1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: The Company has established disclosure controls and procedures designed to ensure that information required to be disclosed in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including the principal executive officer (our Chief Executive Officer) and principal financial officer (our Chief Financial Officer), to allow timely decisions regarding required disclosure.
+Added: The Company has established disclosure controls and procedures designed to ensure that information required to be disclosed in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including the principal executive officer (our Chief Executive Officer) and principal financial officer (our Chief Financial Officer), to allow timely decisions regarding required disclosure.
Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report on Form 10-K.
2 unchanged sentences
Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2023.
−Removed: Management’s Annual Report on Internal Control over Financial Reporting
+Added: Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
−Removed: Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’s board of directors, management and other personnel, to provide reasonable
−Removed: assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
+Added: Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
• Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;
• Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
−Removed: Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
+Added: • Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
2 unchanged sentences
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023.
−Removed: In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013 framework) (“COSO”).
+Added: In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013 framework) (“COSO”).
Based on its assessment, management believes that, as of December 31, 2023, our internal control over financial reporting is effective based on those criteria.
1 unchanged sentence
Changes in Internal Controls over Financial Reporting
−Removed: No change in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
+Added: No change in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
2 unchanged sentences
We have audited the internal control over financial reporting of Intellia Therapeutics, Inc.
−Removed: and subsidiary (the “Company”) as of December 31, 2022, based on criteria established in Internal Control —
−Removed: Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
−Removed: In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control —
−Removed: Integrated Framework (2013) issued by COSO.
+Added: and subsidiary (the “Company”) as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
+Added: In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2023, of the Company and our report dated February 22, 2024, expressed an unqualified opinion on those financial statements.
Basis for Opinion
−Removed: The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting.
−Removed: Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
+Added: The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting.
+Added: Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
5 unchanged sentences
Definition and Limitations of Internal Control over Financial Reporting
−Removed: A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
−Removed: A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
+Added: A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
+Added: A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
−Removed: and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
+Added: and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
4 unchanged sentences
Other Information
+Added: Rule 10b5-1 Trading Plans
+Added: During the three months ended December 31, 2023, none of the Company’s directors or officers adopted , materially modified , or terminated any contract, instruction, or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any non-Rule 10b5-1 trading arrangement.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
−Removed: Certain information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated by reference from our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders, pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, which we expect to file with the SEC no later than May 1, 2023.
+Added: Certain information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated by reference from our definitive proxy statement to be filed with the SEC with respect to our 2024 Annual Meeting of Stockholders, pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, which we expect to file with the SEC no later than April 29, 2024.
Directors, Executive Of ficers and Corporate Governance
15 unchanged sentences
Information about aggregate fees billed to us by our independent principal accountant, Deloitte & Touche LLP (PCAOB ID No.
−Removed: 34), located in Boston, Massachusetts, will be presented in our definitive proxy statement to be filed with the SEC with respect to our 2023 Annual Meeting of Stockholders under the caption “Audit Committee Matters —
−Removed: Principal Accounting Firm Fees”
−Removed: and is incorporated herein by reference.
+Added: 34), located in Boston, Massachusetts, will be presented in our definitive proxy statement to be filed with the SEC with respect to our 2024 Annual Meeting of Stockholders under the caption “Audit Committee Matters — Principal Accounting Firm Fees” and is incorporated herein by reference.
Exhibits, Financ ial Statement Schedules
4 unchanged sentences
Consolidated Statements of Operations and Comprehensive Loss
−Removed: Consolidated Statements of Stockholders’
+Added: Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
9 unchanged sentences
Consolidated Statements of Operations and Comprehensive Loss
−Removed: Consolidated Statements of Stockholders’
+Added: Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
4 unchanged sentences
We have audited the accompanying consolidated balance sheets of Intellia Therapeutics, Inc.
−Removed: and subsidiary (the "Company") as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders’
−Removed: equity, and cash flows, for each of the three years in the period ended December 31, 2022, and the related notes (collectively referred to as the "financial statements").
+Added: and subsidiary (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows, for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the "financial statements").
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
−Removed: We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control —
−Removed: Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 23, 2023, expressed an unqualified opinion on the Company's internal control over financial reporting.
+Added: We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 22, 2024, expressed an unqualified opinion on the Company’s internal control over financial reporting.
Basis for Opinion
12 unchanged sentences
The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Rewrite Asset Acquisition - Contingent Consideration Liability –
−Removed: Refer to Notes 2, 4, and 11 to the financial statements
+Added: Revenue Recognition — Collaboration Arrangements – Refer to Note 9 to the financial statements .
Critical Audit Matter Description
−Removed: In February 2022, the Company completed the acquisition of Rewrite Therapeutics, Inc.
−Removed: (“Rewrite”) and the transaction was accounted for as an asset acquisition.
−Removed: Pursuant to the terms of the agreement to acquire Rewrite (the “Rewrite Merger Agreement”), the Company may be required to make a payment to the previous stockholders and option holders of Rewrite in the form of the Company’s common stock based on the achievement of a research milestone.
−Removed: As this milestone is payable in the
−Removed: Company’s common stock, the contingent consideration qualifies as a liability under ASC 480, Distinguishing Liabilities from Equity .
−Removed: As of the acquisition date and as of December 31, 2022, the Company recorded an estimated liability for the acquisition-related contingent consideration at its fair value.
−Removed: The Company estimated the fair value using unobservable inputs by applying a probability-based valuation model.
−Removed: The key assumptions management used in the valuation model are the probability and estimated timing of achieving the research milestone.
−Removed: These assumptions are not observable in the market and therefore represent Level 3 measurements within the fair value hierarchy.
−Removed: Given that the fair value of the Rewrite contingent consideration liability is estimated based on unobservable inputs and is sensitive to changes in the probability and timing of milestone achievement, auditing the key assumptions required a high degree of auditor judgment and additional audit procedures, including the need to involve our fair value specialists.
+Added: The Company recognizes collaboration revenue on license and collaboration agreements as they fulfill their performance obligations and transfer control of goods and services to the customer.
+Added: During 2023, a customer exercised an extension (the “Extension”) for one of the customer's collaboration agreements, which resulted in management applying judgment in determining the accounting for the modified agreement, and in particular, in identifying if the promised performance obligations were distinct.
+Added: Auditing the Company’s accounting for revenues pertaining to the Extension required an increased extent of effort and a high degree of auditor judgment, due to the complex and judgmental nature of evaluating the terms and assumptions of the related Extension and the appropriate accounting for the modification under the guidance in ASC 606, Revenue from Contracts with Customers .
How the Critical Audit Matter Was Addressed in the Audit
−Removed: Our principal audit procedures related to the Rewrite contingent consideration liability included the following, among others:
−Removed: We read the Rewrite Merger Agreement and other documents related to the acquisition to understand the terms of the contingent consideration obligation and compared the contract terms to the valuation model to evaluate consistency.
−Removed: We tested the design, implementation, and effectiveness of controls over management’s review of the inputs and assumptions used in the valuation of the Rewrite contingent consideration liability, including the probability and timing of achievement of the research milestone.
−Removed: With the assistance of our fair value specialists, we evaluated the reasonableness of the valuation methodology.
−Removed: We also assessed the qualification, competence and objectivity of the external valuation professionals engaged by the Company.
−Removed: We inquired of management and the Company’s scientific personnel to understand the milestone and the underlying assumptions, including current progress of development and underlying data associated with development efforts and timing of the related milestone.
−Removed: We evaluated the reasonableness of management’s assumptions of the probability and timing of achievement of the research milestone by reviewing internal communications to management and the board of directors.
−Removed: We evaluated whether management’s assumptions used for the research milestone were consistent with evidence obtained in other areas of the audit.
+Added: Our principal audit procedures related to the Company’s revenue recognition for the Extension included the following:
+Added: • We tested the effectiveness of controls over the Company’s processes for assessing the accounting treatment of modifications to existing collaboration agreements.
+Added: • Obtained and read the Extension agreement along with the original and amended collaboration agreements and the Company’s accounting position paper for the Extension.
+Added: • We tested and evaluated, among other things, the performance obligations identified and the Company’s conclusion that the promised goods and services under the Extension are not distinct from the combined performance obligations identified in the existing arrangement.
+Added: • Performed corroborative inquiries with those overseeing the work relating to the Extension.
+Added: • We tested the mathematical accuracy of management’s calculations of revenue and the associated timing of revenue recognized in the financial statements.
/s/ Deloitte & Touche LLP
8 unchanged sentences
Marketable securities
−Removed: Accounts receivable ($ 0.3 million and $ 0.1 million from related party)
+Added: Accounts receivable ($ 0.2 million and $ 0.3 million, respectively,
+Added: from related party)
Prepaid expenses and other current assets
5 unchanged sentences
Investments and other assets
−Removed: LIABILITIES AND STOCKHOLDERS’
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
−Removed: Accrued expenses ($ 1.6 million and $ 0 million due to related party)
+Added: Accrued expenses ($ 1.0 million and $ 1.6 million, respectively, from related party)
Current portion of operating lease liability
−Removed: Current portion of deferred revenue ($ 19.9 million and $ 34.2 million from related party)
+Added: Current portion of deferred revenue ($ 0 and $ 19.9 million, respectively,
+Added: from related party)
Total current liabilities
−Removed: Deferred revenue, net of current portion ($ 0 million and $ 19.9 million from related party)
+Added: Deferred revenue, net of current portion
Long-term operating lease liability
Contingent consideration liability
+Added: Total liabilities
Commitments and contingencies (Note 8)
−Removed: Stockholders’
+Added: Stockholders’ Equity:
Common stock, $ 0.0001 par value;
−Removed: 120,000,000 shares authorized;
−Removed: 87,103,007 and 74,485,883 shares issued and outstanding at
−Removed: December 31, 2022 and 2021, respectively
+Added: 240,000,000 and 120,000,000 shares
+Added: authorized at December 31, 2023 and December 31, 2022, respectively;
+Added: 92,997,158 and 87,103,007 shares issued and outstanding at December 31, 2023
+Added: and December 31, 2022, respectively
Additional paid-in capital
1 unchanged sentence
Accumulated deficit
−Removed: Total stockholders’
−Removed: Total Liabilities and Stockholders’
−Removed: See notes to consolidated financial statements.
+Added: Total stockholders’ equity
+Added: Total Liabilities and Stockholders’ Equity
+Added: The accompanying notes are an integral part of these consolidated financial statements.
INTELLIA THERAPEUTICS, INC.
8 unchanged sentences
Operating loss
−Removed: Other (expense) income, net:
+Added: Other income (expense), net:
Interest income
1 unchanged sentence
Change in fair value of contingent consideration
−Removed: Total other (expense) income, net
+Added: Total other income (expense), net
Net loss per share, basic and diluted
1 unchanged sentence
Other comprehensive loss:
−Removed: Unrealized loss on marketable securities
−Removed: Other comprehensive loss from equity method investment
+Added: Unrealized gain (loss) on marketable securities
+Added: Other comprehensive gain (loss) from equity method
Comprehensive loss
(1) Including the following revenue from related party (see Notes 9 and 16):
−Removed: See notes to consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
INTELLIA THERAPEUTICS, INC.
−Removed: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
+Added: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Amounts in thousands, except share data)
Comprehensive
−Removed: Stockholders’
+Added: Stockholders’
Income (Loss)
2 unchanged sentences
net of issuance costs of $ 284
−Removed: Issuance of common stock to Regeneron
Issuance of common stock through at-the-market offerings, net
3 unchanged sentences
Issuance of shares under employee stock purchase plan
−Removed: Equity-based compensation
+Added: Stock-based compensation
Other comprehensive loss - unrealized loss on marketable securities
+Added: Other comprehensive loss - equity method investment
Balance at December 31, 2021
2 unchanged sentences
Issuance of common stock through at-the-market offerings, net
−Removed: of issuance costs of $ 52
+Added: of issuance costs of $ 164 - 2019 Sale Agreement
+Added: Issuance of common stock through at-the-market offerings, net
+Added: of issuance costs of $ 125 - 2022 Sale Agreement
Exercise of stock options
1 unchanged sentence
Issuance of shares under employee stock purchase plan
−Removed: Equity-based compensation
+Added: Stock-based compensation
Other comprehensive loss - unrealized loss on marketable securities
1 unchanged sentence
Balance at December 31, 2022
−Removed: Issuance of common stock through follow-on offerings,
−Removed: net of issuance costs of $ 253
Issuance of common stock through at-the-market offerings, net
of issuance costs of $ 376 - 2022 Sale Agreement
−Removed: Issuance of common stock through at-the-market offerings, net
−Removed: of issuance costs of $ 125 - 2022 Sale Agreement
+Added: Contingent consideration paid to Rewrite Holders
Exercise of stock options
1 unchanged sentence
Issuance of shares under employee stock purchase plan
−Removed: Equity-based compensation
−Removed: Other comprehensive loss - unrealized loss on marketable securities
−Removed: Other comprehensive loss - equity method investment
+Added: Stock-based compensation
+Added: Other comprehensive gain - unrealized gain on marketable securities
+Added: Other comprehensive gain - equity method investment
Balance at December 31, 2023
+Added: The accompanying notes are an integral part of these consolidated financial statements.
INTELLIA THERAPEUTICS, INC.
5 unchanged sentences
Depreciation and amortization
−Removed: (Gain) loss on disposal of property and equipment
−Removed: Equity-based compensation
−Removed: Amortization of investment premiums
+Added: Loss (gain) on disposal of property and equipment
+Added: Stock-based compensation
+Added: (Accretion) amortization of investment discounts and premiums
Loss from equity method investment
1 unchanged sentence
Change in fair value of contingent consideration
−Removed: In-process research and development charge
+Added: In-process research and development expense
Changes in operating assets and liabilities:
14 unchanged sentences
Investment in Kyverna Therapeutics, Inc.
−Removed: Net cash provided by (used in) investing activities
+Added: Net cash (used in) provided by investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Proceeds from issuance of common stock through follow-on
+Added: Net proceeds from issuance of common stock through follow-on
offerings, net of issuance costs
−Removed: Proceeds from issuance of common stock through at-the-market
+Added: Net proceeds from issuance of common stock through at-the-market
offerings, net of issuance costs
−Removed: Proceeds from issuance of common stock to Regeneron Pharmaceuticals, Inc.
Proceeds from options exercised
1 unchanged sentence
Net cash provided by financing activities
−Removed: Net increase (decrease) in cash and cash equivalents and restricted cash
−Removed: Cash and cash equivalents and restricted cash equivalents, beginning of period
−Removed: Cash and cash equivalents and restricted cash equivalents, end of period
−Removed: Reconciliation of cash and cash equivalents and restricted cash equivalents to consolidated balance sheet:
+Added: Net (decrease) increase in cash and cash equivalents and restricted cash
+Added: Cash, cash equivalents and restricted cash equivalents, beginning of period
+Added: Cash, cash equivalents and restricted cash equivalents, end of period
+Added: Reconciliation of cash, cash equivalents and restricted cash equivalents to consolidated balance sheet:
Cash and cash equivalents
Restricted cash equivalents, included in investments and other assets
−Removed: Total cash and cash equivalents and restricted cash equivalents
+Added: Total cash, cash equivalents and restricted cash equivalents
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Purchases of property and equipment unpaid at period end
+Added: Shares issued for Rewrite contingent consideration
Right-of-use assets acquired under operating leases
+Added: Proceeds from at-the-market offerings unpaid at period end
Contingent consideration liability assumed in asset acquisition
3 unchanged sentences
Non-cash contribution of intellectual property to Kyverna Therapeutics, Inc.
−Removed: See notes to consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
INTELLIA THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Nature of Operations
Intellia Therapeutics, Inc.
−Removed: (“Intellia”
−Removed: or the “Company”) is a leading clinical-stage genome editing company focused on developing potentially curative therapies using CRISPR/Cas9-based technologies.
−Removed: CRISPR/Cas9, an acronym for C lustered, R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”)/ C RISPR a ssociated 9 (“Cas9”), is a technology for genome editing, the process of altering selected sequences of genomic deoxyribonucleic acid (“DNA”).
−Removed: To fully realize the transformative potential of CRISPR/Cas9-based technologies, Intellia is building a full-spectrum genome editing company, by leveraging its modular platform, to advance in vivo and ex vivo therapies for diseases with high unmet need by pursuing two primary approaches.
−Removed: For in vivo applications to address genetic diseases, the Company deploys CRISPR/Cas9 as the therapy that targets cells within the body.
−Removed: In parallel, the Company is developing ex vivo applications to address immuno-oncology and autoimmune diseases, where we use CRISPR/Cas9 as the tool to create the engineered cell therapy.
−Removed: The Company's deep scientific, technical and clinical development experience, along with its robust intellectual property (“IP”) portfolio, have enabled it to unlock broad therapeutic applications of CRISPR/Cas9 and related technologies to create new classes of genetic medicine.
−Removed: The Company was founded and commenced active operations in mid-2014.
+Added: (“Intellia” or the “Company”) is a leading clinical-stage gene editing company, focused on developing potentially curative therapeutics using CRISPR/Cas9-based technologies.
+Added: CRISPR/Cas9, an acronym for C lustered, R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”)/ C RISPR a ssociated 9 (“Cas9”), is a technology for genome editing, the process of altering selected sequences of genomic deoxyribonucleic acid (“DNA”).
