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AVENUE THERAPEUTICS INC

For the period ended Mar 31, 2025. Filed May 15, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 15, 2025

ATXI$0.42-50.7%Stored close · as of Mar 18, 2025

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Notes to Unaudited Condensed Consolidated Financial Statements

AVENUE THERAPEUTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1 - Organization, Plan of Business Operations

Avenue Therapeutics, Inc. (the “Company” or “Avenue”) was incorporated in Delaware on* February**9,* 2015, as a wholly-owned subsidiary of Fortress Biotech, Inc. (“Fortress”). Avenue is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. Avenue's current product candidates include intravenous tramadol ("IV tramadol") for the treatment of post-operative acute pain and BAER-101 for the treatment of epilepsy and panic disorders.

Nasdaq Delisting

On* March 17, 2025,the Nasdaq Stock Market LLC (“Nasdaq”) notified the Company that Nasdaq had determined to delist the Company’s common stock and that trading of the Company’s securities would be suspended at the open of trading on March 19, 2025.Nasdaq will file a Form25* with the SEC notifying the SEC of Nasdaq’s determination to remove the Company’s securities from listing on Nasdaq, at which time the common stock will be formally delisted, cease to be registered pursuant to Section12(b) of the Act and immediately be deemed registered pursuant to Section12(g) of the Act. Since* March 19, 2025,*the Company’s common stock has been traded on the over-the-counter market under the symbol “ATXI”.

AJ201 Termination

On* February 28, 2023,Avenue entered into a license agreement with AnnJi Pharmaceutical Co. Ltd. ("AnnJi"), whereby Avenue obtained an exclusive license (the "AnnJi License Agreement") from AnnJi to the intellectual property rights pertaining to the molecule known asJM17,* which activatesNrf1 andNrf2, enhances androgen receptor degradation and underliesAJ201, a clinical product candidate currently in a Phase1b/2a clinical trial in the U.S. for the treatment of spinal and bulbar muscular atrophy (“SBMA”, also known as Kennedy's Disease). Under the AnnJi License Agreement, in exchange for exclusive rights to the intellectual property underlying theAJ201 product candidates, Avenue paid $3.0 million, issued shares of Avenue stock intwo tranches, and agreed to make additional payments including: reimbursement of payments up to $10.8 million in connection with the product’s Phase1b/2a clinical trial, up to $14.5 million in connection with certain development milestones pertaining to thefirst indication in the U.S., up to $27.5 million in connection with certain drug development milestones pertaining to additional indications and development outside the U.S., up to $165 million upon the achievement of certain net sales milestones ranging from $75 million to $750 million in annual net sales, and royalty payments based on a percentage of net sales ranging from mid-single digits to the low-double digits, which were subject to potential diminution in certain circumstances. On* March 3, 2025,*Avenue received a notice of AnnJi’s intent to terminate the AnnJi License Agreement, in which AnnJi asserted several bases for its right to terminate the AnnJi License Agreement.

On* April 24, 2025 (the “Termination Effective Date”), Avenue and AnnJi entered into a License Termination and Program Transfer Agreement (the “Termination and Transfer Agreement”), pursuant to which: (i) the AnnJi License Agreement and related agreements were terminated with immediate effect; (ii) the parties dismissed all pending dispute resolution proceedings and provided mutual releases of claims; (iii) Avenue transferred to AnnJi all of its rights, title and interest to and under the assets arising under the AnnJi License Agreement and otherwise related toAJ201* and (iv) Avenue agreednot to, for48 months following the date of the Termination and Transfer Agreement, develop, commercialize, manufacture or sell any product competing withAJ201 in the US, Canada, the European Union, Great Britain or Israel. Under the Termination and Transfer Agreement, Avenue will repurchase all shares of common stock held by AnnJi for an aggregate payment of $1.00, and Avenue also made a payment of $0.2 million to AnnJi as consideration for legal expenses.

AnnJi agreed to make payments to Avenue of $2.0 million, with $1.0 million due within30 days after the Termination Effective Date and $1 million due within90 days after the Termination Effective Date. Additionally, Avenue will be eligible to receive from AnnJi:

•payments totaling up to $5 million in the aggregate upon the occurrence of certain development and regulatory milestone events pertaining to AJ201;
•payments totaling up to $17 million in the aggregate upon AJ201 experiencing certain commercial sales milestone events;
•a 1.75% royalty on net sales of AJ201, which royalty percentage is subject to potential diminution in certain circumstances; and
•in the event that AnnJi enters into one or more subsequent licenses of rights to AJ201 with third party licensee(s), 15% of payments received by AnnJi from such licensee(s), up to a cap of $7.5 million, and with a minimum of $4 million owing under certain mechanism in the event of an approval of a New Drug Application in the U.S. with respect to AJ201.

