Avenue Therapeutics Reports Second Quarter 2019 Financial Results and Recent Corporate Highlights
August 14 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 second quarter ended June 30, 2019.
“We recently reported positive data from our
second pivotal Phase 3 trial of IV tramadol for the management of
postoperative pain in patients following abdominoplasty surgery,
which compared IV tramadol to placebo and an active-comparator arm
of IV morphine,” said Lucy Lu, M.D., Avenue’s President and Chief
Executive Officer. “We have successfully completed our Phase 3
program of IV tramadol for the management of postoperative pain and
we are on track to submit a New Drug Application to the U.S. Food
and Drug Administration by year-end.”
Recent Achievements:
- In the second quarter of 2019, Avenue completed the open-label,
single-arm safety study of IV tramadol in post-surgical pain. The
results showed 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.
- In June 2019, Avenue announced that its second pivotal Phase 3
trial of IV tramadol achieved the primary endpoint of a
statistically significant improvement in Sum of Pain Intensity
Difference over 24 hours (SPID24) compared to placebo in patients
with postoperative pain following abdominoplasty surgery. In
addition, the trial met all of its key secondary endpoints. The
study also included a standard-of-care IV opioid as an active
comparator: IV morphine 4 mg. In this study, IV tramadol also
demonstrated similar efficacy and safety to that of IV
morphine.
- In August 2019, Avenue announced the appointment of Ms. Garrett
Ingram to its Board of Directors.
Financial Results:
- Cash Position: As of June 30, 2019, Avenue’s
cash and cash equivalents and short-term investments totaled $15.5
million, compared to $29.4 million at March 31, 2019. This
decrease reflects the completion of the abdominoplasty and safety
studies in the second quarter of 2019. Based on its current
development plans, Avenue expects that its existing cash and cash
equivalents and short-term investments and line of credit related
to the InvaGen agreement, will enable it to fund its operations
into the Second Stage Closing with InvaGen.
- R&D Expenses: Research and development
expenses for the three months ended June 30, 2019, were $6.4
million, compared to $3.8 million for the same quarter in 2018. The
$2.6 million increase was primarily attributable to the completion
of the Phase 3 trial of IV tramadol following abdominoplasty
surgery, partially offset by the completion of the Phase 3 trial of
IV tramadol following bunionectomy in the same quarter last
year.
- G&A Expenses: General and administrative
expenses for the three months ended June 30, 2019, were $0.7
million, compared to $0.9 million for the same quarter in 2018. The
$0.2 million decrease was primarily attributable to a decrease in
market research costs and professional fees.
- Net Loss: Net loss attributable to common
stockholders for the three months ended June 30, 2019, was $7.0
million, or $0.43 per share, compared to a net loss of $4.7
million, or $0.45 per share, for the three months ended June 30,
2018.
About Avenue TherapeuticsAvenue
is a specialty pharmaceutical company focused on the development
and commercialization of intravenous (IV) tramadol for the
management of moderate to moderately severe postoperative pain. IV
tramadol may fill a gap in the acute pain market between IV
acetaminophen/NSAIDs and IV conventional narcotics. Avenue has
completed its Phase 3 program of IV tramadol for the management of
postoperative pain and plans to submit a New Drug Application to
the U.S. Food and Drug Administration by year-end. 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)
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|
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June 30, |
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December 31, |
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|
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2019 |
|
2018 |
|
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(unaudited) |
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ASSETS |
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Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
10,455 |
|
$ |
2,671 |
|
|
Short-term investments |
5,000 |
|
- |
|
|
Deferred financing costs |
61 |
|
1,702 |
|
|
Prepaid expenses and other current assets |
161 |
|
152 |
|
|
Total Assets |
$ |
15,677 |
|
$ |
4,525 |
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
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Current Liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
1,728 |
|
$ |
4,669 |
|
|
Accounts payable and accrued expenses - related party |
45 |
|
487 |
|
|
Total current liabilities |
1,773 |
|
5,156 |
|
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|
|
|
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|
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Total Liabilities |
1,773 |
|
5,156 |
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Commitments and Contingencies |
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Stockholders' Equity
(Deficit) |
|
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Preferred Stock
($0.0001 par value), 2,000,000 shares authorized |
|
|
|
|
|
Class A Preferred Stock, 250,000 shares issued and
outstanding as of June 30, 2019 and December 31, 2018 |
- |
|
- |
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Common Stock ($0.0001
par value), 50,000,000 shares authorized |
|
|
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Common shares; 16,559,747 and 10,667,714 shares issued and
outstanding as of June 30, 2019 and December 31, 2018,
respectively |
2 |
|
1 |
|
|
Additional paid-in capital |
74,362 |
|
41,577 |
|
|
Accumulated deficit |
(60,460) |
|
(42,209) |
|
|
Total Stockholders' Equity (Deficit) |
13,904 |
|
(631) |
|
|
Total Liabilities and Stockholders' Equity
(Deficit) |
$ |
15,677 |
|
$ |
4,525 |
|
|
|
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AVENUE THERAPEUTICS,
INC.Condensed Statements of
Operations(Unaudited) ($ in thousands,
except for share and per share amounts)
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For the Three Months Ended |
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For the Six Months Ended |
|
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June 30, |
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June 30, |
|
June 30, |
|
June 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
6,392 |
|
$ |
3,754 |
|
$ |
16,633 |
|
$ |
13,193 |
|
General and administrative |
716 |
|
927 |
|
1,835 |
|
1,913 |
|
Loss from operations |
(7,108) |
|
(4,681) |
|
(18,468) |
|
(15,106) |
|
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|
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|
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Interest income |
(126) |
|
(24) |
|
(217) |
|
(72) |
|
Net Loss |
$ |
(6,982) |
|
$ |
(4,657) |
|
$ |
(18,251) |
|
$ |
(15,034) |
|
|
|
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Net loss per common share
outstanding, basic and diluted |
$ |
(0.43) |
|
$ |
(0.45) |
|
$ |
(1.21) |
|
$ |
(1.48) |
|
|
|
|
|
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Weighted average number of common shares outstanding, basic and
diluted |
16,314,763 |
|
10,251,950 |
|
15,035,811 |
|
10,176,062 |
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