Financial Data and Key Metrics Changes - The company held its 2025 Annual Meeting of Stockholders, confirming a quorum was present, indicating strong shareholder engagement [3][4] - The appointment of KPMG LLP as the independent registered public accounting firm for the 2025 fiscal year was ratified, reflecting confidence in the company's financial oversight [6][8] Business Line Data and Key Metrics Changes - No specific financial data or business line metrics were provided in the meeting records Market Data and Key Metrics Changes - No specific market data or metrics were discussed in the meeting records Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining strong governance with the election of directors to serve until the 2026 Annual Meeting, indicating a commitment to stability and continuity in leadership [4][5] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during the meeting Other Important Information - The meeting concluded with an invitation for questions from shareholders, indicating an open line of communication for stakeholder engagement [9] Q&A Session Summary - No questions or answers were recorded during the meeting, as the focus was primarily on formal business and the election of directors [9][10]

Financial Data and Key Metrics Changes - The company held its 2025 Annual Meeting of Stockholders, confirming a quorum was present, indicating strong shareholder engagement [3][4] - The appointment of KPMG LLP as the independent registered public accounting firm for the 2025 fiscal year was ratified, reflecting confidence in the company's financial oversight [6][8] Business Line Data and Key Metrics Changes - No specific financial data or business line metrics were provided in the meeting records Market Data and Key Metrics Changes - No specific market data or metrics were discussed in the meeting records Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining strong governance with the election of directors to serve until the 2026 Annual Meeting, indicating a commitment to stability and continuity in leadership [4][5] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during the meeting Other Important Information - The meeting concluded with an invitation for questions from shareholders, indicating an open line of communication for stakeholder engagement [9] Q&A Session Summary - No questions or answers were recorded during the meeting, as the focus was primarily on formal business and the election of directors [9][10]

Financial Data and Key Metrics Changes - The meeting confirmed the election of directors and the ratification of KPMG LLP as the independent registered public accounting firm for the 2025 fiscal year, indicating stable governance and oversight [4][7]. Business Line Data and Key Metrics Changes - No specific financial data or business line metrics were discussed in the provided content. Market Data and Key Metrics Changes - No specific market data or metrics were discussed in the provided content. Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining strong governance through the election of experienced directors and the appointment of reputable auditors, which is crucial for its strategic direction [4][6]. Management Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook in the provided content. Other Important Information - The meeting was conducted virtually, allowing stockholders to participate and vote online, reflecting a modern approach to shareholder engagement [2][5]. Q&A Session Summary - No questions or answers were recorded in the provided content.

Financial Performance - For the nine months ended September 30, 2025, Avenue Therapeutics reported a net loss of approximately $2.2 million, compared to a net loss of $10.1 million for the same period in 2024, indicating a significant reduction in losses [107]. - As of September 30, 2025, Avenue Therapeutics had an accumulated deficit of approximately $104.8 million, primarily due to research and development and general administrative costs [107]. - For the three months ended September 30, 2025, total operating expenses decreased by 77% to $724,000 from $3.2 million in the same period of 2024 [133]. - The net loss for the three months ended September 30, 2025, was $692,000, a reduction of 78% compared to a net loss of $3.1 million in 2024 [133]. - For the nine months ended September 30, 2025, total operating expenses were $3.7 million, a decrease of 61% from $9.7 million in 2024 [140]. - General and administrative expenses for the nine months ended September 30, 2025, were $3.0 million, down 18% from $3.6 million in 2024 [147]. - The company reported a net cash decrease of $979,000 from operating activities for the nine months ended September 30, 2025, compared to a decrease of $8.3 million for the same period in 2024 [153]. Research and Development - Avenue Therapeutics plans to continue incurring operating losses for the foreseeable future as it develops its product candidates [108]. - Avenue Therapeutics is currently evaluating the feasibility of a Phase 3 safety study for IV tramadol, which is subject to obtaining necessary financing or partnerships [121]. - The FDA has agreed on the majority of the proposed protocol items for the IV tramadol study, which will assess the risk of opioid-induced respiratory depression [120]. - The company expects a decrease in research and development activities due to no further development obligations for certain products, while continuing efforts to gain regulatory approval for existing candidates [136][146]. - Research and development expenses for the three months ended September 30, 2025, were $177,000, down 92% from $2.3 million in 2024, primarily due to reduced clinical development costs [133][135]. Financing and Capital Structure - The company intends to raise additional capital through the sale of debt or equity securities, but there is no assurance that it will be able to do so on acceptable terms [109]. - As of September 30, 2025, the company had $3.7 million in cash and cash equivalents, requiring additional financing to sustain operations beyond 12 months [152]. - Financing activities provided $2.1 million in cash for the nine months ended September 30, 2025, primarily from the sale of common stock [156]. - The common stock was suspended from trading on the Nasdaq Capital Market on March 17, 2025, and subsequently delisted on July 18, 2025, affecting funding opportunities [152]. - The company is evaluating various financing alternatives to enhance its capital structure amid liquidity challenges [152]. Licensing and Agreements - Avenue Therapeutics entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. for the AJ201 product candidate, paying an initial cash license fee of $3.0 million and agreeing to additional payments of up to $10.8 million [115]. - The company terminated the AnnJi License Agreement on April 24, 2025, transferring all rights related to AJ201 back to AnnJi [116]. - Avenue Therapeutics sold its former product candidate BAER-101 to Axsome for an upfront payment of $0.3 million and is eligible to receive approximately 74% of future payments and royalties under the Baergic Agreement [124][125]. - The company has contractual obligations totaling approximately $81.5 million in development milestones and up to $151.0 million in commercial milestones related to licensing agreements [159]. - A regulatory milestone payment of $3.0 million is due upon approval of IV tramadol, with royalties payable on net sales in the low to high single digits [160]. Other Financial Metrics - The company generated $1.4 million in net revenue for the nine months ended September 30, 2025, related to the AnnJi license termination, with no revenue recognized in the same period of 2024 [143]. - Interest income for the three months ended September 30, 2025, was $34,000, a decrease of 33% from $51,000 in 2024 [138]. - The change in fair value of warrant liabilities resulted in a loss of approximately $2,000 for the three months ended September 30, 2025, compared to a gain of $18,000 in 2024 [139]. - The company has paid $0.2 million and $0.7 million towards a share repurchase agreement with InvaGen for the nine months ended September 30, 2025, and 2024, respectively [161].

