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

TL;DR

<b>Avenue Therapeutics, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

AVENUE THERAPEUTICS, INC. (ATXI) filed a Annual Report (10-K) with the SEC on March 18, 2024. Avenue Therapeutics, Inc. filed its 2023 Form 10-K on March 18, 2024. The company's fiscal year ends on December 31st. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal executive offices are located at 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154. The business phone number is 781-652-4500.

Why It Matters

For investors and stakeholders tracking AVENUE THERAPEUTICS, INC., this filing contains several important signals. This filing provides a comprehensive overview of Avenue Therapeutics' financial health, operational status, and strategic direction for investors and stakeholders. As a pharmaceutical company, the 10-K filing is crucial for understanding its progress in drug development, regulatory compliance, and market positioning.

Risk Assessment

Risk Level: medium — AVENUE THERAPEUTICS, INC. shows moderate risk based on this filing. The company is in the pharmaceutical industry, which is subject to significant regulatory hurdles, lengthy development cycles, and substantial R&D costs, as indicated by the nature of its business and typical industry risks.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess the company's current financial position and future prospects.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-18 — Filing Date (10-K submission date)

Key Players & Entities

• AVENUE THERAPEUTICS, INC. (company) — Filer name
• ATXI (company) — Ticker symbol
• 2024-03-18 (date) — Filing date
• 2023-12-31 (date) — Fiscal year end
• 1111 KANE CONCOURSE, SUITE 301, BAY HARBOR ISLANDS, FL 33154 (address) — Business address
• 781-652-4500 (phone) — Business phone

FAQ

Industry Context

Avenue Therapeutics operates in the pharmaceutical industry, focusing on the development and commercialization of therapies. This sector is characterized by high R&D investment, stringent regulatory oversight, and significant market competition.

Regulatory Implications

As a pharmaceutical company, Avenue Therapeutics is subject to extensive regulation by bodies such as the FDA, governing drug development, clinical trials, manufacturing, and marketing.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section for potential challenges and uncertainties facing the company.
3. Monitor future filings for updates on clinical trial progress and regulatory milestones.

Key Dates

• 2024-03-18: 10-K Filing — Annual report submission for fiscal year 2023
• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K

Year-Over-Year Comparison

This is the 2023 Form 10-K filing, providing updated information compared to previous filings.

Key Financial Figures

• $0.0001 — h registered) Common Stock, par value $0.0001 per share ATXI Nasdaq Capital Marke

Filing Documents

• atxi20221231_10k.htm (10-K) — 1792KB
• ex_631260.htm (EX-4.3) — 55KB
• ex_640800.htm (EX-10.19) — 46KB
• ex_597578.htm (EX-21.1) — 2KB
• ex_597579.htm (EX-23.1) — 3KB
• ex_597581.htm (EX-31.1) — 13KB
• ex_597582.htm (EX-31.2) — 13KB
• ex_597583.htm (EX-32.1) — 5KB
• ex_597584.htm (EX-32.2) — 5KB
• ex_635063.htm (EX-97.1) — 28KB
• ksig.jpg (GRAPHIC) — 2KB
• 0001437749-24-008294.txt (&nbsp;) — 6912KB
• atxi-20231231.xsd (EX-101.SCH) — 61KB
• atxi-20231231_cal.xml (EX-101.CAL) — 25KB
• atxi-20231231_def.xml (EX-101.DEF) — 413KB
• atxi-20231231_lab.xml (EX-101.LAB) — 381KB
• atxi-20231231_pre.xml (EX-101.PRE) — 435KB
• atxi20221231_10k_htm.xml (XML) — 806KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 25 Item 1B. Unresolved Staff Comments 52 Item 1C. Cybersecurity 52 Item 2.

Properties

Properties 52 Item 3.

Legal Proceedings

Legal Proceedings 52 Item 4. Mine Safety Disclosures 52 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 52 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 54 Item 8. Consolidated Financial Statements and Supplementary Data 62 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 62 Item 9A.

Controls and Procedures

Controls and Procedures 62 Item 9B. Other Information 62 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 63 PART III Item 10. Directors, Executive Officers and Corporate Governance 63 Item 11.

Executive Compensation

Executive Compensation 63 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 63 Item 13. Certain Relationships and Related Transactions, and Director Independence 63 Item 14. Principal Accountant Fees and Services 63 PART IV Item 15. Exhibits and Consolidated Financial Statement Schedules 64 Item 16. Form 10-K Summary 67 Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain matters discussed in this report may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended (the "Securities Act"), and the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of current or historical fact contained in this report, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "predict," "should," "project," "will," "would," and similar expressions are generally intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: the fact that we currently have no drug products for

Business

Item 1. Business Overview Avenue Therapeutics, Inc. ("Avenue" or the "Company") is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. Our current product candidates include AJ201 for the treatment of spinal and bulbar muscular atrophy ("SBMA"), intravenous tramadol ("IV tramadol") for the treatment of post-operative acute pain, and BAER-101 for the treatment of epilepsy and panic disorders. We may in the future acquire additional product candidates. In February 2023, we announced that we entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. ("AnnJi") whereby the Company obtained an exclusive license from AnnJi to intellectual property rights pertaining to the molecule known as JM17, which activates Nrf1 and Nrf2, enhances androgen receptor degradation and underlies AJ201, a clinical product candidate currently in a Phase 1b/2a clinical trial in the United States ("U.S.") for the treatment of SBMA, also known as Kennedy's Disease. In November 2022, we completed a Share Contribution Agreement, dated May 11, 2022 (the "Share Contribution Agreement") with Fortress Biotech, Inc ("Fortress") to acquire the shares in Baergic Bio, Inc. ("Baergic"), which is developing BAER-101, a novel 2/3–subtype-selective gamma-aminobutyric acid ("GABA") A positive allosteric modulator ("PAM"). As a result, Baergic is a majority-controlled and owned subsidiary company of Avenue. We have been developing IV tramadol since inception of the Company and prior to our initial public offering in 2017. As used throughout this filing, the words "we", "us" and "our" may refer to Avenue individually or together with our subsidiary, Baergic, each as dictated by context. We are a majority-controlled subsidiary of Fortress. Product Candidates Under Development AJ201 AJ201 is a novel, first-in-class asset in development for the treatment of SBMA. It was designed to modify SBMA through mult

View Full Filing

View this 10-K filing on SEC EDGAR