Avenue Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights
13 Noviembre 2023 - 3:05PM
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 third quarter ended September 30,
2023.
“In the third quarter, Avenue continued to
successfully execute across our pipeline of innovative CNS
treatments," said Alexandra MacLean, M.D., Chief Executive Officer
of Avenue. “We presented trial-in-progress posters for our lead
product candidate, AJ201 for the treatment of spinal and bulbar
muscular atrophy (“SBMA”), at important medical meetings attended
by the neurology scientific community in recent months, and we are
pleased to report that enrollment continues to progress on-track in
the Phase 1b/2a clinical trial of AJ201, with initial clinical
results anticipated in the second quarter of 2024. Turning to
BAER-101, we look forward to presenting the full dataset of
August’s promising preclinical results at the American Epilepsy
Society Annual Meeting in December, further showcasing this novel
drug’s robust anti-seizure activity in a translational animal model
of absence epilepsy. This quarter, we also reached alignment with
the U.S. Food and Drug Administration (“FDA”) on the key aspects of
the Phase 3 safety study design for IV tramadol, a crucial
milestone for the program as positive study results have the
potential to support an approval in acute post-operative pain.
Importantly, we closed a public offering of common stock and
warrants, resulting in $5 million in gross proceeds, to strengthen
Avenue’s balance sheet and continue to fund our clinical and
corporate progress. We look forward to providing updates in the
quarters to come as we work to deliver near-term value for Avenue
shareholders and realize our mission of providing impactful
therapies to patients suffering from neurologic diseases.”
Recent Corporate
Highlights:
AJ201 (Nrf1 and Nrf2 activator,
androgen receptor degradation enhancer for SBMA)
- Avenue presented trial-in-progress
posters for the Phase 1b/2a clinical trial of AJ201 for the
treatment of SBMA, also known as Kennedy’s Disease, at three
scientific congresses, including the 2023 Neuromuscular Study Group
Annual Scientific Meeting in Orlando, World Muscle Society in
Charleston and the European Neuro Muscular Centre (ENMC) Meeting on
SBMA in Amsterdam. The 12-week, multicenter, randomized,
double-blind Phase 1b/2a clinical trial of AJ201 is expected to
enroll approximately 24 patients, randomly assigned to AJ201 (600
mg/day) or placebo. Topline data for the Phase 1b/2a clinical trial
of AJ201 in SBMA are expected in the second quarter of 2024. More
information about this study can be found at ClinicalTrials.gov
(Identifier: NCT05517603).
BAER-101 (GABAA α2/3 positive
allosteric modulator)
- In August 2023, Avenue reported
preclinical results for BAER-101, a potentially best-in-class
selective GABA-A α2,3 positive allosteric modulator, demonstrating
that it significantly suppressed seizures in a translational animal
model of absence epilepsy. In an in vivo evaluation using the
SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”)
model of absence epilepsy, BAER-101 fully suppressed seizure
activity with a minimal effective dose of 0.3 mg/kg, PO.
The effect was fast in onset and stable throughout the duration of
testing. The detailed preclinical results were accepted to be
presented in a poster presentation at the American Epilepsy Society
(AES) Annual Meeting taking place December 1-5th in Orlando. The
combination of safety and tolerability in hundreds of patients and
the preclinical efficacy data support BAER-101’s continued
development in a Phase 2a trial.
IV Tramadol
- In July 2023, Avenue reached
agreement with the FDA on key elements of the Phase 3 safety study,
including the primary endpoint and statistical analysis approach
for intravenous (“IV”) tramadol, which is in development for the
treatment of acute postoperative pain in a medically supervised
setting. The non-inferiority study is designed to assess the
theoretical risk of opioid-induced respiratory depression related
to opioid stacking on IV tramadol compared to IV morphine. The
study will randomize 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 for rescue of breakthrough pain. The full study
protocol, including the statistical plan, has been submitted to the
FDA for final review. Pending additional financing or partnering,
Avenue aims to initiate the Phase 3 safety study as soon as
feasible.
Financial Results:
- Cash
Position: As of September 30, 2023, our cash and cash
equivalents totaled $0.2 million, compared to $6.7 million at
December 31, 2022, a decrease of $6.5 million. In November 2023, we
completed a follow-on public offering of our common stock and
warrants, raising approximately $5.0 million in gross
proceeds.
- R&D
Expenses: Research and development expenses for the
third quarter of 2023 were $0.9 million, compared to $0.2 million
for the third quarter of 2022.
- G&A
Expenses: General and administrative expenses for the
third quarter of 2023 were $1.2 million, compared to $0.5 million
for the third quarter of 2022.
