1. SPARTA, N.J., Sept. 09, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 liquid-filled aspirin capsules (referred to together as "VAZALORE"), today announced that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present virtually at two upcoming healthcare conferences as follows:

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit:
     
    Date:Tuesday, September 21, 2021
      
    Time:2:55PM Eastern Time
      
    Webcast Link:https://wsw.com/webcast/oppenheimer16/plxp/2825452

    SPARTA, N.J., Sept. 09, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 liquid-filled aspirin capsules (referred to together as "VAZALORE"), today announced that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present virtually at two upcoming healthcare conferences as follows:

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit:

     
    Date:Tuesday, September 21, 2021
      
    Time:2:55PM Eastern Time
      
    Webcast Link:https://wsw.com/webcast/oppenheimer16/plxp/2825452
      
    2021 Cantor Global Healthcare Conference:

     
    Date:Wednesday, September 29, 2021
      
    Time:8:40AM Eastern Time
      
    Webcast Link:https://wsw.com/webcast/cantor12/plxp/2118760
      

    The presentations will be webcast live at the aforementioned times, and archived for 30 days thereafter, via the Company's website at www.plxpharma.com, under the ‘Investors Relations' Section.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com



    Primary Logo

    View Full Article Hide Full Article
  2. -- Executing broad reach television advertising to support the launch of VAZALORE --

    -- Media campaign reach matches extensive distribution at retailers --

    SPARTA, N.J., Aug. 26, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 liquid-filled aspirin capsules (referred to together as "VAZALORE"), today announced that VAZALORE is now on shelves at major retailers and e-commerce sites nationwide. A national television campaign will also kick-off today and feature spots on high-visibility…

    -- Executing broad reach television advertising to support the launch of VAZALORE --

    -- Media campaign reach matches extensive distribution at retailers --

    SPARTA, N.J., Aug. 26, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 liquid-filled aspirin capsules (referred to together as "VAZALORE"), today announced that VAZALORE is now on shelves at major retailers and e-commerce sites nationwide. A national television campaign will also kick-off today and feature spots on high-visibility sports programming as well as popular cable networks.

    "We are excited that VAZALORE has hit the shelves nationally and look forward to communicating the benefits of this innovative aspirin therapy to millions of patients at risk for vascular disease," stated Natasha Giordano, Chief Executive Officer of PLx. "We are confident consumers will recognize VAZALORE as a breakthrough in aspirin delivery, designed to help protect the stomach while providing all of the benefits of aspirin to help prevent another heart attack or clot-related stroke."

    VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, is available in VAZALORE 81 mg, 12 count; VAZALORE 81 mg, 30 count and VAZALORE 325 mg, 30 count.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d8d9940c-c2da-487f-b090-acaada2dbcdc



    Primary Logo

    View Full Article Hide Full Article
  3. --Walmart, Walgreens, Rite Aid, CVS and many other retailers placing VAZALORE on shelves later this month--

    --VAZALORE launch inventory manufactured and currently shipping to retailers across the country--

    SPARTA, N.J., Aug. 06, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 six months ended June 30, 2021.

    Highlights of, and certain events subsequent to, the second…

    --Walmart, Walgreens, Rite Aid, CVS and many other retailers placing VAZALORE on shelves later this month--

    --VAZALORE launch inventory manufactured and currently shipping to retailers across the country--

    SPARTA, N.J., Aug. 06, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 six months ended June 30, 2021.

    Highlights of, and certain events subsequent to, the second quarter of 2021 include:

    • Walmart, Walgreens, Rite Aid, and CVS among the leading retailers to reserve shelf space for all three SKUs of VAZALORE;
    • Extensive distribution for VAZALORE in over 30,000 U.S. retail stores;
    • Launched specialty field force to raise awareness amongst healthcare professionals;
    • Continue to inform specialists through medical conferences, publications and continuing professional education events; and
    • VAZALORE launch inventory manufactured and currently shipping to retailers across the country.

    "We are continuing to execute on our commercial strategy with retailers, professionals and consumers," stated Natasha Giordano, President and Chief Executive Officer of PLx. "We recently deployed our cardiovascular field force to raise awareness amongst specialists and now have sufficient inventory shipping to retailers to fulfill this widespread distribution."

    "Keeping the patient top of mind has always been our guiding principle and we are excited to bring VAZALORE to millions of patients at risk," concluded Giordano.

    Second Quarter 2021 Financial Results

    The Company recognized no revenue for the second quarter of 2021 compared to $27,907 for the second quarter of 2020. All the revenue recognized in the 2020 period was attributable to work performed under an award of a National Institutes of Health ("NIH") grant, which came to an end in the second quarter of 2020.

    Research and development expenses were $1.0 million for the second quarter of 2021, compared to $1.4 million in the second quarter of 2020. This decrease is primarily attributable to lower pre-commercial manufacturing-related activities for VAZALORE and the non-recurrence of clinical-related spending for the bioequivalence study in 2020.

    Selling, marketing and administrative expense totaled $5.5 million in the second quarter of 2021 compared to $2.2 million in the second quarter of 2020. This increase primarily reflects higher sales and marketing expenses to prepare for the VAZALORE launch and increased non-cash stock-based compensation.

    Other expense totaled $10.0 million in the second quarter of 2021 compared to $2.0 million in the second quarter of 2020. The increase 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 due to the payoff of the term loan with Silicon Valley Bank in February 2021.

    Net loss attributable to common stockholders for the second quarter of 2021 was $18.7 million, or ($0.79) per basic and diluted share, compared $6.0 million, or ($0.66) per basic and diluted share, for the second quarter of 2020. The second quarter of 2021 included a non-cash loss of $10.0 million, or ($0.42) per share, related to the change in fair value of warrant liability versus a non-cash loss of $1.9 million, or ($0.21) per share for the second quarter of 2020. The second quarter of 2021 also included $2.2 million or ($0.09) per share for the beneficial conversion feature related to the conversion of Series A convertible preferred stock dividends. The second quarter of 2020 included $0.4 million, or ($0.04) per share, for dividends on the Series A and Series B convertible preferred stock. All convertible preferred stock dividends stopped accruing upon U.S. Food and Drug Administration ("FDA") approval of VAZALORE in first quarter of 2021.

    First Half 2021 Financial Results

    For the six months ended June 30, 2021, the Company recognized no revenue compared to $30,430 in the comparable period in 2020. All the revenue recognized in the 2020 period was attributable to work performed under an award of an NIH grant, which concluded in the second quarter of 2020.

    Research and development expense was $1.9 million for the six months ended June 30, 2021 and for the comparable 2020 period. Research and development expenses primarily reflect pre-commercial manufacturing-related activities for VAZALORE and 2020 included costs related to the bioequivalence study.

    Selling, marketing and administrative expense was $8.1 million for the six months ended June 30, 2021, compared to $4.7 million in the comparable period in 2020. The increase primarily reflects higher sales and marketing expenses to prepare for the VAZALORE launch and increased non-cash stock-based compensation.

    Other income (expense) was $18.0 million of other expense for the first half of 2021, compared to $2.5 million of net other income for the first six months of 2020. This difference is largely attributable to the non-cash change in fair value of warrant liability due to the fluctuation of the price of the Company's common stock combined with lower net interest due to the payoff of the term loan in February 2021.

    Net loss attributable to common stockholders for the six months ended June 30, 2021 was $30.6 million or ($1.53) per share compared to net loss attributable to common stockholders of $4.8 million, or ($0.53) per share, for the first half of 2020. The first half of 2021 included a non-cash loss of $18.0 million, or ($0.90) per share, as a result of a change in the fair value of the warrant liability versus a non-cash gain of $2.7 million or $0.29 per share for the first half of 2020. The first half of 2021 also included a charge of $2.5 million or ($0.13) per share for the beneficial conversion feature related to the conversion of the Series A convertible preferred stock dividends combined with dividends on the Series A and Series B convertible preferred stock compared to $0.7 million or ($0.08) per share in the first half of 2020 for preferred stock dividends which stopped accruing upon FDA approval of VAZALORE.

    As of June 30, 2021, the Company had cash and cash equivalents of $80.2 million.

