Century Therapeutics(IPSC) - 2023 Q3 - Quarterly Report

Cautionary Note Regarding Forward-Looking Statements This section cautions that forward-looking statements are subject to substantial risks and uncertainties, potentially altering actual results Forward-Looking Statements Overview This section outlines forward-looking statements, detailing substantial risks and uncertainties that may cause actual results to differ - The report contains forward-looking statements that involve substantial risks and uncertainties, based on assumptions and expectations that may not be realized[8] - Key forward-looking statements include the ability to raise additional capital, successfully advance product candidates (CNTY-101, iPSC-derived cells), achieve profitability, and manage reliance on collaborations with FCDI and Bristol-Myers Squibb[9][12] - Factors that could cause actual results to differ materially include the timing and success of preclinical studies and clinical trials, regulatory approvals, manufacturing capabilities, intellectual property protection, and market volatility[9][12] PART I. Financial Information This section presents the company's comprehensive financial data, including statements, notes, and management's discussion and analysis Item 1. Financial Statements This section presents the unaudited consolidated financial statements for Century Therapeutics, Inc., providing a snapshot of the company's financial position and performance Consolidated Balance Sheets This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates Consolidated Balance Sheet Highlights (in thousands) | Metric | September 30, 2023 | December 31, 2022 | | :--------------------------------- | :------------------- | :------------------ | | Total Current Assets | $173,703 | $319,721 | | Total Assets | $397,551 | $486,544 | | Total Current Liabilities | $20,435 | $29,817 | | Total Liabilities | $178,321 | $183,806 | | Total Stockholders' Equity | $219,230 | $302,738 | - Total current assets decreased significantly from $319.7 million at December 31, 2022, to $173.7 million at September 30, 2023, primarily due to reductions in cash, cash equivalents, and short-term investments[19] - Total stockholders' equity decreased from $302.7 million to $219.2 million, reflecting accumulated deficits[19] Consolidated Statements of Operations and Comprehensive Loss This section presents the company's financial performance over specific periods, detailing revenues, expenses, and net loss Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands) | Metric | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Collaboration Revenue | $148 | $2,224 | $1,967 | $4,678 | | R&D Expenses | $22,788 | $25,898 | $70,414 | $71,588 | | G&A Expenses | $8,986 | $8,064 | $26,117 | $23,615 | | In-process R&D | $4,000 | $- | $4,000 | $10,000 | | Impairment of Long-Lived Assets | $- | $- | $4,220 | $- | | Net Loss | $(32,720) | $(30,749) | $(97,275) | $(99,250) | | Basic & Diluted EPS | $(0.55) | $(0.53) | $(1.65) | $(1.72) | - Collaboration revenue decreased significantly for both the three-month ($2.2 million to $0.1 million) and nine-month ($4.7 million to $2.0 million) periods year-over-year[21] - Net loss for the nine months ended September 30, 2023, was $97.3 million, a slight improvement from $99.3 million in the prior year, despite a $4.2 million impairment charge on long-lived assets in 2023[21] Consolidated Statements of Changes in Stockholders' Equity This section details changes in stockholders' equity over specific periods, including common stock, paid-in capital, and accumulated deficit Stockholders' Equity Changes (in thousands) | Metric | Balance, Dec 31, 2022 | Balance, Sep 30, 2023 | | :------------------------- | :-------------------- | :-------------------- | | Common Stock | $6 | $6 | | Additional Paid-in Capital | $824,292 | $836,901 | | Accumulated Deficit | $(519,098) | $(616,373) | | Total Stockholders' Equity | $302,738 | $219,230 | - Accumulated deficit increased from $519.1 million at December 31, 2022, to $616.4 million at September 30, 2023, primarily due to net losses incurred during the period[22] - Additional paid-in capital increased by $12.6 million, driven by stock-based compensation and common stock issuances from option exercises[22] Consolidated Statements of Cash Flows This section presents the company's cash flows from operating, investing, and financing activities over specific periods Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | | Operating Activities | $(62,118) | $36,959 | | Investing Activities | $42,529 | $(8,855) | | Financing Activities | $(9,369) | $27,063 | | Net (Decrease) Increase in Cash | $(28,958) | $55,167 | | Cash, Cash Equivalents, and Restricted Cash, End of Period | $57,286 | $113,329 | - Net cash used in operating activities was $62.1 million for the nine months ended September 30, 2023, a significant shift from $37.0 million provided in the prior year, primarily due to lower deferred revenue recognition[25] - Investing activities provided $42.5 million in 2023, compared to $8.9 million used in 2022, mainly driven by net sales of fixed maturity securities[25] - Financing activities used $9.4 million in 2023, primarily due to long-term debt payments, contrasting with $27.1 million provided in 2022 from common stock issuance to a collaboration partner[25] Notes to Unaudited Consolidated Financial Statements This section provides detailed disclosures and explanations for the unaudited consolidated financial statements, covering the company's organization, significant accounting policies, and strategic changes Note 1—Organization and description of the business This note describes the company's business, its focus on allogeneic cell therapies, and recent strategic changes and workforce reduction - Century Therapeutics, Inc. is a biotechnology company focused on developing allogeneic cell therapies for solid tumor and hematological malignancies[26] - The company has incurred net losses since inception, with $32.7 million and $97.3 million net losses for the three and nine months ended September 30, 2023, respectively, and used $62.1 million cash in operations during the nine-month period[30] - In January 2023, the company implemented a portfolio prioritization, pausing investment in CNTY-103 and a discovery program, shifting focus to CNTY-101, CNTY-102, and CNTY-107, and reducing its workforce by approximately 25%[31] Note 2—Summary of significant accounting policies and basis of presentation This note outlines the significant accounting policies and basis of presentation used in preparing the unaudited consolidated financial statements - The unaudited consolidated financial statements are prepared in accordance with GAAP for interim financial information and Form 10-Q requirements, with results not necessarily indicative of the full year[32] - The company operates as one segment and uses estimates for stock compensation, operating lease rates, and standalone selling prices in collaboration agreements[34][35] - Investments in fixed maturity securities are classified as available-for-sale and reported at fair value, with unrealized gains/losses recorded in other comprehensive income (loss)[45] - Research and development expenses, including clinical trial costs, are expensed as incurred[49][50] Note 3—Reduction in force This note details expenses incurred for employee severances, benefits, and stock-based compensation related to the January 2023 workforce reduction - During the nine months ended September 30, 2023, the Company incurred $2.0 million in cash-based expenses for employee severances and benefits, and a $0.6 million non-cash stock-based compensation charge due to equity award modifications related to the January 2023 restructuring[75] Note 4—Asset purchase by Century Therapeutics Canada ULC This note describes Century Canada's acquisition of an IPR&D asset from Empirica Therapeutics, detailing cash payments and escrow deposit - Century Canada acquired an IPR&D asset from Empirica Therapeutics, Inc. in June 2020, involving a $4.5 million cash payment and a $1.5 million escrow deposit[76] - The final $0.5 million installment of the escrow deposit was released in February 2023, with no remaining outstanding liabilities related to the promissory note as of September 30, 2023[76] Note 5—Financial instruments and fair value measurements This note details the company's financial instruments and their fair value measurements, including cash equivalents and fixed maturity securities Fair Value Measurements of Assets (in thousands) | Asset Type | September 30, 2023 | December 31, 2022 | | :-------------- | :----------------- | :---------------- | | Cash equivalents| $42,911 | $77,736 | | U.S. Treasury | $31,256 | $86,475 | | Corporate bonds | $199,245 | $196,603 | | Total | $273,412 | $360,814 | Fixed Maturity Securities - Fair Value and Unrealized Losses (in thousands) | Metric | September 30, 2023 | December 31, 2022 | | :-------------- | :----------------- | :---------------- | | Amortized Cost | $231,725 | $285,466 | | Gross Unrealized Losses | $(1,232) | $(2,390) | | Fair Value | $230,501 | $283,078 | - The company held 71 and 42 available-for-sale investment debt securities in an