Going Concern

These consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP") assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, as described below, substantial doubt about the Company’s ability to continue as a going concern exists.

The Company isnot yet generating revenue, has incurred substantial operating losses since its inception and expects to continue to incur significant operating losses for the foreseeable future as it executes on its product development plan and* maynever become profitable. As of March 31, 2025*, the Company had an accumulated deficit of $104.4 million. Due to uncertainties regarding future operations of the Company for a potential Phase3 safety study for IV tramadol, and the expansion of the Company's development portfolio within neuroscience with the consummation of the transaction with Baergic Bio, Inc. ("Baergic"), the Company will need to secure additional funds through equity or debt offerings, the timing of which is unknown at this time. The Company cannot be certain that additional funding will be available to it on acceptable terms, or at all. These factors individually and collectively cause substantial doubt about the Company’s ability to continue as a going concern to exist withinone year from the date of this report. The consolidated financial statements donot include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that* may*be necessary if the Company were unable to continue as a going concern.

Note2 - Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The Company’s consolidated financial statements have been prepared in conformity with U.S. GAAP, include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented and are stated in U.S. dollars. The Company’s consolidated financial statements include the accounts of the Company and the accounts of the Company’s subsidiary. All intercompany balances and transactions have been eliminated.

The accompanying unaudited interim condensed financial statements include the accounts of the Company's subsidiary, Baergic. Because the Company owns less than100% of Baergic, the Company records net loss attributable to non-controlling interests in its consolidated statements of operations equal to the percentage of the economic or ownership interest retained in Baergic by the respective non-controlling parties. The Company continually assesses whether changes to existing relationships or future transactions* may*result in the consolidation or deconsolidation of its subsidiary.

Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These unaudited interim condensed financial statement results arenot necessarily indicative of results to be expected for the full fiscal year or any future period. Therefore, these unaudited interim condensed financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the fiscal year ended* December 31, 2024,which were included in the Company’s Annual Report on Form10*-K (the*“2024* Form10-K”) and filed with the U.S. Securities and Exchange Commission (“SEC”) on* March 31, 2025.*

Segments

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business inone operating and reportable segment.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Fair Value Measurements

The Company follows accounting guidance on fair value measurements for financial assets and liabilities measured at fair value on a recurring basis. Under the accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.

The accounting guidance requires fair value measurements be classified and disclosed inone of the followingthree categories:

Level1: Quoted prices in active markets for identical assets or liabilities.

Level2: Observable inputs other than Level1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.

Level3: Unobservable inputs which are supported by little orno market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.

The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

Certain of the Company’s financial instruments arenot measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.

Non-Controlling Interests

Non-controlling interests in consolidated entities represent the component of equity in consolidated entities held bythird parties. Any change in ownership of a subsidiary while the controlling financial interest is retained is accounted for as an equity transaction between the controlling and non-controlling interests. Intercompany activity is eliminated entirely in consolidation prior to the allocation of net gain/loss attributable to non-controlling interest, which is based on ownership interests.

Net Loss per Share

Basic and diluted net loss per share is computed by dividing net loss attributable to common shares outstanding, including prefunded warrants and shares held in abeyance, during the period, without consideration of potential dilutive securities. For periods in which the Company generated a net loss, the Company doesnot include potential shares of common stock in diluted net loss per share when the impact of these items is anti-dilutive. The Company has generated a net loss for all periods presented, therefore diluted net loss per share is the same as basic net loss per share since the inclusion of potentially dilutive securities would be anti-dilutive. Dividends declared are paid and set aside among the holders of shares of common stock and Class A Preferred stock pro-rata on an as-if-converted basis.

The following table sets forth the potential common shares that could potentially dilute basic income per share in the future that werenot included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented:

As of
March 31,
20252024
Unvested restricted stock units/awards7441,028
Deferred stock units235,000—
Warrants1,476,200745,139
Options256,47422,474
Class A Preferred shares(1)223223
Total potential dilutive effect1,968,641768,864

(1) Class A preferred shares are presented on an as-if converted basis.

In connection with the exercise of certain existing warrants in* January 2024,the Company recorded deemed dividends of $4.3 million for the issuance of new warrants. For thethree* months ended* March 31, 2024,*net loss attributable to common stockholders consisted of net loss, as adjusted for deemed dividends.

