Welcome to our dedicated page for Avenue Therapeutics SEC filings (Ticker: ATXI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Avenue Therapeutics files regulatory documents revealing the operational and financial details of a clinical-stage pharmaceutical company advancing pain management and neurological therapies through FDA approval pathways. The company's SEC filings provide transparency into research progress, capital requirements, clinical trial designs, and regulatory interactions that shape the development timeline for investigational drugs.
Quarterly reports (10-Q) and annual reports (10-K) detail Avenue's financial position, including cash runway projections, research and development expenditures, and explanations of clinical trial costs. These filings break down spending across programs, explain the rationale for regulatory strategies, and disclose material developments in FDA communications. For clinical-stage biotechnology companies, understanding burn rate and capital sufficiency is essential for assessing the company's ability to complete planned studies.
Form 8-K filings capture material events such as clinical trial milestone achievements, regulatory correspondence, partnership agreements, or changes in capital structure. These real-time disclosures often precede detailed explanations in subsequent quarterly reports. Proxy statements (DEF 14A) reveal executive compensation structures, board composition, and governance matters, providing insight into how the company aligns management incentives with shareholder interests during the high-risk development phase.
Form 4 insider transaction reports track purchases and sales by executives and directors, which can signal management's confidence in development prospects. For small specialty pharmaceutical companies, insider activity patterns may reflect views on upcoming regulatory decisions or clinical data readouts. Our AI summaries extract key financial metrics, highlight material regulatory updates, and explain complex clinical trial designs without requiring you to review hundreds of pages of technical disclosure.
Fortress Biotech, Inc. filed Amendment No. 8 to its Schedule 13D for Avenue Therapeutics, Inc., reporting beneficial ownership of 439,955 shares of Avenue common stock, equal to 13.4% of the outstanding common shares. This total includes 250,000 shares of Class A preferred stock, which are convertible into 222 shares of common stock and are structured so that the Class A preferred will at all times constitute a voting majority. Fortress owns all outstanding Class A preferred shares, giving it majority voting control despite a minority economic stake.
Fortress’s ownership also reflects an Annual Equity Grant under a Founders Agreement, through which Avenue issues to Fortress each year shares equal to 2.5% of Avenue’s fully diluted outstanding equity. In addition, as holder of the Class A preferred, Fortress is entitled each January 1 to stock dividends in Avenue common equal to 2.5% of Avenue’s fully diluted outstanding capitalization. The filing notes 296 Avenue common shares underlying outstanding warrants granted by Fortress to two of its executives, with Fortress retaining sole voting power but shared dispositive power over those warrant shares.
Avenue Therapeutics, Inc. reported an insider stock award linked to preferred stock dividends. A reporting person who is both a director and a 10% owner received 111,209 shares of common stock on 01/02/2026 at a price of $0. These shares were granted as the 2025 annual dividend on the holder’s Class A Preferred Stock, which is entitled to a 2.5% annual dividend based on Avenue’s fully diluted outstanding capitalization on December 31. After this grant, the reporting person beneficially owned 439,733 shares of Avenue Therapeutics common stock in direct ownership.
Avenue Therapeutics, Inc. reported the results of its 2025 annual meeting of stockholders held virtually on December 30, 2025. Stockholders elected six directors to serve until the 2026 annual meeting and ratified the appointment of KPMG LLP as the company’s independent registered public accounting firm for the year ending December 31, 2025.
As of the November 25, 2025 record date, 3,183,426 shares of common stock and 250,000 shares of Class A preferred stock were outstanding and entitled to vote, representing 3,183,426 and 3,500,000 votes, respectively. Each director nominee received between 3,861,558 and 3,862,060 votes in favor, with just over 100,000 votes withheld and no broker non-votes. The auditor ratification received 3,862,335 votes for, 104,651 against, and 1,010 abstentions, indicating strong support from voting stockholders.
Avenue Therapeutics is registering 731,061 shares of common stock for resale by existing warrant holders. These shares consist of 689,680 Series C Warrant Shares with a $6.20 exercise price and 41,381 Placement Agent Warrant Shares with a $7.75 exercise price. The company will not receive proceeds from stockholder resales, but would receive cash if the warrants are exercised.
This post-effective amendment moves a prior resale registration from Form S-3 to Form S-1 after Avenue’s common stock was delisted from Nasdaq and began trading on the OTCID Market under the symbol “ATXI.” On December 11, 2025, 3,183,558 shares of common stock were outstanding; this is a baseline figure, not the amount being offered.
