Avenue Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights
November 10 2022 - 4:10PM
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 (“CNS”), today reported financial
results and recent corporate highlights for the third quarter ended
September 30, 2022.
“I am pleased that Avenue has achieved important
financial milestones providing a path to continue developing drugs
for central nervous system disorders. We recently had a
collaborative meeting with the U.S. Food and Drug Administration
(“FDA”) laying the foundation for conducting a study that could
support NDA resubmission for IV Tramadol, and we also completed the
acquisition of Baergic Bio, which added a novel clinical-stage
anxiolytic and antiepileptic therapy to our portfolio,” said
Alexandra MacLean, M.D., Avenue’s Chief Executive Officer.
Recent Corporate Highlights (for Third
Quarter and Subsequent Events):
- In September 2022, Avenue received
the official meeting minutes from the FDA regarding a meeting
conducted on August 9, 2022, for IV Tramadol. At the meeting,
Avenue presented a study design for a single safety clinical trial
that Avenue 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.
- Also in September 2022, Avenue
effected a 1-for-15 reverse stock split and, in October 2022,
closed a $12 million underwritten public offering, to bring the
Company in compliance with Nasdaq listing requirements. In October
2022, Avenue received correspondence from Nasdaq indicating that
the Company had evidenced compliance with the Nasdaq Listing Rules
and all other applicable criteria for continued listing on The
Nasdaq Capital Market.
- Avenue received net proceeds from
the offering of approximately $10.4 million after deducting
underwriting discounts and commissions and other expenses of the
offering. In addition, concurrent with the closing of the offering,
Avenue completed the buyout of a minority shareholder through the
acquisition of their shares for $3.0 million.
- In November 2022, Avenue completed
the acquisition of Baergic Bio, Inc. (“Baergic”) through a Share
Contribution Agreement with Fortress Biotech, Inc. (“Fortress”), an
affiliate of Avenue. The acquisition provides Avenue with another
clinical-stage CNS drug (“BAER-101”) that Avenue expects to develop
for conditions with high unmet need, potentially including
refractory epilepsies and panic disorders. BAER-101 is a novel oral
small molecule selective GABA-A α2/3 receptor positive allosteric
modulator originally developed at and licensed from AstraZeneca
plc. BAER-101 has been shown to be safe with mild to moderate side
effects in over 700 patients to-date.
Financial Results:
- Cash Position: As
of September 30, 2022, Avenue’s cash and cash equivalents totaled
$0.2 million, compared to $3.8 million at December 31, 2021, a
decrease of $3.6 million year-to-date. Subsequently, in October
2022, Avenue received net proceeds of approximately $10.4 million
upon the closing of its underwritten public offering.
- R&D Expenses:
Research and development expenses for the third quarter of 2022
were $0.2 million, compared to $0.3 million in the third quarter of
2021.
- G&A Expenses:
General and administrative expenses for the third quarter of 2022
were $0.5 million, compared to $0.6 million in the third quarter of
2021.
- Net Loss: Net loss
attributable to common stockholders for the third quarter of 2022
was $0.7 million, or $0.45 per share, compared to a net loss of
$0.9 million, or $0.79 per share, in the third quarter of
2021.
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 and was founded by
Fortress Biotech, Inc. (Nasdaq: FBIO). 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; ability to
successfully integrate Baergic Bio in the Company’s operations; 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 Jaffe Avenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
AVENUE THERAPEUTICS,
INC.Condensed Balance Sheets($ in
thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
217 |
|
|
$ |
3,763 |
|
Other receivables - related party |
|
|
– |
|
|
|
90 |
|
Deferred financing costs |
|
|
338 |
|
|
|
– |
|
Prepaid expenses and other current assets |
|
|
20 |
|
|
|
107 |
|
Total
Assets |
|
$ |
575 |
|
|
$ |
3,960 |
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
573 |
|
|
$ |
451 |
|
Accounts payable and accrued expenses – related party |
|
|
41 |
|
|
|
58 |
|
Total current liabilities |
|
|
614 |
|
|
|
509 |
|
|
|
|
|
|
|
|
Total
Liabilities |
|
$ |
614 |
|
|
$ |
509 |
|
|
|
|
|
|
|
|
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, 2022 and December 31,
2021 |
|
|
– |
|
|
|
– |
|
Common Stock ($0.0001
par value), 20,000,000 shares authorized |
|
|
|
|
|
|
Common shares, 1,481,439 and 1,405,934 shares issued and
outstanding as of September 30, 2022 and December 31, 2021,
respectively |
|
|
– |
|
|
|
2 |
|
Additional
paid-in-capital |
|
|
81,087 |
|
|
|
80,448 |
|
Accumulated deficit |
|
|
(81,126 |
) |
|
|
(76,999 |
) |
Total Stockholders' Equity
(Deficit) |
|
|
(39 |
) |
|
|
3,451 |
|
Total Liabilities and
Stockholders' Equity (Deficit) |
|
$ |
575 |
|
|
$ |
3,960 |
|
|
|
|
|
|
|
|
AVENUE THERAPEUTICS,
INC.Condensed Statements of Operations($
in thousands, except for share and per share
amounts)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Operating
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
194 |
|
|
$ |
278 |
|
|
$ |
2,153 |
|
|
$ |
864 |
|
General and administrative |
|
|
469 |
|
|
|
594 |
|
|
|
1,978 |
|
|
|
1,960 |
|
Loss from operations |
|
|
(663 |
) |
|
|
(872 |
) |
|
|
(4,131 |
) |
|
|
(2,824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
(4 |
) |
|
|
(6 |
) |
Net Loss |
|
$ |
(662 |
) |
|
$ |
(871 |
) |
|
$ |
(4,127 |
) |
|
$ |
(2,818 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share
outstanding, basic and diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.79 |
) |
|
$ |
(2.86 |
) |
|
$ |
(2.55 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
1,465,691 |
|
|
|
1,108,495 |
|
|
|
1,441,542 |
|
|
|
1,105,352 |
|
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