The Company considers Class A preferred stock to be an additional class of common stock for the purpose of calculating net loss per share, as it doesnot have preferential rights in liquidation when compared to the Company's common stock, and therefore losses are allocated to these additional classes using thetwo-class method. Thetwo-class method is an earnings allocation formula that treats participating securities as having rights that would otherwise have been available to common stockholders. Earnings allocated to the Class A preferred stock arenot material for thethree months ended* March 31, 2025and2024.*

Summary of Significant Accounting Policies

There have beenno material changes in the Company’s significant accounting policies to those previously disclosed in the2024 Form10-K.

Accounting StandardsNot Yet Adopted**

In* December 2023,the FASB issued ASU2023*-09,* Income Taxes (Topic740): Improvements to Income Tax Disclosures*, which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after* December 15, 2024,with early adoption permitted. The Company is currently evaluating the impact of adopting ASU2023*-09 and will adopt it for fiscal year ending* December 31, 2025.*

In* November 2024,the FASB issued ASUNo.* 2024-03, Income Statement–* Reporting Comprehensive Income*–* Expense Disaggregation Disclosures (Subtopic220-40): Disaggregation of Income Statement Expenses*, which requires new financial statement disclosures in tabular format, in the notes to financial statements, of specified information about certain costs and expenses. The amendments in this update donot change or remove current expense disclosure requirements. The amendments in this update are effective for fiscal years beginning after* December 15, 2026,and interim periods within fiscal years beginning after December 15, 2027.*Early adoption is permitted. The Company is currently evaluating the impact of the new standard on its financial statement disclosures.

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Note 3 —Licenses/Supplier Agreements

IV Tramadol License

Effective as of* February**17,* 2015, Fortress transferred the Revogenex license and all other rights and obligations under the IV Tramadol License Agreement to the Company, pursuant to the terms of the Founders Agreement. In connection with the terms of the IV Tramadol License Agreement, Fortress purchased an exclusive license to IV tramadol for the U.S. market from Revogenex, a privately held company in Dublin, Ireland, for $3.0 million and paid an additional $1.0 million following the Company’s submission of its NDA for IV Tramadol. In addition, under the terms of the agreement, Revogenex is eligible to receive an additional milestone payment totaling $3.0 million upon the approval of IV tramadol from the U.S. Food and Drug Administration ("FDA") as well as royalty payments on net sales of the product ranging in the high single digits to low double digits.

On* October**29,* 2018, the Company and Zaklady Farmaceutyczne Polpharma (“Polpharma”) extended the term of their exclusive supply agreement for drug product of IV tramadol toeight years from the date of the launch of the product. In addition, under the terms of the amended agreement, Polpharma is eligible to receive a milestone payment totaling $2.0 million upon the approval of IV tramadol from the FDA, as well as a low single digit royalty on net sales of the product forfive years after launch.

Baergic Licenses

In* December 2019,Baergic entered intotwo* license agreements: (i) a license agreement with AstraZeneca AB (“AZ”) to acquire an exclusive license to patent and related intellectual property rights pertaining to their proprietary compound Gamma-aminobutyric acid receptor A alpha2 &3 (GABAAα2,3) positive allosteric modulators; and (ii) a license agreement with Cincinnati Children’s Hospital Medical Center (“CCHMC”) to acquire patent and related intellectual property rights pertaining to a GABA inhibitor program for neurological disorders. Baergic paid an upfront fee of $3.0 million to AZ and $0.2 million to CCHMC, as well as issued common shares of Baergic of approximately 20% and 5% of Baergic to each at the time of the license agreement, respectively.

Development milestones totaling approximately $81.5 million in the aggregate are due upon achievement of each milestone. Commercial and sales-based milestone payments totaling approximately $151 million are due upon achievement of each milestone, as well as royalty payments in the low to high single digits on any future aggregate, annual, worldwide net sales.

AnnJi License Agreement

On* February 28, 2023,Avenue entered into a license agreement with AnnJi, whereby Avenue obtained an exclusive license (the "AnnJi License Agreement") from AnnJi to the intellectual property rights pertaining to the molecule known asJM17,* which activatesNrf1 andNrf2, enhances androgen receptor degradation and underliesAJ201, a clinical product candidate currently in a Phase1b/2a clinical trial in the U.S. for the treatment of spinal and bulbar muscular atrophy (“SBMA”, also known as Kennedy's Disease). Under the AnnJi License Agreement, in exchange for exclusive rights to the intellectual property underlying theAJ201 product candidates, Avenue paid $3.0 million, issued shares of Avenue stock intwo tranches, and agreed to make additional payments including: reimbursement of payments up to $10.8 million in connection with the product’s Phase1b/2a clinical trial, up to $14.5 million in connection with certain development milestones pertaining to thefirst indication in the U.S., up to $27.5 million in connection with certain drug development milestones pertaining to additional indications and development outside the U.S., up to $165 million upon the achievement of certain net sales milestones ranging from $75 million to $750 million in annual net sales, and royalty payments based on a percentage of net sales ranging from mid-single digits to the low-double digits, which were subject to potential diminution in certain circumstances. On* March 3, 2025,*Avenue received a notice of AnnJi’s intent to terminate the AnnJi License Agreement, in which AnnJi asserted several bases for its right to terminate the AnnJi License Agreement.

