Avenue Therapeutics Reports Third Quarter 2019 Financial Results and Recent Corporate Highlights
November 04 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 third quarter ended September 30, 2019.
“We are pleased with the progress made during
the third quarter of 2019, especially with the fact that our
partner company, Cipla Limited, brought on Ms. Garrett Ingram as
head of their U.S. specialty hospital business to lead the
potential commercialization of IV tramadol,” said Lucy Lu, M.D.,
Avenue’s President and Chief Executive Officer. “Looking ahead, we
are on track to submit a New Drug Application for IV tramadol to
the U.S. Food and Drug Administration by year-end 2019.”
Recent Achievements:
- In August 2019, Avenue announced the appointment of Ms. Garrett
Ingram to its Board of Directors.
- In October 2019, an eAbstract was presented at ANESTHESIOLOGY®
2019, the Annual Meeting of the American Society of
Anesthesiologists in Orlando, FL, highlighting the Phase 3 data for
IV tramadol in the management of post-surgical pain in patients
undergoing bunionectomy, an orthopedic model. As previously
announced, IV tramadol 50 mg met the primary endpoint, as well as
all of the key secondary endpoints.
- Also in October 2019, Avenue announced the publication of IV
tramadol Phase 1 clinical data in the peer-reviewed journal
Clinical Pharmacology in Drug Development. The paper titled
“Comparing the Pharmacokinetics of 2 Novel Intravenous Tramadol
Dosing Regimens to Oral Tramadol: A Randomized 3-Arm Crossover
Study” can be accessed here.
Financial Results:
- Cash Position: As of September 30, 2019,
Avenue’s cash and cash equivalents and short-term investments
totaled $13.7 million, compared to $15.5 million at June 30,
2019.
- R&D Expenses: Research and development
expenses for the three months ended September 30, 2019, were $1.7
million, relatively flat compared to $1.8 million for the same
quarter in 2018.
- G&A Expenses: General and administrative
expenses for the three months ended September 30, 2019, were $0.6
million, compared to $0.8 million for the same quarter in 2018. The
$0.2 million decrease was primarily attributable to decreased
market research costs and non cash stock compensation.
- Net Loss: Net loss attributable to common
stockholders for the three months ended September 30, 2019, was
$2.2 million, or $0.14 per share, compared to a net loss of $2.6
million, or $0.25 per share, for the three months ended September
30, 2018.
About Avenue TherapeuticsAvenue Therapeutics is
a specialty pharmaceutical company whose mission is to develop
intravenous 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 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
December 31, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current
Assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
8,741 |
|
|
$ |
2,671 |
|
|
|
Short-term investments |
|
5,000 |
|
|
|
- |
|
|
|
Deferred financing costs |
|
61 |
|
|
|
1,702 |
|
|
|
Prepaid expenses and other current assets |
|
76 |
|
|
|
152 |
|
|
|
Total Assets |
$ |
13,878 |
|
|
$ |
4,525 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
1,901 |
|
|
$ |
4,669 |
|
|
|
Accounts payable and accrued expenses - related party |
|
16 |
|
|
|
487 |
|
|
|
Total current liabilities |
|
1,917 |
|
|
|
5,156 |
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
1,917 |
|
|
|
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 September 30, 2019 and December 31,
2018 |
|
- |
|
|
|
- |
|
|
|
Common Stock ($0.0001 par value), 50,000,000 shares
authorized |
|
|
|
|
|
Common shares, 16,661,355 and 10,667,714 shares issued and
outstanding as of September 30, 2019 and December 31, 2018,
respectively |
|
2 |
|
|
|
1 |
|
|
|
Additional
paid-in capital |
|
74,661 |
|
|
|
41,577 |
|
|
|
Accumulated
deficit |
|
(62,702 |
) |
|
|
(42,209 |
) |
|
|
Total
Stockholders' Equity (Deficit) |
|
11,961 |
|
|
|
(631 |
) |
|
|
Total Liabilities and Stockholders' Equity
(Deficit) |
$ |
13,878 |
|
|
$ |
4,525 |
|
|
|
|
|
|
|
|
AVENUE THERAPEUTICS,
INC.Condensed Statements of
Operations(Unaudited) ($ in thousands,
except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
For the Nine Months Ended |
|
|
|
September
30, |
September
30, |
September
30, |
September
30, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$
1,706 |
|
$
1,788 |
|
$
18,339 |
|
$
14,981 |
|
|
|
|
General and administrative |
617 |
|
820 |
|
2,452 |
|
2,733 |
|
|
|
|
Loss from
operations |
(2,323) |
|
(2,608) |
|
(20,791) |
|
(17,714) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
(81) |
|
(13) |
|
(298) |
|
(85) |
|
|
|
|
Net
Loss |
$ (2,242) |
|
$ (2,595) |
|
$ (20,493) |
|
$ (17,629) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share outstanding, basic and diluted |
$
(0.14) |
|
$
(0.25) |
|
$
(1.32) |
|
$
(1.73) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding, basic and diluted |
16,376,204 |
|
10,295,958 |
|
15,487,519 |
|
10,216,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From Apr 2023 to Apr 2024