You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year endedDecember 31, 2021 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year endedDecember 31, 2021 (Annual Report), which was filed with theSecurities and Exchange Commission (SEC) onFebruary 23, 2022 . Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to the "Company", "Allogene," "we," "us" and "our" refer toAllogene Therapeutics, Inc. , and references to "Servier" collectively refer toLes Laboratoires Servier SAS and Institut de Recherches Internationales Servier SAS. In addition to historical financial information, this discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled "Risk Factors" under Part II, Item 1A below. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potentially," "predict," "should," "will" or the negative of these terms or other similar expressions. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Overview We are a clinical-stage immuno-oncology company pioneering the development of genetically engineered allogeneic T cell therapies for the treatment of cancer. We are developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. Our engineered T cells are allogeneic, meaning they are derived from healthy donors for intended use in any patient, rather than from an individual patient for that patient's use, as in the case of autologous T cells. We believe this key difference will enable us to deliver readily available treatments faster, more reliably, at greater scale, and to more patients. 22
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We have a deep pipeline of allogeneic chimeric antigen receptor (CAR) T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors. Pursuant to our Exclusive Collaboration and License Agreement withServier (Servier Agreement), we have exclusive rights to ALLO-501 and ALLO-501A, CAR T cell product candidates targeting CD19, inthe United States . ALLO-501 and ALLO-501A useCellectis S.A. (Cellectis) technologies under whichServier holds an exclusive worldwide license from Cellectis. OnSeptember 15, 2022 ,Servier sent a notice of discontinuation (Discontinuation) of its involvement in the development of all licensed products directed against CD19, including UCART19, ALLO-501 and ALLO-501A (collectively, CD19 Products), pursuant to the Servier Agreement.Servier's Discontinuation provides us with the right to elect a license to the CD19 Products outside ofthe United States (Ex-US Option) and does not otherwise affect our current exclusive license for the development and commercialization of CD19 Products inthe United States . Upon any exercise of the Ex-US Option by us, our potential milestone payments with respect to ALLO-501A would increase for any first dosing in Phase 2, first dosing in Phase 3 and regulatory approval by €46 million in the aggregate. In addition, upon any such exercise of the Ex-US Option,Servier's obligation to reimburse us for 40% of the development costs for CD19 Products would cease. See "Risk Factors-Servier's Discontinuation of its involvement in the development of CD19 Products may have adverse consequences.*" We are conducting long-term follow-up in our Phase 1 clinical trial (the ALPHA trial) of ALLO-501 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). We are also progressing the development of the second-generation version of ALLO-501, known as ALLO-501A. We have removed rituximab recognition domains in ALLO-501A, which we believe will potentially facilitate treatment of more patients, as rituximab is a typical part of a treatment regimen for a patient with NHL. We recently initiated a Phase 2 clinical trial for ALLO-501A (the ALPHA2 trial) in R/R large B cell lymphoma (LBCL). We conducted an extensive Phase 1 program designed to evaluate and optimize all aspects of our therapy, including multiple doses and schedules of ALLO-501A and one of our lymphodepletion agents, ALLO-647. In addition, we conducted a review of the Phase 1 program, which determined a manufacturing process associated with robust clinical performance. Our selected manufacturing process, named Alloy, will be deployed in the ALPHA2 trial and the EXPAND trial discussed below. The Phase 2 trial will begin with previously manufactured material from our prior contract manufacturing organization and we may transition to product from our manufacturing facility during the course of the ALPHA2 and EXPAND trials. The single-arm ALPHA2 trial will utilize a single dose of ALLO-501A at 120 million CAR+ cells with a lymphodepletion regimen comprised of fludarabine (30 mg/m2/day x 3 days) and cyclophosphamide (300 mg/m2/day x 3 days) plus ALLO-647 (90 mg). We plan to enroll approximately 100 patients who have received at least two prior lines of therapy and have not received any prior anti-CD19 therapy, including CAR T therapy. The primary endpoint is objective response rate (ORR) and the key secondary endpoint is duration of response (DoR). We are also in the process of initiating the EXPAND trial, which is expected to enroll approximately 70 patients with R/R LBCL and is intended to demonstrate the contribution of ALLO-647 to the overall benefit of the lymphodepletion regimen. Patients will be randomized to receive the same single 120 million CAR+ cell dose of ALLO-501A as in the ALPHA2 trial and either lymphodepletion with fludarabine and cyclophosphamide (control arm) or the lymphodepletion regimen of the ALPHA2 trial (active arm). The primary endpoint of this trial is progression free survival, and the key secondary endpoints are ORR, DoR, and the safety of ALLO-647. Assuming favorable outcomes and subject to FDA discussions, we plan to seek FDA approval of ALLO-501A and ALLO-647 on the basis of the ALPHA2 trial and the EXPAND companion trial. We are sponsoring two clinical trials in adult patients with R/R multiple myeloma, a Phase 1 clinical trial (the UNIVERSAL trial) of ALLO-715 and a Phase 1 clinical trial (the IGNITE trial) of ALLO-605, our first product candidate to incorporate our TurboCAR technology. TurboCAR technology allows cytokine signaling to be engineered selectively into CAR T cells and has shown the ability to improve the potency and persistence of the cells and to delay exhaustion of the cells in preclinical models. We also continue to advance the Phase 1 clinical trial (the TRAVERSE trial) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). Subject to results from the TRAVERSE trial, we may investigate the use of ALLO-316 for other solid tumor and hematologic indications.
