Avenue Therapeutics Reports Full Year 2019 Financial Results and Recent Corporate Highlights
March 30 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 year ended December 31, 2019.
“2019 was a tremendous year for Avenue. In
February 2019, we closed the first stage of a two-stage equity
investment and contingent acquisition transaction with InvaGen
Pharmaceuticals Inc. (“InvaGen”), a subsidiary of Cipla Limited,”
said Lucy Lu, MD, Avenue’s President and Chief Executive
Officer. “In June, we announced positive data from our second
pivotal Phase 3 trial evaluating IV tramadol in patients following
abdominoplasty surgery. The year culminated with the filing of a
New Drug Application (“NDA”) with the FDA for IV tramadol in
December, and we recently learned that the FDA accepted the
submission for review and set a Prescription Drug User Fee Act
(“PDUFA”) goal action date of October 10, 2020. We look
forward to working with the FDA during their review process with a
goal of bringing IV tramadol to patients suffering from acute pain
in the U.S. as soon as possible.”
2019 and Recent Corporate
Highlights:
- The stock purchase stage of the
strategic transaction between InvaGen and Avenue closed in February
2019. InvaGen acquired approximately 5.8 million shares of Avenue
Therapeutics’ common stock at $6.00 per share for total gross
consideration of $35.0 million, representing a 33.3% stake in
Avenue’s capital stock on a fully-diluted basis. Avenue anticipates
that the merger with InvaGen will be completed shortly after the
PFUDA date of October 10, 2020, if IV tramadol is approved by the
FDA.
- In June 2019, Avenue announced that
the 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 October 2019, an eAbstract was
presented at ANESTHESIOLOGY 2019, the American Society of
Anesthesiologists’ annual meeting highlighting the Phase 3 data for
IV tramadol in the management of post-surgical pain in patients
undergoing bunionectomy, an orthopedic model.
- Also in October 2019, IV tramadol
Phase 1 clinical data were published 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. We are not including the information
in the paper on our website as a part of, or incorporating it by
reference into, this press release.
- In December 2019, Avenue submitted
its NDA to the FDA for IV tramadol for managing moderate to
moderately severe pain in adults in a medically supervised health
care setting. The FDA accepted the IV tramadol NDA for review in
February 2020 with a PDUFA goal action date of October 10,
2020.
2019 Financial Results:
- Cash Position: As of December 31, 2019, our
cash and cash equivalents totaled $8.7 million, compared to $2.7
million at December 31, 2018, an increase of $6.0
million.
- R&D Expenses: Research and development
expenses for the full year 2019 were $22.2 million, compared to
$17.7 million in 2018. This increase of $4.5 million was primarily
attributable to the completion of our abdominoplasty study as well
as NDA submission costs.
- R&D Expenses – Licenses Acquired: Research
and development expenses - licenses acquired for the full year 2019
were $1.0 million, compared to $0 in 2018. The 2019 expense was
related to the milestone payment due to our licensor in connection
with the submission of our NDA for IV tramadol.
- G&A Expenses: General and administrative
expenses for the full year 2019 were $3.1 million, compared to $4.1
million in 2018. This decrease of $1.0 million was primarily
attributable to decreases in legal costs and other professional
fees partially offset by non-cash stock compensation expenses.
- Net Loss: Net loss attributable to common
stockholders for the full year 2019 was $25.9 million, or $1.65 per
share, compared to a net loss of $21.5 million, or $2.10 per share,
in 2018.
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 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; risks relating to
the COVID-19 outbreak and its potential impact on our employees’
and consultants’ ability to complete work in a timely manner; 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. Balance
Sheets ($ in thousands, except for share and per share
amounts)
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
|
December
31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current
Assets: |
|
|
|
|
Cash and cash equivalents |
$ |
8,745 |
|
|
$ |
2,671 |
|
|
Deferred financing costs |
|
- |
|
|
|
1,702 |
|
|
Prepaid expenses and other current assets |
|
170 |
|
|
|
152 |
|
|
Total Assets |
$ |
8,915 |
|
|
$ |
4,525 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
$ |
1,101 |
|
|
$ |
4,669 |
|
|
Accounts payable and accrued expenses - related party |
|
14 |
|
|
|
487 |
|
|
Licenses payable |
|
1,000 |
|
|
|
- |
|
|
Total current liabilities |
|
2,115 |
|
|
|
5,156 |
|
|
|
|
|
|
|
Total Liabilities |
|
2,115 |
|
|
|
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 December 31, 2019 and 2018 |
|
- |
|
|
|
- |
|
|
Common Stock ($0.0001 par value), 50,000,000 shares
authorized |
|
|
|
|
Common shares, 16,682,190 and 10,667,714 shares issued and
outstanding as of December 31, 2019 and 2018,
respectively |
|
2 |
|
|
|
1 |
|
|
Additional
paid-in capital |
|
74,915 |
|
|
|
41,577 |
|
|
Accumulated
deficit |
|
(68,117 |
) |
|
|
(42,209 |
) |
|
Total
Stockholders' Equity (Deficit) |
|
6,800 |
|
|
|
(631 |
) |
|
Total Liabilities and Stockholders' Equity
(Deficit) |
$ |
8,915 |
|
|
$ |
4,525 |
|
|
|
|
|
|
AVENUE THERAPEUTICS,
INC.Statements of Operations ($ in
thousands, except for share and per share amounts)
|
|
|
For the Years Ended |
|
|
|
|
December
31, |
|
December
31, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
22,194 |
|
|
$ |
17,696 |
|
|
|
Research and development - licenses acquired |
|
|
1,000 |
|
|
|
- |
|
|
|
General and administrative |
|
|
3,071 |
|
|
|
4,120 |
|
|
|
Loss from
operations |
|
|
(26,265 |
) |
|
|
(21,816 |
) |
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
(357 |
) |
|
|
(93 |
) |
|
|
Other
income |
|
|
- |
|
|
|
(175 |
) |
|
|
Net
Loss |
|
$ |
(25,908 |
) |
|
$ |
(21,548 |
) |
|
|
|
|
|
|
|
|
|
Net loss per
common share outstanding, basic and diluted |
|
$ |
(1.65 |
) |
|
$ |
(2.10 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding, basic and diluted |
|
|
15,721,619 |
|
|
|
10,239,169 |
|
|
|
|
|
|
|
|
|
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