You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited Condensed Consolidated Financial Statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forth in the section titled "Risk Factors" in Part II, Item 1A of this Quarterly Report on Form 10-Q. See also the section titled "Special Note Regarding Forward-Looking Statements." Overview We are a clinical-stage cell therapy company advancing a pipeline of product candidates for patients with solid tumors utilizing our proprietary ex vivo genetic and epigenetic Tcell reprogramming technologies. Our investigational therapies use the patient's own cells as the starting point to generate highly tumor-reactive, longer-lasting functional T cells with enhanced ability to defeat solid tumors. Our innovative reprogramming technologies address what we believe are the primary barriers that limit consistent and long-lasting responses to Tcell therapy in solid tumors: Tcell exhaustion and lack of durable stemness. Our technologies are designed to generate T cells with the ability to persist and selfrenew while driving durable tumor cytotoxicity, even in the setting of an immunosuppressive tumor microenvironment. The goal is for our technologies to provide patients with T cells that are potent and long-lasting to achieve durable antitumor responses. Furthermore, our technologies can be applied in a target agnostic manner to multiple Tcell modalities, including chimeric antigen receptor (CAR), tumor-infiltrating lymphocytes (TIL) and Tcell receptor (TCR) therapies. We apply our technologies with the aim to develop Tcell therapies with improved durable clinical outcomes. Our growing pipeline of promising cell product candidates targets solid tumor indications with large unmet needs that are collectively responsible for approximately 180,000 deaths in the US annually. Each of our programs provide opportunities to expand into additional indications beyond the patient populations we are initially targeting. Our lead product candidates are summarized in the table below: [[Image Removed: 10K_2022_Pipeline_v3.jpg]] 19
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We were incorporated inJune 2018 . Our primary activities to date have included developing T-cell therapies, performing research and development, acquiring technology, entering into strategic collaboration and license agreements, enabling and executing manufacturing activities in support of our product candidate development efforts, organizing and staffing our company, business planning, establishing our intellectual property portfolio, regulatory submissions and other preparations to initiate clinical trials, raising capital and providing general and administrative support for these activities. We are early in our research and development efforts and are in Phase 1 clinical development of LYL797, our ROR-1 targeted CAR-T cell product candidate overexpressing c-Jun, and LYL845, an epigenetically reprogrammed TIL product candidate. Two additional product candidates are in preclinical development and include LYL119, a ROR-1 targeted CAR-T cell product candidate and a TIL product candidate, each incorporating novel genetic and epigenetic reprogramming technologies. We do not have any products approved for sale. We anticipate that our expenses and operating losses will increase substantially over the foreseeable future. The expected increase in expenses will be driven in large part by our ongoing activities, if and as we:
•continue preclinical development of our current and future product candidates and initiate additional nonclinical studies;
•commence and continue clinical trials of our current and future product candidates;
•advance our genetic and epigenetic reprogramming technologies as well as other research and development efforts;
•expand our manufacturing and process development capabilities;
•seek regulatory approval of our current and future product candidates;
•expand our operational, financial and management systems;
•attract, hire and retain qualified personnel;
•acquire and license technology or technology platforms;
•continue to develop, protect and defend our intellectual property portfolio; and
•incur additional legal, accounting or other expenses in operating our business, including the additional costs associated with operating as a public company.
Pipeline Programs and Operational Updates
Pipeline Programs
We are advancing four wholly-owned product candidates; two product candidates, LYL797 and LYL845, are in Phase 1 clinical development and two additional product candidates, LYL119 and a TIL product candidate incorporating novel genetic and epigenetic reprogramming technologies, are in preclinical development.
