UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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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:
Precision BioSciences, Inc.
(Exact Name of Registrant as Specified in its Charter)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
(Zip Code) |
(
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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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, 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.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
As November 3, 2021, the registrant had
Table of Contents
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Page |
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3 |
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6 |
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PART I. |
7 |
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Item 1. |
7 |
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7 |
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8 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity |
9 |
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10 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
11 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
25 |
Item 3. |
41 |
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Item 4. |
41 |
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PART II. |
42 |
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Item 1. |
42 |
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Item 1A. |
42 |
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Item 2. |
93 |
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Item 3. |
93 |
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Item 4. |
93 |
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Item 5. |
93 |
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Item 6. |
94 |
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96 |
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2
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of present and historical facts contained in this Quarterly Report on Form 10-Q, including without limitation, statements regarding our future results of operations and financial position, business strategy and approach, including related results, prospective products, planned preclinical or greenhouse studies and clinical or field trials, the status and results of our preclinical and clinical studies, expected release of interim data, expectations regarding our allogeneic chimeric antigen receptor T cell immunotherapy product candidates, expectations regarding the use and effects of ARCUS, including in connection with in vivo genome editing, potential new partnerships or alternative opportunities for our product candidates, capabilities of our manufacturing facility, regulatory approvals, research and development costs, timing, expected results and likelihood of success, plans and objectives of management for future operations, as well as the impact of COVID-19 and variants thereof may be forward-looking statements. Without limiting the foregoing, in some cases, you can identify forward-looking statements by terms such as “aim,” “may,” “will,” “should,” “expect,” “exploring,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. No forward-looking statement is a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.
Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified in Part I. Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Part II. Item 1A. “Risk Factors.” These risks and uncertainties include, but are not limited to:
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our ability to become profitable; |
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our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; |
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risks associated with raising additional capital; |
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our operating expenses and our ability to predict what those expenses will be; |
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our limited operating history; |
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the success of our programs and product candidates in which we expend our resources; |
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our dependence on our ARCUS technology; |
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the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; |
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the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; |
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public perception about genome editing technology and its applications; |
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competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; |
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our or our collaborators’ ability to identify, develop and commercialize product candidates; |
3
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pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; |
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the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; |
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our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; |
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our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; |
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potential manufacturing problems associated with the development or commercialization of any of our product candidates; |
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our ability to obtain an adequate supply of T cells from qualified donors; |
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our ability to achieve our anticipated operating efficiencies at our manufacturing facility; |
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delays or difficulties in our and our collaborators’ ability to enroll patients; |
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changes in interim “top-line” data that we announce or publish; |
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if our product candidates do not work as intended or cause undesirable side effects; |
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risks associated with applicable healthcare, data privacy and security regulations and our compliance therewith; |
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the rate and degree of market acceptance of any of our product candidates; |
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the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; |
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our current and future relationships with third parties including suppliers and manufacturers; |
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our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; |
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potential litigation relating to infringement or misappropriation of intellectual property rights; |
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our ability to effectively manage the growth of our operations; |
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our ability to attract, retain, and motivate key scientific and management personnel; |
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market and economic conditions; |
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effects of system failures and security breaches; |
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effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; |
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effects of COVID-19 and variants thereof, or any pandemic, epidemic, or outbreak of an infectious disease; |
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insurance expenses and exposure to uninsured liabilities; |
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effects of tax rules; and |
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risks related to ownership of our common stock, including fluctuations in our stock price. |
4
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
You should read this Quarterly Report on Form 10-Q and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. All forward-looking statements contained herein speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
As used in this Quarterly Report on Form 10-Q, unless otherwise stated or the context requires otherwise, references to “Precision,” the “Company,” “we,” “us,” and “our,” refer to Precision BioSciences, Inc. and its subsidiaries on a consolidated basis.
5
RISK FACTOR SUMMARY
Our business is subject to numerous risks and uncertainties, including those described in Part II. Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. You should carefully consider these risks and uncertainties when investing in our common stock. Some of the principal risks and uncertainties include the following.
