PLx Pharma Inc. Reports Third Quarter 2018 Results
PLx has identified the alternate supply of a key ingredient for Vazalore
Highlights of, and certain events subsequent to, the third quarter of 2018 include:
- Net loss totaled
$3.4 million , or($0.39) per share, compared with a net loss of$3.8 million , or($0.44) per share, for the third quarter of 2017;
- Identified alternate supply of a key ingredient in Vazalore to ensure the highest quality product, achieving consistent, successful dissolution and stability results in initial tests;
- Attended the
European Society of Cardiology and Transcatheter Cardiovascular Therapeutics conferences to raise awareness around the unmet need for a better aspirin formulation and articulate the clinical value proposition of Vazalore with global cardiovascular disease and interventional cardiology key opinion leaders;
- Continue partnering discussions with major retailers to ensure a successful launch of Vazalore; and
- Remain on target for mid-2020 launch of Vazalore.
“We are very pleased with the progress we’ve made during the third quarter. Most importantly, we have identified the alternate supply of a key ingredient to achieve the optimal formulation of Vazalore, which will help to advance our program to obtain approval and bring Vazalore to market. Stability and dissolution testing is ongoing, and the initial results have been successful. As we continue to optimize our manufacturing process, our goal remains to provide the highest quality product in Vazalore,” said
“We remain excited about the progress we have made toward these very important milestones in our manufacturing process and on our path to commercialization with an expected launch in mid-2020. We also continue to gain visibility within the medical community through global conferences and ongoing engagement with retailers. We are confident that Vazalore, as the first-ever
Third Quarter 2018 Financial Results
The Company recognized revenue of
Research and development expenses were
General and administrative expense totaled
Other income (expense), net totaled approximately
Net loss for the third quarter of 2018 was
Nine MonthsEndedSeptember 30, 2018 and 2017 FinancialResults
For the nine months ended
Research and development expense increased to
General and administrative expense decreased
Other income (expense), net totaled approximately
Net loss for the nine months ended
As of
About Vazalore
Vazalore 325 mg is an FDA-approved aspirin product being developed to provide high-risk cardiovascular and stroke patients 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 manufacturing, scale-up and label finalization for Vazalore 325 mg aspirin dosage form and preparing an sNDA for Vazalore 81 mg maintenance dose form.
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 and 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 (
Contact
Investor Relations:
T: 212-452-2793
E: lwilson@insitecony.com
Source:
FINANCIAL TABLES FOLLOW
PLx Pharma Inc. | |||||||
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||||
September 30, 2018 |
December 31, 2017 |
||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 16,537,259 | $ | 24,404,368 | |||
Accounts receivable | 41,491 | 19,384 | |||||
Inventory, net | - | 246,374 | |||||
Vendor deposits | 86,250 | 715,603 | |||||
Prepaid expenses | 470,525 | 300,169 | |||||
Security deposit | 4,064 | 4,064 | |||||
TOTAL CURRENT ASSETS | 17,139,589 | 25,689,962 | |||||
NON-CURRENT ASSETS | |||||||
Property and equipment, net | 1,449,969 | 1,029,875 | |||||
Goodwill | 2,061,022 | 2,061,022 | |||||
Security deposit | 67,714 | 67,714 | |||||
TOTAL ASSETS | $ | 20,718,294 | $ | 28,848,573 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable and accrued liabilities | $ | 750,502 | $ | 852,155 | |||
Accrued bonus and severance | 755,074 | 849,703 | |||||
Accrued interest | 56,458 | 54,219 | |||||
Current portion of term loan, net of discount and fees | 1,952,258 | - | |||||
Other current liabilities | 26,545 | 59,614 | |||||
TOTAL CURRENT LIABILITIES | 3,540,837 | 1,815,691 | |||||
NON-CURRENT LIABILITIES | |||||||
Accrued interest | 253,920 | 89,717 | |||||
Term loan, net of discount and fees | 5,175,032 | 6,942,151 | |||||
Warrant liability | 8,224,992 | 15,242,915 | |||||
Other liabilities | 124,370 | 141,707 | |||||
TOTAL LIABILITIES | 17,319,151 | 24,232,181 | |||||
STOCKHOLDERS' EQUITY | |||||||
Preferred stock; $0.001 par value; 10,000,000 shares authorized; none issued and outstanding | - | - | |||||
Common stock; $0.001 par value; 100,000,000 shares authorized; 8,738,163 and 8,722,823 shares issued and outstanding | 8,739 | 8,723 | |||||
Additional paid-in capital | 72,772,537 | 71,939,917 | |||||
Accumulated deficit | (69,382,133 | ) | (67,332,248 | ) | |||
TOTAL STOCKHOLDERS' EQUITY | 3,399,143 | 4,616,392 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 20,718,294 | $ | 28,848,573 | |||
PLx Pharma Inc. | |||||||||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
REVENUES: | |||||||||||||||
Federal grant | $ | 216,530 | $ | 62,259 | $ | 465,446 | $ | 438,210 | |||||||
TOTAL REVENUES | 216,530 | 62,259 | 465,446 | 438,210 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | 1,219,144 | 958,255 | 3,032,426 | 1,712,890 | |||||||||||
General and administrative | 1,800,159 | 3,021,290 | 5,870,745 | 8,263,019 | |||||||||||
TOTAL OPERATING EXPENSES | 3,019,303 | 3,979,545 | 8,903,171 | 9,975,909 | |||||||||||
OPERATING LOSS | (2,802,773 | ) | (3,917,286 | ) | (8,437,725 | ) | (9,537,699 | ) | |||||||
OTHER INCOME (EXPENSE): | |||||||||||||||
Interest income | 77,276 | 33,600 | 219,374 | 48,082 | |||||||||||
Interest and other expense | (290,773 | ) | (168,272 | ) | (849,457 | ) | (891,835 | ) | |||||||
Change in fair value of warrant liability | (408,803 | ) | 252,458 | 7,017,923 | 1,998,878 | ||||||||||
TOTAL OTHER INCOME (EXPENSE) | (622,300 | ) | 117,786 | 6,387,840 | 1,155,125 | ||||||||||
LOSS BEFORE INCOME TAX BENEFIT | (3,425,073 | ) | (3,799,500 | ) | (2,049,885 | ) | (8,382,574 | ) | |||||||
Income tax benefit | - | - | - | 920,000 | |||||||||||
NET LOSS | $ | (3,425,073 | ) | $ | (3,799,500 | ) | $ | (2,049,885 | ) | $ | (7,462,574 | ) | |||
Net loss per common share - basic | $ | (0.39 | ) | $ | (0.44 | ) | $ | (0.23 | ) | $ | (1.16 | ) | |||
Net loss per common share - diluted | $ | (0.39 | ) | $ | (0.44 | ) | $ | (0.23 | ) | $ | (1.16 | ) | |||
Weighted average common shares outstanding- basic | 8,735,790 | 8,704,985 | 8,730,303 | 6,447,053 | |||||||||||
Weighted average common shares outstanding- diluted | 8,735,790 | 8,704,985 | 8,730,303 | 6,447,053 | |||||||||||
Source: PLx Pharma Inc.