    Conference Call

    As previously announced, PLx management will host its second quarter 2021 conference call as follows:

    Date:Friday, August 6, 2021
    Time:8:30 a.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 VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain 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, 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, 2020 filed with the SEC on March 12, 2021, 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

    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. 
    CONSOLIDATED BALANCE SHEETS 
    (Unaudited) 
       
     June 30,

    2021
     December 31,

    2020
     
    ASSETS    
    CURRENT ASSETS    
    Cash and cash equivalents$80,169,469  $22,448,651  
    Inventory 1,262,481   143,380  
    Prepaid expenses and other current assets 581,014   393,470  
    TOTAL CURRENT ASSETS 82,012,964   22,985,501  
    NON-CURRENT ASSETS    
    Property and equipment, net 918,856   1,225,879  
    Right of use assets 298,651   327,161  
    Goodwill 2,061,022   2,061,022  
    Security deposit 17,036   17,036  
    TOTAL ASSETS$85,308,529  $26,616,599  
         
    LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)    
    CURRENT LIABILITIES    
    Accounts payable and accrued liabilities$2,382,322  $862,568  
    Accrued bonuses 516,199   1,184,823  
    Accrued interest -   597,411  
    Term loan, net of discount and fees -   622,265  
    Other current liabilities 166,244   275,247  
    TOTAL CURRENT LIABILITIES 3,064,765   3,542,314  
    NON-CURRENT LIABILITIES    
    Warrant liability 25,791,417   9,691,271  
    Accrued dividends 128,722   2,795,795  
    Other liabilities 194,471   134,184  
    TOTAL LIABILITIES 29,179,375   16,163,564  
         
    Series A convertible preferred stock: $0.001 par value; liquidation value of $12,642,000; 45,000 shares authorized, 12,642 and 15,000 issued and outstanding, respectively 13,707,935   13,661,578  
    Series B convertible preferred stock: $0.001 par value; liquidation value of $2,492,722; 25,000 shares authorized, 2,364 and 8,000 issued and outstanding, respectively 2,305,667   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; 26,145,008 and 13,911,633 shares issued and outstanding, respectively 26,145   13,912  
    Additional paid-in capital 170,283,101   91,203,050  
    Accumulated deficit (130,193,694)  (102,148,817) 
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT) 40,115,552   (10,931,855) 
    TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)$85,308,529  $26,616,599  
         



        
       
    PLx Pharma Inc.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
          
     Three Months Ended Six Months Ended
     June 30,

    2021
     June 30,

    2020
     June 30,

    2021
     June 30,

    2020
    REVENUES:       
    Federal grant$-  $27,907  $-  $30,430 
    TOTAL REVENUES -   27,907   -   30,430 
            
    OPERATING EXPENSES:       
    Research and development 982,730   1,394,881   1,942,233   1,908,795 
    Selling, marketing and administrative 5,497,747   2,207,164   8,134,076   4,700,415 
    TOTAL OPERATING EXPENSES 6,480,477   3,602,045   10,076,309   6,609,210 
    OPERATING LOSS (6,480,477)  (3,574,138)  (10,076,309)  (6,578,780)
            
    OTHER INCOME (EXPENSE):       
    Interest income (expense), net 4,286   (95,983)  (5,506)  (194,508)
    Change in fair value of warrant liability (10,028,175)  (1,928,843)  (17,963,062)  2,670,410 
    TOTAL OTHER INCOME (EXPENSE) (10,023,889)  (2,024,826)  (17,968,568)  2,475,902 
    LOSS BEFORE INCOME TAXES (16,504,366)  (5,598,964)  (28,044,877)  (4,102,878)
    Income taxes -   -   -   - 
    NET LOSS (16,504,366)  (5,598,964)  (28,044,877)  (4,102,878)
            
    Preferred dividends and beneficial conversion feature (2,202,687)  (407,335)  (2,524,958)  (727,625)
    NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS$(18,707,053) $(6,006,299) $(30,569,835) $(4,830,503)
            
    Net loss per common share - basic and diluted$(0.79) $(0.66) $(1.53) $(0.53)
            
    Weighted average shares of common shares - basic and diluted 23,638,239   9,156,260   20,020,012   9,156,260 
            

     



    Primary Logo

    View Full Article Hide Full Article
  4. SPARTA, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in nearly 8,000 CVS stores later this month.

    CVS, a leading health solutions company, is preparing its retail space with ‘Coming Soon' placeholders and shelf trays in many of its stores…

    SPARTA, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in nearly 8,000 CVS stores later this month.

    CVS, a leading health solutions company, is preparing its retail space with ‘Coming Soon' placeholders and shelf trays in many of its stores. This includes all three SKUs: VAZALORE 81 mg, 12 count; VAZALORE 81 mg, 30 count; and VAZALORE 325 mg, 30 count.

    "As we continue to execute the launch of VAZALORE, we are excited that CVS has committed to placing our innovative aspirin product in its stores nationwide. CVS's focus on the patient is well aligned with our mission in providing access to VAZALORE for millions of patients," stated Natasha Giordano, Chief Executive Officer of PLx.

    CVS joins Walmart, Walgreens, Rite Aid, and many other retailers in the nationwide launch of VAZALORE, the first and only FDA-approved liquid-filled aspirin capsules.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d8d9940c-c2da-487f-b090-acaada2dbcdc



    Primary Logo

    View Full Article Hide Full Article
  5. SPARTA, N.J., July 26, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in over 2,400 Rite Aid stores later in August.

    Rite Aid is also reserving shelf space with "Coming Soon" placeholders for all three SKUs -- VAZALORE 81 mg, 12 count; VAZALORE 81 mg…

    SPARTA, N.J., July 26, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in over 2,400 Rite Aid stores later in August.

    Rite Aid is also reserving shelf space with "Coming Soon" placeholders for all three SKUs -- VAZALORE 81 mg, 12 count; VAZALORE 81 mg, 30 count; and VAZALORE 325 mg, 30 count – to alert consumers about the new aspirin therapy that will soon be available.

    "Our commercial launch plans are well under way, and we are delighted that Rite Aid is preparing its stores for VAZALORE later this summer. We look forward to adding Rite Aid to the growing number of retail pharmacy leaders that are providing access to this innovative aspirin therapy," stated Natasha Giordano, Chief Executive Officer of PLx.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/63eb4491-f9b7-4c20-9a6b-5cf48bc22c80



    Primary Logo

    View Full Article Hide Full Article
  6. SPARTA, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 that the Company will release its 2021 second quarter financial results on Friday, August 6, 2021, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, August 6, 2021

    SPARTA, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 that the Company will release its 2021 second quarter financial results on Friday, August 6, 2021, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, August 6, 2021
    Time8:30 a.m. ET
    Toll free (U.S.)(866) 394-2901
    International

    Conference ID
    (616) 548-5567

    8277376
    Webcast (live and replay)www.plxpharma.com under the ‘Investor Relations' section.

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 8277376. The archived webcast will be available for 30 days via the aforementioned URL.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc.

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com



    Primary Logo

    View Full Article Hide Full Article
  7. SPARTA, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in over 8,000 Walgreens stores nationwide later in August. Walgreens is a global leader in retail pharmacy.

    Walgreens has already inserted placeholders to reserve space on shelves for all…

    SPARTA, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in over 8,000 Walgreens stores nationwide later in August. Walgreens is a global leader in retail pharmacy.

    Walgreens has already inserted placeholders to reserve space on shelves for all three SKUs: VAZALORE 81 mg, 12 count; VAZALORE 81 mg, 30 count; and VAZALORE 325 mg, 30 count.

    "As we continue to execute on our commercial launch plans, we are delighted that Walgreens has committed to carrying all three SKUs of VAZALORE in over 8,000 of its stores throughout the country. Walgreens' focus on health and wellbeing aligns closely with our mission to bring VAZALORE to the millions of people who can benefit from our unique aspirin therapy," stated Natasha Giordano, Chief Executive Officer of PLx.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0a91fca5-c90b-4bb9-b5e1-f4189df5f818

     



    Primary Logo

    View Full Article Hide Full Article
  8. SPARTA, N.J., July 12, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in over 4,500 Walmart stores across the United States in mid-August.

    The three SKUs include: VAZALORE 81 mg, 12 count; VAZALORE 81 mg, 30 count; and VAZALORE 325 mg, 30 count. Walmart, one…

    SPARTA, N.J., July 12, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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"), today announced that three stock-keeping units ("SKUs") of VAZALORE, the first and only U.S. Food and Drug Administration ("FDA") approved liquid-filled aspirin capsules, will be available in over 4,500 Walmart stores across the United States in mid-August.

    The three SKUs include: VAZALORE 81 mg, 12 count; VAZALORE 81 mg, 30 count; and VAZALORE 325 mg, 30 count. Walmart, one of the largest retailers in the world, has already inserted placeholders to reserve space on shelves and alert customers that VAZALORE is coming soon.