We are planning an Allogene R&D Showcase on
Enrollment of patients and the ability to conduct patient follow-up has been adversely impacted by the COVID-19 pandemic. The exact timing of delays and overall impact of the COVID-19 pandemic to our business, preclinical studies and clinical trials is currently unknown, and we are monitoring the pandemic as it continues to evolve. 23
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Since inception, we have had significant operating losses. Our net losses were$83.1 million and$237.8 million for the three and nine months endedSeptember 30, 2022 , respectively. As ofSeptember 30, 2022 , we had an accumulated deficit of$1.1 billion . As ofSeptember 30, 2022 , we had$637.3 million in cash and cash equivalents and investments. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses and general and administrative expenses will continue to increase. 24
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Our Research and Development and License Agreements
Asset Contribution Agreement with Pfizer
InApril 2018 , we entered into an Asset Contribution Agreement (Pfizer Agreement) with Pfizer pursuant to which we acquired certain assets and assumed certain liabilities from Pfizer, including agreements with Cellectis andServier as described below, and other intellectual property for the development and administration of CAR T cells for the treatment of cancer. See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further description of the Pfizer Agreement.
Research Collaboration and License Agreement with Cellectis
InJune 2014 , Pfizer entered into a Research Collaboration and License Agreement with Cellectis. InApril 2018 , Pfizer assigned the agreement to us pursuant to the Pfizer Agreement. InMarch 2019 , we terminated the agreement with Cellectis and entered into a new license agreement with Cellectis. See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further descriptions of the prior agreement with Cellectis and the new license agreement with Cellectis.
Exclusive License and Collaboration Agreement with
InOctober 2015 , Pfizer entered into the Servier Agreement to develop, manufacture and commercialize certain allogeneic anti-CD19 CAR products inthe United States with the option to obtain the rights over certain additional allogeneic anti-CD19 CAR product candidates and for allogeneic CAR T cell product candidates directed against one additional target. InApril 2018 , Pfizer assigned the agreement to us pursuant to the Pfizer Agreement. InOctober 2019 , we agreed to waive our rights to the one additional target. See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further description of the Servier Agreement.
Collaboration and License Agreement with Notch
OnNovember 1, 2019 , we entered into a Collaboration and License Agreement (the Notch Agreement) withNotch Therapeutics Inc. (Notch), pursuant to which Notch granted us an exclusive, worldwide, royalty-bearing, sublicensable license under certain of Notch's intellectual property to develop, make, use, sell, import, and otherwise commercialize therapeutic gene-edited T cell and/or natural killer cell products from induced pluripotent stem cells directed at certain CAR targets for initial application in NHL, ALL and multiple myeloma. In addition, Notch has granted us an option to add certain specified targets to our exclusive license in exchange for an agreed upon per-target option fee. The Notch Agreement includes a research collaboration to conduct research and pre-clinical development activities to generate engineered cells directed to our exclusive targets, which will be conducted in accordance with an agreed research plan and budget under the oversight of a joint development committee. In connection with the execution of the Notch Agreement, we made an upfront payment to Notch of$10.0 million . In addition, we made a$5.0 million investment in Notch's series seed convertible preferred stock, resulting in us having a 25% ownership interest in Notch's outstanding capital stock on a fully diluted basis immediately following the investment. InFebruary 2021 , we made an additional$15.9 million investment in Notch's Series A preferred stock. InOctober 2021 , we made an additional$1.8 million investment in Notch's common stock. Immediately following this transaction, our share in Notch was 23.0% on a voting interest basis. See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further description of the Notch Agreement.
