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, 2020
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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 001-39303
PLIANT THERAPEUTICS, INC.
(Exact name of Registrant as specified in its Charter)
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Delaware |
47-4272481 |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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260 Littlefield Avenue South San Francisco, CA |
94080 |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (650) 481-6770
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
Name of Each Exchange on which Securities are |
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Title of Each Class of Securities Registered |
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Registered |
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Common Stock, par value $0.0001 per share |
PLRX |
The Nasdaq Global Select Market |
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 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
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 NASDAQ Stock Market on June 30, 2020, was $855,889,147.
The number of shares of Registrant’s Common Stock outstanding as of March 9, 2021 was 35,738,192.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive Proxy Statement for the 2021 Annual Meeting of Stockholders to be filed with the U.S. Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K are incorporated by reference in Part III, Items 10-14 of this Annual Report on Form 10-K
Table of Contents
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Page |
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1 |
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2 |
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Item 1. |
3 |
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Item 1A. |
54 |
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Item 1B. |
99 |
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Item 2. |
100 |
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Item 3. |
100 |
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Item 4. |
100 |
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Item 5. |
101 |
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Item 6. |
101 |
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Item 7. |
102 |
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Item 7A. |
112 |
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Item 8. |
113 |
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Item 9. |
141 |
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Item 9A. |
141 |
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Item 9B. |
141 |
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Item 10. |
142 |
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Item 11. |
142 |
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Item 12. |
142 |
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Item 13. |
142 |
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Item 14. |
142 |
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Item 15. |
143 |
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Item 16 |
144 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains forward-looking statements that involve risks, uncertainties, and assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Annual Report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. Forward-looking statements in this Annual Report include, but are not limited to, statements about:
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Our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
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The success, cost and timing of our product development activities and clinical trials of our lead product candidate, PLN-74809, as well as PLN-1474 and our other product candidates; |
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The outbreak of the novel coronavirus disease, COVID-19, pandemic which has had an adverse impact on our business, including our preclinical studies and clinical trials; |
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Ours or our current or future collaborators plans to initiate, recruit and enroll patients in, and conduct our clinical trials at the pace that we project; |
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Our plans and strategy to obtain and maintain regulatory approvals of our product candidates; |
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Our plans and strategy to obtain funding for our operations, including funding necessary to complete further development and, upon successful development, if approved, commercialize any of our product candidates; |
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The potential benefit of orphan drug designations for PLN-74809; |
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Our ability to compete with companies currently marketing or engaged in the development of treatments for fibrosis; |
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Our plans and strategy regarding obtaining and maintaining intellectual property protection for our product candidates and the duration of such protection; |
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Our plans and strategy regarding the manufacture of our product candidates for clinical trials and for commercial use, if approved; |
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Our dependence on current and future collaborators for developing, obtaining regulatory approval for and commercializing product candidates in the collaboration; |
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Our receipt and timing of any milestone payments or royalties under any current of future research collaboration or license agreements or arrangements; |
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Our plans and strategy regarding the commercialization of any products that are approved for marketing and our ability to establish adequate pricing in the U.S. and international markets; |
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The size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in combination with others; |