LYL797 - A genetically and epigenetically reprogrammed ROR1 CAR T-cell product candidate designed for differentiated potency and durability targeting multiple solid tumor indications. We are applying our c-Jun and EpiR technologies to our lead CAR Tcell product candidate, LYL797, which is expected to be an intravenouslyadministered CAR Tcell product targeting the receptor tyrosine kinase-like orphan receptor 1 (ROR1) protein. ROR1 is a fetal protein expressed during embryogenesis and is believed to be important in cell migration, polarity and survival. It is expressed in several cancer types, including triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), ovarian cancer and chronic lymphocytic leukemia, and is generally associated with a poor prognosis. LYL797 contains a CAR with a 4-1BB/CD3? intracellular domain, a transmembrane domain, an optimized spacer domain and a single-chain variable fragment (scFv) derived from an R12 rabbit monoclonal antibody that recognizes and binds with high specificity to human ROR1. LYL797 also incorporates c-Jun and a proprietary optimized truncated version of human EGFR (EGFRopt) used for tracking the CAR T cells in the peripheral blood post treatment and can also be used as a safety measure with the administration of cetuximab, if needed. LYL797 is manufactured utilizing our proprietary EpiR technology. We are initially developing LYL797 for the treatment of ROR1-positive TNBC and NSCLC. Significant subsets of patients with common cancers express ROR1, including TNBC (~60%) and NSCLC (~40%), two of the highest ROR1expressing solid tumor indications. If successful, we may expand into other ROR1-positive cancers with a lower incidence of ROR1 expression, including potentially hormone-receptor positive breast cancer, ovarian and other solid tumors. 20
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•Enrollment in the Phase 1 clinical trial of LYL797 is ongoing at nine sites in theU.S. The study will enroll at least 15 patients each with relapsed or refractory triple-negative breast cancer or with non-small cell lung cancer. Initial clinical data from the Phase 1 trial of LYL797 are expected in the first half of 2024. •The Phase 1 clinical trial is designed as an open label, dose escalation and expansion trial in patients with relapsed/refractory TNBC who have failed at least two lines of therapy and patients with relapsed/refractory NSCLC who have failed at least one line of therapy.
LYL845 - A novel epigenetically reprogrammed TIL product candidate designed for differentiated potency and durability targeting multiple solid tumor indications.
We are applying our epigenetic reprogramming technology, EpiR, to develop LYL845, which is expected to be an intravenouslyadministered autologous TIL therapy for multiple solid tumors. Our EpiR protocol comprises proprietary media, optimized cytokine compositions and well-defined cell activation and expansion protocols used during our manufacturing process. TIL have previously shown clinical benefit in patients with advanced melanoma and other solid tumors with high mutational burden. Published data from third-party TIL trials show that treating metastatic melanoma patients with TIL can result in complete and durable responses. Response rates to TIL therapy in patients with other advanced solid tumors such as lung, colorectal and breast are much lower than that observed in advanced melanoma. Broad TIL efficacy has been limited by poor enrichment of tumor-reactive T cells and the poor quality and limited growth potential of expanded T cells. Failure to maintain polyclonality of TIL during production may also limit their ability to eradicate cancer cells given the inherent heterogeneous nature of solid tumors. LYL845 incorporates our EpiR technology that has shown promising improvements in enhancing T-cell potency, antitumor activity and increased polyclonality of TIL in nonclinical experiments. We are initially developing LYL845 for advanced melanoma, NSCLC and colorectal cancer (CRC). Based on our success with those, we may include patients with other solid tumors, potentially including head and neck, cervical, breast and pancreatic cancer. •Enrollment in the Phase 1 clinical trial for LYL845 is ongoing at five sites in theU.S. The study will enroll at least 15 patients each with advanced melanoma, and relapsed or refractory non-small cell lung cancer or colorectal cancer. Initial clinical data from the Phase 1 trial of LYL845 are expected in 2024.
•The Phase 1 clinical trial is designed as an open label, dose escalation and expansion trial in patients with relapsed and/or refractory metastatic or locally advanced melanoma, NSCLC and CRC.
LYL119 - An innovative ROR1 CAR T-cell product designed for enhanced cytotoxicity.
