PLx Pharma Inc. Reports Fourth Quarter and Full Year 2020 Results and Provides Business Update
-- Received FDA approval of sNDAs for both VAZALORE 325 mg and 81 mg, the first-ever novel, liquid-filled aspirin capsule --
--
-- Secured
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 inNovember 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
“The successful
Public Offering
On
Fourth Quarter 2020 Financial Results
The Company recognized no revenue for the fourth quarter of 2020 compared to
Research and development expenses were
General and administrative expense totaled
Other (expense) income totaled
Net loss attributable to common stockholders for the fourth quarter of 2020 was
Full Year 2020 Financial Results
For the year ended
Research and development expenses totaled
General and administrative expenses totaled
Other (expense) income totaled
Net loss attributable to common stockholders for the year ended
On
As of
Conference Call
As previously announced, PLx management will host its fourth quarter 2020 conference call as follows:
Date: | |
Time: | |
Toll free ( |
(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.
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
Contact
Investor Relations:
T: 212-452-2793
E: lwilson@insitecony.com
Source:
FINANCIAL TABLES FOLLOW
CONSOLIDATED BALANCE SHEETS | ||||||||
2020 |
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: |
13,661,578 | 13,661,578 | ||||||
Series B convertible preferred stock: |
7,723,312 | - | ||||||
STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
Preferred stock; |
- | - | ||||||
Common stock; |
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 |
Year Ended |
||||||||||||||
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 | |||||||||||
Source: PLx Pharma Inc.