+Added: To fully realize the transformative potential of CRISPR/Cas9-based technologies, the Company is building a full-spectrum gene editing company, by leveraging its modular platform, to advance in vivo and ex vivo therapies for diseases with high unmet need by pursuing two primary approaches.
+Added: For in vivo applications to address genetic diseases, the Company deploys CRISPR/Cas9 as the therapy.
+Added: The Company’s in vivo programs use CRISPR to enable precise editing of disease-causing genes directly inside the human body.
+Added: In addition, the Company is advancing ex vivo applications to address immuno-oncology and autoimmune diseases, where it uses CRISPR/Cas9 as the tool to create the engineered cell therapy.
+Added: For its ex vivo programs, CRISPR/Cas9 is used to engineer human cells outside the body.
+Added: The Company’s deep scientific, technical and clinical development experience, along with its robust intellectual property (“IP”) portfolio, have enabled it to unlock broad therapeutic applications of CRISPR/Cas9 and related technologies to create new classes of genetic medicine.
+Added: The Company was founded and commenced active operations in 2014.
The Company will require substantial additional capital to fund its research and development.
−Removed: The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of more advanced or effective therapies, dependence on key executives, protection of and dependence on proprietary technology, compliance with government regulations and ability to secure additional capital to fund operations.
+Added: The Company is subject to risks and uncertainties common to clinical-stage companies in the biotechnology industry, including, but not limited to, development by competitors of more advanced or effective therapies, dependence on key executives, protection of and dependence on proprietary technology, compliance with government regulations and ability to secure additional capital to fund operations.
Programs currently in development or moving into development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization.
These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities.
−Removed: Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
−Removed: Since its inception through December 31, 2022, the Company has raised an aggregate of $ 2,395.2 million to fund its operations through its initial public offering (“IPO”) and concurrent private placements, follow-on public offerings, at-the-market offerings and the sale of convertible preferred stock, as well as through its collaboration agreements.
+Added: Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
+Added: Since its inception through December 31, 2023, the Company has raised an aggregate of $ 2,534.1 million to fund its operations through its initial public offering (“IPO”) and concurrent private placements, follow-on public offerings, at-the-market offerings and the sale of convertible preferred stock, as well as through its collaboration agreements.
The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2023 will enable the Company to fund its ongoing operating expenses and capital expenditure requirements for at least the twelve-month period following the issuance of these consolidated financial statements.
5 unchanged sentences
Comprehensive loss is comprised of net loss and gain/loss on marketable securities and equity method investments.
−Removed: On February 2, 2022, the Company entered into an agreement to acquire Rewrite Therapeutics, Inc., a Delaware corporation (“Rewrite”).
+Added: In February 2022, the Company entered into an agreement to acquire Rewrite Therapeutics, Inc., a Delaware corporation (“Rewrite”).
On the effective date of the agreement, Rewrite became a wholly owned subsidiary of the Company.
1 unchanged sentence
Use of Estimates
−Removed: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S.
−Removed: GAAP”) requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes.
−Removed: Significant estimates in these consolidated financial statements have been made in connection with the calculation of revenues, research and development expenses, valuation of equity and fair value method investments, contingent consideration and equity-based compensation expense.
+Added: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S.
+Added: GAAP”) requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes.
+Added: Significant estimates in these consolidated financial statements have been made in connection with the calculation of revenues, research and development expenses, valuation and determination of impairment of equity and fair value method investments, contingent consideration and stock-based compensation expense.
The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances at the time such estimates are made.
1 unchanged sentence
The Company periodically reviews its estimates in light of changes in circumstances, facts and experience.
−Removed: The extent of the impact of the coronavirus disease 19 (“COVID-19”) pandemic on the Company’s operational and financial performance will depend on certain developments, including the length and severity of this pandemic, as well as its effect on the Company's employees, collaborators and vendors, all of which are uncertain and cannot be predicted.
−Removed: The Company cannot reasonably estimate the extent to which the disruption may materially impact its consolidated results of operations or financial position.
The effects of material revisions in estimates are reflected in the consolidated financial statements prospectively from the date of the change in estimate.
Fair Value Measurements
−Removed: The Company’s financial instruments include cash equivalents, marketable securities, accounts receivable, non-marketable securities, accounts payable, accrued expenses and a contingent consideration liability.
−Removed: Certain of the Company’s financial assets, including cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services or other observable market data.
+Added: The Company’s financial instruments include cash equivalents, restricted cash equivalents, marketable securities, accounts receivable, non-marketable securities, accounts payable and accrued expenses.
+Added: Certain of the Company’s financial assets, including cash equivalents, restricted cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third party pricing services or other observable market data.
The pricing services utilize industry standard valuation models and observable market inputs to determine value.
−Removed: Refer to Note 4 for further information regarding the Company’s fair value measurements.
+Added: Investments in non-marketable securities are accounted for using the measurement alternative at cost minus impairment, adjusted for changes in observable prices.
+Added: Refer to Note 4 for further information regarding the Company’s fair value measurements.
Other financial instruments, including accounts receivable, accounts payable and accrued expenses, are carried at cost, which approximate fair value due to the short duration and term to maturity.
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The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents.
−Removed: As of December 31, 2022, cash equivalents consisted of interest-bearing money market accounts and reverse repurchase agreements.
−Removed: As of December 31, 2021, cash equivalents consisted of interest-bearing money market accounts.
+Added: As of December 31, 2023, cash equivalents consisted of interest-bearing money market accounts, U.S.
+Added: Treasury bills and other government securities.
+Added: As of December 31, 2022, cash equivalents consisted of interest-bearing money market accounts and reverse purchase agreements.
Restricted Cash Equivalents
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in some cases, the Company is able to reduce the amounts held over time.
−Removed: These restricted cash equivalents are long-term in nature and are included in “Investments and other assets”
−Removed: in the Company’s consolidated balance sheets.
+Added: These restricted cash equivalents are long-term in nature and are included in “Investments and other assets” in the Company’s consolidated balance sheets.
Marketable Securities
−Removed: The Company’s marketable securities are accounted for as available-for-sale and recorded at fair value with the related unrealized gains and losses included in accumulated other comprehensive (loss)/income, a component of stockholders’
+Added: The Company’s marketable securities are accounted for as available-for-sale and recorded at fair value with the related unrealized gains and losses included in accumulated other comprehensive (loss)/income, a component of stockholders’ equity.
The Company reviews its investment portfolio to identify and evaluate investments that have an indication of possible other-than-temporary impairment.
−Removed: Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value.
−Removed: Refer to Note 3 for further information regarding the Company’s marketable securities.
+Added: Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value.
+Added: Refer to Note 3 for further information regarding the Company’s marketable securities.
Asset Acquisitions
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Non-Marketable Equity Securities
−Removed: The Company also invests in equity securities of companies whose securities are not publicly traded and where fair value is not readily available.
+Added: The Company periodically invests in equity securities of companies whose securities are not publicly traded and where fair value is not readily available.
These investments are accounted for using the measurement alternative at cost minus impairment adjusted for changes in observable prices.
−Removed: The Company monitors these investments to evaluate whether any increase or decline in their value has occurred, based on the implied value of recent company financings and general market conditions, or if the investment has a readily determinable fair value.
−Removed: These investments are included in “Investments and other assets”
−Removed: in the Company’s consolidated balance sheets.
−Removed: Refer to Note 10 for further information regarding the Company’s investments in non-marketable equity securities.
+Added: The Company monitors these investments to evaluate whether there are any indicators of impairment, and if so determines the fair value of the investment and compares to the recorded balance, to determine if there is an impairment, or if the investment has a readily determinable fair value.
+Added: These investments are included in “Investments and other assets” in the Company’s consolidated balance sheets.
+Added: Refer to Note 10 for further information regarding the Company’s investments in non-marketable equity securities.
Concentrations of Credit Risk
−Removed: The Company’s cash, cash equivalents and marketable securities may potentially be subject to concentrations of credit risk.
+Added: The Company’s cash, cash equivalents, restricted cash equivalents and marketable securities may potentially be subject to concentrations of credit risk.
The Company generally maintains balances in various accounts in excess of federally insured limits with financial institutions that management believes to be of high credit quality.
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The Company monitors economic conditions to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection.
−Removed: As of December 31, 2022, the Company’s accounts receivable were related to its collaborations with Regeneron Pharmaceuticals, Inc.
−Removed: (“Regeneron”), AvenCell Therapeutics, Inc.
−Removed: (“AvenCell”), SparingVision SAS (“SparingVision”) and ONK Therapeutics, Ltd.
−Removed: (“ONK”).
−Removed: As of December 31, 2021, the Company’s accounts receivable were related to its collaborations with Regeneron and AvenCell.
+Added: As of December 31, 2023, the Company’s accounts receivable were related to its collaborations with Regeneron Pharmaceuticals, Inc.
+Added: (“Regeneron”), SparingVision SAS (“SparingVision”), AvenCell Therapeutics, Inc.
+Added: (“AvenCell”), and Kyverna Therapeutics, Inc.
+Added: As of December 31, 2022, the Company’s accounts receivable were related to its collaborations with Regeneron, AvenCell, SparingVision and ONK Therapeutics, Ltd.
Property and Equipment
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Leasehold improvements
−Removed: 5 years or term of respective lease, if shorter
+Added: Shorter of useful life or remaining lease term
Expenditures for repairs and maintenance of assets are expensed as incurred.
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Contingent Consideration
−Removed: The Company accounts for contingent consideration identified in an asset acquisition, that is payable in cash and does not meet the definition of a derivative under Accounting Standard Codification (“ASC”) 815, Derivatives and Hedging , when the contingency is resolved and the consideration is paid or becomes payable.
−Removed: The Company accounts for contingent consideration identified in an asset acquisition that is settled in shares of common stock under ASC 480, Distinguishing Liabilities from Equity (“ASC 480”).
+Added: The Company accounts for contingent consideration identified in an asset acquisition, that is payable in cash and does not meet the definition of a derivative under Accounting Standard Codification (“ASC”) 815, Derivatives and Hedging , when the contingency is resolved and the consideration is paid or becomes payable.
+Added: The Company accounts for contingent consideration identified in an asset acquisition that is settled in shares of common stock under ASC 480, Distinguishing Liabilities from Equity (“ASC 480”).
The contingent consideration liability will be recorded at fair value at the end of each reporting period with changes in estimated fair values recorded in other (expense) income in the consolidated statements of operations and comprehensive loss.
−Removed: The estimated fair value of the contingent consideration liability related to the acquisition of Rewrite (see Notes 4 and 11) is determined based on a probability adjusted discounted cash flow model that includes significant estimates and assumptions pertaining to research and development.
−Removed: Significant changes in any of the probabilities of success or in the probabilities as to the periods in which the milestone would be achieved would result in a significantly higher or lower fair value measurement.
−Removed: The Company will continue to adjust the liability for changes in fair value until the obligation is settled or the research is abandoned.
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences attributable to differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax reporting purposes and for operating loss and tax credit carryforwards.
Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.
−Removed: The Company’s deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which these temporary differences are expected to be recovered or settled.
+Added: The Company’s deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which these temporary differences are expected to be recovered or settled.
A valuation allowance is recorded to reduce deferred tax assets if it is determined that it is more likely than not that all or a portion of the deferred tax asset will not be realized.
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The Company records changes in the required valuation allowance in the period that the determination is made.
−Removed: The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available as of the reporting date.
+Added: The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available as of the reporting date.
For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50 % likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information.
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Revenue Recognition
−Removed: The Company recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) and its related amendments (collectively known as “ASC 606”).
+Added: The Company recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) and its related amendments (collectively known as “ASC 606”).
At inception, the Company determines whether contracts are within the scope of ASC 606 or other topics.
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and (v) recognize revenue when or as the Company satisfies a performance obligation.
−Removed: The Company only applies the five-step model to contracts when the Company determines that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration.
+Added: The Company only applies the five-step model to contracts when the Company determines that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration.
Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both capable of being distinct and are distinct in the context of the contract.
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To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method, depending on the nature of the variable consideration.
−Removed: Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.
+Added: Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.
Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes.
−Removed: Determining the transaction price requires significant judgment, which is discussed in further detail for each of the Company’s collaboration agreements in Note 9.
−Removed: In addition, none of the Company’s contracts as of December 31, 2022 or 2021 contained a significant financing component.
+Added: Determining the transaction price requires significant judgment, which is discussed in further detail for each of the Company’s collaboration agreements in Note 9.
+Added: In addition, none of the Company’s contracts as of December 31, 2023 or 2022 contained a significant financing component.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
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The Company satisfies performance obligations either over time or at a point in time.
−Removed: Revenue is recognized over time if either (i) the customer simultaneously receives and consumes the benefits provided by the entity’s performance, (ii) the entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced, or (iii) the entity’s performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date.
−Removed: If the entity does not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring the control of a promised good or service to a customer.
+Added: Revenue is recognized over time if either (i) the customer simultaneously receives and consumes the benefits provided by the entity’s performance, (ii) the entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced, or (iii) the entity’s performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date.
+Added: If the entity does not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring
+Added: the control of a promised good or service to a customer.
The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
−Removed: As of December 31, 2022, the Company’s only revenue recognized is related to collaboration agreements with third parties which are either within the scope of ASC 606, under which the Company licenses certain rights to its product candidates to third parties, or within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) if it involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards with respect to the arrangement.
+Added: As of December 31, 2023, the Company’s revenue recognized is solely related to collaboration agreements with third parties which are either within the scope of ASC 606, under which the Company licenses certain rights to its product candidates to third parties, or within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) if it involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards with respect to the arrangement.
For the collaboration arrangements under the scope of ASC 606, as discussed in further detail in Note 9, the terms of these arrangements typically include payment to the Company of one or more of the following:
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Licenses of intellectual property:
−Removed: If the license to the Company’s IP is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from consideration allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the licenses.
+Added: If the license to the Company’s IP is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from consideration allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the licenses.
For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue.
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The Company receives payments from its customers based on billing schedules or upon the achievement of milestones established in each contract.
−Removed: The Company’s contract liabilities consist of deferred revenue.
+Added: The Company’s contract liabilities consist of deferred revenue.
Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company satisfies its obligations under these arrangements.
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If the Company is an active participant and is exposed to the significant risks and rewards with respect to the arrangement, the Company accounts for the arrangement under ASC 808 .
−Removed: Based on this consideration, the Company accounts for its co-development and co-promotion (“Co/Co”) agreements with Regeneron and AvenCell under ASC 808.
−Removed: Because ASC 808 does not
−Removed: provide recognition and measurement guidance for collaborative arrangements, the Company has analogized to ASC 606.
−Removed: Refer to Note 9 for additional information regarding the Company’s collaboration agreements.
+Added: Based on this consideration, the Company accounts for its co-development agreements with Regeneron and AvenCell under ASC 808.
+Added: Because ASC 808 does not provide recognition and measurement guidance for collaborative arrangements, the Company has analogized to ASC 606.
+Added: Refer to Note 9 for additional information regarding the Company’s collaboration agreements.
Research and Development Expenses
Research and development costs are expensed as incurred.
−Removed: Research and development costs consist of expenses incurred in performing research and development activities, such as salaries, equity-based compensation and benefits of employees, allocated facility-related expenses, overhead expenses, license, sublicense and milestone fees, contract research, clinical trial costs, development and manufacturing services, and other related costs.
+Added: Research and development costs consist of expenses incurred in performing research and development activities, such as salaries, stock-based compensation and benefits of employees, allocated facility-related expenses, overhead expenses, license, sublicense and milestone fees, contract research, clinical trial costs, development and manufacturing services, and other related costs.
The Company records payments made for research and development services prior to the services being rendered as prepaid expenses on the consolidated balance sheet and expenses them as the services are provided.
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The cost of obtaining licenses for certain technology or IP is recorded to research and development expense when incurred if the licensed technology or IP has not yet reached technological feasibility and has no alternative future use.
−Removed: Equity-Based Compensation
−Removed: The Company measures employee equity-based compensation based on the grant date fair value of the equity awards using the Black-Scholes option pricing model.
−Removed: Equity-based compensation expense is recognized on a straight-line basis over the requisite service period of the awards and is adjusted for pre-vesting forfeitures in the period in which the forfeitures occur.
−Removed: For equity awards that have a performance condition, the Company recognizes stock-based compensation expense using the accelerated attribution method, based on its assessment of the probability that the performance condition will be achieved.
−Removed: The Company classifies equity-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified.
+Added: Stock-Based Compensation
+Added: The Company’s stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as an expense over the requisite service period.
+Added: The fair value of stock option grants is estimated using the Black-Scholes option pricing model.
+Added: Use of the valuation model requires management to make certain assumptions with respect to selected model inputs.
+Added: The risk-free interest rate is based on the U.S.
+Added: Treasury yield curve in effect at the time of grant for a term consistent with the expected life of the stock options.
+Added: Volatility assumptions are calculated based on historical volatility of the Company’s stock.
+Added: The Company estimates the expected term of options using the simplified method.
+Added: In addition, an expected dividend yield of zero is used in the option valuation model because the Company does not pay cash dividends and does not expect to pay any cash dividends in the foreseeable future.
+Added: Forfeitures are recorded as they occur.
+Added: The fair value of market-based restricted stock units is determined using a Monte Carlo simulation model, which uses multiple input variables to determine the probability of satisfying the market condition requirements.
