PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a
specialty pharmaceutical company focused on its
clinically-validated and patent-protected PLxGuard™ drug delivery
platform to provide more effective and safer products, with its
lead products VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to
together as “VAZALORE”), announced today certain financial and
operational results for the three months and full year ended
December 31, 2020.
Highlights of, and certain events subsequent to, the fourth
quarter of 2020 include:
- Received U.S. Food and Drug
Administration (“FDA”) approval of its supplemental new drug
applications (“sNDAs”) for its lead products, VAZALORE 325 mg and
VAZALORE 81 mg, the first-ever liquid-filled aspirin capsules;
- Completed a $63 million financing
of 7,875,000 shares of common stock, offered at a price of $8.00
for the launch of VAZALORE;
- Entered into an $18 million private placement in November 2020;
and
- VAZALORE commercial launch planned for the third quarter
2021.
“We are delighted to receive FDA approval of the sNDAs for both
dose strengths and are excited to launch this breakthrough product
to the medical community and to patients who can benefit from a
reliable and predictable antiplatelet therapy,” stated Natasha
Giordano, President and Chief Executive Officer of PLx.
“The successful $63 million financing provides the capital
needed to commercialize VAZALORE. Our experienced leadership team
is well prepared to execute our strategy, and this funding will
enable us to launch the product successfully,” concluded
Giordano.
Public Offering
On March 5, 2021, the Company
completed an underwritten public offering in which PLx issued and
sold 7,875,000 shares of its common stock at a price to the public
of $8.00 per share. The gross proceeds to the Company from this
offering were $63 million, before deducting underwriting discounts
and commissions and other offering expenses payable by the
Company.
Fourth Quarter 2020 Financial Results
The Company recognized no revenue for the fourth quarter of 2020
compared to $24,000 for the fourth quarter of 2019. All the revenue
recognized in 2019 was attributable to work performed under an
award of a National Institutes of Health (“NIH”) grant, which came
to an end in the second quarter of 2020.
Research and development expenses were $1.2 million for the
fourth quarter of 2020, compared to $0.9 million in the fourth
quarter of 2019. This increase reflected the expiration of raw
materials combined with higher regulatory costs supporting the
filing of the supplemental new drug applications in October
2020.
General and administrative expense totaled $2.5 million in the
fourth quarter of 2020 compared to $2.8 million in the fourth
quarter of 2019. This decrease was due to lower pre-launch
marketing costs combined with lower conference and related travel
costs due to COVID-19 restrictions.
Other (expense) income totaled $4.3 million of other expense and
$1.8 million of net other income in the three months ended December
31, 2020 and 2019, respectively. The decrease was largely
attributable to the non-cash change in fair value of warrant
liability primarily due to the fluctuation of the price of the
Company’s common stock, combined with lower net interest expense,
which was impacted by a lower principal debt balance and lower
interest rates.
Net loss attributable to common stockholders for the fourth
quarter of 2020 was $8.5 million, or ($0.87) per basic and diluted
share, compared to net loss of $2.3 million, or ($0.25) per share,
for the fourth quarter of 2019. The fourth quarter of 2020 included
a non-cash loss of $4.2 million, or ($0.44) per share, related to
the change in fair value of warrant liability and $0.5 million, or
($0.05) per share, of Series A and Series B convertible preferred
stock dividends. The fourth quarter of 2019 included a non-cash
gain of $1.9 million, or $0.20 per share, related to the change in
the warrant liability and $0.3 million, or ($0.03) per share, for
preferred stock dividends related to the Series A convertible
preferred stock.
Full Year 2020 Financial Results
For the year ended December 31, 2020, total revenues were $0.03
million, compared with $0.6 million for the prior year. All the
revenue recognized in 2020 and 2019 was attributable to work
performed under a federal grant from the NIH, which came to an end
in the second quarter of 2020.
Research and development expenses totaled $4.3 million for the
year ended December 31, 2020, compared to $4.7 million in the prior
year, reflecting continued product development and manufacturing
activities for VAZALORE. This decrease was due to 2020 activities,
which included the bioequivalence study to provide data for the
sNDA filing, stability and validation work, compared to
manufacture, packaging, stability, and analytical costs related to
the registration batches in 2019.
General and administrative expenses totaled $9.2 million for the
year ended December 31, 2020, compared to $10.0 million in the
prior year. The decrease was due to lower compensation-related
expenses combined with savings from COVID-19 restrictions on
conference and travel costs.
Other (expense) income totaled $1.8 million of other expense for
the year ended December 31, 2020, compared to $6.3 million of other
expense in the prior year. The change is primarily attributable to
the non-cash change in fair value of warrant liability primarily
due to the fluctuation of the price of the Company’s common stock,
combined with lower net interest expense due to lower interest
rates and lower principal debt balance.
