HOUSTON, May 11, 2018 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) (“PLx” or the “Company”), a late-stage specialty pharmaceutical company focused on commercializing two patent-protected products, Aspertec™ 325 mg and Aspertec™ 81 mg (referred to together as “Aspertec”™), announced today certain financial and operational results for the three months ended March 31, 2018. 

Highlights of, and certain events subsequent to, the first quarter of 2018 include:

  • Net income totaled $5.0 million, or $0.57 per share, compared to net loss of $1.4 million, or ($0.33) per share, for the first quarter of 2017. This includes a non-cash gain of $8.4 million for a change in the fair value of warrant liability, or $0.97 per share;
     
  • Attended American Academy of Neurology (AAN) and National Association of Chain Drug Stores (NACDS) conferences, to build awareness and articulate the clinical value proposition of Aspertec with the medical community and with key members of the retail trade;
     
  • Progressing in our plan to obtain an alternate supply of material and anticipate launching Aspertec by mid-2020. 

“We continue to engage with members of the medical community and the retail trade to build awareness of Aspertec.  We have received additional positive feedback as these important constituents learn more about the benefits of Aspertec, namely its more predictable and reliable antiplatelet efficacy than enteric-coated aspirin, and improved gastrointestinal safety over regular aspirin.  We believe our products have the potential to change the standard of care in the treatment of coronary disease,” said Natasha Giordano, President and Chief Executive Officer of PLx Pharma.

First Quarter 2018 Financial Results

The Company recognized revenue of $81,000 in the first quarter of 2018, attributable to work performed under an award from the National Institutes of Health (NIH) federal grant received in 2017.  The Company had no revenue in the first quarter of 2017.

Research and development expenses were approximately $1.1 million for the first quarter of 2018, reflecting the initiation of technology transfer, contract manufacturing activities, and other product development activities for Aspertec. The Company incurred $128,000 of research and development expenses in the first quarter of 2017.

General and administrative expense totaled $2.2 million in the first quarter of 2018 compared to $1.2 million in the first quarter of 2017, primarily due to $0.6 million of increased compensation and benefits, including non-cash stock compensation expense, and prelaunch marketing to healthcare professionals of $0.2 million and other professional and administrative fees of $0.2 million. 

Other income (net of expense), was $8.2 million in the first quarter of 2018, compared to $0.1 million of net expense in the first quarter of 2017. This increase related to the non-cash gain related to the change in fair value of a warrant liability of $8.4 million, partially offset by $0.2 million of additional interest expense and debt discount amortization related to the Company’s term loan with Silicon Valley Bank in the 2018 period.

Net income for the first quarter of 2018 was $5.0 million, or $0.57 per share, compared to a net loss of $1.4 million, or ($0.33) per share, for the first quarter of 2017. 

As of March 31, 2018, The Company had $20.4 million in cash and cash equivalents.

About Aspertec
Aspertec 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 Aspertec 325 mg aspirin dosage form and preparing an sNDA for Aspertec 81 mg maintenance dose form.

About PLx Pharma Inc.
PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide effective and safe aspirin products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients (API) to various portions of the gastrointestinal (GI) tract. PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce acute GI side effects—including erosions, ulcers and bleeding—associated with aspirin and ibuprofen, and potentially other drugs.

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 (SEC), which are available at www.sec.gov. Other risks and uncertainties are more fully described in PLx’s prospectus supplement filed with the SEC on June 12, 2017, and in other filings that PLx 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
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Source: PLx Pharma Inc.

FINANCIAL TABLES FOLLOW

  
PLx Pharma Inc. 
     
UNAUDITED CONSOLIDATED BALANCE SHEETS 
     
 March 31,
2018		 December 31,
2017		 
     
ASSETS    
CURRENT ASSETS    
Cash and cash equivalents$20,418,155  $24,404,368  
Accounts receivable, net 76,027   19,384  
Inventory, net -   246,374  
Vendor deposits 1,168,687   715,603  
Prepaid expenses 268,965   300,169  
Security deposit 4,064   4,064  
TOTAL CURRENT ASSETS 21,935,898   25,689,962  
NON-CURRENT ASSETS    
Property and equipment, net 1,181,936   1,029,875  
Goodwill 2,061,022   2,061,022  
Security deposit 67,714   67,714  
TOTAL ASSETS$25,246,570  $28,848,573  
     
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
CURRENT LIABILITIES    
Accounts payable and accrued liabilities$821,931  $852,155  
Accrued bonus and severance 307,689   849,703  
Accrued interest 55,418   54,219  
Other current liabilities 59,972   59,614  
TOTAL CURRENT LIABILITIES 1,245,010   1,815,691  
NON-CURRENT LIABILITIES    
Accrued interest 144,061   89,717  
Term loan, net of discount and fees 7,003,264   6,942,151  
Warrant liability 6,818,268   15,242,915  
Other liabilities 136,978   141,707  
TOTAL LIABILITIES 15,347,581   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; 8,726,198 and 8,722,823 shares issued and outstanding at March 31, 2018 and December 31, 2017  respectively 8,727   8,723  
Additional paid-in capital 72,243,918   71,939,917  
Accumulated deficit (62,353,656)  (67,332,248) 
TOTAL STOCKHOLDERS' EQUITY 9,898,989   4,616,392  
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$25,246,570  $28,848,573  
     


  
PLx Pharma Inc.
 
     
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
   
 Three Months Ended March 31, 
 2018 2017 
REVENUES:    
Federal grant$81,457  $-  
TOTAL REVENUES 81,457   -  
     
OPERATING EXPENSES:    
Research and development 1,079,036   128,339  
General and administrative 2,240,000   1,217,071  
TOTAL OPERATING EXPENSES 3,319,036   1,345,410  
OPERATING LOSS (3,237,579)  (1,345,410) 
     
OTHER INCOME (EXPENSE)    
Interest income 66,923   -  
Interest and other expense (275,399)  (81,557) 
Change in fair value of warrant liability 8,424,647   -  
TOTAL OTHER INCOME (EXPENSE) 8,216,171   (81,557) 
         
INCOME (LOSS) BEFORE PROVISION FOR INCOME TAXES 4,978,592   (1,426,967) 
Income taxes -   -  
NET INCOME (LOSS)$4,978,592  $(1,426,967) 
     
Net income (loss) per common share - basic$0.57  $(0.33) 
Net income (loss) per common share - diluted$0.57  $(0.33) 
     
Weighted average shares of common shares - basic 8,725,038   4,383,433  
Weighted average shares of common shares - diluted 8,725,038   4,383,433