The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes included in this Annual Report on Form 10-K. This discussion contains forward-looking statements that reflect our plans, estimates and beliefs and involve numerous risks and uncertainties, including but not limited to those described in the "Risk Factors" section of this Annual Report. Actual results may differ materially from those contained in any forward-looking statements. You should carefully read "Forward-Looking Statements" and "Risk Factors." Forward-Looking Statements 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 I, Item 1A, "Risk Factors" in this Annual Report on Form 10-K. 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.
Overview
We are a clinical-stage biopharmaceutical company focused on developing an innovative cell therapy pipeline of autologous tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. We have assembled an accomplished team with a successful track record in cell therapy innovation. We are developing a novel class of genetically engineered TIL therapies using our Co-Stimulatory Antigen Receptor, or CoStAR, platform. These modified CoStAR-TILs still rely on their native, patient-specific T cell receptors, or TCRs, to bind to tumor neoantigens, but have been enhanced to express novel CoStAR molecules, which bind to shared tumor-associated antigens and provide potent costimulation to T cells within the tumor microenvironment. We believe that the ability of CoStAR to augment the activation of TILs upon native TCR-mediated recognition of tumor neoantigens has the potential to bring TIL therapy to patients with cancer types that have been historically resistant to immunotherapy and increase the benefit from TIL therapy in patients with cancer types that have been historically sensitive to immunotherapy. In 2022, we submitted an investigational new drug application, or IND, for ITIL-306, our first CoStAR-TIL therapy, to theU.S. Food and Drug Administration , or FDA, and, following clearance, opened a Phase 1 dose escalation trial of ITIL-306 in non-small cell lung cancer, or NSCLC, ovarian, and renal cancers. InOctober 2022 , we announced the successful dosing of the first patient with NSCLC in the ITIL-306 Phase 1 trial.
We were founded in
InMarch 2020 , we acquired 100% of the share capital of Immetacyte. We acquired Immetacyte primarily for this in-process research and development (IPR&D), which is critical to achieve our objective of developing an innovative cell therapy pipeline of autologous TIL therapies for the treatment of patients with cancer, as well as the dedicated workforce of Immetacyte. Utilizing this IPR&D, we have designed and developed our initial CoStAR 97 -------------------------------------------------------------------------------- construct targeting folate receptor alpha and are advancing our first CoStAR-TIL product candidate, ITIL-306, for the treatment of multiple solid tumors. We have initiated a Phase 1 clinical trial of ITIL-306 inthe United States , and plan to initiate a Phase 1 clinical trial of ITIL-306 in theUnited Kingdom in 2023. Since inception, we have had significant operating losses. Our net loss was$223.2 million and$156.8 million for the years endedDecember 31, 2022 and 2021, respectively. As ofDecember 31, 2022 , we had an accumulated deficit of$424.9 million . As ofDecember 31, 2022 , we had cash, cash equivalents and marketable securities of$260.9 million which consists of$43.7 million in cash and cash equivalents and$217.2 million in marketable securities. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase.
Recent Developments
InMay 2022 , we achieved IND clearance from the FDA for a Phase 1 dose escalation study of ITIL-306 in NSCLC, ovarian cancer, and renal cell carcinoma, and we announced the successful dosing of the first patient with NSCLC inOctober 2022 . InJanuary 2023 , we announced the consolidation of substantially all of our research and development operations, including clinical product manufacturing and clinical trial operations, to ourManchester, United Kingdom site to further extend our expected cash runway beyond 2026. We expect initial clinical data from the ITIL-306 program in 2024. InDecember 2022 , our Board of Directors approved a strategic reprioritization of our preclinical and clinical development programs. This decision involves reallocating resources to focus on advancing ITIL-306, our CoStAR platform, and other next-generation TIL technologies, while discontinuing our ITIL-168 development program. As part of this strategic restructuring plan, we have reduced ourU.S. workforce to a team of approximately 15 individuals responsible for leading our global business operations. Additionally, we are currently concentrating our efforts with ourUK workforce to re-align our operating model.