Core Viewpoint - Avenue Therapeutics has announced the acquisition of its subsidiary Baergic Bio by Axsome Therapeutics, which includes the global rights to BAER-101, a novel therapy for epilepsy, potentially enhancing treatment options in a field with high unmet needs [1][2][7]. Company Overview - Avenue Therapeutics, Inc. is a specialty pharmaceutical company focused on developing therapies for neurologic diseases, headquartered in Miami, FL, and founded by Fortress Biotech, Inc. [5]. Transaction Details - The acquisition involves Axsome obtaining worldwide commercial, development, and manufacturing rights to BAER-101, with Baergic shareholders eligible for up to approximately $82 million in potential payments, including a $0.3 million upfront payment and milestone payments based on development and sales achievements [1][7]. - Avenue expects to receive approximately 74% of all future payments and royalties under the agreement [7]. Product Information - BAER-101, now referred to as AXS-17 by Axsome, has shown a promising safety and tolerability profile in clinical studies involving over 700 patients and is being evaluated for its anti-convulsant effects in epilepsy [3][2].

[PART I. FINANCIAL INFORMATION](index=2&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's analysis of financial condition and operations [Item 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Avenue Therapeutics, Inc., including the balance sheets, statements of operations, statements of changes in stockholders' equity, and statements of cash flows, along with accompanying notes [Unaudited Condensed Consolidated Balance Sheets](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 ($ in thousands) | December 31, 2024 ($ in thousands) | | :----------------------------------- | :------------------------------- | :--------------------------------- | | Cash and cash equivalents | 3,326 | 2,594 | | Total assets | 4,161 | 2,672 | | Total current liabilities | 1,329 | 816 | | Total liabilities | 1,329 | 816 | | Total stockholders' equity | 2,832 | 1,856 | - Total assets increased by **$1,489 thousand** from December 31, 2024, to June 30, 2025, primarily due to an increase in cash and cash equivalents and a new receivable from a license termination agreement[9](index=9&type=chunk) - Total stockholders' equity increased by **$976 thousand**, driven by changes in additional paid-in capital and a reduction in accumulated deficit[9](index=9&type=chunk) [Unaudited Condensed Consolidated Statements of Operations](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) The financial statements reflect the company's financial performance for the periods ended June 30, 2025, highlighting a net income for the three months ended June 30, 2025, compared to a net loss in the prior year, and a reduced net loss for the six months ended June 30, 2025 | Metric | Three Months Ended June 30, 2025 ($ in thousands) | Three Months Ended June 30, 2024 ($ in thousands) | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Other revenue | 1,404 | — | 1,404 | — | | Research and development expenses | 192 | 1,361 | 603 | 3,752 | | General and administrative expenses | 915 | 1,462 | 2,408 | 2,778 | | Net income (loss) | 329 | (2,701) | (1,529) | (7,050) | | Net income (loss) attributable to Avenue | 335 | (2,692) | (1,517) | (7,032) | | Net income (loss) per common share (basic & diluted) | 0.11 | (6.43) | (0.49) | (18.86) | - The company reported a net income of **$329 thousand** for the three months ended June 30, 2025, a significant improvement from a net loss of **$2,701 thousand** in the same period of 2024, primarily due to **$1.4 million** in other revenue from the AnnJi license termination and reduced operating expenses[12](index=12&type=chunk) - For the six months ended June 30, 2025, the net loss decreased to **$1,529 thousand** from **$7,050 thousand** in the prior year, driven by the new revenue stream and substantial reductions in research and development expenses[12](index=12&type=chunk) [Unaudited Condensed Consolidated Statement of Changes in Stockholders' Equity](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Stockholders'%20Equity) This section details changes in stockholders' equity, including additional paid-in capital and accumulated deficit, for the six months ended June 30, 2025 | Metric | Balance at Dec 31, 2024 ($ in thousands) | Balance at June 30, 2025 ($ in thousands) | | :-------------------------------- | :------------------------------------- | :------------------------------------ | | Additional paid-in capital | 105,377 | 108,155 | | Accumulated deficit | (102,580) | (104,097) | | Total stockholders' equity | 1,856 | 2,832 | - Additional paid-in capital increased by **$2,778 thousand** for the six months ended June 30, 2025, primarily due to ATM sales of common stock and share-based compensation[16](index=16&type=chunk) - The accumulated deficit increased by **$1,517 thousand** during the six months ended June 30, 2025, reflecting the net loss for the period[16](index=16&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's cash flows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 | Cash Flow Activity | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--------------------------------- | :---------------------------------------------- | :---------------------------------------------- | | Operating activities | (1,362) | (5,373) | | Financing activities | 2,094 | 8,509 | | Net change in cash and cash equivalents | 732 | 3,136 | | Cash and cash equivalents, end of period | 3,326 | 4,919 | - Net cash used in operating activities significantly decreased to **$1,362 thousand** for the six months ended June 30, 2025, from **$5,373 thousand** in the prior year, mainly due to a reduced net loss and changes in operating assets and liabilities[20](index=20&type=chunk) - Net cash provided by financing activities was **$2,094 thousand** for the six months ended June 30, 2025, primarily from ATM sales of common stock, a decrease from **$8,509 thousand** in the prior year which included significant proceeds from warrant exercises[20](index=20&type=chunk) [NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS](index=8&type=section&id=NOTES%20TO%20UNAUDITED%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements [Note 1 - Organization, Plan of Business Operations](index=8&type=section&id=Note%201%20-%20Organization,%20Plan%20of%20Business%20Operations) This note describes the company's business, product candidates, recent Nasdaq delisting, AnnJi license termination, and going concern considerations - Avenue Therapeutics, Inc. is a specialty pharmaceutical company focused on developing therapies for neurologic diseases, with current product candidates including IV tramadol for post-operative acute pain and BAER-101 for epilepsy and panic disorders[22](index=22&type=chunk) - The company's common stock was delisted from Nasdaq on March 19, 2025, due to