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 its financial and certain operational results for the three-
and nine-month periods ended September 30, 2017.
Highlights of and subsequent to the third quarter of 2017
include:
- Net loss totaled $3.8 million, or ($0.44) per basic and diluted
share, compared to net loss of $1.1 million, or ($0.25) per basic
and diluted share, for the third quarter of 2016;
- Expect to file a supplemental NDA for our 81 mg dosage with the
U.S. Food and Drug Administration (FDA) by the mid first half of
2018. Once the sNDA is approved, the Company plans to
launch the 81mg dose together with the already approved 325 mg
strength by the end of 2018;
- Retained Dr. Efthymios N. Deliargyris, an
internationally-recognized expert in the field of thrombosis, as
Chief Medical Advisor to oversee critical scientific and medical
affairs activities that are expected to advance the market
readiness of Aspertec;
- Appointed Tom Long as Vice President, Manufacturing &
Technical Operations, and Steven Valentino as Vice President, Trade
Sales; and,
- Entered into a term loan facility with Silicon Valley Bank in
August under which the Company initially borrowed $7.5 million, and
will have the right to borrow an additional $7.5 million on or
before December 31, 2018, under certain terms.
“We continue to make significant progress preparing for the
future launch of Aspertec, which when launched is expected to be
the only over-the-counter (OTC) aspirin product approved by the FDA
as a New Drug Application. We believe Aspertec has the potential to
set a new standard of care for Secondary Prevention of Coronary
Artery Disease and to become the best-in-class alternative for
physicians treating patients at risk of having a cardiovascular or
cerebrovascular event,” said Natasha Giordano, President and Chief
Executive Officer of PLx Pharma.
“Aspertec and its novel delivery system, which is protected by
44 issued patents, has been clinically proven to have more
predictable and reliable antiplatelet efficacy than enteric-coated
aspirin, as well as improved GI safety over regular aspirin, in an
acute setting. We intend to implement a unique and
comprehensive launch campaign targeting both the OTC and
prescription markets.” “We have now put in place a strong
management team, Board of Directors, and Scientific Advisory Board.
We are excited about making these differentiated aspirin products
available to patients at risk at the end of 2018,” concluded
Giordano.
Third Quarter 2017
Financial Results
The Company recognized revenue of $62,000 in the third quarter
of 2017 from a federal grant received earlier in the year.
The Company had no revenue in the third quarter of 2016.
Research and development expenses were
approximately $1.0 million for the third quarter of 2017
reflecting, the initiation of technology transfer, contract
manufacturing activities, and other product development activities
for Aspertec. The Company incurred less than $13,000 of
research and development expenses in 2016.
General and administrative expense increased to $3.0 million in
the third quarter of 2017 from $1.0 million in the third quarter of
2016, due to increased compensation of $1.4 million, including
non-cash stock-based compensation expense, and other professional
and administrative fees associated with being a public company of
approximately $0.6 million.
Other income/expense increased to $118,000 of income, as
compared to $29,000 of expense in 2016. This increase related to
the non-cash change in fair value of a warrant liability of
$252,000 tempered by $168,000 of interest expense and debt discount
amortization related to the Company’s new term loan with Silicon
Valley Bank.
Net loss for the third quarter of 2017 was $3.8 million, or
($0.44) per basic and diluted share, compared to a net loss of $1.1
million, or ($0.25) per basic and diluted share, for the third
quarter of 2016.
Nine Months
Ended September 30, 2017
and 2016 Financial
Results
For the nine months ended September 30, 2017, the Company
recognized revenue of $438,000, compared to $20,000 in 2016. This
increase resulted from the new federal grant received in 2017.
Research and development expenses were $1.7 million in the nine
months ended September 30, 2017, reflecting the initiation of
technology transfer, contract manufacturing activities, and other
product development activities for Aspertec. The Company
incurred less than $66,000 of research and development expenses in
the same period of 2016.
