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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
September 22, 2022
Avenue Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware
(State or Other Jurisdiction
of Incorporation) |
001-38114
(Commission File Number)
|
47-4113275
(IRS Employer Identification No.)
|
2 Gansevoort Street, 9th Floor
New York, New York 10014
(Address of Principal Executive Offices)
(781) 652-4500
(Registrant’s telephone number, including
area code)
Check the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act. |
| |
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| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act. |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
Securities registered pursuant to Section 12(b) of the
Act:
| Title of Class |
|
Trading Symbol(s) |
|
Exchange Name |
| Common Stock |
|
ATXI |
|
Nasdaq Capital Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter). x
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
| Item 3.03 |
Material Modification to Rights of Security Holders. |
On September 22, 2022, Avenue Therapeutics, Inc.
(the “Company”) filed a Certificate of Amendment to its Third Amended and Restated Certificate of Incorporation (the
“Amendment”) with the Secretary of State of the State of Delaware to (i) effect a 1-for-15 reverse stock split (the
“Reverse Stock Split”) of the Company’s shares of common stock, $0.0001 par value (the “Common Stock”),
and (ii) effect a related reduction in the number of the Company’s authorized shares from
50,000,000 to 20,000,000 (the “Authorized Share Reduction”).
As previously
disclosed in a Definitive Information Statement on Schedule 14C filed with the Securities and Exchange Commission on August 22, 2022 (the
“Information Statement”), the Company’s stockholders approved the Reverse Stock Split within a range of
between 10-for-1 and 20-for-1, such ratio to be determined by the Board of Directors of the Company (the “Board”),
and the Authorized Share Reduction, each of which the Board also approved. On September 6, 2022, the Board selected the 1-for-15 reverse
stock split ratio.
As a result of the Reverse Stock Split, every 15
shares of the Company’s pre-reverse split Common Stock will be combined and reclassified as one share of Common Stock. Proportionate
voting rights and other rights of common stockholders will not be affected by the reverse split, other than as a result of the payment
for fractional shares. No fractional shares will be issued in connection with the Reverse Stock Split. Stockholders who would otherwise
hold a fractional share of Common Stock will receive (upon surrender to the exchange agent of certificates representing such shares),
a cash payment in lieu thereof, without interest or deduction, rounded to the nearest cent, in an amount equal to the product obtained
by multiplying (a) the closing price per share of our common stock as reported on the Nasdaq Stock Market as of the effective date of
the Reverse Stock Split, by (b) the fraction of one share owned by the stockholder.
The Reverse Stock Split became
effective on September 22, 2022, and the Common Stock will be quoted on the Nasdaq Stock Market on a post-split basis at the open of business
on September 23, 2022. The Company’s post-reverse split Common Stock has a new CUSIP number, 05360L304, but the par value and other
terms of the Common Stock were not affected by the Reverse Stock Split.
The Company’s transfer agent, VStock Transfer,
LLC, is acting as exchange agent for the Reverse Stock Split and will send instructions to stockholders of record regarding the exchange
of certificates for Common Stock.
The foregoing description of the Amendment and
the Reverse Stock Split set forth above does not purport to be complete and is qualified in its entirety by reference to the Amendment
and the Information Statement. A copy of the Amendment is being filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
| Item 5.03 |
Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year |
The disclosures set forth in Item 3.03 of this
Current Report on Form 8-K are incorporated into this Item 5.03 by reference.
On September 22, 2022, Avenue
Therapeutics, Inc. issued a press release announcing (i) the Reverse Stock Split ratio and (ii) the receipt of official meeting minutes
from the U.S. Food and Drug Administration regarding a meeting conducted on August 9, 2022, for intravenous Tramadol. A copy of such press
release is being furnished as Exhibit 99.1 to this report.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
The following exhibit is furnished herewith:
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
| |
AVENUE THERAPEUTICS, INC. |
| |
|
| |
(Registrant) |
| |
|
| Date: September 22, 2022 |
|
| |
|
| |
By: |
/s/ David Jin |
| |
|
David Jin |
| |
|
Interim Principal Financial Officer and Chief Operating Officer |
Exhibit 3.1
CERTIFICATE OF AMENDMENT
TO
THE THIRD AMENDED
AND RESTATED CERTIFICATE OF INCORPORATION
OF
AVENUE THERAPEUTICS, INC.