non-compliance with listing rules and now trades on the OTCID under the symbol 'ATXI'[23](index=23&type=chunk) - The license agreement for AJ201 with AnnJi Pharmaceutical Co. Ltd. was terminated on April 24, 2025. Avenue transferred all rights to AJ201 back to AnnJi and received **$1.4 million** in net revenue, with potential for future milestone and royalty payments[25](index=25&type=chunk)[26](index=26&type=chunk) - The company has incurred substantial operating losses and has an accumulated deficit of **$104.1 million** as of June 30, 2025, raising substantial doubt about its ability to continue as a going concern without additional funding[30](index=30&type=chunk) [Note 2 - Significant Accounting Policies](index=9&type=section&id=Note%202%20-%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and policies used in preparing the consolidated financial statements, including revenue recognition and fair value measurements - The consolidated financial statements are prepared in conformity with U.S. GAAP and include the accounts of the Company and its subsidiary, Baergic, with all intercompany balances eliminated[31](index=31&type=chunk)[32](index=32&type=chunk) - The Company operates and manages its business as one operating and reportable segment[34](index=34&type=chunk) - Fair value measurements are classified into a three-level hierarchy based on the observability of inputs, with Level 3 inputs being unobservable and requiring significant judgment[38](index=38&type=chunk) - Basic and diluted net loss per share are computed by dividing net loss attributable to common shares outstanding, with potential dilutive securities excluded when anti-dilutive[41](index=41&type=chunk) | Potential Dilutive Securities | As of June 30, 2025 | As of June 30, 2024 | | :---------------------------- | :------------------ | :------------------ | | Unvested restricted stock units/awards | 532 | 1,028 | | Deferred stock units | 235,000 | — | | Warrants | 1,476,200 | 1,476,200 | | Options | 256,474 | 22,474 | | Class A Preferred shares | 222 | 222 | | Total potential dilutive effect | 1,968,428 | 1,499,924 | - The Company is evaluating the impact of ASU 2023-09 (Income Tax Disclosures) and ASU No. 2024-03 (Expense Disaggregation Disclosures), with adoption planned for fiscal years beginning after December 15, 2024, and December 15, 2026, respectively[47](index=47&type=chunk)[48](index=48&type=chunk) [Note 3 — Licenses/Supplier Agreements](index=12&type=section&id=Note%203%20%E2%80%94%20Licenses/Supplier%20Agreements) This note details the company's exclusive license agreements for IV tramadol and neurological disorder compounds, including potential milestone and royalty payments - The Company holds an exclusive license for IV tramadol in the U.S. market from Revogenex, with potential future milestone payments of **$3.0 million** upon FDA approval and high single-digit to low double-digit royalties on net sales[49](index=49&type=chunk) - Baergic, a subsidiary, has license agreements with AstraZeneca AB and Cincinnati Children's Hospital Medical Center for compounds related to neurological disorders, involving potential development milestones up to **$81.5 million** and commercial/sales-based milestones up to **$151 million**, plus low to high single-digit royalties[51](index=51&type=chunk)[52](index=52&type=chunk) [Note 4 — Related Party Agreements](index=12&type=section&id=Note%204%20%E2%80%94%20Related%20Party%20Agreements) This note describes agreements and transactions with related parties, including management services from Fortress Biotech and consulting fees for Baergic - Fortress Biotech, Inc. provides management services to Avenue, with related expenses recorded **50% in R&D** and **50% in G&A**, totaling **$0.1 million** for the three months and **$0.3 million** for the six months ended June 30, 2025[53](index=53&type=chunk) - Avenue issued **22,476 common shares** to Fortress as an Annual Equity Fee on January 2, 2025, representing **2.5%** of fully-diluted outstanding equity[55](index=55&type=chunk) - For the six months ended June 30, 2025, Avenue recorded a Financing Equity Fee of **$0.1 million** and issued **23,474 common shares** to Fortress[56](index=56&type=chunk) - Avenue provides management, advisory, and consulting services to its subsidiary Baergic, for an annual consulting fee of **$0.5 million**, which increases to **$1.0 million** if Baergic's net assets exceed **$100 million**[61](index=61&type=chunk) [Note 5 — Accounts Payable and Accrued Expenses](index=14&type=section&id=Note%205%20%E2%80%94%20Accounts%20Payable%20and%20Accrued%20Expenses) This note provides a breakdown of accounts payable and accrued expenses as of June 30, 2025, and December 31, 2024 | Category | As of June 30, 2025 ($ in thousands) | As of December 31, 2024 ($ in thousands) | | :------------------------------ | :----------------------------------- | :------------------------------------- | | Accounts payable | 79 | 155 | | Accrued employee compensation | 107 | 18 | | Accrued contracted services and other | 766 | 481 | | Total accounts payable and accrued expenses | 952 | 654 | - Total accounts payable and accrued expenses increased by **$298 thousand** from December 31, 2024, to June 30, 2025, primarily due to increases in accrued employee compensation and accrued contracted services[63](index=63&type=chunk) [Note 6 - Commitments and Contingencies](index=14&type=section&id=Note%206%20-%20Commitments%20and%20Contingencies) This note discloses the company's commitments and contingencies, including the absence of material litigation or lease obligations - The Company is not party to any leases for office space or equipment[64](index=64&type=chunk) - As of June 30, 2025, there was no litigation against the Company that is expected to have a material adverse effect on its business, financial condition, results of operations, or cash flows[65](index=65&type=chunk) [Note 7 - Stockholder's Equity](index=15&type=section&id=Note%207%20-%20Stockholder's%20Equity) This note details the components of stockholders' equity, including preferred stock, common stock, warrants, and stock-based compensation plans - Class A Preferred Stock holders have superior voting rights, casting **1.1 times** the votes of common stock on an as-if-converted basis, ensuring a voting majority[67](index=67&type=chunk) - Each share of Class A Preferred Stock is convertible into **1,125 shares** of Common Stock, adjusted for reverse stock splits in September 2022 and April 2024[68](index=68&type=chunk) - The Company is no longer eligible to use its Form S-3 shelf registration statement or the ATM facility due to its delisting from Nasdaq[71](index=71&type=chunk)[72](index=72&type=chunk) - In January 2024 and May 2024, the Company conducted warrant inducement and private placement transactions, resulting in the issuance of new warrants and the exercise of existing ones, with associated losses on settlement and