Components of Operating Results
Operating Expenses Research and Development 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 theUK government. For the years endedDecember 31, 2022 and 2021, we did not allocate our research and development expenses by program. We expect our future research and development expenses to change in line with our prioritization of advancing our clinical development activities for ITIL-306, our CoStAR platform, and other next-generation TIL technologies, 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: •the scope, rate of progress and expenses of clinical trials and other research and development activities, including the impacts of our voluntary pause in our clinical trials and the related investigation into our manufacturing processes;
•potential safety monitoring and other studies requested by regulatory agencies;
•significant and changing government regulation; and
•the timing and receipt of regulatory approvals, if any.
98 -------------------------------------------------------------------------------- The process of conducting the necessary clinical research to obtain FDA and other regulatory approval is costly and time consuming and the successful development of product candidates is highly uncertain. The risks and uncertainties associated with our research and development projects are discussed more fully in the section of this Annual Report titled "Risk Factors." As a result of these risks and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects, or if, when or to what extent we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates.
General and Administrative
General and administrative expenses consist primarily of compensation and personnel-related expenses, including stock-based compensation, for our personnel in executive, finance and other administrative functions. General and administrative expenses also include professional fees paid for accounting, auditing, legal, tax and consulting services, insurance costs, recruiting costs, travel expenses, amortization and depreciation, and other general and administrative costs. We expect our future general and administrative expenses to change in line with our prioritization of advancing our CoStAR platform and other next-generation TIL technologies, changes in the size of our company to support our research and development activities and operations generally, and the potential growth of our business. If any of our product candidates receive marketing approval, we expect to incur additional expenses related to commercialization activities. 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 theSEC , additional director and officer insurance expenses, and investor relations activities, as well as other administrative and professional services.
Restructuring and Impairment Charges
Restructuring and impairment charges consist primarily of asset impairment charges, contract terminations, severance and other employee-related costs. Restructuring and impairment charges are related to our strategic prioritization of the Company's preclinical and clinical development programs. Our restructuring plan is designed to reduce costs and reallocate resources to focus on advancing our CoStAR platform and other next-generation TIL technologies. As part of the restructuring plan, our ITIL-168 development program was discontinued and we reduced ourU.S. workforce by approximately 60%.
Interest Income
Interest income consists of interest income from funds held in our cash and cash equivalent accounts, and marketable securities.
Interest Expense
Interest expense consists of interest expense on our note payable and amortization of loan origination costs.
Other Expense, Net
Other expense, net consists primarily of derivative instrument fair value gains, foreign exchange remeasurement gains and other expenses and income.
Income Tax Provision
We are subject to income taxes inthe United States and the foreign jurisdiction where we operate, theUnited Kingdom . TheUnited Kingdom has statutory tax rates that differ from those inthe United States . Accordingly, our 99 -------------------------------------------------------------------------------- effective tax rates will vary depending on the relative proportion ofUnited Kingdom toUnited States income, the availability of research and development tax credits, changes in the valuation of our deferred tax assets and liabilities and changes in tax laws. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Due to the uncertainty of the business in which we operate, projections of future profitability are difficult and past profitability is not necessarily indicative of future profitability. AtDecember 31, 2022 , we maintained a full valuation allowance against net deferred tax assets forthe United States and theUnited Kingdom . The valuation allowance has been provided based on the positive and negative evidence relative to our company, including the existence of cumulative net operating losses, or NOLs, since the Company's inception, and the inability to carryback these NOLs to prior periods. Furthermore, the Company determined that it is more likely than not that the benefit of these assets would not be realized in the foreseeable future. The timing and the reversal of the Company's valuation allowance will continue to be monitored.
Results of Operations
Comparison of the Years Ended
The following table summarizes our results of operations for the years ended
Year Ended December 31, Change 2022 2021 $ Operating expenses: Research and development$ 141,056 $ 107,251 $ 33,805 General and administrative 62,235 48,309
13,926
Restructuring and impairment charges 23,167 - 23,167 Total operating expenses 226,458 155,560 70,898 Loss from operations (226,458) (155,560) (70,898) Interest income 3,655 80 3,575 Interest expense (1,883) - (1,883) Other expense, net (564) (1,275) 711 Loss before income tax expense (225,250) (156,755) (68,495) Income tax benefit (expense) 2,073 (39) 2,112 Net loss$ (223,177) $ (156,794) $ (66,383)
Research and Development Expenses
Research and development expenses were$141.1 million and$107.3 million for the years endedDecember 31, 2022 and 2021, respectively. The increase in research and development expenses during this period of$33.8 million was primarily due to: •$14.0 million in costs from an increase in headcount, consisting of$15.5 million in wages and benefits, partially offset by a decrease in stock-based compensation expense of$1.0 million and a decrease of$0.5 million for other employee-related expenses in relation to our research and development personnel;
•$8.2 million in costs related to research and clinical development activities, including from our clinical trials and expanded clinical manufacturing activities; and
•$11.6 million of expenses related to facilities and overhead, depreciation and amortization, and other expenses.
