PLx Pharma Inc. Reports Third Quarter 2020 Results and Provides Business Update
--Announces
--Submitted sNDAs for VAZALORE 325 mg and 81 mg doses to FDA end of October--
--On target for third quarter 2021 commercial launch of VAZALORE--
Highlights of, and certain events subsequent to, the third quarter of 2020 include:
- Entered into an
$18 million private placement with investors led byWhite Rock Capital Management, L.P. andLevel One Partners, LLC ; - Submitted supplemental New Drug Applications (“sNDAs”) for VAZALORE 325 mg and 81 mg doses to the
U.S. Food and Drug Administration (“FDA”) for regulatory approval at the end of October ahead of previously announced timeline; and - Targeting commercial launch of both VAZALORE 325 mg and 81 mg doses for the third quarter of 2021, assuming FDA approval, adequate capital funding and no COVID-related delays.
“The submission of our two sNDAs marks a significant milestone for PLx in our efforts to bring VAZALORE, our novel aspirin therapy to market. While VAZALORE is under regulatory review, we will continue our precommercial activities focused on specialists treating vascular disease, retailers and consumers. Our upcoming priorities are to execute our commercial strategy for a successful product launch that will bring this much-needed aspirin alternative to the millions of at-risk patients,” said
Private Placement
On
“We are pleased to be leading the financing in support of PLx and VAZALORE, as the Company advances its innovative aspirin product through the regulatory process and prepares for market entry. With management’s extensive experience launching large, commercially successful products, we are confident in PLx’s ability to execute its strategic plan and to take full advantage of the significant market opportunity for VAZALORE,” stated
Third Quarter 2020 Financial Results
The Company recognized no revenue for the three months ended
Research and development expense totaled
General and administrative expenses totaled
Other income (expense), net, totaled
Net loss attributable to common stockholders for the third quarter of 2020 was
Nine Months Ended
For the nine months ended
Research and development expense decreased to
General and administrative expense totaled
Other income (expense), net was
Net loss attributable to common stockholders for the nine months ended
As of
Conference Call
As previously announced, PLx management will host its third 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 faster, reliable and more predictable platelet inhibition as compared to enteric-coated aspirin, while also reducing the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. PLx’s supplemental New Drug Applications for VAZALORE 325 mg and VAZALORE 81 mg doses, submitted in
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
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 9,086,525 | $ | 14,001,304 | |||
Accounts receivable | - | 18,683 | |||||
Inventory, net | 143,380 | - | |||||
Prepaid expenses and other current assets | 387,801 | 263,268 | |||||
TOTAL CURRENT ASSETS | 9,617,706 | 14,283,255 | |||||
NON-CURRENT ASSETS | |||||||
Property and equipment, net | 1,252,434 | 1,466,646 | |||||
Right of use assets | 402,640 | 618,158 | |||||
2,061,022 | 2,061,022 | ||||||
Security deposit | 17,035 | 73,665 | |||||
TOTAL ASSETS | $ | 13,350,837 | $ | 18,502,746 | |||
LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable and accrued liabilities | $ | 612,367 | $ | 928,921 | |||
Accrued bonuses | 718,092 | 1,166,821 | |||||
Accrued interest | 589,840 | 34,964 | |||||
Current portion of term loan, net of discount and fees | 1,548,865 | 3,658,121 | |||||
Other current liabilities | 342,175 | 304,603 | |||||
TOTAL CURRENT LIABILITIES | 3,811,339 | 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 | 5,442,717 | 8,247,679 | |||||
Accrued dividends | 2,285,920 | 1,058,498 | |||||
Other liabilities | 146,424 | 409,431 | |||||
TOTAL LIABILITIES | 11,686,400 | 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; |
9,156 | 9,156 | |||||
Additional paid-in capital | 74,437,924 | 74,837,046 | |||||
Accumulated deficit | (94,167,533 | ) | (86,938,163 | ) | |||
TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | (19,720,453 | ) | (12,091,961 | ) | |||
TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 13,350,837 | $ | 18,502,746 | |||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
Three Months Ended |
Nine Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
REVENUES: | |||||||||||||||
Federal grant | $ | - | $ | 41,106 | $ | 30,430 | $ | 541,571 | |||||||
TOTAL REVENUES | - | 41,106 | 30,430 | 541,571 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | 1,207,302 | 1,214,029 | 3,116,097 | 3,805,617 | |||||||||||
General and administrative | 1,981,037 | 2,503,314 | 6,681,452 | 7,180,674 | |||||||||||
TOTAL OPERATING EXPENSES | 3,188,339 | 3,717,343 | 9,797,549 | 10,986,291 | |||||||||||
OPERATING LOSS | (3,188,339 | ) | (3,676,237 | ) | (9,767,119 | ) | (10,444,720 | ) | |||||||
OTHER INCOME (EXPENSE): | |||||||||||||||
Interest and other expense, net | (72,705 | ) | (118,432 | ) | (267,213 | ) | (476,084 | ) | |||||||
Change in fair value of warrant liability | 134,552 | 5,498,391 | 2,804,962 | (7,581,521 | ) | ||||||||||
TOTAL OTHER INCOME (EXPENSE) | 61,847 | 5,379,959 | 2,537,749 | (8,057,605 | ) | ||||||||||
(LOSS) INCOME BEFORE INCOME TAXES | (3,126,492 | ) | 1,703,722 | (7,229,370 | ) | (18,502,325 | ) | ||||||||
Income taxes | - | - | - | - | |||||||||||
NET (LOSS) INCOME | (3,126,492 | ) | 1,703,722 | (7,229,370 | ) | (18,502,325 | ) | ||||||||
Preferred dividends and beneficial conversion feature | (499,797 | ) | (311,136 | ) | (1,227,422 | ) | (13,433,397 | ) | |||||||
NET (LOSS) INCOME ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (3,626,289 | ) | $ | 1,392,586 | $ | (8,456,792 | ) | $ | (31,935,722 | ) | ||||
Net (loss) income per common share - basic | $ | (0.40 | ) | $ | 0.09 | $ | (0.92 | ) | $ | (3.60 | ) | ||||
Net (loss) income per common share - diluted | $ | (0.40 | ) | $ | 0.09 | $ | (0.92 | ) | $ | (3.60 | ) | ||||
Weighted average shares of common shares - basic | 9,156,260 | 8,921,345 | 9,156,260 | 8,860,168 | |||||||||||
Weighted average shares of common shares - diluted | 9,156,260 | 8,936,255 | 9,156,260 | 8,860,168 | |||||||||||
Source: PLx Pharma Inc.