On the Termination Effective Date, Avenue and AnnJi entered into the Termination and Transfer Agreement, pursuant to which: (i) the AnnJi License Agreement and related agreements were terminated with immediate effect; (ii) the parties dismissed all pending dispute resolution proceedings and provided mutual releases of claims; (iii) Avenue transferred to AnnJi all of its rights, title and interest to and under the assets arising under the AnnJi License Agreement and otherwise related toAJ201 and (iv) Avenue agreednot to, for48 months following the date of the Termination and Transfer Agreement, develop, commercialize, manufacture or sell any product competing withAJ201 in the US, Canada, the European Union, Great Britain or Israel. Under the Termination and Transfer Agreement, Avenue will repurchase all shares of common stock held by AnnJi for an aggregate payment of $1.00, and Avenue also made a payment of $0.2 million to AnnJi as consideration for legal expenses.

AnnJi agreed to make payments to Avenue of $2.0 million, with $1.0 million due within30 days after the Termination Effective Date and $1 million due within90 days after the Termination Effective Date. Additionally, Avenue will be eligible to receive from AnnJi:

•payments totaling up to $5 million in the aggregate upon the occurrence of certain development and regulatory milestone events pertaining to AJ201;
•payments totaling up to $17 million in the aggregate upon AJ201 experiencing certain commercial sales milestone events;
•a 1.75% royalty on net sales of AJ201, which royalty percentage is subject to potential diminution in certain circumstances; and
•in the event that AnnJi enters into one or more subsequent licenses of rights to AJ201 with third party licensee(s), 15% of payments received by AnnJi from such licensee(s), up to a cap of $7.5 million, and with a minimum of $4 million owing under certain mechanism in the event of an approval of a New Drug Application in the U.S. with respect to AJ201.

Note 4 —Related Party Agreements

Founders Agreement and Management Services Agreement with Fortress

In* February 2015,Fortress entered into a Management Services Agreement (the "MSA") with the Company to provide services for the Company pursuant to the terms of the MSA. Expenses related to the MSA are recorded 50% in research and development expenses and 50% in general and administrative expenses in the Unaudited Condensed Consolidated Statements of Operations. For thethree* months ended* March 31, 2025and2024,* the Company recorded expense related to the MSA of $0.1 million and $0.1 million, respectively.

In* February 2015,Fortress entered into a Founders Agreement with the Company, under which the Company agreed to: (i) issue annually to Fortress, shares of common stock equal totwo* andone half percent (2.5%) of the fully-diluted outstanding equity of the Company at the time of issuance (the "Annual Equity Fee") and (ii) issue shares of the common stock equal totwo andone half percent (2.5%) of the gross amount of any equity or debt financing (the "Financing Equity Fee").

Annual Equity Fee

For thethree months ended* March 31, 2025,the Company didnot have an Annual Equity Fee expense. There were 102,185 shares of the Company's common stock issued to Fortress in January 2025related to the2024* Annual Equity Fee.

For thethree months ended* March 31, 2024,the Company didnot have an Annual Equity Fee expense. There were 22,476 shares of the Company's common stock issued to Fortress in January 2024related to the2023* Annual Equity Fee.

Financing Equity Fee

For thethree months ended* March 31, 2025,*the Company recorded a Financing Equity Fee of $0.1 million and issued 23,474 shares of the Company's common stock to Fortress.

For thethree months ended* March 31, 2024,*the Company recorded a Financing Equity Fee of $0.1 million and issued 5,543 shares of the Company's common stock to Fortress.

Founders Agreement and Management Services Agreement with Baergic

Pursuant to the Share Contribution Agreement between Avenue and Fortress, the Founders Agreement and Management Services Agreement that had previously been existing between Fortress and Baergic were assigned to Avenue, such that they now exist between Avenue and Baergic; those agreements are referred to herein as the Avenue-Baergic Founders Agreement and the Avenue-Baergic MSA, as applicable. The Annual Stock Dividend payable to the Company is 2.5% of common stock calculated as a percentage of fully diluted outstanding capital and became effective as of* November 8, 2022.*

The Avenue-Baergic Founders Agreement has an effective date of* March 9, 2017,and a term of15* years, which upon expiration automatically renews for successiveone-year periods unless terminated by Avenue and Baergic or a Change in Control (as defined in the Avenue-Baergic Founders Agreement) occurs.