General and administrative expense increased to $8.3 million for
the nine months ended September 30, 2017 from $3.3 million for the
first nine months of 2016, reflecting increased compensation of
$2.2 million, including non-cash stock-based compensation and a
one-time bonus, expenses attributable to the warrant liability
associated with the June 2017 equity offering of $1.3 million, and
professional and administrative fees associated with being a public
company of approximately $1.4 million.
Other income/expense increased to $1.2 million of income as
compared to $62,000 of expense in 2016. The increase related
to income from the non-cash change in the fair value of a warrant
liability of $2.0 million partially offset by $0.9 million of
interest expense. Interest expense in 2017 includes $0.7
million of non-cash interest expense upon recognition upon
conversion of convertible notes and $0.2 million of interest
expense and debt discount amortization related to the Company’s new
term loan with Silicon Valley Bank.
Net loss for the nine months ended September 30, 2017 was $7.5
million, or ($1.16) per basic and diluted share, compared with a
net loss of $3.5 million, or ($0.79) per basic and diluted share in
the prior year period.
Conference Call
As previously announced, PLx management will host its 2017 third
quarter conference call as follows:
Date |
Friday, November 10,
2017 |
Time |
8:30 a.m. EST |
Toll free (U.S.) |
(866) 394-2901 |
International |
(616) 548-5567 |
Webcast (live and
replay) |
www.plxpharma.com under
the ‘Investor Relations’ section. |
A replay of the conference call will be available for two weeks
after the call's completion by dialing (855) 859-2056 (U.S.) or
(404) 537-3406 (International). The conference ID for the
replay is 3388277. The archived webcast will be available for 30
days via the aforementioned URL.
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 completing 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 safe and effective 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
FINANCIAL TABLES FOLLOW
PLx Pharma Inc. |
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UNAUDITED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
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|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2017 |
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2016 |
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2017 |
|
|
|
2016 |
|
|
REVENUES: |
|
|
|
|
|
|
|
|
Federal
grant |
$ |
62,259 |
|
|
$ |
- |
|
|
$ |
438,210 |
|
|
$ |
- |
|
|
License
revenue |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
20,000 |
|
|
TOTAL REVENUES |
|
62,259 |
|
|
|
- |
|
|
|
438,210 |
|
|
|
20,000 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
Research and
development |
|
958,255 |
|
|
|
12,496 |
|
|
|
1,712,890 |
|
|
|
65,537 |
|
|
General and
administrative |
|
3,021,290 |
|
|
|
1,041,142 |
|
|
|
8,263,019 |
|
|
|
3,343,458 |
|
|
TOTAL
OPERATING EXPENSES |
|
3,979,545 |
|
|
|
1,053,638 |
|
|
|
9,975,909 |
|
|
|
3,408,995 |
|
|
OPERATING LOSS |
|
(3,917,286 |
) |
|
|
(1,053,638 |
) |
|
|
(9,537,699 |
) |
|
|
(3,388,995 |
) |
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE) |
|
|
|
|
|
|
|
|
Interest income |
|
33,600 |
|
|
|
166 |
|
|
|
48,082 |
|
|
|
544 |
|
|
