Avenue Therapeutics Reports Full Year 2018 Financial Results and Recent Corporate Highlights
March 12 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 year ended December 31, 2018.
“2018 was an exciting year for Avenue. We
announced positive data from our first pivotal Phase 3 trial
evaluating IV tramadol in patients following bunionectomy surgery
in May, and signed a two-stage equity investment and contingent
acquisition agreement with InvaGen Pharmaceuticals Inc.
(“InvaGen”), a subsidiary of Cipla Limited, in November,” said Lucy
Lu, MD, Avenue’s President and Chief Executive Officer. “The first
stage of the transaction closed in February of 2019 and we look
forward to reporting topline data from our second Phase 3 trial in
patients following abdominoplasty surgery in the coming
months.”
2018 and Recent Corporate
Highlights:
- In May 2018, we announced that our
first pivotal Phase 3 trial of IV tramadol achieved the primary
endpoint of a statistically significant improvement in Sum of Pain
Intensity Difference over 48 hours compared to placebo in patients
with moderate to moderately severe postoperative pain following
bunionectomy surgery. In addition, the trial met its key secondary
endpoints and demonstrated a clear dose response.
- In November 2018, we announced
definitive agreements regarding an equity investment and contingent
acquisition of Avenue by InvaGen, a subsidiary of Cipla Limited, a
leading pharmaceutical company. The first stage of the transaction
closed in February 2019, and InvaGen acquired 5,833,333 shares of
our common stock at $6.00 per share for total gross proceeds of
$35.0 million, representing a 33.3% stake in Avenue’s capital stock
on a fully diluted basis.
- In December 2018, we announced that
the first patient has been dosed in a pivotal Phase 3 clinical
trial of IV tramadol for the management of moderate to moderately
severe pain in patients following abdominoplasty surgery.
Topline data is expected to be available in mid-2019.
2018 Financial Results:
- Cash Position: As
of December 31, 2018, our cash and short-term investments totaled
$2.7 million, compared to $21.8 million at December 31, 2017, a
decrease of $19.1 million. However, on February 8, 2019, we
completed the first stage of the Acquisition agreement and we sold
5,833,333 shares of our common stock to InvaGen for total gross
proceeds of $35.0 million.
- R&D Expenses:
Research and development expenses for the full year 2018 were $17.7
million, compared to $6.7 million in 2017. This increase of $11.0
million was primarily attributable to the completion of our
bunionectomy study, continuation of our safety study and the
initiation of our abdominoplasty study.
- G&A Expenses:
General and administrative expenses for the full year 2018 were
$4.1 million, compared to $3.6 million in 2017. This increase of
$0.5 million was primarily attributable to increases 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 2018 was
$21.5 million, or $2.10 per share, compared to a net loss of $12.3
million, or $1.85 per share, in 2017.
About Avenue
TherapeuticsAvenue, a company founded by Fortress Biotech,
is a specialty pharmaceutical company focused on the development
and commercialization of IV Tramadol for the management of moderate
to moderately severe post-operative pain. IV Tramadol may fill a
gap in the acute pain market between IV acetaminophen/NSAIDs and IV
conventional narcotics. Avenue is currently evaluating IV Tramadol
in a pivotal Phase 3 program for the management of post-operative
pain. Avenue is headquartered in New York City. For more
information, visit www.avenuetx.com.