unrealized loss position as of September 30, 2023, and December 31, 2022, respectively, which are considered temporary due to high credit quality and management's intent to hold to maturity[80] Note 6—Prepaid expenses and other current assets This note details the composition of prepaid expenses and other current assets, including R&D, insurance, and accrued interest receivable Prepaid Expenses and Other Current Assets (in thousands) | Category | September 30, 2023 | December 31, 2022 | | :------------------------ | :----------------- | :---------------- | | Research and development | $46 | $110 | | Insurance | $1,489 | $1,454 | | Software licenses and other | $872 | $1,417 | | Reimbursement receivable | $123 | $780 | | Accrued interest receivable | $1,542 | $- | | Total | $4,198 | $4,003 | - Accrued interest receivable significantly increased to $1.5 million at September 30, 2023, from zero at December 31, 2022[82] Note 7—Property and equipment, net This note details property and equipment, net, including lab equipment, leasehold improvements, and construction in progress, with impairment information Property and Equipment, Net (in thousands) | Category | September 30, 2023 | December 31, 2022 | | :------------------------ | :----------------- | :---------------- | | Lab equipment | $29,303 | $28,811 | | Leasehold improvements | $68,299 | $48,951 | | Construction in progress | $567 | $13,998 | | Total | $103,159 | $96,440 | | Less: Acc. Depreciation | $(21,166) | $(13,655) | | Property and equipment, net | $81,993 | $82,785 | - Leasehold improvements increased significantly from $49.0 million to $68.3 million, while construction in progress decreased from $14.0 million to $0.6 million, indicating completion and capitalization of projects[83] - The company recognized $4.0 million in impairment on property and equipment, net, during the nine months ended September 30, 2023[83] Note 8—Accrued expenses and other liabilities This note details the composition of accrued expenses and other liabilities, including payroll, income tax payable, and operating lease liabilities Accrued Expenses and Other Liabilities (in thousands) | Category | September 30, 2023 | December 31, 2022 | | :---------------------------- | :----------------- | :---------------- | | Payroll and bonuses | $5,566 | $7,062 | | Income tax payable | $851 | $- | | Operating lease liability, current | $2,040 | $475 | | Total | $9,932 | $9,841 | - Operating lease liability, current, increased significantly from $0.5 million to $2.0 million[85] - Income tax payable of $0.9 million was recorded at September 30, 2023, compared to none at December 31, 2022[85] Note 9—Long-term debt This note details the company's long-term debt, including the full prepayment of the Term Loan Agreement and related interest expenses - The company fully prepaid its $10.0 million Term Loan Agreement with Hercules Capital, Inc. on May 1, 2023, including a $0.1 million prepayment charge and a $0.4 million end-of-term fee[87] Interest Expense on Long-Term Debt (in thousands) | Metric | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Interest expense| $- | $296 | $540 | $787 | | Amortization | $- | $77 | $- | $230 | | Total | $- | $373 | $540 | $1,017 | - Interest expense decreased to zero for the three months ended September 30, 2023, following the loan repayment[91] Note 10 – Bristol-Myers Squibb Collaboration This note details the Bristol-Myers Squibb collaboration, including upfront payments, potential milestones, and transaction price allocation - The company entered into a collaboration agreement with Bristol-Myers Squibb on January 7, 2022, for iNK and iT cell programs, receiving a $100 million upfront cash payment and $50 million from common stock purchase[93][95][98] - Bristol-Myers Squibb has options to license development candidates and will pay up to $235 million in development/regulatory milestones and up to $500 million in net sales-based milestones per licensed product, plus tiered royalties[95] Transaction Price Allocation and Deferred Revenue (in thousands) | Performance Obligation | Transaction Price | Cumulative Revenue Recognized (Sep 30, 2023) | Deferred Revenue (Sep 30, 2023) | | :--------------------- | :---------------- | :------------------------------------------- | :------------------------------ | | Option rights | $109,164 | $- | $109,164 | | R&D services | $14,023 | $(7,166) | $6,857 | | Total | $123,187 | $(7,166) | $116,021 | - The company incurred $10 million in fees to amend the FCDI agreement to gain access to Japan territory rights as a direct result of the Bristol-Myers Squibb