PLx Pharma Inc. (NASDAQ:PLXP) (“PLx” or the “Company”), a
late-stage specialty pharmaceutical company focused on
commercializing two patent-protected products, Aspertec™ 325 mg and
Aspertec™ 81 mg (referred to together as “Aspertec”™), announced
today certain financial and operational results for the three
months ended March 31, 2018.
Highlights of, and certain events subsequent to, the first
quarter of 2018 include:
- Net income totaled $5.0 million, or $0.57 per share, compared
to net loss of $1.4 million, or ($0.33) per share, for the first
quarter of 2017. This includes a non-cash gain of $8.4 million for
a change in the fair value of warrant liability, or $0.97 per
share;
- Attended American Academy of Neurology (AAN) and National
Association of Chain Drug Stores (NACDS) conferences, to build
awareness and articulate the clinical value proposition of Aspertec
with the medical community and with key members of the retail
trade;
- Progressing in our plan to obtain an alternate supply of
material and anticipate launching Aspertec by mid-2020.
“We continue to engage with members of the medical community and
the retail trade to build awareness of Aspertec. We have
received additional positive feedback as these important
constituents learn more about the benefits of Aspertec, namely its
more predictable and reliable antiplatelet efficacy than
enteric-coated aspirin, and improved gastrointestinal safety over
regular aspirin. We believe our products have the potential
to change the standard of care in the treatment of coronary
disease,” said Natasha Giordano, President and Chief Executive
Officer of PLx Pharma.
First Quarter 2018 Financial
Results
The Company recognized revenue of $81,000 in the first quarter
of 2018, attributable to work performed under an award from the
National Institutes of Health (NIH) federal grant received in
2017. The Company had no revenue in the first quarter of
2017.
Research and development expenses were approximately $1.1
million for the first quarter of 2018, reflecting the initiation of
technology transfer, contract manufacturing activities, and other
product development activities for Aspertec. The Company incurred
$128,000 of research and development expenses in the first quarter
of 2017.
General and administrative expense totaled $2.2 million in the
first quarter of 2018 compared to $1.2 million in the first quarter
of 2017, primarily due to $0.6 million of increased compensation
and benefits, including non-cash stock compensation expense, and
prelaunch marketing to healthcare professionals of $0.2 million and
other professional and administrative fees of $0.2
million.
Other income (net of expense), was $8.2 million in the first
quarter of 2018, compared to $0.1 million of net expense in the
first quarter of 2017. This increase related to the non-cash gain
related to the change in fair value of a warrant liability of $8.4
million, partially offset by $0.2 million of additional interest
expense and debt discount amortization related to the Company’s
term loan with Silicon Valley Bank in the 2018 period.
Net income for the first quarter of 2018 was $5.0 million, or
$0.57 per share, compared to a net loss of $1.4 million, or ($0.33)
per share, for the first quarter of 2017.
As of March 31, 2018, The Company had $20.4 million in cash and
cash equivalents.
About AspertecAspertec 325 mg is
an FDA-approved aspirin product being developed to provide
high-risk cardiovascular and stroke patients with more reliable and
predictable antiplatelet efficacy as compared to enteric-coated
aspirin, while also reducing the adverse gastric events common in
an acute setting. PLx is focused on manufacturing, scale-up and
label finalization for Aspertec 325 mg aspirin dosage form and
preparing an sNDA for Aspertec 81 mg maintenance dose form.
About PLx Pharma Inc.PLx Pharma
Inc. is a late-stage specialty pharmaceutical company focused
on developing its clinically validated and patent-protected
PLxGuard™ delivery system to provide effective and safe aspirin
products. The PLxGuard delivery system works by targeting delivery
of active pharmaceutical ingredients (API) to various portions of
the gastrointestinal (GI) tract. PLx believes this has the
potential to improve the absorption of many drugs currently on the
market or in development, and to reduce acute GI side
effects—including erosions, ulcers and bleeding—associated with
aspirin and ibuprofen, and potentially other drugs.
To learn more about PLx Pharma Inc. and its pipeline,
please visit www.plxpharma.com.
Forward-Looking StatementsAny statements made
in this press release relating to future financial or business
performance, conditions, plans, prospects, trends, or strategies
and other financial and business matters, including without
limitation, the prospects for commercializing or selling any
products or drug candidates, are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. In addition, when or if used in this press release, the words
“may,” “could,” “should,” “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “plan,” “predict” and similar expressions and
their variants, as they relate to PLx may identify forward-looking
statements. PLx cautions that these forward-looking statements are
subject to numerous assumptions, risks, and uncertainties, which
change over time. Important factors that may cause actual results
to differ materially from the results discussed in the
forward-looking statements or historical experience include risks
and uncertainties, including the failure by PLx to secure and
maintain relationships with collaborators; risks relating to
clinical trials; risks relating to the commercialization, if any,
of PLx’s proposed product candidates (such as marketing,
regulatory, product liability, supply, competition, and other
risks); dependence on the efforts of third parties; dependence on
intellectual property and risks that PLx may lack the financial
resources and access to capital to fund proposed operations.
Further information on the factors and risks that could affect
PLx’s business, financial conditions and results of operations are
contained in PLx’s filings with the U.S. Securities and
Exchange Commission (SEC), which are available
at www.sec.gov. Other risks and uncertainties are more fully
described in PLx’s prospectus supplement filed with
the SEC on June 12, 2017, and in other filings that
PLx will make going forward. The forward-looking statements
represent PLx’s estimate as of the date hereof only, and PLx
specifically disclaims any duty or obligation to update
forward-looking statements.
