Aligos Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Aligos Therapeutics filed its 2023 10-K, detailing financial performance, business operations, and key agreements.</b>

AI Summary

Aligos Therapeutics, Inc. (ALGS) filed a Annual Report (10-K) with the SEC on March 12, 2024. Aligos Therapeutics, Inc. filed its 2023 Form 10-K on March 12, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business is in Biological Products (No Diagnostic Substances). Key agreements mentioned include those with Emory University, Katholieke Universiteit Leuven, and Merck. The filing details various stock and warrant plans, including the 2018 Equity Incentive Plan and the 2020 Employee Stock Purchase Plan.

Why It Matters

For investors and stakeholders tracking Aligos Therapeutics, Inc., this filing contains several important signals. This 10-K provides a comprehensive overview of Aligos Therapeutics' financial health and strategic partnerships for the fiscal year 2023, crucial for investors assessing the company's trajectory. The detailed information on licensing agreements and stock plans offers insights into the company's R&D strategy, potential future revenue streams, and executive compensation structures.

Risk Assessment

Risk Level: — Aligos Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the highly competitive and regulated biotechnology sector, with significant R&D expenses and reliance on successful drug development and partnerships, as evidenced by the numerous license agreements and research collaborations mentioned.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand the company's current financial position and future prospects, particularly concerning its drug development pipeline and commercialization strategies.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period end date)
• 2024-03-12 — Filing Date (Date the 10-K was filed)
• 2836 — SIC Code (Standard Industrial Classification for Biological Products)

Key Players & Entities

• Aligos Therapeutics, Inc. (company) — Filer name
• Merck (company) — Mentioned in relation to license and research collaboration agreements.
• Emory University (company) — Mentioned in relation to license agreements.
• Katholieke Universiteit Leuven (company) — Mentioned in relation to license agreements.
• National Institute of Health (NIH) (company) — Mentioned in relation to a grant for research.

FAQ

Risk Factors

• Research and Development Expenses [high — financial]: The company incurs significant research and development expenses, which are critical to its business operations and future success.
• Regulatory Approval Process [high — regulatory]: The development and commercialization of pharmaceutical products are subject to extensive regulatory review and approval processes.
• Competition [medium — market]: The biotechnology and pharmaceutical markets are highly competitive, with numerous companies developing similar therapies.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-12: 10-K Filing Date — Date Aligos Therapeutics submitted its annual report.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), giving a comprehensive summary of a company's financial performance. (This is the primary document filed by Aligos Therapeutics, providing detailed financial and operational information.)

Research and Development Expense

Costs incurred by a company in the process of developing new products or services. (Crucial for understanding Aligos Therapeutics' investment in innovation and future growth potential.)

Key Financial Figures

• $0.0001 — h registered Common Stock, par value, $0.0001 per share ALGS The Nasdaq Stock Mar
• $11.0 million — act. We expect to receive approximately $11.0 million in funds across these two NIH awards an

Filing Documents

• algs-20231231.htm (10-K) — 2820KB
• algs-ex10_16.htm (EX-10.16) — 92KB
• algs-ex10_17.htm (EX-10.17) — 87KB
• algs-ex10_18.htm (EX-10.18) — 119KB
• algs-ex23_1.htm (EX-23.1) — 9KB
• algs-ex31_1.htm (EX-31.1) — 16KB
• algs-ex31_2.htm (EX-31.2) — 15KB
• algs-ex32_1.htm (EX-32.1) — 10KB
• algs-ex32_2.htm (EX-32.2) — 11KB
• algs-ex97_1.htm (EX-97.1) — 41KB
• img16670836_0.jpg (GRAPHIC) — 41KB
• img16670836_1.jpg (GRAPHIC) — 41KB
• img16670836_2.jpg (GRAPHIC) — 44KB
• img16670836_3.jpg (GRAPHIC) — 24KB
• img16670836_4.jpg (GRAPHIC) — 12KB
• img16670836_5.jpg (GRAPHIC) — 11KB
• img16670836_6.jpg (GRAPHIC) — 28KB
• img16670836_7.jpg (GRAPHIC) — 28KB
• img16670836_8.jpg (GRAPHIC) — 84KB
• 0000950170-24-029953.txt (&nbsp;) — 12225KB
• algs-20231231.xsd (EX-101.SCH) — 1750KB
• algs-20231231_htm.xml (XML) — 1780KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 92 Item 1C. Cybersecurity 92 Item 2.

Properties

Properties 93 Item 3.

Legal Proceedings

Legal Proceedings 93 Item 4. Mine Safety Disclosures 94 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 95 Item 6. [Reserved] 95 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 96 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 107 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 108 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 141 Item 9A.

Controls and Procedures

Controls and Procedures 141 Item 9B. Other Information 141 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 142 PART III Item 10. Directors, Executive Officers and Corporate Governance 143 Item 11.

Executive Compensation

Executive Compensation 143 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 143 Item 13. Certain Relationships and Related Transactions, and Director Independence 143 Item 14. Principal Accounting Fees and Services 143 PART IV Item 15. Exhibits, Financial Statement Schedules 144 Item 16. Form 10-K Summary 144 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-055009, ALG000184, ALG097558 and ALG125755 clinical trials; the scope, progress, results and costs related to th

B usiness

Item 1. B usiness. Overview We are a clinical-stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver diseases and viral infections, including in the areas of metabolic dysfunction associated steatohepatitis (MASH), chronic hepatitis B (CHB) and coronavirus (e.g., SARS-CoV-2 and related infections). We utilize our proprietary small molecule and oligonucleotide platforms to develop pharmacologically optimized drug candidates designed to achieve improved treatment outcomes. Our primary area of focus is MASH, a complex, chronic liver disease where combination regimens may prove beneficial. Our most advanced drug candidate for MASH is ALG055009, a small molecule thyroid hormone receptor beta (THR) agonist. This drug candidate recently completed evaluation in a Phase 1 study in healthy volunteers (HVs) (oral single ascending doses (SAD)) and in subjects with hyperlipidemia (14 oral daily doses). Clinical data after single doses up to 4 mg and multiple doses up to 1 mg showed that ALG055009 was well tolerated, had dose proportional pharmacokinetics (PK) with low intersubject variability, and demonstrated expected thyromimetic effects (i.e., generally dose proportional increases in sex hormone binding globulin and decreases in various atherogenic lipids and thyroid hormones). In this same study, we have also evaluated relative bioavailability where we have shown the soft gelatin capsules to be used on Phase 2 studies, delivers similar exposures compared to the solution used in Phase 1 studies; we observed low intersubject PK variability and there was no evidence of a meaningful food effect. Currently, we are initiating a Phase 2a proof of concept study (HERALD) under an amendment to an open investigational new drug application (IND). The study's design is a 12-week randomized, placebo-controlled trial evaluating 4 doses of ALG-055009 vs. placebo in approximately 100 subjects with presumed liver fibrosis stage 1

View Full Filing

View this 10-K filing on SEC EDGAR