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Instil Bio Inc

For the period ended Jun 30, 2024. Filed Aug 13, 2024.

View on SEC.gov

About 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.

Jun 30, 2024 · Filed Aug 13, 2024

TIL$6.83-2.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-10.

0001789769-24-000059

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-13.

0001789769-24-000086

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 119 previous paragraphs and 140 current paragraphs.

66 unchanged; 40 reworded; 25 added; 11 removed; 2 previous and 9 current paragraphs rearranged.

Tables are not compared: 2 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

We seek to in-license or acquire and develop novel therapeutic candidates in diseases with significant unmet medical need. Most recently, on August 1, 2024, our wholly owned subsidiary, SynBioTx, Inc. (“SynBioTx”), in-licensed certain bispecific antibodies, including the product candidate known as SYN-2510/IMM2510, a bispecific antibody targeting both programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF), as well as SYN-27M/IMM27M, a monoclonal antibody targeting cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), from ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“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 (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 (“Greater China”). ImmuneOnco retains development and commercialization rights in Greater China.

Current report

As discussed above, in August 2024, SynBioTx entered into the IO Collaboration Agreement with ImmuneOnco pursuant to which SynBioTx in-licensed certain antibodies, including SYN-2510 and SYN-27M.

Current report

In addition, in July 2024, Complex Therapeutics LLC entered into a lease (the “Lease”) with AstraZeneca Pharmaceuticals LP pursuant to which with 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 $627,276 per month ($7,527,312 annually), the base rent will escalate by 3% per annum and AstraZeneca 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.

Current report

Research and development expenses were$2.9 million and $8.5 million for the three months ended June 30, 2024 and 2023, respectively. The net decrease of $5.5 million was primarily due to:

Current report

•$1.4 million decrease in costs from reduced headcount mainly due to decreases in wages of $0.9 million and stock-based compensation expense of $0.5 million; offset by

Current report

•$0.5 million increase in consulting and professional services costs, mainly consisting of an increase in costs of legal consultants and executive service fees; and

Current report

Restructuring and impairment charges were approximately $0.5 million and $1.0 million for the three months ended June 30, 2024 and 2023, respectively. The net decrease of $0.5 million was primarily due to:

Current report

•$0.2 million increase in costs from impairments of right-of-use assets; and

Current report

Interest Income, Interest Expense and Other (Expense) Income, Net

Current report

Interest income, interest expense and other (expense) income, netwas $0.8 million of expense and $2.3 million of income for the three months ended June 30, 2024 and 2023, respectively. The increase in expense of $3.1 million was primarily due to:

Current report

•$0.9 million increase in changes in fair value of our derivative financial instrument;

Current report

•$0.4 million decrease of interest income related to our investments.

Current report

Research and development expenses were$10.2 millionand $29.1 million for the six months ended June 30, 2024 and 2023, respectively. The decrease in research and development expenses of $19.0 million was primarily due to:

Current report

General and administrative expenses were $23.1 millionand $24.7 million for the six months ended June 30, 2024 and 2023, respectively. The net decrease of $1.6 million was primarily due to:

Current report

•$0.4 million increase in insurance expense and depreciation; and

Current report

Restructuring and impairment charges were $4.8 million and $25.6 million for thesix months ended June 30, 2024 and 2023, respectively. The net decrease of $20.8 million was primarily due to:

Current report

•$0.8 million decrease in severance payments and benefits continuation costs; and

Current report

•$0.4 million decrease of interest income related to our investments;

Current report

•$0.8 million of other losses, including loss from our derivative financial instrument.