- Net Income
(Loss): Net income attributable to common
stockholders for the third quarter of 2023 was $0.5 million, or
$0.06 per share, compared to a net loss of $0.7 million, or $0.45
per share, for the third quarter of 2022.
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. The Company 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 GABA-A α2/3 receptor positive allosteric
modulator for CNS diseases, and IV tramadol, which is in Phase 3
clinical development for the management of acute postoperative 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: 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
candidates; 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; 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) |
|
|
September 30, |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
161 |
|
|
$ |
6,708 |
|
Other receivables - related party |
|
13 |
|
|
|
— |
|
Deferred financing costs |
|
310 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
18 |
|
|
|
137 |
|
Total assets |
$ |
502 |
|
|
$ |
6,845 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
1,460 |
|
|
$ |
949 |
|
Accounts payable and accrued expenses - related party |
|
264 |
|
|
|
21 |
|
Warrant liability |
|
3,300 |
|
|
|
2,609 |
|
Total current liabilities |
|
5,024 |
|
|
|
3,579 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
5,024 |
|
|
|
3,579 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit) |
|
|
|
|
|
|
|
Preferred stock ($0.0001 par value), 2,000,000 shares
authorized |
|
|
|
|
|
|
|
Class A Preferred Stock, 250,000 shares issued and outstanding as
of September 30, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
Common stock ($0.0001 par value), 75,000,000 shares
authorized |
|
|
|
|
|
|
|
Common shares, 8,964,222 and 4,773,841 shares issued and
outstanding as of September 30, 2023 and December 31, 2022,
respectively |
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
87,917 |
|
|
|
84,456 |
|
Accumulated deficit |
|
(91,568 |
) |
|
|
(80,551 |
) |
Total stockholders’ equity attributed to the Company |
|
(3,650 |
) |
|
|
3,905 |
|
|
|
|
|
|
|
|
|
Non-controlling interests |
|
(872 |
) |
|
|
(639 |
) |
Total stockholders’ equity (deficit) |
|
(4,522 |
) |
|
|
3,266 |
|
Total liabilities and stockholders’ equity |
$ |
502 |
|
|
$ |
6,845 |
|
AVENUE THERAPEUTICS, INC.Unaudited
Condensed Consolidated Statements of Operations($ in
thousands, except for share and per share amounts) |
|
|
For the Three Months Ended September 30, |
|
|
For the Nine MonthsEnded September
30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
907 |
|
|
$ |
194 |
|
|
$ |
5,149 |
|
|
$ |
2,153 |
|
Research and development – licenses acquired |
|
— |
|
|
|
— |
|
|
|
4,230 |
|
|
|
— |
|
General and administrative |
|
1,161 |
|
|
|
469 |
|
|
|
3,042 |
|
|
|
1,978 |
|
Loss from operations |
|
(2,068 |
) |
|
|
(663 |
) |
|
|
(12,421 |
) |
|
|
(4,131 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
9 |
|
|
|
1 |
|
|
|
104 |
|
|
|
4 |
|
Financing costs – warrant liabilities |
|
— |
|
|
|
— |
|
|
|
(332 |
) |
|
|
— |
|
Change in fair value of warrant liabilities |
|
2,572 |
|
|
|
— |
|
|
|
1,544 |
|
|
|
— |
|
Total other income
(expense) |
|
2,581 |
|
|
|
1 |
|
|
|
1,316 |
|
|
|
4 |
|
Net income
(loss) |
$ |
513 |
|
|
$ |
(662 |
) |
|
$ |
(11,105 |
) |
|
$ |
(4,127 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
non-controlling interests |
|
(13 |
) |
|
|
— |
|
|
|
(88 |
) |
|
|
— |
|
Net loss attributable
to common stockholders |
$ |
526 |
|
|
$ |
(662 |
) |
|
$ |
(11,017 |
) |
|
$ |
(4,127 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common
share attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.06 |
|
|
$ |
(0.45 |
) |
|
$ |
(1.54 |
) |
|
$ |
(2.86 |
) |
Diluted |
$ |
0.06 |
|
|
$ |
(0.45 |
) |
|
$ |
(1.54 |
) |
|
$ |
(2.86 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
8,114,155 |
|
|
|
1,465,691 |
|
|
|
7,155,050 |
|
|
|
1,441,542 |
|
Diluted |
|
8,200,069 |
|
|
|
1,465,691 |
|
|
|
7,155,050 |
|
|
|
1,441,542 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avenue Therapeutics (NASDAQ:ATXI)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Avenue Therapeutics (NASDAQ:ATXI)
Gráfica de Acción Histórica
De May 2023 a May 2024