UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2018
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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 001-38419
Arcus Biosciences, Inc.
(Exact name of Registrant as specified in its Charter)
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Delaware |
47-3898435 |
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( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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3928 Point Eden Way Hayward, CA 94545 (Address of principal executive offices) |
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Registrant’s telephone number, including area code: (510) 694-6200
Securities registered pursuant to Section 12(b) of the Act:
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Titles of Each Class |
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Name of Each Exchange on which Registered |
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Common Stock, Par Value $0.0001 Per Share |
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The New York Stock Exchange |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒
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. YES ☒ NO ☐
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). YES ☒ NO ☐
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein, and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒
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.
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Large accelerated filer |
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Accelerated filer |
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Non-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 ☐ NO ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on The New York Stock Exchange on June 30, 2018, was $446,627,012.
The number of shares of Registrant’s Common Stock outstanding as of March 1, 2019 was 44,534,594.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Registrant’s Definitive Proxy Statement relating to the 2019 Annual Meeting of Shareholders, scheduled to be held on June 6, 2019, are incorporated by reference into Part III of this Report. The Definitive Proxy Statement will be filed within 120 days of the Registrant’s fiscal year ended December 31, 2018.
Table of Contents
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Page |
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PART I |
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Item 1. |
3 |
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Item 1A. |
41 |
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Item 1B. |
86 |
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Item 2. |
86 |
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Item 3. |
86 |
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Item 4. |
86 |
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PART II |
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Item 5. |
87 |
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Item 6. |
89 |
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Item 7. |
90 |
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Item 7A. |
102 |
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Item 8. |
103 |
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Item 9. |
129 |
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Item 9A. |
129 |
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Item 9B. |
130 |
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PART III |
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Item 10. |
131 |
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Item 11. |
131 |
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Item 12. |
131 |
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Item 13. |
131 |
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Item 14. |
131 |
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PART IV |
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Item 15. |
132 |
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Item 16 |
132 |
INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (Annual Report) includes forward-looking statements. All statements regarding future events, results or other future matters contained in this Annual Report are forward-looking statements, including statements about:
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our expectations regarding the timing and achievement of our product candidate development activities and ongoing and planned clinical trials; |
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our expectations for reporting data from clinical trials in certain timeframes; |
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our ability to develop intra-portfolio combinations and highly-differentiated small-molecule candidates, including our ability to create small-molecule product candidates with ideal pharmacological properties and desired clinical effects; |
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our expectations regarding the efficiency and speed with which we can create and advance small-molecule product candidates and develop our product candidates and combination therapies; |
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our reliance on third parties to conduct our ongoing and future clinical trials and third-party manufacturers to manufacture and supply our product candidates; |
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our expectations regarding the nature of the immuno-oncology pathways we are targeting, the size of the potential patient population and the potential market size; |
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our ability to obtain and maintain control of our combination products and maximize the commercial potential of our product candidates; |
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our ability to obtain and maintain regulatory approvals of our product candidates, the potential market opportunities for commercializing our product candidates; |
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our ability to retain and recruit key personnel, estimates of our expenses, future revenue, capital requirements and our needs for additional financing; |
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our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials; |
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our initiation, timing, progress and results of future research and development programs, preclinical studies and clinical trials; |
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our ability to obtain and maintain intellectual property rights covering our product candidates; |
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our expectations regarding the developments and projections relating to our competitors; and |
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our industry and the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012. |
The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or the negative version of these words and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives and financial needs.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Annual Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, advancements, discoveries, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Annual Report to conform these statements to actual results or to changes in our expectations.
Item 1. Business
Company Overview
We are a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies by leveraging underexploited biological opportunities. Specifically, we target well-characterized biological pathways with significant scientific data supporting their importance in regulating the immune response against cancer and for which either there are no molecules in development or those that exist have suboptimal profiles. To exploit these pathways, we have built a robust and highly efficient discovery capability to create and optimize highly differentiated small-molecule immuno-oncology product candidates. Since our inception in 2015, we have built a broad portfolio of small-molecule and antibody product candidates that we plan to develop together as intra-portfolio combinations.