Avenue Therapeutics Announces Reverse Stock Split and Provides Regulatory Update for IV Tramadol Including Receipt of Type A Meeting Minutes from the FDA
September 22 2022 - 4:25PM
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
central nervous system diseases, today announced that it will
effect a 1-for-15 reverse split of its common stock, which will be
effective for trading purposes on the Nasdaq Capital Market as of
the commencement of trading on September 23, 2022, and also
provided a regulatory update related to its intravenous (“IV”)
Tramadol product candidate.
Reverse Stock Split
The reverse stock split was approved on July 25,
2022 by stockholders representing approximately 73% of the voting
power of the outstanding voting stock of the Company, with
authorization to determine the final ratio having been granted to
the Company’s Board of Directors.
Avenue’s common stock will continue to trade on
the Nasdaq Capital Market under the symbol “ATXI” following the
reverse stock split, with a new CUSIP number of 05360L304. After
the effectiveness of the reverse stock split, we expect that the
number of outstanding shares of common stock will 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 stockholders would have received in the reverse stock split.
No fractional shares will be issued in connection with the reverse
stock split and stockholders 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 Nasdaq’s $1.00 per share
minimum bid price requirement for continued listing. The Company is
simultaneously effecting a reduction in the number of authorized
shares of common stock from 50,000,000 to 20,000,000.
Avenue’s transfer agent, VStock Transfer, LLC,
which is also acting as the exchange and paying agent for the
reverse stock split, will provide instructions to stockholders
regarding the process for exchanging physical share certificates.
We do not expect that stockholders holding their shares in
book-entry form or through a bank, broker or other nominee need to
take any action in connection with the reverse stock split.
Beneficial holders are encouraged to contact their bank, broker or
other nominee with any procedural questions. Additional information
concerning the reverse stock split can be found in 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 received the official meeting minutes
from the FDA regarding a meeting conducted on August 9, 2022, for
IV Tramadol. Avenue submitted the Type A Meeting Request and
related briefing documents to the FDA on June 17, 2022, and
included a proposed study design to address the concerns around 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 medically supervised healthcare setting that was
discussed in detail at the previously disclosed Advisory Committee
meeting on February 15, 2022 and in the Appeal Denied letter
received on March 18, 2022.
At the meeting, Avenue presented a study design
for a single safety clinical trial that the Company believes could
address the concerns regarding risks related to opioid stacking.
The FDA stated that the proposed study design appears reasonable
and agreed on various study design aspects with the expectation
that additional feedback 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 could form the basis for the
submission of a complete response to the second Complete Response
Letter for IV Tramadol.
About Avenue TherapeuticsAvenue
Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical
company focused on the development and commercialization of
therapies for the treatment of central nervous system diseases.
Avenue is headquartered in New York City. For more information,
visit www.avenuetx.com.
Forward-Looking StatementsThis
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
candidate; 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; uncertainty
surrounding the Baergic Bio acquisition; ability to effectuate the
reverse stock split; 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.
Contacts: Jaclyn Jaffe and Bill BegienAvenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
Avenue Therapeutics (NASDAQ:ATXI)
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