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 ended March 31, 2021.
Highlights of, and certain events subsequent to,
the first quarter of 2021 include:
- The U.S. Food and Drug
Administration (“FDA”) approved the Company’s supplemental new drug
applications (“sNDAs”) for its lead products, VAZALORE 325 mg and
VAZALORE 81 mg;
- The Company completed a $71.4
million financing to support the launch of VAZALORE;
- Company paid off the balance of its
term loan due in February 2021; and
- VAZALORE product launch remains on
track for the third quarter 2021.
“Receiving FDA approval for both dose strengths of VAZALORE was
an exciting achievement for us, and we now have the capital to
execute a national commercial launch that will ensure widespread
access to this innovative aspirin therapy for health care
professionals and consumers,” stated Natasha Giordano, President
and Chief Executive Officer of PLx.
Public Offering
In March 2021, the Company completed
an underwritten public offering in which PLx sold 8,924,700 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 $71.4
million, before deducting underwriting discounts and commissions
and other offering expenses payable by the Company.
First Quarter 2021 Financial Results
The Company recognized no revenue for the first quarter of 2021
compared to $2,523 for the first quarter of 2020. All the revenue
recognized in the 2020 period 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 $1.0 million for the
first quarter of 2021, compared to $0.5 million in the first
quarter of 2020. This increase is primarily attributable to
increased manufacturing-related activities for VAZALORE.
General and administrative expense totaled $2.6 million in the
first quarter of 2021 compared to $2.5 million in the first quarter
of 2020. This increase primarily reflects higher pre-launch
marketing expenses and increased non-cash stock-based compensation.
The increase was partially offset by lower compensation-related
expenses combined with savings from COVID-19 travel
restrictions.
Other income (expense), totaled $7.9 million of other expense
and $4.5 million of net other income in the first quarters of 2021
and 2020, respectively. The variance is 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. Net
interest decreased due to the payoff of the remaining balance of
the loan which was due and paid in February 2021.
Net loss attributable to common stockholders for the first
quarter of 2021 was $11.9 million, or ($0.73) per basic and diluted
share, compared to net income attributable to common stockholders
of $1.2 million, or $0.08 per basic and diluted share, for the
first quarter of 2020. The first quarter of 2021 included a
non-cash loss of $7.9 million, or ($0.48) per share, related to the
change in fair value of warrant liability whereas the first quarter
of 2020 included a non-cash gain of $4.6 million, or $0.50 per
share, related to the change in the fair value of the warrant
liability.
As of March 31, 2021, the Company had
cash and cash equivalents of $84.4 million.
Conference Call
As previously announced, PLx management will host its first
quarter 2021 conference call as follows:
Date: |
Friday, May 14, 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 Statements Any
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 |
(Unaudited) |
|
|
|
March 31,2021 |
|
December 31,2020 |
ASSETS |
|
|
|
CURRENT
ASSETS |
|
|
|
Cash and cash equivalents |
$ |
84,423,464 |
|
|
$ |
22,448,651 |
|
Inventory |
|
143,380 |
|
|