Current report

As discussed above, in August 2024, we entered into the IO Collaboration Agreement with ImmuneOnco. Among other things, pursuant to that agreement, SynBioTx agreed to pay ImmuneOnco an up-front payment of $10 million and up to $40 million in potential near-term payments, as well as up to $2.1 billion in commercial, development and regulatory milestones (including up to $270 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 report

Cash provided by investing activities for the six months ended June 30, 2024 was $21.2 million, consisting primarily of $20.6 million of cash provided by marketable securities investments and $0.5 million of cash received from held for sale assets.
Removed paragraphs (11)

Previous report

Using our Co-Stimulatory Antigen Receptor, or CoStAR™, platform we generated ITIL-306, a genetically modified TIL targeting folate receptor alpha, or FRα, which was previously our lead product candidate. These modified TILs, or CoStAR-TILs, provide potent costimulation to T cells within the tumor microenvironment by expressing novel CoStAR molecules which bind to tumor associated antigens, such as FRα. In October 2022, we announced the successful dosing of the first patient with non-small cell lung cancer, or NSCLC, in a Phase 1 clinical trial of ITIL-306 in the United States, ITIL-306-201. In 2023, we closed our U.S. manufacturing and clinical trial operations, ceased enrollment in the ITIL-306-201 clinical trial and pivoted our manufacturing and clinical operations to the United Kingdom with the expectation of commencing another Phase 1 clinical trial of ITIL-306 in the United States and the United Kingdom, ITIL-306-202, in 2023. In January 2024, we announced that we plan to close our UK manufacturing and clinical trial operations. As a result, we have ceased all ITIL-306 Phase 1 clinical trial activities.

Previous report

While we have ceased our ITIL-306 Phase 1 clinical trial, we plan to retain certain key process development, research, and related personnel to advance early-stage pipeline development of CoStAR-TILs and other novel TIL technologies, and to support our collaboration.

Previous report

As discussed above, in December 2023, we entered into a collaboration to develop our Collaboration Product for potential IITs in NSCLC in China. In addition, as discussed above, in January 2024, our Board of Directors approved a restructuring plan, or the 2024 Plan, to effect the closure of our Manchester, UK manufacturing and clinical trial operations, including discontinuing our ITIL-306-202 clinical trial. As a part of the 2024 Plan, we reduced our UK workforce. This workforce reduction is expected to be substantially completed by the end of 2024.

Previous report

We expect our future general and administrative expenses to change in line with our updated strategy, including potential business development activities, as well as changes in the size of our company.

Previous report

Research and development expenses were $7.3 million and $20.7 million for the three months ended March 31, 2024 and 2023, respectively. The net decrease of $13.4 million was primarily due to:

Previous report

We anticipate that our future research and development expenses will generally decrease in the near term as a result of implementing significant workforce reductions, adapting to changes in our company’s size, and adopting a more efficient clinical development strategy.

Previous report

•$0.4 million decrease of consulting and professional services costs, mainly consisting of a reduction in business operations consultants; offset by

Previous report

We anticipate our general and administrative expenses to decrease generally in the near term as a result of implementing significant workforce reductions and adapting to changes in our company’s size.

Previous report

Restructuring and impairment charges were $4.3 million and $24.6 million for the three months ended March 31, 2024 and 2023, respectively. The net decrease of $20.3 million was primarily due to:

Previous report

•$0.1 million change in fair value from interest cap derivative instrument.

Previous report

Cash provided by investing activities for the three months ended March 31, 2024 was $9.2 million related to marketable securities.
Reworded paragraphs (40)

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 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, 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.

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. We seek to in-license/acquire and develop novel therapeutic candidates in diseases with significant unmet medical need. Our first such program is an engineered tumor infiltrating lymphocyte (TIL) cell therapy for the treatment of cancer, which we acquired in 2020. We intend to evaluate and explore additional opportunities to in-license promising therapeutic candidates.

Current wording

We are a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies.

Previous wording

In January 2024, concurrent with announcing our plan to close our UK manufacturing and clinical trial operations, we announced that we entered into an agreement with a third-party to develop an autologous FRα CoStAR-TIL, or the Collaboration Product, for potential open-label investigator-initiated trials, or IITs, in NSCLC, in China. Initial feasibility studies for the Collaboration Product have been completed and, assuming continued collaboration progress, the next steps would be for our collaborator to lead opening an IIT to enroll patients. The Collaboration Product will be manufactured by our collaborator utilizing our proprietary FRα CoStAR construct in our collaborator’s manufacturing process. Our collaborator has an option to exclusively license the Collaboration Product in China and Taiwan.