Avenue Therapeutics, Inc.
(the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law
of the State of Delaware (the “DGCL”), does hereby certify:
FIRST. The Certificate
of Incorporation of the Corporation is hereby amended by changing ARTICLE IV, so that, as amended, the first paragraph of said Section 5
shall be amended and restated as follows:
Authorized
Stock. The total number of shares of all classes of capital stock that the Corporation shall have the authority to issue is (i) twenty
million (20,000,000) shares of Common Stock, with $0.0001 par value, and (ii) 2,000,000 shares of Preferred Stock, with $.0001 par
value (the “Preferred Stock”), 250,000 of which are designated as Class A Preferred Stock (the “Class A
Preferred Stock”) and the remainder are undesignated Preferred Stock.
SECOND. Upon the filing
and effectiveness (the “Effective Time”) pursuant to the DGCL of this Certificate of Amendment to the Certificate
of Incorporation, every fifteen (15) issued and outstanding shares or shares held by the Corporation as treasury stock of the Corporation’s
common stock, par value $.0001 per share, as of the date and time immediately preceding the Effective Time (the “Old Shares”),
shall automatically be reclassified as and converted into one (1) validly issued, fully paid and non-assessable share of common stock
of the Corporation (the “New Shares”) without any further action by the Corporation or the holder thereof, subject
to the treatment of fractional share interests as described below (the “Reverse Stock Split”). Further, every
right, option and warrant to acquire Old Shares outstanding immediately prior to the Effective Time shall, as of the Effective Time and
without any further action, automatically be reclassified into the right to acquire one (1) New Share based on the conversion ratio
of shares of Old Shares to New Shares set forth in the preceding sentence, but otherwise upon the terms of such right, option or warrant
(except that the exercise or purchase price of such right, option or warrant shall be proportionately adjusted).
No fractional shares shall
be issued in connection with the Reverse Stock Split. Stockholders who otherwise would be entitled to receive fractional shares of Common
Stock shall be entitled to receive cash (without interest or deduction) from the Corporation’s transfer agent in lieu of such fractional
share interests upon the submission of a transmission letter by a stockholder holding the shares in book-entry form and, where shares
are held in certificated form, upon the surrender of the stockholder’s Old Certificates (as defined below), in an amount equal to
the product obtained by multiplying (a) the closing price per share of the Common Stock as reported on the Nasdaq Stock Market as
of the date of the Effective Time, by (b) the fraction of one share owned by the stockholder.
THIRD. Each holder of
record of a certificate which immediately prior to the last trading day preceding the date of the Split Effective Time (the “Split
Effective Date”) represents Old Shares (the “Old Certificates”) shall be entitled to receive upon
surrender of such Old Certificates to the Corporation’s transfer agent for cancellation, a certificate (the “New Certificates”)
representing the number of whole shares of common stock into and for which the shares formerly represented by such Old Certificates so
surrendered are exchangeable. From and after the Effective Date, Old Certificates shall represent only the right to receive New Certificates
pursuant to the provisions hereof.
FOURTH. That a resolution
was duly adopted by unanimous written consent of the directors of the Corporation, pursuant to Section 242 of the General Corporation
Law of the State of Delaware, setting forth the above mentioned amendment to the Certificate of Incorporation and declaring said amendment
to be advisable.
FIFTH. That this amendment
was duly authorized by the holders of a majority of the voting stock of the Corporation by written consent of the stockholders of the
Corporation. Said amendment was duly adopted in accordance with the provisions of the General Corporation Law.
IN WITNESS WHEREOF, this
Certificate of Amendment of the Certificate of Incorporation has been signed by the Chief Executive Officer of the Corporation this 22nd
day of September, 2022.
| AVENUE THERAPEUTICS, INC. |
|
| |
|
|
| By: |
/s/ Alexandra MacLean |
|
| Name: Alexandra MacLean |
|
| Title: Chief Executive Officer |
|
Exhibit 99.1
Avenue Therapeutics Announces Reverse Stock
Split and Provides Regulatory Update for IV Tramadol Including Receipt of Type A Meeting Minutes from the FDA
New York, NY – September 22, 2022
– 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 Therapeutics
Avenue 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 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 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 Begien
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com