A key pillar of our strategy is to continually innovate to develop and advance novel, breakthrough technologies that address key barriers to successful cell therapy for solid tumors. We have advanced a new genetic reprogramming technology, NR4A3 knockout, and a new epigenetic reprogramming technology, StimR, that are being applied in our new CAR T-cell product candidate, LYL119. These technologies are stackable and complementary to c-Jun and EpiR and are designed to further improve the antitumor potency and durability of T cells. LYL119 is being advanced with the goal of potentially creating even greater benefit for patients with ROR1-positive solid tumors.
•An IND application is expected to be submitted for LYL119 in the first half of 2024.
•An abstract highlighting preclinical development of LYL119 has been selected for presentation at theAmerican Society for Gene andCell Therapy (ASGCT) 26th Annual Meeting taking place inLos Angeles, California onMay 16-20, 2023 . Tcell rejuvenation technologies: We and others have documented the impact of aging on Tcell function, which begins to decline after puberty, and at an increasingly accelerated rate after age 65. Morbidity and mortality from cancer also increase with age. Thus, we are working to advance another novel reprogramming technology that focuses on rejuvenation of antitumor T cells. We are developing a method to maintain Tcell identity while reducing the epigenetic age of the cells. This technology is currently in the research stage. We have generated data illustrating the ability to "turn back" the epigenetic clock in a process called cellular rejuvenation, without changing the Tcell's identity as would occur in the setting of induced pluripotent stem cell-derived T cells.
Our Manufacturing Capabilities
We believe it is critically important to own, control and continuously monitor all aspects of the cell therapy manufacturing process to mitigate risks, including challenges in managing production, supply chain, patient specimen chain of custody and quality control. We made a strategic decision to invest in building our own manufacturing facility to 21
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control our supply chain, maximize efficiencies in cell product production time, optimize cost and quality, and have the ability to rapidly incorporate disruptive advancements and new innovations. Controlling manufacturing also enables us to protect proprietary aspects of our reprogramming technologies. We view our manufacturing team and capabilities as a significant competitive advantage. Our LyFE™ manufacturing center located inBothell, Washington is approximately 73,000 square feet and is comprised of manufacturing suites, laboratories and offices. LyFE is commissioned and designed to be in compliance withU.S. andEuropean Union current Good Manufacturing Practices (cGMP) standards and has a flexible and modular design enabling CAR T cell, TIL, TCR T cell and GMP viral vector production to control and de-risk the manufacturing sequence and timing of the major components of our supply chain. Owning our own facility encourages seamless collaboration across research, process development and manufacturing for high-quality reproducibility at manufacturing scale. We are currently producing clinical supply for our Phase 1 trials at LyFE. At full staffing and capacity, we expect to be able to manufacture approximately 500 infusions per year depending on product candidate mix. At this time, we believe this capacity is sufficient to support our pipeline programs into pivotal trials and, if approved, early commercialization.
Macroeconomic Environment
Our business and operations may be affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as the effects of the ongoing geopolitical conflicts inUkraine , tensions inU.S. -China relations, the continuing effects of the COVID-19 pandemic, inflationary pressures, interest rate environment, instability in the banking industry and overall market volatility. Fiscal year 2022 and the first quarter of 2023 were marked by significant market uncertainty, increasing inflationary pressures, banking turmoil, supply constraints and ongoing effects from the COVID-19 pandemic. These market dynamics may continue in the rest of 2023, and these and similar adverse market conditions may negatively impact our business. The effects of the global COVID-19 pandemic continue to evolve and, as a result, the ultimate impact of the COVID-19 pandemic or other similar health epidemic or pandemic on our business, operations and development timelines and plans remains uncertain and will continue to depend on certain developments, including virus transmission rates and duration of the pandemic, other next-level effects and the resulting impact on our CROs, contract manufacturing organizations, clinical sites and other third parties with whom we do business, as well as the impact on regulatory authorities and our key scientific and management personnel. For a further discussion of trends, uncertainties and other factors that could impact our operating results, see the section entitled "Risk Factors" in Part II, Item 1A of this Quarterly Report on Form 10-Q.