OnOctober 6, 2020 , we entered into a strategic five-year collaboration agreement withThe University of Texas MD Anderson Cancer Center (MD Anderson) for the preclinical and clinical investigation of allogeneic CAR T cell product candidates. See Note 6 to our consolidated financial statements included elsewhere in this report for further description of the agreement with MD Anderson.
License Agreement with Allogene Overland
OnDecember 14, 2020 , we entered into a License Agreement withAllogene Overland Biopharm (CY) Limited (Allogene Overland), a joint venture established by us andOverland Pharmaceuticals (CY) Inc. (Overland), pursuant to a Share Purchase Agreement, datedDecember 14, 2020 , for the purpose of developing, manufacturing and commercializing certain allogeneic CAR T cell therapies for patients in greaterChina ,Taiwan ,South Korea andSingapore (the JV Territory). Allogene 25 -------------------------------------------------------------------------------- Table of Contents Overland subsequently assigned the Licensed Agreement to a wholly-owned subsidiary,Allogene Overland BioPharm (HK) Limited (Allogene Overland HK). OnApril 1, 2022 , Allogene Overland HK assigned the License Agreement toAllogene Overland Biopharm (PRC) Co., Limited . See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further description of the License Agreement and Share Purchase Agreement with Allogene Overland.
Collaboration and License Agreement with Antion
OnJanuary 5, 2022 , we entered into an exclusive collaboration and global license agreement (Antion Agreement) withAntion Biosciences SA (Antion) for Antion's miRNA technology (miCAR), to advance multiplex gene silencing as an additional tool to develop next generation allogeneic CAR T products. Pursuant to the agreement, Antion will exclusively collaborate with us on oncology products for a defined period. We will also have exclusive worldwide rights to commercialize products incorporating Antion technology developed during the collaboration. See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further description of the Antion Agreement.
Components of Results of Operations
Revenues
As ofSeptember 30, 2022 , our revenue has been exclusively generated from our collaboration and license agreement withAllogene Overland Biopharm (PRC) Co., Limited . See Note 6 to our financial statements appearing elsewhere in this Quarterly Report for more information related to our recognition of revenue and theAllogene Overland Biopharm (PRC) Co., Limited agreement. In the future, we may generate revenue from a combination of product sales, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. We expect that any revenue we generate will fluctuate from quarter to quarter as a result of the timing and amount of license fees, milestones and other payments, and the amount and timing of payments that we receive upon the sale of our products, to the extent any are successfully commercialized. If we fail to complete the development of our product candidates in a timely manner or obtain regulatory approval of them, our ability to generate future revenue, and our results of operations and financial position, will be materially adversely affected.
Operating Expenses
Research and Development
To date, our research and development expenses have related primarily to discovery efforts, preclinical and clinical development, and manufacturing of our product candidates. Research and development expenses for the three and nine months endedSeptember 30, 2022 included costs associated with our clinical and preclinical stage pipeline candidates and research into newer technologies. The most significant research and development expenses for the year to date relate to costs incurred for the development of our most advanced product candidates and include:
•expenses incurred under agreements with our collaboration partners and third-party contract organizations, investigative clinical trial sites that conduct research and development activities on our behalf, and consultants;
•costs related to production of clinical materials, including fees paid for raw materials and to contract manufacturers;
•laboratory and vendor expenses related to the execution of preclinical and clinical trials;
•employee-related expenses, which include salaries, benefits and stock-based compensation;
•facilities and other expenses, which include expenses for rent and maintenance of facilities, depreciation and amortization expense and supplies; and
•other significant research and development costs including overhead costs.