+Added: For awards with service conditions only, the Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period.
+Added: For awards with service and performance-based conditions, the Company recognizes stock-based compensation expense using the graded vesting method over the requisite service period.
+Added: For awards with market-based conditions, the Company recognizes stock-based compensation expense using the accelerated attribution method over the requisite service period.
+Added: Estimates of stock-based compensation expense for an award with performance conditions are based on the probable outcome of the performance conditions and the cumulative effect of any changes in the probability outcomes are recorded in the period in which the changes occur.
+Added: The Company classifies stock-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified.
(Loss) Earnings per Share
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The Company’s chief executive officer, its chief operating decision maker, manages the Company’ s operations as a single segment for the purpose of assessing performance and making operating decisions.
−Removed: The Company’s one business segment is the development of genome editing-based therapies.
−Removed: All of the Company’s assets are held in the U.S.
−Removed: and all of the Company’s revenue has been generated in the U.S.
+Added: The Company’s one business segment is the development of genome editing-based therapies.
+Added: All of the Company’s assets are held in the U.S.
+Added: and all of the Company’s revenue has been generated in the U.S.
Variable Interest Entity
−Removed: The Company evaluates at the inception of each arrangement, and whenever a reconsideration event occurs, whether an entity in which the Company holds an investment or in which the Company has other variable interests is considered a variable interest entity (“VIE”) in accordance with FASB ASC Topic 810, Consolidation (“ASC 810”).
−Removed: If the entity meets the criteria to qualify as a VIE, the Company assesses whether or not the Company is the primary beneficiary of that VIE based on a number of factors, including (i) which party has the power to direct the activities that most significantly affect the VIE’s economic performance, (ii) the parties’
−Removed: contractual rights and responsibilities pursuant to any contractual agreements and (iii) which party has the obligation to absorb losses or the right to receive benefits from the VIE.
+Added: The Company evaluates at the inception of each arrangement, and whenever a reconsideration event occurs, whether an entity in which the Company holds an investment or in which the Company has other variable interests is considered a variable interest entity (“VIE”) in accordance with FASB ASC Topic 810, Consolidation (“ASC 810”).
+Added: If the entity meets the criteria to qualify as a VIE, the Company assesses whether or not the Company is the primary beneficiary of that VIE based on a number of factors, including (i) which party has the power to direct the activities that most significantly affect the VIE’s economic performance, (ii) the parties’ contractual rights and responsibilities pursuant to any contractual agreements and (iii) which party has the obligation to absorb losses or the right to receive benefits from the VIE.
If the Company is deemed the primary beneficiary of a VIE, the Company consolidates such entity and reflects the non-controlling interest of other beneficiaries of that entity.
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In circumstances where the Company has the ability to exercise significant influence, but not control, over the operating and financial policies of an entity in which the Company has a common stock or in-substance common stock investment, the Company utilizes the equity method of accounting for recording related investment activity.
−Removed: In assessing whether the Company exercises significant influence, the Company considers the nature and magnitude of the investment, the voting and protective rights the Company holds, any
−Removed: participation in the governance of the other entity and other relevant factors such as the presence of a collaborative or other business relationship.
−Removed: Under the equity method of accounting, the Company’s investments are initially recorded at cost on the consolidated balance sheets.
−Removed: Upon recording an equity method investment, the Company evaluates whether there are basis differences between the carrying value and fair value of the Company’s proportionate share of the investee’s underlying net assets.
−Removed: Typically, the Company amortizes basis differences identified on a straight-line basis over the underlying assets’
−Removed: estimated useful lives when calculating the attributable earnings or losses, excluding the basis differences attributable to in-process research and development (“IPR&D”) that has no alternative future use.
−Removed: If the Company is unable to attribute all of the basis difference to specific assets or liabilities of the investee, the residual excess of the cost of the investment over the proportional fair value of the investee’s assets and liabilities is considered to be Equity Method Goodwill and is recognized within the equity investment balance, which is tracked separately within the Company’s memo accounts.
+Added: In assessing whether the Company exercises significant influence, the Company considers the nature and magnitude of the investment, the voting and protective rights the Company holds, any participation in the governance of the other entity and other relevant factors such as the presence of a collaborative or other business relationship.
+Added: Under the equity method of accounting, the Company’s investments are initially recorded at cost on the consolidated balance sheets.
+Added: Upon recording an equity method investment, the Company evaluates whether there are basis differences between the carrying value and fair value of the Company’s proportionate share of the investee’s underlying net assets.
+Added: Typically, the Company amortizes basis differences identified on a straight-line basis over the underlying assets’ estimated useful lives when calculating the attributable earnings or losses, excluding the basis differences attributable to in-process research and development (“IPR&D”) that has no alternative future use.
+Added: If the Company is unable to attribute all of the basis difference to specific assets or liabilities of the investee, the residual excess of the cost of the investment over the proportional fair value of the investee’s assets and liabilities is considered to be Equity Method Goodwill and is recognized within the equity investment balance, which is tracked separately within the Company’s memo accounts.
The Company subsequently records in the consolidated statements of operations and comprehensive loss its share of income or loss of the other entity within other income/expense.
−Removed: If the share of losses exceeds the carrying value of the Company’s investment, the Company will suspend recognizing additional losses and will continue to do so unless it commits to providing additional funding;
+Added: If the share of losses exceeds the carrying value of the Company’s investment, the Company will suspend recognizing additional losses and will continue to do so unless it commits to providing additional funding;
however, if there are intra-entity profits this can cause the investment balance to go negative.
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Refer to Note 10 for further details.
−Removed: Recent Accounting Pronouncements
−Removed: There were no accounting pronouncements adopted by the Company in 2022 other than as noted above.
+Added: Recently Adopted Accounting Pronouncements
+Added: There were no accounting pronouncements adopted by the Company in 2023.
+Added: Recent Issued Accounting Pronouncements Not Yet Effective
+Added: In November 2023, the FASB issued ASU No.
+Added: 2023-07, “Segment Reporting - Improvements to Reportable Segment Disclosures.” The amendments require disclosure of incremental segment information on an annual and interim basis.
+Added: The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in ASC 280, “Segment Reporting.” The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024.
+Added: The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
+Added: In December 2023, the FASB issued ASU No.
+Added: 2023-09, “Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.” This ASU updates income tax disclosure requirements primarily by requiring specific categories and greater disaggregation within the rate reconciliation and disaggregation of income taxes paid by jurisdiction.
+Added: This ASU is effective for annual periods beginning after December 15, 2024 and is applicable to the Company’s fiscal year beginning January 1, 2025, with early application permitted.
+Added: The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
Marketable Securities
−Removed: The following table summarizes the Company’s available-for-sale marketable securities as of December 31, 2022 and 2021 at net book value:
+Added: The following table summarizes the Company’s available-for-sale marketable securities:
December 31, 2023
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Marketable securities:
−Removed: Treasury and other government securities
+Added: Treasury and other government-backed securities
Financial institution debt securities
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Marketable securities:
−Removed: Treasury and other government securities
+Added: Treasury and other government-backed securities
Financial institution debt securities
2 unchanged sentences
The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity.
−Removed: At December 31, 2022 and 2021, the balance in the Company’s accumulated other comprehensive (loss)/income was composed of activity related to the Company’s available-for-sale marketable securities and equity method investment.
+Added: At December 31, 2023 and 2022, the balance in the Company’s accumulated other comprehensive loss was composed of activity related to the Company’s available-for-sale marketable securities and equity method investment.
There were no material realized gains or losses in the years ended December 31, 2023, 2022 or 2021.
−Removed: The Company did not reclassify any amounts out of accumulated other comprehensive income (loss) during these periods.
+Added: The Company did not reclassify any amounts out of accumulated other comprehensive loss during these periods.
T he Company generally does not intend to sell any investments prior to recovery of their amortized cost basis for any investment in an unrealized loss position.
−Removed: As such, the Company has classified these losses as temporary in nature.
−Removed: The Company's available-for-sale securities that are classified as short-term marketable securities in the consolidated balance sheet mature within one year or less as of the balance sheet date.
−Removed: Available-for-sale securities that are classified as noncurrent in the consolidated balance sheet are those that mature after one year but within five years from the balance sheet date and that the Company does not intend to dispose of within the next twelve months.
+Added: As such, the Company has classified these unrealized losses as temporary in nature.
+Added: The Company’ s available-for-sale securities that are classified as current marketable securities in the consolidated balance sheet mature within one year or less as of the balance sheet date.
+Added: Available-for-sale securities that are classified as noncurrent marketable securities in the consolidated balance sheet are those that mature after one year but within five years from the balance sheet date and that the Company does not intend to dispose of within the next twelve months.
At December 31, 2023 and 2022, the Company did no t hold any investments that matured beyond five years of the balance sheet date.
+Added: Accrued interest on marketable securities is included in “Prepaid expenses and other current assets” on the Company's consolidated balance sheets.
Fair Value Measurements
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and Level 3, unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
−Removed: As of December 31, 2022 and 2021, the Company’s financial assets recognized at fair value on a recurring basis consisted of the following:
+Added: The Company’s financial assets and liabilities recognized at fair value on a recurring basis consisted of the following:
Fair Value as of December 31, 2023
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Marketable securities:
−Removed: Treasury and other government securities
+Added: Treasury and other government-backed securities
Financial institution debt securities
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Marketable securities:
−Removed: Treasury and other government securities
+Added: Treasury and other government-backed securities
Financial institution debt securities
2 unchanged sentences
Total marketable securities
−Removed: Certain of the Company’s financial assets, including cash equivalents, restricted cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services or other observable market data.
+Added: Contingent consideration
+Added: Certain of the Company’s financial assets, including cash equivalents, restricted cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third party pricing services or other observable market data.
The pricing services utilize industry standard valuation models and observable market inputs to determine value.
−Removed: After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by the pricing services as of December 31, 2022 or 2021.
Other financial instruments, including accounts receivable, accounts payable and accrued expense, are carried at cost, which approximates fair value due to the short duration and term to maturity.
−Removed: The Company's investment in AvenCell was initially recorded at fair value, determined according to Level 3 inputs in the fair value hierarchy described above.
+Added: Level 3 Assets and Liabilities
+Added: Equity-Method Investments
+Added: The Company’s equity-method investment in AvenCell is classified as a Level 3 asset and is not included in the fair value table above as it is not valued at fair value on a recurring basis.
Refer to Note 10 for further details.
+Added: The carrying value of the Company’s equity-method investment as of December 31, 2023 and 2022 was $ 11.8 million and $ 32.5 million, respectively.
+Added: Other Investments
+Added: The Company’s other investments are classified as Level 3 assets and are not included in the fair value table above as they are not valued at fair value on a recurring basis .
The Company’s investment in SparingVision was initially recorded at fair value, determined according to Level 3 inputs in the fair value hierarchy described above.
−Removed: The Company's investment in Kyverna Therapeutics, Inc.
−Removed: (“Kyverna”) was initially recorded at cost, which is representative of fair value.
+Added: The SparingVision investment is included in “Investments and other assets” on the consolidated balance sheets.
+Added: This investment is accounted for using the measurement alternative at cost minus impairment adjusted for changes in observable prices.
+Added: There were no changes in observable prices or impairment of this investment as of December 31, 2023 or 2022.
+Added: The carrying value of the SparingVision investment was $ 14.8 million as of December 31, 2023 and 2022.
Refer to Note 10 for further details.
−Removed: The SparingVision and Kyverna investments (the “investments”) are included in “Investments and other assets”
−Removed: on the consolidated balance sheets.
−Removed: These investments are accounted for using the measurement alternative at cost minus impairment adjusted for changes in observable prices.
−Removed: There were no changes in observable prices of these investments as of December 31, 2022 or 2021.
−Removed: As discussed further in Note 11, under the Rewrite Merger Agreement, the Rewrite Holders are eligible to receive a $ 25.0 million research milestone payment, payable in a combination of cash and the Company’s common stock valued using the volume-weighted average price of the Company’s stock over the ten-day trading period ending two trading days prior to the date on which the applicable milestone is achieved.
−Removed: The milestone payable in the Company’s common stock results in liability classification under ASC 480.
−Removed: This contingent consideration liability is carried at fair value which was estimated by applying a probability-based model, which utilized inputs based on timing of achievement that were unobservable in the market.
−Removed: The contingent consideration liability is classified within Level 3 of the fair value hierarchy.
−Removed: The following table reconciles the change in fair value of the contingent consideration liability based on the level 3 inputs listed below (in thousands):
−Removed: For the year ended December 31, 2022
+Added: The Company’s investment in Kyverna was initially recorded at cost, which is representative of fair value.
+Added: The Kyverna investment is included in “Investments and other assets” on the consolidated balance sheets.
+Added: This investment is accounted for using the measurement alternative at cost minus impairment adjusted for changes in observable prices.
+Added: There were no changes in observable prices or impairment of this investment as of December 31, 2023 or 2022.
+Added: The carrying value of the Kyverna investment was $ 10.0 million as of December 31, 2023 and 2022.
+Added: Refer to Note 10 for further details.
+Added: Contingent Consideration
+Added: As discussed further in Note 11, as part of its acquisition of Rewrite, the Company made a $ 25.0 million research milestone payment in February of 2023, payable in a combination of $ 0.9 million in cash and the remainder in the Company’s common stock.
+Added: The milestone payable in the Company’s common stock resulted in liability classification under ASC 480.
+Added: This contingent consideration liability was carried at fair value which was estimated by applying a probability-based model, which utilized inputs based on timing of achievements that were unobservable in the market.
+Added: The contingent consideration liability was classified within Level 3 of the fair value hierarchy until it was settled in February of 2023.
+Added: The following table reconciles the change in fair value of the contingent consideration liability based on the level 3 inputs listed below for the years ended December 31, 2023 and 2022 (in thousands):
Balance at February 2, 2022 (at inception)
1 unchanged sentence
Balance at December 31, 2022
+Added: Change in fair value
+Added: Payment of contingent consideration
+Added: Balance at December 31, 2023
As of inception (February 2, 2022)
21 unchanged sentences
Accrued legal and professional expenses
+Added: Accrued construction costs
Accrued other
1 unchanged sentence
The Company did not record net income tax benefits for the operating losses incurred during the periods presented due to the uncertainty of realizing a tax benefit from those losses.
−Removed: Accordingly, any benefit recorded related to these deferred tax assets was offset by a valuation allowance reflecting management’s conclusion that realization of those assets was not more likely than not.
−Removed: A reconciliation of the federal statutory income tax rate and the Company’s effective income tax rate is as follows:
+Added: Accordingly, any benefit recorded related to these deferred tax assets was offset by a valuation allowance reflecting management’s conclusion that realization of those assets was not more likely than not.
+Added: A reconciliation of the federal statutory income tax rate and the Company’s effective income tax rate is as follows:
Year Ended December 31,
3 unchanged sentences
Stock-based compensation
+Added: Non-deductible officers' compensation
In-process research and development
1 unchanged sentence
Effective income tax rate
−Removed: The Company’s net deferred tax assets (liabilities) consisted of the following:
+Added: The Company’s net deferred tax assets (liabilities) consisted of the following:
(in thousands)
Deferred tax assets:
−Removed: Intangibles, including acquired in-process
−Removed: research and development
−Removed: Capitalized start-up costs
Net operating loss carryforwards
Research and development credit carryforwards
+Added: Section 174 capitalized research
Operating lease liability
Deferred revenue
−Removed: Equity-based compensation
+Added: Stock-based compensation
Accruals and allowances
Equity investment adjustments
+Added: Intangibles, including in-process research and development
+Added: Capitalized start-up costs
Gross deferred tax assets
5 unchanged sentences
Net deferred tax asset (liability)
+Added: The Tax Cuts and Jobs Act (“TCJA” ) requires taxpayers to capitalize and amortize, rather than deduct, research and development expenditures under section 174 for tax years beginning after December 31, 2021.
+Added: These rules became effective for the Company during the year ended December 31, 2022.
+Added: As a result, the Company has capitalized research and development costs of $ 322.6 million and $ 365.8 million for the years ended December 31, 2022 and December 31, 2023, respectively.
+Added: The Company will amortize these costs for tax purposes over 5 years if the research and development was performed in the U.S.
+Added: and over 15 years if the research and development was performed outside the U.S.
As of December 31, 2023 and 2022, the Company had federal net operating loss carryforwards of $ 954.0 million and $ 852.1 million, respectively, which may be available to offset future income tax liabilities.
Approximately $ 36.9 million of the federal net operating losses generated prior to 2018 will begin to expire in 2034 , unless previously utilized.
−Removed: Losses incurred prior to 2018 will generally be deductible to the extent of the lesser of a corporation’s net operating loss carryover or 100 % of a corporation’s taxable income and be available for twenty years from the period the loss was generated.
−Removed: The federal net operating losses generated after 2017 of approximately $ 815.2 million will be carried over indefinitely, but will generally limit the net operating loss deduction to the lesser of the net operating loss carryforward or 80 % of a corporation’s taxable income (subject to Section 382 of the Internal Revenue Code of 1986, as amended).
+Added: Losses incurred prior to 2018 will generally be deductible to the extent of the lesser of a corporation’s net operating loss carryover or 100 % of a corporation’s taxable income and be available for twenty years from the period the loss was generated.