collaboration[103] Note 11—Commitments and contingencies This note outlines the company's commitments and contingencies, including agreements with Distributed Bio and iCELL Inc - The company has a Master Service Agreement with Distributed Bio, Inc. for protein binder screening, with potential milestone payments up to $16.1 million per product if brought to clinic[105] - Under a Sublicense Agreement with iCELL Inc., the company will pay low single-digit royalties on net sales and potential sales milestones up to $70 million, plus development and regulatory approval milestones up to $4.25 million[107][109] Note 12—Leases This note provides details on the company's operating leases, including lease expenses, liabilities, right-of-use assets, and impairment charges Operating Lease Expense (in thousands) | Lease Expense Component | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :---------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Fixed lease cost | $1,443 | $1,795 | $4,458 | $3,298 | | Variable lease cost | $474 | $303 | $995 | $840 | | Short term lease expense| $5 | $602 | $901 | $1,971 | | Total | $1,922 | $2,700 | $6,354 | $6,109 | Operating Lease Liabilities (in thousands) | Lease Liability Category | September 30, 2023 | December 31, 2022 | | :----------------------- | :----------------- | :---------------- | | Operating lease right-of-use asset, net | $24,551 | $28,945 | | Operating lease liability, current | $2,040 | $475 | | Operating lease liability, long-term | $45,535 | $38,698 | | Total operating lease liability | $47,575 | $39,173 | - The weighted-average remaining lease term for operating leases was 7.8 years at September 30, 2023, with a weighted-average discount rate of 9.8%[111] - The company recognized $218 thousand in impairment on right-of-use assets during the nine months ended September 30, 2023[113] Note 13—Income taxes This note details income tax expense, the impact of the Bristol-Myers Squibb collaboration, and the valuation allowance on deferred tax assets - The company recorded an income tax expense of $2.75 million for the nine months ended September 30, 2023, including a $0.1 million provision for its Canadian operating company[114] - The tax provision is primarily driven by taxable revenue recognition from the Bristol-Myers Squibb Collaboration Agreement and the limitation of R&D deductions under Section 174 of the Internal Revenue Code[114] - A full valuation allowance has been recorded against U.S. net deferred tax assets due to a history of cumulative net losses and uncertainty of realizing future benefits[116] Note 14—Basic and diluted net loss per common share This note presents the calculation of basic and diluted net loss per common share, including the exclusion of anti-dilutive securities Basic and Diluted Net Loss Per Common Share | Metric | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net loss | $(32,720) | $(30,749) | $(97,275) | $(99,250) | | Weighted-average common shares outstanding | 59,448,229 | 57,973,541 | 59,087,374 | 57,573,406 | | Basic and diluted net loss per common share | $(0.55) | $(0.53) | $(1.65) | $(1.72) | - Potentially dilutive securities (restricted stock, warrants, stock options) were excluded from diluted EPS calculation as their effect would be anti-dilutive due to net losses[118] Potentially Dilutive Securities Excluded from Diluted EPS | Security Type | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :--------------------------------- | :-------------------------- | :-------------------------- | | Stock options to purchase common stock | 8,290,588 | 7,724,059 | | Early exercised stock options | 227,499 | 565,224 | | Restricted stock award | 49,465 | 247,780 | | Unvested restricted stock units | 2,263,195 | - | | Warrants | 32,009 | 32,009 | | Total | 10,862,756 | 8,569,072 | Note 15—Defined contribution plan This note describes the company's 401(k) Plan, including its Safe-Harbor provision and employer contribution matching details - The company's 401(k) Plan includes a Safe-Harbor provision, with employer contributions matching 100% of the first 3% and 50% of the next 2% of participating employee contributions[120] 401(k) Contribution Expense (in thousands) | Period | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Contributions | $514 | $249 | $1,127 | $644 | Note 16—Stock-based compensation This note details the company's stock-based compensation, including the 2021 Equity Incentive Plan, stock option activity, and compensation expense - The 2021 Equity Incentive Plan, adopted June 17, 2021, governs incentive awards, with 4,965,447 shares available for issuance as