Net loss attributable to common stockholders for the year ended
December 31, 2020 was $16.9 million or ($1.74) per basic and
diluted share compared to net loss of $34.3 million, or ($3.84) per
share for the prior year. Full year 2020 included non-cash expense
of $1.4 million, or ($0.15) per share, as a result of a change in
the fair value of the warrant liability and $1.7 million, or
($0.18) per share, of Series A and Series B convertible preferred
stock dividends. Full year 2019 included $13.7 million
or ($1.54) per share, for the beneficial conversion feature and
preferred stock dividends related to the $15 million Series A
convertible preferred stock financing completed in February 2019.
Full year 2019 also included a non-cash expense of $5.7 million, or
($0.64) per share as a result of a change in the fair value of the
warrant liability.
On November 16, 2020, the Company entered into a securities
purchase agreement for the sale of units comprised of shares of
common stock and a warrant to purchase shares of common stock in a
private placement that resulted in gross proceeds to the Company of
approximately $18 million, before deducting placement agent and
other offering expenses, for the issuance of 4,755,373 shares of
common stock and warrants to purchase up to an additional 5,230,910
shares of common stock for a per unit price of $3.787. The private
placement closed on November 18, 2020. The warrants become
exercisable on the date of issuance, have an exercise price of
$4.31 per share and will expire five years from the date of
issuance.
As of December 31, 2020, the Company
had cash and cash equivalents of $22.4 million.
Conference Call
As previously announced, PLx management will host its fourth
quarter 2020 conference call as follows:
Date: |
Friday, March 12, 2021 |
Time: |
8:30 a.m. ET |
Toll free (U.S.): |
(866) 394-2901 |
International: |
(616) 548-5567 |
Webcast (live and replay): |
www.plxpharma.com under the ‘Investor Relations’ section. |
The archived webcast will be available for 30 days via the
aforementioned URL.
About VAZALORE VAZALORE is an FDA-approved
liquid-filled aspirin capsule that provides patients with vascular
disease and diabetic patients who are candidates for aspirin
therapy based on physician recommendation, with fast, reliable and
predictable platelet inhibition as compared to enteric-coated
aspirin. It also reduces the risk of stomach erosions and ulcers,
as compared to immediate-release aspirin, common in an acute
setting.
About PLx Pharma Inc. PLx Pharma Inc. is a
specialty pharmaceutical company focused on its
clinically-validated and patent-protected PLxGuard™ drug delivery
platform to provide more effective and safer products. The PLxGuard
drug delivery platform works by targeting the release of active
pharmaceutical ingredients to various portions of the
gastrointestinal (GI) tract. PLx believes this platform has the
potential to improve the absorption of many drugs currently on the
market or in development, and to reduce the risk of stomach
erosions and ulcers associated with certain 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, 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 Form 10-K for the year ended December 31, 2020 filed with
the SEC on March 12, 2021, and in other filings that PLx has made
or 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, 2020 |
|
December 31, 2019 |
|
ASSETS |
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
Cash and
cash equivalents |
$ |
22,448,651 |
|
|
$ |
14,001,304 |
|
|
Accounts
receivable |
|
- |
|
|
|
18,683 |
|
|
Inventory,
net |
|
143,380 |
|
|
|
- |
|
|
Prepaid
expenses and other current assets |
|
393,470 |
|
|
|
263,268 |
|
|
TOTAL
CURRENT ASSETS |
|
|
|
|
NON-CURRENT
ASSETS |
|
|
|
|
Property and
equipment, net |
|
1,225,879 |
|
|
|
1,466,646 |
|
|
Right of use
assets |
|
327,161 |
|
|
|
618,158 |
|
|
Goodwill |
|
2,061,022 |
|
|
|
2,061,022 |
|
|
Security
deposit |
|
17,036 |
|
|
|
73,665 |
|
|
TOTAL
ASSETS |
$ |
26,616,599 |
|
|
$ |
18,502,746 |
|
|
|
|
|
|
|
LIABILITIES,
SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
EQUITY (DEFICIT) |
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
862,568 |
|
|
$ |
928,921 |
|
|
Accrued
bonuses |
|
1,184,823 |
|
|
|
1,166,821 |
|
|
Accrued
interest |
|
597,411 |
|
|
|
34,964 |
|
|
Current
portion of term loan, net of discount and fees |
|
622,265 |
|
|
|
3,658,121 |
|
|
Other
current liabilities |
|
275,247 |
|
|
|
304,603 |
|
|
TOTAL
CURRENT LIABILITIES |
|
3,542,314 |
|
|
|
6,093,430 |
|
|
NON-CURRENT
LIABILITIES |
|
|
|
|
Accrued
interest, net of current portion |
|
- |
|
|
|
501,826 |
|
|
Term loan,
net of discount, fees and current portion |
|
- |
|
|
|
622,265 |
|
|
Warrant
liability |
|
9,691,271 |
|
|
|
8,247,679 |
|
|
Accrued
dividends |
|
2,795,795 |
|
|
|
1,058,498 |
|
|
Other
liabilities |
|
134,184 |
|
|
|
409,431 |
|
|
TOTAL
LIABILITIES |
|
16,163,564 |
|
|
|
16,933,129 |
|
|
|
|
|
|
|
Series A
convertible preferred stock: $0.001 par value; liquidation value of
$17,385,970; 45,000 shares authorized, 15,000 issued and
outstanding |
|
13,661,578 |
|
|
|
13,661,578 |
|
|
Series B
convertible preferred stock: $0.001 par value; liquidation value of
$8,409,825; 25,000 shares authorized, 8,000 and 0 issued and
outstanding |
|
7,723,312 |
|
|
|
- |
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
Preferred
stock; $0.001 par value; 930,000 shares authorized; none issued and
outstanding |
|
- |
|
|
|
- |
|
|
Common
stock; $0.001 par value; 100,000,000 shares authorized; 13,911,633
and 9,156,260 shares issued and outstanding |
|
13,912 |
|
|
|
9,156 |
|
|
Additional
paid-in capital |
|
91,203,050 |
|
|
|
74,837,046 |
|
|
Accumulated
deficit |
|
(102,148,817 |
) |
|
|
(86,938,163 |
) |
|
TOTAL
STOCKHOLDERS' EQUITY (DEFICIT) |
|
(10,931,855 |
) |
|
|
(12,091,961 |
) |
|
TOTAL
LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (DEFICIT) |
$ |
26,616,599 |
|
|
$ |
18,502,746 |
|
|
|
|
|
|
|
PLx Pharma
Inc. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
|
|
|
|
|
|
Three Months
Ended December 31, |
|
Year Ended
December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
REVENUES: |
|
|
|
|
|
|
|
Federal
grant |
$ |
- |
|
|
$ |
23,893 |
|
|
$ |
30,430 |
|
|
$ |
565,464 |
|
TOTAL
REVENUES |
|
- |
|
|
|
23,893 |
|
|
|
30,430 |
|
|
|
565,464 |
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
Research and
development |
|
1,222,877 |
|
|
|
935,513 |
|
|
|
4,338,974 |
|
|
|
4,741,130 |
|
General and
administrative |
|
2,469,116 |
|
|
|
2,845,953 |
|
|
|
9,150,568 |
|
|
|
10,026,627 |
|
TOTAL
OPERATING EXPENSES |
|
3,691,993 |
|
|
|
3,781,466 |
|
|
|
13,489,542 |
|
|
|
14,767,757 |
|
OPERATING
LOSS |
|
(3,691,993 |
) |
|
|
(3,757,573 |
) |
|
|
(13,459,112 |
) |
|
|
(14,202,293 |
) |
|
|
|
|
|
|
|
|
OTHER
(EXPENSE) INCOME: |
|
|
|
|
|
|
|
Interest and
other expense, net |
|
(40,737 |
) |
|
|
(113,656 |
) |
|
|
(307,950 |
) |
|
|
(589,740 |
) |
Change in
fair value of warrant liability |
|
(4,248,554 |
) |
|
|
1,871,159 |
|
|
|
(1,443,592 |
) |
|
|
(5,710,362 |
) |
TOTAL OTHER
(EXPENSE) INCOME |
|
(4,289,291 |
) |
|
|
1,757,503 |
|
|
|
(1,751,542 |
) |
|
|
(6,300,102 |
) |
LOSS BEFORE
INCOME TAXES |
|
(7,981,284 |
) |
|
|
(2,000,070 |
) |
|
|
(15,210,654 |
) |
|
|
(20,502,395 |
) |
Income
taxes |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
NET
LOSS |
|
(7,981,284 |
) |
|
|
(2,000,070 |
) |
|
|
(15,210,654 |
) |
|
|
(20,502,395 |
) |
|
|
|
|
|
|
|
|
Deemed
dividends |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(12,692,308 |
) |
Preferred
dividends |
|
(509,875 |
) |
|
|
(317,409 |
) |
|
|
(1,737,297 |
) |
|
|
(1,058,498 |
) |
NET LOSS
ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ |
(8,491,159 |
) |
|
$ |
(2,317,479 |
) |
|
$ |
(16,947,951 |
) |
|
$ |
(34,253,201 |
) |
|
|
|
|
|
|
|
|
Net loss per
common share - basic and diluted |
$ |
(0.87 |
) |
|
$ |
(0.25 |
) |
|
$ |
(1.74 |
) |
|
$ |
(3.84 |
) |
|
|
|
|
|
|
|
|
Weighted
average shares of common shares - basic and diluted |
|
9,714,951 |
|
|
|
9,129,854 |
|
|
|
9,714,951 |
|
|
|
8,916,190 |
|
|
|
|
|
|
|
|
|
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