09/11/2018 11:50:00

PLx Pharma Inc. Reports Third Quarter 2018 Results

PLx has

identified the alternate supply of a key ingredient for Vazalore

HOUSTON, Nov. 09, 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, Vazalore™ 325 mg and Vazalore™ 81 mg (referred to together as “Vazalore”™), announced today certain financial and operational results for the three- and nine-month periods ended September 30, 2018.

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 Natasha Giordano, President and Chief Executive Officer of PLx Pharma.

“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 FDA-approved liquid-filled aspirin capsule, has the potential to become the new standard of care aspirin for physicians treating patients at risk of having a cardiovascular or cerebrovascular event,” concluded Giordano.

Third Quarter 2018

Financial

Results

The Company recognized revenue of $0.2 million in the third quarter of 2018 compared to revenue of $0.1 million for the three months ended September 30, 2017. Revenue in both the 2018 and 2017 periods is attributable to work performed under an award from the National Institutes of Health (NIH) federal grant received in 2017.

Research and development expenses were $1.2 million for the third quarter of 2018, compared to $1.0 million in the third quarter of 2017. The expense in both periods reflects continued product development and manufacturing activities for Vazalore.

General and administrative expense totaled $1.8 million in the third quarter of 2018 compared to $3.0 million in the third quarter of 2017. This decrease primarily reflects lower compensation expense.

Other income (expense), net totaled approximately $0.6 million of net other expense for the third quarter of 2018, compared to $0.1 million of net other income in the prior year period. The change 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 ($0.4 million of net other expense in the third quarter of 2018, as compared to $0.3 million of net other income in the comparable 2017 period), along with approximately $0.1 million of additional interest expense in the 2018 period.

Net loss for the third quarter of 2018 was $3.4 million, or ($0.39) per share, compared to a net loss of $3.8 million, or ($0.44) per share, for the third quarter of 2017.

Nine

Months

Ended

September

30, 2018 and 2017

Financial

Results

For the nine months ended September 30, 2018, net revenue was $0.5 million, compared to $0.4 million in 2017, due to a federal grant received in the prior year.

Research and development expense increased to $3.0 million for the nine months ended September 30, 2018, compared to $1.7 million for the first nine months of 2017, reflecting continued product development and manufacturing activities for Vazalore.

General and administrative expense decreased $2.4 million to $5.9 million for the nine months ended September 30, 2018 from $8.3 million in the prior year period. This decrease was due primarily to public offering costs of $1.3 million related to the June 2017 equity offering, lower compensation expense of $1.0 million and lower professional fees of $0.4 million, partially offset by pre-launch marketing spend in 2018 of $0.3 million.

Other income (expense), net totaled approximately $6.4 million of net other income in the nine months ended September 30, 2018, compared to $1.2 million of net other income in the prior year period. The change 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 ($7.0 million of net other income in the nine months ended September 30, 2018, as compared to $2.0 million of net other income in the comparable 2017 period), partially offset by approximately $0.2 million of additional interest income earned in the 2018 period.

Net loss for the nine months ended September 30, 2018, was $2.0 million, or ($0.23) per basic and diluted share, compared with a net loss of $7.5 million, or ($1.16) per basic and diluted share in the prior year period.

As of September 30, 2018, the Company had $16.5 million in cash and cash equivalents.

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.

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 Form 10-K for the year ended December 31, 2017 filed with the SEC on March 23, 2018, 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

    
 

September 30,

2018

 

Dec

ember 3

1

,

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 
        

 

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