100 -------------------------------------------------------------------------------- We anticipate a reduction in our future research and development expenses as a result of discontinuing the ITIL-168 development program, implementing significant workforce reductions inthe United States , and adapting to changes in our company's size.
General and Administrative Expenses
General and administrative expenses were
•$12.0 million in costs resulting from increased headcount and personnel related costs, including increased stock-based compensation expense of$5.3 million , to support our growing business and for preparation of clinical trials; •$1.3 million in consulting and professional service costs, mainly consisting of costs of information technology and facility consultants of$0.6 million , and costs of business operations consultants of$0.7 million ; and
•$0.6 million from an increase in insurance expense and other office expenses.
We anticipate a reduction in our future general and administrative expenses as a result of discontinuing the ITIL-168 development program, implementing significant workforce reductions inthe United States , and adapting to changes in our company's size. If any of our product candidates receive marketing approval, we expect to incur additional expenses related to commercialization activities.
Restructuring and Impairment Charges
Restructuring and impairment charges were approximately$23.2 million for the year endedDecember 31, 2022 and nil for the year endedDecember 31, 2021 , since we did not have any restructuring and impairment charges during the prior year. The net increase of$23.2 million was primarily due to:
•$15.8 million in costs resulting from a goodwill impairment charge of
•$1.9 million in costs resulting from a leasehold improvement charge of
•$3.0 million in costs consisting of severance payments and benefits continuation costs; and
•$2.4 million in costs comprised principally of the termination of software contracts.
Interest Income, Interest Expense and Other Expense, Net
Interest income, interest expense and other expense, net were$1.2 million of income and$1.2 million of expense for the years endedDecember 31, 2022 and 2021, respectively. The increase of$2.4 million was primarily due to:
•$3.6 million of interest income related to our investments;
•$1.0 million from our derivative investment; and
•$0.4 million gain in other income, primarily consisting of a gain on asset disposal, net of other expenses;
•partially offset by an increase of interest expense of
•$0.7 million of loss on foreign currency transactions.
Income Tax Expense 101
-------------------------------------------------------------------------------- Income tax expense, decreased from$39 thousand expense for the year endedDecember 31, 2021 to$2.1 million benefit for the year endedDecember 31, 2022 . During the year endedDecember 31, 2022 , income tax benefit mostly consisted of deferred foreign income taxes from our operations in theUnited Kingdom .
Liquidity and Capital Resources
Sources of Liquidity
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 several years, if ever. As ofDecember 31, 2022 , we had cash, cash equivalents, and marketable securities of$260.9 million , which consists of$43.7 million in cash and cash equivalents, and$217.2 million in marketable securities. As ofDecember 31, 2021 , we had cash and cash equivalents of$37.6 million and$416.5 million in marketable securities. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. InJune 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 ourTarzana, California land and building, which is partially complete and is expected to reach full completion in the second quarter of 2023. The initial principal amount of the Loan was$52.1 million , with additional future principal of up to$32.9 million to fund ongoing construction costs. As ofDecember 31, 2022 , the outstanding principal amount under the Loan was$74.8 million and unamortized debt issuance costs were$2.4 million . OnApril 1, 2022 , we filed an automatic shelf registration statement on Form S-3, or the 2022 Shelf Registration Statement. We have not yet sold and issued any securities under the 2022 Shelf Registration Statement. InMarch 2021 , we raised net proceeds of$339.0 million in our initial public offering, or IPO, pursuant to which we sold an aggregate of 18,400,000 shares of common stock.