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We have incurred significant operating losses since our inception and expect to continue to incur losses for the foreseeable future. We have never been profitable and may never achieve or maintain profitability. |
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We will need substantial additional funding, and if we are unable to raise a sufficient amount of capital when needed on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts. |
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We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment. |
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ARCUS is a novel technology, making it difficult to predict the time, cost and potential success of product candidate development. We have not yet been able to assess the safety and efficacy of most of our product candidates in humans and have only limited safety and efficacy information in humans to date regarding three of our product candidates. |
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We are heavily dependent on the successful development and translation of ARCUS, and due to the early stages of our product development operations, we cannot give any assurance that any product candidates will be successfully developed and commercialized. |
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Adverse public perception of genome editing may negatively impact the developmental progress or commercial success of products that we develop alone or with collaborators. |
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We face significant competition in industries experiencing rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop product candidates or treatments that are safer or more effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any of our product candidates. |
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Our future profitability, if any, depends in part on our and our collaborators’ ability to penetrate global markets, where we would be subject to additional regulatory burdens and other risks and uncertainties associated with international operations that could materially adversely affect our business. |
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Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any products that we develop alone or with collaborators. |
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The regulatory landscape that will apply to development of therapeutic product candidates by us or our collaborators is rigorous, complex, uncertain and subject to change, which could result in delays or termination of development of such product candidates or unexpected costs in obtaining regulatory approvals. |
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Clinical trials are difficult to design and implement, expensive, time-consuming and involve an uncertain outcome, and the inability to successfully and timely conduct clinical trials and obtain regulatory approval for our product candidates would substantially harm our business. |
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Even if we obtain regulatory approval for any products that we develop alone or with collaborators, such products will remain subject to ongoing regulatory requirements, which may result in significant additional expense. |
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Even if any product we develop alone or with collaborators receives marketing approval, such product may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success. |
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The ongoing novel coronavirus disease, COVID-19, has impacted our business and any other pandemic, epidemic or outbreak of an infectious disease may materially and adversely impact our business, including our preclinical studies and clinical trials. |
6
Part I. Financial information
Item 1. Financial Statements.
Precision Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
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September 30, 2021 |
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December 31, 2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Property, equipment, and software—net |
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Intangible assets—net |
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Right-of-use assets—net |
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Investment in equity securities |
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— |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued compensation |
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Accrued clinical and research and development expenses |
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Deferred revenue |
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Lease liabilities |
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Loan payable—net |
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— |
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Other current liabilities |
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Total current liabilities |
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Deferred revenue |
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Lease liabilities |
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Contract liabilities |
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— |
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Other liabilities |
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Total liabilities |
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Commitments and contingencies (Note 4) |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock; $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
) |
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( |
) |
Treasury stock |
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( |
) |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See notes to condensed consolidated financial statements
7
Precision Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
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For the Three Months Ended September 30, |
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For the Nine Months Ended September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Operating expenses |
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Research and development |
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General and administrative |
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Total operating expenses |
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Operating loss |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Other income (expense): |
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Change in fair value of equity investment |
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— |
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— |
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Interest expense |
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( |
) |
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— |
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( |
) |
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— |
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Interest income |
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Total other income, net |
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Net loss and net loss attributable to common stockholders |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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Net loss per share attributable to common stockholders- basic and diluted |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Weighted average shares of common stock outstanding- basic and diluted |
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See notes to condensed consolidated financial statements
8
Precision Biosciences, Inc.
Condensed Consolidated Statements of Changes in
Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
See notes to condensed consolidated financial statements
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Treasury |
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Total Stockholder's |
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Shares |
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Amount |
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Capital |
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Deficit |
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Stock |
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Equity |
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||||||
Balance- January 1, 2020 |
|
|
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$ |
— |
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$ |
|
|
|
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|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Stock option exercises |
|
|
|
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|
— |
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|
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|
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|
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|
|
— |
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|
|
— |
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Issuance of common stock under employee stock purchase plan |
|
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— |
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— |
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— |
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Share-based compensation expense |
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— |
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— |
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|
|
|
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|
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— |
|
|
|
— |
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Net loss |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
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( |
) |
|
|
— |
|
|
|
( |
) |
Balance- March 31, 2020 |
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Stock option exercises |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance- June 30, 2020 |
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Stock option exercises |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
Issuance of common stock under employee stock purchase plan |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
Share-based compensation expense |
|
|
— |
|
|
|
- |
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
Balance - September 30, 2020 |
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance- January 1, 2021 |
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Stock option exercises |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Issuance of common stock under employee stock purchase plan |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Issuance of common stock to collaboration partners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance- March 31, 2021 |
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Stock option exercises |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
Balance- June 30, 2021 |
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Stock option exercises |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Issuance of common stock under employee stock purchase plan |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance cost |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance- September 30, 2021 |
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
See notes to condensed consolidated financial statements
9
Precision Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
For the Nine Months Ended September 30, |
|
|||||
|
|
2021 |
|
|
2020 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
Loss on disposal of assets |
|
|
|
|
|
|
— |
|
Non-cash interest expense |
|
|
|
|
|
|
— |
|
Amortization of right-of-use assets |
|
|
|
|
|
|
|
|
Non-cash consideration received from collaboration partners |
|
|
( |
) |
|
|
— |
|
Change in fair value of equity investments |
|
|
( |
) |
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
( |
) |
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
( |
) |
Other assets and other current assets |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
( |
) |
Other liabilities and other current liabilities |
|
|
( |
) |
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
|
|
Lease liabilities and right-of-use assets |
|
|
( |
) |
|
|
( |
) |
Contract liabilities |
|
|
|
|
|
|
— |
|
Net cash provided by (used in) operating activities |
|
|
|
|
|
|
( |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property, equipment and software |
|
|
( |
) |
|
|
( |
) |
Purchases of intangible assets |