    "We are so excited that Walmart has committed to "Coming Soon" shelf placeholders for the next few weeks in anticipation of the stocking of all three SKUs of VAZALORE. With Walmart's broad reach and millions of customers, patients will have easy access to VAZALORE in most of their stores nationwide," stated Natasha Giordano, Chief Executive Officer of PLx. "Walmart's commitment is a real tribute to their recognition of VAZALORE as an innovative aspirin therapy."

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. To learn more about VAZALORE, please visit www.vazalore.com.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9f2f01e3-74c4-43e8-8b79-9b13d783bd7e 



    Primary Logo

    View Full Article Hide Full Article
  9. SPARTA, N.J., June 09, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present virtually at two upcoming healthcare conferences as follows:

    The JMP Securities Life Sciences Conference:
      
    Date:Wednesday, June 16, 2021
      
    Time:12:30PM Eastern Time
      
    Webcast Link:https://wsw.com/webcast/jmp49/plxp/1710800
      
    The Raymond James Human

    SPARTA, N.J., June 09, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present virtually at two upcoming healthcare conferences as follows:

    The JMP Securities Life Sciences Conference:

      
    Date:Wednesday, June 16, 2021
      
    Time:12:30PM Eastern Time
      
    Webcast Link:https://wsw.com/webcast/jmp49/plxp/1710800
      
    The Raymond James Human Health Innovation Conference 2021:
      
    Date:Monday, June 21, 2021
      
    Time:2:40PM Eastern Time
      
    Webcast Link:https://kvgo.com/rj-health/plx-pharma-inc-june-2021

    The presentations will be webcast live at the aforementioned times, and archived for 30 days thereafter, via the Company's website at www.plxpharma.com, under the ‘Investors Relations' Section.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com



    Primary Logo

    View Full Article Hide Full Article
  10. – VAZALORE 325 mg and 81 mg, the first-ever novel, liquid-filled aspirin capsules, gain FDA approval –

    – Company secured $71.4 million of gross proceeds in an underwritten public offering of common stock for the launch of VAZALORE –

    – VAZALORE's U.S. commercial launch on track for third quarter 2021 –

    SPARTA, N.J., May 14, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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…

    – VAZALORE 325 mg and 81 mg, the first-ever novel, liquid-filled aspirin capsules, gain FDA approval –

    – Company secured $71.4 million of gross proceeds in an underwritten public offering of common stock for the launch of VAZALORE –

    – VAZALORE's U.S. commercial launch on track for third quarter 2021 –

    SPARTA, N.J., May 14, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 months ended March 31, 2021.

    Highlights of, and certain events subsequent to, the first quarter of 2021 include:

    • The U.S. Food and Drug Administration ("FDA") approved the Company's supplemental new drug applications ("sNDAs") for its lead products, VAZALORE 325 mg and VAZALORE 81 mg;
    • The Company completed a $71.4 million financing to support the launch of VAZALORE;
    • Company paid off the balance of its term loan due in February 2021; and
    • VAZALORE product launch remains on track for the third quarter 2021.

    "Receiving FDA approval for both dose strengths of VAZALORE was an exciting achievement for us, and we now have the capital to execute a national commercial launch that will ensure widespread access to this innovative aspirin therapy for health care professionals and consumers," stated Natasha Giordano, President and Chief Executive Officer of PLx.

    Public Offering

    In March 2021, the Company completed an underwritten public offering in which PLx sold 8,924,700 shares of its common stock at a price to the public of $8.00 per share. The gross proceeds to the Company from this offering were $71.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

    First Quarter 2021 Financial Results

    The Company recognized no revenue for the first quarter of 2021 compared to $2,523 for the first quarter of 2020. All the revenue recognized in the 2020 period was attributable to work performed under an award of a National Institutes of Health ("NIH") grant, which came to an end in the second quarter of 2020.

    Research and development expenses were $1.0 million for the first quarter of 2021, compared to $0.5 million in the first quarter of 2020. This increase is primarily attributable to increased manufacturing-related activities for VAZALORE.

    General and administrative expense totaled $2.6 million in the first quarter of 2021 compared to $2.5 million in the first quarter of 2020. This increase primarily reflects higher pre-launch marketing expenses and increased non-cash stock-based compensation. The increase was partially offset by lower compensation-related expenses combined with savings from COVID-19 travel restrictions.

    Other income (expense), totaled $7.9 million of other expense and $4.5 million of net other income in the first quarters of 2021 and 2020, respectively. The variance 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. Net interest decreased due to the payoff of the remaining balance of the loan which was due and paid in February 2021.

    Net loss attributable to common stockholders for the first quarter of 2021 was $11.9 million, or ($0.73) per basic and diluted share, compared to net income attributable to common stockholders of $1.2 million, or $0.08 per basic and diluted share, for the first quarter of 2020. The first quarter of 2021 included a non-cash loss of $7.9 million, or ($0.48) per share, related to the change in fair value of warrant liability whereas the first quarter of 2020 included a non-cash gain of $4.6 million, or $0.50 per share, related to the change in the fair value of the warrant liability.

    As of March 31, 2021, the Company had cash and cash equivalents of $84.4 million.

    Conference Call

    As previously announced, PLx management will host its first quarter 2021 conference call as follows:

    Date:Friday, May 14, 2021
    Time:8:30 a.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 VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain 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, 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, 2020 filed with the SEC on March 12, 2021, 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

    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.
    CONSOLIDATED BALANCE SHEETS
    (Unaudited)
      
     March 31,

    2021
     December 31,

    2020
    ASSETS   
    CURRENT ASSETS   
    Cash and cash equivalents$84,423,464  $22,448,651 
    Inventory 143,380   143,380 
    Prepaid expenses and other current assets 300,556   393,470 
    TOTAL CURRENT ASSETS 84,867,400   22,985,501 
    NON-CURRENT ASSETS   
    Property and equipment, net 1,125,719   1,225,879 
    Right of use assets 249,738   327,161 
    Goodwill 2,061,022   2,061,022 
    Security deposit 17,036   17,036 
    TOTAL ASSETS$88,320,915  $26,616,599 
        
    LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)   
    CURRENT LIABILITIES   
    Accounts payable and accrued liabilities$962,608  $862,568 
    Accrued bonuses 246,647   1,184,823 
    Accrued interest -   597,411 
    Term loan, net of discount and fees -   622,265 
    Other current liabilities 199,939   275,247 
    TOTAL CURRENT LIABILITIES 1,409,194   3,542,314 
    NON-CURRENT LIABILITIES   
    Warrant liability 17,626,158   9,691,271 
    Accrued dividends 3,118,066   2,795,795 
    Other liabilities 121,651   134,184 
    TOTAL LIABILITIES 22,275,069   16,163,564 
        
    Series A convertible preferred stock: $0.001 par value; liquidation value of $17,603,176; 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 $8,514,890; 25,000 shares authorized, 8,000 and 0 issued and outstanding 7,723,312   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; 22,836,333 and 13,911,633 shares issued and outstanding, respectively 22,836   13,912 
    Additional paid-in capital 158,327,448   91,203,050 
    Accumulated deficit (113,689,328)  (102,148,817)
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT) 44,660,956   (10,931,855)
    TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)$88,320,915  $26,616,599 
        



    PLx Pharma Inc.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
      
     Three Months Ended
     March 31,

    2021
     March 31,

    2020
    REVENUES:   
    Federal grant$-  $2,523 
    TOTAL REVENUES -   2,523 
        
    OPERATING EXPENSES:   
    Research and development 959,503   513,914 
    General and administrative 2,636,329   2,493,251 
    TOTAL OPERATING EXPENSES 3,595,832   3,007,165 
    OPERATING LOSS (3,595,832)  (3,004,642)
        
    OTHER INCOME (EXPENSE):   
    Interest expense, net of interest income (9,792)  (98,525)
    Change in fair value of warrant liability (7,934,887)  4,599,253 
    TOTAL OTHER INCOME (EXPENSE) (7,944,679)  4,500,728 
    INCOME (LOSS) BEFORE INCOME TAXES (11,540,511)  1,496,086 
    Income taxes -   - 
    NET INCOME (LOSS) (11,540,511)  1,496,086 
        
    Preferred dividends (322,271)  (320,290)
    NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS$(11,862,782) $1,175,796 
        
    Net income (loss) per common share - basic$(0.73) $0.08 
    Net income (loss) per common share - diluted$(0.73) $0.08 
        
    Weighted average shares of common shares - basic 16,361,583   9,156,260 
    Weighted average shares of common shares - diluted 16,361,583   9,216,667 
        


    Primary Logo

    View Full Article Hide Full Article
  11. SPARTA, N.J., May 03, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform designed 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 that the Company will release its 2021 first quarter financial results on Friday, May 14, 2021, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, May 14,

    SPARTA, N.J., May 03, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform designed 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 that the Company will release its 2021 first quarter financial results on Friday, May 14, 2021, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, May 14, 2021
    Time8:30 a.m. ET
    Toll free (U.S.)(866) 394-2901
    International

    Conference ID
    (616) 548-5567

    6238639
    Webcast (live and replay)www.plxpharma.com under the ‘Investor Relations' section.

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 6238639. The archived webcast will be available for 30 days via the aforementioned URL.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.