As additional consideration under the Avenue-Baergic Founders Agreement, Baergic will also: (i) pay an equity fee in shares of common stock, payable withinfive (5) business days of the closing of any equity or debt financing for Baergic that occurs after the effective date of the Avenue-Baergic Founders Agreement and ends on the date when Avenueno longer has majority voting control in the Baergic’s voting equity, equal totwo andone-half (2.5%) of the gross amount of any such equity or debt financing; and (ii) pay a cash fee equal tofour andone-half percent (4.5%) of the Baergic’s annual net sales, payable on an annual basis, withinninety (90) days of the end of each calendar year. In the event of a Change in Control, Baergic will pay aone-time change in control fee equal tofive (5x) times the product of (A) net sales for thetwelve (12) months immediately preceding the change in control and (B)four andone-half percent (4.5%).

The Avenue-Baergic MSA has an effective date of* March 9, 2017,pursuant to which Avenue renders management, advisory and consulting services to the Company. The Avenue-Baergic MSA has an initial term offive years and is automatically renewed for successive five-year terms unless terminated in accordance with its provisions. Services provided under the Avenue-Baergic MSA mayinclude, without limitation, (i) advice and assistance concerning any and all aspects of the Baergic’s operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of the Baergic with accountants, attorneys, financial advisors and other professionals (collectively, the “Avenue Services”). Baergic is obligated to utilize clinical research services, medical education, communication and marketing services and investor relations/public relation services of companies or individuals designated by Avenue, provided those services are offered at market prices. However, Baergic isnot* obligated to take or act upon any advice rendered from Avenue and Avenue shallnot be liable for any of its actions or inactions based upon their advice. Pursuant to the Avenue-Baergic MSA and Baergic’s Certificate of Incorporation, Avenue and its affiliates, including all members of Baergic’s Board of Directors, will haveno fiduciary or other duty to communicate or present any corporate opportunities to Baergic or to refrain from engaging in business that is similar to that of Baergic. In consideration for the Avenue Services, Baergic will pay Avenue an annual consulting fee of $0.5 million (the “Avenue-Baergic Annual Consulting Fee”), payable in advance in equal quarterly installments on thefirst business day of each calendar quarter in each year, provided, however, that such Avenue-Baergic Annual Consulting Fee shall be increased to $1.0 million for each calendar year in which Baergic has net assets in excess of $100 million at the beginning of the calendar year.

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Note 5 —Accounts Payable and Accrued Expenses

Accounts payable, accrued expenses, and other liabilities consisted of the following (in thousands):

As of March 31,As of December 31,
20252024
Accounts payable$173$155
Accrued employee compensation8518
Accrued contracted services and other745481
Total accounts payable and accrued expenses$1,003$654

Note 6 - Commitments and Contingencies

Leases

The Company isnot party to any leases for office space or equipment.

Litigation

The Company recognizes a liability for a contingency when it is probable that liability has been incurred and when the amount of loss can be reasonably estimated. When a range of probable loss can be estimated, the Company will accrue the most likely amount of such loss, and if such amount isnot determinable, then the Company will accrue the minimum of the range of probable loss. As of* March 31, 2025,there wasno* litigation against the Company.

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Note7 - Stockholder's Equity

Class A Preferred Stock

On* September**13,* 2016, 2,000,000 shares of Preferred Stock were authorized, of which 250,000 have been designated as Class A Preferred Stock and the remainder are undesignated preferred stock. The Class A Preferred Stock, with a par value of $0.0001 per share, is identical to undesignated Common Stock other than as to voting rights, conversion rights, and the Annual Stock Dividend right (as described below). The undesignated Preferred Stock* maybe issued from time to time inone* or more series. The Company’s Board of Directors is authorized to determine or alter the dividend rights, dividend rate, conversion rights, voting rights, rights and terms of redemption (including sinking fund provisions, if any), the redemption price or prices, the liquidation preferences and other designations, powers, preferences and relative, participating, optional or other special rights, if any, and the qualifications, limitations and restrictions granted to or imposed upon any wholly unissued series of Preferred Stock, and to fix the number of shares of any series of Preferred Stock (butnot below the number of shares of any such series then outstanding).

On any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Class A Preferred Stock shall be entitled to cast for each share of Class A Preferred Stock held by such holder as of the record date for determining stockholders entitled to vote on such matter, the number of votes that is equal toone andone-tenth (1.1) times a fraction, the numerator of which is the sum of (A) the number of shares of outstanding Common Stock and (B) the whole shares of Common Stock in to which the shares of outstanding Class A Preferred Stock are convertible, and the denominator of which is number of shares of outstanding Class A Preferred Stock (the “Class A Preferred Stock Ratio”). Thus, the Class A Preferred Stock will at all times constitute a voting majority.