Components of Results of Operations
Revenue
We have no products approved for sale and have never generated any revenue from product sales.
We have generated revenue primarily from the recognition of the upfront payment under the Collaboration and License Agreement, entered into in 2019 and amended inJune 2020 andDecember 2021 (GSK Agreement) with GlaxoSmithKline Intellectual Property (No. 5) Limited andGlaxo Group Limited (together, GSK). GSK terminated the GSK Agreement effectiveDecember 2022 , and we do not expect further revenue from the collaboration. See Note 3, License, Collaboration and Success Payment Agreements, in the accompanying notes to the unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10Q, for additional details regarding termination of the GSK Agreement. In the future, we may generate additional revenue from other collaborations, strategic alliances, licensing agreements, product sales, or a combination of these. Operating Expenses Research and Development To date, research and development expenses consist of costs incurred by us for the discovery and development of our technology platforms and product candidates and include costs incurred in connection with strategic collaborations, costs to license technology, personnel-related costs, including stock-based compensation expense, facility and technology related costs, research and laboratory expenses, as well as other expenses, which include consulting fees and other costs. Upfront payments and milestones paid to third parties in connection with technology platforms that have not reached technological feasibility and do not have an alternative future use are expensed as incurred. 22
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Research and development expenses also include non-cash expenses related to the change in the estimated fair value of the success payment obligations over their respective requisite service terms granted toFred Hutchinson Cancer Center (Fred Hutch) andThe Board of Trustees of theLeland Stanford Junior University (Stanford ). As ofDecember 31, 2022 , Fred Hutch had provided the requisite service obligation to earn the potential success payment consideration under the continued collaboration. For the three months endedMarch 31, 2023 and future periods, the change in the Fred Hutch success payment liability fair value is recognized in other income, net, as the requisite service obligation had been met. See Note 3, License, Collaboration and Success Payment Agreements, in the accompanying notes to the unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10Q. Research and development expenses related to our success payment liabilities are unpredictable and may vary significantly from quartertoquarter and yeartoyear due to changes in our assumptions used in the calculation. We deploy our employee and infrastructure resources across multiple research and development programs for identifying and developing product candidates and establishing manufacturing capabilities. Due to the stage of development and number of ongoing programs and our ability to use resources across several programs, most of our research and development costs are not recorded on a program-specific basis. These include costs for personnel, laboratory and other indirect facility and operating costs. Research and development activities account for a significant portion of our operating expenses. We anticipate that our research and development expenses will increase over the foreseeable future as we expand our research and development efforts including completing nonclinical studies, commencing planned clinical trials, conducting and completing current and planned clinical trials, seeking regulatory approval of our product candidates, identifying new product candidates and incurring costs to acquire and license technology platforms. A change in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates. Because we are early in our research and clinical development efforts of our product candidates, and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the nonclinical development, clinical development and commercialization of product candidates or whether, or when, we may achieve profitability.
Our research and development expenses may vary significantly based on factors such as:
•the number and scope of nonclinical and IND-enabling studies;
•per patient trial costs;
•the number of trials required for approval;
•the number of sites included in the trials;
•the countries in which the trials are conducted;
•the length of time required to enroll eligible patients;
•the number of patients that participate in the trials;
•the drop-out or discontinuation rates of patients;
•potential additional safety monitoring requested by regulatory agencies;
•the duration of patient participation in the trials and follow-up;
•the cost and timing of manufacturing our product candidates;
•the phase of development of our product candidates;
•the efficacy and safety profile of our product candidates;
•the extent to which we establish additional collaboration or license agreements; and
•whether we choose to partner any of our product candidates and the terms of such partnership.