    About PLx Pharma Inc.

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.



    Primary Logo

    View Full Article Hide Full Article
  12. -- Received FDA approval of sNDAs for both VAZALORE 325 mg and 81 mg, the first-ever novel, liquid-filled aspirin capsule --

    -- U.S. commercial launch of VAZALORE planned for third quarter 2021 --

    -- Secured $63 million of gross proceeds in an underwritten public offering of common stock for the launch of VAZALORE --

    SPARTA, N.J., March 12, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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…

    -- Received FDA approval of sNDAs for both VAZALORE 325 mg and 81 mg, the first-ever novel, liquid-filled aspirin capsule --

    -- U.S. commercial launch of VAZALORE planned for third quarter 2021 --

    -- Secured $63 million of gross proceeds in an underwritten public offering of common stock for the launch of VAZALORE --

    SPARTA, N.J., March 12, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 months and full year ended December 31, 2020.

    Highlights of, and certain events subsequent to, the fourth quarter of 2020 include:

    • Received U.S. Food and Drug Administration ("FDA") approval of its supplemental new drug applications ("sNDAs") for its lead products, VAZALORE 325 mg and VAZALORE 81 mg, the first-ever liquid-filled aspirin capsules;
    • Completed a $63 million financing of 7,875,000 shares of common stock, offered at a price of $8.00 for the launch of VAZALORE;
    • Entered into an $18 million private placement in November 2020; and



    • VAZALORE commercial launch planned for the third quarter 2021.

    "We are delighted to receive FDA approval of the sNDAs for both dose strengths and are excited to launch this breakthrough product to the medical community and to patients who can benefit from a reliable and predictable antiplatelet therapy," stated Natasha Giordano, President and Chief Executive Officer of PLx.

    "The successful $63 million financing provides the capital needed to commercialize VAZALORE. Our experienced leadership team is well prepared to execute our strategy, and this funding will enable us to launch the product successfully," concluded Giordano.

    Public Offering

    On March 5, 2021, the Company completed an underwritten public offering in which PLx issued and sold 7,875,000 shares of its common stock at a price to the public of $8.00 per share. The gross proceeds to the Company from this offering were $63 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

    Fourth Quarter 2020 Financial Results

    The Company recognized no revenue for the fourth quarter of 2020 compared to $24,000 for the fourth quarter of 2019. All the revenue recognized in 2019 was attributable to work performed under an award of a National Institutes of Health ("NIH") grant, which came to an end in the second quarter of 2020.

    Research and development expenses were $1.2 million for the fourth quarter of 2020, compared to $0.9 million in the fourth quarter of 2019. This increase reflected the expiration of raw materials combined with higher regulatory costs supporting the filing of the supplemental new drug applications in October 2020.

    General and administrative expense totaled $2.5 million in the fourth quarter of 2020 compared to $2.8 million in the fourth quarter of 2019. This decrease was due to lower pre-launch marketing costs combined with lower conference and related travel costs due to COVID-19 restrictions.

    Other (expense) income totaled $4.3 million of other expense and $1.8 million of net other income in the three months ended December 31, 2020 and 2019, respectively. The decrease was 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 fourth quarter of 2020 was $8.5 million, or ($0.87) per basic and diluted share, compared to net loss of $2.3 million, or ($0.25) per share, for the fourth quarter of 2019. The fourth quarter of 2020 included a non-cash loss of $4.2 million, or ($0.44) 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 fourth quarter of 2019 included a non-cash gain of $1.9 million, or $0.20 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.

    Full Year 2020 Financial Results

    For the year ended December 31, 2020, total revenues were $0.03 million, compared with $0.6 million for the prior year. All the revenue recognized in 2020 and 2019 was attributable to work performed under a federal grant from the NIH, which came to an end in the second quarter of 2020.

    Research and development expenses totaled $4.3 million for the year ended December 31, 2020, compared to $4.7 million in the prior year, reflecting continued product development and manufacturing activities for VAZALORE. This decrease was due to 2020 activities, which included the bioequivalence study to provide data for the sNDA filing, stability and validation work, compared to manufacture, packaging, stability, and analytical costs related to the registration batches in 2019.

    General and administrative expenses totaled $9.2 million for the year ended December 31, 2020, compared to $10.0 million in the prior year. The decrease was due to lower compensation-related expenses combined with savings from COVID-19 restrictions on conference and travel costs.

    Other (expense) income totaled $1.8 million of other expense for the year ended December 31, 2020, compared to $6.3 million of other expense in the prior year. The change is primarily 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 lower principal debt balance.

    Net loss attributable to common stockholders for the year ended December 31, 2020 was $16.9 million or ($1.74) per basic and diluted share compared to net loss of $34.3 million, or ($3.84) per share for the prior year. Full year 2020 included non-cash expense of $1.4 million, or ($0.15) per share, as a result of a change in the fair value of the warrant liability and $1.7 million, or ($0.18) per share, of Series A and Series B convertible preferred stock dividends.   Full year 2019 included $13.7 million or ($1.54) per share, for the beneficial conversion feature and preferred stock dividends related to the $15 million Series A convertible preferred stock financing completed in February 2019. Full year 2019 also included a non-cash expense of $5.7 million, or ($0.64) per share as a result of a change in the fair value of the warrant liability.

    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 resulted 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 closed on November 18, 2020. The warrants 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.

    As of December 31, 2020, the Company had cash and cash equivalents of $22.4 million.

    Conference Call

    As previously announced, PLx management will host its fourth quarter 2020 conference call as follows:

    Date:Friday, March 12, 2021
    Time:8:30 a.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 VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain 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, 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, 2020 filed with the SEC on March 12, 2021, 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

    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. 
    CONSOLIDATED BALANCE SHEETS 
         
     December 31,

    2020
     December 31,

    2019
     
    ASSETS    
    CURRENT ASSETS    
    Cash and cash equivalents $22,448,651  $14,001,304  
    Accounts receivable -   18,683  
    Inventory, net 143,380   -  
    Prepaid expenses and other current assets 393,470   263,268  
    TOTAL CURRENT ASSETS    
    NON-CURRENT ASSETS    
    Property and equipment, net  1,225,879   1,466,646  
    Right of use assets  327,161   618,158  
    Goodwill  2,061,022   2,061,022  
    Security deposit 17,036   73,665  
    TOTAL ASSETS$26,616,599  $18,502,746  
         
    LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)    
    CURRENT LIABILITIES    
    Accounts payable and accrued liabilities$862,568  $928,921  
    Accrued bonuses 1,184,823   1,166,821  
    Accrued interest 597,411   34,964  
    Current portion of term loan, net of discount and fees 622,265   3,658,121  
    Other current liabilities 275,247   304,603  
    TOTAL CURRENT LIABILITIES 3,542,314   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 9,691,271   8,247,679  
    Accrued dividends 2,795,795   1,058,498  
    Other liabilities 134,184   409,431  
    TOTAL LIABILITIES 16,163,564   16,933,129  
         
    Series A convertible preferred stock: $0.001 par value; liquidation value of $17,385,970; 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 $8,409,825; 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; 13,911,633 and 9,156,260 shares issued and outstanding 13,912   9,156  
    Additional paid-in capital 91,203,050   74,837,046  
    Accumulated deficit (102,148,817)  (86,938,163) 
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT) (10,931,855)  (12,091,961) 
    TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)$26,616,599  $18,502,746  
         



    PLx Pharma Inc. 
    CONSOLIDATED STATEMENTS OF OPERATIONS
          
     Three Months Ended December 31, Year Ended December 31,
      2020   2019   2020   2019 
    REVENUES:       
    Federal grant$-  $23,893  $30,430  $565,464 
    TOTAL REVENUES -   23,893   30,430   565,464 
            
    OPERATING EXPENSES:       
    Research and development  1,222,877   935,513   4,338,974   4,741,130 
    General and administrative  2,469,116   2,845,953   9,150,568   10,026,627 
    TOTAL OPERATING EXPENSES  3,691,993   3,781,466   13,489,542   14,767,757 
    OPERATING LOSS  (3,691,993)  (3,757,573)  (13,459,112)  (14,202,293)
            
