Form 8-K - Current report
27 Septiembre 2023 - 3:03PM
Edgar (US Regulatory)
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2023-09-27
2023-09-27
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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 27, 2023
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.)
|
1111 Kane Concourse, Suite 301
Bay Harbor Islands, Florida 33154
(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:
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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. |
|
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¨ |
Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act. |
|
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¨ |
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). ¨
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. ¨
As previously disclosed, on February 28, 2023,
Avenue Therapeutics, Inc. (the “Company”) entered into a license agreement (the “License Agreement”)
with AnnJi Pharmaceutical Co. Ltd., a Taiwanese company (“AnnJi”), whereby the Company obtained an exclusive license
from AnnJi to intellectual property rights pertaining to the molecule known as JM17, which activates Nrf1 and Nrf2, enhances androgen
receptor degradation and underlies AJ201, a clinical product candidate currently in a Phase 1b/2a clinical trial in the U.S. for the treatment
of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy’s Disease. SBMA is a rare, inherited, X-linked
genetic neuromuscular disease primarily affecting men. The condition is caused by a polyglutamine expansion in the androgen receptor (“AR”)
which leads to production of an abnormal AR protein that forms aggregates responsible for muscle atrophy focused in the spinal-bulbar
region of the body. Under the License Agreement, in exchange for exclusive rights to the
intellectual property underlying the AJ201 product candidate, among other things, the Company paid an initial cash license fee of $3.0
million and agreed to issue (i) 831,618 shares of its common stock, par value $0.0001 per share (“Common Stock”), to
AnnJi (the “First Tranche Shares”) shortly after the signing of the License Agreement, and (ii) an additional 276,652
shares of Common Stock upon enrollment of the eighth patient in the ongoing Phase 1b/2a SBMA clinical trial (the “Second Tranche
Shares”).
In July 2023, the Company announced the first
patient was dosed in the Phase 1b/2a trial of AJ201 for the treatment of SBMA. The 12-week, multicenter, randomized, double-blind trial
is expected to enroll approximately 24 patients, randomly assigned to AJ201 (600mg/day) or placebo. The primary endpoint of the study
is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacodynamic
data measuring change from baseline in mutant androgen receptor protein levels in skeletal muscle and changes in the fat and muscle composition
as seen on MRI scans. In September 2023, the Company enrolled its eighth patient in the study and, accordingly, it issued the Second Tranche
Shares to AnnJi under the terms of the License Agreement.
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 27, 2023 | | |
| | |
| By: | /s/ David Jin |
| | David Jin |
| | Interim Principal Financial Officer and Chief Operating Officer |
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