+Added: The federal net operating losses generated after 2017 of approximately $ 917.1 million will be carried over indefinitely, but will generally
+Added: limit the net operating loss deduction to the lesser of the net operating loss carryforward or 80 % of a corporation’s taxable income (subject to Section 382 of the Internal Revenue Code of 1986, as amended).
Also, there will be no carryback for losses incurred after 2017.
−Removed: On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, (the “CARES Act”) was enacted in the U.S.
−Removed: The CARES Act temporarily removes the 80 % limit for taxable years beginning before 2021 to allow a net operating loss carryforward to fully offset an organization’s income.
−Removed: The CARES Act allows a five-year carryback of any net operating loss generated in a taxable year beginning after December 31, 2017, and before January 1, 2021.
−Removed: The impact of the CARES Act was not material to the Company.
−Removed: As of December 31, 2022 and 2021, the Company also had state net operating loss carryforwards of $797.
−Removed: 8 million and $ 767.8 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2034 .
+Added: As of December 31, 2023 and 2022, the Company also had state net operating loss carryforwards of $ 922.8 million and $ 797.8 million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2034 .
As of December 31, 2023 and 2022, the Company had federal tax credit carryforwards of approximately $ 100.7 million and $ 63.4 million, respectively, which begin to expire in 2034 .
5 unchanged sentences
Ownership changes may limit the amount of net operating loss carryforwards or research and development tax credit carryforwards that can be utilized to offset future taxable income or tax liability.
−Removed: In general, an ownership change, as defined by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period.
+Added: In general, an ownership change, as defined by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period.
If the Company has experienced a change of control, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382 and 383 of the Code.
Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization.
−Removed: During 2022, the Company completed an assessment of the available net operating loss carryforwards and other tax attributes under Section 382.
−Removed: The analysis is not expected to result in a material limitation to the Company’s tax attributes and the results of this analysis are reflected herein.
+Added: During 2022, the Company completed an assessment of the available net operating loss carryforwards and other tax attributes under Section 382 that covered the period from inception through December 31, 2022.
+Added: The analysis did not result in a material limitation to the Company’s tax attributes and the results of this analysis are reflected herein.
+Added: The Company has not completed an analysis through December 31, 2023.
+Added: To the extent there was a change in control during 2023, the Company's tax attributes could be subject to limitation.
+Added: However, a full valuation allowance has been provided against the deferred tax assets related to the Company’s net operating loss and tax credit carryforwards and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance.
As of December 31, 2023 , the Company had no t identified any unrecognized tax benefits.
+Added: The Company will recognize interest and/or penalties related to uncertain tax benefits in income tax expense if they arise.
The Company files income tax returns in the U.S.
1 unchanged sentence
The Company is subject to examination by the Internal Revenue Service, Massachusetts taxing authorities and state taxing authorities for tax year 2020 through present.
+Added: To the extent that the Company has tax attribute carryforwards, the tax year in which the attributes were generated may still be adjusted upon examination by the Internal Revenue Service or State taxing authorities to the extent utilized in a future period.
The returns in these jurisdictions since inception remain open for examination;
however, there are currently no pending tax examinations.
−Removed: The Company will recognize interest and/or penalties related to uncertain tax benefits in income tax expense if they arise.
Commitments and Contingencies
−Removed: During the year ended December 31, 2022, there have been no material changes to any outstanding litigation, nor is the Company a party to any new litigation.
+Added: From time to time, the Company is involved in legal and administrative proceedings and claims of various types.
+Added: In some actions, the claimants seek damages, as well as other relief, which, if granted, would require significant expenditures.
+Added: The Company records a liability in its consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated.
+Added: The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate.
+Added: If a matter is both probable to result in a liability to the Company and the amount of the loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss.
+Added: If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements.
+Added: During the year ended December 31, 2023, there have been no material changes to any outstanding litigation, nor is the Company a party to any significant new litigation.
License Agreements
3 unchanged sentences
Collaborations and Other Arrangements
−Removed: To accelerate the development and commercialization of CRISPR-based products in multiple therapeutic areas, the Company has formed, and intends to seek other opportunities to form, strategic alliances with collaborators who can augment its leadership in CRISPR therapeutic development.
−Removed: As of December 31, 2022, the Company’s accounts receivable were related to its collaborations with Regeneron, AvenCell, SparingVision and ONK and the Company's contract liabilities were related to its collaborations with Regeneron, AvenCell, SparingVision and Kyverna.
−Removed: As of December 31, 2021, the Company’s accounts receivable were related to its collaborations with Regeneron and AvenCell and the Company's contract liabilities were related to its collaborations with Regeneron, AvenCell, SparingVision and Kyverna.
−Removed: The following table presents changes in the Company’s accounts receivable and contract liabilities during the years ended December 31, 2022 and 2021 (in thousands):
+Added: To accelerate the development and commercialization of CRISPR/Cas9-based products in multiple therapeutic areas, the Company has formed, and intends to seek other opportunities to form, strategic alliances with collaborators who can augment its leadership in CRISPR/Cas9 therapeutic development.
+Added: As of December 31, 2023, the Company’s accounts receivable were related to its collaborations with Regeneron, SparingVision, AvenCell and Kyverna and the Company’s contract liabilities were related to its collaborations with Regeneron and SparingVision.
+Added: As of December 31, 2022, the Company’s accounts receivable were related to its collaborations with Regeneron, AvenCell, SparingVision and ONK and the Company’s contract liabilities were related to its collaborations with Regeneron, AvenCell, SparingVision and Kyverna.
+Added: The following table presents changes in the Company’s accounts receivable and contract liabilities (in thousands):
Balance at End
6 unchanged sentences
Contract liabilities - deferred revenue
−Removed: During the years ended December 31, 2022, 2021 and 2020, the Company recognized the following revenues as a result of changes in the contract liability balance (in thousands):
+Added: T he Company recognized the following revenues as a result of changes in the contract liability balance (in thousands):
Revenue recognized in the period from:
4 unchanged sentences
Costs to obtain and fulfill a contract
−Removed: The Company did not incur any expenses to obtain collaboration agreements and costs to fulfill those contracts do not generate or enhance resources of the Company.
+Added: The Company has not incurred significant expenses to obtain collaboration agreements and costs to fulfill those contracts do not generate or enhance resources of the Company.
As such, no costs to obtain or fulfill a contract have been capitalized in any period.
Regeneron Pharmaceuticals, Inc.
−Removed: In April 2016, the Company entered into a license and collaboration agreement with Regeneron (the “2016 Regeneron Agreement”).
+Added: In April 2016, the Company entered into a license and collaboration agreement with Regeneron (as amended from time to time, the “2016 Regeneron Agreement”).
The 2016 Regeneron Agreement has two principal components:
−Removed: i) a product development component under which the parties will research, develop and commercialize CRISPR/Cas-based therapeutic products primarily focused on genome editing in the liver, and ii) a technology collaboration component, pursuant to which the Company and Regeneron will engage in research-related activities aimed at discovering and developing novel technologies and improvements to CRISPR/Cas technology to enhance the Company’s genome editing platform.
−Removed: Under this agreement, the Company also may access the Regeneron Genetics Center and proprietary mouse models to be provided by Regeneron for a limited number of the Company’s liver programs.
−Removed: At the inception of the 2016 Regeneron Agreement, Regeneron selected the first of its 10 targets, transthyretin (“ATTR”) amyloidosis, which is subject to a co-development and co-promotion agreement between the Company and Regeneron (the “ATTR Co/Co”).
−Removed: On May 30, 2020, the Company entered into (i) amendment no.
−Removed: 1 (the “2020 Regeneron Amendment”) to the 2016 Regeneron Agreement, (ii) co-development and co-funding agreements for the treatment of hemophilia A and hemophilia B (the “Hemophilia Co/Co”) agreements and (iii) a stock purchase agreement.
+Added: i) a product development component under which the parties will research, develop and commercialize CRISPR/Cas-based therapeutic products primarily focused on genome editing in the liver, and ii) a technology collaboration component, pursuant to which the Company and Regeneron will engage in research-related activities aimed at discovering and developing novel technologies and improvements to CRISPR/Cas technology to enhance the Company’s genome editing platform.
+Added: Under this agreement, the Company also may access the Regeneron Genetics Center and proprietary mouse models to be provided by Regeneron for a limited number of the Company’s liver programs.
+Added: At the inception of the 2016 Regeneron Agreement, Regeneron selected the first of its 10 targets, transthyretin (“ATTR”) amyloidosis, which is subject to a co-development and co-promotion agreement between the Company and Regeneron (the “ATTR Co/Co”).
+Added: In connection with the 2016 Regeneron Agreement, the Company received a nonrefundable upfront payment of $ 75.0 million.
+Added: In addition, on Regeneron programs that are not subject to Co/Co agreements, the Company may be eligible to earn, on a per-licensed target basis, (i) up to $ 25.0 million in development milestones, including for the dosing of the first patient in each of Phase I, Phase II and Phase III clinical trials, (ii) up to $ 110.0 million in regulatory milestones, including for the acceptance of a regulatory filing in the U.S., and for obtaining regulatory approval in the U.S.
+Added: and in certain other identified countries, and (iii) up to $ 185.0 million in sales-based milestone payments.
+Added: The Company is also eligible to earn royalties ranging from the high-single digits to low teens, in each case, on a per-product basis, which royalties are potentially subject to various reductions and offsets and incorporate the Company’s existing
+Added: low- to mid-single-digit royalty obligations under a license agreement with Caribou.
+Added: In connection with the 2016 Regeneron Agreement, Regeneron purchased $ 50.0 million of the Company’s common stock in a private placement under a stock purchase agreement concurrent with the Company’s IPO.
+Added: In May 2020, the Company entered into (i) amendment no.
+Added: 1 (the “2020 Regeneron Amendment”) to the 2016 Regeneron Agreement, (ii) co-development and co-funding agreements for the treatment of hemophilia A and hemophilia B (the “Hemophilia Co/Co”) agreements and (iii) a stock purchase agreement.
The collaboration expansion builds upon the jointly developed targeted transgene insertion capabilities designed to durably restore missing therapeutic protein, and to overcome the limitations of traditional gene therapy.
−Removed: The collaboration was extended until April 2024, at which point Regeneron has an option to renew for an additional two years.
−Removed: The 2020 Regeneron Amendment also grants Regeneron exclusive rights to develop products for five additional in vivo CRISPR/Cas-based therapeutic liver targets and non-exclusive rights to independently develop and commercialize up to 10 ex vivo gene edited products made using certain defined cell types.
−Removed: Since December 31, 2021, there have been no material changes to the key terms of the 2016 Regeneron Agreement and the 2020 Regeneron Amendment (the “Amended Agreements”).
−Removed: For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2021.
+Added: The technology collaboration was extended until April 2024, at which point Regeneron would have an option to renew for an additional two years.
+Added: The 2020 Regeneron Amendment also granted Regeneron exclusive rights to develop products for five additional in vivo CRISPR/Cas-based therapeutic liver targets and non-exclusive rights to independently develop and commercialize up to 10 ex vivo gene edited products made using certain defined cell types.
+Added: As part of the consideration for the 2020 Regeneron Amendment, Regeneron paid the Company an upfront payment of $ 70.0 million, which included the $ 25.0 million fee to extend the Technology Collaboration Term, as defined in the 2016 Regeneron Agreement, to April 2024 .
+Added: The potential future milestones and royalties remain unchanged from the 2016 Regeneron Agreement.
+Added: In addition, on May 30, 2020 , the Company and Regeneron entered into the 2020 Stock Purchase Agreement.
+Added: Under the 2020 Stock Purchase Agreement, the Company sold to Regeneron 925,218 shares of its common stock, par value $ 0.0001 per share, for aggregate cash consideration of $ 30.0 million, or $ 32.42 per share (the “Equity Transaction”), representing a 100 % premium over the volume-weighted average trading price of the Company’s common stock during the 30-day period prior to the closing of the Equity Transaction.
+Added: Under the 2020 Stock Purchase Agreement, Regeneron will not dispose of any shares of common stock it beneficially owns in the Company until the termination of the Technology Collaboration Term.
+Added: In October 2023, Regeneron notified the Company that it was exercising its one-time option to extend the Technology Collaboration Term for an additional two years (the “2024 Technology Collaboration Extension”) , until April 2026 , in exchange for a nonrefundable payment of $ 30.0 million due in April 2024.
+Added: 2024 Technology Collaboration Extension:
+Added: Accounting Analysis.
+Added: The 2024 Technology Collaboration Extension was accounted for as a contract modification.
+Added: The promised goods and services under the 2024 Technology Collaboration Extension are not distinct from the combined performance obligations identified in the 2020 Regeneron Amendment, which was only partially satisfied at the date of option exercise.
+Added: A cumulative catch-up adjustment was recorded during the fourth quarter of 2023 resulting in a charge of $ 10.3 million against revenue previously recognized.
+Added: The transaction price of the 2024 Technology Collaboration Extension was determined to be $ 51.7 million, which is comprised of the $ 11.4 million remaining consideration under the 2020 Regeneron Amendment as of the modification date, the $ 30.0 million extension fee and the $ 10.3 million cumulative catch-up adjustment.
+Added: The $ 51.7 million transaction price was allocated to the performance obligations including the licenses to targets and associated research activities and evaluation plans and the combined performance obligation including the technology collaboration and associated research activities, on a relative standalone selling price basis.
+Added: As a result of this evaluation, the Company allocated $ 48.3 million to the combined performance obligation including the licenses to targets and associated research activities and evaluation plans and $ 3.4 million to the combined performance obligation including the technology collaboration and associated research activities, which are being recognized using a time elapsed inputs method from the October 2023 extension date through April 2026, the remaining period of the collaboration.
+Added: ATTR and Hemophilia Co/Co Agreements:
+Added: Accounting Analysis.
+Added: The Company concluded that the ATTR Co/Co and Hemophilia Co/Co agreements meet the definition of a collaborative arrangement per ASC 808, which is outside of the scope of ASC 606.
+Added: Since ASC 808 does not provide recognition and measurement guidance for collaborative arrangements, the Company has analogized to ASC 606.
+Added: As such, the Company classifies cumulative amounts paid or received under the cost sharing provisions of the ATTR Co/Co and the Hemophilia Co/Co agreements as a component of revenues in the consolidated statements of operations and comprehensive loss, to the extent that this does not result in a cumulative “negative revenue” amount, in which case the cumulative shortfall would be reclassified as an expense.
+Added: In September 2023, Regeneron and Intellia further expanded the research collaboration (the “2023 Regeneron Amendment”) to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases.
+Added: The collaboration will leverage Intellia’s proprietary Nme2 CRISPR/Cas9 genome editing systems adapted for viral vector delivery and designed to precisely modify a target gene and Regeneron’s proprietary antibody-targeted adeno-associated virus vectors and delivery systems.
+Added: Under the terms of the expanded research collaboration, the companies will initially research two in vivo non-liver targets.
+Added: Intellia will lead the design of the editing methodology and Regeneron will lead the design of the targeted viral vector delivery approach and the parties will share research costs equally.
+Added: Each party will have the opportunity to lead potential development and commercialization for one product candidate, and
+Added: the party that is not leading development and commercialization will have the option to enter into a co-development and co-promotion agreement for the target.
+Added: 2023 Regeneron Amendment:
+Added: Accounting Analysis .
+Added: The Company concluded that the accounting for the 2023 Regeneron Amendment is within the scope of ASC 606.
+Added: The Company identified one performance obligation, the transfer of the license and performance of collaborative research and development activities.
+Added: There is no upfront consideration related to the 2023 Regeneron Amendment.
+Added: As the 2023 Regeneron Amendment progresses, the Company and Regeneron will share research costs equally.
+Added: Any cost reimbursements received from Regeneron will be recorded as a component of revenue and any payments made to Regeneron will be recorded as a reduction of revenue.
+Added: Since December 31, 2022, there have been no material changes to the key terms of the 2016 Regeneron Agreement, ATTR Co/Co or Hemophilia Co/Co (the “Regeneron Agreements”), other than as described above.
+Added: For further information on the terms and conditions of these agreements, see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2022.
Revenue Recognition:
Collaboration Revenue.
−Removed: Through December 31, 2022, excluding amounts allocated to Regeneron’s purchase of the Company’s common stock, the Company recorded $ 145.0 million in upfront payments under the Amended Agreements and $ 39.5 million for research and development services, primarily under the ATTR Co/Co agreement.
−Removed: Through December 31, 2022 , the Company has recognized $ 173.1 million of collaboration revenue under all arrangements, including $ 24.1 million, $ 25.7 million and $ 53.0 million of collaboration revenue in the years ended December 31, 2022, 2021 and 2020, respectively, in the consolidated statements of operations and comprehensive loss.
−Removed: This includes $ 11.9 million, $ 5.9 million, and $ 10.7 million, respectively, primarily representing payments due
−Removed: from Regeneron pursuant to the ATTR Co/Co agreement.
−Removed: These revenues are offset in part by contra-revenue related to the Hemophilia Co/Co agreements amounting to $ 10.4 million in the year ended December 31, 2022, $ 2.7 million in the year ended December 31, 2021 and $ 0 million in the year ended December 31, 2020.
−Removed: As of December 31, 2022, there was approximately $ 28.8 million of the aggregate transaction price of the Amended Agreements remaining to be recognized, which the Company expects to be recognized during the research term through April 2024.
