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- and
12-month periods ended December 31, 2017.
Highlights of, and certain events subsequent to, the fourth
quarter of 2017 include:
- Net loss totaled $7.9 million, or ($0.90) per share, compared
to net loss of $1.5 million, or ($0.33) per share, for the fourth
quarter of 2016. This includes non-cash charges of impairment of
intangible assets and change in warrant liability of $3.7 million,
or $0.42 per share;
- Timing of filing of the supplemental New Drug Application
(sNDA) to the FDA for the 81 mg dosage of Aspertec has shifted as a
result of some recent and unexpected inconsistencies with a key
ingredient that is outsourced. PLx has implemented a plan to source
an alternate supply of material to ensure consistency and the
highest quality product. This new plan will impact timing of
the launch of both dosage strengths, which is now anticipated to
occur by mid-2020;
“When considering the need to deliver the highest-quality
product to cardiovascular patients and the overall size of the
Aspertec opportunity, it became clear that obtaining an alternate
supply for this ingredient was in the long-term interest of the
patient, the Aspertec brand and PLx. We must prioritize
product quality and uninterrupted supply to patients who need and
will be depending on Aspertec to maintain their cardiovascular
health in the future,” said Natasha Giordano, President and Chief
Executive Officer of PLx Pharma.
Other key highlights:
- Named 2017 Editor–in–Chief Top Pick by the Journal of the
American College of Cardiology for paper entitled, “Enteric Coating
and Aspirin Nonresponsiveness in Patients with Type 2 Diabetes
Mellitus”;
- Debuted Aspertec and PLx Pharma at the 2018 American College of
Cardiology conference, engaging with top cardiology academic
thought leaders and clinical investigators, and collaborated with
PLx’s Scientific Advisory Board, which includes world-renowned
medical specialists, to build advocacy and articulate the clinical
value proposition of Aspertec; and,
- Granted five additional patents, expanding our patent portfolio
from 44 to 49.
“On the commercial front, we remain focused on building
awareness both within the medical community and with key members of
the retail trade. Feedback from top interventional
cardiologists recently received at the American College of
Cardiology was extremely positive. Aspertec has been clinically
proven to have more predictable and reliable antiplatelet efficacy
than enteric-coated aspirin, as well as improved gastrointestinal
safety over regular aspirin, in an acute setting. Aspertec,
when launched is expected to be the only over-the-counter (OTC)
aspirin product approved by the FDA as a New Drug Application,”
continued Giordano.
“We believe Aspertec has the potential to set a new standard of
care alternative for physicians treating patients at risk of having
a cardiovascular or cerebrovascular event. As physicians gain
a more thorough understanding of the unique benefits of the
Aspertec aspirin delivery system, as well as the limits of
traditional enteric-coated aspirin, we believe our products have
the potential to change the standard of care in the treatment of
coronary disease,” concluded Giordano.
Fourth Quarter 2017 Financial
Results
The Company recognized revenue of $340,000 in the fourth quarter
of 2017, of which $140,000 was from an award of a National
Institutes of Health (NIH) federal grant received earlier in the
year and $200,000 of deferred revenue recognized upon the
completion of effort in the Lee’s Pharmaceutical agreement.
The Company had no revenue in the fourth quarter of 2016.
Research and development expenses were approximately $2.4
million for the fourth quarter of 2017, reflecting the initiation
of technology transfer, contract manufacturing activities, initial
clinical trial expenses and other product development activities
for Aspertec. The Company incurred just over $13,000 of research
and development expenses in the fourth quarter of 2016.
General and administrative expense totaled roughly $1.9 million
in the fourth quarter of 2017 compared to $1.4 million in the
fourth quarter of 2016, due to increased compensation and benefits
of $0.4 million, a loss on the closure of our New York lease of
$0.2 million and other professional and administrative fees,
including those associated with being a public company of
approximately $0.3 million. This increase was partially
offset by lower stock-based compensation expense of $0.4
million.
Operating expenses also include a non-cash impairment charge of
$2.3 million, or $0.26 per share, related to the impairment of its
intangible assets (trademarks and in-process research and
development) acquired from Dipexium in connection with a change in
operational strategy related to its Locilex assets.