Current wording

We are also developing a tumor infiltrating lymphocyte (“TIL”) cell therapy for the treatment of cancer, which was acquired in 2020. In December 2023, we entered into an agreement with a third-party collaborator to develop an autologous FRα CoStAR TIL (the “CoStAR-TIL Collaboration Product”) for a potential investigator-initiated trial (“IIT”) in non-small cell lung cancer (“NSCLC”) in China. The CoStAR-TIL Collaboration Product will be manufactured by the collaborator utilizing our proprietary FRα CoStAR construct in the collaborator’s manufacturing process. The collaborator has an option to exclusively license the CoStAR-TIL Collaboration Product in China and Taiwan.

Previous wording

Since inception, we have had significant operating losses. Our net loss was $24.3 million for the three months ended March 31, 2024. As of March 31, 2024, we had an accumulated deficit of $605.3 million. As of March 31, 2024, we had cash, cash equivalents, marketable securities and long-term investments of $161.5 million, which consists of $5.5 million in cash and cash equivalents, $148.3 million in marketable securities and $7.7 million in long-term investments. We expect to continue to incur net losses for the foreseeable future.

Current wording

Since inception, we have had significant operating losses. Our net loss was $14.9 million for the three months ended June 30, 2024 and $39.2 million for the six months ended June 30, 2024. As of June 30, 2024, we had an accumulated deficit of $620.2 million. As of June 30, 2024, we had cash, cash equivalents, marketable securities and long-term investments of $152.6 million, which consists of $6.8 million in cash and cash equivalents, $141.8 million in marketable securities and $4.0 million in long-term investments. We expect to continue to incur net losses for the foreseeable future.

Previous wording

Research and development expenses account for a significant portion of our operating expenses. 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 months ended March 31, 2024 and March 31, 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. For the three and six months ended June 30, 2024 and 2023, we did not allocate our research and development expenses by program.

Previous wording

We expect our future research and development expenses to change in line with our clinical development activities for our Collaboration Product or other next-generation TIL technologies, other potential business development activities, and changes in the size of our company. 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 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:

Previous wording

•for the three months ended March 31, 2023, building and asset impairment charges related to our facility in Tarzana, which we have ceased using as a manufacturing facility;

Current wording

•for the six months ended June 30, 2023, asset impairment charges related to our facility in Tarzana;

Previous wording

•for the three months ended March 31, 2024, asset impairment charges related to our facility in Manchester;

Current wording

•for the six months ended June 30, 2024, asset impairment charges related to our former manufacturing facility in Manchester;

Previous wording

As part of the 2023 Plan, 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, during the three months ended March 31, 2024, we decided to close our UK manufacturing and clinical operations and incurred charges of $4.3 million during the three months ended March 31, 2024 with this restructuring, and we estimate we will incur additional charges of up to $1.3 million in 2024 related to the 2024 Plan.

Current wording

As part of the 2023 Plan, 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 incurred charges of $4.8 million during the six months ended June 30, 2024 with this restructuring, and we estimate we will incur additional charges of up to $0.5 million in 2024 related to the 2024 Plan.

Previous wording

Interest expense consists of interest expense on our note payable and amortization of loan origination costs.

Current wording

Interest expense consists of interest expense on our Loan and amortization of loan origination costs.

Previous wording

Other income (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 (expense) income, net consists primarily of interest cap derivative instrument fair value gain or loss, foreign exchange remeasurement gain or loss and other expenses and income.