−Removed: As of December 31, 2022 and 2021, the Company had accounts receivable of $ 3.2 million and $ 2.0 million, respectively, and deferred revenue of $ 28.8 million and $ 51.4 million, respectively, related to the Amended Agreements.
+Added: The Company recognized $ 21.0 million, $ 24.1 million and $ 25.7 million of collaboration revenue in the years ended December 31, 2023, 2022 and 2021, respectively, in the consolidated statements of operations and comprehensive loss.
+Added: This includes $ 19.6 million, $ 11.9 million, and $ 5.9 million, respectively, primarily representing payments due from Regeneron pursuant to the ATTR Co/Co agreement.
+Added: These revenues are offset in part by contra-revenue related to the Hemophilia Co/Co agreements amounting to approximately $ 10.7 million in the year ended December 31, 2023, $ 10.4 million in the year ended December 31, 2022 and $ 2.7 million in the year ended December 31, 2021.
+Added: As of December 31, 2023, there was approximately $ 47.1 million of the aggregate transaction price remaining to be recognized that will be recognized through April 2026, the remaining period of the collaboration.
+Added: As of December 31, 2023 and 2022, the Company had accounts receivable of $ 35.7 million and $ 3.2 million, respectively, and deferred revenue of $ 47.1 million and $ 28.8 million, respectively, related to the Regeneron Agreements.
AvenCell Therapeutics, Inc.
−Removed: On July 30, 2021 (the “Effective Date”), the Company entered into two agreements with AvenCell, a privately held chimeric antigen receptor T (“CAR-T”) cell therapy company formed on that date in a joint venture between the Company, Cellex Cell Professionals GmbH (“Cellex”) and funds managed by Blackstone Life Sciences Advisors L.L.C.
−Removed: (“BXLS”):
−Removed: (i) a license and collaboration agreement (the “AvenCell LCA”), under which the Company will collaborate to develop allogeneic universal CAR-T cell therapies and which granted AvenCell a license to develop and commercialize genome edited universal CAR-T cell therapies (limited to its use with their switchable, universal CAR-T cell UniCAR and RevCAR platforms);
−Removed: and (ii) a co-development and co-funding agreement (the “AvenCell Co/Co”), under which the Company will co-develop and co-commercialize allogeneic universal CAR-T cell products for an immuno-oncology indication.
−Removed: Since December 31, 2021, there have been no material changes to the key terms of the AvenCell LCA and AvenCell Co/Co agreements.
+Added: In July 2021, the Company entered into two agreements with AvenCell, a privately held chimeric antigen receptor T (“CAR-T”) cell therapy company formed on that date in a joint venture between the Company, Cellex Cell Professionals GmbH (“Cellex”) and funds managed by Blackstone Life Sciences Advisors L.L.C.
+Added: (i) a license and collaboration agreement (the “AvenCell LCA”), under which the Company will collaborate to develop allogeneic universal CAR-T cell therapies and which granted AvenCell a license to develop and commercialize genome edited universal CAR-T cell therapies (limited to its use with their switchable, universal CAR-T cell UniCAR and RevCAR platforms);
+Added: and (ii) a co-development and co-funding agreement (the “AvenCell Co/Co”), under which the Company will co-develop and co-commercialize allogeneic universal CAR-T cell products for an immuno-oncology indication.
In November 2022, the Company decided to re-prioritize its ex vivo programs and terminated the AvenCell Co/Co, effectively turning over control of the program to AvenCell.
−Removed: The Company will also have one option to enter into an additional co-development and co-funding agreement for a payment of $ 30.0 million to AvenCell.
−Removed: For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company's Annual Report for the year ended December 31, 2021.
−Removed: Revenue Recognition –
−Removed: Collaboration Revenue.
−Removed: The Company recognized $ 22.8 million and $ 5.9 million in revenue related to the AvenCell LCA for the years ended December 31, 2022 and 2021, respectively, after eliminating $ 11.4 million and $ 2.9 million in intra-entity profits during those respective periods.
−Removed: The elimination of intra-entity profits results in the deferral of revenue that will be recognized if and when AvenCell commercializes a product with the Company's license or abandons the related project.
+Added: The Company’s obligations under the terminated agreement were completed in the second quarter of 2023.
+Added: Since December 31, 2022, there have been no other material changes to the key terms of the AvenCell LCA and AvenCell Co/Co agreements.
+Added: Revenue Recognition – Collaboration Revenue.
+Added: The Company recognized $ 13.2 million, $ 22.8 million and $ 5.9 million in revenue related to the AvenCell LCA for the years ended December 31, 2023, 2022 and 2021, respectively, after eliminating $ 6.6 million, $ 11.4 million and $ 2.9 million in intra-entity profits during those respective periods, which will be deferred and recognized if and when AvenCell commercializes a product with the Company ’ s license or abandons the related project.
Until such time, this revenue is indefinitely deferred and excluded from the results of operations of the Company.
−Removed: The Company also recognized $ 0.3 million related to materials shipped in accordance with the AvenCell LCA in the year ended December 31, 2022.
−Removed: The Company recognized $ 2.0 million in contra-revenue in the year ended December 31, 2022 related to the AvenCell Co/Co agreement.
+Added: The Company also recognized $ 0.2 million and $ 0.3 million related to materials shipped in accordance with the AvenCell LCA in the years ended December 31, 2023 and 2022, respectively.
+Added: The Company recognized $ 0.6 million and $ 2.0 million in contra-revenue in the years ended December 31, 2023 and 2022, respectively, related to the AvenCell Co/Co agreement.
The Company recognized $ 0.2 million in revenues related to the AvenCell Co/Co agreement for the year ended December 31, 2021.
−Removed: As of December 31, 2022, there was approximately $ 19.9 million of the aggregate transaction price of the AvenCell LCA remaining to be recognized, which the Company expects to recognize through July 2023.
−Removed: As of December 31, 2022 and 2021, the Company had $ 0.3 million and $ 0.1 million in accounts receivable, respectively, related to the AvenCell agreements.
−Removed: The Company had deferred revenue of $ 19.9 million and $ 54.1 million as of December 31, 2022 and 2021, respectively, related to the AvenCell LCA.
+Added: As of December 31, 2023, there was no remaining transaction price of the AvenCell LCA to be recognized.
+Added: The Company had $ 0.2 million in accounts receivable and no deferred revenue related to the AvenCell agreements as of December 31, 2023.
+Added: As of December 31, 2022 , the Company had $ 0.3 million in accounts receivable and deferred revenue of $ 19.9 million related to the AvenCell agreements.
SparingVision SAS
−Removed: In October 2021, the Company and SparingVision, a genomic medicine company developing vision saving treatments for ocular diseases, entered into a license and collaboration agreement (the “SparingVision LCA”) to develop novel genomic medicines utilizing CRISPR/Cas9 technology for the treatment of ocular diseases.
−Removed: Since December 31, 2021, there have been no material changes to the key terms of the SparingVision LCA agreement.
−Removed: For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company's Annual Report for the year ended December 31, 2021.
+Added: In October 2021, the Company and SparingVision, a genomic medicine company developing vision saving treatments for ocular diseases, entered into a license and collaboration agreement (the “SparingVision LCA”) to develop novel genomic medicines utilizing CRISPR/Cas9 technology for the treatment of ocular diseases.
+Added: Since December 31, 2022, there have been no material changes to the key terms of the SparingVision LCA.
+Added: For further information on the terms and conditions of these agreements, see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2022.
Revenue Recognition:
Collaboration Revenue.
−Removed: The Company recognized $ 0.2 million in revenue related to the SparingVision LCA for the year ended December 31, 2022.
+Added: The Company recognized $ 1.8 million and $ 0.2 million in revenue related to the SparingVision LCA for the years ended December 31, 2023 and 2022, respectively.
The Company did no t recognize collaboration revenue in the year ended December 31, 2021 related to the SparingVision LCA.
−Removed: As of December 31, 2022, the Company had $ 0.1 million in accounts receivable related to the SparingVision LCA.
−Removed: The Company did no t have accounts receivable related to the SparingVision LCA as of December 31, 2021.
+Added: As of December 31, 2023 and 2022, the Company had $ 0.5 million and $ 0.1 million in accounts receivable, respectively, related to the SparingVision LCA.
As of December 31, 2023 and 2022, the Company had deferred revenue of $ 13.9 million and $ 14.7 million related to the SparingVision LCA, respectively, which is expected to be recognized over a six to nine year period from the signing of the agreement.
Kyverna Therapeutics, Inc.
−Removed: In December 2021, the Company and Kyverna, a cell therapy company engineering a new class of therapies for autoimmune and inflammatory diseases, entered into a licensing and collaboration agreement (the “Kyverna LCA”), for the development of an allogeneic CD19 CAR-T cell therapy for the treatment of a variety of B cell-mediated autoimmune diseases.
−Removed: Since December 31, 2021, there have been no material changes to the key terms of the Kyverna LCA agreement.
−Removed: For further information on the terms and conditions of this agreement, please see the notes to the consolidated financial statements included in the Company's Annual Report for the year ended December 31, 2021.
+Added: In December 2021, the Company and Kyverna, a cell therapy company engineering a new class of therapies for autoimmune and inflammatory diseases, entered into a licensing and collaboration agreement (the “Kyverna LCA”), for the development of an allogeneic CD19 CAR-T cell therapy for the treatment of a variety of B cell-mediated autoimmune diseases.
+Added: Since December 31, 2022, there have been no material changes to the key terms of the Kyverna LCA.
+Added: For further information on the terms and conditions of this agreement, see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2022.
Revenue Recognition:
Collaboration Revenue.
−Removed: The Company recognized $ 6.6 million in revenue for the year ended December 31, 2022 re lated to the Kyverna LCA.
+Added: The Company had recognized revenue from the Kyverna LCA in full as of March 31, 2023, including $ 0.4 million and $ 6.6 million in revenue for the years ended December 31, 2023 and 2022, respectively .
+Added: The Company recognized approximately $ 0.1 million in revenue in the year ended December 31, 2023 related to materials shipped to Kyverna.
The Company did no t recognize any revenue for the year ended December 31, 2021 re lated to the Kyverna LCA.
−Removed: As of December 31, 2022 and 2021, the Company did no t have accounts receivable related to the Kyverna LCA.
−Removed: As of December 31, 2022 and 2021 the Company had deferred revenue of $ 0.4 million and $ 7.0 million, respectively, related to the Kyverna LCA, which is expected to be recognized through January 2023.
+Added: As of December 31, 2023, the Company had $ 0.1 million in accounts receivable related to the Kyverna LCA.
+Added: As of December 31, 2022, the Company did no t have accounts receivable related to the Kyverna LCA.
+Added: As of December 31, 2023, the Company did no t have deferred revenue related to the Kyverna LCA.
+Added: As of December 31, 2022 the Company had deferred revenue of $ 0.4 million related to the Kyverna LCA.
ONK Therapeutics, Ltd.
−Removed: On February 12, 2022 the Company entered into a license, collaboration and option agreement with ONK (the “ONK LCA”), an innovative company dedicated to developing optimally engineered natural killer (“NK”) cell therapies to cure patients with cancer.
−Removed: The agreement grants ONK a non-exclusive license to the Company's proprietary ex vivo CRISPR/Cas9-based genome editing platform and its Lipid Nanoparticle (“LNP”)-based delivery technologies for development of up to five allogeneic NK cell therapy products, which license is exclusive with respect to certain guide ribonucleic acids (“gRNAs”).
−Removed: Responsibilities in the earlier stage of the license and collaboration agreement (the “evaluation program”) will be shared between the two parties, with each party bearing their own cost burden.
−Removed: Upon completion of the evaluation program, ONK will identify up to five allogeneic targets for further development under a development program.
−Removed: Once these allogeneic targets have been selected by ONK, any further development costs incurred by the Company are eligible for reimbursement.
−Removed: ONK will be responsible for preclinical and clinical development for the engineered NK cell therapies enabled by the agreement.
−Removed: Financial Terms:
−Removed: The Company will be eligible to receive up to $ 184 million per product in future development and commercial milestone payments as achieved, as well as up to mid-single-digit royalties on potential future sales.
−Removed: In addition, the agreement grants the Company options to co-develop and co-commercialize up to two products developed through the collaboration worldwide with rights to lead commercialization in the U.S.
−Removed: There is no fee related to the exercise of these co-development and co-commercialization options.
−Removed: The parties formed a joint steering committee, which is responsible for monitoring and managing the collaboration prior to program completion.
−Removed: ONK LCA –
−Removed: Accounting Analysis:
−Removed: The Company determined that the accounting for the ONK LCA is within the scope of ASC 606.
−Removed: The Company identified one combined performance obligation related to the license, evaluation and development programs.
−Removed: The LCA did not include an exchange of upfront consideration between the parties.
−Removed: As the ONK LCA progresses, the Company will incur certain expenses.
−Removed: Expenses incurred under the evaluation program will be accounted for under ASC 730, Research and Development .
−Removed: Reimbursements under the development programs represent variable constrained consideration, whereas the Company is acting as the principal, and revenue will be recognized as expenses are incurred.
−Removed: Milestone payments and royalties are constrained consideration and will be recorded as revenue upon achievement.
+Added: On February 12, 2022 the Company entered into a license, collaboration and option agreement (the “ONK LCA”) with ONK, an innovative company dedicated to developing optimally engineered natural killer (“NK”) cell therapies to cure patients with cancer.
+Added: Since December 31, 2022, there have been no material changes to the key terms of the ONK LCA.
Revenue Recognition:
Collaboration Revenue.
−Removed: The Company recognized $ 0.1 million in revenue for the year ended December 31, 2022 related to materials shipped in accordance with the ONK LCA.
−Removed: Novartis Institutes for BioMedical Research, Inc.
−Removed: In December 2014, the Company entered into a strategic collaboration agreement with Novartis Institutes for BioMedical Research, Inc.
−Removed: (“Novartis”) (the “2014 Novartis Agreement”), primarily focused on the research of new ex vivo CRISPR/Cas9-edited therapies using CAR-T cells and hematopoietic stem cells (“HSCs”).
−Removed: The agreement was amended in December 2018 (the “Novartis Amendment”) to also include research on ocular stem cells (“OSCs”).
−Removed: In December 2019, per the terms of the 2014 Novartis Agreement, the research term ended, although the 2014 Novartis Agreement remains in effect, for which the Company will be eligible to receive milestone and royalty payments in the future.
−Removed: In June 2021, the Company entered into Amendment No.
−Removed: 3 (the “Amendment”) to the 2014 Novartis Agreement.
−Removed: The Amendment amends Novartis’
−Removed: rights with respect to all of the CAR-T Therapeutic Targets (as defined in the 2014
−Removed: Novartis Agreement) that Novartis selected under the 2014 Novartis Agreement, including (a) making Novartis’
−Removed: license non-exclusive for such CAR-T Therapeutic Targets, (b) removing Novartis’
−Removed: diligence and related reporting obligations for such CAR-T Therapeutic Targets, and (c) refining the scope of Novartis’
−Removed: sublicense rights for such CAR-T Therapeutic Targets.
−Removed: The Company made a one-time payment to Novartis of $10.0 million within 30 days after the effective date of the Amendment, which was recorded as research and development expense in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2021.
−Removed: Since December 31, 2021, there have been no material changes to the key terms of the 2014 Novartis Agreement and the Novartis Amendments.
−Removed: For further information on the terms and conditions of these agreements, please see the notes to the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2021.
−Removed: Revenue Recognition –
−Removed: No milestones under the 2014 Novartis Agreement and the Novartis Amendments were achieved during the year ended December 31, 2022.
−Removed: In September 2021, a milestone related to a CRISPR/Cas9-based engineered cell therapy for the treatment of sickle cell disease was reached and, as a result, the Company recognized $ 0.3 million as collaboration revenue within the consolidated statement of operations and comprehensive loss.
−Removed: In March 2020, the U.S.
−Removed: Food and Drug Administration (“FDA”) accepted the Investigational New Drug (“IND”) application submitted by Novartis for a CRISPR/Cas9-based engineered cell therapy for the treatment of sickle cell disease.
−Removed: As a result of meeting this milestone, the Company recognized $ 5.0 million as collaboration revenue within the consolidated statement of operations and comprehensive loss.
−Removed: The Company is eligible to receive additional downstream success-based milestones and royalties.
−Removed: As of December 31, 2022 and 2021, the Company had no accounts receivable or deferred revenue related to the 2014 Novartis Agreement and the Novartis Amendments .
+Added: The Company recognized $ 0.2 million and $ 0.1 million in revenue for the years ended December 31, 2023 and 2022, respectively, related to materials shipped in accordance with the ONK LCA.
+Added: As of December 31, 2023, the Company did no t have accounts receivable related to the ONK LCA.
+Added: As of December 31, 2022, the Company had $ 0.1 million in accounts receivable related to the ONK LCA.
Equity-Method Investment and Other Investments
AvenCell Therapeutics, Inc.
−Removed: On July 30, 2021, the Company finalized a transaction in which the Company, Cellex and BXLS established AvenCell, a joint venture and privately held company.
+Added: In July 2021, the Company, Cellex and BXLS established AvenCell, a joint venture and privately held company.
In exchange for contributing an exclusive license to the joint venture, the Company entered into a Preferred Stock Purchase Agreement with AvenCell for a 33.33 % equity interest in AvenCell at the time of the initial closing.
