UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____________ to ________
Commission File Number
(Exact name of registrant as specified in its charter)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
⌧ | Accelerated filer | ☐ | |
Non-accelerated filer | ☐ | Smaller reporting company | |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The number of shares of Common Stock outstanding as of July 28, 2023 was
Editas Medicine, Inc.
TABLE OF CONTENTS
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
Editas Medicine, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(amounts in thousands, except share and per share data)
| June 30, |
| December 31, | |||
2023 | 2022 | |||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | | $ | | ||
Marketable securities | | | ||||
Accounts receivable |
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Prepaid expenses and other current assets |
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Total current assets |
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Marketable securities | | | ||||
Property and equipment, net |
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Right-of-use assets | | | ||||
Restricted cash and other non-current assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable | $ | | $ | | ||
Accrued expenses |
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Deferred revenue, current | | | ||||
Operating lease liabilities | | | ||||
Total current liabilities |
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Operating lease liabilities, net of current portion | | | ||||
Deferred revenue, net of current portion | | | ||||
Total liabilities | | | ||||
Stockholders’ equity | ||||||
Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss | ( | ( | ||||
Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ equity | | | ||||
Total liabilities and stockholders’ equity | $ | | $ | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
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Editas Medicine, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(amounts in thousands, except share and per share data)
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
| 2023 |
| 2022 | 2023 |
| 2022 | ||||||
$ | | $ | | $ | | $ | | |||||
Operating expenses: | ||||||||||||
Research and development |
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General and administrative |
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Total operating expenses |
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Operating loss |
| ( |
| ( |
| ( |
| ( | ||||
Other income, net: | ||||||||||||
Other (expense) income, net |
| ( |
| |
| ( |
| | ||||
Interest income, net | | | | | ||||||||
Total other income, net |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net loss per share, basic and diluted | ( | ( | ( | ( | ||||||||
Weighted-average common shares outstanding, basic and diluted | | |
| |
| |
The accompanying notes are an integral part of the condensed consolidated financial statements.
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Editas Medicine, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(unaudited)
(amounts in thousands)
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Other comprehensive loss: | ||||||||||||
Unrealized (loss) gain on marketable debt securities |
| ( |
| ( |
| |
| ( | ||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( |
The accompanying notes are an integral part of the condensed consolidated financial statements.
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Editas Medicine, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(unaudited)
(amounts in thousands, except share data)
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| Accumulated |
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Additional | Other | Other | Total | ||||||||||||||
Common Stock | Paid-In | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
Shares |
| Amount | Capital | (Loss) Gain | Deficit | Equity | |||||||||||
Balance at December 31, 2022 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Exercise of stock options | — | — | — | — | |||||||||||||
Vesting of restricted common stock awards | | — | — | — | — | — | |||||||||||
Stock-based compensation expense | — | — | | — | — | | |||||||||||
Unrealized gain on marketable debt securities | — | — | — | | — | | |||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||
Balance at March 31, 2023 | $ | $ | $ | ( | $ | ( | $ | ||||||||||
Issuance of common stock from public offering, net commissions, underwriting discounts and offering costs | — | — | | ||||||||||||||
Exercise of stock options | | — | | — | — | | |||||||||||
Stock-based compensation expense | — | — | | — | — | | |||||||||||
Vesting of restricted common stock awards | | — | — | — | — | — | |||||||||||
Issuance of common stock under employee stock purchase plan | | — | | — | — | | |||||||||||
Unrealized loss on marketable debt securities | — | — | — | ( | — | ( | |||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||
Balance at June 30, 2023 | $ | $ | $ | ( | $ | ( | $ |
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| Accumulated |
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| Additional | Other | Other | Total | |||||||||||||
| Common Stock | Paid-In | Comprehensive | Accumulated | Stockholders’ | ||||||||||||
| Shares |
| Amount | Capital | (Loss) Gain | Deficit | Equity | ||||||||||
Balance at December 31, 2021 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Exercise of stock options | | — | | — | — | | |||||||||||
Vesting of restricted common stock awards | | — | — | — | — | — | |||||||||||
Stock-based compensation expense | — | — | | — | — | | |||||||||||
Unrealized loss on marketable debt securities | — | — | — | ( | — | ( | |||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||
Balance at March 31, 2022 | $ | $ | $ | ( | $ | ( | $ | ||||||||||
Exercise of stock options | | — | — | — | — | — | |||||||||||
Vesting of restricted common stock awards | | — | — | — | — | — | |||||||||||
Stock-based compensation expense | — | — | | — | — | | |||||||||||
Issuance of common stock under employee stock purchase plan | | — | | — | — | | |||||||||||
Unrealized loss on marketable debt securities | — | — | — | ( | — | ( | |||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||
Balance at June 30, 2022 | $ | $ | $ | ( | $ | ( | $ |
The accompanying notes are an integral part of the condensed consolidated financial statements.
