Avenue Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Highlights
May 15 2024 - 8:30AM
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
neurologic diseases, today reported financial results and recent
corporate highlights for the first quarter ended March 31, 2024.
“The first quarter was incredibly productive for
Avenue, as we’ve successfully executed on key milestones across our
pipeline of CNS treatments,” said Alexandra MacLean, M.D., Chief
Executive Officer of Avenue. “We made significant strides advancing
our lead clinical program, AJ201, in spinal and bulbar muscular
atrophy (“SBMA”), also known as Kennedy’s Disease and look forward
to reporting topline data in the middle of 2024. Additionally, this
quarter we continued to showcase the potential of BAER-101 for the
treatment of epilepsy with preclinical data at the American Society
for Experimental Neurotherapeutics (ASENT) Annual Meeting and in
the publication, Drug Development Research. We believe that with
the proper financing or a partnership, BAER-101 has the potential
to make a meaningful difference for patients facing great unmet
need. Finally, we reached agreement with the U.S. FDA on the safety
study design and statistical analysis approach for IV tramadol,
setting this program up for a successful Phase 3 study as soon as
the necessary funding is acquired. We look forward to progressing
our pipeline in the quarters to come as we seek to bring long-term
value to our shareholders and provide impactful therapies to
patients suffering from neurologic diseases.”
Recent Corporate
Highlights:
AJ201 (Nrf1 and Nrf2 activator,
androgen receptor degradation enhancer for SBMA)
- In April, Avenue hosted a virtual
key opinion leader (“KOL”) event highlighting expert perspectives
on SBMA. The event featured Christopher Grunseich, M.D., Lasker
Clinical Research Scholar and Investigator and Head of the
Inherited Neuromuscular Diseases Unit at the National Institute of
Neurological Disorders and Stroke, and Tahseen Mozaffar, M.D.,
Professor of Neurology, Pathology and Laboratory Medicine, Director
of the Division of Neuromuscular Diseases and Director of the ALS
and Neuromuscular Center at the University of California, Irvine.
The two featured speakers discussed the characteristics and
treatment landscape of SBMA, as well as the trial design and
potential of AJ201 in SBMA. A replay of the event can be accessed
here.
BAER-101 (GABAA α2/3
positive allosteric modulator)
- Avenue presented preclinical
results for BAER-101, a potentially best-in-class selective GABAA
α2,3 positive allosteric modulator, in the publication Drug
Development Research in February 2024 and the ASENT Annual Meeting
in March 2024. The in vivo data showcase BAER-101’s ability to
significantly suppress seizures using the SynapCell’s Genetic
Absence Epilepsy Rat from Strasbourg (“GAERS”) model of epilepsy.
BAER-101 fully suppressed seizure activity in the GAERS model with
a minimal effective dose of 0.3 mg/kg, PO, and the effect was fast
in onset and stable throughout the duration of testing. The data
also demonstrated BAER-101’s ability to selectively target GABAA α2
and α3 subtypes more than α1 and α5, potentially improving
anti-convulsant and anxiolytic activity while minimizing the risk
of tolerance and abuse associated with existing treatments in this
drug class. Subject to obtaining the necessary financing, which
could be provided through a strategic partnership, Avenue plans to
initiate a Phase 2a clinical trial of BAER-101 to further study its
anti-seizure properties in patients with common or rare
epilepsies.
IV Tramadol
- In January, Avenue reached final
agreement with the FDA on the safety study protocol and statistical
analysis approach for the Phase 3 study of intravenous (“IV”)
tramadol, which is being developed for the treatment of acute
post-operative pain in a medically supervised setting. The proposed
study will randomize approximately 300 post bunionectomy patients
to IV tramadol or IV morphine for pain relief administered during a
48-hour post-operative period. Patients will have access to IV
hydromorphone, a Schedule II opioid, for rescue of breakthrough
pain. Avenue aims to initiate the Phase 3 safety study as soon as
feasible. The Company believes that the study can be completed and
submitted to the FDA within 12 months of the study’s
initiation.
Corporate Highlights
- In January and May 2024, Avenue
raised a total of approximately $9.4 million in gross proceeds from
warrant exercise transactions.
- In April 2024, the Company effected
a 1-for-75 reverse stock split of its issued and outstanding common
stock which we expect will bring the Company into compliance with
Nasdaq’s $1.00 per share minimum bid price requirement for
continued listing.
Financial Results:
- Cash
Position: As of March 31, 2024, cash and cash
equivalents totaled $3.2 million, compared to $1.8 million at
December 31, 2023, an increase of $1.4 million. In May 2024, the
Company completed a warrant inducement transaction for $4.4 million
in gross proceeds.
- R&D
Expenses: Research and development expenses for the
first quarter of 2024 were $2.4 million, compared to $1.2 million
for the first quarter of 2023. Additionally, there was $4.2 million
in expense for the acquisition of the AJ201 license in the first
quarter of 2023.
- G&A
Expenses: General and administrative expenses for the
first quarter of 2024 were $1.3 million, compared to $1.0 million
for the first quarter of 2023.
- Net Loss: Net
loss attributable to common stockholders for the first quarter of
2024 was $4.3 million, or $15.40 per share, compared to a net loss
of $7.5 million, or $101.57 per share, for the first quarter of
2023.
