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 and six months ended June 30,
2021.
Highlights of, and certain events subsequent to,
the second quarter of 2021 include:
- Walmart, Walgreens, Rite Aid, and
CVS among the leading retailers to reserve shelf space for all
three SKUs of VAZALORE;
- Extensive distribution for VAZALORE
in over 30,000 U.S. retail stores;
- Launched specialty field force to
raise awareness amongst healthcare professionals;
- Continue to inform specialists
through medical conferences, publications and continuing
professional education events; and
- VAZALORE launch inventory
manufactured and currently shipping to retailers across the
country.
“We are continuing to execute on our commercial strategy with
retailers, professionals and consumers,” stated Natasha Giordano,
President and Chief Executive Officer of PLx. “We recently deployed
our cardiovascular field force to raise awareness amongst
specialists and now have sufficient inventory shipping to retailers
to fulfill this widespread distribution.”
“Keeping the patient top of mind has always been our guiding
principle and we are excited to bring VAZALORE to millions of
patients at risk,” concluded Giordano.
Second Quarter 2021 Financial Results
The Company recognized no revenue for the second quarter of 2021
compared to $27,907 for the second 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
second quarter of 2021, compared to $1.4 million in the second
quarter of 2020. This decrease is primarily attributable to lower
pre-commercial manufacturing-related activities for VAZALORE and
the non-recurrence of clinical-related spending for the
bioequivalence study in 2020.
Selling, marketing and administrative expense totaled $5.5
million in the second quarter of 2021 compared to $2.2 million in
the second quarter of 2020. This increase primarily reflects higher
sales and marketing expenses to prepare for the VAZALORE launch and
increased non-cash stock-based compensation.
Other expense totaled $10.0 million in the second quarter of
2021 compared to $2.0 million in the second quarter of 2020. The
increase 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 combined with lower net
interest due to the payoff of the term loan with Silicon Valley
Bank in February 2021.
Net loss attributable to common stockholders for the second
quarter of 2021 was $18.7 million, or ($0.79) per basic and diluted
share, compared $6.0 million, or ($0.66) per basic and diluted
share, for the second quarter of 2020. The second quarter of 2021
included a non-cash loss of $10.0 million, or ($0.42) per share,
related to the change in fair value of warrant liability versus a
non-cash loss of $1.9 million, or ($0.21) per share for the second
quarter of 2020. The second quarter of 2021 also included $2.2
million or ($0.09) per share for the beneficial conversion feature
related to the conversion of Series A convertible preferred stock
dividends. The second quarter of 2020 included $0.4 million, or
($0.04) per share, for dividends on the Series A and Series B
convertible preferred stock. All convertible preferred stock
dividends stopped accruing upon U.S. Food and Drug Administration
(“FDA”) approval of VAZALORE in first quarter of 2021.
First Half 2021 Financial Results
For the six months ended June 30,
2021, the Company recognized no revenue compared to $30,430 in the
comparable period in 2020. All the revenue recognized in the 2020
period was attributable to work performed under an award of an NIH
grant, which concluded in the second quarter of 2020.
Research and development expense was $1.9 million for the six
months ended June 30, 2021 and for the comparable 2020 period.
Research and development expenses primarily reflect pre-commercial
manufacturing-related activities for VAZALORE and 2020 included
costs related to the bioequivalence study.
Selling, marketing and administrative
expense was $8.1 million for the six months ended June 30, 2021,
compared to $4.7 million in the comparable period in 2020. The
increase primarily reflects higher sales and marketing expenses to
prepare for the VAZALORE launch and increased non-cash stock-based
compensation.
Other income (expense) was $18.0
million of other expense for the first half of 2021, compared to
$2.5 million of net other income for the first six months of 2020.
This difference is largely attributable to the non-cash change in
fair value of warrant liability due to the fluctuation of the price
of the Company’s common stock combined with lower net interest due
to the payoff of the term loan in February 2021.
Net loss attributable to common
stockholders for the six months ended June 30, 2021 was $30.6
million or ($1.53) per share compared to net loss attributable to
common stockholders of $4.8 million, or ($0.53) per share, for the
first half of 2020. The first half of 2021 included a non-cash loss
of $18.0 million, or ($0.90) per share, as a result of a change in
the fair value of the warrant liability versus a non-cash gain of
$2.7 million or $0.29 per share for the first half of 2020. The
first half of 2021 also included a charge of $2.5 million or
($0.13) per share for the beneficial conversion feature related to
the conversion of the Series A convertible preferred stock
dividends combined with dividends on the Series A and Series B
convertible preferred stock compared to $0.7 million or ($0.08) per
share in the first half of 2020 for preferred stock dividends which
stopped accruing upon FDA approval of VAZALORE.
As of June 30, 2021, the Company had
cash and cash equivalents of $80.2 million.
Conference Call
As previously announced, PLx management will host its second
quarter 2021 conference call as follows:
Date: |
Friday, August 6, 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. To learn
more about VAZALORE, please visit www.vazalore.com.
