Avalo Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Avalo Therapeutics, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

Avalo Therapeutics, Inc. (AVTX) filed a Annual Report (10-K) with the SEC on March 29, 2024. Avalo Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company was formerly known as Cerecor Inc., with a name change effective November 2, 2011. Avalo Therapeutics operates in the Pharmaceutical Preparations industry (SIC code 2834). The filing includes financial data for the fiscal years 2023 and 2022. The company's principal executive offices are located at 540 Gaither Road, Suite 400, Rockville, MD 20850.

Why It Matters

For investors and stakeholders tracking Avalo Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Avalo Therapeutics' financial health and strategic direction for the fiscal year 2023, crucial for investors assessing the company's current standing and future prospects. As a pharmaceutical preparations company, the detailed financial disclosures in this report are essential for understanding its operational costs, revenue streams, and overall market position within the biotech sector.

Risk Assessment

Risk Level: medium — Avalo Therapeutics, Inc. shows moderate risk based on this filing. The company's financial performance and operational status are detailed in this 10-K, which is a standard disclosure for public companies. However, specific financial figures and growth rates are not provided in the initial filing header, requiring a deeper dive into the document for a full assessment.

Analyst Insight

Review the full 10-K filing to analyze Avalo Therapeutics' financial statements, risk factors, and management discussion for a comprehensive understanding of its business and investment potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period)
• 2024-03-29 — Filing Date (Date of submission)
• 2011-11-02 — Date of Name Change (Former name Cerecor Inc.)

Key Players & Entities

• Avalo Therapeutics, Inc. (company) — Filer name
• Cerecor Inc. (company) — Former company name
• 2023-12-31 (date) — Fiscal year end
• 2024-03-29 (date) — Filing date
• Rockville, MD (location) — Business address city and state
• 2834 (industry_code) — Standard Industrial Classification

FAQ

Industry Context

Avalo Therapeutics operates within the pharmaceutical preparations sector, focusing on the development and commercialization of therapeutic products.

Regulatory Implications

As a publicly traded company, Avalo Therapeutics is subject to the reporting requirements of the Securities and Exchange Commission (SEC), including the annual filing of Form 10-K.

What Investors Should Do

1. Thoroughly review the financial statements and notes within the 10-K for detailed revenue, expenses, and cash flow information.
2. Examine the 'Risk Factors' section to understand potential challenges and uncertainties facing Avalo Therapeutics.
3. Analyze the 'Management's Discussion and Analysis of Financial Condition and Results of Operations' for insights into the company's performance drivers and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-29: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This filing represents the annual report for the fiscal year ended December 31, 2023, superseding previous filings and providing updated financial and operational data.

Key Financial Figures

• $0.001 — ange on which registered Common Stock, $0.001 Par Value AVTX Nasdaq Capital Market
• $70 million — 2023. Avalo is required to pay up to $70 million based on the achievement of specified d
• $720 million — ales-based milestones aggregating up to $720 million. Additionally, Avalo 1 Table of Cont
• $7.5 million — the Company will make a cash payment of $7.5 million due to the former AlmataBio stockholder
• $5 million — former AlmataBio stockholders including $5 million due upon the first patient dosed in a P
• $15 million — dradenitis suppurativa for AVTX-009 and $15 million due upon the first patient dosed in a P
• $10 million — pany paid KKC an upfront license fee of $10 million. Avalo is also required to pay KKC up t
• $112.5 million — quired to pay KKC up to an aggregate of $112.5 million based on the achievement of specified d
• $75 million — stone payments to KKC aggregating up to $75 million tied to the achievement of annual net s
• $24 million — ford Burnham Prebys up to approximately $24 million based on the achievement of specified d
• $50 million — ales-based milestones aggregating up to $50 million tied to the achievement of annual net s