Other expense (net of other income) was $1.6 million in the
fourth quarter of 2017, compared to $32,000 in the fourth quarter
of 2016. This increase related to the non-cash change in fair value
of a warrant liability of $1.4 million and $0.3 million of interest
expense and debt discount amortization related to the Company’s
term loan with Silicon Valley Bank.
Net loss for the fourth quarter of 2017 was $7.9 million, or
($0.90) per share, compared to a net loss of $1.5 million, or
($0.33) per share, for the fourth quarter of 2016.
Full Year 2017 Financial
Results
Total revenues were $779,000 for the year ended December 31,
2017, as compared to $20,000 for the year ended December 31,
2016. Revenue recognized in fiscal year 2017 is attributable
to work performed under a recent award of a NIH grant, along with
previously deferred revenue recognized upon the completion of
related effort in the Lee’s Pharmaceutical agreement.
Research and development expenses were $4.2 million for the year
ended December 31, 2017 compared to $79,000 in the prior year, an
increase of approximately $4.1 million. The increase was
attributable to the near absence of any research and development
expenses in 2016 and the initiation of technology transfer,
contract manufacturing activities, initial clinical trial expenses
and other product development activities for Aspertec throughout
2017.
General and administrative expenses increased to $10.2 million
for the year ended December 31, 2017 compared to approximately $4.8
million in the prior year, an increase of approximately $5.4
million. The increase was primarily attributable to increased
compensation and benefits and outside director fees of
$2.2 million, including stock compensation
expense, and other professional fees including legal,
accounting, financial advisory, insurance and other administrative
costs totaling approximately $1.8 million and expenses of $1.3
million allocated to the warrants issued in connection with the
June 2017 equity offering.
Operating expenses also include a non-cash charge of $2.3
million, or $0.26 per share, related to the impairment of its
intangible assets (trademarks and in-process research and
development) acquired from Dipexium, in connection with a change in
operational strategy related to its Locilex assets.
Other expense (net of other income), totaled approximately $0.4
million in the year ended December 31, 2017 compared to $95,000 of
net expense in the prior year. The change is largely attributable
to interest expense under a new credit facility (including the
amortization of discounts and deferred issuance costs) of
approximately $0.4 million, a beneficial conversion feature expense
associated with the conversion of our convertible notes of $0.6
million, offset in part by the change in fair value of warrant
liability of $0.6 million of other income.
Net loss for the year ended December 31, 2017 was $15.3 million,
or ($2.19) per share, compared with a net loss of $4.9 million, or
($1.12) per share in the prior year period.
Conference Call
As previously announced, PLx management will host its fourth
quarter and full year 2017 conference call as follows:
Date |
Friday, March 23,
2018 |
Time |
8:30 a.m. EDT |
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 8198566. 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 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. |
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
December
31, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
24,404,368 |
|
|
$ |
59,335 |
|
Accounts receivable,
net |
|
19,384 |
|
|
|
5,077 |
|
Inventory, net |
|
246,374 |
|
|
|
116,726 |
|
Vendor deposits |
|
715,603 |
|
|
|
- |
|
Prepaid expenses |
|
300,169 |
|
|
|
4,652 |
|