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Editas Medicine, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(amounts in thousands)
Six Months Ended | ||||||
June 30, | ||||||
| 2023 |
| 2022 | |||
Cash flow from operating activities | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Stock-based compensation expense |
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Depreciation |
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Loss on disposal of fixed assets | | — | ||||
Other non-cash items, net |
| ( |
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Changes in operating assets and liabilities: |
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Accounts receivable | | ( | ||||
Prepaid expenses and other current assets | | ( | ||||
Right-of-use assets | | | ||||
Other non-current assets | — | ( | ||||
Accounts payable | ( | | ||||
Accrued expenses | ( | | ||||
Deferred revenue |
| — |
| ( | ||
Operating lease liabilities |
| ( |
| ( | ||
Net cash used in operating activities |
| ( |
| ( | ||
Cash flow from investing activities | ||||||
Purchases of property and equipment |
| ( | ( | |||
Proceeds from the sale of equipment | — | | ||||
Purchases of marketable securities | ( | ( | ||||
Proceeds from maturities of marketable securities | | | ||||
Net cash provided by investing activities |
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Cash flow from financing activities | ||||||
Proceeds from offering of common stock, net of issuance costs | | — | ||||
Proceeds from exercise of stock options |
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Proceeds from issuance of common stock under employee stock purchase plan |
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Net cash provided by financing activities |
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Net increase (decrease) in cash, cash equivalents, and restricted cash | | ( | ||||
Cash, cash equivalents, and restricted cash, beginning of period | | | ||||
Cash, cash equivalents, and restricted cash, end of period | $ | | $ | | ||
Supplemental disclosure of cash and non-cash activities: | ||||||
Fixed asset additions included in accounts payable and accrued expenses | $ | | $ | | ||
Offering expenses included in accounts payable and accrued expenses | | — | ||||
Cash paid in connection with operating lease liabilities | | | ||||
Right-of-use assets obtained in exchange of operating lease obligations | | — |
The accompanying notes are an integral part of the condensed consolidated financial statements.
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Editas Medicine, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
1. Nature of Business
Editas Medicine, Inc. (the “Company”) is a clinical stage genome editing company dedicated to developing potentially transformative genomic medicines to treat a broad range of serious diseases. The Company was incorporated in the state of Delaware in September 2013. Its principal offices are in Cambridge, Massachusetts.
Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital. The Company has primarily financed its operations through various equity financings, payments received under a research collaboration with Juno Therapeutics, Inc., a wholly-owned subsidiary of the Bristol-Myers Squibb Company (“BMS”), and payments received under a strategic alliance and option agreement with Allergan Pharmaceuticals International Limited, which was terminated in August 2020.
The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations and ability to transition from pilot-scale manufacturing to large-scale production of products.
Liquidity
In June 2023, the Company completed a public offering in which it sold
The Company has incurred annual net operating losses in every year since its inception. The Company expects that its existing cash, cash equivalents and marketable securities at June 30, 2023 will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2025. The Company had an accumulated deficit of $
2. Summary of Significant Accounting Policies
Unaudited Interim Financial Information
The condensed consolidated financial statements of the Company included herein have been prepared, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “Annual Report”).
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The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Editas Securities Corporation and Editas Medicine, LLC. All intercompany transactions and balances of the subsidiaries have been eliminated in consolidation. In the opinion of management, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the results for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The three months ended June 30, 2023 and 2022 are referred to as the second quarter of 2023 and 2022, respectively. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” to the consolidated financial statements included in the Annual Report. There have been no material changes to the significant accounting policies previously disclosed in the Annual Report.