Previous wording

•$0.1 million decrease in costs related to research and clinical development activities and our clinical trials resulting from our discontinuation of our ITIL-168 clinical manufacturing activities, closure of our UK manufacturing, and clinical operations, cessation of our ITIL-306 clinical trial; and

Current wording

•$3.4 million decrease in costs related to research and clinical development activities and our clinical trials resulting from our discontinuation of our ITIL-168 clinical manufacturing activities; and

Previous wording

•$4.4 million decrease in expenses related to facilities and overhead, depreciation, and other expenses due to strategic reductions made in these areas.

Current wording

•$1.2 million decrease in expenses related to facilities and overhead, depreciation, and other expenses due to reductions made in these areas.

Previous wording

General and administrative expenses were $12.4 million and $13.2 million for the three months ended March 31, 2024 and 2023, respectively. The net decrease of $0.8 million was primarily due to:

Current wording

General and administrative expenses were $10.7 million and $11.5 million forthe three months ended June 30, 2024 and 2023, respectively. The net decrease of $0.8 million was primarily due to:

Previous wording

•$1.2 million increase in facility and other general office expenses.

Current wording

•$0.1 million increase in facility and other office expenses.

Previous wording

•$1.0 million reduction in costs from severance payments and benefits continuation.

Current wording

•$0.3 million increase in severance payments and benefits continuation costs.

Previous wording

•$8.9 million decrease in employee-related costs from reduced headcount, consisting primarily of a decrease of $9.1 million in wages and benefits and a $0.2 million decrease for other employee-related expenses in relation to our research and development personnel, offset by a $0.4 million increase in stock-based compensation expense;

Current wording

•$9.8 million decrease in costs from reduced headcount, consisting primarily of a decrease of $10.1 million in wages and benefits, offset by an increase of $0.7 million in stock-based compensation expense, $0.2 million decrease in other employee-related expenses in relation to our research and development personnel and $0.2 million decrease in professional services;

Previous wording

•$1.6 million decrease in employee-related costs from reduced headcount mainly due to a decrease in wages of $1.2 million and a decrease in stock-based compensation expense of $0.4 million; and

Current wording

•$3.0 million decrease in costs, mainly due to a decrease in wages of $2.1 million and a decrease in stock-based compensation expense of $0.9 million; offset by

Previous wording

•$7.9 million reduction in costs as a result of impairments of assets held for sale;

Current wording

•$8.9 million decrease in costs from impairments of assets held for sale;

Previous wording

•$7.6 million reduction in costs from impairments of right-of-use assets;

Current wording

•$7.4 million decrease in costs from impairments of right-of-use assets;

Previous wording

•$2.4 million reduction in costs resulting from leasehold improvement impairments; and

Current wording

•$2.4 million decrease in costs from leasehold improvement impairments;

Previous wording

•$1.4 million reduction in costs from termination of contracts;

Current wording

•$1.3 million decrease in costs resulting from termination of contracts.

Previous wording

Interest income, interest expense and other expense, net were $0.3 million of expense and $1.4 million of income for the three months ended March 31, 2024 and 2023, respectively. The decrease of approximately $1.7 million was primarily due to:

Current wording

Interest income, interest expense and other expense, net were $1.1 million of expense and $3.7 million of income for the six months ended June 30, 2024 and 2023, respectively. The increase in expense of $4.8 million was primarily due to:

Previous wording

•$0.5 million increase in loss on foreign currency transactions; offset by

Current wording

•$0.9 million increase in loss on foreign currency transactions;

Previous wording

•$1.3 million increase of interest expense from our note payable; and

Current wording

•$2.7 million increase of interest expense from our Loan; and

Previous wording

As of March 31, 2024, we had cash, cash equivalents, marketable securities, and long-term investments of $161.5 million, which consisted of $5.5 million in cash and cash equivalents, $148.3 million in marketable securities and $7.7 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 June 30, 2024, we had cash, cash equivalents, marketable securities and long-term investments of $152.6 million, which consisted of $6.8 million in cash and cash equivalents, $141.8 million in marketable securities and $4.0 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

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. 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 March 31, 2024, the outstanding principal amount under the Loan was $82.8 million and unamortized debt issuance costs were $1.2 million.