of September 30, 2023[121][123] Stock Option Activity (9 Months Ended Sep 30, 2023) | Metric | Shares | Weighted Average Exercise Price | | :------------------------- | :---------- | :------------------------------ | | Outstanding Jan 1, 2023 | 7,489,678 | $7.77 | | Granted | 4,603,561 | $4.35 | | Exercised | (601,588) | $1.00 | | Forfeited | (3,098,457) | $7.01 | | Cancelled | (102,606) | $12.94 | | Outstanding Sep 30, 2023 | 8,290,588 | $6.57 | | Exercisable Sep 30, 2023 | 3,721,875 | $6.74 | Stock-Based Compensation Expense (in thousands) | Category | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | | Stock options | $7,919 | $7,202 | | Restricted stock units | $2,774 | $- | | Restricted stock awards | $183 | $735 | | Employee stock purchase plan | $184 | $- | | Total | $11,060 | $7,937 | - Total unrecognized compensation expense for unvested stock options was $19.1 million (weighted average period of 2.73 years) and for unvested restricted stock units was $5.9 million (weighted average period of 1.70 years) as of September 30, 2023[127][131] Note 17—Related party transactions This note outlines agreements with related parties, including FUJIFILM Cellular Dynamics, Inc. and Bayer Health, LLC - The company has multiple agreements with FUJIFILM Cellular Dynamics, Inc. (FCDI), a shareholder, including non-exclusive (Reprogramming) and exclusive (Differentiation) license agreements, and a Master Collaboration Agreement for iPSC and immune cell development and manufacturing[136][137][138] - In September 2023, the company and FCDI entered into a worldwide license agreement (Autoimmune License) and amended existing licenses to expand into inflammatory and autoimmune diseases, resulting in a $4.0 million upfront payment recorded as In-process R&D[141][143] - Bayer Health, LLC has a right of first refusal to acquire certain products developed by the company, exercisable for up to four products in a non-sequential and alternating manner[146] Note 18—Impairment on Long-Lived Assets This note details the impairment charge on a right-of-use asset and related property and equipment due to lab facility consolidation - In Q2 2023, the company made a strategic decision to consolidate lab facilities in Philadelphia, leading to an impairment analysis of a right-of-use asset and related property and equipment[147] - An impairment charge of $4.22 million was recognized in June 2023, representing the difference between the fair value and carrying value of the right-of-use asset[149] Note 19—Subsequent Events This note confirms that no subsequent events requiring adjustments or disclosures were identified through the filing date of the 10-Q - The company evaluated subsequent events through the filing date of the 10-Q and determined no events required adjustments to disclosures in the consolidated financial statements[150] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition, results of operations, and cash flows, highlighting key business developments and future outlook Overview This section provides an overview of Century Therapeutics' business, strategic shifts, clinical trial progress, and financial outlook - Century Therapeutics is an innovative biotechnology company developing allogeneic cell therapies for solid tumor and hematological malignancies, leveraging iPSC-derived cells and CRISPR gene editing[152] - The company has an accumulated deficit of $616.4 million as of September 30, 2023, primarily from R&D and general and administrative costs[153] - The ELiPSE-1 clinical trial for CNTY-101 in B-cell malignancies began dosing patients in February 2023, with preliminary data showing a complete response in one patient[156] - A strategic portfolio prioritization in January 2023 de-prioritized CNTY-103 and a discovery program, consolidating research activities in Philadelphia and reducing the workforce by 25%[157] - Existing cash, cash equivalents, and investments of $284.3 million as of September 30, 2023, are expected to fund operations into 2026, but additional financing will be needed for future development and commercialization[155][158][162] License and Collaboration Agreements This section details the company's key license and collaboration agreements, including those with Bristol-Myers Squibb and FCDI - The collaboration with Bristol-Myers Squibb, initiated in January 2022, focuses on iNK and iT cell programs for hematologic malignancies and solid tumors, with an upfront payment of $100 million and potential milestones up to $735 million per licensed product[164][165] - The company has exclusive and non-exclusive license agreements with FCDI for