Avenue Therapeutics Reports First Quarter 2020 Financial Results and Recent Corporate Highlights
May 11 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 first quarter ended March 31, 2020.
“In the first quarter of 2020, the U.S. Food and
Drug Administration (“FDA”) accepted our IV tramadol New Drug
Application (“NDA”) submission for review and set a Prescription
Drug User Fee Act (“PDUFA”) goal action date of October 10, 2020,”
stated Lucy Lu, M.D., Avenue’s President and CEO. “2020 is gearing
up to be an exciting year for Avenue as we anticipate that the
merger with InvaGen Pharmaceuticals Inc., a subsidiary of Cipla
Limited, will be completed shortly after the PDUFA date, pending a
positive outcome and other certain conditions being satisfied.”
Recent Corporate
Highlights:
- In February 2020, the FDA accepted
Avenue’s IV tramadol NDA for review with a PDUFA goal action date
of October 10, 2020.
- In April 2020, we announced that
two e-posters highlighting efficacy and safety results from our
Phase 3 program are 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 (“ASRA”).
- 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.
2020 Financial Results:
- Cash Position: As of March 31, 2020, our cash
and cash equivalents totaled $6.6 million, compared to $8.7 million
at December 31, 2019, a decrease of $2.1 million.
- R&D Expenses: Research and development
expenses for the first quarter of 2020 were $0.7 million, compared
to $10.2 million in the first quarter of 2019. This decrease of
$9.5 million was primarily attributable to the completion of our
abdominoplasty and safety studies in 2019.
- G&A Expenses: General and administrative
expenses for the first quarter of 2020 were $0.6 million, compared
to $1.1 million in the first quarter of 2019. This decrease of $0.5
million was primarily attributable to decreases in non-cash stock
compensation expenses and professional fees.
- Net Loss: Net loss attributable to common
stockholders for the first quarter of 2020 was $1.2 million, or
$0.08 per share, compared to a net loss of $11.3 million, or $0.82
per share, in the first 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)
|
|
|
|
|
March
31, |
|
December
31, |
|
|
2020 |
|
|
|
2019 |
|
|
(unaudited) |
|
|
|
|
|
|
ASSETS |
|
|
|
Current
Assets: |
|
|
|
Cash and cash equivalents |
$ |
6,574 |
|
|
$ |
8,745 |
|
Prepaid expenses and other current assets |
|
122 |
|
|
|
170 |
|
Total Assets |
$ |
6,696 |
|
|
$ |
8,915 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
790 |
|
|
$ |
1,101 |
|
Accounts payable and accrued expenses - related party |
|
133 |
|
|
|
14 |
|
Licenses payable |
|
- |
|
|
|
1,000 |
|
Total current liabilities |
|
923 |
|
|
|
2,115 |
|
|
|
|
|
Total Liabilities |
|
923 |
|
|
|
2,115 |
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
Stockholders' Equity |
|
|
|
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, 2020 and December 31, 2019,
respectively |
|
- |
|
|
|
- |
|
Common Stock ($0.0001 par value), 50,000,000 shares
authorized |
|
|
|
Common shares, 16,682,803 and 16,682,190 shares issued and
outstanding as of March 31, 2020 and December 31, 2019,
respectively |
|
2 |
|
|
|
2 |
|
Additional
paid-in capital |
|
75,130 |
|
|
|
74,915 |
|
Accumulated
deficit |
|
(69,359 |
) |
|
|
(68,117 |
) |
Total
Stockholders' Equity |
|
5,773 |
|
|
|
6,800 |
|
Total Liabilities and Stockholders' Equity |
$ |
6,696 |
|
|
$ |
8,915 |
|
|
|
|
|
AVENUE THERAPEUTICS,
INC.Condensed Statements of Operations ($
in thousands, except for share and per share
amounts)(Unaudited)
|
For the Three Months Ended |
|
March
31, |
|
March
31, |
|
|
2020 |
|
|
|
2019 |
|
Operating
expenses: |
|
|
|
Research and development |
$ |
697 |
|
|
$ |
10,241 |
|
General and administrative |
|
577 |
|
|
|
1,119 |
|
Loss from
operations |
|
(1,274 |
) |
|
|
(11,360 |
) |
|
|
|
|
Interest
income |
|
(32 |
) |
|
|
(91 |
) |
Net
Loss |
$ |
(1,242 |
) |
|
$ |
(11,269 |
) |
|
|
|
|
Net loss per
common share outstanding, basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.82 |
) |
|
|
|
|
Weighted
average number of common shares outstanding, basic and diluted |
|
16,474,655 |
|
|
|
13,742,649 |
|
|
|
|
|
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