PLx Pharma Inc. Reports Third Quarter 2020 Results and Provides Business Update
11/16/2020 - 04:05 PM
--Announces $18 million private placement--
--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--
SPARTA, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products, with its lead products VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as “VAZALORE”), announced today certain financial and operational results for the three and nine months ended September 30, 2020.
Highlights of, and certain events subsequent to, the third quarter of 2020 include:
Entered into an $18 million private placement with investors led by White Rock Capital Management, L.P. and Level 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 Natasha Giordano, President and Chief Executive Officer of PLx.
Private Placement
On November 16, 2020, the Company entered into a securities purchase agreement for the sale of units comprised of shares of common stock and a warrant to purchase shares of common stock in a private placement that will result in gross proceeds to the Company of approximately $18 million , before deducting placement agent and other offering expenses, for the issuance of 4,755,373 shares of common stock and warrants to purchase up to an additional 5,230,910 shares of common stock for a per unit price of $3.787. The private placement is expected to close on or prior to November 18, 2020. The warrants will become exercisable on the date of issuance, have an exercise price of $4.31 per share and will expire five years from the date of issuance.
“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 Tom Barton, White Rock Capital Management, L.P.
Third Quarter 20 20 Financial Results
The Company recognized no revenue for the three months ended September 30, 2020, compared to revenue of $41,106 for the three months ended September 30, 2019. Revenue in the 2019 period is attributable to work performed under a federal grant from the National Institutes of Health (“NIH”), which came to an end in the second quarter of 2020.
Research and development expense totaled $1.2 million in the three months ended September 30, 2020 and 2019. The expense in the 2020 period includes clinical-related spending for the bioequivalence study combined with pre-validation manufacturing costs. The prior year period included manufacture and packaging costs for the VAZALORE registration batches.
General and administrative expenses totaled $2.0 million in the three months ended September 30, 2020, compared to $2.5 million in the prior year period. The decrease primarily reflects lower compensation-related expenses combined with reduced spending on conferences and related travel due to COVID-19 restrictions.
Other income (expense), net, totaled $61,847 and $5.4 million of net other income in the three months ended September 30, 2020 and 2019, respectively. The decrease is largely attributable to the non-cash change in fair value of warrant liability primarily due to the fluctuation of the price of the Company’s common stock, combined with lower net interest expense, which was impacted by a lower principal debt balance and lower interest rates.
Net loss attributable to common stockholders for the third quarter of 2020 was $3.6 million , or ($0.40) per basic and diluted share, compared to net income of $1.4 million , or $0.09 per share, for the third quarter of 2019. The third quarter of 2020 includes non-cash income of $134,552, or $0.01 per share, related to the change in fair value of warrant liability and $0.5 million , or ($0.05) per share, of Series A and Series B convertible preferred stock dividends. The third quarter of 2019 included non-cash income of $5.5 million , or $0.55 per share, related to the change in the warrant liability and $0.3 million , or ($0.03) per share, for preferred stock dividends related to the Series A convertible preferred stock.
Nine Months Ended September 30 , 2020 Financial Results
For the nine months ended September 30, 2020, revenue was $30,430 compared to $541,571 in the comparable period in 2019. All the revenue recognized is attributable to work performed under an award of an NIH grant, which came to an end in the second quarter of 2020.
Research and development expense decreased to $3.1 million for the nine months ended September 30, 2020, compared to $3.8 million for the first nine months of 2019. The decrease is due to lower manufacturing-related activities for VAZALORE, as the prior year included the manufacture and packaging of the registration batches. The decrease also reflects lower reimbursable grant expenses, as the grant from the NIH came to an end in the second quarter 2020. Higher clinical-related spending, primarily for the bioequivalence study, partially offset this decrease.
General and administrative expense totaled $6.7 million for the nine months ended September 30, 2020, compared to $7.2 million in the comparable 2019 period. The decrease was due to compensation-related expense and reduced spending on conferences and related travel due to COVID-19 restrictions, offset somewhat by higher spending on pre-launch marketing activities and higher stock compensation expense.
Other income (expense), net was $2.5 million of net other income for the first nine months of 2020, compared to $8.1 million of net other expense for the first nine months of 2019. The difference is largely attributable to the non-cash change in fair value of warrant liability, primarily due to the fluctuation of the price of the Company’s common stock, combined with lower net interest expense due to lower interest rates and a lower principal debt balance.
Net loss attributable to common stockholders for the nine months ended September 30, 2020 was $8.5 million , or ($0.92) per share, compared to net loss attributable to common stockholders of $31.9 million , or ($3.60) per share, for the first nine months of 2019. The first nine months of 2020 included non-cash income of $2.8 million , or $0.31 per share, as a result of a change in the fair value of the warrant liability and $1.2 million of Series A and Series B convertible preferred stock dividends. The first nine months of 2019 included a charge of $13.4 million , or ($1.52) per share, for the beneficial conversion feature and dividends related to the Series A convertible preferred stock. The first nine months of 2019 also included a non-cash charge of $7.6 million , or ($0.86) per share, as a result of a change in the fair value of the warrant liability.
As of September 30, 2020, cash and cash equivalents were $9.1 million .
Conference Call
As previously announced, PLx management will host its third quarter 2020 conference call as follows:
Date: Monday, November 16, 2020 Time: 4:30 p.m. ET Toll free (U.S.): (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 VAZAL ORE
About PLx Pharma Inc.
To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com .
Forward-Looking Statements www.sec.gov . Other risks and uncertainties are more fully described in PLx’s Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020, and in other filings that PLx has made or will make going forward. The forward-looking statements represent PLx’s estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.
Contact lwilson@insitecony.com
Source: PLx Pharma Inc.
FINANCIAL TABLES FOLLOW
PLx Pharma Inc. UNAUDITED CONSOLIDATED BALANCE SHEETS September 30, 2020 December 31, 2019 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 Goodwill 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: $0.001 par value; liquidation value of $17,042,322; 45,000 shares authorized, 15,000 issued and outstanding 13,661,578 13,661,578 Series B convertible preferred stock: $0.001 par value; liquidation value of $8,243,598; 25,000 shares authorized, 8,000 and 0 issued and outstanding 7,723,312 - STOCKHOLDERS' EQUITY (DEFICIT) Preferred stock; $0.001 par value; 930,000 shares authorized; none issued and outstanding - - Common stock; $0.001 par value; 100,000,000 shares authorized; 9,156,260 shares issued and outstanding 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
PLx Pharma Inc. UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended September 30, Nine Months Ended September 30, 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