In the first quarter of 2021, we raised aggregate net cash proceeds of
Future Funding Requirements Based on our current operating plan, we believe our existing cash and cash equivalents, and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements beyond 2026. We are also evaluating opportunities for a potential sale or lease of theTarzana manufacturing site, as well as subleases of other facilities under lease, which would further extend our expected cash runway. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We expect to continue to expend significant resources for the foreseeable future. We use our cash to fund operations, primarily to fund our 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 our product candidates into later stages of development and conduct larger 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 research, development and commercialization of our 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: 102 --------------------------------------------------------------------------------
•the scope, rate of progress, costs and results of our clinical and preclinical development activities, including the impacts of our voluntary pause in our clinical trials, the results of our discussions with the FDA and other regulatory agencies, and the related investigation into our manufacturing process;
•the number and characteristics of any additional product candidates we develop or acquire;
•the timing of, and the costs involved in, obtaining regulatory approvals for ITIL-306 or any future product candidates, and the number of trials required for regulatory approval;
•the cost of manufacturing ITIL-306 or any future product candidates as well as any products we successfully commercialize;
•costs related to our manufacturing and other facilities;
•the cost of commercialization activities of our product candidates, if approved for sale, including marketing, sales and distribution costs;
•the timing, receipt and amount of sales of ITIL-306 or any future product candidates, if approved;
•the costs associated with constructing our new clinical and commercial
manufacturing facility and building out lab space, as well as our ability to
complete a sale or lease of our
•the extent to which we acquire or in-license other companies' product candidates and technologies;
•our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of any such arrangements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;
•any product liability or other lawsuits;
•the expenses needed to attract, hire and retain skilled personnel;
•our investments in our operational, financial and management information systems;
•the costs associated with operating as a public company;
•the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing our intellectual property portfolio; and
•any delays or issues resulting from the ongoing COVID-19 pandemic or adverse geopolitical and economic conditions.
InMarch 2020 , we acquired 100% of the share capital of Immetacyte for total cash and non-cash consideration, including contingent consideration, of$15.4 million . In connection with the acquisition, we terminated the Immetacyte license agreement and associated payment obligations. The maximum consideration that remained unpaid atDecember 31, 2022 , which payment is contingent on future events, was$13.3 million . 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 shares. 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 inthe United States and worldwide resulting from, among other 103 -------------------------------------------------------------------------------- things, inflation, rising interest rates, the war inUkraine and the COVID-19 pandemic. 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." We lease various operating spaces inthe United States and theUnited 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 ofDecember 31, 2022 , our future minimum lease payments under committed or non-cancelable lease agreements were$8.4 million , as discussed in Note 7 to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K. Our contractual obligations and commitments primarily consist of amounts we will pay to the general contractor constructing and developing land and buildings inTarzana, California which we acquired inOctober 2020 for$37.6 million . We are in the process of developing this land for ourU.S. operations and our contractual commitments for this development project are limited to unreimbursed spend by the general contractor. As ofDecember 31, 2022 ,$4.0 million was contractually committed to the development of this project.
In the normal course of business, we enter into contracts with Clinical Research
Organizations, or CROs, and other third parties for preclinical studies and
clinical trials, research and development supplies and other testing and
manufacturing services. We are committed to approximately
InDecember 2022 , the Company's Board of Directors approved a restructuring plan to implement a strategic prioritization of the Company's preclinical and clinical development programs. In the year endedDecember 31, 2022 , the Company recorded aggregate restructuring and impairment charges of approximately$23.2 million related to contract termination, severance payments and other employee-related costs. OnJanuary 30, 2023 , the Company's Board of Directors approved an expansion of its previously announced restructuring plan implementing a strategic prioritization of the Company's preclinical and clinical development programs. The Company currently estimates that it will incur charges of up to$9.0 million in connection with the restructuring plan, consisting primarily of cash expenditures for severance payments, retention bonus payments, contract terminations and related costs, as well as non-cash expenses related to vesting of share-based awards, excluding any charges or costs associated with any potential sale of its facilities and asset impairments. The Company expects that the majority of the restructuring and impairment charges will be incurred in the next 12 months and that the execution of the restructuring will be substantially complete by the end ofApril 2023 .