3. Cash Equivalents and Marketable Securities
Cash equivalents and marketable securities consisted of the following at June 30, 2023 (in thousands):
Allowance | Gross | Gross | ||||||||||||||
Amortized | for Credit | Unrealized | Unrealized | Fair | ||||||||||||
June 30, 2023 | Cost | Losses | Gains | Losses | Value | |||||||||||
Cash equivalents and marketable securities: | ||||||||||||||||
Money market funds | $ | | $ | — | $ | — | $ | — | $ | | ||||||
Government agency securities | | — | — | ( | | |||||||||||
Corporate notes/bonds | | — | — | ( | | |||||||||||
Commercial paper | | — | — | ( | | |||||||||||
U.S. Treasuries | | — | — | ( | | |||||||||||
Total | $ | | $ | — | $ | — | $ | ( | $ | |
Cash equivalents and marketable securities consisted of the following at December 31, 2022 (in thousands):
Allowance | Gross | Gross | ||||||||||||||
Amortized | for Credit | Unrealized | Unrealized | Fair | ||||||||||||
December 31, 2022 | Cost | Losses | Gains | Losses | Value | |||||||||||
Cash equivalents and marketable securities: | ||||||||||||||||
Government agency securities | $ | | $ | — | $ | | $ | ( | $ | | ||||||
Money market funds | | — | — | — | | |||||||||||
Corporate notes/bonds | | — | | ( | | |||||||||||
U.S. Treasuries | | — | | ( | | |||||||||||
Commercial paper | | — | | ( | | |||||||||||
Total | $ | | $ | — | $ | | $ | ( | $ | |
As of June 30, 2023, the Company did
There were
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4. Fair Value Measurements
Assets measured at fair value on a recurring basis as of June 30, 2023 were as follows (in thousands):
|
|
| Quoted Prices |
| Significant |
| ||||||
in Active | Other | Significant | ||||||||||
Markets for | Observable | Unobservable | ||||||||||
June 30, | Identical Assets | Inputs | Inputs | |||||||||
Financial Assets | 2023 | (Level 1) | (Level 2) | (Level 3) | ||||||||
Cash equivalents: | ||||||||||||
Money market funds | $ | | $ | | $ | — | $ | — | ||||
Marketable securities: | ||||||||||||
Government agency securities | | — | | — | ||||||||
Corporate notes/bonds | | — | | — | ||||||||
Commercial paper | | — | | — | ||||||||
U.S. Treasuries | | | — | — | ||||||||
Restricted cash and other non-current assets: | ||||||||||||
Money market funds | | | — | — | ||||||||
Total financial assets | $ | | $ | | $ | | $ | — |
Assets measured at fair value on a recurring basis as of December 31, 2022 were as follows (in thousands):
|
| Quoted Prices |
| Significant |
| |||||||
in Active | Other | Significant | ||||||||||
Markets for | Observable | Unobservable | ||||||||||
December 31, | Identical Assets | Inputs | Inputs | |||||||||
Financial Assets | 2022 | (Level 1) | (Level 2) | (Level 3) | ||||||||
Cash equivalents: | ||||||||||||
Money market funds | $ | | $ | | $ | — | $ | — | ||||
Marketable securities: | | | ||||||||||
Government agency securities | | — | | — | ||||||||
Corporate bonds | | — | | — | ||||||||
U.S. Treasuries | | | — | — | ||||||||
Commercial paper | | — | | — | ||||||||
Restricted cash and other non-current assets: | | | ||||||||||
Money market funds | | | — | — | ||||||||
Total financial assets | $ | | $ | | $ | | $ | — |
5. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
As of | ||||||
June 30, | December 31, | |||||
| 2023 |
| 2022 | |||
External research and development expenses | $ | | $ | | ||
Employee related expenses | | | ||||
Intellectual property and patent related fees | | | ||||
Professional service expenses | | | ||||
Other expenses | | | ||||
Total accrued expenses | $ | | $ | | ||
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6. Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
| As of | |||||
June 30, | December 31, | |||||
| 2023 |
| 2022 | |||
Laboratory equipment | $ | | $ | | ||
Leasehold improvements | | | ||||
Computer equipment |
| |
| | ||
Construction-in-progress | | | ||||
Furniture and office equipment | | | ||||
Software |
| |
| | ||
Total property and equipment |
| |
| | ||
Less: accumulated depreciation |
| ( |
| ( | ||
Property and equipment, net | $ | | $ | |
7. Commitments and Contingencies
In the second quarter of 2023, we entered into a License and Service Agreement pursuant to which we will lease manufacturing space for our continued research and development activities. As of June 30, 2023, the lease has not commenced for accounting purposes and it is not expected to commence until the second quarter of 2024. The lease agreement provides for total remaining lease payments of $