We expense all research and development costs in the periods in which they are incurred. We accrue for costs incurred as the services are being provided by monitoring the status of the project and the invoices received from our external service providers. We adjust our accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when the milestone results are achieved. We are required to reimburseServier for 60% of the costs associated with the prior development of UCART19, including for the long-term follow-up of patients in the CALM and PALL clinical trials of UCART19. We accrue for costs 26
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incurred by monitoring the status of clinical trials and the invoices received fromServier . We adjust our accrual as actual costs become known. Pending any exercise by us of the Ex-US Option,Servier is required to reimburse us for 40% of the costs associated with the development of ALLO-501 and ALLO-501A. Collaboration expenses and cost reimbursement are recorded on a net basis as a research and development expense in our condensed consolidated statements of operations and comprehensive loss. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase in the future as our clinical programs progress and as we seek to initiate clinical trials of additional product candidates. The cost of advancing our manufacturing process as well as the cost of manufacturing product candidates for clinical trials are included in our research and development expense. We also expect to incur increased research and development expenses as we selectively identify and develop additional product candidates. However, it is difficult to determine with certainty the duration and completion costs of our current or future preclinical programs and clinical trials of our product candidates. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the following: •per patient trial costs; •biomarker analysis costs;
•the cost and timing of manufacturing for the trials;
•the number of patients that participate in the trials;
•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 total number of cells that patients receive;
•the drop-out or discontinuation rates of patients;
•potential additional safety monitoring or other studies requested by regulatory agencies, including to resolve any future clinical hold;
•the duration of patient follow-up; and
•the efficacy and safety profile of the product candidates.
In addition, the probability of success for each product candidate will depend on numerous factors, including safety, efficacy, competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate's commercial potential. Because our product candidates are still in clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when, we may achieve profitability.
General and Administrative
General and administrative expenses consist primarily of salaries and other staff-related costs, including stock-based compensation for options and restricted stock units granted. Other significant costs include costs relating to facilities and overhead costs, legal fees relating to corporate and patent matters, insurance, investor relations costs, fees for accounting and consulting services, information technology, costs and support for our board of directors and board committees, and other general and administrative costs. General and administrative costs are expensed as incurred, and we accrue for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from our service providers, and adjusting our accruals as actual costs become known. We expect our general and administrative expenses to increase over the next several years to support our continued research and development activities, manufacturing activities, potential commercialization of our product candidates and the increased costs of operating as a public company, including additional compliance-related expenses as a result of no longer 27
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being an emerging growth company. These increases are anticipated to include increased costs related to the hiring of additional personnel, developing commercial infrastructure, fees to outside consultants, lawyers and accountants, and increased costs associated with being a public company such as expenses related to services associated with maintaining compliance with Nasdaq listing rules andSEC requirements, complying with and advancing environmental, social and governance matters, and insurance and investor relations costs.
Interest and Other Income, Net
Interest and other income, net consists of interest earned on our cash and cash equivalents and investments, as well as investment gains and losses recognized during the period. Other Expense
Other expense consists of non-operating expenses, including our share of equity investments' net losses for the period.
Results of Operations
Comparison of the Three Months Ended
The following sets forth our results of operations for the three months ended
Three Months Ended September 30, Change 2022 2021 $ % Collaboration revenue - related party$ 49 $ 49 $ - - % Operating expenses: Research and development 63,641 58,720 4,921 8 % General and administrative 18,897 18,999 (102) (1) % Total operating expenses 82,538 77,719 4,819 6 % Loss from operations (82,489) (77,670) (4,819) 6 % Other income (expense), net: Interest and other income, net 1,002 393 609 155 % Other expenses (1,661) (909) (752) 83 % Total other income (expense), net (659) (516) (143) 28 % Net Loss$ (83,148) $ (78,186) $ (4,962) 6 %
Collaboration revenue - related party
Collaboration revenue was less than$0.1 million for the three months endedSeptember 30, 2022 and 2021. Revenue recognized in the three months endedSeptember 30, 2022 and 2021 was due to the delivery of the know-how performance obligations related to the License Agreement entered into with Allogene Overland onDecember 14, 2020 .
Research and Development Expenses
Research and development expenses were$63.6 million and$58.7 million for the three months endedSeptember 30, 2022 and 2021, respectively. The increase of$4.9 million was driven primarily by an increase in personnel related costs of$5.9 million , of which$0.9 million was stock-based compensation expense, and an increase in facilities costs and depreciation expense of$4.3 million , offset by a$5.9 million decrease in external costs relating to the advancement of our product candidates primarily due to the timing of development activities and manufacturing runs.
