in selling the Tarzana facility, such a transaction could extend our expected cash runway. We have based this estimate on assumptions that may prove to be wrong, we may not be successful in securing a sale of the Tarzana facility or sublease of the other facilities on favorable terms, or at all and we could utilize our available capital resources sooner than we expect. AstraZeneca Pharmaceuticals LP has leased the Tarzana manufacturing facility and has a right of first offer to purchase the property.
Current 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. In March 2025, the Board of Directors approved a plan to sell the Tarzana facility and we listed our Tarzana facility for sale. The facility is leased, and Tenant has a right of first offer to purchase it. If we are successful in selling the Tarzana facility, such a transaction could extend our expected cash runway. We have based this estimate on assumptions that may prove to be wrong, we may not be successful in securing a sale of the Tarzana facility, or at all, and we could utilize our available capital resources sooner than we expect.
Previous wording
•the results of our collaborations and the number and characteristics of any product candidates we develop or acquire;
Current wording
•the results of our collaboration with ImmuneOnco and the number and characteristics of any product candidates we develop or acquire;
Previous wording
•costs related to our Tarzana facility and our ability to complete a sale of our Tarzana, California facility, as well as subleases of other facilities under lease;
Current wording
•costs related to our Tarzana facility and our ability to complete a sale of our Tarzana facility;
Previous wording
As discussed above, in August 2024, we entered into the IO Collaboration Agreement with ImmuneOnco. Among other things, pursuant to that agreement, SynBioTx paid ImmuneOnco an up-front payment of $10.0 million and prepaid ImmuneOnco $5.0 million in development costs, and has agreed to pay up to $35.0 million in potential near-term payments, as well as 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.
Current wording
As discussed above, in August 2024, we entered into the IO Collaboration Agreement with ImmuneOnco. Among other things, pursuant to that agreement, Axion Bio made an up-front payment of $10.0 million to ImmuneOnco and also prepaid $5.0 million in development costs. As of March 31, 2025, the $5.0 million prepayment was fully expensed. An additional $5.0 million prepayment, of which $0.2 million in development costs was accrued as of March 31, 2025 and subsequently paid to ImmuneOnco during the quarter ended June 30, 2025. ImmuneOnco is eligible to receive additional potential near-term payments of up to $30.0 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.
Previous wording
We lease various operating spaces in the United States and the United Kingdom under non-cancelable operating lease arrangements that expire on various dates through 2026. These arrangements require us to pay certain operating expenses, such as taxes, repairs, and insurance and contain landlord or tenant incentives or allowances, renewal and escalation clauses. As of September 30, 2024, our future minimum lease payments under committed or non-cancelable lease agreements were $3.5 million.
Current wording
We lease operating spaces in the United States and the United Kingdom under non-cancelable operating lease arrangements that expire on various dates through 2026. These arrangements require us to pay certain operating expenses, such as taxes, repairs and insurance, and contain landlord or tenant incentives or allowances, renewal and escalation clauses. As of March 31, 2025, our future minimum lease payments under committed or non-cancelable lease agreements were $2.8 million.
Previous wording
As discussed above, in connection with the 2024 Plan, we currently estimate that we will incur additional charges of up to $0.5 million in 2024, including employee termination costs, severance and other benefits, and contract termination costs. The charges that we expect to incur in connection with the 2024 Plan are subject to a number of assumptions, and actual results may differ materially. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the 2024 Plan as well as additional costs in connection with any additional restructuring actions.
Current wording
As discussed above, in connection with the Plan, we may incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the Plan as well as additional costs in connection with any additional restructuring actions.
Previous wording
Until we can generate substantial revenue from the 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 shareholders. 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, higher interest rates, conflicts in Ukraine and the Middle East, and recent and potential future bank failures. 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 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.”
Previous wording
Cash used in operating activities for the nine months ended September 30, 2023 was $68.6 million, which consisted of the net loss of $143.2 million, and a $8.0 million net change to our net operating assets and liabilities, partially offset by $82.5 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 $0.7 million in accounts payable, a decrease of $5.3 million in accrued expenses, accrued restructuring expenses and other current liabilities, an increase of $1.1 million in prepaid expenses and other current assets, a decrease of $0.3 million in other long-term assets, and a decrease of $1.2 million in operating lease liabilities. The non-cash charges primarily consisted of stock-based compensation expense of $13.6 million, impairment of fixed assets of $60.1 million, impairment of right-of-use assets of $7.7 million and depreciation expense of $3.7 million, offset by accretion on invested securities of $4.7 million.
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 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, a $8.5 million net change to our net operating assets and liabilities, and $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, an increase of $4.0 million in prepaid expenses and other current assets, an increase of $3.1 million in other long-term assets, and a decrease of $1.0 million in operating lease liabilities. 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, offset by accretion on invested securities of $3.9 million and the 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, 2024 was $14.4 million, which consisted of the net loss of $24.3 million, partially offset by a $1.8 million net change to our net operating assets and liabilities and $8.1 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 $1.3 million in prepaid expenses and other current assets, a decrease of $0.2 million in other long-term assets, a decrease of $0.2 million in operating lease liabilities, and an increase of $0.8 million in accrued restructuring liabilities. The non-cash charges primarily consisted of stock-based compensation expense of $4.5 million, impairment of fixed assets of $2.5 million, impairment of right-of-use assets of $0.2 million, depreciation expense of $1.0 million, change in fair value of contingent consideration of $0.1 million, change in foreign exchange remeasurement of $0.2 million, impairment of leasehold improvements of $0.3 million, and non-cash interest expense of $0.3 million, offset by accretion on invested securities of $1.1 million.
Previous wording
Cash provided by investing activities for the nine months ended September 30, 2024 was $41.0 million, consisting primarily of $52.0 million of cash provided by marketable securities investments and $0.5 million of cash received from held for sale assets, offset by $10.0 million of acquired in-process research and development and $1.6 million from the renewal of our derivative financial instrument.
Current wording
Cash provided by investing activities for the three months ended March 31, 2025 was $9.6 million, consisting primarily 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, 2024 was $0.2 million, which was primarily related to proceeds from 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 primarily 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
For a description of critical accounting policies that require significant judgments and estimates during the preparation of our financial statements, refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” and Note 2 to our Consolidated Financial Statements contained in our Annual Report on Form 10-K for the year ended December 31, 2023 and Note 2 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Current wording
For a description of critical accounting policies that require significant judgments and estimates during the preparation of our financial statements, refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” and Note 2 to our Consolidated Financial Statements contained in our Annual Report on Form 10-K for the year ended December 31, 2024 and Note 2 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10Q.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
•$0.2 million change in fair value from derivative instrument; and
Current report — wording carried from elsewhere
Cash provided by financing activities for the three months ended March 31, 2024 was nil.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
ImmuneOnco is also conducting a Phase I open label clinical trial in China of SYN-2510/IMM2510 combined with SYN-27M/IMM27M in patients with advanced solid tumors that have failed prior therapies.
Previous report — wording carried elsewhere
•$8.1 million decrease in expenses related to facilities and overhead, depreciation, and other expenses due to reductions made in these areas; and
Previous report — wording carried elsewhere
•$0.1 million incr ease in gain on foreign currency transactions; and