Avenue Therapeutics announces a reverse stock split and

NEW YORK, Sept. 22, 2022 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing therapies for the treatment Central Nervous System Diseases, today announced that it will effect a 1 for 15 reverse split of its common stock, effective for trading on the Nasdaq Capital Markets from the commencement of trading on September 23, 2022, and also provided a regulatory update regarding its intravenous (“IV”) tramadol product candidate.

Reverse stock split

The reverse stock split was approved on July 25, 2022 by shareholders representing approximately 73% of the voting rights of the Company’s outstanding voting shares, with authorization to determine the final ratio having been granted to the Board of Directors. administration of the Company.

Avenue common stock will continue to trade on the Nasdaq Capital Market under the symbol “ATXI” after the reverse stock split, with a new CUSIP number of 05360L304. Following the effectiveness of the reverse stock split, we expect the number of common shares outstanding to be reduced from approximately 22.7 million to approximately 1.5 million, subject to adjustment to give effect to the treatment of any fractional shares that the shareholders would have received as part of the share consolidation. No fractional shares will be issued in connection with the reverse stock split and shareholders who would otherwise be entitled to a fractional share will receive a proportional cash payment.

The reverse stock split is primarily intended to bring the Company into compliance with the Nasdaq minimum bid price requirement of $1.00 per share for continued listing. The Company is simultaneously reducing the number of ordinary shares authorized from 50,000,000 to 20,000,000.

Avenue’s transfer agent, VStock Transfer, LLC, which is also acting as exchange agent and payer for the stock consolidation, will provide instructions to shareholders regarding the process for the exchange of stock certificates physical. We do not expect that shareholders holding their shares in book-entry form or through a bank, broker or other agent will need to take any action in connection with the consolidation of shares. Beneficial owners are encouraged to contact their bank, broker or other agent for any procedural questions. Additional information regarding the stock consolidation can be found in the company’s final Schedule 14C disclosure statement filed with the Securities and Exchange Commission on August 22, 2022.

Tramadol IV Regulatory Update

Avenue has received official meeting minutes from the FDA regarding a meeting held on August 9, 2022 for IV Tramadol. Avenue submitted the Type A meeting request and related informational documents to the FDA on June 17, 2022, and included a study design proposal to address concerns about the safety risk of IV tramadol in combination with other opioid analgesics for the management of moderate-to-moderately severe pain in adults in a health care setting under medical supervision which was discussed in detail at the previously disclosed advisory committee meeting on February 15, 2022 and in the denied appeal letter received on March 18, 2022.

At the meeting, Avenue presented a study design for a single safety clinical trial that the company says could address concerns about the risks of opioid stacking. The FDA stated that the proposed study design appears reasonable and agreed to various aspects of the study design in the expectation that additional comments would be provided to Avenue upon review of a more detailed study protocol. . The Company intends to incorporate the FDA’s suggestions from the meeting minutes and submit a detailed study protocol that may form the basis for submission of a full response to the second response letter. complete for tramadol IV.

About Avenue Therapeutics
Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on developing and commercializing therapies for the treatment of diseases of the central nervous system. Avenue is headquartered in New York. 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 facts contained in this press release, including statements that express our intentions, plans, goals, beliefs, expectations, strategies, predictions or any other statements regarding our future business 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”, “should” and similar expressions are intended to identify forward-looking statements. These statements are based on management’s current expectations, estimates and projections regarding our business, 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 results and results may differ materially from what is expressed or anticipated in, or implied by, forward-looking statements due to numerous risks and uncertainties. Factors that could cause these outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: expectations of increased or decreased expenditures; expectations regarding the clinical and preclinical development, manufacturing, regulatory approval and commercialization of our drug product candidate or any other product that we may acquire or in-license; our use of clinical research centers and other contractors; expectations for capital expenditures to expand our research and development and manufacturing capabilities; expectations for revenue generation or sustainable profitability; expectations or ability to enter into marketing and other partnership agreements; expectations or the ability to complete product acquisition and licensing transactions; expectations or ability to build our own business infrastructure to manufacture, market and sell our product candidate; acceptance of our products by physicians, patients or payers; our ability to compete with other companies and research institutions; our ability to provide adequate protection for our intellectual property; our ability to attract and retain key personnel; availability of reimbursement for our products; estimates of the adequacy of our existing cash and cash equivalents and investments to fund our operating needs, including expectations regarding the value and liquidity of our investments; the volatility of our stock price; expectations of expected losses for future capital requirements; the uncertainty surrounding the acquisition of Baergic Bio; ability to effect the reverse stock split; and risks discussed in our filings with the SEC. All forward-looking statements speak only as of the date they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may occur after the date of this press release, except as required by applicable law. Investors should evaluate all statements we make in light of these important factors.

Jaclyn Jaffe and Bill Begien
Avenue Therapeutics, Inc.
(781) 652-4500
[email protected]

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