Interest expense |
|
(168,272 |
) |
|
|
(28,969 |
) |
|
|
(891,835 |
) |
|
|
(63,010 |
) |
|
Change in fair value of
warrant liability |
|
252,458 |
|
|
|
- |
|
|
|
1,998,878 |
|
|
|
- |
|
|
TOTAL
OTHER INCOME (EXPENSE) |
|
117,786 |
|
|
|
(28,803 |
) |
|
|
1,155,125 |
|
|
|
(62,466 |
) |
|
LOSS BEFORE INCOME TAX
BENEFIT |
|
(3,799,500 |
) |
|
|
(1,082,441 |
) |
|
|
(8,382,574 |
) |
|
|
(3,451,461 |
) |
|
Income
tax benefit |
|
- |
|
|
|
- |
|
|
|
920,000 |
|
|
|
- |
|
|
NET LOSS |
$ |
(3,799,500 |
) |
|
$ |
(1,082,441 |
) |
|
$ |
(7,462,574 |
) |
|
$ |
(3,451,461 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per common
share - basic and diluted |
$ |
(0.44 |
) |
|
$ |
(0.25 |
) |
|
$ |
(1.16 |
) |
|
$ |
(0.79 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted
average shares of common shares - basic and diluted |
|
8,704,985 |
|
|
|
4,383,433 |
|
|
|
6,447,053 |
|
|
|
4,383,433 |
|
|
|
|
|
|
|
|
|
|
|
PLx Pharma Inc. |
|
|
UNAUDITED CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
|
|
|
|
|
September 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
Cash and cash
equivalents |
$ |
30,438,464 |
|
|
$ |
59,335 |
|
|
|
Accounts Receivable,
net |
|
56,713 |
|
|
|
5,077 |
|
|
|
Inventory, net |
|
372,533 |
|
|
|
116,726 |
|
|
|
Contract manufacturing
deposit |
|
247,050 |
|
|
|
- |
|
|
|
Prepaid expenses |
|
336,707 |
|
|
|
4,652 |
|
|
|
Security deposit |
|
4,064 |
|
|
|
4,064 |
|
|
|
TOTAL CURRENT
ASSETS |
|
31,455,531 |
|
|
|
189,854 |
|
|
|
NON-CURRENT ASSETS |
|
|
|
|
|
Property and equipment,
net |
|
902,368 |
|
|
|
426,634 |
|
|
|
Intangible assets,
net |
|
2,296,429 |
|
|
|
- |
|
|
|
Goodwill |
|
2,061,022 |
|
|
|
- |
|
|
|
Security deposit |
|
56,630 |
|
|
|
|
|
TOTAL ASSETS |
$ |
36,771,980 |
|
|
$ |
616,488 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
Accounts payable and
accrued liabilities |
$ |
1,045,406 |
|
|
$ |
862,995 |
|
|
|
Accrued severance |
|
2,409,000 |
|
|
|
- |
|
|
|
Accrued interest |
|
51,563 |
|
|
|
64,781 |
|
|
|
Accrued interest -
related parties |
|
- |
|
|
|
30,344 |
|
|
|
Convertible notes
payable |
|
- |
|
|
|
1,297,700 |
|
|
|
Convertible notes
payable - related parties |
|
- |
|
|
|
480,000 |
|
|
|
TOTAL CURRENT
LIABILITIES |
|
3,505,969 |
|
|
|
2,735,820 |
|
|
|
NON-CURRENT
LIABILITIES |
|
|
|
|
|
Deferred revenue |
|
200,000 |
|
|
|
200,000 |
|
|
|
Accrued interest - net
of current portion |
|
35,759 |
|
|
|
- |
|
|
|
Term loan, net of
discount and fees |
|
6,868,143 |
|
|
|
- |
|
|
|
Warrant liability |
|
13,877,668 |
|
|
|
- |
|
|
|
Security Deposit |
|
68,415 |
|
|
|
- |
|
|
|
TOTAL LIABILITIES |
|
24,555,954 |
|
|
|
2,935,820 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
STOCKHOLDERS'
EQUITY (DEFICIT) |
|
|
|
|
|
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; 8,719,535 and 4,282,433
shares issued and outstanding at September 30, 2017 and December
31, 2016, respectively |
|
8,720 |
|
|
|
4,383 |
|
|
|
Additional paid-in
capital |
|
71,655,397 |
|
|
|
49,661,802 |
|
|
|
Accumulated
deficit |
|
(59,448,091 |
) |
|
|
(51,985,517 |
) |
|
|
TOTAL
STOCKHOLDERS' EQUITY (DEFICIT) |
|
12,216,026 |
|
|
|
(2,319,332 |
) |
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
$ |
36,771,980 |
|
|
$ |
616,488 |
|
|
|
|
|
|
|
|
|
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