Cellex and BXLS each equally owned the remaining 66.67 % at that time.
−Removed: The Company has significant influence over, but does not control, AvenCell through its noncontrolling representation on AvenCell’s Board of Directors and the Company’s equity interest in AvenCell.
+Added: The Company has significant influence over, but does not control, AvenCell through its noncontrolling representation on AvenCell’s Board of Directors and the Company’s equity interest in AvenCell.
The Company has determined that the preferred stock it owns is in-substance common stock.
−Removed: The Company is not the primary beneficiary as it does not have the power to direct the activities of AvenCell that most significantly impact AvenCell’s economic performance.
+Added: The Company is not the primary beneficiary as it does not have the power to direct the activities of AvenCell that most significantly impact AvenCell’s economic performance.
Accordingly, the Company does not consolidate the financial statements of AvenCell and accounts for its investment using the equity method of accounting.
−Removed: As of the closing date, the fair value of the Company’s investment in AvenCell was $ 62.9 million which represents the fair value of the preferred stock received in exchange for the exclusive license to the Company’s CRISPR/Cas9 allogeneic platform (See Note 9).
−Removed: In determining the fair value of the Company’s investment, the Company used an option pricing model which requires the input of certain subjective assumptions.
−Removed: The key assumptions used in the option pricing model, which are level 3 inputs, include the anticipated holding period to an exit and liquidity event, the volatility of market participants ( 76 %), the probability of AvenCell achieving certain milestones to obtain subsequent financings ( 75 %) and the discount for lack of marketability ( 11 %).
−Removed: The Company recorded the initial investment in AvenCell of $ 62.9 million in “Equity method investments”
−Removed: on its consolidated balance sheet.
−Removed: Due to the timing and availability of AvenCell's financial information, the Company is recording its share of losses from AvenCell on a quarterly basis on a one-quarter lag.
−Removed: Therefore, the Company recorded its share of twelve months of AvenCell ’s losses generated in the fourth quarter of 2021 and the first three quarters of 2022 in the Company's operating results and other comprehensive loss for the year ended December 31, 2022, resulting in a reduction of the Company's investment by $ 14.3 million.
−Removed: The Company recorded its share of two months of AvenCell's losses generated in the third quarter of 2021 in the Company's operating results and other comprehensive loss in the fourth quarter of 2021, resulting in a reduction of the Company's investment by $ 1.8 million.
−Removed: The elimination of the intra-entity profit component of $ 11.4 million and $ 2.9 million for the years ended December 31, 2022 and 2021, respectively (See Note 9) resulted in a further reduction in the balance of the investment in AvenCell , bringing the carrying value of the investment to $ 32.5 million and $ 58.1 million as of December 31, 2022 and 2021, respectively.
−Removed: The Company is not aware of any material events or transactions during this period that would warrant additional disclosure or recognition in the financial statements.
−Removed: At December 31, 2022, the maximum exposure to loss is limited to the Company’s equity investment in the joint venture.
+Added: The Company recorded the initial investment in AvenCell of $ 62.9 million in “Equity method investments” on its consolidated balance sheet.
+Added: Due to the timing and availability of AvenCell’s financial information, the Company records its share of losses from AvenCell on a quarterly basis on a one-quarter lag.
+Added: The Company evaluates material events occurring during the quarter lag to determine whether the effects of any such events should be disclosed in the financial statements.
+Added: The Company’s share of AvenCell ’s losses were $ 14.1 million, $ 14.3 million and $ 1.8 million for the years ended December 31, 2023, 2022 and 2021, respectively, and are reflected in its operating results and comprehensive loss.
+Added: The Company eliminated intra-entity profit of $ 6.6 million, $ 11.4 million and $ 2.9 million for the years ended December 31, 2023, 2022 and 2021, respectively (see Note 9).
+Added: The carrying value of the Company ’ s investment in AvenCell was $ 11.8 million and $ 32.5 million as of December 31, 2023 and 2022, respectively.
+Added: In February 2024, AvenCell notified the Company that it is evaluating the valuation of its intangible assets for potential impairment which may result in the reduction of the Company’s equity method investment.
+Added: AvenCell’s financial statements for the three months ended December 31, 2023, had not been finalized at the time the Company’s financial statements were issued.
+Added: At December 31, 2023, the maximum exposure to loss is limited to the Company’s equity investment in the joint venture as adjusted for intra-entity profits that have been deferred to date.
SparingVision SAS
−Removed: In connection with the SparingVision LCA (See Note 9), the Company received 83,316 shares of Series A2 Preferred Stock (“Series A2”).
−Removed: Attached to each share of Series A2, the Company received three warrants for the right to purchase additional Series A2 shares at designated prices that are subject to certain vesting conditions (collectively referred to as the “SparingVision investments”).
+Added: In connection with the SparingVision LCA (see Note 9), the Company received 83,316 shares of Series A2 Preferred Stock (“Series A2”).
+Added: Attached to each share of Series A2, the Company received three warrants for the right to purchase additional Series A2 shares at designated prices that are subject to certain vesting conditions (collectively referred to as the “SparingVision investments”).
The Company accounts for the SparingVision investments using the measurement alternative as SparingVision is a private company and there is no readily observable transaction price.
−Removed: In determining the fair value of the SparingVision investments, the Company used an option pricing model which requires the input of certain subjective assumptions.
−Removed: The key assumptions used in the option pricing model, which are level 3 inputs, include the anticipated holding period to an exit and liquidity event, the volatility of market participants ( 90 %), and the rate of return ( 65 %).
−Removed: The Company recorded the initial investment in SparingVision of $ 14.8 million in “Investments and other assets”
−Removed: on its consolidated balance sheet.
−Removed: There was no change in the observable price or impairment of the SparingVision investment as of December 31, 2022 or 2021.
+Added: The Company recorded the initial investment in SparingVision of $ 14.8 million in “Investments and other assets” on its consolidated balance sheet.
+Added: There have been no changes in the valuation of the investment in SparingVision as of December 31, 2023.
Kyverna Therapeutics, Inc.
In connection with the Kyverna LCA (see Note 9), the Company received 3,739,515 shares of Series B Preferred Stock with a fair value of $ 7.0 million.
−Removed: The Company separately made an additional investment in Kyverna, purchasing 1,602,649 shares of Series B Preferred Stock in exchange for $ 3.0 million in cash (collectively referred to as the “Kyverna investment”).
−Removed: The Company accounts for the Kyverna investment using the measurement alternative as Kyverna is a private company and there is no readily observable transaction price.
−Removed: The Company recorded the initial investment in Kyverna of $ 10.0 million in “Investments and other assets”
−Removed: on its consolidated balance sheet.
−Removed: There was no change in the observable price or impairment of the Kyverna investment as of December 31, 2022 or 2021.
+Added: The Company separately made an additional investment in Kyverna, purchasing 1,602,649 shares of Series B Preferred Stock in exchange for $ 3.0 million in cash (collectively referred to as the “Kyverna investments”).
+Added: As of December 31, 2023, t he Company accounted for the Kyverna investments using the measurement alternative as Kyverna was a private company with no readily observable transaction price.
+Added: The Company recorded the initial investment in Kyverna of $ 10.0 million in “Investments and other assets” on its condensed consolidated balance sheet.
+Added: There have been no changes in the valuation of the investment in Kyverna as of December 31, 2023.
+Added: In February 2024, Kyverna announced the completion of its IPO and its common stock began trading on the Nasdaq Global Select Market under the ticker symbol “KYTX” .
Rewrite Acquisition
−Removed: On February 2, 2022, the Company entered into an agreement to acquire Rewrite (the “Rewrite Merger Agreement”).
−Removed: Under the Rewrite Merger Agreement, the Company paid Rewrite’s former stockholders and optionholders (the “Rewrite Holders”) upfront consideration in an aggregate amount of $ 45.0 million, excluding customary purchase price adjustments and closing costs, payable in cash.
+Added: In February 2022, the Company entered into an Agreement and Plan of Merger by and among the Company, Rewrite, RW Acquisition Corp.
+Added: and Shareholder Representative Services, LLC as Securityholder representative (the “Rewrite Merger Agreement”).
+Added: Under the Rewrite Merger Agreement, the Company paid Company Securityholders (as defined in the Rewrite Merger Agreement) (the “Rewrite Holders”) upfront consideration in an aggregate amount of $ 45.0 million, excluding customary purchase price adjustments and closing costs, payable in cash.
Pursuant to the Rewrite Merger Agreement, the Company acquired all of the issued and outstanding shares of Rewrite.
−Removed: The Rewrite transaction resulted in the acquisition of certain know-how and IP assets related to Rewrite’s proprietary DNA writing technology.
−Removed: The Company's management determined that the acquired assets did not meet the definition of a business pursuant to ASC 805, Business Combinations , as substantially all of the fair value of the acquired assets is concentrated into one identifiable asset, the DNA writing technology.
−Removed: As of the date of closing of the transactions contemplated by the Rewrite Merger Agreement (the “Rewrite Merger Agreement Date”), the asset acquired had no alternative future use and had not reached a stage of technological feasibility.
−Removed: As a result, all payment obligations have been recorded as research and development expense in the Company's consolidated statements of operations and other comprehensive loss in the amount of $ 56.0 million (see table below for details).
+Added: The Rewrite transaction resulted in the acquisition of certain know-how and IP assets related to Rewrite’s proprietary DNA writing technology.
+Added: The Company’s management determined that the acquired assets do not meet the definition of a business pursuant to ASC 805, Business Combinations , as substantially all of the fair value of the acquired assets is concentrated into one identifiable asset, the DNA writing technology.
+Added: As of the date of closing of the transactions contemplated by the Rewrite Merger Agreement (the “Rewrite Merger Agreement Date”), the asset acquired had no alternative future use and had not reached a stage of technological feasibility.
+Added: As a result, all payment obligations were recorded as research and development expense in the condensed consolidated statements of operations and other comprehensive loss in the amount of $ 56.0 million.
The total transaction price was allocated to the assets acquired and liabilities assumed on a relative fair value basis.
−Removed: In addition, the Rewrite Holders are eligible to receive up to an additional $ 155.0 million in milestone payments, including $ 55.0 million upon the achievement of certain pre-specified research milestones and $ 100.0 million upon the achievement of a certain regulatory approval milestone, payable through a mixture of $ 130.0 million in cash and $ 25.0 million in a combination of cash and the Company’s common stock, which will be valued using the volume-weighted average price of the Company’s Common Stock over the ten consecutive trading day period ending on and including the trading day that is two trading days immediately prior to the issuance of the consideration issued in connection with the applicable milestone.
−Removed: In September 2022, Rewrite Therapeutics, Inc.
−Removed: merged into Intellia, with Intellia the surviving entity.
−Removed: The Company determined that the research milestone settled in the Company’s common stock is classified as a contingent consideration liability under ASC 480 and, therefore, the Company recorded a liability for this milestone payment as of the Rewrite Merger Agreement Date at its fair value of $ 10.5 million.
−Removed: The contingent consideration liability is remeasured at fair value each financial reporting period, with the resulting impact reflected in the Company’s consolidated statements of operations and other comprehensive loss, presented within other (expense) income.
−Removed: The milestones that will be settled in cash will be recorded when the contingency is resolved and the consideration is paid or becomes payable.
−Removed: As of December 31, 2022, none of the milestones that will be settled in cash were resolved.
−Removed: In January 2023, the $ 25.0 million research milestone noted above was achieved and, in February 2023, the Company paid the Rewrite Holders a mixture of cash and 567,045 shares of common stock in order to fulfill this obligation.
−Removed: The transaction price was determined and allocated as follows (in thousands):
+Added: In addition, the Rewrite Holders are eligible to receive up to an additional $ 155.0 million, including $ 55.0 million upon the achievement of pre-specified research milestones and $ 100.0 million upon the achievement of a regulatory approval milestone, payable through a mixture of $ 130.0 million in cash and $ 25.0 million in a combination of cash and the Company’s common stock which would be valued using the volume-weighted average price of the Company’s Common Stock over the ten consecutive trading day period ending on and including the trading day that is two trading days immediately prior to the issuance of the consideration issued in connection with the applicable milestone.
+Added: In September 2022, Rewrite merged into Intellia, with Intellia the surviving entity.
+Added: In January 2023, the $ 25.0 million research milestone noted above was achieved and, in February 2023, the Company paid the Rewrite Holders $ 0.9 million in cash and issued 567,045 shares of Intellia common stock in order to fulfill its obligation under the Rewrite Merger Agreement.
+Added: The cash obligation was recorded as research and development expense in the consolidated statement of operations
+Added: and other comprehensive loss in the first quarter of 2023.
+Added: The Company had determined that the research milestone settled in the Company’s common stock would be classified as a contingent consideration liability under ASC 480 and, therefore, the Company initially recorded a liability for this milestone payment as of the Rewrite Merger Agreement Date at its original fair value of $ 10.5 million.
+Added: The contingent consideration liability was remeasured at fair value each financial reporting period, with the resulting impact reflected in the Company’s consolidated statements of operations and other comprehensive loss, presented within other income (expense).
+Added: The remaining milestones to be settled in cash would be recorded when the contingency is resolved and the consideration is paid or becomes payable.
+Added: The transaction price on the Rewrite Merger Agreement Date was determined and allocated as follows (in thousands):
Transaction Price
9 unchanged sentences
Total transaction price
−Removed: In October 2014, the Company entered into an agreement to lease office and laboratory space at 130 Brookline Street in Cambridge, Massachusetts under an operating lease agreement with a term through January 2020 .
−Removed: In April 2019, the lease was amended to extend the term for an additional five-year period, through January 2025 .
−Removed: In March 2020, the Company entered into a second amendment to this lease which extended the term by approximately six years through January 31, 2031 .
−Removed: There is an option to extend the lease for two consecutive five-year terms .
−Removed: The option for these further extensions is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
−Removed: In January 2016, the Company entered into a ten-year agreement to lease office and laboratory space at 40 Erie Street (the “40 Erie Lease”) in Cambridge, Massachusetts under an operating lease agreement, with an option to terminate the lease at the end of the sixth year and an option to extend the term of the lease for an additional three years .
−Removed: In November 2020, the Company entered into a second amendment to the 40 Erie Lease which provides the Company with a right of first offer with respect to any space that becomes available at the 40 Erie Street building, and in consideration for this right the Company agreed to nullify the option to terminate the lease at the end of the sixth year that was included in the 40 Erie Lease .
−Removed: The option to extend the term of the lease for an additional three years is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
−Removed: In March 2020, the Company entered into an agreement to lease approximately 39,000 square feet of office and laboratory space at 281 Albany Street in Cambridge, Massachusetts under an operating lease agreement (the “281 Albany Lease”).
−Removed: The initial term of the 281 Albany Lease is ten years following the rent commencement date which was determined to be March 2021.
−Removed: The Company has the option to extend the 281 Albany Lease for two successive five-year terms ;
−Removed: this option is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
−Removed: In July 2021, the Company entered into an agreement to lease 13,662 square feet of office space at 17 Tudor Street in Cambridge, Massachusetts under an operating lease agreement (the “17 Tudor Lease”).
−Removed: The initial term of the 17 Tudor Lease is five years , and the Company has an option to extend the 17 Tudor Lease for one three-year term.
−Removed: The option is not included as part of the lease liability and right-of-use asset at December 31, 2022, as it is not reasonably certain that it will be exercised.
−Removed: In January 2022, the Company entered into an agreement to lease approximately 38,000 square feet of office and laboratory space at 730 Main Street, Cambridge, Massachusetts under an operating lease agreement (the “730 Main Lease”).
−Removed: The initial term of the 730 Main Lease is for ten years following the Rent Commencement Date and the Company has the option to extend the 730 Main Lease for one five-year term.
−Removed: The base rent under the 730 Main Lease is $ 130.00 per square foot per year during the first year of the term, which is subject to scheduled 3 % annual increases, plus certain operating expenses and taxes.
−Removed: In October 2022, the Company determined that in accordance with ASC 842, Leases (Topic 842) ( “
−Removed: ASC 842 ”
−Removed: ), the commencement date of the lease had been met as the lessor had made the space available for the Company's use.
−Removed: Therefore, the Company recognized a right-of-use asset and a lease liability of approximately $ 36.4 million in the fourth quarter of 2022 related to the 730 Main Lease.
−Removed: In determining the lease liability, the Company used an incremental borrowing rate of 9.33 % based on a number of factors including the Company’s credit rating and the lease term.
−Removed: In January 2023, the Company executed a sublease for a portion of the 730 Main Lease.
−Removed: In February 2022, the Company entered into an agreement to lease approximately 140,000 square feet of office, general laboratory and manufacturing space located at 840 Winter Street, Waltham, Massachusetts (the “840 Winter Lease”), which will provide the Company with the ability to manufacture its own products in a good manufacturing practice (“GMP”) compliant facility as well as to supplement the Company’s current leased premises in Cambridge, Massachusetts.
−Removed: The 840 Winter Lease, including the obligation to pay rent, is expected to commence in 2024 for an initial term of twelve years .
−Removed: The base rent under the 840 Winter Lease is $ 73.50 per square foot per year during the first year of the term, which is subject to scheduled 3 % annual increases, plus certain operating expenses and taxes.