Each share of Class A Preferred Stock is convertible, at the option of the holder, intoone fully paid and nonassessable share of Common Stock (the “Conversion Ratio”), subject to certain adjustments. If the Company, at any time effects a subdivision or combination of the outstanding Common Stock (by any stock split, stock dividend, recapitalization, reverse stock split or otherwise), the applicable Conversion Ratio in effect immediately before that subdivision is proportionately decreased or increased, as applicable, so that the number of shares of Common Stock issuable on conversion of each share of Class A Preferred Stock shall be increased or decreased, as applicable, in proportion to such increase or decrease in the aggregate number of shares of Common Stock outstanding. Additionally, if any reorganization, recapitalization, reclassification, consolidation or merger involving the Company occurs in which the Common Stock (butnot the Class A Preferred Stock) is converted into or exchanged for securities, cash or other property, then each share of Class A Preferred Stock becomes convertible into the kind and amount of securities, cash or other property which a holder of the number of shares of Common Stock of the Company issuable upon conversion ofone share of the Class A Preferred Stock immediately prior to such reorganization, recapitalization, reclassification, consolidation or merger would have been entitled to receive pursuant to such transaction. Pursuant to the reverse stock splits by the Company in* September 2022and April 2024,the Class A Preferred Stock has a Conversion Ratio of 1,125 Class A Preferred toone* share of Common Stock.

Common Stock

Holders of the Company's common stock are entitled toone vote for each share held on all matters submitted to a vote of stockholders and donot have cumulative voting rights. An election of directors by the stockholders is determined by a plurality of the votes cast by the stockholders entitled to vote on the election. Holders of common stock are entitled to receive proportionately any dividends as* may*be declared by the Company's Board of Directors, subject to any preferential dividend rights of outstanding preferred stock.

In the event of the Company's liquidation or dissolution, the holders of common stock are entitled to receive proportionately all assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock. Holders of common stock haveno preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges of holders of common stock are subject to, and* maybe adversely affected by, the rights of the holders of shares of any series of preferred stock that the Company may*designate and issue in the future.

Capital Raises

2021 Shelf

On* December 7, 2021,the Company filed a shelf registration statement (FileNo.* 333-261520) on Form S-3, which was declared effective on* December 10, 2021 (the "Shelf"). The Company filed a replacement shelf registration on Form S-3 on December 4, 2024 (the "Replacement Shelf"), which hasnot* yet become effective under the Securities Act of1933, as amended (the "Securities Act"). However, upon the Company's formal delisting from Nasdaq, effective upon Nasdaq's filing of a Form25 with the SEC, the Company will be ineligible to use Form S-3 and therefore unable to use the Shelf or the Replacement Shelf.

ATM Facility

On* May 10, 2024,the Company entered into an At the Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co. LLC (the “ATM Manager”) under which the Company mayoffer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share, through or to the ATM Manager. Offers and sales of the shares are made pursuant to the Shelf, and the related prospectus supplement dated May 10, 2024 (including such replacement registration statement as maybe filed with the SEC, the “ATM Registration Statement”) and filed with the SEC on such date pursuant to Rule424*(b) under the Securities Act. As a result of the limitations of General InstructionI.B.6 of Form S-3, the Company* may*currently sell up to a maximum of $3,850,000 of its shares pursuant to the ATM Agreement.

Under the ATM Agreement, the ATM Manager* maysell shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule415*(a)(4) under the Securities Act. The ATM Manager will use commercially reasonable efforts to sell the shares from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company* mayimpose). The Company agreed to pay the ATM Manager a commission of 3.0% of the gross proceeds from the sales of shares sold through the ATM Manager under the ATM Agreement and has provided the ATM Manager with customary indemnification and contribution rights. The Company also agreed to reimburse the ATM Manager for certain expenses incurred in connection with the ATM Agreement. The Company and the ATM Manager may*each terminate the ATM Agreement at any time upon specified prior written notice.

For thethree months ended* March 31, 2025,the Company sold an aggregate of 938,990 shares of its common stock pursuant to the ATM Agreement, resulting in net proceeds of approximately $2.1 million after deducting underwriting discounts. The Company isno* longer able to utilize the ATM Agreement as a result of the suspension of its common stock from trading on the Nasdaq.