A change in the outcome of any of these variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any of our product candidates. We may obtain unexpected results from our nonclinical studies and clinical trials. General and Administrative General and administrative costs include personnel-related expenses, including stock-based compensation expense for personnel in executive, legal, finance and other administrative functions, legal costs, transaction costs related to 23
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collaboration and licensing agreements, as well as fees paid for accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include those related to corporate, dispute and patent matters. We anticipate that our general and administrative expenses will increase over the foreseeable future to support our continued research and development activities, operations generally, future business development opportunities, consulting fees, as well as due to the increased costs of operating as a public company such as costs related to accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing andSecurities and Exchange Commission (SEC) requirements, director and officer insurance costs and investor and public relations costs.
Other Operating Income, Net
Other operating income, net consists primarily of service and occupancy fees received associated with subleases as well as losses on the retirement of property and equipment.
Interest Income, Net
Interest income, net consists primarily of interest earned on our cash, cash equivalents and marketable securities balances.
Other Income, Net
Other income, net consists primarily of the change in fair value associated with our success payment liabilities to Fred Hutch for three months endedMarch 31, 2023 and primarily of changes in the fair value of an equity warrant investment held for the three months endedMarch 31, 2022 .
Impairment of Other Investments
Impairment of other investments consists of a reduction in the value of certain other investments.
Results of Operations
Three Months Ended
The following table summarizes our results of operations for the periods presented (in thousands): Three Months Ended March 31, 2023 2022 Change Revenue$ 65 $ 553 $ (488) Operating expenses: Research and development 44,630 35,830 8,800 General and administrative 19,279 34,421 (15,142) Other operating income, net (1,288) (1,122) (166) Total operating expenses 62,621 69,129 (6,508) Loss from operations (62,556) (68,576) 6,020 Interest income, net 4,497 397 4,100 Other income, net 1,100 35 1,065 Impairment of other investments (10,000) - (10,000) Total other (loss) income, net (4,403) 432 (4,835) Net loss$ (66,959) $ (68,144) $ 1,185 Revenue Revenue was$0.1 million and$0.6 million for the three months endedMarch 31, 2023 and 2022, respectively. The GSK Agreement was terminated inDecember 2022 and, therefore, no further research and development pursuant to the GSK Agreement was performed in the first quarter of 2023, which drove the decrease in revenue of$0.5 million . See Note 3, License, Collaboration and Success Payment Agreements - GSK, in the accompanying notes to the unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information about the termination of the GSK Agreement. 24
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Research and Development Expenses
The following table summarizes the components of our research and development expenses for the periods presented (in thousands):
Three Months Ended March 31, 2023 2022 Change Personnel$ 19,644 $ 16,541 $ 3,103 Facilities and technology 13,138 12,830 308
Research activities, collaborations and outside services 12,456
10,310 2,146 Success payments (608) (3,851) 3,243 Total research and development expenses$ 44,630
Research and development expenses were$44.6 million and$35.8 million for the three months endedMarch 31, 2023 and 2022, respectively. The increase of$8.8 million was primarily due to a$3.2 million increase associated with our success payment liabilities, noting$2.8 million of the change was due to recognizing the Fred Hutch success payment liability fair value change in other income, net for the three months endedMarch 31, 2023 and the remaining$0.4 million was due to the change in theStanford success payment liability; an increase of$3.1 million in personnel-related expenses primarily related to an increase in headcount to expand our research, development and manufacturing capabilities; an increase of$2.1 million in research activities, collaborations and outside services primarily driven by an increase in research and laboratory costs principally due to clinical trials, partially offset by a reduction in collaboration and license fees and expenses, including research and development expenses attributable to the termination of the GSK Agreement; and an increase of$0.3 million in facilities and technology costs.
General and Administrative Expenses
General and administrative expenses were$19.3 million and$34.4 million for the three months endedMarch 31, 2023 and 2022, respectively. The decrease of$15.1 million was primarily due to a decrease of$9.0 million in stock-based compensation expense, primarily related to significant awards being previously fully expensed. Additionally, outside services decreased by$5.6 million primarily due to a decrease in legal expenses.