|
143,380 |
|
Prepaid
expenses and other current assets |
|
300,556 |
|
|
|
393,470 |
|
TOTAL
CURRENT ASSETS |
|
84,867,400 |
|
|
|
22,985,501 |
|
NON-CURRENT
ASSETS |
|
|
|
Property and
equipment, net |
|
1,125,719 |
|
|
|
1,225,879 |
|
Right of use
assets |
|
249,738 |
|
|
|
327,161 |
|
Goodwill |
|
2,061,022 |
|
|
|
2,061,022 |
|
Security
deposit |
|
17,036 |
|
|
|
17,036 |
|
TOTAL
ASSETS |
$ |
88,320,915 |
|
|
$ |
26,616,599 |
|
|
|
|
|
LIABILITIES,
SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
EQUITY (DEFICIT) |
|
|
|
CURRENT
LIABILITIES |
|
|
|
Accounts
payable and accrued liabilities |
$ |
962,608 |
|
|
$ |
862,568 |
|
Accrued
bonuses |
|
246,647 |
|
|
|
1,184,823 |
|
Accrued
interest |
|
- |
|
|
|
597,411 |
|
Term loan,
net of discount and fees |
|
- |
|
|
|
622,265 |
|
Other
current liabilities |
|
199,939 |
|
|
|
275,247 |
|
TOTAL
CURRENT LIABILITIES |
|
1,409,194 |
|
|
|
3,542,314 |
|
NON-CURRENT
LIABILITIES |
|
|
|
Warrant
liability |
|
17,626,158 |
|
|
|
9,691,271 |
|
Accrued
dividends |
|
3,118,066 |
|
|
|
2,795,795 |
|
Other
liabilities |
|
121,651 |
|
|
|
134,184 |
|
TOTAL
LIABILITIES |
|
22,275,069 |
|
|
|
16,163,564 |
|
|
|
|
|
Series A
convertible preferred stock: $0.001 par value; liquidation value of
$17,603,176; 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
$8,514,890; 25,000 shares authorized, 8,000 and 0 issued and
outstanding |
|
7,723,312 |
|
|
|
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; 22,836,333
and 13,911,633 shares issued and outstanding, respectively |
|
22,836 |
|
|
|
13,912 |
|
Additional
paid-in capital |
|
158,327,448 |
|
|
|
91,203,050 |
|
Accumulated
deficit |
|
(113,689,328 |
) |
|
|
(102,148,817 |
) |
TOTAL
STOCKHOLDERS' EQUITY (DEFICIT) |
|
44,660,956 |
|
|
|
(10,931,855 |
) |
TOTAL
LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (DEFICIT) |
$ |
88,320,915 |
|
|
$ |
26,616,599 |
|
|
|
|
|
PLx Pharma
Inc. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
Three Months
Ended |
|
March 31,2021 |
|
March 31,2020 |
REVENUES: |
|
|
|
Federal grant |
$ |
- |
|
|
$ |
2,523 |
|
TOTAL
REVENUES |
|
- |
|
|
|
2,523 |
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
Research and
development |
|
959,503 |
|
|
|
513,914 |
|
General and
administrative |
|
2,636,329 |
|
|
|
2,493,251 |
|
TOTAL
OPERATING EXPENSES |
|
3,595,832 |
|
|
|
3,007,165 |
|
OPERATING
LOSS |
|
(3,595,832 |
) |
|
|
(3,004,642 |
) |
|
|
|
|
OTHER INCOME
(EXPENSE): |
|
|
|
Interest
expense, net of interest income |
|
(9,792 |
) |
|
|
(98,525 |
) |
Change in
fair value of warrant liability |
|
(7,934,887 |
) |
|
|
4,599,253 |
|
TOTAL OTHER
INCOME (EXPENSE) |
|
(7,944,679 |
) |
|
|
4,500,728 |
|
INCOME
(LOSS) BEFORE INCOME TAXES |
|
(11,540,511 |
) |
|
|
1,496,086 |
|
Income
taxes |
|
- |
|
|
|
- |
|
NET INCOME
(LOSS) |
|
(11,540,511 |
) |
|
|
1,496,086 |
|
|
|
|
|
Preferred
dividends |
|
(322,271 |
) |
|
|
(320,290 |
) |
NET INCOME
(LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ |
(11,862,782 |
) |
|
$ |
1,175,796 |
|
|
|
|
|
Net income
(loss) per common share - basic |
$ |
(0.73 |
) |
|
$ |
0.08 |
|
Net income
(loss) per common share - diluted |
$ |
(0.73 |
) |
|
$ |
0.08 |
|
|
|
|
|
Weighted
average shares of common shares - basic |
|
16,361,583 |
|
|
|
9,156,260 |
|
Weighted
average shares of common shares - diluted |
|
16,361,583 |
|
|
|
9,216,667 |
|
|
|
|
|
PLx Pharma (NASDAQ:PLXP)
Historical Stock Chart
From Jun 2024 to Jul 2024
PLx Pharma (NASDAQ:PLXP)
Historical Stock Chart
From Jul 2023 to Jul 2024