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 001-39386
ALX ONCOLOGY HOLDINGS INC.
(Exact name of Registrant as specified in its Charter)
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Delaware |
85-0642577 |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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866 Malcolm Road, Suite 100 Burlingame, California |
94010 |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: 650-466-7125
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, par value $0.001 per share |
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ALXO |
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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, 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.
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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 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 common stock held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on The Nasdaq Stock Market on December 31, 2020, was $1.5 billion. The Registrant has elected to use December 31, 2020 as the calculation date, which was the last trading date of the Registrant’s most recently completed fiscal year, because on June 30, 2020 (the last business day of the Registrant’s most recently completed second fiscal quarter), the Registrant was a privately held company. Shares of common stock owned by each executive officer, director, and holder of more than 5% of the Registrant’s common stock have been excluded in that such persons may be deemed to be affiliates of the Registrant. This calculation does not reflect a determination that certain persons are affiliates of the Registrant for any other purpose.
The number of shares of Registrant’s Common Stock outstanding as of March 12, 2021 was 40,127,198.
DOCUMENTS INCORPORATED BY REFERENCE
Certain portions of the registrant's definitive proxy statement relating to the Company's 2021 Annual Meeting of Stockholders, to be filed with the Securities and Exchange Commission within 120 days of the registrant's fiscal year ended December 31, 2020, are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated.
Table of Contents
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Page |
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PART I |
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Item 1. |
1 |
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Item 1A. |
40 |
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Item 1B. |
92 |
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Item 2. |
92 |
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Item 3. |
92 |
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Item 4. |
92 |
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PART II |
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Item 5. |
93 |
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Item 6. |
95 |
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Item 7. |
96 |
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Item 7A. |
109 |
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Item 8. |
110 |
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Item 9. |
139 |
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Item 9A. |
139 |
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Item 9B. |
139 |
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PART III |
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Item 10. |
140 |
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Item 11. |
140 |
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Item 12. |
140 |
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Item 13. |
140 |
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Item 14. |
140 |
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PART IV |
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Item 15. |
141 |
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Item 16. |
144 |
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145 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Annual Report include, but are not limited to, statements about:
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our financial performance; |
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the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements; |
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the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; |
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our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and our ability to grow a sales team; |
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the implementation of our strategic plans for our business and product candidates; |
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our ability to obtain and maintain regulatory approval of our product candidates and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations, such as orphan drug designation, for our product candidates for various diseases; |
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our reliance on third parties to conduct preclinical research activities, and for the manufacture of our product candidates; |
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the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; |
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the progress and focus of our current and future clinical trials, and the reporting of data from those trials; |
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our ability to advance product candidates into and successfully complete clinical trials; |
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the ability of our clinical trials to demonstrate the safety and efficacy of our product candidates, and other positive results; |
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the success of competing therapies that are or may become available; |
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developments relating to our competitors and our industry, including competing product candidates and therapies; |
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our plans relating to the further development and manufacturing of our product candidates, including additional indications that we may pursue; |
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existing regulations and regulatory developments in the United States and other jurisdictions; |
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our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; |
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our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates; |