The Company is a party to a number of license agreements under which the Company licenses patents, patent applications and other intellectual property from third parties. As such, the Company is obligated to pay licensors for various costs including upfront licenses fees, annual license fees, certain licensor expense reimbursements, success payments, research funding payments, and milestones triggerable upon certain development, regulatory, and commercial events as well as royalties on future products. These contracts are generally cancellable, with notice, at the Company’s option and do not have significant cancellation penalties. The terms and conditions as well as the accounting analysis for the Company’s significant commitments and contingencies are described in Note 8, “Commitments and Contingencies” to the consolidated financial statements included in the Annual Report. There have been no material changes to the terms and conditions, or the accounting conclusions, previously disclosed in the Annual Report.
Licensor Expense Reimbursement
The Company is obligated to reimburse The Broad Institute, Inc. (“Broad”) and the President and Fellows of Harvard College (“Harvard”) for expenses incurred by each of them associated with the prosecution and maintenance of the patent rights that the Company licenses from them pursuant to the license agreement by and among the Company, Broad and Harvard, including the interference and opposition proceedings involving patents licensed to the Company under the license agreement, and other license agreements between the Company and Broad. As such, the Company anticipates that it has a substantial commitment in connection with these proceedings until such time as these proceedings have been resolved, but the amount of such commitment is not determinable. The Company incurred an aggregate of $
8. Collaboration and Profit-Sharing Agreements
The Company has entered into multiple collaborations, out-licenses and strategic alliances with third parties that typically involve payments to or from the Company, including up-front payments, payments for research and development services, option payments, milestone payments and royalty payments to or from the Company. The terms and conditions as well as the accounting analysis for the Company’s significant collaborations, out-licenses and strategic alliances are described in Note 9, “Collaboration and Profit-Sharing Agreements” to the consolidated financial
11
statements included in the Annual Report. There have been no material changes to the terms and conditions, or the accounting conclusions, previously disclosed in the Annual Report.
Collaboration Revenue
As of June 30, 2023, the Company’s contract liabilities were primarily related to the Company’s collaboration with BMS.
For the six months ended June 30, 2023 | Balance at December 31, 2022 | Additions | Deductions | Balance at June 30, 2023 | |||||||
Accounts receivable | $ | | $ | | $ | ( | $ | | |||
Contract liabilities: | |||||||||||
Deferred revenue | $ | | $ | — | $ | — | $ | |
During the three and six months ended June 30, 2023, the Company did not recognize any collaboration revenue that had been allocated to deferred revenue from BMS.
9. Stock-based Compensation
Total compensation cost recognized for all stock-based compensation awards in the condensed consolidated statements of operations was as follows (in thousands):
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||
Research and development | $ | | $ | | $ | | $ | | ||||
General and administrative |
| |
| |
| |
| | ||||
Total stock-based compensation expense | $ | | $ | | $ | | $ | |
Restricted Stock Unit Awards
The following is a summary of restricted stock unit awards activity for the six months ended June 30, 2023:
|
| Weighted | |||
Average | |||||
Grant Date | |||||
Fair Value | |||||
Shares | Per Share | ||||
Unvested restricted stock unit awards as of December 31, 2022 |
| | $ | | |
Issued |
| | $ | | |
Vested |
| ( | $ | | |
Forfeited | ( | $ | | ||
Unvested restricted stock unit awards as of June 30, 2023 |
| | $ | |
The restricted stock units issued in the six months ended June 30, 2023 include
As of June 30, 2023, total unrecognized compensation expense related to unvested restricted stock unit awards was $
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