** January 2024** Warrant Inducement and Private Placement

On* January 5, 2024,the Company entered into (i) an inducement offer letter agreement (the “January 2023Investor Inducement Letter”) with a certain investor (the “January 2023Investor”) in connection with certain outstanding warrants to purchase up to an aggregate of 25,871 of the Company’s common stock originally issued to the January 2023Investor on January 31, 2023 (the “January 2023Warrants”) and (ii) an inducement offer letter agreement (the “November 2023Investor Inducement Letter Agreement” and, together with the January 2023Investor Inducement Letter, the “January 2024Warrant Inducement”) with certain investors (the “November 2023Investors” and, together with the January 2023Investor, the “Holders”) in connection with certain outstanding warrants to purchase up to an aggregate of 194,667 shares of common stock, originally issued to the November 2023Investors on November 2, 2023 (the “November 2023Warrants” and, together with the January 2023Warrants, the “Existing Warrants”). The January 2023Warrants had an exercise price of $116.25 per share, and the November 2023*Warrants had an exercise price of $22.545 per share.

Pursuant to the* January 2024Warrant Inducement, (i) the January 2023Investor agreed to exercise for cash its January 2023Warrants at a reduced exercise price of $22.545 per share and (ii) the November 2023Investors agreed to exercise for cash their November 2023Warrants at the existing exercise price of $22.545 in consideration for the Company’s agreement to issue in a private placement (x) new Series A common stock purchase warrants (the “January 2024Series A Warrants”) to purchase up to 220,538 shares of common stock (the “January 2024Series A Warrants Shares”) and (y) new Series B common stock purchase warrants (the “January 2024Series B Warrants” and, together with the January 2024Series A Warrants, the “January 2024Warrants”) to purchase up to 220,538 shares of common stock (the “January 2024Series B Warrants Shares”). The January 2024Series A Warrants were to expire five years following the issuance date and the January 2024Series B Warrants were to expireeighteen* months following the issuance date. The* January 2024*Warrants were all subsequently exercised, andnone remain outstanding as of the date of this report.

The approximately $0.6 million of the* January 2024Warrants’ fair value allocated to the January 2023Warrants was recorded as a loss on common stock warrant liabilities in the Condensed Consolidated Statements of Operations with a corresponding offset to additional paid-in-capital. Approximately $4.3 million of the January 2024Warrants fair value was allocated to the November 2023Warrants and deemed to be a dividend and recorded to additional paid-in-capital because the Company had an accumulated deficit on the exercise date. The deemed dividend was included in net loss attributable to common stockholders in the calculation of net loss per share in the condensed consolidated statements of operations (see Note2*).

Equity Incentive Plan

The Company has in effect the Avenue Therapeutics, Inc.2015 Incentive Plan (as amended, the*“2015* Incentive Plan"). The2015 Incentive Plan was adopted in* January**2015* by the Company's stockholders and, in* December 2021,the Company’s stockholders approved an amendment to the plan to increase the number of authorized shares issuable to 3,556 shares. On January 30, 2023,the Company’s stockholders approved an amendment to the2015* Incentive Plan to increase the number of authorized shares issuable to 70,223 shares. On* June 24, 2024,the Company’s stockholders approved an amendment to the2015* Incentive Plan to increase the number of authorized shares issuable to 5,070,223 shares, which extended the term of the2015 Incentive Plan to* June 24, 2034,to increase the limit of the number of shares that maybe issued upon exercise of incentive stock options by 5,000,000 shares, and to increase the annual share limit awards for non-employee directors to 500,000. Under the2015* Incentive Plan, the compensation committee of the Company’s board of directors is authorized to grant stock-based awards to directors, officers, employees and consultants. The2015 Incentive Plan authorizes grants to issue up to 5,070,223 shares of authorized but unissued common stock and expires 10 years from adoption and limits the term of each option tono more than 10 years from the date of grant.

Total shares available for the issuance of stock-based awards under the Company’s2015 Incentive Plan was 4,575,701 shares at* March 31, 2025*.

Restricted Stock Units and Restricted Stock Awards

The following table summarizes the restricted stock unit and award activity during thethree months ended* March 31, 2025*:

Number ofWeighted
Units andAverage Grant
AwardsDate Fair Value
Unvested balance at December 31, 2024236,028$3.44
Granted——
Forfeited——
Vested(284)85.50
Unvested balance at March 31, 2025235,744$3.34

At* March 31, 2025*, the Company had unrecognized stock-based compensation expense related to restricted stock units and restricted stock awards of $0.2 million, which is expected to be recognized over the remaining weighted-average vesting period of 1.1 years. This amount doesnot include, as of* March 31, 2025*,45 shares of restricted stock outstanding which are performance-based and vest upon achievement of certain corporate milestones. The expense is recognized over the vesting period of the award. Stock-based compensation for awards containing performance conditions will be measured as of the grant date and recorded if and when it is probable that the performance condition will be achieved.