Current 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 June 30, 2024, the outstanding principal amount under the Loan was $82.8 million and unamortized debt issuance costs were $0.9 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.

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 or lease of the Tarzana manufacturing site, as well as subleases of other facilities under lease. If we are successful in leasing and/or 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 or lease 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. Regardless of whether we are successful in leasing or selling the Tarzana facility or subleasing other facilities, we expect to continue to expend significant resources for the foreseeable future.

Current wording

Based on our current operating plan, we believe our existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements beyond 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.

Previous wording

We use our cash to fund operations, primarily to fund our business development, research and development expenditures and related personnel costs. We expect our expenses to continue to be significant as we invest in research and development activities, particularly as we advance product candidates into later stages of development and conduct clinical trials, seek regulatory approvals for and commercialize any product candidates that successfully complete clinical trials, hire personnel and invest in and grow our business, expand and protect our intellectual property portfolio, and operate as a public company. Because of the numerous risks and uncertainties associated with acquiring product candidates, and the research, development and commercialization of product candidates, we are unable to estimate the exact timing and amount of our funding requirements. Our future operating expenditures will depend on many factors, including:

Current wording

We use our cash to fund operations, primarily to fund our business development, research and development expenditures and related personnel costs. We expect our expenses to continue to be significant as we invest in research and development activities, particularly as we in-license or acquire product candidates, advance product candidates into later stages of development and conduct clinical trials, seek regulatory approvals for and commercialize any product candidates that successfully complete clinical trials, hire personnel and invest in and grow our business, expand and protect our intellectual property portfolio, and operate as a public company. Because of the numerous risks and uncertainties associated with acquiring product candidates, and the research, development and commercialization of product candidates, we are unable to estimate the exact timing and amount of our funding requirements. Our future operating expenditures will depend on many factors, including:

Previous wording

•the results of our collaboration and the number and characteristics of any product candidates we develop or acquire;

Current wording

•the results of our collaborations 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 or lease 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, California facility, as well as subleases of other facilities under lease;

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 March 31, 2024, our future minimum lease payments under committed or non-cancelable lease agreements were$4.5 million.

Current 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 June 30, 2024, our future minimum lease payments under committed or non-cancelable lease agreements were $4.0 million.

Previous wording

As discussed above, in connection with the 2024 Plan, we currently estimate that we will incur additional charges of up to $1.3 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.

Current 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.

Previous wording

Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through equity offerings, debt financings or other capital sources, which may include strategic collaborations or other arrangements with third parties. Additional funds may not be available to us on acceptable terms or at all. If we raise additional funds by issuing equity or convertible debt securities, our stockholders will suffer dilution, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common 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 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.”

Previous 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 on operating lease liabilities, and an increase of $0.8 million in accrued restructuring liabilities. The non-cash charges primarily consisted of stock-based compensation 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, loss on disposals of property and equipment of $0.3 million, and non-cash interest expense of $0.3 million, offset by accretion on invested securities of $1.1 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2024 was $25.0 million, which consisted of the net loss of $39.2 million, partially offset by a $0.8 million net change to our net operating assets and liabilities, and $13.4 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 a decrease of $0.2 million in accrued expenses, accrued restructuring expenses and other current liabilities, a decrease of $2.5 million in prepaid expenses and other current assets, an increase of $0.9 million in other long-term assets, and a decrease of $0.6 million in operating lease liabilities. The non-cash charges primarily consisted of stock-based compensation of $8.7 million, impairment of fixed assets and right-of-use assets, and loss on disposal of property and equipment of $3.3 million, change in fair value of interest cap derivative instrument and non-cash interest expense of $1.4 million, and depreciation expense of $2.0 million, offset by accretion on invested securities of $2.4 million.