deemed dividends recorded[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) - The 2015 Incentive Plan was amended in June 2024 to increase authorized shares issuable to **5,070,223** and extend its term to June 24, 2034[79](index=79&type=chunk) - As of June 30, 2025, the Company had **235,532** unvested restricted stock units and awards, with **$0.1 million** in unrecognized stock-based compensation expense expected to be recognized over **1.0 years**[81](index=81&type=chunk)[82](index=82&type=chunk) - Total stock-based compensation expense for the six months ended June 30, 2025, was **$360 thousand**, slightly down from **$383 thousand** in the prior year[87](index=87&type=chunk) - The Company made payments totaling **$0.2 million** to InvaGen during the six months ended June 30, 2025, under a share repurchase agreement, with approximately **$1.4 million** paid in aggregate to date[89](index=89&type=chunk) [Note 8 - Common Stock Warrants](index=19&type=section&id=Note%208%20-%20Common%20Stock%20Warrants) This note explains the accounting treatment and fair value measurement of common stock warrants, classified as liability instruments - Warrants are classified as either equity or liability instruments based on specific terms and accounting guidance, with liability-classified warrants re-measured at fair value each reporting period[90](index=90&type=chunk)[91](index=91&type=chunk) - The October 2022 Warrants are classified as liabilities due to redemption terms outside the Company's control and are valued using the Black-Scholes Model[92](index=92&type=chunk)[93](index=93&type=chunk) | Metric | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :-------------- | | Stock price | $2.00 | $0.20 | | Risk-free interest rate | 4.27% | 3.72% | | Expected term in years | 2.8 | 2.3 | | Expected volatility | 155% | 132% | - The fair value of warrant liabilities decreased from **$16 thousand** at December 31, 2024, to **$0** at June 30, 2025, primarily due to changes in fair value and the exercise of warrants[94](index=94&type=chunk) [Note 9 - Subsequent Events](index=19&type=section&id=Note%209%20-%20Subsequent%20Events) This note reports on events occurring after the balance sheet date that may require disclosure - No subsequent events requiring disclosure were reported as of the date of this report[95](index=95&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three and six months ended June 30, 2025, compared to the same periods in 2024 [Forward-Looking Statements](index=21&type=section&id=Forward-Looking%20Statements) This section highlights the inherent risks and uncertainties associated with forward-looking statements in the report - The report contains forward-looking statements regarding future activities, events, and financial conditions, which are subject to risks and uncertainties, including the need for regulatory approval of product candidates, potential adverse side effects, and the ability to secure future financing[96](index=96&type=chunk) - Key risks include the company's lack of drug products for sale, substantial doubt about its ability to continue as a going concern, reliance on third parties, and the impact of Nasdaq delisting on liquidity and market price[96](index=96&type=chunk)[105](index=105&type=chunk) [Overview](index=22&type=section&id=Overview) This section provides a general business description, financial performance summary, and future capital needs of the company - Avenue Therapeutics, Inc. is a specialty pharmaceutical company developing IV tramadol for post-operative acute pain and BAER-101 for epilepsy and panic disorders[99](index=99&type=chunk) - The company reported a net loss of approximately **$1.5 million** for the six months ended June 30, 2025, and had an accumulated deficit of **$104.1 million**, primarily from R&D and G&A costs[100](index=100&type=chunk) - Additional capital through debt or equity offerings or strategic partnerships is needed to fund operations and product development, with no assurance of availability on acceptable terms[102](index=102&type=chunk) [Recent Developments](index=22&type=section&id=Recent%20Developments) This section details key recent events, including Nasdaq delisting, AnnJi license termination, and updates on IV tramadol and BAER-101 development - The company's common stock was delisted from Nasdaq on March 19, 2025, due to non-compliance with the **$2.5 million** stockholders' equity rule and now trades on the OTCID under 'ATXI'[104](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The AnnJi License Agreement for AJ201 was terminated on April 24, 2025. Avenue transferred all rights to AnnJi and received **$1.4 million** in net revenue, with potential future milestone and royalty payments[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) - Avenue reached final agreement with the FDA in January 2024 on the Phase 3 safety study protocol for IV tramadol, designed to assess respiratory depression risk compared to IV morphine, but currently lacks plans to initiate the study without financing[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) - Preclinical data for BAER-101 showed full suppression of seizure activity in an epilepsy model, and the company is exploring strategic alternatives for Baergic and/or BAER-101, including partnerships or a sale, or initiating a Phase 2a study with additional financing[118](index=118&type=chunk)[119](index=119&type=chunk) [Critical Accounting Policies and Use of Estimates](index=25&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section discusses management's significant judgments and estimates used in preparing the financial statements - The preparation of financial statements requires management to make estimates and judgments, particularly for accrued expenses and stock-based compensation, which are based on historical experience and known trends[120](index=120&type=chunk) - There were no material changes in critical accounting estimates or policies from December 31, 2024[121](index=121&type=chunk) [Accounting Pronouncements](index=25&type=section&id=Accounting%20Pronouncements) This section refers to Note 2 for details on recent accounting pronouncements and their potential impact - Refer to Note 2, 'Significant Accounting Policies,' for a discussion of recent accounting pronouncements[122](index=122&type=chunk) [Smaller Reporting Company Status](index=25&type=section&id=Smaller%20Reporting%20Company%20Status) This section clarifies the company's status as a smaller reporting company and its reduced disclosure obligations - The company qualifies as a 'smaller reporting company,' allowing for reduced disclosure obligations, such as presenting only two years of audited financial statements and simplified executive compensation disclosures[123](index=123&type=chunk) [Basis of Presentation and Principles of Consolidation](index=25&type=section&id=Basis%20of%20Presentation%20and%20Principles%20of%20Consolidation) This