General and Administrative Expenses
General and administrative expenses were$18.9 million and$19.0 million for the three months endedSeptember 30, 2022 and 2021, respectively. The decrease of$0.1 million was primarily due to a decrease in business and consulting fees of$1.4 million , offset by a$0.9 million increase in personnel related costs. 28
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Interest and Other Income, Net
Interest and other income, net was
Comparison of the Nine Months Ended
The following sets forth our results of operations for the nine months ended
Nine Months Ended September 30, Change 2022 2021 $ % Collaboration revenue - related party $ 196$ 38,438 $ (38,242) * Operating expenses: Research and development 180,968 166,193 14,775 9 % General and administrative 58,303 54,144 4,159 8 % Total operating expenses 239,271 220,337 18,934 9 % Loss from operations (239,075) (181,899) (57,176) 31 %
Other income (expense), net:
Interest and other income, net 1,809 1,528 281 18 % Other expenses (519) (1,766) 1,247 (71) % Total other income (expense), net 1,290 (238) 1,528 * Net Loss$ (237,785) $ (182,137) $ (55,648) 31 %
* - Percentage is not meaningful
Collaboration revenue - related party
Collaboration revenue was$0.2 million and$38.4 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The decrease of$38.2 million was due to the revenue recognized related to the license of intellectual property and delivery of the know-how performance obligation, which was delivered in the first quarter of 2021, under the License Agreement entered into with Allogene Overland inDecember 2020 .
Research and Development Expenses
Research and development expenses were$181.0 million and$166.2 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase of$14.8 million was driven primarily by an increase in personnel related costs of$18.5 million , of which$6.6 million was stock-based compensation expense, and an increase in facilities costs and depreciation expense of$14.0 million , offset by a$20.3 million decrease in external costs relating to the advancement of our product candidates due to the timing of development activities and manufacturing runs.
General and Administrative Expenses
General and administrative expenses were$58.3 million and$54.1 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase of$4.2 million was primarily due to an increase in personnel related costs of$5.0 million , of which$1.0 million was stock-based compensation expense, and an increase in expenses related to corporate communications of$1.2 million , offset by a$2.0 million decrease in business and consulting fees.
Interest and Other Income, Net
Interest and other income, net was
Liquidity and Capital Resources
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To date, we have incurred significant net losses and negative cash flows from operations. As ofSeptember 30, 2022 , we had$637.3 million in cash and cash equivalents and investments. We anticipate that the aggregate of our current cash and cash equivalents and investments available for operations will enable us to maintain our operations for a period of at least one year from the date this Quarterly Report on Form 10-Q is filed with theSEC . Our operations have been financed primarily by net proceeds from the sale and issuance of our convertible preferred stock, the issuance of convertible promissory notes, net proceeds from our IPO, our at-the-market (ATM) offerings, ourJune 2020 underwritten public offering, and upfront cash payment of$40.0 million received inDecember 2020 pursuant to our License Agreement with Allogene Overland. In connection with our IPO in 2018, we sold an aggregate of 20,700,000 shares of our common stock (inclusive of 2,700,000 shares of common stock pursuant to the over-allotment option granted to the underwriters) at a price of$18.00 per share and received approximately$343.3 million in net proceeds. InNovember 2019 , we entered into a sales agreement withCowen and Company, LLC (Cowen) under which we may from time to time issue and sell shares of our common stock through Cowen in ATM offerings for an aggregate offering price of up to$250.0 million . As ofSeptember 30, 2022 ,$167.3 million remains available for sale under the sales agreement with Cowen. InJune 2020 , we sold 13,457,447 shares of our common stock, which included 1,755,319 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, in an underwritten public offering at a price of$47.00 per share, which resulted in net proceeds of approximately$595.7 million after deducting the underwriting discounts and commissions and other expenses.