Cash Flows
The following table sets forth the significant sources and uses of cash for the periods set forth below (in thousands):
Years Ended
2022 2021 Net cash provided by (used in): Cash used in operating activities$ (180,164) $ (122,138) Cash provided by (used in) investing activities 114,541 (474,396) Cash provided by financing activities 71,886 393,164
Net increase (decrease) in cash, cash equivalents, and restricted cash
$ 6,263$ (203,370)
Cash Flows from Operating Activities
Cash used in operating activities for the year ended
104 -------------------------------------------------------------------------------- by$52.6 million in non-cash charges and other adjustments to reconcile net loss to net cash used in operating activities. The net change in our operating assets and liabilities was primarily due to a decrease of$1.8 million in accounts payable, decrease of$9.0 million in accrued expenses and other current liabilities, and a decrease of$0.4 million in prepaid expenses and other current assets, offset partially by an increase of$1.6 million in long-term liabilities. The non-cash charges primarily consisted of stock-based compensation expense of$30.4 million , goodwill and intangible assets impairment of$15.8 million , depreciation and amortization expense of$6.0 million and change in foreign exchange measurement of$1.4 million . Cash used in operating activities for the year endedDecember 31, 2021 was$122.1 million , which consisted of the net loss of$156.8 million , partially offset by$30.3 million in non-cash charges and other adjustments to reconcile net loss to net cash used in operating activities and a$4.4 million net change to our net operating assets and liabilities. The non-cash charges primarily consisted stock-based compensation of$26.2 million , and depreciation and amortization expense of$2.8 million . The net change in our operating assets and liabilities was primarily due to an increase of$3.9 million in accounts payable, an increase of$12.0 million in accrued expenses and other current liabilities, partially offset by an increase of$5.0 million in prepaid expenses and other current assets and an increase in$6.5 million in other long-term assets.
Cash Flows from Investing Activities
Cash provided by investing activities for the year ended
Cash used in investing activities for the year ended
Cash Flows from Financing Activities
Cash provided by financing activities for the year endedDecember 31, 2022 was$71.9 million , which was primarily related to net cash proceeds from our note payable of$70.3 million and cash proceeds from exercise of stock options of$1.5 million . Cash provided by financing activities for the year endedDecember 31, 2021 was$393.2 million , which was primarily related to net cash proceeds from our IPO of$339.0 million , net cash proceeds from the issuance of Series C convertible preferred stock of$52.5 million and cash proceeds from exercise of stock options of$1.8 million .
Contractual Obligations and Commitments
Our construction contractual obligations and commitments primarily consist of amounts we will pay to the general contractor for constructing and developing our land and buildings inTarzana, California . As ofDecember 31, 2022 ,$4.0 million was contractually committed to the development of this project. InJune 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 (together, the "Loan") and as ofDecember 31, 2022 , the outstanding principal amount under the Loan was$74.8 million and unamortized debt issuance costs were$2.4 million . As ofDecember 31, 2022 , we had non-cancelable purchase commitments of approximately$18.3 million consisting mainly of CROs, software and operating commitments. Additionally, future minimum lease payments under noncancellable operating leases as ofDecember 31, 2022 totaled$8.4 million , as discussed in Note 7. 105
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As part of our restructuring plan, as of
Critical Accounting Policies and Estimates
This management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in the notes to our consolidated financial statements, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results.
Intangible Assets and
Our intangible assets classified as in-process research and development or IPR&D, are composed of intangible assets acquired in a business combination and used in research and development activities that have not yet reached technological feasibility, regardless of their potential future use. The main criterion we use to determine the technological feasibility or completion of these projects is regulatory approval to market the underlying products in a relevant geographic region. However, obtaining regulatory approval is often subject to significant risks and uncertainties, which may result in the eventual realized value of the acquired IPR&D projects differing from their fair value at the date of acquisition. We classify IPR&D intangible assets acquired in a business combination as indefinite-lived until the completion or abandonment of the associated research and development efforts. Once the associated research and development activities are completed, we will assess the useful life and begin amortizing the assets to reflect their use over their remaining lives. In the event of permanent abandonment, we will write off the remaining carrying amount of the associated IPR&D intangible asset. Our indefinite-lived IPRD intangible assets are tested at least annually for impairment, or upon the occurrence of a triggering event. The impairment test for IPR&D involves comparing the fair value of the asset, based on updated forecasts and commercial development plans, with its carrying value. Impairment is deemed to exist when the fair value of IPR&D assets is less than their carrying value.Goodwill represents the excess of the purchase price over the fair value of the net tangible and intangible assets acquired in a business combination.Goodwill is not amortized but is tested for impairment. We review goodwill for impairment at least annually or more frequently for triggering events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable based on management's assessment of the fair value of the Company's reporting