About Avenue TherapeuticsAvenue
Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical
company focused on the development and commercialization of
therapies for the treatment of neurologic diseases. It is currently
developing three assets including AJ201, a first-in-class asset for
spinal and bulbar muscular atrophy, BAER-101, an oral small
molecule selective GABAA α2, α3 receptor positive allosteric
modulator for CNS diseases, and IV tramadol, which is in Phase 3
clinical development for the management of acute post-operative
pain in adults in a medically supervised healthcare setting. Avenue
is headquartered in Miami, FL and was founded by Fortress Biotech,
Inc. (Nasdaq: FBIO). 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: the fact that we currently have no drug products for sale and
that our success is dependent on our product candidates receiving
regulatory approval and being successfully commercialized; the
possibility that serious adverse or unacceptable side effects are
identified during the development of our current or future product
candidates, such that we would need to abandon or limit development
of some of our product candidates; our ability to successfully
develop, partner, or commercialize any of our current or future
product candidates including AJ201, IV tramadol, and BAER-101; the
substantial doubt raised about our ability to continue as a going
concern, which may hinder our ability to obtain future financing;
the significant losses we have incurred since inception and our
expectation that we will continue to incur losses for the
foreseeable future; our need for substantial additional funding,
which may not be available to us on acceptable terms, or at all,
which unavailability of could force us to delay, reduce or
eliminate our product development programs or commercialization
efforts; our reliance on third parties for several aspects of our
operations; our reliance on clinical data and results obtained by
third parties that could ultimately prove to be inaccurate, or
unreliable, or unacceptable to regulatory authorities; the
possibility that we may not receive regulatory approval for any or
all of our product candidates, or that such approval may be
significantly delayed due to scientific or regulatory reasons; the
fact that even if one or more of our product candidates receives
regulatory approval, they will remain subject to substantial
regulatory scrutiny; the effects of current and future laws and
regulations relating to fraud and abuse, false claims,
transparency, health information privacy and security, and other
healthcare laws and regulations; the effects of competition for our
product candidates and the potential for new products to emerge
that provide different or better therapeutic alternatives for our
targeted indications; the possibility that the government or
third-party payors fail to provide adequate coverage and payment
rates for our product candidates or any future products; our
ability to establish sales and marketing capabilities or to enter
into agreements with third parties to market and sell our product
candidates; our exposure to potential product liability claims;
related to the protection of our intellectual property and our
potential inability to maintain sufficient patent protection for
our technology and products; our ability to maintain compliance
with the obligations under our intellectual property licenses and
funding arrangements with third parties, without which licenses and
arrangements we could lose rights that are important to our
business; the fact that Fortress Biotech, Inc. controls a majority
of the voting power of our outstanding capital stock and has rights
to receive significant share grants annually; 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.
Contact: Jaclyn JaffeAvenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
AVENUE THERAPEUTICS, INC.Unaudited
Condensed Consolidated Balance Sheets($ in
thousands, except for share and per share amounts) |
|
|
|
|
March 31,2024 |
|
December 31,2023 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
3,194 |
|
|
$ |
1,783 |
|
|
Prepaid expenses and other current assets |
|
116 |
|
|
|
67 |
|
|
Total assets |
$ |
3,310 |
|
|
$ |
1,850 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
647 |
|
|
$ |
287 |
|
|
Accounts payable and accrued expenses - related party |
|
352 |
|
|
|
323 |
|
|
Warrant liability |
|
413 |
|
|
|
586 |
|
|
Total current liabilities |
|
1,412 |
|
|
|
1,196 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
1,412 |
|
|
|
1,196 |
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred stock ($0.0001 par value), 2,000,000 shares
authorized |
|
|
|
|
|
|
|
|
Class A Preferred stock, 250,000 shares issued and outstanding as
of December 31, 2023 and 2022, respectively |
|
— |
|
|
|
— |
|
|
Common stock ($0.0001 par value) 200,000,000 and 75,000,000
shares authorized as ofMarch 31, 2024 and December 31, 2023,
respectively |
|
|
|
|
|
|
|
|
Common shares, 590,188 and 341,324 shares issued and outstanding as
of March 31, 2024 and December 31, 2023,
respectively |
|
— |
|
|
|
3 |
|
|
Additional paid-in capital |
|
98,104 |
|
|
|
92,507 |
|
|
Accumulated deficit |
|
(95,268 |
) |
|
|
(90,928 |
) |
|
Total stockholders’ equity attributed to the Company |
|
2,836 |
|
|
|
1,582 |
|
|
|
|
|
|
|
|
|
|
|
Non-controlling interests |
|
(938 |
) |
|
|
(928 |
) |
|
Total stockholders’ equity |
|
1,898 |
|
|
|
654 |
|
|
Total liabilities and stockholders’ equity |
$ |
3,310 |
|
|
$ |
1,850 |
|
|
|
|
AVENUE THERAPEUTICS, INC.Unaudited
Condensed Consolidated Statements of Operations($
in thousands, except for share and per share amounts) |
|
|
|
|
For the Three Months EndedMarch 31, |
|
|
2024 |
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
$ |
2,392 |
|
|
$ |
1,215 |
|
|
Research and development - licenses acquired |
|
— |
|
|
|
4,230 |
|
|
General and administrative |
|
1,316 |
|
|
|
984 |
|
|
Loss from operations |
|
(3,708 |
) |
|
|
(6,429 |
) |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
49 |
|
|
|
37 |
|
|
Financing costs – warrant
liabilities |
|
— |
|
|
|
(332 |
) |
|
Loss on settlement of common
stock warrant liabilities |
|
(574 |
) |
|
|
— |
|
|
Change in fair value of
warrant liabilities |
|
(116 |
) |
|
|
(878 |
) |
|
Net loss |
$ |
(4,349 |
) |
|
$ |
(7,602 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
non-controlling interests |
|
(9 |
) |
|
|
(66 |
) |
|
Net loss attributable
to common stockholders |
$ |
(4,340 |
) |
|
$ |
(7,536 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per common share
attributable to common stockholders, basic and diluted |
$ |
(15.40 |
) |
|
$ |
(101.57 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding, basic and diluted |
|
562,031 |
|
|
|
74,198 |
|
|
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