Previous wording

Cash used in operating activities for the three months ended March 31, 2023 was $34.7 million, which consisted of the net loss of $57.1 million and a $3.8 million net change to our net operating assets and liabilities, partially offset by $26.2 million in non-cash charges and other adjustments to reconcile net loss to net cash used in operating activities. The net change in our operating assets and liabilities was primarily due to a decrease of $1.0 million in accounts payable, a decrease of $1.5 million in accrued expenses and other current liabilities, a decrease of $0.8 million in prepaid expenses and other current assets, a decrease of $0.4 million in other long-term assets and operating lease liabilities, and a decrease of $0.2 million in accrued restructuring liabilities. The non-cash charges primarily consisted of stock-based compensation of $4.5 million, impairment of fixed assets of $13.1 million, impairment of right-of-use assets of $7.8 million, depreciation expense of $1.8 million, non-cash lease expense of $0.3 million, and non-cash interest expense of $0.3 million, offset by accretion on invested securities of $1.3 million, change in fair value of contingent consideration of $0.2 million and change in foreign exchange remeasurement of $0.4 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2023 was $54.2 million, which consisted of the net loss of $75.7 million, and a $9.2 million net change to our net operating assets and liabilities, partially offset by $30.7 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 $0.2 million in accounts payable, a decrease of $5.9 million in accrued expenses, accrued restructuring expenses and other current liabilities, an increase of $1.5 million in prepaid expenses and other current assets, an increase of $1.0 million in other long-term assets and a decrease of $0.5 million in operating lease liabilities. The non-cash charges primarily consisted of stock-based compensation of $8.9 million, impairment of fixed assets of $14.0 million, impairment of right-of-use assets of $7.6 million and depreciation expense of $2.8 million, offset by accretion on invested securities of $2.9 million.

Previous wording

Cash provided by investing activities for the three months ended March 31, 2023 was $14.5 million, of which $23.0 million was related to marketable securities, partially offset by $8.5 million used related to purchases of property and equipment.

Current wording

Cash provided by investing activities for the six months ended June 30, 2023 was $24.9 million, which consisted primarily of $40.3 million of cash provided by marketable securities investments, offset by $15.4 million used related to purchases of property, plant and equipment.

Previous wording

Cash provided by financing activities for the three months ended March 31, 2024 was nil.

Current wording

Cash provided by financing activities for the six months ended June 30, 2024 was nil.

Previous wording

Cash provided by financing activities for the three months ended March 31, 2023 was $4.5 million, which was primarily related to cash proceeds from our note payable.

Current wording

Cash provided by financing activities for the six months ended June 30, 2023 was $8.7 million, which was primarily related to cash proceeds of $8.7 million drawn from the Loan.
Rearranged current paragraphs (9)

Current report — wording carried from elsewhere

•$0.9 million decrease in costs from reduced headcount, consisting primarily of a decrease of $1.2 million in wages and benefits, offset by a $0.3 million increase in stock-based compensation expense;

Current report — wording carried from elsewhere

•$1.0 million decrease in costs from impairments of assets held for sale; offset by

Current report — wording carried from elsewhere

•$1.4 million increase of interest expense from our Loan;

Current report — wording carried from elsewhere

•$0.4 million increase in loss on foreign currency transactions; and

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):

Current report — wording carried from elsewhere

•$3.0 million decrease in costs related to research and clinical development activities and our clinical trials resulting from our discontinuation of our ITIL-168 clinical manufacturing activities; and

Current report — wording carried from elsewhere

•$6.2 million decrease in expenses related to facilities and overhead, depreciation, and other expenses due to reductions made in these areas.

Current report — wording carried from elsewhere

•$1.0 million increase in facility and other office expenses.

Current report — wording carried from elsewhere

We expect additional restructuring and impairment charges in 2024 as result of reducing our UK workforce and other actions related to our 2024 Plan referenced in Note 10 to the financial statements included elsewhere in this Quarterly Report.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

In connection with the 2024 Plan, we currently estimate that we will incur charges of up to $5.6 million, 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.

Previous report — wording carried elsewhere

Interest Income, Interest Expense and Other Expense, Net