section outlines the basis for financial statement preparation and consolidation principles, including non-controlling interests - The consolidated financial statements are prepared in conformity with U.S. GAAP and include the accounts of the Company and its subsidiary, Baergic, with all intercompany balances and transactions eliminated[124](index=124&type=chunk) - Net loss attributable to non-controlling interests is recorded based on the percentage of economic or ownership interest retained by third parties in Baergic[124](index=124&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the three and six months ended June 30, 2025, compared to prior periods [General](index=27&type=section&id=General) This section provides an overview of the company's accumulated deficit and expected future operating losses - As of June 30, 2025, the company had an accumulated deficit of **$104.1 million** and expects to incur substantial operating losses for the foreseeable future as product candidates are still in development[126](index=126&type=chunk) [Comparison of the Three Months Ended June 30, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial results for the second quarter of 2025 against the same period in 2024 | Metric | Q2 2025 ($ in thousands) | Q2 2024 ($ in thousands) | Change ($ in thousands) | Change (%) | | :------------------------------------------ | :----------------------- | :----------------------- | :---------------------- | :--------- | | Other revenue | 1,404 | — | 1,404 | —% | | Research and development expenses | 192 | 1,361 | (1,169) | (86)% | | General and administrative expenses | 915 | 1,462 | (547) | (37)% | | Income (loss) from operations | 297 | (2,823) | 3,120 | (111)% | | Net income (loss) attributable to Avenue | 335 | (2,692) | 3,027 | (112)% | - Other revenue of **$1.4 million** was recognized in Q2 2025 due to the AnnJi license termination, compared to no revenue in Q2 2024[128](index=128&type=chunk) - Research and development expenses decreased by **$1.2 million (86%)** in Q2 2025, primarily due to a **$1.1 million** decrease in AJ201 development costs following its sale[130](index=130&type=chunk) - General and administrative expenses decreased by **$0.6 million (37%)** in Q2 2025, driven by lower legal expenses, reduced stock issuance to Fortress, and decreased professional fees[132](index=132&type=chunk) - The company recorded a gain of **$1 thousand** from the change in fair value of warrant liabilities in Q2 2025, compared to a gain of **$0.3 million** in Q2 2024[135](index=135&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=29&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial results for the first half of 2025 against the same period in 2024 | Metric | H1 2025 ($ in thousands) | H1 2024 ($ in thousands) | Change ($ in thousands) | Change (%) | | :------------------------------------------ | :----------------------- | :----------------------- | :---------------------- | :--------- | | Other revenue | 1,404 | — | 1,404 | —% | | Research and development expenses | 603 | 3,752 | (3,149) | (84)% | | General and administrative expenses | 2,408 | 2,778 | (370) | (13)% | | Income (loss) from operations | (1,607) | (6,530) | 4,923 | (75)% | | Net loss attributable to Avenue | (1,517) | (7,032) | 5,515 | (78)% | - Other revenue of **$1.4 million** was generated in H1 2025 from the AnnJi license termination, with no revenue in H1 2024[138](index=138&type=chunk) - Research and development expenses decreased by **$3.2 million (84%)** in H1 2025, primarily due to a **$2.9 million** reduction in AJ201 development costs[140](index=140&type=chunk) - General and administrative expenses decreased by **$0.4 million (13%)** in H1 2025, mainly due to lower professional fees and reduced equity issuance to Fortress[142](index=142&type=chunk) - The company recorded a gain of **$16 thousand** from the change in fair value of warrant liabilities in H1 2025, compared to a loss of **$0.1 million** in H1 2024[145](index=145&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, future funding requirements, and the impact of Nasdaq delisting on capital access - As of June 30, 2025, the company had **$3.3 million** in cash and cash equivalents. It expects to require additional financing to fund operations and product development for more than 12 months[147](index=147&type=chunk) - The Nasdaq delisting on July 18, 2025, makes it more difficult to obtain additional funding, as the company is no longer eligible to use its Form S-3 shelf registration statement or ATM facility[147](index=147&type=chunk) | Cash Flow Activity | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--------------------------------- | :---------------------------------------------- | :---------------------------------------------- | | Operating activities | (1,362) | (5,373) | | Financing activities | 2,094 | 8,509 | | Net increase (decrease) in cash and cash equivalents | 732 | 3,136 | - Net cash used in operating activities decreased significantly to **$1.4 million** in H1 2025 from **$5.4 million** in H1 2024, primarily due to a reduced net loss and changes in operating assets and liabilities[149](index=149&type=chunk) - Net cash provided by financing activities was **$2.1 million** in H1 2025, mainly from ATM sales of common stock, a decrease from **$8.5 million** in H1 2024 which included substantial proceeds from warrant exercises[151](index=151&type=chunk)[152](index=152&type=chunk) - Contractual obligations include potential milestone payments for Baergic's licenses (up to **$81.5 million** development, **$151 million** commercial) and IV tramadol (**$3.0 million** regulatory), plus royalties[154](index=154&type=chunk)[155](index=155&type=chunk) - The company has paid approximately **$1.4 million** to InvaGen under a share repurchase agreement as of June 30, 2025, with a remaining contingent fee of up to **$4.0 million** from future financings[156](index=156&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Avenue Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is therefore not required to provide quantitative and qualitative disclosures about market risk[157](index=157&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Disclosure Controls and Procedures](index=32&type=section&id=Disclosure%20Controls%20and%20Procedures) This section describes the company's disclosure controls and procedures and management's conclusion on their effectiveness - The company maintains disclosure controls and procedures designed to ensure timely recording, processing, summarizing, and reporting of information required under the Exchange Act[158](index=158&type=chunk) - As of June 30, 2025, management, including the CEO and interim CFO, concluded that the company's disclosure controls and procedures were effective[160](index=160&type=chunk) - A control system provides only reasonable, not absolute, assurance that objectives are met, acknowledging inherent