+Added: Property Leases - Commenced
+Added: The Company leases approximately 230,000 square feet of real estate, including laboratory and office space in Cambridge, Massachusetts, and the surrounding areas.
+Added: The Company’s leases have remaining terms ranging from one to approximately nine years.
+Added: Certain leases include options to renew, exercised at the Company’s sole discretion, with varying renewal terms that can extend the lease term for an additional three to five years.
+Added: All of the Company’s leases qualify as operating leases.
+Added: In January 2023, the Company executed a sublease for approximately 13,000 square feet of space of laboratory and office space in Cambridge, Massachusetts for a term of approximately three years.
+Added: The sublease agreement grants an option to renew the term for one additional year.
+Added: Property Leases – Not Yet Commenced
+Added: In February 2022, the Company entered into an agreement to lease approximately 140,000 square feet of office, general laboratory and planned good manufacturing practice (“GMP”) manufacturing space at 840 Winter Street in Waltham , Massachusetts (the “840 Winter Lease”).
+Added: The Company has committed to making at least $ 146.0 million in rental payments over a lease term of 144 months estimated to begin in the second half of 2024.
The Company has the option to extend the 840 Winter Lease for two five-year terms.
−Removed: The Company did not record a right of use asset or liability related to the 840 Winter Lease under ASC 842 during the twelve months ended December 31, 2022, as the Company had not taken control of the premises.
−Removed: In June 2022, the Company entered into an agreement to lease approximately 62,000 square feet of office and laboratory space located at 640 Memorial Drive, Cambridge, Massachusetts under an operating lease agreement (the “640 Memorial Drive Lease”).
−Removed: The term of the lease is five years , ending in August 2027.
−Removed: The Company does not have an option to extend the 640 Memorial Drive Lease .
−Removed: The base rent under the 640 Memorial Drive Lease is approximately $ 97 per square foot per year during the first year of the term, which is subject to scheduled 4 % annual increases, plus certain operating expenses and taxes.
−Removed: In September 2022 the Company determined, in accordance with ASC 842, that the commencement date for the lease had been met as the lessor had made the space available for the Company's use.
−Removed: The Company recorded a right of use asset of $ 30.7 million and a lease liability of $ 30.2 million related to the 640 Memorial Drive Lease under ASC 842.
−Removed: The difference between the right of use asset and the lease liability of $ 0.5 million relates to prepaid rent.
−Removed: In determining the lease liability, the Company used an incremental borrowing rate of 7.99 % based on a number of factors including the Company's credit rating and the lease term.
+Added: In June 2023, the Company executed an amendment to the 840 Winter Lease, which outlines the Company’s and the landlord’s responsibilities regarding the construction of the leased space.
+Added: The Company will be responsible for the oversight of the construction of the tenant improvements, which will be primarily funded by a tenant improvement allowance of up to $ 400 per rentable square foot, a portion of which would be repaid over the term of the lease with interest.
+Added: The Company will also be responsible for certain future construction costs to the extent that they exceed the tenant improvement allowance.
+Added: The Company anticipates a phased move-in process during the second half of 2024.
+Added: As of December 31, 2023, the Company had not taken control of the premises and therefore there are no right of use assets or liabilities recorded related to the 840 Winter Lease under ASC 842, Leases (Topic 842) ( “ ASC 842 ” ).
Throughout the term of its leases, the Company is responsible for paying certain costs and expenses, in addition to the rent, as specified in the lease, including a proportionate share of applicable taxes, operating expenses and utilities.
The variable portion of these costs are expensed as incurred and are disclosed as variable lease costs.
−Removed: The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the years ended December 31, 2022 and 2021:
+Added: The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases:
Year Ended December 31,
1 unchanged sentence
Operating lease cost
−Removed: Short-term lease cost
Variable lease cost
−Removed: Total lease cost
+Added: Sublease income
+Added: Net lease cost
Year Ended December 31,
2 unchanged sentences
Operating cash flows used for operating leases
−Removed: Operating lease liabilities arising from obtaining right-of-use
+Added: Operating lease liabilities arising from obtaining right-of-use assets
As Of December 31,
9 unchanged sentences
Total operating lease liabilities at December 31, 2023
−Removed: Equity-Based Compensation
−Removed: Equity-based compensation expense is classified in the consolidated statements of operations and comprehensive loss as follows:
+Added: Stock-Based Compensation
+Added: Stock-based compensation expense is classified in the consolidated statements of operations and comprehensive loss as follows:
Year Ended December 31,
3 unchanged sentences
Amended and Restated 2015 Stock Option and Incentive Plan
−Removed: In April 2016, the Company adopted the Amended and Restated 2015 Stock Option and Incentive Plan (the “2015 Plan”).
−Removed: The 2015 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards (“RSAs”), restricted stock units (“RSUs”) and other stock-based awards.
−Removed: Recipients of incentive stock options and non-qualified stock options are eligible to purchase shares of the Company’s common stock at an exercise price equal to the fair value of such stock on the grant date.
−Removed: Effective July 1, 2022, the Company adopted a retirement policy for equity awards granted to all employees other than the Company’s CEO (the “Policy”) and in December 2022, the Policy was amended to include the Company's CEO (the “Amended Policy”) upon approval by the Company's board of directors.
−Removed: No other changes were made to the Policy in the amendment.
−Removed: The Amended Policy applies to all equity awards granted after the date of adoption to employees who meet certain retirement eligibility criteria set forth in the Amended Policy (the “Retirees”).
−Removed: Pursuant to the terms of the Amended Policy, upon a Retiree’s eligible retirement:
−Removed: (i) all stock options held by the Retiree will continue to vest following the Retiree’s retirement date according to the original vesting schedule of the option until fully vested and all vested stock options held by such Retiree will remain exercisable until the earlier of the five-year anniversary of the Retiree’s retirement date or the original expiration date of the option, (ii) all unvested time-based RSUs held by the Retiree will vest in full on the Retiree’s retirement date and (iii) all unvested performance-based awards held by the Retiree will remain outstanding following the Retiree’s retirement date and the Retiree will remain eligible to earn a pro-rated portion of such performance-based awards at the end of the performance period based on actual performance during the performance period.
+Added: In April 2016, the Company adopted the Amended and Restated 2015 Stock Option and Incentive Plan (the “2015 Plan”).
+Added: The 2015 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards (“RSAs”), restricted stock units (“RSUs”) and other stock-based awards.
+Added: Recipients of incentive stock options and non-qualified stock options are eligible to purchase shares of the Company’s common stock at an exercise price equal to the fair value of such stock on the grant date.
+Added: The Company maintains a retirement policy for equity awards granted to all employees (the “Retirement Policy”), which applies to all equity awards granted after July 1, 2022 to employees who meet certain retirement eligibility criteria set forth in the Retirement Policy
+Added: (the “Retirees”).
+Added: Pursuant to the terms of the Retirement Policy, upon a Retiree’s eligible retirement:
+Added: (i) all stock options held by the Retiree will continue to vest following the Retiree’s retirement date according to the original vesting schedule of the option until fully vested and all vested stock options held by such Retiree will remain exercisable until the earlier of the five-year anniversary of the Retiree’s retirement date or the original expiration date of the option, (ii) all unvested time-based RSUs held by the Retiree will vest in full on the Retiree’s retirement date and (iii) all unvested performance-based awards held by the Retiree will remain outstanding following the Retiree’s retirement date and the Retiree will remain eligible to earn a pro-rated portion of such performance-based awards at the end of the performance period based on actual performance during the performance period.
As of December 31, 2023, there were 3,875,539 shares available for future issuance under the 2015 Plan.
−Removed: The number of shares reserved for issuance under the 2015 Plan shall be cumulatively increased by four percent of the number of shares of stock issued and outstanding on the immediately preceding December 31 or such lesser number of shares of stock as determined by the board of directors .
+Added: The number of shares reserved for issuance under the 2015 Plan will be cumulatively increased on each January 1 st by four percent of the number of shares of stock issued and outstanding on the immediately preceding December 31 st or such lesser number of shares of stock as determined by the board of directors.
Restricted Stock Units
−Removed: RSUs are measured at fair value based on the quoted price of the Company’s common stock.
−Removed: The following table summarizes the Company’s RSU activity for the year ended December 31, 2022:
+Added: The following table summarizes the Company’s RSU activity for the year ended December 31, 2023:
Average Grant
2 unchanged sentences
Unvested restricted stock units as of December 31, 2023
−Removed: In March 2022, the Company granted 794,424 RSUs with a service condition to employees as part of their annual grant, which vest over a period of three years .
+Added: In March 2023, the Company granted 2,195,135 RSUs with a service condition to employees as part of their annual grant, which have the potential to vest over a period of three years .
The weighted average grant date fair value of these RSUs was $ 40.75 and the vesting start date for these RSUs was January 1, 2023.
+Added: Also in March 2023, 181,743 market-based RSUs were granted to senior executives as part of their annual grant.
+Added: These RSUs have the potential to vest after a period of three years , with a vesting start date of January 1, 2023, and the number of shares to be delivered will depend on the Company’s Total Shareholder Return (“TSR”), a market condition, over that period relative to a defined group of biotechnology companies.
+Added: The grant date fair value for these RSUs, calculated using a Monte Carlo valuation model, was $ 68.55 .
+Added: The following assumptions were used to determine the grant date fair value:
+Added: risk free interest rate:
+Added: expected dividend yield:
+Added: expected volatility:
+Added: expected term (in years):
+Added: In March 2022, the Company granted 794,424 RSUs with a service condition to employees as part of their annual grant, which have the potential to vest over a period of three years .
+Added: The weighted average grant date fair value of these RSUs was $ 79.85 and the vesting start date for these RSUs was January 1, 2022.
Also in March 2022, 55,144 RSUs were granted to senior executives as part of their annual grant.
−Removed: These RSUs have the potential to vest after a period of 3 years, with a vesting start date of January 1, 2022, and the number of shares to be delivered will depend on the Company's Total Shareholder Return (“TSR”), a market condition, over that period relative to a defined group of biotechnology companies.
+Added: These RSUs have the potential to vest after a period of 3 years , with a vesting start date of January 1, 2022, and the number of shares to be delivered will depend on the Company’s TSR, a market condition, over that period relative to a defined group of biotechnology companies.
The grant date fair value for these RSUs, calculated using a Monte Carlo valuation model, was $ 126.49 .
6 unchanged sentences
There were two separate tranches, each attached to a different set of milestones.
−Removed: The milestone related to the first tranche, made up of 21,878 RSUs, is deemed to be probable of achievement as of December 31, 2022;
−Removed: the Company recorded $ 1.7 million in expense related to this tranche in 2022 and these RSUs vested in the first quarter of 2023 upon achievement of the milestone.
−Removed: The remaining performance milestones were considered not probable of achievement as of December 31, 2022 and, therefore, no related stock-based compensation was recorded during the period then ending.
+Added: The milestone related to the first tranche, made up of 21,878 RSUs, was achieved in the first quarter of 2023 and these RSUs vested.
+Added: The remaining performance milestones were considered not probable of achievement as of December 31, 2023 and, therefore, no related stock-based compensation was recorded during the period then ending for those RSUs.
+Added: RSUs granted under the 2015 Plan in 2023 generally vest as to one-third on the first anniversary of the original vesting date, with the balance vesting annually over the remaining two years.
The weighted-average grant date fair value of RSUs granted for the years ended December 31, 2023, 2022 and 2021 was $ 41.30 , $ 70.90 and $ 73.81 , respectively.
The total fair value of RSUs vested (measured on the date of vesting) for the years ended December 31, 2023, 2022 and 2021 was $ 24.9 million, $ 10.4 million and $ 14.1 million, respectively.
−Removed: As of December 31, 2022, there was $ 99.3 million of unrecognized equity-based compensation expense related to RSUs that are expected to vest.
+Added: As of December 31, 2023, there was $ 125.2 million of unrecognized stock-based compensation expense related to RSUs that are expected to vest;
these costs are expected to be recognized over a weighted average remaining vesting period of 1.7 years.
1 unchanged sentence
The weighted average grant date fair value of options, estimated as of the grant date using the Black-Scholes option pricing model, was $ 28.92 , $ 57.23 and $ 54.09 per option for options granted during the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised during the years ended December 31, 2022, 2021 and 2020 was $ 42.8 million, $ 262.0 million, and $ 20.3 million, respectively.
Weighted average assumptions used to apply this pricing model were as follows:
6 unchanged sentences
The risk-free interest rate is based on the U.S.
−Removed: Treasury yield curve in effect at the time of grant with maturities approximately equal to the option’s expected term.
−Removed: Expected Dividend Yield.
−Removed: The expected dividend yield assumption is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends.
−Removed: Expected Volatility.
−Removed: The expected volatility was derived from a blend of the Company’s historical volatility and an average of the historical stock volatilities of several peer companies within the Company’s industry, both over a period equivalent to the expected term of the stock option grants.
+Added: Treasury yield curve in effect at the time of grant with maturities approximately equal to the option’s expected term.
Expected Term.
The expected term represents the period that stock option awards are expected to be outstanding.
−Removed: For option grants that are considered to be “plain vanilla,”
−Removed: the Company determines the expected term using the simplified method.
+Added: For option grants that are considered to be “plain vanilla,” the Company determines the expected term using the simplified method.
The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the options.
The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate the expected term.
−Removed: Stock options granted under the 2015 Plan generally vest 25% on the first anniversary of the original vesting date, with the balance vesting monthly over the remaining three years, unless they contain specific performance-based vesting provisions.
+Added: Expected Volatility.
+Added: Beginning in the first quarter of 2023, expected volatility is estimated based on actual movements in the Company’s stock price over the most recent historical periods, over the expected term of their stock option grants.
+Added: Prior to 2023, the expected volatility was derived from a blend of the Company’s historical volatility and an average of the historical stock volatilities of several peer companies within the Company’s industry, both over a period equivalent to the expected term of the stock option grants.
+Added: Expected Dividend Yield.
+Added: The expected dividend yield assumption is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends.
+Added: Stock options granted under the 2015 Plan in 2023 generally vest as to one-third on the first anniversary of the original vesting date, with the balance vesting monthly over the remaining two years, unless they contain specific performance-based vesting provisions.
The maximum term of stock options granted under the 2015 Plan is ten years.
5 unchanged sentences
Exercisable at December 31, 2023
+Added: The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 7.6 million, $ 42.8 million, and $ 262.0 million, respectively.
As of December 31, 2023, there was $ 56.1 million of unrecognized compensation cost related to stock options that have not yet vested;
1 unchanged sentence
2016 Employee Stock Purchase Plan
−Removed: In May 2016, the Company adopted the 2016 Employee Stock Purchase Plan (the “2016 Plan”).
−Removed: The 2016 Plan allows eligible employees to purchase shares of the Company’s common stock on the last day of each predetermined six-month offering period at 85 % of the lower of the fair market value per share at the beginning or end of the applicable offering period .
+Added: In May 2016, the Company adopted the 2016 Employee Stock Purchase Plan (the “2016 Plan”).
+Added: The 2016 Plan allows eligible employees to purchase shares of the Company’s common stock on the last day of each predetermined six-month offering period at 85 % of the lower of the fair market value per share at the beginning or end of the applicable offering period .
The 2016 Plan provides for six-month offering periods beginning in January and July of each year.
21 unchanged sentences
Net loss per share, basic and diluted
−Removed: The following common stock equivalents were excluded from the calculation of diluted loss per share in 2022, 2021 and 2020 because their inclusion would have been anti-dilutive:
+Added: The following common stock equivalents were excluded from the calculation of diluted loss per share because their inclusion would have been anti-dilutive:
Year Ended December 31,
(In thousands)
−Removed: Unvested restricted stock
+Added: Unvested restricted stock units
Stock options
−Removed: Stockholders’
+Added: Stockholders’ Equity
+Added: At-the-Market Offering Programs
+Added: 2019 Sale Agreement
+Added: In August 2019, the Company entered into an Open Market Sale Agreement (the “2019 Sale Agreement”) with Jefferies LLC (“Jefferies”), under which Jefferies was able to offer and sell, from time to time in “at-the-market” offerings, common stock having aggregate gross proceeds of up to $ 150.0 million.
+Added: The Company agreed to pay cash commissions of 3.0 % of the gross proceeds of sales of common stock under the 2019 Sale Agreement.
+Added: Under the 2019 Sale Agreement, the Company issued 3,778,889 shares of its common stock.
+Added: During the first quarter of 2022, the Company issued 579,788 shares of its common stock, in a series of sales, at an average price of $ 69.43 per share, in accordance with the 2019 Sale Agreement for aggregate net proceeds of $ 38.9 million, after payment of cash commissions and legal, accounting and other fees in connection with the sales.
+Added: The 2019 Sale Agreement expired in the third quarter of 2022.
+Added: 2022 Sale Agreement
+Added: In March 2022, the Company entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies, under which Jefferies is able to offer and sell, from time to time in “at-the-market” offerings, shares of the Company’s common stock having aggregate gross proceeds of up to $ 400.0 million.
+Added: The Company agreed to pay cash commissions of 3.0 % of the gross proceeds of sales of common stock under the 2022 Sale Agreement.
+Added: Through December 31, 2023, the Company issued 7,518,163 shares of its common stock under the 2022 Sale Agreement.