Contact Investor Relations:Lisa M. Wilson, In-Site
Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com
Source: PLx Pharma Inc.
FINANCIAL TABLES FOLLOW
|
|
PLx Pharma Inc. |
|
|
|
|
|
|
UNAUDITED CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
|
|
|
March 31,2018 |
|
December
31,2017 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
Cash and cash
equivalents |
$ |
20,418,155 |
|
|
$ |
24,404,368 |
|
|
Accounts receivable,
net |
|
76,027 |
|
|
|
19,384 |
|
|
Inventory, net |
|
- |
|
|
|
246,374 |
|
|
Vendor deposits |
|
1,168,687 |
|
|
|
715,603 |
|
|
Prepaid expenses |
|
268,965 |
|
|
|
300,169 |
|
|
Security deposit |
|
4,064 |
|
|
|
4,064 |
|
|
TOTAL CURRENT
ASSETS |
|
21,935,898 |
|
|
|
25,689,962 |
|
|
NON-CURRENT
ASSETS |
|
|
|
|
Property and equipment,
net |
|
1,181,936 |
|
|
|
1,029,875 |
|
|
Goodwill |
|
2,061,022 |
|
|
|
2,061,022 |
|
|
Security deposit |
|
67,714 |
|
|
|
67,714 |
|
|
TOTAL ASSETS |
$ |
25,246,570 |
|
|
$ |
28,848,573 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
Accounts payable and
accrued liabilities |
$ |
821,931 |
|
|
$ |
852,155 |
|
|
Accrued bonus and
severance |
|
307,689 |
|
|
|
849,703 |
|
|
Accrued interest |
|
55,418 |
|
|
|
54,219 |
|
|
Other current
liabilities |
|
59,972 |
|
|
|
59,614 |
|
|
TOTAL CURRENT
LIABILITIES |
|
1,245,010 |
|
|
|
1,815,691 |
|
|
NON-CURRENT
LIABILITIES |
|
|
|
|
Accrued interest |
|
144,061 |
|
|
|
89,717 |
|
|
Term loan, net of
discount and fees |
|
7,003,264 |
|
|
|
6,942,151 |
|
|
Warrant liability |
|
6,818,268 |
|
|
|
15,242,915 |
|
|
Other liabilities |
|
136,978 |
|
|
|
141,707 |
|
|
TOTAL
LIABILITIES |
|
15,347,581 |
|
|
|
24,232,181 |
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY |
|
|
|
|
Preferred stock; $0.001 par value; 10,000,000 shares authorized;
none issued and outstanding |
|
- |
|
|
|
- |
|
|
Common
stock; $0.001 par value; 100,000,000 shares authorized; 8,726,198
and 8,722,823 shares issued and outstanding at March 31, 2018 and
December 31, 2017 respectively |
|
8,727 |
|
|
|
8,723 |
|
|
Additional paid-in
capital |
|
72,243,918 |
|
|
|
71,939,917 |
|
|
Accumulated
deficit |
|
(62,353,656 |
) |
|
|
(67,332,248 |
) |
|
TOTAL
STOCKHOLDERS' EQUITY |
|
9,898,989 |
|
|
|
4,616,392 |
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
25,246,570 |
|
|
$ |
28,848,573 |
|
|
|
|
|
|
|
|
|
PLx Pharma Inc. |
|
|
|
|
|
|
UNAUDITED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
|
Three Months Ended March 31, |
|
|
2018 |
|
2017 |
|
REVENUES: |
|
|
|
|
Federal
grant |
$ |
81,457 |
|
|
$ |
- |
|
|
TOTAL REVENUES |
|
81,457 |
|
|
|
- |
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
Research and
development |
|
1,079,036 |
|
|
|
128,339 |
|
|
General and
administrative |
|
2,240,000 |
|
|
|
1,217,071 |
|
|
TOTAL
OPERATING EXPENSES |
|
3,319,036 |
|
|
|
1,345,410 |
|
|
OPERATING LOSS |
|
(3,237,579 |
) |
|
|
(1,345,410 |
) |
|
|
|
|
|
|
OTHER INCOME
(EXPENSE) |
|
|
|
|
Interest income |
|
66,923 |
|
|
|
- |
|
|
Interest and other
expense |
|
(275,399 |
) |
|
|
(81,557 |
) |
|
Change in fair value of
warrant liability |
|
8,424,647 |
|
|
|
- |
|
|
TOTAL
OTHER INCOME (EXPENSE) |
|
8,216,171 |
|
|
|
(81,557 |
) |
|
|
|
|
|
|
|
|
|
|
INCOME (LOSS) BEFORE
PROVISION FOR INCOME TAXES |
|
4,978,592 |
|
|
|
(1,426,967 |
) |
|
Income
taxes |
|
- |
|
|
|
- |
|
|
NET INCOME (LOSS) |
$ |
4,978,592 |
|
|
$ |
(1,426,967 |
) |
|
|
|
|
|
|
Net income (loss) per
common share - basic |
$ |
0.57 |
|
|
$ |
(0.33 |
) |
|
Net
income (loss) per common share - diluted |
$ |
0.57 |
|
|
$ |
(0.33 |
) |
|
|
|
|
|
|
Weighted
average shares of common shares - basic |
|
8,725,038 |
|
|
|
4,383,433 |
|
|
Weighted
average shares of common shares - diluted |
|
8,725,038 |
|
|
|
4,383,433 |
|
|
|
|
|
|
|
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