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) |
|
|
|
|
|
June 30,2021 |
|
December 31,2020 |
|
ASSETS |
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
Cash and cash equivalents |
$ |
80,169,469 |
|
|
$ |
22,448,651 |
|
|
Inventory |
|
1,262,481 |
|
|
|
143,380 |
|
|
Prepaid
expenses and other current assets |
|
581,014 |
|
|
|
393,470 |
|
|
TOTAL
CURRENT ASSETS |
|
82,012,964 |
|
|
|
22,985,501 |
|
|
NON-CURRENT
ASSETS |
|
|
|
|
Property and
equipment, net |
|
918,856 |
|
|
|
1,225,879 |
|
|
Right of use
assets |
|
298,651 |
|
|
|
327,161 |
|
|
Goodwill |
|
2,061,022 |
|
|
|
2,061,022 |
|
|
Security
deposit |
|
17,036 |
|
|
|
17,036 |
|
|
TOTAL
ASSETS |
$ |
85,308,529 |
|
|
$ |
26,616,599 |
|
|
|
|
|
|
|
LIABILITIES,
SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
EQUITY (DEFICIT) |
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
2,382,322 |
|
|
$ |
862,568 |
|
|
Accrued
bonuses |
|
516,199 |
|
|
|
1,184,823 |
|
|
Accrued
interest |
|
- |
|
|
|
597,411 |
|
|
Term loan,
net of discount and fees |
|
- |
|
|
|
622,265 |
|
|
Other
current liabilities |
|
166,244 |
|
|
|
275,247 |
|
|
TOTAL
CURRENT LIABILITIES |
|
3,064,765 |
|
|
|
3,542,314 |
|
|
NON-CURRENT
LIABILITIES |
|
|
|
|
Warrant
liability |
|
25,791,417 |
|
|
|
9,691,271 |
|
|
Accrued
dividends |
|
128,722 |
|
|
|
2,795,795 |
|
|
Other
liabilities |
|
194,471 |
|
|
|
134,184 |
|
|
TOTAL
LIABILITIES |
|
29,179,375 |
|
|
|
16,163,564 |
|
|
|
|
|
|
|
Series A
convertible preferred stock: $0.001 par value; liquidation value of
$12,642,000; 45,000 shares authorized, 12,642 and 15,000 issued and
outstanding, respectively |
|
13,707,935 |
|
|
|
13,661,578 |
|
|
Series B
convertible preferred stock: $0.001 par value; liquidation value of
$2,492,722; 25,000 shares authorized, 2,364 and 8,000 issued and
outstanding, respectively |
|
2,305,667 |
|
|
|
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; 26,145,008
and 13,911,633 shares issued and outstanding, respectively |
|
26,145 |
|
|
|
13,912 |
|
|
Additional
paid-in capital |
|
170,283,101 |
|
|
|
91,203,050 |
|
|
Accumulated
deficit |
|
(130,193,694 |
) |
|
|
(102,148,817 |
) |
|
TOTAL
STOCKHOLDERS' EQUITY (DEFICIT) |
|
40,115,552 |
|
|
|
(10,931,855 |
) |
|
TOTAL
LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (DEFICIT) |
$ |
85,308,529 |
|
|
$ |
26,616,599 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PLx Pharma
Inc. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
|
|
Three Months
Ended |
|
Six Months
Ended |
|
June 30,2021 |
|
June 30,2020 |
|
June 30,2021 |
|
June 30,2020 |
REVENUES: |
|
|
|
|
|
|
|
Federal grant |
$ |
- |
|
|
$ |
27,907 |
|
|
$ |
- |
|
|
$ |
30,430 |
|
TOTAL
REVENUES |
|
- |
|
|
|
27,907 |
|
|
|
- |
|
|
|
30,430 |
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
Research and
development |
|
982,730 |
|
|
|
1,394,881 |
|
|
|
1,942,233 |
|
|
|
1,908,795 |
|
Selling,
marketing and administrative |
|
5,497,747 |
|
|
|
2,207,164 |
|
|
|
8,134,076 |
|
|
|
4,700,415 |
|
TOTAL
OPERATING EXPENSES |
|
6,480,477 |
|
|
|
3,602,045 |
|
|
|
10,076,309 |
|
|
|
6,609,210 |
|
OPERATING
LOSS |
|
(6,480,477 |
) |
|
|
(3,574,138 |
) |
|
|
(10,076,309 |
) |
|
|
(6,578,780 |
) |
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE): |
|
|
|
|
|
|
|
Interest
income (expense), net |
|
4,286 |
|
|
|
(95,983 |
) |
|
|
(5,506 |
) |
|
|
(194,508 |
) |
Change in
fair value of warrant liability |
|
(10,028,175 |
) |
|
|
(1,928,843 |
) |
|
|
(17,963,062 |
) |
|
|
2,670,410 |
|
TOTAL OTHER
INCOME (EXPENSE) |
|
(10,023,889 |
) |
|
|
(2,024,826 |
) |
|
|
(17,968,568 |
) |
|
|
2,475,902 |
|
LOSS BEFORE
INCOME TAXES |
|
(16,504,366 |
) |
|
|
(5,598,964 |
) |
|
|
(28,044,877 |
) |
|
|
(4,102,878 |
) |
Income
taxes |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
NET
LOSS |
|
(16,504,366 |
) |
|
|
(5,598,964 |
) |
|
|
(28,044,877 |
) |
|
|
(4,102,878 |
) |
|
|
|
|
|
|
|
|
Preferred
dividends and beneficial conversion feature |
|
(2,202,687 |
) |
|
|
(407,335 |
) |
|
|
(2,524,958 |
) |
|
|
(727,625 |
) |
NET LOSS
ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ |
(18,707,053 |
) |
|
$ |
(6,006,299 |
) |
|
$ |
(30,569,835 |
) |
|
$ |
(4,830,503 |
) |
|
|
|
|
|
|
|
|
Net loss per
common share - basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.53 |
) |
|
$ |
(0.53 |
) |
|
|
|
|
|
|
|
|
Weighted
average shares of common shares - basic and diluted |
|
23,638,239 |
|
|
|
9,156,260 |
|
|
|
20,020,012 |
|
|
|
9,156,260 |
|
|
|
|
|
|
|
|
|
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