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Avenue Therapeutics Receives Positive Listing Determination from Nasdaq

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Avenue Therapeutics, Inc. (ATXI) has been granted an extension by the Nasdaq Hearings Panel to evidence compliance with listing criteria, including bid price and stockholders' equity requirements, until May 20, 2024. The company is exploring options to meet these criteria but cannot guarantee compliance.
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The Nasdaq Hearings Panel's decision to grant Avenue Therapeutics an extension to meet continued listing criteria is a significant development for the company's shareholders and potential investors. The extension until May 20, 2024, offers Avenue a window to address the bid price and stockholders' equity requirements, which are essential indicators of a company's financial health and market confidence. The bid price requirement ensures that the stock is sufficiently liquid and valued by the market, while the stockholders' equity requirement reflects the company's ability to finance its operations and growth.

Investors should note that the company's ability to maintain its Nasdaq listing is critical, as delisting can lead to reduced liquidity and investor interest, potentially impacting the stock price negatively. The announcement also suggests that the company is actively exploring options to meet the criteria, which may include measures such as strategic financing, cost restructuring, or asset divestiture. Stakeholders should closely monitor the company's progress and strategic decisions in the coming weeks.

Avenue Therapeutics operates within the specialty pharmaceutical sector, which is highly competitive and capital-intensive. The extension for Nasdaq compliance provides the company with a strategic advantage to stabilize its operations and seek partnerships or funding opportunities. In the context of neurologic diseases, the market is driven by the increasing prevalence of such conditions and the demand for innovative treatments. The company's focus on this area could attract interest from larger pharmaceutical entities looking for promising additions to their pipelines.

However, the uncertainty highlighted by the statement 'there can be no assurance' is a common disclaimer that underscores the inherent risks involved. This uncertainty may affect investor sentiment and the company's ability to secure necessary capital. It is important for stakeholders to consider the broader industry trends, such as regulatory hurdles and the competitive landscape, which could influence Avenue's ability to capitalize on this extension period.

MIAMI, March 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that by decision dated March 11, 2024, the Nasdaq Hearings Panel granted the Company’s request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through May 20, 2024. The Company is considering all available options that may enable it to timely evidence compliance with the continued listing criteria and maintain its listing on Nasdaq; however, there can be no assurance that the Company will be able to do so.

About Avenue Therapeutics
Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABAA α2, α3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute postoperative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com.

Forward-Looking Statements
This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: expectations for increases or decreases in expenses; expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidate or any other products we may acquire or in-license; our use of clinical research centers and other contractors; expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities; expectations for generating revenue or becoming profitable on a sustained basis; expectations or ability to enter into marketing and other partnership agreements; expectations or ability to enter into product acquisition and in-licensing transactions; expectations or ability to build our own commercial infrastructure to manufacture, market and sell our product candidates; acceptance of our products by doctors, patients or payors; our ability to compete against other companies and research institutions; our ability to secure adequate protection for our intellectual property; our ability to attract and retain key personnel; availability of reimbursement for our products; estimates of the sufficiency of our existing cash and cash equivalents and investments to finance our operating requirements, including expectations regarding the value and liquidity of our investments; the volatility of our stock price; expected losses; expectations for future capital requirements; the ability to achieve and maintain continued compliance with certain Nasdaq continued listing rules; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors.

Contact:
Jaclyn Jaffe
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com


Avenue Therapeutics, Inc. (ATXI) has been granted an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including bid price and stockholders' equity requirements, until May 20, 2024.

Avenue Therapeutics, Inc. (ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases.

Avenue Therapeutics, Inc. (ATXI) is considering all available options that may enable it to timely evidence compliance with the continued listing criteria and maintain its listing on Nasdaq.

There can be no assurance that Avenue Therapeutics, Inc. (ATXI) will be able to evidence compliance with the continued listing criteria and maintain its listing on Nasdaq.
Avenue Therapeutics Inc

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Pharmaceutical Preparation Manufacturing
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About ATXI

avenue therapeutics, inc. (nasdaq: atxi), a fortress biotech (nasdaq: fbio) company, is a specialty pharmaceutical company focused on the development and commercialization of intravenous (iv) tramadol for the management of moderate to moderately severe postoperative pain. iv tramadol may fill a gap in the acute pain market between iv acetaminophen/nsaids and iv conventional narcotics. avenue is currently evaluating iv tramadol in a pivotal phase 3 program for the management of postoperative pain.