PLx Pharma Inc. Reports First Quarter 2020 Results
-- Company to begin bioequivalence study of VAZALORE 325 mg dose --
-- sNDA submissions expected by year-end --
Highlights of, and certain events subsequent to, the first quarter of 2020 include:
- Net income attributable to common stockholders totaled
$1.2 million , or$0.08 per basic and diluted share, compared to net loss of$23.7 million , or ($2.71 ) per basic and diluted share, for the first quarter of 2019. This includes a non-cash gain of$4.6 million , or$0.45 per share, compared to a 2019 non-cash charge of$7.7 million for a change in the fair value of warrant liability, or ($0.88 ) per share; - Held Type-C meeting with the
U.S. Food and Drug Administration (“FDA”) on the bioequivalence study design to support the supplemental New Drug Application (“sNDA”) for VAZALORE 325 mg dose strength and awaiting meeting minutes; - Engaged a contract research organization to conduct the required bioequivalence study once study is finalized with FDA;
- Presented two original abstracts showcasing: first, VAZALORE’s improved pharmacologic profile over enteric-coated aspirin, and second, VAZALORE’s ability to largely mitigate the negative impact of increasing weight on antiplatelet efficacy at the virtual
American College of Cardiology AnnualScientific Session ; - Announced an
$8 million Series B Convertible Preferred Stock financing withPark West Asset Management, LLC andMSD Partners, L.P. , providing a cash runway through the second quarter of 2021, subject to stockholder approval; and - Targeting filing sNDA submissions for both VAZALORE 325 mg dose and VAZALORE 81 mg dose to the FDA by year-end 2020, provided no delays caused by COVID-19.
“We are pleased to be moving ahead with the bioequivalence study and look forward to completing the regulatory requirements to support our sNDA submissions. This additional study will serve to reinforce our application for approval and will proceed alongside the ongoing pre-launch commercial activities already under way. We are excited about VAZALORE’s unique and innovative qualities and are eager to bring this critical new aspirin to millions of people with vascular disease,” said
First Quarter 2020 Financial Results
The Company recognized revenue of
Research and development expenses totaled
General and administrative expenses totaled
Other income (expense), net, totaled
Net income attributable to common stockholders for the first quarter of 2020 was
As of
Conference Call
As previously announced, PLx management will host its first 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 325 mg is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy 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 collecting the data required for post-approval manufacturing changes, which will be included in the sNDA filing for VAZALORE 325 mg and to support approval of low dose VAZALORE 81 mg.
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, the proposed Series B Preferred Stock and the expected timetable for completing such transaction, 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, PLx’s ability to obtain stockholder approval of the Series B Preferred Stock transaction, and the possibility that such transaction will not close or that the closing will be delayed. 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
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||||
2020 |
2019 |
||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 9,286,571 | $ | 14,001,304 | |||
Accounts receivable | 2,523 | 18,683 | |||||
Prepaid expenses and other current assets | 248,597 | 263,268 | |||||
Deferred financing costs | 43,518 | - | |||||
TOTAL CURRENT ASSETS | 9,581,209 | 14,283,255 | |||||
NON-CURRENT ASSETS | |||||||
Property and equipment, net | 1,437,324 | 1,466,646 | |||||
Right of use assets | 548,089 | 618,158 | |||||
2,061,022 | 2,061,022 | ||||||
Security deposit | 73,665 | 73,665 | |||||
TOTAL ASSETS | $ | 13,701,309 | $ | 18,502,746 | |||
LIABILITIES, SERIES A CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable and accrued liabilities | $ | 761,588 | $ | 928,921 | |||
Accrued bonuses | 317,634 | 1,166,821 | |||||
Accrued interest | 557,643 | 34,964 | |||||
Current portion of term loan, net of discount and fees | 3,377,855 | 3,658,121 | |||||
Other current liabilities | 319,835 | 304,603 | |||||
TOTAL CURRENT LIABILITIES | 5,334,555 | 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 | 3,648,426 | 8,247,679 | |||||
Accrued dividends | 1,378,788 | 1,058,498 | |||||
Other liabilities | 321,590 | 409,431 | |||||
TOTAL LIABILITIES | 10,683,359 | 16,933,129 | |||||
Series A convertible preferred stock: |
13,661,578 | 13,661,578 | |||||
STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
Preferred stock; |
- | - | |||||
Common stock; |
9,156 | 9,156 | |||||
Additional paid-in capital | 74,789,293 | 74,837,046 | |||||
Accumulated deficit | (85,442,077 | ) | (86,938,163 | ) | |||
TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | (10,643,628 | ) | (12,091,961 | ) | |||
TOTAL LIABILITIES, SERIES A CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 13,701,309 | $ | 18,502,746 | |||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
Three Months Ended |
|||||||
2020 | 2019 | ||||||
REVENUES: | |||||||
Federal grant | $ | 2,523 | $ | 317,560 | |||
TOTAL REVENUES | 2,523 | 317,560 | |||||
OPERATING EXPENSES: | |||||||
Research and development | 513,914 | 992,704 | |||||
General and administrative | 2,493,251 | 2,244,160 | |||||
TOTAL OPERATING EXPENSES | 3,007,165 | 3,236,864 | |||||
OPERATING LOSS | (3,004,642 | ) | (2,919,304 | ) | |||
OTHER INCOME (EXPENSE): | |||||||
Interest income | 47,303 | 82,350 | |||||
Interest and other expense | (145,828 | ) | (294,862 | ) | |||
Change in fair value of warrant liability | 4,599,253 | (7,726,935 | ) | ||||
TOTAL OTHER INCOME (EXPENSE) | 4,500,728 | (7,939,447 | ) | ||||
INCOME (LOSS) BEFORE INCOME TAXES | 1,496,086 | (10,858,751 | ) | ||||
Income taxes | - | - | |||||
NET INCOME (LOSS) | $ | 1,496,086 | $ | (10,858,751 | ) | ||
Preferred dividends and beneficial conversion feature | (320,290 | ) | (12,820,526 | ) | |||
NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | 1,175,796 | $ | (23,679,277 | ) | ||
Net income (loss) per common share - basic | $ | 0.08 | $ | (2.71 | ) | ||
Net income (loss) per common share - diluted | $ | 0.08 | $ | (2.71 | ) | ||
Weighted average shares of common shares - basic | 9,156,260 | 8,750,543 | |||||
Weighted average shares of common shares - diluted | 9,216,667 | 8,750,543 | |||||
Source: PLx Pharma Inc.