    OTHER (EXPENSE) INCOME:       
    Interest and other expense, net  (40,737)  (113,656)  (307,950)  (589,740)
    Change in fair value of warrant liability  (4,248,554)  1,871,159   (1,443,592)  (5,710,362)
    TOTAL OTHER (EXPENSE) INCOME (4,289,291)  1,757,503   (1,751,542)  (6,300,102)
    LOSS BEFORE INCOME TAXES  (7,981,284)  (2,000,070)  (15,210,654)  (20,502,395)
    Income taxes -   -   -   - 
    NET LOSS  (7,981,284)  (2,000,070)  (15,210,654)  (20,502,395)
            
    Deemed dividends -   -   -   (12,692,308)
    Preferred dividends  (509,875)  (317,409)  (1,737,297)  (1,058,498)


    NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS 
    $(8,491,159) $(2,317,479) $(16,947,951) $(34,253,201)
            
    Net loss per common share - basic and diluted $(0.87) $(0.25) $(1.74) $(3.84)
            
    Weighted average shares of common shares - basic and diluted 9,714,951   9,129,854   9,714,951   8,916,190 
            



    Primary Logo

    View Full Article Hide Full Article
  13. SPARTA, N.J., March 11, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present at the Oppenheimer 31st Annual Healthcare Conference as follows:

      
    Date:Wednesday, March 17, 2021
      
    Time:2:30PM Eastern Time
      
    Webcast Link:https://wsw.com/webcast/oppenheimer9/plxp/2764916
      

    The presentation will be webcast live at the aforementioned…

    SPARTA, N.J., March 11, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a 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 that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present at the Oppenheimer 31st Annual Healthcare Conference as follows:

      
    Date:Wednesday, March 17, 2021
      
    Time:2:30PM Eastern Time
      
    Webcast Link:https://wsw.com/webcast/oppenheimer9/plxp/2764916
      

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.plxpharma.com, under the ‘Investors Relations' Section.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.

    About PLx Pharma Inc.

    PLx Pharma Inc. is a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com



    Primary Logo

    View Full Article Hide Full Article
  14. SPARTA, N.J., March 04, 2021 (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 designed to provide more effective and safer products, announced today that the Company will release its 2020 fourth quarter financial results on Friday, March 12, 2021, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, March 12, 2021
    Time8:30 a.m. ET
    Toll free (U.S.)(866) 394-2901
    International
    Conference ID
    (616)

    SPARTA, N.J., March 04, 2021 (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 designed to provide more effective and safer products, announced today that the Company will release its 2020 fourth quarter financial results on Friday, March 12, 2021, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, March 12, 2021
    Time8:30 a.m. ET
    Toll free (U.S.)(866) 394-2901
    International

    Conference ID
    (616) 548-5567

    7293573
    Webcast (live and replay)www.plxpharma.com under the ‘Investor Relations' section.
      

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 7293573. The archived webcast will be available for 30 days via the aforementioned URL.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.

    About PLx Pharma Inc. 

    PLx Pharma Inc. is 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. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.



    Primary Logo

    View Full Article Hide Full Article
  15. SPARTA, N.J., March 03, 2021 (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 designed to provide more effective and safer products, today announced the pricing of an underwritten public offering of 7,875,000 shares of its common stock, offered at a price of $8.00 to the public. Additionally, the Company has granted the underwriters a 30-day option to purchase up to an additional 1,181,250 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the offering are being offered by the Company. The offering is expected to…

    SPARTA, N.J., March 03, 2021 (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 designed to provide more effective and safer products, today announced the pricing of an underwritten public offering of 7,875,000 shares of its common stock, offered at a price of $8.00 to the public. Additionally, the Company has granted the underwriters a 30-day option to purchase up to an additional 1,181,250 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the offering are being offered by the Company. The offering is expected to close on or about March 5, 2021, subject to customary closing conditions. The gross proceeds to the Company from this offering are expected to be approximately $63 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. This amount assumes no exercise of the underwriters' option.

    The Company intends to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include additions to working capital and capital expenditures.

    Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as joint book-running managers for the offering.

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-230478) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on April 4, 2019. A preliminary prospectus supplement relating to the offering was filed with the SEC on March 2, 2021 and is available on the SEC's website at www.sec.gov. The final prospectus supplement relating to the offering will be filed with the SEC and will also be available on the SEC's web site at www.sec.gov.  Before investing in the offering, you should read the prospectus supplement and the accompanying prospectus in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering. Copies of the final prospectus supplement and accompanying prospectus , when available, may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at prospectus@raymondjames.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About PLx Pharma Inc.

    PLx Pharma Inc. is 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. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain 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, 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, 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

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.



    Primary Logo

    View Full Article Hide Full Article
  16. SPARTA, N.J., March 02, 2021 (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 designed to provide more effective and safer products, announced today that it intends to offer shares of its common stock for sale in an underwritten public offering. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions and there can be no assurance as to whether or when…

    SPARTA, N.J., March 02, 2021 (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 designed to provide more effective and safer products, announced today that it intends to offer shares of its common stock for sale in an underwritten public offering. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by PLx.

    PLx intends to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include additions to working capital and capital expenditures.

    Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as the joint book-running managers for the public offering.

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-230478) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on April 4, 2019. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at prospectus@raymondjames.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.

    Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About PLx Pharma Inc.

    PLx Pharma Inc. is 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. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain 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, 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, 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

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.



    Primary Logo

    View Full Article Hide Full Article
  17. -- VAZALORE is the first ever liquid-filled aspirin capsule with an innovative delivery platform indicated as a pain reliever, fever reducer and for aspirin therapy in vascular indications –

    -- U.S. commercial launch of VAZALORE planned for third quarter 2021 --

    SPARTA, N.J., March 01, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company") is a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform designed to provide more effective and safer products. PLx announced today that the U.S. Food and Drug Administration ("FDA") approved supplemental new drug applications ("sNDAs") for its lead products, VAZALORE™ 325 mg and VAZALORE™ 81…

    -- VAZALORE is the first ever liquid-filled aspirin capsule with an innovative delivery platform indicated as a pain reliever, fever reducer and for aspirin therapy in vascular indications –

    -- U.S. commercial launch of VAZALORE planned for third quarter 2021 --

    SPARTA, N.J., March 01, 2021 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company") is a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform designed to provide more effective and safer products. PLx announced today that the U.S. Food and Drug Administration ("FDA") approved supplemental new drug applications ("sNDAs") for its lead products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"), the first ever novel, liquid-filled aspirin capsule.

    "The approval of the VAZALORE sNDAs marks a significant milestone that brings us closer to providing an innovative aspirin to millions of patients who need reliable and predictable antiplatelet therapy," stated Natasha Giordano, President and Chief Executive Officer of PLx.

    "We are delighted that the FDA approved both sNDAs for VAZALORE, and we are eager to implement our commercial launch plans later this year. We look forward to introducing VAZALORE to the medical community and to patients who can benefit from this breakthrough technology designed to reduce the risk of stomach injury," concluded Giordano.

    In October 2020, the Company submitted separate supplemental new drug applications ("sNDAs") for each dose strength. The submissions were considered chemistry and manufacturing control ("CMC") filings as they included information on a change in formulation and the new manufacturing site for VAZALORE 325 mg and a new product strength for the 81 mg dose.

    The submission for the 325 mg dose also contained the results of a clinical study, demonstrating VAZALORE's bioequivalence to immediate-release aspirin, further supporting the change in formulation. The submission for the 81 mg dose builds off the information in the original approved new drug application, as well as the recent sNDA submitted for VAZALORE 325 mg.

    About VAZALORE

    VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.

    About PLx Pharma Inc.

    PLx Pharma Inc. is 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. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx Pharma believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with certain 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, 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, 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

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.



    Primary Logo

    View Full Article Hide Full Article
  18. --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…

    --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 2020 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 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's supplemental New Drug Applications for VAZALORE 325 mg and VAZALORE 81 mg doses, submitted in October 2020 to the FDA, are currently under regulatory review.

    About PLx Pharma Inc.

    PLx Pharma Inc. is 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. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients 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 the risk of stomach erosions and ulcers 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, 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, 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

    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, 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 
            

     



    Primary Logo

    View Full Article Hide Full Article
  19. -- FDA sets estimated completion review date for the end of February 2021 --

    -- Targeting launch of VAZALORE for third quarter 2021 –

    SPARTA, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP), 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, announced today that two chemistry and manufacturing control ("CMC") supplemental New Drug Applications ("sNDAs"), one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as "VAZALORE"), were submitted to the U.S. Food and Drug Administration ("FDA") in October for regulatory approval.