Other Operating Income, Net
Other operating income, net was
Interest Income, Net
Interest income, net was
Other Income, Net
Other income, net was$1.1 million and$0.0 million for the three months endedMarch 31, 2023 and 2022, respectively. The increase of$1.1 million was primarily due to the change in fair value associated with our success payment liabilities to Fred Hutch for the three months endedMarch 31, 2023 ; the fair value change of Fred Hutch success payment liabilities is recognized in other income, net for the three months endedMarch 31, 2023 as Fred Hutch had provided the requisite service obligation to earn the potential success payment consideration under the continued collaboration as ofDecember 2022 .
Impairment of Other Investments
For the three months ended
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have funded our operations primarily through the sale and issuance of convertible preferred stock, the sale of common stock in connection with our initial public offering (IPO) and business development activities. As ofMarch 31, 2023 , we had$668.0 million in cash, cash equivalents and marketable securities. Since our inception, we have incurred significant operating losses. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. We had an 25
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accumulated deficit of$834.4 million as ofMarch 31, 2023 . FromJune 29, 2018 (inception) throughMarch 31, 2023 , we raised an aggregate of$1,405.7 million in gross proceeds from the sales of our convertible preferred stock prior to the IPO and sales of our common stock in the IPO. OnAugust 4, 2022 , we entered into an Equity Distribution Agreement (the Equity Distribution Agreement) withGoldman Sachs & Co. LLC (Goldman Sachs) andBofA Securities, Inc. (BofA , and together with Goldman Sachs, the Agents) with respect to an at-the-market offering program. In accordance with the terms of the Equity Distribution Agreement, we may offer and sell from time to time, through the Agents, shares of our common stock having an aggregate offering amount of up to$200.0 million (the Placement Shares). Sales of the Placement Shares, if any, will be made at prevailing market prices on Nasdaq at the time of sale, or as otherwise agreed with the Agents, by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415 of the Securities Act of 1933, as amended (the Securities Act). We will pay commissions to the Agents of up to 3.0% of the gross proceeds of the sale of the Placement Shares sold under the Equity Distribution Agreement and reimburse the Agents for certain expenses. Neither us nor the Agents are obligated to sell any shares and, to date, we have not made any sales under the Equity Distribution Agreement.
Future Funding Requirements
We expect to incur additional losses in the foreseeable future as we conduct and expand our research and development efforts, including conducting nonclinical studies and clinical trials, developing new product candidates, establishing internal manufacturing capabilities and funding our operations generally. Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to meet our working capital and capital expenditure needs into 2026. However, we anticipate that we will need to raise additional capital in the future to fund our operations, including further development of our product candidates and the commercialization of any approved product candidates. In addition, we regularly consider fund-raising opportunities and may decide, from time to time, to raise additional capital, including pursuant to the Equity Distribution Agreement, based on various factors, including market conditions and our plans of operation. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.
Our future capital requirements will depend on many factors, including:
•the scope, timing, progress, costs and results of discovery, nonclinical development and clinical trials for our current and future product candidates;
•the number of clinical trials required for regulatory approval of our current and future product candidates;
•the costs, timing and outcome of regulatory review of any of our current and future product candidates;
•the cost of manufacturing clinical and commercial supplies of our current and future product candidates;
•the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
•further investment to build additional manufacturing facilities or expand the capacity of our existing ones;
•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; •our ability to maintain existing, and establish new, collaborations, licenses, product acquisitions or other strategic transactions and the fulfillment of our financial obligations under any such agreements, including the timing and amount of any success payment, future contingent payments, milestone, royalty or other payments due under any such agreement;
•the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
•expenses to attract, hire and retain skilled personnel;
•the costs of operating as a public company;
•addressing any potential interruptions or delays resulting from factors related to the effects of the COVID-19 pandemic;
•addressing or responding to any potential disputes or litigation; and
•the extent to which we acquire or invest in businesses, products and technology platforms.