About Fortress BiotechFortress
Biotech, Inc. (“Fortress”) (NASDAQ: FBIO) is an innovative
biopharmaceutical company focused on identifying, in-licensing and
developing high-potential clinical-stage assets. The company has
over 25 programs in clinical development at Fortress, at its
majority-owned and majority-controlled subsidiaries and at entities
it founded and in which it holds significant minority ownership
positions. Such product candidates span six large-market
therapeutic areas, including oncology, rare diseases and gene
therapy, which allow it to create value while mitigating risk for
shareholders. Fortress advances its diversified pipeline through a
streamlined operating structure that fosters efficient drug
development. The Fortress model is driven by a world-class business
development team that is focused on leveraging its significant
biopharmaceutical industry expertise to further expand the
company’s portfolio of product opportunities. Fortress has
established partnerships with some of the world’s leading academic
research institutions and biopharmaceutical companies to maximize
each opportunity to its full potential, including Alexion
Pharmaceuticals, Inc., City of Hope, Fred Hutchinson Cancer
Research Center, InvaGen Pharmaceuticals, Inc. (a subsidiary of
Cipla Limited), St. Jude Children’s Research Hospital and UCL
Business PLC. For more information, visit
www.fortressbiotech.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. |
Balance Sheets |
($ in thousands, except for share and per share
amounts) |
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2018 |
|
2017 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and
cash equivalents |
$ |
2,671 |
|
|
$ |
11,782 |
|
|
Short-term investments |
|
- |
|
|
|
10,000 |
|
|
Deferred
financing costs |
|
1,702 |
|
|
|
- |
|
|
Prepaid
expenses and other current assets |
|
152 |
|
|
|
388 |
|
|
Total
Assets |
$ |
4,525 |
|
|
$ |
22,170 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts
payable and accrued expenses |
$ |
4,669 |
|
|
$ |
2,737 |
|
|
Accounts
payable and accrued expenses - related party |
|
487 |
|
|
|
53 |
|
|
Total
current liabilities |
|
5,156 |
|
|
|
2,790 |
|
|
|
|
|
|
|
Total
Liabilities |
|
5,156 |
|
|
|
2,790 |
|
|
|
|
|
|
|
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, 2018and 2017, respectively |
|
- |
|
|
|
- |
|
|
Common Stock
($0.0001 par value), 50,000,000 shares authorized |
|
- |
|
|
|
- |
|
|
Common
shares; 10,667,714 and 10,265,083 shares issued and
outstanding as ofDecember 31, 2018 and 2017, respectively |
|
1 |
|
|
|
1 |
|
|
Common
stock issuable, 0 and 273,837 shares as of December 31, 2018 and
2017,respectively |
|
- |
|
|
|
1,103 |
|
|
Additional paid-in
capital |
|
41,577 |
|
|
|
38,937 |
|
|
Accumulated
deficit |
|
(42,209 |
) |
|
|
(20,661 |
) |
|
Total Stockholders'
Equity (Deficit) |
|
(631 |
) |
|
|
19,380 |
|
|
Total
Liabilities and Stockholders' Equity (Deficit) |
$ |
4,525 |
|
|
$ |
22,170 |
|
|
|
AVENUE THERAPEUTICS, INC. |
Statements of Operations |
($ in thousands, except for share and per share
amounts) |
|
|
|
For the Year Ended |
|
|
December 31, |
|
December 31, |
|
|
2018 |
|
2017 |
|
Operating
expenses: |
|
|
|
|
Research
and development |
$ |
17,696 |
|
|
$ |
6,698 |
|
|
Research
and development - licenses acquired |
|
- |
|
|
|
1,103 |
|
|
General
and administrative |
|
4,120 |
|
|
|
3,620 |
|
|
Loss from
operations |
|
(21,816 |
) |
|
|
(11,421 |
) |
|
|
|
|
|
|
Interest income |
|
(93 |
) |
|
|
(88 |
) |
|
Interest expense |
|
- |
|
|
|
294 |
|
|
Interest expense -
related party |
|
- |
|
|
|
81 |
|
|
Change in fair value of
convertible notes payable |
|
- |
|
|
|
99 |
|
|
Change in fair value of
warrant liabilities |
|
- |
|
|
|
451 |
|
|
Other income |
|
(175 |
) |
|
|
- |
|
|
Net
Loss |
$ |
(21,548 |
) |
|
$ |
(12,258 |
) |
|
|
|
|
|
|
Net loss per common
share outstanding, basic and diluted |
$ |
(2.10 |
) |
|
$ |
(1.85 |
) |
|
|
|
|
|
|
Weighted average number
of common shares outstanding,basic and diluted |
|
10,239,169 |
|
|
|
6,634,937 |
|
|
|
|
|
|
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