    The 325 mg sNDA provided information…

    -- FDA sets estimated completion review date for the end of February 2021 --

    -- Targeting launch of VAZALORE for third quarter 2021 –

    SPARTA, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP), 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, announced today that two chemistry and manufacturing control ("CMC") supplemental New Drug Applications ("sNDAs"), one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as "VAZALORE"), were submitted to the U.S. Food and Drug Administration ("FDA") in October for regulatory approval.

    The 325 mg sNDA provided information on a change in formulation and a new manufacturing site for the currently approved VAZALORE and also contains a bioequivalence ("BE") clinical study report with the required data and analyses from the recently completed BE study. The submission for the 81 mg dose provided for a new product strength of VAZALORE and builds off the information in the original approved NDA (New Drug Application) and the recent sNDA submitted for VAZALORE 325 mg.

    The Company received acknowledgement letters from the FDA, officially confirming the receipt of the submissions and setting the estimated completion date for its reviews for VAZALORE 325 mg and VAZALORE 81 mg for the end of February 2021. If approved, the Company plans to bring both doses of VAZALORE to market in the third quarter of 2021.

    "We are delighted to have achieved this major milestone for the submissions of our two sNDAs to the FDA earlier than previously announced. This is a significant step for PLx and the millions of patients with vascular disease who can benefit from a novel aspirin therapy. We are highly confident our submissions are supported by strong and compelling data that FDA requires for CMC submissions and we look forward to their review," stated Natasha Giordano, President and Chief Executive Officer of PLx. "I'd also like to thank our teams and our partners for their extraordinary efforts preparing these filings and our shareholders for their support in advancing VAZALORE to regulatory review," concluded Giordano.

    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's supplemental New Drug Applications for VAZALORE 325 mg and VAZALORE 81 mg dose strengths, submitted in October 2020 to the U.S. Food and Drug Administration, are currently under regulatory review.

    About PLx Pharma Inc.

    PLx Pharma Inc. is 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. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients 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 the risk of stomach erosions and ulcers 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, 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, 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

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.



    Primary Logo

    View Full Article Hide Full Article
  20. SPARTA, N.J., Nov. 12, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the Company has rescheduled its 2020 third quarter financial results call to Monday, November 16, 2020.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateMonday, November 16, 2020
    Time4:30 p.m. ET
    Toll free (U.S.)(866)

    SPARTA, N.J., Nov. 12, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the Company has rescheduled its 2020 third quarter financial results call to Monday, November 16, 2020.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateMonday, November 16, 2020
    Time4:30 p.m. ET
    Toll free (U.S.)(866) 394-2901
    International

    Conference ID
    (616) 548-5567

    2219797
    Webcast (live and replay)www.plxpharma.com under the ‘Investor Relations' section.

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 2219797. 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.

    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach erosions and ulcers associated with aspirin and ibuprofen, and potentially other drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Primary Logo

    View Full Article Hide Full Article
  21. SPARTA, N.J., Nov. 03, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the Company will release its 2020 third quarter financial results on Friday, November 13, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, November 13, 2020

    SPARTA, N.J., Nov. 03, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the Company will release its 2020 third quarter financial results on Friday, November 13, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

    DateFriday, November 13, 2020
    Time8:30 a.m. ET
    Toll free (U.S.)(866) 394-2901
    International

    Conference ID
    (616) 548-5567

    2219797
    Webcast (live and replay)www.plxpharma.com under the ‘Investor Relations' section.

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 2219797. 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.

    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach erosions and ulcers associated with aspirin and ibuprofen, and potentially other drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Primary Logo

    View Full Article Hide Full Article
  22. SPARTA, N.J., Sept. 14, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present virtually at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit as follows:

    Date:Tuesday, September 22, 2020
      
    Time:11:40 AM Eastern Time
      
    Webcast:https://wsw.com/webcast/oppenheimer5/plxp/2759652 

    The presentation will be webcast live at…

    SPARTA, N.J., Sept. 14, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present virtually at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit as follows:

    Date:Tuesday, September 22, 2020
      
    Time:11:40 AM Eastern Time
      
    Webcast:https://wsw.com/webcast/oppenheimer5/plxp/2759652 

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.plxpharma.com, under the ‘Investors Relations' Section.

    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.

    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach erosions and ulcers associated with aspirin and ibuprofen, and potentially other drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Primary Logo

    View Full Article Hide Full Article
  23. --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 mid-November 2020--

    --Targeting launch of VAZALORE 325 mg and 81 mg for third quarter 2021--

    SPARTA, N.J., Aug. 14, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today certain financial and operational results for the three and…

    --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 mid-November 2020--

    --Targeting launch of VAZALORE 325 mg and 81 mg for third quarter 2021--

    SPARTA, N.J., Aug. 14, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today certain financial and operational results for the three and six months ended June 30, 2020.

    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 with Park West Asset Management LLC and MSD 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 Natasha Giordano, President and Chief Executive Officer of PLx.

    Second Quarter 2020 Financial Results

    The Company recognized revenue of $27,907 for the three months ended June 30, 2020, compared to revenue of $182,905 for the three months ended June 30, 2019. Revenue in both the 2020 and 2019 periods 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 expenses totaled $1.4 million in the three months ended June 30, 2020 and $1.6 million in the prior year period. The decrease is due to lower manufacturing-related activities for VAZALORE, as the prior year period included the manufacture of the registration batches. The decrease also reflected lower reimbursable grant expenses as the completion of the grant from the NIH came to an end in second quarter. Higher clinical-related spending, primarily the bioequivalence study partially offset this decrease.

    General and administrative expenses totaled $2.2 million in the three months ended June 30, 2020, compared to $2.4 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 restrictions. These decreases were partially offset by higher pre-launch activities for VAZALORE.

    Other income (expense), net, totaled $2.0 million and $5.5 million of net other expense in the three months ended June 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.

    Net loss attributable to common stockholders for the second quarter of 2020 was $6.0 million, or ($0.66) per basic and diluted share, compared to a net loss of $9.6 million, or ($1.10) per share, for the second quarter of 2019. The second quarter of 2020 includes a non-cash charge of $1.9 million, or ($0.21) per share related to the change in fair value of warrant liability and $0.4 million, or ($0.04) per share, for dividends on the Series A and Series B convertible preferred stock. The second quarter of 2019 included a charge of $5.4 million, or ($0.61) 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.

    First Half 2020 Financial Results

    For the six months ended June 30, 2020, net revenue was $30,430 compared to $500,465 in the comparable period in 2019. All the revenue recognized is attributable to work performed under an award of a NIH grant, which came to an end in the second quarter of 2020.

    Research and development expense decreased to $1.9 million for the six months ended June 30, 2020, compared to $2.6 million for the first six months of 2019. The decrease is due to lower manufacturing-related activities for VAZALORE, as the prior year included the manufacture of the registration batches.  The decrease also reflected 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 remained flat at $4.7 million for the six months ended June 30, 2020 and 2019 as lower expenses for compensation and reduced spending on conferences and related travel due to COVID restrictions, were offset by higher spending on pre-launch activities.

    Other income (expense), net was $2.5 million of net other income for the first half of 2020, compared to $13.4 million of net other expense for the first six months of 2019. This 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.

    Net loss attributable to common stockholders for the six months ended June 30, 2020 was $4.8 million or ($0.53) per share compared to net loss attributable to common stockholders of $33.3 million, or ($3.80) per share, for the first half of 2019. The first half of 2020 included non-cash income of $2.7 million, or $0.29 per share, as a result of a change in the fair value of the warrant liability and $0.7 million, or ($0.08) per share, for preferred stock dividends related to Series A and Series B convertible preferred stock. The first half of 2019 included a charge of $13.1 million or ($1.49) per share related to the change in the warrant liability and a charge of  $13.1 million or ($1.49) per share, for the beneficial conversion feature and dividends related to the Series A convertible preferred stock financing.

    As of June 30, 2020, cash and cash equivalents were $13.3 million. The Company plans to obtain additional financing upon submission of the sNDAs to fund pre-launch marketing spending and commercial inventory build prior to approval of VAZALORE.

    Conference Call

    As previously announced, PLx management will host its second quarter 2020 conference call as follows:

    Date:Friday, August 14, 2020
    Time:8:30 a.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 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.

    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach erosions and ulcers 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, 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, 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

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.