limitations and resource constraints[161](index=161&type=chunk) [Changes in Internal Control over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in internal control over financial reporting during the quarter - There were no changes in internal control over financial reporting during the fiscal quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[162](index=162&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section includes legal proceedings, risk factors, and other required disclosures not covered in the financial information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) This section states that there are no material legal proceedings pending against the company, beyond routine actions not expected to have a material adverse effect on its business - To the company's knowledge, there are no legal proceedings pending against it that are expected to have a material adverse effect on its business, financial condition, results of operations, or cash flows[163](index=163&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the 'Risk Factors' disclosed in the company's 2024 Form 10-K and other information in the current 10-Q, emphasizing that these may not cover all potential risks - Readers should carefully consider the 'Risk Factors' outlined in the 2024 Form 10-K and other information in this Quarterly Report on Form 10-Q, as additional unknown risks may also adversely affect the business[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is marked as 'N/A', indicating no information to report regarding unregistered sales of equity securities and use of proceeds - This item is not applicable, indicating no unregistered sales of equity securities or use of proceeds to report[165](index=165&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is marked as 'N/A', indicating no information to report regarding defaults upon senior securities - This item is not applicable, indicating no defaults upon senior securities to report[166](index=166&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is marked as 'N/A', indicating no information to report regarding mine safety disclosures - This item is not applicable, indicating no mine safety disclosures to report[167](index=167&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) This section reports that no directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025 - No directors or officers adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[168](index=168&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including various certificates of incorporation, bylaws, the AnnJi License Termination and Program Transfer Agreement, certifications from executive officers, and financial information in iXBRL format - The exhibits include amendments to the Certificate of Incorporation, Second Amended and Restated Bylaws, the AnnJi License Termination and Program Transfer Agreement, and certifications from the Principal Executive Officer and Principal Financial Officer[170](index=170&type=chunk) - Financial information for the period ended June 30, 2025, is provided in Inline Extensible Business Reporting Language (iXBRL) format[170](index=170&type=chunk) [SIGNATURES](index=36&type=section&id=SIGNATURES) This section contains the required signatures of the registrant's authorized officers, confirming the due filing of the report - The report is signed by Alexandra MacLean, M.D., Chief Executive Officer and Director, and David Jin, Interim Chief Financial Officer and Chief Operating Officer, on August 14, 2025[174](index=174&type=chunk)

Financial Performance - The net loss for the three months ended March 31, 2025, was approximately $1.9 million, compared to a net loss of $4.3 million for the same period in 2024, resulting in an accumulated deficit of approximately $104.4 million[103]. - The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future[104]. - As of March 31, 2025, the company reported an accumulated deficit of $104.4 million, indicating ongoing financial challenges[128]. - The net loss for the three months ended March 31, 2025, was $1.9 million, a 49% improvement from a net loss of $3.7 million in the same period in 2024[129]. - Net cash used in operating activities was $1.2 million for the three months ended March 31, 2025, compared to $3.1 million in the same period in 2024, reflecting improved cash management[140][141]. - The company had $3.5 million in cash and cash equivalents as of March 31, 2025, and anticipates needing additional financing to support ongoing operations[137][138]. Research and Development - Avenue expects to continue incurring research and development costs and general and administrative costs, leading to operating losses for at least the next several years[104]. - For the three months ended March 31, 2025, research and development expenses decreased by 83% to $0.4 million from $2.4 million in the same period in 2024, primarily due to reduced clinical development costs[129][131]. - BAER-101 demonstrated full suppression of seizure activity in a preclinical model with a minimal effective dose of 0.3 mg/kg[120]. - The company reached a final agreement with the FDA on the Phase 3 safety study protocol for IV tramadol, designed to assess the risk of opioid-induced respiratory depression[115]. - The company is exploring strategic alternatives for Baergic and/or BAER-101, which may include engaging a development partner or initiating a Phase 2a study if financing is secured[121]. Licensing and Agreements - The company entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. for the exclusive rights to the AJ201 product candidate, paying an initial cash license fee of $3.0 million[111]. - The AnnJi License Agreement was terminated on April 24, 2025, with the company transferring all rights related to AJ201 back to AnnJi[112]. - Future milestone payments under license agreements could total approximately $232.5 million, including $81.5 million for development milestones and $151.0 million for commercial milestones[144]. Capital and Financing - The company intends to obtain additional capital through the sale of debt or equity securities, but there is no assurance that necessary capital can be raised under acceptable terms[105]. - The company has obligations under a share repurchase agreement requiring payment of 7.5% of future financing proceeds, with $0.2 million paid in the three months ended March 31, 2025[146]. - The company reported a net cash inflow of $2.1 million from financing activities for the three months ended March 31, 2025, primarily from the sale of common stock[142]. Stock Market and Compliance - On March 17, 2025, Nasdaq notified the company of its delisting due to a violation of the stockholders' equity requirement of at least $2,500,000[107]. - General and administrative expenses increased by 14% to $1.5 million for the three months ended March 31, 2025, compared to $1.3 million in 2024, driven by higher legal expenses[133].