The Company offers certain executives and key employees the opportunity to defer settlement of vested restricted stock units as part of our nonqualified deferred compensation plan. As of* March 31, 2025,*the Company had 235,000 outstanding deferred restricted stock units.

Stock Options

The following table summarizes stock option activity during thethree months ended* March 31, 2025*:

Weighted
Average
Weighted · Remaining · Aggregate
NumberAverageContractualIntrinsic Value
of OptionsExercise PriceTerm (years)(in thousands)
Outstanding at December 31, 2024256,474$9.749.6$—
Granted—$—$—
Exercised—$—$—
Cancelled/forfeited—$—$—
Expired—$—$—
Outstanding at Balance at March 31, 2025256,474$9.749.4$—
Expected to vest166,125$7.529.4$—
Exercisable90,349$13.819.3$—

The aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair value of the Company's common stock for those options that had exercise prices lower than the fair value of the Company's common stock. As of* March 31, 2025*, the total compensation cost related to non-vested options awardsnot yet recognized is approximately $0.5 million with a weighted average remaining vesting period of 1.2 years.

Stock-based compensation expense has been reported in the Company's condensed consolidated statements of operations as follows:

For the Three Months Ended
March 31,
20252024
Research and development$40$45
General and administrative145146
Total stock-based compensation expense$185$191

Stock Warrants

The following table summarizes the warrant activity for thethree months ended* March 31, 2025:*

Weighted
Average · Aggregate
Exercise · Intrinsic Value
WarrantsPrice(in thousands)
Outstanding, December 31, 20241,476,200$8.64$—
Granted—
Exercised—
Outstanding, March 31, 20251,476,200$8.64$—

Upon the exercise of warrants, the Company will issue new shares of its common stock.

InvaGen Share Repurchase

Under the Share Repurchase Agreement, the Company agreed to pay InvaGen an additional amount as a contingent fee, payable in the form ofseven and a half percent (7.5%) of the proceeds of future financings, up to $4.0 million. In connection with the common share sales pursuant to the ATM Agreement, the Company made payments totaling approximately $0.2 million to InvaGen during thethree months ended* March 31, 2025.Approximately $1.4 million in aggregate has been paid to InvaGen under the Share Repurchase Agreement through thethree* months ended* March, 31, 2025.*Payments to InvaGen are recorded in general and administrative expense on the condensed consolidated statements of operations.

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Note8 - Common Stock Warrants

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC480 and ASC815. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC480, meet the definition of a liability pursuant to ASC480, and whether the warrants meet all of the requirements for equity classification under ASC815, including whether the warrants are indexed to the Company’s own common stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that donot meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and each consolidated balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a gain or loss on the condensed consolidated statements of operations.

Warrant Liability

The Company has previously issued freestanding warrants to purchase shares of its common stock in connection with financing activities. The outstanding warrants to purchase common stock originally issued by the Company in* October 2022 (the "October 2022Warrants") are classified as liabilities on the balance sheet as they contain terms for redemption of the underlying security that are outside the Company's control. The previously outstanding warrants to purchase common stock originally issued by the Company in January 2023 (the "January 2023Warrants") classified as liabilities were fully exercised during thethree* months ended* March 31, 2024.*The Black-Scholes Model is used to value the warrants classified as liabilities and the approach required management to estimate inputs including expected volatility and expected term and is most significantly impacted by the volatility of the Company's common stock price. These inputs are inherently subjective and require significant analysis and judgment to develop.

The fair value of the warrants was measured at the time of issuance and is re-measured at each financial reporting date with any changes in fair value being recognized in change in fair value of warrant liabilities, a component of other income (expense), in the consolidated statements of operations and comprehensive income (loss). The Company will continue to re-measure the fair value of the* October 2022Warrant liabilities until exercise or expiration of the warrants on October 10, 2027.*

Fair Value of Warrant Liabilities

Warrant liabilities are categorized within Level3 of the fair value hierarchy and are measured at fair value on a recurring basis as follows (in thousands):

Warrants
Fair value of warrants outstanding as of December 31, 2024$16
Change in fair value of warrants(15)
Fair value of warrants outstanding as of March 31, 2025$1

The key inputs for the* October 2022*Warrants using the Black-Scholes model were as follows:

March 31,December 31,
20252024
Stock price$0.30$2.00
Risk-free interest rate4.35%4.27%
Expected dividend yield——
Expected term in years2.52.8
Expected volatility160%155%

Note9 - Subsequent Events

AnnJi Termination and Transfer Agreement

On* April 24, 2025,the Company and AnnJi entered into the Termination and Transfer Agreement. See Note3* for additional details.

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