    PLx Pharma Inc.
    UNAUDITED CONSOLIDATED BALANCE SHEETS
        
     June 30, 2020 December 31, 2019
    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 
    Goodwill 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: $0.001 par value; liquidation value of $16,705,466; 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 $8,080,657; 25,000 shares authorized, 8,000 and 0 issued and outstanding 7,731,379   - 
        
    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 74,651,536   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 June 30, Six Months Ended June 30,
     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 

    Primary Logo

    View Full Article Hide Full Article
  24. SPARTA, N.J., Aug. 05, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™),  announced today that the Company will release its 2020 second quarter financial results on Friday, August 14, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call and provide a business update to discuss the results as follows:

    DateFriday, August 14, 2020
    Time

    SPARTA, N.J., Aug. 05, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically-validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™),  announced today that the Company will release its 2020 second quarter financial results on Friday, August 14, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call and provide a business update to discuss the results as follows:

    DateFriday, August 14, 2020
    Time8:30 a.m. ET
    Toll free (U.S.)(866) 394-2901
    International

    (616) 548-5567

    Conference ID8049305
    Webcast (live and replay)www.plxpharma.com under the ‘Investor Relations' section.

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 4388184. 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.

    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach erosions and ulcers associated with aspirin and ibuprofen, and potentially other drugs.

    To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

    Contact

    Investor Relations:

    Lisa M. Wilson, In-Site Communications, Inc.

    T: 212-452-2793

    E: lwilson@insitecony.com

     

    Primary Logo

    View Full Article Hide Full Article
  25. SPARTA, N.J., May 18, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced that at its special meeting of stockholders, held May 15, 2020, the stockholders approved the issuance of more than 20% of the Company's common stock pursuant to a private placement transaction with certain accredited investors and a change of control for purposes of NASDAQ Listing Rule 5635. Upon this stockholder approval, on May 15, 2020, the Company completed…

    SPARTA, N.J., May 18, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced that at its special meeting of stockholders, held May 15, 2020, the stockholders approved the issuance of more than 20% of the Company's common stock pursuant to a private placement transaction with certain accredited investors and a change of control for purposes of NASDAQ Listing Rule 5635. Upon this stockholder approval, on May 15, 2020, the Company completed the $8 million convertible preferred stock financing by investment funds affiliated with Park West Asset Management LLC and MSD Partners, L.P.

    "We are pleased to have received stockholder approval for this financing, which will fund VAZALORE through the final steps of the regulatory process. We are excited to continue our partnership with our largest stockholder, Park West, and welcome our new investor, MSD Partners, as we continue the commercialization of our novel aspirin therapy," said Natasha Giordano, President and Chief Executive Officer of PLx Pharma.

    Please refer to the Company's Form 8-K, filed with the U.S. Securities and Exchange Commission on March 13, 2020, for a description of the terms of the convertible preferred stock transaction.

    This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration  

    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 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 collecting the data 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.
    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach 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.

    Safe Harbor Statements Regarding Forward Looking Statements

    The statements in this news release made by representatives of PLx relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of PLx's product candidates and the sufficiency of PLx's cash and other capital resources, PLx's ability to fund its operations, the continued development by PLx of Vazalore are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the U.S. or abroad, or PLx's ability to fund such efforts with or without partners. PLx undertakes no obligation to update any of these statements. In addition, there can be no assurance that PLx will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for stockholders. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in PLx's filings with the SEC, including those discussed in PLx's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and periodic reports filed on Form 8-K.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.

    Primary Logo

    View Full Article Hide Full Article
  26. -- Company to begin bioequivalence study of VAZALORE 325 mg dose --
    -- sNDA submissions expected by year-end --

    SPARTA, N.J., May 15, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today certain financial and operational results for the three months ended March 31, 2020.

    Highlights of, and certain events subsequent to, the first quarter of 2020 include:

    • Net income attributable to common stockholders totaled $1.2 million, or $0.08…

    -- Company to begin bioequivalence study of VAZALORE 325 mg dose --
    -- sNDA submissions expected by year-end --

    SPARTA, N.J., May 15, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today certain financial and operational results for the three months ended March 31, 2020.

    Highlights of, and certain events subsequent to, the first quarter of 2020 include:

    • Net income attributable to common stockholders totaled $1.2 million, or $0.08 per basic and diluted share, compared to net loss of $23.7 million, or ($2.71) per basic and diluted share, for the first quarter of 2019. This includes a non-cash gain of $4.6 million, or $0.45 per share, compared to a 2019 non-cash charge of $7.7 million for a change in the fair value of warrant liability, or ($0.88) per share;
    • Held Type-C meeting with the U.S. Food and Drug Administration ("FDA") on the bioequivalence study design to support the supplemental New Drug Application ("sNDA") for VAZALORE 325 mg dose strength and awaiting meeting minutes;
    • Engaged a contract research organization to conduct the required bioequivalence study once study is finalized with FDA;
    • Presented two original abstracts showcasing: first, VAZALORE's improved pharmacologic profile over enteric-coated aspirin, and second, VAZALORE's ability to largely mitigate the negative impact of increasing weight on antiplatelet efficacy at the virtual American College of Cardiology Annual Scientific Session;   
    • Announced an $8 million Series B Convertible Preferred Stock financing with Park West Asset Management, LLC and MSD Partners, L.P., providing a cash runway through the second quarter of 2021, subject to stockholder approval; and
    • Targeting filing sNDA submissions for both VAZALORE 325 mg dose and VAZALORE 81 mg dose to the FDA by year-end 2020, provided no delays caused by COVID-19.

    "We are pleased to be moving ahead with the bioequivalence study and look forward to completing the regulatory requirements to support our sNDA submissions. This additional study will serve to reinforce our application for approval and will proceed alongside the ongoing pre-launch commercial activities already under way. We are excited about VAZALORE's unique and innovative qualities and are eager to bring this critical new aspirin to millions of people with vascular disease," said Natasha Giordano, President and Chief Executive Officer of PLx.

    First Quarter 2020 Financial Results

    The Company recognized revenue of $2,523 for the three months ended March 31, 2020, compared to revenue of $317,560 for the three months ended March 31, 2019. Revenue in both the 2020 and 2019 periods is attributable to work performed under a federal grant from the National Institutes of Health which will be coming to an end in the second quarter of 2020.

    Research and development expenses totaled $0.5 million in the three months ended March 31, 2020 and $1.0 million in the prior year period. The decrease reflects lower reimbursable grant expenses combined with reduced spending on manufacturing-related activities for VAZALORE.

    General and administrative expenses totaled $2.5 million in the three months ended March 31, 2020, compared to $2.2 million in the prior year period. The increase is primarily due to pre-commercial related activities for VAZALORE and increased stock-based compensation.

    Other income (expense), net, totaled $4.5 million of net other income in the three months ended March 31, 2020, compared to $7.9 million of net other expense 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 ($4.6 million of other income in the three months ended March 31, 2020, compared to $7.7 million of other expense in the comparable 2019 period).

    Net income attributable to common stockholders for the first quarter of 2020 was $1.2 million, or $0.08 per basic and diluted share, compared to net loss of $23.7 million, or ($2.71) per share, for the first quarter of 2019. The first quarter of 2020 includes a non-cash gain of $4.6 million, or $0.45 per share compared to a non-cash loss of $7.7 million, or ($0.88) per share in the first quarter of 2019, related to the change in warrant liability. The first quarter of 2020 also included $0.3 million, or ($0.03) per share, for preferred stock dividends related to the $15 million Series A convertible preferred stock financing completed in February 2019. The first quarter of 2019 included $12.8 million or ($1.47) per share, for the beneficial conversion feature and preferred stock dividends related to the Series A $15 million convertible preferred stock financing completed in February 2019.

    As of March 31, 2020, cash and cash equivalents were $9.3 million. The $8 million Series B Preferred Stock financing should provide a cash runway until the second quarter of 2021. The Company will need additional financing upon submission of the sNDAs. The timing of submissions and the amount of capital raised will determine the level of pre-launch marketing spending and commercial inventory build prior to approval of VAZALORE.