iPSC and immune cell differentiation and reprogramming, which were amended in September 2023 to include inflammatory and autoimmune diseases[169][170][173] - In connection with the Bristol-Myers Squibb collaboration, the company paid FCDI an upfront payment of $10 million for access to Japan territory rights[172] Components of Operating Results This section explains the key components of operating results, including collaboration revenue, R&D expenses, and interest income/expense - Collaboration revenue is currently derived solely from the Bristol-Myers Squibb agreement and is recognized over the expected performance period[178] - Research and development expenses, which are expensed as incurred, constitute a significant portion of operating expenses and are expected to increase as the company advances its pipeline and manufacturing capabilities[179][182] - In-process research and development expenses include $4 million in fees paid to FCDI in 2023 for expanded license rights related to autoimmune diseases[185] - Interest expense decreased due to the full repayment of the Hercules loan in May 2023, while interest income increased due to higher interest rates on cash and investments[186][187] Results of Operations This section provides a detailed analysis of the company's financial performance, comparing key metrics for the reported periods Key Financial Results (3 Months Ended Sep 30, in thousands) | Metric | 2023 | 2022 | Change | | :------------------------- | :---------- | :---------- | :---------- | | Collaboration revenue | $148 | $2,224 | $(2,076) | | R&D expenses | $22,788 | $25,898 | $(3,110) | | G&A expenses | $8,986 | $8,064 | $922 | | In-process R&D | $4,000 | $- | $4,000 | | Net loss | $(32,720) | $(30,749) | $(1,971) | Key Financial Results (9 Months Ended Sep 30, in thousands) | Metric | 2023 | 2022 | Change | | :------------------------- | :---------- | :---------- | :---------- | | Collaboration revenue | $1,967 | $4,678 | $(2,711) | | R&D expenses | $70,414 | $71,588 | $(1,174) | | G&A expenses | $26,117 | $23,615 | $2,502 | | In-process R&D | $4,000 | $10,000 | $(6,000) | | Impairment of long-lived assets | $4,220 | $- | $4,220 | | Net loss | $(97,275) | $(99,250) | $1,975 | - R&D expenses decreased by $3.1 million for the three months and $1.2 million for the nine months ended September 30, 2023, primarily due to a decrease in research and laboratory costs and collaborations, partially offset by increased facility costs[191][198][205] - General and administrative expenses increased by $0.9 million for the three months and $2.5 million for the nine months, mainly due to higher stock-based compensation, recruiting fees, and one-time charges from the Q1 2023 reduction in force[192][200] Liquidity, Capital Resources, and Capital Requirements This section discusses the company's liquidity, available capital resources, and future capital requirements, including cash flow analysis - As of September 30, 2023, the company had $55.3 million in cash and cash equivalents and $229.0 million in investments, totaling $284.3 million[204] - The company believes its current financial resources are sufficient to fund operating expenses and capital expenditures into 2026, but anticipates needing additional financing for future operations and commercialization[204][207] Cash Flow Summary (9 Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | Change | | :------------------------- | :---------- | :---------- | :---------- | | Operating activities | $(62,118) | $36,959 | $(99,077) | | Investing activities | $42,529 | $(8,855) | $51,384 | | Financing activities | $(9,369) | $27,063 | $(36,432) | | Net (decrease) increase in cash | $(28,958) | $55,167 | $(84,125) | - Operating cash flow shifted from a $37.0 million inflow in 2022 to a $62.1 million outflow in 2023, primarily due to lower deferred revenue recognition[213][214] - Investing activities provided $42.5 million in 2023, mainly from the net sale of fixed maturity securities, a reversal from $8.9 million used in 2022[215][216] - Financing activities used $9.4 million in 2023, primarily for long-term debt payments, compared to $27.1 million provided in 2022 from common stock issuance to a collaboration partner[217][219] Contractual Obligations and Commitments This section outlines the company's contractual obligations and commitments, primarily operating leases, and notes contingent payment obligations Contractual Obligations and Commitments (as of Sep 30, 2023, in thousands) | Obligation | 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | Total | | :-------------- | :----- | :----------- | :----------- | :---------------- | :---- | | Operating leases| $7,616 | $16,595 | $16,541 | $44,754 | $85,506 | - Payment obligations under license, collaboration, and acquisition agreements are contingent on future events (milestones, royalties) and are not included in the table due to uncertainty in timing and likelihood[221] JOBS Act Accounting Election This section explains the company's status as an 'emerging growth company' and 'smaller reporting company' under the JOBS Act - As an 'emerging growth company' under the JOBS Act, the company benefits from reduced reporting requirements, including an extended transition period for complying with new or revised accounting standards[223][225] - The company will remain an emerging growth company until the earliest of December 31, 2026, or meeting certain revenue or market value thresholds[226] - The company also qualifies as a 'smaller reporting company,' allowing for reduced disclosure obligations, such as presenting only two years of audited financial statements[227] Critical Accounting Policies and Significant Judgments and Estimates This section confirms no material changes to critical accounting policies or significant judgments and estimates during the reported period - There were no material changes to critical accounting policies during the nine months ended September 30, 2023, from those described in the 2022 Annual Report on Form 10-K[229] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section discusses the company's exposure to market risks, primarily interest rate sensitivities, and assesses the potential impact of banking instability and inflation - The company's primary market risk exposure is interest income sensitivity, affected by changes in U.S. interest rates, but a material impact on financial condition is not expected due to the low-risk profile of its investment portfolio[230][231] - Future disruptions of financial institutions could adversely affect access to cash and cash equivalents[232] - Inflation has not had a material effect on the company's financial statements, though it generally increases labor and consumable costs[233] Item 4. Controls and Procedures This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2023[234] - No material changes in internal control over financial reporting occurred during the three months ended September 30, 2023[235] PART II. Other Information This section provides additional information not covered in Part I, including legal proceedings, risk factors, and equity sales Item 1. Legal Proceedings This section addresses any legal proceedings the company may be involved in, noting no material adverse effects are anticipated - Management believes there are no pending claims or actions that would have a material adverse effect on the company's results of operations, financial condition, or cash flows[237] Item 1A. Risk Factors This section refers to the company's risk factors, confirming no material changes from the previously disclosed Annual Report - There have been no material changes in the company's risk factors from those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2022[238] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section details the company's IPO and unregistered sales of equity securities, confirming no material change in the planned use of proceeds - The company completed its IPO on June 22, 2021, issuing 12,132,500 shares of common stock at $20.00 per share, generating net proceeds of $221.4 million[239] - There has been no material change in the planned use of proceeds from the IPO as described in the prospectus filed on June 21, 2021[240] Item 3. Defaults Upon Senior Securities This section reports on any defaults upon senior securities, confirming that no such defaults occurred during the reported period - There were no defaults upon senior securities[242] Item 4. Mine Safety Disclosures This section provides mine safety disclosures, if applicable, confirming that this item is not relevant to the company's operations - This item is not applicable to the company[243] Item 5. Other Information This section includes any other information not covered in previous items, confirming that there is no additional information to report - There is no other information to report under this item[244] Item 6. Exhibits This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including amendments to agreements and certifications - The exhibits include amendments to license and collaboration agreements with FUJIFILM Cellular Dynamics Inc., certifications of principal executive and financial officers, and Inline XBRL documents[247]