Cash Flows
The following table summarizes our cash flows for the periods indicated:
Nine Months Ended September 30, 2022 2021 (In thousands) Net cash (used in) provided by: Operating activities$ (158,423) $ (139,376) Investing activities 56,562 134,405 Financing activities 2,904 11,641 Net increase (decrease) in cash, cash equivalents and restricted cash$ (98,957) $ 6,670 Operating Activities During the nine months endedSeptember 30, 2022 , cash used in operating activities of$158.4 million was attributable to a net loss of$237.8 million , partially offset by non-cash charges of$86.5 million and an increase of$7.1 million in our net operating assets and liabilities. The non-cash charges consisted primarily of stock-based compensation expense of$66.4 million , depreciation of$11.2 million , our share of equity investments' net losses for the period of$4.0 million , net amortization and accretion on investment securities of$2.7 million , and non-cash rent expense of$2.2 million . The change in operating assets and liabilities was primarily due to a$3.2 million increase in other long-term assets, a$2.8 million increase in prepaid expenses and other current assets, a$1.4 million decrease in accrued and other current liabilities, and a$2.1 million decrease in other long-term liabilities, offset by a$1.9 million increase in accounts payable and a$0.5 million increase in deferred revenue. Investing Activities During the nine months endedSeptember 30, 2022 , net cash provided by investing activities of$56.6 million was related to cash provided by investment maturities of$260.4 million , offset by cash used in purchases of investments of$200.3 million and cash used in the purchase of property and equipment of$3.5 million . Financing Activities During the nine months endedSeptember 30, 2022 , cash provided by financing activities of$2.9 million was related to$2.5 million of cash provided by the sale of common stock through our employee stock purchase plan and$0.4 million of cash provided by the issuance of common stock upon exercise of stock options. 30
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Material Cash Commitments and Requirements
Our primary use of cash is for operating expenses, which consist primarily of clinical manufacturing and research and development expenditures related to our lead product candidates, other research efforts, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses and other current liabilities. Our product candidates are still in the early stages of clinical and preclinical development and the outcome of these efforts is uncertain. Accordingly, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration and license arrangements. If, and when, we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders' rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to raise capital when needed, we will need to delay, reduce or terminate planned activities to reduce costs. Doing so will likely harm our ability to execute our business plans. Our commitments primarily consist of obligations under our agreements with Pfizer, Cellectis,Servier and Notch. Under these agreements we are required to make milestone payments upon successful completion of certain regulatory and sales milestones on a target-by-target and country-by-country basis. The payment obligations under the license agreements are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones and we will be required to make development milestone payments and royalty payments in connection with the sale of products developed under these agreements. As ofSeptember 30, 2022 , we were unable to estimate the timing or likelihood of achieving the milestones or making future product sales. For additional information regarding our agreements, see Note 6 to our condensed consolidated financial statements included elsewhere in this report. Additionally, we have entered into agreements with third-party contract manufacturers for the manufacture and processing of certain of our product candidates for clinical testing purposes, and we have entered and will enter into other contracts in the normal course of business with contract research organizations for clinical trials and other vendors for other services and products for operating purposes. These agreements generally provide for termination or cancellation, other than for costs already incurred. As ofSeptember 30, 2022 , the Company had non-cancellable purchase commitments of$0.4 million . OnOctober 6, 2020 , we announced we entered into a strategic five-year collaboration agreement with MD Anderson for the preclinical and clinical investigation of allogeneic CAR T cell product candidates. We and MD Anderson are collaborating on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee. Under the terms of the agreement, we have committed up to$15.0 million of funding for the duration of the agreement. Payment of this funding is contingent on mutual agreement to study orders in order for any study to be included under the alliance. We made an upfront payment of$3.0 million to MD Anderson in the year endedDecember 31, 2020 . We are obligated to make further payments to MD Anderson each year upon the anniversary of the agreement effective date through the duration of the agreement term. The agreement may be terminated by either party for material breach by the other party. Individual studies may be terminated for, among other things, material breach, health and safety concerns or where the institutional review board, the review board at the clinical site with oversight of the clinical study, requests termination of any study. Where any legal or regulatory authorization is finally withdrawn or terminated, the relevant study will also terminate automatically. InJuly 2020 , we entered into a Solar Power Purchase and Energy Services Agreement for the installation and operation of a solar photovoltaic generating system and battery energy storage system at our manufacturing facility inNewark, California . The agreement has a term of 20 years and commenced inSeptember 2022 . We are obligated to pay for electricity generated from the system at an agreed rate for the duration of the agreement term. Termination of the agreement by us will result in a termination payment due of approximately$4.3 million . In connection with the agreement, we maintain a letter of credit for the benefit of the service provider in the amount of$4.3 million . We also have a Change in Control and Severance Plan that require the funding of specific payments, if certain events occur, such as a change of control and the termination of employment without cause.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance withUnited States generally accepted 31
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accounting principles. The preparation of these 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 condensed consolidated 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.
We believe that the assumptions and estimates associated with accrued research and development expenditures and stock-based compensation have the most significant impact on our condensed consolidated financial statements. Therefore, we consider these to be our critical accounting policies and estimates.
There have been no significant changes in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled "Management's Discussion and Analysis of Financial Condition and Operations" included in our Annual Report.
Recent Accounting Pronouncements
There have been no new accounting pronouncements issued or effective that are expected to have a material impact on our unaudited condensed financial statements.
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