PLx Pharma Inc. Reports Second Quarter 2020 Results and Provides Business Update
--Bioequivalence study of VAZALORE 325 mg on track with top-line data demonstrating bioequivalence to immediate release aspirin--
--Shifting the date of sNDA filings for VAZALORE 325 mg and 81 mg doses earlier to
--Targeting launch of VAZALORE 325 mg and 81 mg for third quarter 2021--
Highlights of, and certain events subsequent to, the second quarter of 2020 include:
- Net loss attributable to common stockholders totaled
$6.0 million , or ($0.66 ) per basic and diluted share, compared to net loss of$9.6 million , or ($1.10 ) per basic and diluted share, for the second quarter of 2019. This includes a non-cash charge related to the change in warrant liability of$1.9 million , or ($0.21 ) per share, compared to a non-cash charge of$5.4 million , or ($0.61 ) per share in the second quarter of 2019; - Confirmed the design of the VAZALORE 325 mg bioequivalence study with the
U.S. Food and Drug Administration (“FDA”) in writing after the April Type C meeting; - Bioequivalence study with VAZALORE 325 mg on track with top-line data demonstrating bioequivalence to immediate release aspirin further supporting the change in formulation;
- Finalizing supplemental New Drug Application (“sNDA”) filings for VAZALORE 325 mg and VAZALORE 81 mg dose strengths to be submitted to the FDA mid-November, ahead of the previously committed timeline of the end of the year;
- Targeting launch of both VAZALORE 325 mg and 81 mg dose strengths for third quarter of 2021, assuming FDA approval, adequate capital funding and no COVID-related delays; and
- Completed
$8 million Series B convertible preferred stock financing by investment funds affiliated withPark West Asset Management LLC andMSD Partners, L.P. (“Series B”).
“We are pleased with the top-line data from the bioequivalence study and eager to complete the remaining steps to submit our sNDAs to bring this innovative therapy to market next year. We are also building out our pre-commercialization plans and engaging with the medical and retail communities about VAZALORE’s potential to help the millions of vascular patients who can benefit from a novel aspirin therapy,” said
Second 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 loss attributable to common stockholders for the second quarter of 2020 was
First Half 2020 Financial Results
For the six months ended
Research and development expense decreased to
General and administrative expense remained flat at
Other income (expense), net was
Net loss attributable to common stockholders for the six months ended
As of
Conference Call
As previously announced, PLx management will host its second 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 is focused on collecting the data, including results from a bioequivalence study, 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 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:
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 13,257,204 | $ | 14,001,304 | |||
Accounts receivable | - | 18,683 | |||||
Inventory, net | 143,380 | - | |||||
Prepaid expenses and other current assets | 363,539 | 263,268 | |||||
TOTAL CURRENT ASSETS | 13,764,123 | 14,283,255 | |||||
NON-CURRENT ASSETS | |||||||
Property and equipment, net | 1,401,939 | 1,466,646 | |||||
Right of use assets | 476,268 | 618,158 | |||||
2,061,022 | 2,061,022 | ||||||
Security deposit | 73,665 | 73,665 | |||||
TOTAL ASSETS | $ | 17,777,017 | $ | 18,502,746 | |||
LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable and accrued liabilities | $ | 1,299,611 | $ | 928,921 | |||
Accrued bonuses | 492,296 | 1,166,821 | |||||
Accrued interest | 575,822 | 34,964 | |||||
Current portion of term loan, net of discount and fees | 2,467,372 | 3,658,121 | |||||
Other current liabilities | 335,467 | 304,603 | |||||
TOTAL CURRENT LIABILITIES | 5,170,568 | 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 | 5,577,269 | 8,247,679 | |||||
Accrued dividends | 1,786,123 | 1,058,498 | |||||
Other liabilities | 230,449 | 409,431 | |||||
TOTAL LIABILITIES | 12,764,409 | 16,933,129 | |||||
Series A convertible preferred stock: |
13,661,578 | 13,661,578 | |||||
Series B convertible preferred stock: |
7,731,379 | - | |||||
STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
Preferred stock; |
- | - | |||||
Common stock; |
9,156 | 9,156 | |||||
Additional paid-in capital | 74,651,536 | 74,837,046 | |||||
Accumulated deficit | (91,041,041 | ) | (86,938,163 | ) | |||
TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | (16,380,349 | ) | (12,091,961 | ) | |||
TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 17,777,017 | $ | 18,502,746 | |||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
REVENUES: | |||||||||||||||
Federal grant | $ | 27,907 | $ | 182,905 | $ | 30,430 | $ | 500,465 | |||||||
TOTAL REVENUES | 27,907 | 182,905 | 30,430 | 500,465 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | 1,394,881 | 1,598,884 | 1,908,795 | 2,591,588 | |||||||||||
General and administrative | 2,207,164 | 2,433,200 | 4,700,415 | 4,677,360 | |||||||||||
TOTAL OPERATING EXPENSES | 3,602,045 | 4,032,084 | 6,609,210 | 7,268,948 | |||||||||||
OPERATING LOSS | (3,574,138 | ) | (3,849,179 | ) | (6,578,780 | ) | (6,768,483 | ) | |||||||
OTHER INCOME (EXPENSE): | |||||||||||||||
Interest income | 8,688 | 135,092 | 55,991 | 217,442 | |||||||||||
Interest and other expense | (104,671 | ) | (280,232 | ) | (250,499 | ) | (575,094 | ) | |||||||
Change in fair value of warrant liability | (1,928,843 | ) | (5,352,977 | ) | 2,670,410 | (13,079,912 | ) | ||||||||
TOTAL OTHER INCOME (EXPENSE) | (2,024,826 | ) | (5,498,117 | ) | 2,475,902 | (13,437,564 | ) | ||||||||
LOSS BEFORE INCOME TAXES | (5,598,964 | ) | (9,347,296 | ) | (4,102,878 | ) | (20,206,047 | ) | |||||||
Income taxes | - | - | - | - | |||||||||||
NET LOSS | (5,598,964 | ) | (9,347,296 | ) | (4,102,878 | ) | (20,206,047 | ) | |||||||
Preferred dividends and beneficial conversion feature | (407,335 | ) | (301,735 | ) | (727,625 | ) | (13,122,261 | ) | |||||||
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (6,006,299 | ) | $ | (9,649,031 | ) | $ | (4,830,503 | ) | $ | (33,328,308 | ) | |||
Net loss per common share - basic | $ | (0.66 | ) | $ | (1.10 | ) | $ | (0.53 | ) | $ | (3.80 | ) | |||
Net loss per common share - diluted | $ | (0.66 | ) | $ | (1.10 | ) | $ | (0.53 | ) | $ | (3.80 | ) | |||
Weighted average shares of common shares - basic | 9,156,260 | 8,779,909 | 9,156,260 | 8,779,096 | |||||||||||
Weighted average shares of common shares - diluted | 9,156,260 | 8,779,909 | 9,156,260 | 8,779,096 |
Source: PLx Pharma Inc.