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Until such time as we complete nonclinical and clinical development and receive regulatory approval of our product candidates and can generate significant revenue from product sales, if ever, we expect to finance our operations from the sale of additional equity or debt financings, or other capital which come in the form of strategic collaborations, licensing, or other arrangements. In the event that additional capital is required, we may not be able to raise it on terms acceptable to us, or at all. If we raise additional funds through the issuance of equity or convertible debt securities, including pursuant to the Equity Distribution Agreement, it may result in dilution to our existing stockholders. Debt financing or preferred equity financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations. If we raise funds through strategic collaboration, licensing, or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets inthe United States and worldwide resulting from the ongoing effects of the COVID-19 pandemic, actual or perceived changes in interest rates and economic inflation and otherwise. If we are unable to raise additional capital when desired, our business, results of operations and financial condition would be adversely affected. Material Cash Requirements We continually evaluate our liquidity and capital resources to ensure that we can adequately and efficiently finance our operations. As ofMarch 31, 2023 , our material cash requirements consisted primarily of paying salaries and benefits, administering clinical trials, conducting research, improving our manufacturing capabilities, providing the technology and facilities necessary to support our operations, funding operating lease obligations and other payments related to our collaborative agreements, including anticipated success payments and license fees. See Note 3, License, Collaboration and Success Payment Agreements, and Note 7, Leases, in the accompanying notes to the unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information.
Cash Flows
The following table summarizes our cash flows for the periods indicated (in thousands): Three Months Ended March 31, 2023 2022 Net cash (used in) provided by: Operating activities$ (46,212) $ (47,852) Investing activities 32,154 (26,122) Financing activities (69) 2,555
Net decrease in cash, cash equivalents and restricted cash
$ (71,419) Operating Activities During the three months endedMarch 31, 2023 , net cash used in operating activities was$46.2 million , reflecting our net loss of$67.0 million , partially offset by$25.1 million of non-cash items primarily related to stock-based compensation of$13.9 million , impairment of other investments of$10.0 million and depreciation and amortization of$5.0 million , partially offset by net amortization and accretion on marketable securities of$1.9 million and the change in fair value of the success payment liabilities of$1.7 million . Additionally, net operating assets and liabilities decreased$4.3 million primarily driven by a$5.9 million decrease in accrued liabilities and other current liabilities partially offset by a$2.1 million increase in accounts payable. During the three months endedMarch 31, 2022 , net cash used in operating activities was$47.9 million , reflecting our net loss of$68.1 million , partially offset by non-cash items such as stock-based compensation expense of$22.0 million and depreciation and amortization expense of$4.2 million . Additionally, net operating assets and liabilities decreased$2.4 million , which included a$6.4 million decrease of accrued liabilities and other current liabilities due primarily to annual employee bonus payments, offset by a$2.9 million increase in accounts payable and a$2.1 million increase in operating lease liabilities primarily due to tenant improvement allowances received during the three months endedMarch 31, 2022 .
Investing Activities
During the three months endedMarch 31, 2023 , cash provided by investing activities was$32.2 million , consisting of net maturities, sales and purchases of marketable securities of$33.7 million offset by purchases of property and equipment of$1.5 million . 27
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During the three months endedMarch 31, 2022 , cash used in investing activities was$26.1 million , consisting of net purchases of marketable securities of$16.4 million and purchases of property and equipment of$9.7 million .
Financing Activities
During the three months endedMarch 31, 2023 , cash used in financing activities was$0.1 million , consisting of taxes paid related to the net share settlement of equity awards.
During the three months ended
Off-Balance Sheet Arrangements
Since our inception, we did not have, and we do not currently have, any
off-balance sheet arrangements as defined under the applicable rules and
regulations of the
Critical Accounting Policies and Significant Judgments and Estimates
Our unaudited Condensed Consolidated Financial Statements are prepared in accordance withU.S. generally accepted accounting principles (GAAP). The preparation of these unaudited Condensed Consolidated 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 unaudited Condensed Consolidated Financial Statements, as well as the reported revenue and 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.
There have been no material changes to our critical accounting policies and
estimates as compared to those described in our Annual Report on Form 10K for
the year ended
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