Financial Performance - The net loss for Avenue Therapeutics for the years ended December 31, 2024 and 2023 was approximately $11.7 million and $10.5 million, respectively, with an accumulated deficit of approximately $102.6 million as of December 31, 2024[386]. - The net loss for 2024 was $11.7 million, a 12% increase from the $10.5 million net loss in 2023[419]. - Cash and cash equivalents increased to $2.6 million in 2024 from $1.8 million in 2023[430]. - The company reported a loss on common stock warrant liabilities of $0.8 million in 2024, compared to no such loss in 2023[427]. - The change in fair value of warrant liabilities improved by 96%, from a loss of $4.3 million in 2023 to a loss of $0.2 million in 2024[419]. - Total cash used in operating activities was approximately $9.0 million in 2024, slightly lower than the $9.5 million used in 2023[432][433]. - The company maintained a full valuation allowance on deferred tax assets due to not achieving sustained profitable operations[415]. Research and Development - Avenue Therapeutics expects to continue incurring research and development costs and general administrative costs, leading to operating losses for at least the next several years[387]. - The company paid an initial cash license fee of $3.0 million for the exclusive rights to the AJ201 product candidate, with additional payments of up to $10.8 million expected for the Phase 1b/2a clinical trial[391]. - The Phase 1b/2a trial for AJ201 is expected to enroll approximately 25 patients, with the primary endpoint assessing safety and tolerability[394]. - In January 2024, Avenue Therapeutics announced the completion of enrollment for the Phase 1b/2a trial, with the last patient visit reported in May 2024[395]. - The company reached a final agreement with the FDA on the Phase 3 safety study protocol for IV tramadol, which will involve approximately 300 post bunionectomy patients[401]. - BAER-101 demonstrated full suppression of seizure activity in preclinical data with a minimal effective dose of 0.3 mg/kg, presented at the American Epilepsy Society 2023 Annual Meeting[404]. Stock and Financing Activities - On March 17, 2025, Avenue Therapeutics was notified of its delisting from Nasdaq due to a violation of the stockholders' equity requirement of at least $2,500,000[405]. - Following the delisting, the company's common stock began trading on the OTC Markets under the symbol "ATXI" on March 19, 2025[406]. - Avenue Therapeutics plans to continue filing required periodic reports and other filings with the SEC despite the change in trading platform[406]. - In September 2023, the company issued 10,227 shares in a private placement for approximately $0.6 million at a price of $53.775 per share[441]. - The November 2023 public offering included the sale of 221,779 units, generating net proceeds of approximately $3.8 million after deducting fees and expenses[446]. - The November 2023 Series A and B Warrants are exercisable at $22.545 per share for five years and 18 months, respectively[445]. - The company entered into inducement agreements in January 2024, resulting in gross proceeds of approximately $5.0 million from the exercise of existing warrants[447]. - The May 2024 Warrant Inducement involved the exercise of warrants for cash at a reduced price of $6.20 per share, with net proceeds of approximately $3.7 million[452]. - The company has a maximum obligation of $10.8 million for Phase 1b/2a clinical development payments related to the AJ201 product candidate, with $6.3 million remaining as of December 31, 2023[457]. - Development milestones totaling approximately $81.5 million are due under license agreements with AstraZeneca and Cincinnati Children's Hospital, with additional commercial payments of approximately $151.0 million possible[458]. - The company has entered into an At the Market Offering Agreement allowing for the sale of up to $3.85 million of common stock[453]. - For the twelve months ended December 31, 2024, the company sold 591,205 shares under the ATM Agreement, resulting in net proceeds of approximately $1.6 million[455]. - The company has obligations under various contracts with third parties for services related to biopharmaceutical development, which may include cancellation fees[456]. - The company entered into a license agreement with Revogenex for IV tramadol, receiving a $3.0 million regulatory milestone upon approval and will pay high single-digit to low double-digit royalties on net sales[459]. - A share repurchase agreement with InvaGen requires the company to pay 7.5% of future financing proceeds, capped at $4 million, with $0.7 million and $0.5 million paid in 2024 and 2023, respectively[460]. Company Classification - The company is classified as a "smaller reporting company," with a market value of shares held by non-affiliates below $250 million[417].

