NEW YORK, Sept. 22, 2022 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical firm targeted on the event and commercialization of therapies for the remedy of central nervous system illnesses, as we speak introduced that it’s going to impact a 1-for-15 reverse cut up of its frequent inventory, which can be efficient for buying and selling functions on the Nasdaq Capital Market as of the graduation of buying and selling on September 23, 2022, and additionally offered a regulatory replace associated to its intravenous (“IV”) Tramadol product candidate.
Reverse Stock Split
The reverse inventory cut up was authorized on July 25, 2022 by stockholders representing roughly 73% of the voting energy of the excellent voting inventory of the Company, with authorization to find out the ultimate ratio having been granted to the Company’s Board of Directors.
Avenue’s frequent inventory will proceed to commerce on the Nasdaq Capital Market underneath the image “ATXI” following the reverse inventory cut up, with a brand new CUSIP variety of 05360L304. After the effectiveness of the reverse inventory cut up, we count on that the variety of excellent shares of frequent inventory can be decreased from roughly 22.7 million to roughly 1.5 million, topic to adjustment to provide impact to the remedy of any fractional shares that stockholders would have acquired within the reverse inventory cut up. No fractional shares can be issued in reference to the reverse inventory cut up and stockholders who would in any other case be entitled to a fractional share will obtain a proportional money cost.
The reverse inventory cut up is primarily meant to deliver the Company into compliance with Nasdaq’s $1.00 per share minimal bid worth requirement for continued itemizing. The Company is concurrently effecting a discount within the variety of licensed shares of frequent inventory from 50,000,000 to twenty,000,000.
Avenue’s switch agent, VStock Transfer, LLC, which can be performing because the trade and paying agent for the reverse inventory cut up, will present directions to stockholders relating to the method for exchanging bodily share certificates. We don’t count on that stockholders holding their shares in book-entry kind or via a financial institution, dealer or different nominee have to take any motion in reference to the reverse inventory cut up. Beneficial holders are inspired to contact their financial institution, dealer or different nominee with any procedural questions. Additional data regarding the reverse inventory cut up could be discovered within the Company’s definitive Information Statement on Schedule 14C filed with the Securities and Exchange Commission on August 22, 2022.
IV Tramadol Regulatory Update
Avenue acquired the official assembly minutes from the FDA relating to a gathering carried out on August 9, 2022, for IV Tramadol. Avenue submitted the Type A Meeting Request and associated briefing paperwork to the FDA on June 17, 2022, and included a proposed research design to deal with the considerations across the security threat of IV Tramadol together with different opioid analgesics for the administration of moderate-to-moderately-severe ache in adults in a medically supervised healthcare setting that was mentioned intimately on the beforehand disclosed Advisory Committee assembly on February 15, 2022 and within the Appeal Denied letter acquired on March 18, 2022.
At the assembly, Avenue offered a research design for a single security scientific trial that the Company believes might deal with the considerations relating to dangers associated to opioid stacking. The FDA said that the proposed research design seems cheap and agreed on varied research design facets with the expectation that further suggestions could be offered to Avenue upon evaluate of a extra detailed research protocol. The Company intends to include the FDA’s options from the assembly minutes and submit an in depth research protocol that might kind the idea for the submission of an entire response to the second Complete Response Letter for IV Tramadol.
About Avenue Therapeutics
Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical firm targeted on the event and commercialization of therapies for the remedy of central nervous system illnesses. Avenue is headquartered in New York City. For extra data, go to www.avenuetx.com.
Forward-Looking Statements
This press launch accommodates predictive or “forward-looking statements” throughout the that means of the Private Securities Litigation Reform Act of 1995. All statements aside from statements of present or historic truth contained on this press launch, together with statements that categorical our intentions, plans, targets, beliefs, expectations, methods, predictions or every other statements referring to our future actions or different future occasions or situations are forward-looking statements. The phrases “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and comparable expressions are meant to establish forward-looking statements. These statements are based mostly on present expectations, estimates and projections made by administration about our business, our trade and different situations affecting our monetary situation, outcomes of operations or business prospects. These statements usually are not ensures of future efficiency and contain dangers, uncertainties and assumptions which might be troublesome to foretell. Therefore, precise outcomes and outcomes could differ materially from what’s expressed or forecasted in, or implied by, the forward-looking statements as a consequence of quite a few dangers and uncertainties. Factors that might trigger such outcomes and outcomes to vary embody, however usually are not restricted to, dangers and uncertainties arising from: expectations for will increase or decreases in bills; expectations for the scientific and pre-clinical growth, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidate or every other merchandise we could purchase or in-license; our use of scientific analysis facilities and different contractors; expectations for incurring capital expenditures to broaden our analysis and growth and manufacturing capabilities; expectations for producing income or changing into worthwhile on a sustained foundation; expectations or means to enter into advertising and different partnership agreements; expectations or means to enter into product acquisition and in-licensing transactions; expectations or means to construct our personal business infrastructure to fabricate, market and promote our product candidate; acceptance of our merchandise by medical doctors, sufferers or payors; our means to compete in opposition to different firms and analysis establishments; our means to safe sufficient safety for our mental property; our means to draw and retain key personnel; availability of reimbursement for our merchandise; estimates of the sufficiency of our current money and money equivalents and investments to finance our working necessities, together with expectations relating to the worth and liquidity of our investments; the volatility of our inventory worth; anticipated losses expectations for future capital necessities; uncertainty surrounding the Baergic Bio acquisition; means to effectuate the reverse inventory cut up; and these dangers mentioned in our filings which we make with the SEC. Any forward-looking statements converse solely as of the date on which they’re made, and we undertake no obligation to publicly replace or revise any forward-looking statements to mirror occasions or circumstances that will come up after the date of this press launch, besides as required by relevant regulation. Investors ought to consider any statements made by us in gentle of those essential elements.
Contacts:
Jaclyn Jaffe and Bill Begien
Avenue Therapeutics, Inc.
(781) 652-4500
[email protected]
