Avenue Therapeutics Reports First Quarter 2019 Financial Results and Recent Corporate Highlights
May 13 2019 - 7:30AM
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company
focused on the development of intravenous (“IV”) tramadol for the
U.S. market, today reported financial results and recent corporate
highlights for the first quarter ended March 31, 2019.
“We recently completed the safety study for IV
tramadol and expect to report data by the end of this quarter from
our pivotal Phase 3 trial of IV tramadol for the management of
postoperative pain in patients following abdominoplasty surgery,”
said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer.
“We look forward to the results from this important study, as it
not only compares IV tramadol to placebo, but also includes an
active-comparator arm of IV morphine.”
Recent Achievements:
- The Company has completed the
open-label, single-arm safety study of IV tramadol in post-surgical
pain. The results show that IV tramadol is well-tolerated with a
side effect profile consistent with known pharmacology.
- In April 2019, Avenue announced the
appointment of Dr. Thomas G. Moore to its Board of Directors.
Financial Results:
- Cash Position: As
of March 31, 2019, Avenue’s cash and cash equivalents totaled $29.4
million, compared to $2.7 million at December 31, 2018. The $26.7
million increase was primarily attributable to the stock purchase
by InvaGen Pharmaceuticals Inc. (“InvaGen”) in connection with the
first stage closing of the agreement between InvaGen and
Avenue.
- R&D Expenses:
Research and development expenses for the three months ended March
31, 2019, were $10.2 million, compared to $9.4 million for the same
quarter in 2018. The $0.8 million increase was primarily
attributable to the ongoing Phase 3 trial of IV tramadol following
abdominoplasty surgery and to the Phase 3 safety trial of IV
tramadol.
- G&A Expenses:
General and administrative expenses for the three months ended
March 31, 2019, were $1.1 million, compared to $1.0 million for the
same quarter in 2018. The $0.1 million increase was primarily
attributable to an increase in non-cash stock compensation offset
by reductions in market research costs and professional fees.
- Net Loss: Net loss
attributable to common stockholders for the three months ended
March 31, 2019, was $11.3 million, or $0.82 per share, compared to
a net loss of $10.4 million, or $1.03 per share, for the three
months ended March 31, 2018.
About Avenue TherapeuticsAvenue
is a specialty pharmaceutical company focused on the development
and commercialization of IV tramadol for the management of moderate
to moderately severe post-operative pain. IV tramadol may fill a
gap in the acute pain market between IV acetaminophen/NSAIDs and IV
conventional narcotics. Avenue is currently evaluating IV tramadol
in a pivotal Phase 3 program for the management of post-operative
pain. 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 StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, each as amended. Such
statements include, but are not limited to, any statements relating
to our growth strategy and product development programs and any
other statements that are not historical facts. Forward-looking
statements are based on management’s current expectations and are
subject to risks and uncertainties that could negatively affect our
business, operating results, financial condition and stock value.
Factors that could cause actual results to differ materially from
those currently anticipated include: risks relating to our growth
strategy; risks relating to the results of research and development
activities; risks relating to the timing of starting and completing
clinical trials; our ability to obtain, perform under and maintain
financing and strategic agreements and relationships; uncertainties
relating to preclinical and clinical testing; our dependence on
third-party suppliers; our ability to attract, integrate and retain
key personnel; the early stage of products under development; our
need for substantial additional funds; government regulation;
patent and intellectual property matters; competition; as well as
other risks described in our SEC filings. We expressly disclaim any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in our expectations or any changes in events,
conditions or circumstances on which any such statement is based,
except as required by law.
Contacts: Jaclyn Jaffe and William BegienAvenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
AVENUE THERAPEUTICS, INC. Condensed
Balance Sheets ($ in thousands, except for share and per
share amounts)
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
|
(unaudited) |
|
|
|
|
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
29,448 |
|
$ |
2,671 |
Deferred financing costs |
61 |
|
1,702 |
Prepaid expenses and other current assets |
254 |
|
152 |
Total
Assets |
$ |
29,763 |
|
$ |
4,525 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
9,326 |
|
$ |
4,669 |
Accounts payable and accrued expenses - related party |
86 |
|
487 |
Total current liabilities |
9,412 |
|
5,156 |
|
|
|
|
Total
Liabilities |
9,412 |
|
5,156 |
|
|
|
|
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 March 31, 2019 and December 31, 2018 |
|
|
|
Common Stock ($0.0001
par value), 50,000,000 shares authorized |
- |
|
- |
Common shares; 16,557,122 and 10,667,714 shares issued and
outstanding as of March 31, 2019 and December 31, 2018,
respectively |
2 |
|
1 |
Additional paid-in
capital |
73,827 |
|
41,577 |
Accumulated deficit |
(53,478) |
|
(42,209) |
Total Stockholders' Equity
(Deficit) |
20,351 |
|
(631) |
Total Liabilities and
Stockholders' Equity (Deficit) |
$ |
29,763 |
|
$ |
4,525 |
AVENUE THERAPEUTICS,
INC.Condensed Statements of
Operations(Unaudited) ($ in thousands,
except for share and per share amounts)
|
For the Three Months Ended |
|
March 31, |
|
March 31, |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
Research and development |
$ |
10,241 |
|
$ |
9,439 |
General and administrative |
1,119 |
|
986 |
Loss from operations |
(11,360) |
|
(10,425) |
|
|
|
|
Interest income |
(91) |
|
(48) |
Net Loss |
$ |
(11,269) |
|
$ |
(10,377) |
|
|
|
|
Net loss per common share
outstanding, basic and diluted |
$ |
(0.82) |
|
$ |
(1.03) |
|
|
|
|
Weighted average number of
common shares outstanding, basic and diluted |
13,742,649 |
|
10,099,331 |
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