Financial Performance - For the nine months ended September 30, 2024, the company reported a net loss of approximately $10.1 million, compared to a net loss of $11.1 million for the same period in 2023, resulting in an accumulated deficit of approximately $101.0 million[106]. - Net loss for Q3 2024 was $3.1 million compared to a net income of $0.5 million in Q3 2023, representing a decrease of 702%[126]. - Net cash used in operating activities was $8.3 million for the nine months ended September 30, 2024, compared to $7.1 million in 2023[146]. - The loss on settlement of common stock warrant liabilities was $0.8 million for the nine months ended September 30, 2024, with no comparable expense in 2023[141]. - The change in fair value of warrant liabilities resulted in a gain of $0.2 million for the nine months ended September 30, 2024, down from a gain of $1.5 million in 2023, a decrease of 87%[142]. Research and Development - The company expects to continue incurring research and development costs and general administrative expenses, leading to operating losses for at least the next several years[107]. - Research and development expenses increased to $2.3 million in Q3 2024 from $0.9 million in Q3 2023, a rise of 157%[128]. - For the nine months ended September 30, 2024, research and development expenses were $6.1 million, up from $5.1 million in the same period of 2023, an increase of 18%[137]. - The Phase 1b/2a trial for AJ201, which enrolled 25 patients, is expected to provide top-line data readout around year-end 2024[114]. - BAER-101, a novel GABA A positive allosteric modulator, demonstrated full suppression of seizure activity in preclinical data with a minimal effective dose of 0.3 mg/kg[118]. Administrative Expenses - General and administrative expenses decreased to $0.8 million in Q3 2024 from $1.2 million in Q3 2023, a decline of 29%[130]. - General and administrative expenses for the nine months ended September 30, 2024, were $3.6 million, compared to $3.0 million in 2023, an increase of 19%[139]. Capital and Financing - The company plans to obtain additional capital through the sale of debt or equity securities, but there is no assurance that necessary capital will be raised under acceptable terms[108]. - The company had $2.6 million in cash and cash equivalents as of September 30, 2024, and anticipates needing additional financing to support its operations beyond the first half of 2025[143]. Regulatory and Licensing - The company entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. for the exclusive rights to AJ201, paying an initial cash license fee of $3.0 million and agreeing to additional payments of up to $10.8 million for clinical trial reimbursements[111]. - The company reached a final agreement with the FDA on the Phase 3 safety study protocol for IV tramadol, which will involve approximately 300 post bunionectomy patients[116]. Company Structure and Governance - The company is a majority-controlled subsidiary of Fortress Biotech, Inc., which holds significant voting power over the company's outstanding capital stock[109]. - The company anticipates continued reliance on third parties for various operational aspects, including clinical data and regulatory approvals[108]. - The company is classified as a "smaller reporting company," which allows for reduced disclosure obligations and the option to delay the adoption of certain recent accounting standards[122].

[Corporate Highlights and Pipeline Update](index=1&type=section&id=Corporate%20Highlights%20and%20Pipeline%20Update) Avenue Therapeutics made significant progress in its neurologic disease treatment pipeline, with AJ201 topline data expected by year-end 2024, and other programs contingent on financing [AJ201 for SBMA](index=1&type=section&id=AJ201%20for%20SBMA) AJ201's Phase 1b/2a clinical trial for SBMA completed patient visits in May 2024, with topline safety and tolerability data expected by year-end - Topline data from the Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy (SBMA) is anticipated around **year-end 2024**[1](index=1&type=chunk)[3](index=3&type=chunk) - The final patient visit for the 12-week, 25-patient trial was completed in **May 2024**, marking the last clinical milestone before the data announcement[3](index=3&type=chunk) - The primary endpoint of the study is to evaluate the **safety and tolerability** of AJ201, with secondary endpoints measuring changes in mutant AR protein levels and Nrf2-activated genes[3](index=3&type=chunk) [BAER-101 for Epilepsy](index=1&type=section&id=BAER-101%20for%20Epilepsy) Avenue plans a Phase 2a clinical trial for BAER-101 in focal epilepsy, contingent on securing additional financing - Avenue plans to initiate a Phase 2a clinical trial of BAER-101 for patients with focal epilepsy, but this is **contingent upon receiving additional financing**[4](index=4&type=chunk) [IV Tramadol for Post-Operative Pain](index=1&type=section&id=IV%20Tramadol%20for%20Post-Operative%20Pain) Avenue reached final FDA agreement on the IV tramadol Phase 3 safety study protocol, with initiation contingent on financing or partnership - Final agreement has been reached with the U.S. FDA on the safety study protocol for the **Phase 3 trial of IV tramadol**[4](index=4&type=chunk) - The initiation of the Phase 3 study, which will compare IV tramadol to IV morphine in post-bunionectomy patients, is **pending additional financing or a partnership**[4](index=4&type=chunk) [Third Quarter 2024 Financial Results](index=1&type=section&id=Third%20Quarter%202024%20Financial%20Results) Avenue Therapeutics reported a **net loss of $3.1 million** for Q3 2024, a significant shift from prior year's net income, with increased R&D and reduced cash Q3 2024 Financial Highlights (in millions, except per share data) | Financial Metric | Q3 2024 | Q3 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $2.6 million | N/A | -$2.3M vs Q2 2024 | | R&D Expenses | $2.3 million | $0.9 million | +$1.4 million | | G&A Expenses | $0.8 million | $1.2 million | -$0.4 million | | Net (Loss) Income | ($3.1 million) | $0.5 million | -$3.6 million | | (Loss) Income Per Share | ($1.92) | $4.86 | -$6.78 | [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2024, Avenue Therapeutics reported **total assets of $2.6 million**, primarily cash, and total stockholders' equity of $1.7 million Balance Sheet Summary (in thousands) | Account | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,597 | $1,783 | | Total assets | $2,625 | $1,850 | | Total current liabilities | $973 | $1,196 | | Total stockholders' equity | $1,652 | $654 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2024, Avenue Therapeutics reported a **loss from operations of $3.2 million** and a net loss of $3.1 million, a significant decline from prior year Statement of Operations Summary - Three Months Ended Sep 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Research and development | $2,327 | $907 | | General and administrative | $829 | $1,161 | | Loss from operations | ($3,156) | ($2,068) | | Net (loss) income | ($3,087) | $513 | | Net (loss) income per share | ($1.92) | $4.86 | Statement of Operations Summary - Nine Months Ended Sep 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Research and development | $6,080 | $5,149 | | General and administrative | $3,607 | $3,042 | | Loss from operations | ($9,687) | ($12,421) | | Net loss | ($10,137) | ($11,105) | | Net loss per share | ($17.27) | ($115.55) |