UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
|
☒ |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2020
|
☐ |
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 001-39617
Aligos Therapeutics, Inc.
(Exact name of Registrant as specified in its Charter)
|
Delaware |
82-4724808 |
|
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
One Corporate Drive, 2nd Floor South San Francisco, California |
94080 |
|
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (800) 466-6059
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
Common Stock, par value, $0.0001 per share |
|
ALGS |
|
The Nasdaq Stock Market LLC (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.
|
Large accelerated filer |
|
☐ |
|
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 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 Act). Yes ☐ No ☒
The registrant’s common stock was not publicly traded as of the last business day of the registrant’s most recently completed second fiscal quarter.
As of March 18, 2021, the registrant had 38,143,228 shares of common stock, $0.0001 par value per share, outstanding, comprised of 35,050,890 shares of voting common stock, $0.0001 par value per share and 3,092,338 shares of non-voting common stock, $0.0001 par value per share.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Registrant’s Definitive Proxy Statement relating to the 2021 Annual Meeting of Stockholders, which will be filed with the Securities and Exchange Commission within 120 days after the end of the Registrant’s fiscal year ended December 31, 2020, are incorporated by reference into Part III of this Report.
Table of Contents
|
|
|
Page |
|
PART I |
|
|
|
Item 1. |
1 |
|
|
Item 1A. |
42 |
|
|
Item 1B. |
103 |
|
|
Item 2. |
103 |
|
|
Item 3. |
103 |
|
|
Item 4. |
103 |
|
|
|
|
|
|
PART II |
|
|
|
Item 5. |
104 |
|
|
Item 6. |
106 |
|
|
Item 7. |
107 |
|
|
Item 7A. |
116 |
|
|
Item 8. |
118 |
|
|
Item 9. |
155 |
|
|
Item 9A. |
155 |
|
|
Item 9B. |
155 |
|
|
|
|
|
|
PART III |
|
|
|
Item 10. |
156 |
|
|
Item 11. |
156 |
|
|
Item 12. |
156 |
|
|
Item 13. |
156 |
|
|
Item 14. |
156 |
|
|
|
|
|
|
PART IV |
|
|
|
Item 15. |
157 |
|
|
Item 16 |
157 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business, operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be 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 terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
|
|
• |
the scope, progress, results and costs of developing our drug candidates or any other future drug candidates, and conducting nonclinical studies and clinical trials, including our ALG-010133 and ALG-000184 Phase 1 clinical trials; |
|
|
• |
the scope, progress, results and costs related to the research and development of our pipeline; |
|
|
• |
the timing of and costs involved in obtaining and maintaining regulatory approval for any of our current or future drug candidates, and any related restrictions or limitations; |
|
|
• |
the impact of COVID-19 on our business and operations, including clinical trials, manufacturing suppliers, collaborators, use of contract research organizations and employees; |
|
|
• |
our expectations regarding the potential market size and size of the potential patient populations for ALG-010133 and ALG-000184, our other drug candidates and any future drug candidates, if approved for commercial use; |
|
|
• |
our ability to maintain existing, and establish new, collaborations, licensing or other arrangements and the financial terms of any such agreements; |
|
|
• |
our commercialization, marketing and manufacturing capabilities and expectations; |
|
|
• |
the rate and degree of market acceptance of our drug candidates, as well as the pricing and reimbursement of our drug candidates, if approved; |
|
|
• |
the implementation of our business model and strategic plans for our business, drug candidates and technology, including additional indications for which we may pursue; |
|
|
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates, including the projected term of patent protection; |
|
|
• |
estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital; |
|
|
• |
developments and projections relating to our competitors and our industry, including competing therapies and procedures; |
|
|
• |
regulatory and legal developments in the United States and foreign countries; |
|
|
• |
the performance of our third-party suppliers and manufacturers; |
|
|
• |
our ability to attract and retain key management, scientific and medical personnel; |