Avenue Therapeutics Reports Second Quarter 2020 Financial Results and Recent Corporate Highlights
August 14 2020 - 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, 2020.
“We were pleased to announce several
publications pertaining to IV tramadol in peer-reviewed journals
recently. These publications highlight the positive data and
accomplishments from our Phase 3 program,” said Lucy Lu, M.D.,
Avenue’s President and CEO. “We look forward to an eventful second
half of 2020 as we approach IV tramadol’s Prescription Drug User
Fee Act (“PDUFA”) date of October 10, 2020.”
Recent Corporate
Highlights:
- In April 2020, Avenue announced
that two e-posters highlighting efficacy and safety results from
its Phase 3 program were available for online viewing from the
cancelled Annual Regional Anesthesiology and Acute Pain Medicine
Meeting hosted by the American Society of Regional Anesthesia and
Pain Medicine.
- The e-poster (816) titled
“Intravenous Tramadol is Effective in Management of Postoperative
Pain Following Abdominoplasty: A 3-arm Randomized Controlled Trial”
presents data from the Phase 3 abdominoplasty study and can be
found here.
- The e-poster (1001) titled “IV
tramadol – A New Treatment Option for Management of Post-Operative
Pain: A Safety Trial Including Various Types of Surgery” presents
data from the Phase 3 safety study and can be found here.
- In June 2020, Avenue announced the
following clinical study publications in peer-reviewed journals.
- The publication titled “Intravenous
Tramadol is Effective in the Management of Postoperative Pain
Following Abdominoplasty: A Three-Arm Randomized Placebo- and
Active-Controlled Trial” was published in Drugs in
R&D and can be accessed here.
- The publication titled “IV Tramadol
– A New Treatment Option for Management of Post-Operative Pain in
the U.S: An Open-Label, Single-Arm, Safety Trial Including Various
Types of Surgery” was published in Journal of Pain
Research and can be accessed here.
- In July 2020, Avenue announced the
following publication of its Phase 3 bunionectomy study.
- The publication titled “Efficacy
and Safety of Intravenously Administered Tramadol in Patients with
Moderate to Severe Pain Following Bunionectomy: A Randomized,
Double-Blind, Placebo-Controlled, Dose-Finding Study” was published
in Pain and Therapy and can be accessed here.
2020 Financial Results:
- Cash Position: As
of June 30, 2020, Avenue’s cash and cash equivalents totaled $5.3
million, compared to $6.6 million at March 31, 2020 and $8.7
million at December 31, 2019, a decrease of $1.3 million for the
quarter and a decrease of $3.4 million year-to-date.
- R&D Expenses:
Research and development expenses for the second quarter of 2020
were $1.2 million, compared to $6.4 million in the second quarter
of 2019. This decrease of $5.2 million was primarily attributable
to the completion of the abdominoplasty and safety studies in
2019.
- G&A Expenses:
General and administrative expenses for the second quarters of 2020
and 2019 were flat at approximately $0.7 million, each.
- Net Loss: Net loss
attributable to common stockholders for the second quarter of 2020
was $1.9 million, or $0.11 per share, compared to a net loss of
$7.0 million, or $0.43 per share, in the second quarter of
2019.
About Avenue TherapeuticsAvenue
Therapeutics is a specialty pharmaceutical company whose mission is
to develop IV tramadol, a potential alternative that could reduce
the use of conventional opioids, for patients suffering from acute
pain in the U.S. 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 related to us obtaining
regulatory approval from the FDA for our product candidate, risks
relating to the COVID-19 outbreak and its potential impact on our
employees’ and consultants’ ability to complete work in a timely
manner, 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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June
30, |
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December
31, |
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2020 |
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2019 |
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(unaudited) |
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ASSETS |
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Current
Assets: |
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Cash and cash equivalents |
$ |
5,257 |
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$ |
8,745 |
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Prepaid expenses and other current assets |
|
74 |
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|
170 |
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Total Assets |
$ |
5,331 |
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$ |
8,915 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current
Liabilities: |
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Accounts payable and accrued expenses |
$ |
1,193 |
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$ |
1,101 |
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Accounts payable and accrued expenses - related party |
|
37 |
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14 |
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Licenses payable |
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- |
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1,000 |
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Total current liabilities |
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1,230 |
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2,115 |
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Total Liabilities |
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1,230 |
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2,115 |
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Commitments and Contingencies |
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Stockholders' Equity |
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Preferred Stock ($0.0001 par value), 2,000,000 shares
authorized |
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Class A Preferred Stock, 250,000 shares issued and
outstanding as of June 30, 2020 and December 31, 2019,
respectively |
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- |
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- |
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Common Stock ($0.0001 par value), 50,000,000 shares
authorized |
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Common shares, 16,702,803 and 16,682,190 shares issued and
outstanding as of June 30, 2020 and December 31, 2019,
respectively |
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2 |
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2 |
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Additional
paid-in capital |
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75,346 |
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74,915 |
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Accumulated
deficit |
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(71,247 |
) |
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(68,117 |
) |
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Total
Stockholders' Equity |
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4,101 |
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|
6,800 |
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Total Liabilities and Stockholders' Equity |
$ |
5,331 |
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$ |
8,915 |
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AVENUE THERAPEUTICS,
INC.Condensed Statements of Operations ($
in thousands, except for share and per share
amounts)(Unaudited)
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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, |
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June
30, |
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June
30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Operating
expenses: |
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Research and development |
$ |
1,219 |
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$ |
6,392 |
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$ |
1,916 |
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$ |
16,633 |
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General and administrative |
|
684 |
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|
716 |
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|
1,261 |
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|
1,835 |
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Loss from
operations |
|
(1,903 |
) |
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|
(7,108 |
) |
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(3,177 |
) |
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(18,468 |
) |
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Interest
income |
|
(15 |
) |
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|
(126 |
) |
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(47 |
) |
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(217 |
) |
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Net
Loss |
$ |
(1,888 |
) |
|
$ |
(6,982 |
) |
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$ |
(3,130 |
) |
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$ |
(18,251 |
) |
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Net loss per
common share outstanding, basic and diluted |
$ |
(0.11 |
) |
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$ |
(0.43 |
) |
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$ |
(0.19 |
) |
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$ |
(1.21 |
) |
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Weighted
average number of common shares outstanding, basic and diluted |
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16,474,655 |
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16,314,763 |
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|
16,474,655 |
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15,035,811 |
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