unit as compared to their related carrying value. Under the authoritative guidance issued by theFinancial Accounting Standards Board , we have the option to first assess the qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative goodwill impairment test. Our impairment tests are based on a single operating segment and reporting unit structure. If the carrying value of the reporting unit exceeds its fair value, an impairment charge is recognized for the excess of the carrying value of the reporting unit over its fair value. InDecember 2022 , we performed a quantitative goodwill impairment test for our Immetacyte acquisition. The test was prompted by the discontinuation of the ITIL-168 development program (see Note 12 to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K), the realignment of our preclinical and clinical development programs and decline in our stock price. Based on the results of the test as ofDecember 31, 2022 , we determined that the carrying amount of our goodwill and intangible assets exceeded their fair value. The fair value of the IPR&D was determined through utilizing the multiperiod excess earnings method (MPEEM), which 106 -------------------------------------------------------------------------------- considered various factors such as future cash flows, discount rates, and market conditions. The fair value of the reporting unit was determined through an income approach, the discounted cash flow model, considering projected future cash flows (including timing and profitability), discount rate reflecting the risk inherent in future cash flows, a perpetual growth rate, and projected future economic and market conditions. As a result of the analysis, we recognized a non-cash impairment charge of$15.8 million for the year endedDecember 31, 2022 . The charge consisted of$10.1 million for IPR&D impairment and$5.7 million for goodwill impairment during the fourth quarter of 2022. These impairment charges were recorded in the consolidated statements of operations and comprehensive loss in the line item "restructuring and impairment charges".
Stock-Based Compensation
We maintain a stock-based compensation plan as a long-term incentive for employees, directors and consultants. The plan allows for the issuance of stock options, stock appreciation rights and restricted stock units.
For stock-based awards with only service conditions, we recognize stock-based compensation expense for stock-based awards on a straight-line basis over the requisite service period and account for forfeitures as they occur. For stock-based awards with performance conditions, stock-based compensation expense is not recognized until the performance condition is probable to occur. Our stock-based compensation costs are based upon the grant date fair value estimated using the Black-Scholes option pricing model. This model utilizes inputs that are highly subjective assumptions and generally require significant judgment. These assumptions include: •Fair Value of Common Stock-Prior to our IPO inMarch 2021 , the fair value of the shares of common stock underlying stock options had historically been determined by the Board of Directors. Because there has been no public market for the our common stock, the Board of Directors has determined fair value of the common stock at the time of grant of the option by considering a number of objective and subjective factors including important developments in our operations, contemporaneous valuations performed by an independent third party firm, sales of our convertible preferred stock, our operating results and financial performance, the conditions in the biotechnology industry and the economy in general, the stock price volatility of similar public companies and the lack of marketability of our common stock, among other factors. After our IPO inMarch 2021 , the fair value of common stock is determined using the closing price of our common stock on the Nasdaq Global Select Market. •Expected Term-The expected term represents the period that stock-based awards are expected to be outstanding and is determined as the average of the time-to-vesting and the contractual life of the awards. •Expected Volatility-Since we do not have sufficient trading history for our common stock, the expected volatility was estimated based on the average volatility for comparable publicly traded biotechnology companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty.
•Risk-Free Interest Rate-The risk-free interest rate is based on the
•Expected Dividend Yield-We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we used an expected dividend yield of zero.
Recent Accounting Pronouncements
Information regarding recent accounting pronouncements applicable to us is included in Note 2 to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Emerging Growth Company Status and Smaller Reporting Company Status
We are an "emerging growth company" as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our 107
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independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock. In addition, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to avail ourselves of this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. We will remain an emerging growth company until the earliest of (i)December 31, 2026 , (ii) the last day of the fiscal year in which we have total annual gross revenue of at least$1.235 billion , (iii) the last day of the fiscal year in which we are deemed to be a "large accelerated filer" as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded$700.0 million as of the last business day of the second fiscal quarter of such year or (iv) the date on which we have issued more than$1.0 billion in non-convertible debt securities during the prior three-year period. We are also a "smaller reporting company," as defined in Rule 12b-2 under the Exchange Act. We may continue to be a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than$250.0 million or (ii) our annual revenue was less than$100.0 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than$700.0 million . If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
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