+Added: During the year ended December 31, 2023, the Company issued 4,122,824 shares of its common stock, in a series of sales, at an average price of $ 30.57 per share, in accordance with the 2022 Sale Agreement for aggregate net proceeds of $ 121.9 million, after payment of cash commissions and legal, accounting and other fees in connection with the sales.
+Added: During the year ended December 31, 2022, the Company issued 3,395,339 shares of its common stock, in a series of sales, at an average price of $ 57.43 per share, in accordance with the 2022 Sale Agreement for aggregate net proceeds of $ 189.0 million, after payment of cash commissions and legal, accounting and other fees in connection with the sales.
+Added: As of December 31, 2023, $ 2.1 million of these proceeds are included in “Prepaid expenses and other current assets” on the Company’s consolidated balance sheet, representing offerings with trade dates in December 2023 that were settled in January 2024.
+Added: As of December 31, 2023, $ 79.0 million in shares of common stock remain eligible for sale under the 2022 Sale Agreement.
Follow-on Offerings
−Removed: On June 1, 2020, the Company entered into an underwriting agreement related to a public offering of 6,301,370 shares of its common stock, par value $ 0.0001 per share, including the exercise in full by the underwriters of their option to purchase an additional 821,917 shares, at the public offering price of $ 18.25 per share.
−Removed: The offering closed on June 5, 2020 and the Company received net proceeds of $ 107.7 million, after deducting the underwriting discount, commissions and offering expenses.
−Removed: On December 1, 2020, the Company entered into an underwriting agreement related to a public offering of 5,513,699 shares of its common stock, par value $ 0.0001 per share, including the exercise in full by the underwriters of their option to purchase an additional 719,178 shares, at the public offering price of $ 36.50 per share.
−Removed: The offering closed on December 4, 2020 and the Company received net proceeds of $ 188.9 million, after deducting the underwriting discount, commissions and offering expenses.
On June 29, 2021, the Company entered into an underwriting agreement related to a public offering of 4,758,620 shares of its common stock , par value $ 0.0001 per share, including the exercise in full by the underwriters of their option to purchase an additional 620,689 shares at a public offering price of $ 145.00 per share.
3 unchanged sentences
The offering closed on December 2, 2022 and the Company received net proceeds of $ 337.9 million, including the exercise in full of the underwriters' option to purchase additional shares, after deducting the underwriting discount, commissions and offering expenses.
−Removed: At-the-Market Offering Programs
−Removed: In August 2019, the Company entered into an Open Market Sale Agreement (the “2019 Sale Agreement”) with Jefferies LLC (“Jefferies”) , under which Jefferies was able to offer and sell, from time to time in “at-the-market”
−Removed: offerings, common stock having aggregate gross proceeds of up to $ 150.0 million.
−Removed: The Company agreed to pay Jefferies cash commissions of 3.0 % of the gross proceeds of sales of common stock under the 2019 Sale Agreement.
−Removed: During the year ended December 31, 2020, the Company issued 2,270,161 shares of its common stock in a series of sales at an average price of $ 22.53 per share in accordance with the 2019 Sale Agreement, for aggregate net proceeds of $ 49.5 million after payment of cash commissions to Jefferies and approximately $ 0.2 million related to legal, accounting and other fees in connection with the sales.
−Removed: During the year ended December 31, 2021, the Company issued 641,709 shares of its common stock in a series of sales at an average price of $ 72.79 per share in accordance with the 2019 Sale Agreement, for aggregate net proceeds of $ 45.3 million after payment of cash commissions to Jefferies and approximately $ 0.1 million related to legal, accounting and other fees in connection with the sales.
−Removed: During the first quarter of 2022, the Company issued 579,788 shares of its common stock, in a series of sales, at an average price of $ 69.43 per share, in accordance with the 2019 Sale Agreement for aggregate net proceeds of $ 38.9 million, after payment of cash
−Removed: commissions to Jefferies and approximately $ 0.2 million related to legal, accounting and other fees in connection with the sales.
−Removed: The 2019 Sale Agreement expired during the third quarter of 2022.
−Removed: In March 2022, the Company entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies, under which Jefferies will be able to offer and sell, from time to time in “at-the-market”
−Removed: offerings, common stock having aggregate gross proceeds of up to $ 400.0 million.
−Removed: The Company agreed to pay Jefferies cash commissions of 3.0 % of the gross proceeds of sales of common stock under the 2022 Sale Agreement.
−Removed: During the year ended December 31, 2022, the Company issued 3,395,339 shares of its common stock, in a series of sales, at an average price of $ 57.43 per share, in accordance with the 2022 Sale Agreement for aggregate net proceeds of $ 189.0 million, after payment of cash commissions to Jefferies and approximately $ 0.1 million related to legal, accounting and other fees in connection with the sales.
−Removed: As of December 31, 2022, $ 205.0 million in shares of common stock remain eligible for sale under the 2022 Sale Agreement.
−Removed: Shares Issued in Private Placement to Regeneron
−Removed: As described in Note 9 above, in May 2020 the Company entered into an amendment to its collaboration agreement with Regeneron that was entered into in April 2016.
−Removed: Simultaneously, the Company and Regeneron entered into the 2020 Stock Purchase Agreement , under which the Company sold to Regeneron 925,218 shares of its common stock, par value $ 0.0001 per share, for aggregate cash consideration of $ 30.0 million, or $ 32.42 per share, representing a 100 % premium over the volume-weighted average trading price of the Company’s common stock during the 30-day period prior to the closing.
−Removed: Under the 2020 Stock Purchase Agreement, Regeneron will not dispose of any shares of common stock it beneficially owns in the Company until the termination of the Technology Collaboration Term (see Note 9).
−Removed: After applying equity accounting guidance to measure the issuance of the shares, $ 12.6 million was recorded as fair value in the consolidated statement of stockholders’
−Removed: equity for the shares.
+Added: Approval of Additional Authorized Shares
+Added: In June 2023, the Company filed a Certificate of Amendment to the Company’s Second Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 120,000,000 to 240,000,000 .
+Added: The increase in the number of authorized shares was approved by the holders of a majority of the outstanding shares of the Company’s common stock at its Annual Meeting of Stockholders held on June 14, 2023.
Related Party Transactions
In the ordinary course of business, the Company may purchase materials or supplies from entities that are associated with a party that meets the criteria of a related party of the Company.
−Removed: These transactions are reviewed quarterly and to date have not been material to the Company’s consolidated financial statements.
−Removed: The Company and AvenCell are parties to the AvenCell LCA and AvenCell Co/Co, as described in Note 9.
−Removed: The Company’s relationship with AvenCell is considered to be as a related party due to the Company’s 33.33 % investment in AvenCell being accounted for under the equity method.
−Removed: The Company recognized $ 22.8 million and $ 5.9 million in revenue related to the AvenCell LCA for the years ended December 31, 2022 and 2021, respectively, after eliminating $ 11.4 million and $ 2.9 million in intra-entity profits during those respective periods.
+Added: These transactions are reviewed quarterly and to date have not been material to the Company’s consolidated financial statements.
+Added: The Company and AvenCell are parties to the AvenCell LCA, as described in Note 9.
+Added: The Company’s relationship with AvenCell is considered to be as a related party due to the Company’s 33.33 % investment in AvenCell being accounted for under the equity method.
+Added: The Company recognized $ 13.2 million, $ 22.8 million and $ 5.9 million in revenue related to the AvenCell LCA for the years ended December 31, 2023, 2022 and 2021, respectively, after eliminating $ 6.6 million, $ 11.4 million and $ 2.9 million in intra-entity profits during those respective periods.
The elimination of intra-entity profits results in the deferral of revenue that will be recognized if and when AvenCell commercializes a product with the Company ’ s license or abandons the related project.
Until such time, this revenue is indefinitely deferred and excluded from the results of operations of the Company.
−Removed: The Company also recognized $ 0.3 million related to materials shipped in accordance with the AvenCell LCA in the year ended December 31, 2022.
−Removed: The Company recognized $ 2.0 million in contra-revenue in the year ended December 31, 2022 related to the AvenCell Co/Co agreement.
+Added: The Company also recognized $ 0.2 million and $ 0.3 million related to materials shipped in accordance with the AvenCell LCA in the years ended December 31, 2023 and 2022, respectively.
+Added: The Company and AvenCell were also parties to the AvenCell Co/Co, under which the Company would co-develop and co-commercialize allogeneic universal CAR-T cell products for an immuno-oncology indication.
+Added: This agreement was terminated by the Company, and all obligations under the terminated agreement were completed in the second quarter of 2023.
+Added: The Company recognized $ 0.6 million and $ 2.0 million in contra-revenue in the years ended December 31, 2023 and 2022, respectively, related to the AvenCell Co/Co agreement.
The Company recognized $ 0.2 million in revenues related to the AvenCell Co/Co agreement for the year ended December 31, 2021.
−Removed: As of December 31, 2022 the Company had $ 19.9 million in current deferred revenue related to the AvenCell LCA.
+Added: As of December 31, 2023 , there was no remaining transaction price of the AvenCell LCA to be recognized.
In 2015, the Company established the Intellia Therapeutics, Inc.
−Removed: 401(k) Plan (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue Code.
+Added: 401(k) Plan (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue Code.
Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits.
1 unchanged sentence
The Company made matching contributions of $ 3.3 million, $ 2.7 million and $ 1.6 million for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: Subsequent Event
+Added: On February 15, 2024, the Company announced a strategic collaboration with ReCode Therapeutics, Inc.
+Added: (“ReCode”), a clinical-stage genetic medicines company, to develop novel genomic medicines for the treatment of cystic fibrosis (“CF”).
+Added: CF is a genetic disease caused by mutations in the CFTR gene, leading to the accumulation of thick mucus in the lungs, digestive systems and other organs.
+Added: CF can result in life-threatening infections, respiratory failure and other serious complications.
+Added: The collaboration will leverage the Company’s proprietary CRISPR-based gene editing platform, including its DNA writing technology, and ReCode’s proprietary Selective Organ Targeting (“SORT” ) lipid nanoparticle delivery platform to precisely correct one or more CF disease-causing gene mutations.
+Added: As part of the agreement, the companies will focus initial research efforts on therapeutic approaches that address CF for patients who have limited or no treatment options available, with the opportunity to expand the scope of the collaboration in later phases.
+Added: The Company will be responsible for the design of the editing strategy and research-grade components for the investigational therapies.
+Added: ReCode will lead the subsequent preclinical and clinical development.
+Added: ReCode will also lead worldwide commercialization for certain programs arising from the collaboration.
+Added: The Company will be eligible to receive pre-specified development and commercial milestone payments, as well as royalties on potential sales.
+Added: The Company may also exercise an option to lead commercialization in the U.S.
+Added: for certain programs.
EXHIBIT INDEX
2 unchanged sentences
Second Amended and Restated By-laws of the Registrant (1)
−Removed: Amendment to the Second Amended and Restated By-laws of the Registrant (11)
−Removed: Description of Certain Registrant’s Securities (15)
+Added: Description of Certain Registrant’s Securities (15)
2015 Amended and Restated Stock Option and Incentive Plan and forms of award agreements thereunder (3)
2 unchanged sentences
Services Agreement dated as of July 16, 2014 by and between the Registrant (as successor in interest of Intellia Therapeutics, LLC) and Caribou Biosciences, Inc.
−Removed: License and Collaborative Research Agreement dated as of December 18, 2014 by and between the Registrant and Novartis Institutes for BioMedical Research, Inc.
Form of Indemnification Agreement (3)
7 unchanged sentences
Common Stock Purchase Agreement dated as of April 26, 2016 between the Registrant and Regeneron Pharmaceuticals, Inc.
−Removed: Common Stock Purchase Agreement dated as of April 26, 2016 between the Registrant and Novartis Institutes for BioMedical Research, Inc.
Form of Employment Agreement for Executive Officers (3)
4 unchanged sentences
and the corresponding Form of Co-Development and Co-Promotion Agreement, by and between the Company and Regeneron Pharmaceuticals, Inc.
−Removed: Agreement and Amendment to License and Collaborative Research Agreement, dated as of December 3, 2018, by and between Novartis and the Company (9)
First Amendment to Lease, dated as of April 5, 2019, by and between the Company and MIT 130 Brookline Leasehold LLC.
5 unchanged sentences
Stock Purchase Agreement, dated as of May 30, 2020 by and between the Company and Regeneron Pharmaceuticals, Inc.
−Removed: Corporate Bonus Plan, effective April 3, 2020 (14)
−Removed: Amendment #3 to License and Collaborative Research Agreement, dated as of June 14, 2021, by and between the Registrant and Novartis (16)
+Added: Second Amended and Restated Corporate Bonus Plan, effective November 30, 2023
Agreement and Plan of Merger, by and among Intellia Therapeutics, Inc., Rewrite Therapeutics, Inc., RW Acquisition Corp., and Shareholder Representative Services, LLC, as securityholder representative, dated as of February 2, 2022 (17)
1 unchanged sentence
Amended and Restated Retirement Policy for Equity Awards, effective December 6, 2022 (11)
+Added: Amendment to Lease Agreement by and between the Registrant and Are-Winter Street Property, LLC, dated as of June 20, 2023 (14)
+Added: Letter Agreement (Second Amendment) to License and Collaboration Agreement by and between Registrant and Regeneron Pharmaceuticals, Inc., dated November 22, 2022 .
+Added: Third Amendment to License and Collaboration Agreement by and between Registrant and Regeneron Pharmaceuticals, Inc., dated September 29, 2023 .
Subsidiaries of the Registrant
5 unchanged sentences
Leonard, M.D., President and Chief Executive Officer of the Company, and Glenn Goddard, Executive Vice President, Chief Financial Officer of the Company (19)
+Added: Intellia Therapeutics, Inc.
+Added: Compensation Recovery Policy
Inline XBRL Instance Document.
−Removed: Inline XBRL Taxonomy Extension Schema Document.
−Removed: Inline XBRL Taxonomy Extension Calculation Linkbase Document.
−Removed: Inline XBRL Taxonomy Extension Definition Linkbase Document.
−Removed: Inline XBRL Taxonomy Extension Label Linkbase Document.
−Removed: Inline XBRL Taxonomy Extension Presentation Linkbase Document.
+Added: Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents.
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101*)
2 unchanged sentences
# Indicates a management contract or any compensatory plan, contract or arrangement
−Removed: (1) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
+Added: (1) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
001-37766) filed with the Securities and Exchange Commission on May 7, 2020
3 unchanged sentences
333-210689) filed with the Securities and Exchange Commission on April 27, 2016
−Removed: (4) Incorporated by reference to the Registration Statement on Registrant’s Quarterly Report on Form 10-Q (File No.
+Added: (4) Incorporated by reference to the Registration Statement on Registrant’s Quarterly Report on Form 10-Q (File No.
001-37766) filed with the Securities and Exchange Commission on May 5, 2022
3 unchanged sentences
333-210689) filed with the Securities and Exchange Commission on April 12, 2016
−Removed: (7) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
+Added: (7) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
001-37766) filed with the Securities and Exchange Commission on April 17, 2018
−Removed: (8) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
+Added: (8) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
001-37766) filed with the Securities and Exchange Commission on October 31, 2018
−Removed: (9) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No.
+Added: (9) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No.
001-37766) filed with the Securities and Exchange Commission on February 27, 2019
−Removed: (10) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
+Added: (10) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
001-37766) filed with the Securities and Exchange Commission on May 2, 2019
−Removed: (11) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
−Removed: 001-37766) filed with the Securities and Exchange Commission on April 9, 2020
−Removed: (12) Incorporated by reference to the Registrant’s Current Report on Form 10-Q (File No.
+Added: (11) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No.
+Added: 001-37766) filed with the Securities and Exchange Commission on February 23, 2023
+Added: (12) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
001-37766) filed with the Securities and Exchange Commission on May 7, 2020
−Removed: (13) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
+Added: (13) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
001-37766) filed with the Securities and Exchange Commission on June 1, 2020
−Removed: (14) Incorporated by reference to the Registrant’s Current Report on Form 10-Q (File No.
+Added: (14) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
001-37766) filed with the Securities and Exchange Commission on August 3, 2023
−Removed: (15) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No.
+Added: (15) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No.
001-37766) filed with the Securities and Exchange Commission on February 27, 2020
−Removed: (16) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
+Added: (16) Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No.
001-37766) filed with the Securities and Exchange Commission on June 17, 2021
−Removed: (17) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No.
+Added: (17) Incorporated by reference to the Registrant’s Annual Report on Form 10-K (File No.
001-37766) filed with the Securities and Exchange Commission on February 24, 2022
−Removed: (18) The certifications furnished in Exhibit 32.1 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed”
−Removed: for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
+Added: (18) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q (File No.
+Added: 001-37766) filed with the Securities and Exchange Commission on November 9, 2023
+Added: (19) The certifications furnished in Exhibit 32.1 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
Such certifications will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
16 unchanged sentences
February 22, 2024
+Added: /s/ Bill Chase
+Added: February 22, 2024
/s/ Fred Cohen
1 unchanged sentence
Fred Cohen, M.D.
−Removed: /s/ John Crowley
−Removed: February 23, 2023
−Removed: /s/ Caroline Dorsa
−Removed: February 23, 2023
−Removed: Caroline Dorsa
−Removed: /s/ Jean François Formela
−Removed: February 23, 2023
−Removed: Jean François Formela, M.D.
/s/ Jesse Goodman
8 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.