Filing Documents

• avtx-20231231.htm (10-K) — 1895KB
• ex-32fifthamendedandrestat.htm (EX-3.2) — 137KB
• ex-2312023.htm (EX-23.1) — 16KB
• ex-3112023.htm (EX-31.1) — 10KB
• ex-3122023.htm (EX-31.2) — 10KB
• ex-3212023.htm (EX-32.1) — 11KB
• avtx-20231231_g1.jpg (GRAPHIC) — 481KB
• 0001628280-24-013786.txt (&nbsp;) — 9812KB
• avtx-20231231.xsd (EX-101.SCH) — 67KB
• avtx-20231231_cal.xml (EX-101.CAL) — 80KB
• avtx-20231231_def.xml (EX-101.DEF) — 357KB
• avtx-20231231_lab.xml (EX-101.LAB) — 805KB
• avtx-20231231_pre.xml (EX-101.PRE) — 578KB
• avtx-20231231_htm.xml (XML) — 898KB

Risk Factors

Item 1A. Risk Factors 12

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 44

Cybersecurity

Item 1C. Cybersecurity 44

Properties

Item 2. Properties 45

Legal Proceedings

Item 3. Legal Proceedings 46

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 46 PART II 47

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 47

Reserved

Item 6. Reserved 48

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

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 49

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 57

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 57

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 57

Controls and Procedures

Item 9A. Controls and Procedures 57

Other Information

Item 9B. Other Information 58

Disclosure Regarding Foreign Jurisdictions that Prevent Inspection

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 58 PART III 59

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 59

Executive Compensation

Item 11. Executive Compensation 63

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

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 68

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 70

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 72 PART IV 73

Exhibits; Financial Statement Schedules

Item 15. Exhibits; Financial Statement Schedules 73

Form 10-K Summary

Item 16. Form 10-K Summary 81 i Table of Contents PART I SPECIAL NOTE REGARDING FORWARDLOOKING STATEMENTS This report and the information incorporated herein by reference contain forward-looking statements that involve a number of risks and uncertainties, as well as assumptions that, if they never materialize or if they prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Although our forward-looking statements reflect the good faith judgment of our management, these statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in the forward-looking statements. Forward-looking statements can be identified by the use of forward-looking words such as "projects," "may," "might," "will," "could," "would," "should," "continue," "seeks," "aims," "predicts," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "pro forma" or other similar words (including their use in the negative), or by discussions of future matters such as: the future financial and operational outlook; the development of product candidates; and other statements that are not historical. These statements include but are not limited to statements under the captions "Business," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" as well as other sections in this report. You should be aware that the occurrence of any of the events discussed under the caption "Risk Factors" and elsewhere in this report could substantially harm our business, results of operations and financial condition and cause our results to differ materially from those expressed or implied by our forward-looking statements. If any of these events occurs, the trading price of o

Business

Item 1. Business. Overview Avalo Therapeutics, Inc. (the "Company", "Avalo" or "we") is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo's lead asset is AVTX-009, an anti-IL-1 monoclonal antibody ("mAb"), targeting inflammatory diseases. Avalo's pipeline also includes quisovalimab (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein). Avalo was incorporated in Delaware and commenced operation in 2011, and completed its initial public offering in October 2015. Our Strategy Our strategy for increasing stockholder value includes: Advancing our pipeline of compounds through development to regulatory approval; Developing the go-to-market strategy to quickly and effectively market, launch, and distribute each of our compounds that receive regulatory approval; Opportunistically out-licensing rights to indications or geographies; and Acquiring or in-licensing rights to targeted, complementary differentiated preclincal and clinical stage compounds. Pipeline — Overview, Competition, and Intellectual Property AVTX-009: Anti-IL-1 monoclonal antibody ("mAb") targeting inflammatory diseases. Overview: AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1 ("IL-1") with high affinity and neutralizes its activity. IL-1 is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1 is implicated in many autoimmune and inflammatory diseases. IL-1 is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1 could be effective in HS and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology. Competition: As of the date of this report, and to our knowledge, AVTX-009 is one of three anti-IL-1 antibodies in clinical development worldwide. Currently, worldwide there are two drugs approved for hidradenitis suppurativa ("HS"). License: AVTX-009 is being developed through a world-wide exclusive lic

View Full Filing

View this 10-K filing on SEC EDGAR