Security deposit |
|
4,064 |
|
|
|
4,064 |
|
TOTAL CURRENT
ASSETS |
|
25,689,962 |
|
|
|
189,854 |
|
NON-CURRENT ASSETS |
|
|
|
|
|
|
|
Property and equipment,
net |
|
1,029,875 |
|
|
|
426,634 |
|
Goodwill |
|
2,061,022 |
|
|
|
- |
|
Security deposit |
|
67,714 |
|
|
|
|
|
TOTAL ASSETS |
$ |
28,848,573 |
|
|
$ |
616,488 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities |
$ |
852,155 |
|
|
$ |
862,995 |
|
Accrued bonus and
severance |
|
849,703 |
|
|
|
- |
|
Accrued interest |
|
54,219 |
|
|
|
64,781 |
|
Accrued interest -
related parties |
|
- |
|
|
|
30,344 |
|
Convertible notes
payable |
|
- |
|
|
|
1,297,700 |
|
Convertible notes
payable - related parties |
|
- |
|
|
|
480,000 |
|
Other current
liabilities |
|
59,614 |
|
|
|
- |
|
TOTAL CURRENT
LIABILITIES |
|
1,815,691 |
|
|
|
2,735,820 |
|
NON-CURRENT
LIABILITIES |
|
|
|
|
|
|
|
Deferred revenue |
|
- |
|
|
|
200,000 |
|
Accrued interest - net
of current portion |
|
89,717 |
|
|
|
- |
|
Term loan, net of
discount and deferred issuance costs |
|
6,942,151 |
|
|
|
- |
|
Warrant liability |
|
15,242,915 |
|
|
|
- |
|
Other liabilities |
|
141,707 |
|
|
|
- |
|
TOTAL LIABILITIES |
|
24,232,181 |
|
|
|
2,935,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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; 8,722,823 and 4,383,433
shares issued and outstanding, respectively |
|
8,723 |
|
|
|
4,383 |
|
Additional paid-in
capital |
|
71,939,917 |
|
|
|
49,661,802 |
|
Accumulated
deficit |
|
(67,332,248 |
) |
|
|
(51,985,517 |
) |
TOTAL
STOCKHOLDERS' EQUITY (DEFICIT) |
|
4,616,392 |
|
|
|
(2,319,332 |
) |
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
$ |
28,848,573 |
|
|
$ |
616,488 |
|
|
|
|
|
|
|
|
|
PLx Pharma Inc.CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
REVENUES: |
|
|
|
|
|
|
|
Federal grant |
$ |
140,447 |
|
|
$ |
- |
|
|
$ |
578,657 |
|
|
$ |
- |
|
License revenue |
|
200,000 |
|
|
|
- |
|
|
|
200,000 |
|
|
|
20,000 |
|
TOTAL REVENUES |
|
340,447 |
|
|
|
- |
|
|
|
778,657 |
|
|
|
20,000 |
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
Research and
development |
|
2,444,564 |
|
|
|
13,119 |
|
|
|
4,157,454 |
|
|
|
78,656 |
|
General and
administrative |
|
1,911,978 |
|
|
|
1,408,610 |
|
|
|
10,174,997 |
|
|
|
4,752,068 |
|
Impairment of
intangibles assets |
|
2,294,048 |
|
|
|
- |
|
|
|
2,294,048 |
|
|
|
- |
|
TOTAL OPERATING
EXPENSES |
|
6,650,590 |
|
|
|
1,421,729 |
|
|
|
16,626,499 |
|
|
|
4,830,724 |
|
OPERATING LOSS |
|
(6,310,143 |
) |
|
|
(1,421,729 |
) |
|
|
(15,847,842 |
) |
|
|
(4,810,724 |
) |
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE) |
|
|
|
|
|
|
|
Interest income |
|
64,295 |
|
|
|
27 |
|
|
|
112,377 |
|
|
|
571 |
|
Interest expense |
|
(273,062 |
) |
|
|
(32,115 |
) |
|
|
(1,164,897 |
) |
|
|
(95,125 |
) |
Change in fair value of
warrant liability |
|
(1,365,247 |
) |
|
|
- |
|
|
|
633,631 |
|
|
|
- |
|
TOTAL OTHER INCOME
(EXPENSE) |
|
(1,574,014 |
) |
|
|
(32,088 |
) |
|
|
(418,889 |
) |
|
|
(94,554 |
) |
LOSS BEFORE INCOME TAX
BENEFIT |
|
(7,884,157 |
) |
|
|
(1,453,817 |
) |
|
|
(16,266,731 |
) |
|
|
(4,905,278 |
) |
Income tax benefit |
|
- |
|
|
|
- |
|
|
|
920,000 |
|
|
|
- |
|
NET LOSS |
$ |
(7,884,157 |
) |
|
$ |
(1,453,817 |
) |
|
$ |
(15,346,731 |
) |
|
$ |
(4,905,278 |
) |
|
|
|
|
|
|
|
|
Net loss per common
share - basic and diluted |
$ |
(0.90 |
) |
|
$ |
(0.33 |
) |
|
$ |
(2.19 |
) |
|
$ |
(1.12 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
of common shares - basic and diluted |
|
8,721,765 |
|
|
|
4,383,433 |
|
|
|
7,020,479 |
|
|
|
4,383,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PLx Pharma (NASDAQ:PLXP)
Historical Stock Chart
From Mar 2024 to Apr 2024
PLx Pharma (NASDAQ:PLXP)
Historical Stock Chart
From Apr 2023 to Apr 2024