Avenue is a specialty pharmaceutical company developing intravenous tramadol for post-operative acute pain, with a Phase 3 safety study protocol and statistical plan agreed with the FDA, and study initiation dependent on additional financing or a partnership. In November 2025 it sold subsidiary Baergic Bio, transferring epilepsy candidate BAER-101 to Axsome Therapeutics for a $0.3 million upfront payment plus contingent milestones and royalties, and in April 2025 it terminated its AnnJi AJ201 license in exchange for $2.0 million in scheduled payments while returning product rights to AnnJi.
Avenue Therapeutics, Inc. (ATXI) is asking stockholders to vote at its all-virtual 2025 Annual Meeting on December 30, 2025. Stockholders will elect six directors for one-year terms and ratify the appointment of KPMG LLP as independent registered public accounting firm for the year ending December 31, 2025.
The proxy describes a six‑member board with a majority of independent directors and details audit and compensation committee structures, meeting attendance, and director qualifications. It explains that Fortress Biotech, Inc. beneficially owns more than 50% of the voting power and that Avenue relies on “controlled company” exemptions while still maintaining key independent oversight.
The filing outlines 2023–2024 executive and director compensation, including salaries, bonuses, stock options, and RSUs, as well as a new clawback policy and equity plan capacity of 4,575,701 shares available for future issuance. It also summarizes significant related‑party arrangements with Fortress, the 2022 acquisition and 2025 sale of Baergic, and the termination and transfer of the AJ201 program back to AnnJi, under which Avenue received $1.6 million in other revenue and agreed to a 48‑month non‑compete for competing products in key markets.
Avenue Therapeutics, Inc. has scheduled its 2025 annual meeting of stockholders for December 30, 2025. The exact time and location will be provided in the company’s definitive proxy statement on Schedule 14A to be filed with the SEC.
Stockholders who want their proposals included in the proxy statement under SEC Rule 14a-8 must ensure the company receives them by November 28, 2025 and that they meet all requirements of the Exchange Act and the company’s Second Amended and Restated Bylaws. Proposals or director nominations submitted outside Rule 14a-8, including those using universal proxy rules to solicit support for alternate director nominees, also require written notice to the Corporate Secretary by November 28, 2025 at the company’s Florida headquarters address.
Avenue Therapeutics (ATXI) reported Q3 2025 results showing a net loss of $0.7 million, narrowing from the prior year. For the nine months, net loss was $2.2 million. Operating expenses fell sharply in Q3 to $0.7 million (R&D $0.18 million; G&A $0.55 million) versus $3.2 million a year ago. The company recognized $1.4 million of other revenue year-to-date tied to the AnnJi AJ201 termination and program transfer.
Cash and cash equivalents were $3.709 million at September 30, 2025. Avenue raised $2.094 million earlier in 2025 via its ATM before losing Nasdaq eligibility; the stock now trades on the OTC market. Management disclosed substantial doubt about the ability to continue as a going concern and said additional financing is needed to support a potential Phase 3 safety study of IV tramadol.
Shares outstanding were 3,183,558 as of November 12, 2025. Subsequent to quarter-end, Avenue sold Baergic to Axsome for $0.3 million upfront plus potential milestones and royalties.
Avenue Therapeutics entered a definitive agreement to sell 100% of its majority‑owned subsidiary Baergic Bio to Axsome Therapeutics for an upfront payment of $0.3 million (less transaction fees), plus contingent consideration. Axsome also obtained worldwide commercial, development, and manufacturing rights to BAER‑101, now referred to as AXS‑17, including all available nonclinical and clinical data.
Former Baergic stockholders, including Avenue, are eligible for up to $2.5 million in development and regulatory milestones for the first indication of AXS‑17 and $1.5 million for each additional indication; up to $79 million in commercial sales milestones; and a tiered mid‑to‑high single‑digit royalty on potential global net sales. Avenue expects to receive approximately 74% of all future payments and royalties under the agreement.
In connection with the disposition, Baergic approved equity awards that vest at closing: 443,578 restricted shares to CEO Alexandra MacLean, M.D. and 266,147 restricted shares to CFO/COO David Jin, entitling them to a portion of future payments and royalties tied to the agreement.
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