    Conference Call

    As previously announced, PLx management will host its first quarter 2020 conference call as follows:

    Date: Friday, May 15, 2020
    Time: 8:30 a.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 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 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 collecting the data 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.
    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach 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, the proposed Series B Preferred Stock and the expected timetable for completing such transaction, 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, PLx's ability to obtain stockholder approval of the Series B Preferred Stock transaction, and the possibility that such transaction will not close or that the closing will be delayed. 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, 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
    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,
    2020
      December 31,
    2019
    ASSETS      
    CURRENT ASSETS      
    Cash and cash equivalents $ 9,286,571     $ 14,001,304  
    Accounts receivable   2,523       18,683  
    Prepaid expenses and other current assets   248,597       263,268  
    Deferred financing costs   43,518       -  
    TOTAL CURRENT ASSETS   9,581,209       14,283,255  
    NON-CURRENT ASSETS      
    Property and equipment, net   1,437,324       1,466,646  
    Right of use assets   548,089       618,158  
    Goodwill   2,061,022       2,061,022  
    Security deposit   73,665       73,665  
    TOTAL ASSETS $ 13,701,309     $ 18,502,746  
           
    LIABILITIES, SERIES A CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)      
    CURRENT LIABILITIES      
    Accounts payable and accrued liabilities $ 761,588     $ 928,921  
    Accrued bonuses   317,634       1,166,821  
    Accrued interest   557,643       34,964  
    Current portion of term loan, net of discount and fees   3,377,855       3,658,121  
    Other current liabilities   319,835       304,603  
    TOTAL CURRENT LIABILITIES   5,334,555       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   3,648,426       8,247,679  
    Accrued dividends   1,378,788       1,058,498  
    Other liabilities   321,590       409,431  
    TOTAL LIABILITIES   10,683,359       16,933,129  
           
    Series A convertible preferred stock: $0.001 par value; liquidation value of $16,378,788 and $16,058,498, respectively; 45,000 shares designated, 15,000 shares issued and outstanding   13,661,578       13,661,578  
           
    STOCKHOLDERS' EQUITY (DEFICIT)      
    Preferred stock; $0.001 par value; 955,000 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   74,789,293       74,837,046  
    Accumulated deficit   (85,442,077 )     (86,938,163 )
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT)   (10,643,628 )     (12,091,961 )
    TOTAL LIABILITIES,  SERIES A CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) $ 13,701,309     $ 18,502,746  
           

     

     
    PLx Pharma Inc.
    UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
       
      Three Months Ended March 31,
        2020       2019  
    REVENUES:      
    Federal grant $ 2,523     $ 317,560  
    TOTAL REVENUES   2,523       317,560  
           
    OPERATING EXPENSES:      
    Research and development   513,914       992,704  
    General and administrative   2,493,251       2,244,160  
    TOTAL OPERATING EXPENSES   3,007,165       3,236,864  
    OPERATING LOSS   (3,004,642 )     (2,919,304 )
           
    OTHER INCOME (EXPENSE):      
    Interest income   47,303       82,350  
    Interest and other expense   (145,828 )     (294,862 )
    Change in fair value of warrant liability   4,599,253       (7,726,935 )
    TOTAL OTHER INCOME (EXPENSE)   4,500,728       (7,939,447 )
    INCOME (LOSS) BEFORE INCOME TAXES   1,496,086       (10,858,751 )
    Income taxes   -       -  
    NET INCOME (LOSS) $ 1,496,086     $ (10,858,751 )
           
    Preferred dividends and beneficial conversion feature   (320,290 )     (12,820,526 )
    NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS $ 1,175,796     $ (23,679,277 )
           
    Net income (loss) per common share - basic $ 0.08     $ (2.71 )
    Net income (loss) per common share - diluted $ 0.08     $ (2.71 )
           
    Weighted average shares of common shares - basic   9,156,260       8,750,543  
    Weighted average shares of common shares - diluted   9,216,667       8,750,543  
           

    Primary Logo

    View Full Article Hide Full Article
  27. SPARTA, N.J., May 04, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the Company will release its 2020 first quarter financial results on Friday, May 15, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Friday, May 15, 2020
    Time 8:30 a.m. ET
    Toll free (U.S.) (866) 394-2901

    SPARTA, N.J., May 04, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the Company will release its 2020 first quarter financial results on Friday, May 15, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Friday, May 15, 2020
    Time 8:30 a.m. ET
    Toll free (U.S.) (866) 394-2901
    International
    Conference ID
    (616) 548-5567
    4388184
    Webcast (live and replay) www.plxpharma.com under the ‘Investor Relations' section.

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 4388184. 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 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 collecting the data 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.
    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach 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.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E: lwilson@insitecony.com

    Primary Logo

    View Full Article Hide Full Article
  28. -- Planning a Bioequivalence Study to Support VAZALORE 325 mg sNDA -- 
    -- Announces $8 Million Convertible Preferred Stock Financing with Park West and MSD Partners --

    SPARTA, New Jersey, March 13, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today certain financial and operational results for the three months and full year ended December 31, 2019, and provided a regulatory update on VAZALORE.

    Highlights of, and certain events subsequent…

    -- Planning a Bioequivalence Study to Support VAZALORE 325 mg sNDA -- 
    -- Announces $8 Million Convertible Preferred Stock Financing with Park West and MSD Partners --

    SPARTA, New Jersey, March 13, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today certain financial and operational results for the three months and full year ended December 31, 2019, and provided a regulatory update on VAZALORE.

    Highlights of, and certain events subsequent to, the fourth quarter of 2019 include:

    • Net loss attributable to common stockholders totaled $2.3 million, or ($0.25) per basic and diluted share, compared to net income of $2.9 million, or $0.34 per basic and diluted share, for the fourth quarter of 2018. Q4 2019 includes a non-cash gain of $1.9 million, or $0.20 per share, compared to a 2018 non-cash gain of $5.7 million for a change in the fair value of warrant liability, or $0.65 per share;

    • Plan to initiate a bioequivalence study to support the supplemental New Drug Application ("sNDA") for VAZALORE 325 mg dose strength which will impact the previously announced timeline. The Company will announce an updated timeline once aligned with the U.S. Food and Drug Administration ("FDA") on the study design;

    • Announces an $8 million Series B Convertible Preferred Stock ("Series B Preferred Stock") financing with funds affiliated with Park West Asset Management, LLC ("Park West"), the Company's largest stockholder, and an affiliate of MSD Partners, L.P. ("MSD Partners"), a new investor to PLx, subject to stockholder approval;

    • Continued pre-commercial activities, including the presentation of abstracts at large medical conferences and the publication of study results in scientific journals, to build awareness of VAZALORE among health care professionals; and

    • Received FDA approval for the updated labeling for VAZALORE 325 mg strength, which will be applied to the 81 mg dose.

    Regulatory Update

    The Company's discussions with the FDA have centered on data requirements for the approval of the new formulation of VAZALORE 325 mg. In accordance with the FDA's guidance, the Company will conduct a bioequivalence study for VAZALORE 325 mg to support approval of the sNDA which will impact the timeline previously announced. The Company currently has a meeting with the FDA scheduled for the end of April and will provide an updated timeline once details of the study design are confirmed. As previously announced, the sNDA for VAZALORE 81 mg will follow the submission of the VAZALORE 325 mg dose strength.

    "Our discussions with the FDA over the past few months have led to a clearer understanding of the data requirements for our upcoming sNDA submissions, and we look forward to confirming the bioequivalence study design. We remain confident about the regulatory path forward for VAZALORE," said Natasha Giordano, President and Chief Executive Officer of PLx.

    Convertible Preferred Stock Financing

    PLx announced today that it has entered into a purchase agreement with Park West and MSD Partners pursuant to which the Company has agreed to issue 8,000 shares of Series B Preferred Stock for gross proceeds of $8 million. The Company intends to use the proceeds to advance VAZALORE to market readiness and for working capital and general purposes.

    Subject to approval of the Company's stockholders and the satisfaction of certain customary closing conditions, the Series B Preferred Stock transaction is expected to close in the second quarter of 2020. The Company intends to set a date for a stockholder meeting to approve the transaction. Once a meeting date has been determined, the Company will send a notice and definitive proxy statement. 

    The Series B Preferred Stock will be issued at $1,000 per share and will be convertible into common shares at a conversion price of $3.10 per share. Holders of the Series B Preferred Stock will be entitled to an initial dividend rate of 8% per annum, which will stop accruing on the date of the FDA approval of the sNDAs of VAZALORE.  The dividends are compounded quarterly and payable in cash or preferred stock at the Company's option.

    "We are pleased that our largest stockholder, Park West, and new investor MSD Partners have committed $8 million of capital which will help support bringing VAZALORE to market. We continue to execute on our publication strategy to disseminate the scientific information to the clinical community, as well as to ensure that retailers and consumers understand the unique safety and efficacy profile of VAZALORE. In addition, the FDA's approval of the labeling for VAZALORE 325 mg is an important milestone on our way to commercialization," concluded Giordano.

    Please refer to the Company's Form 8-K to be filed with the U.S. Securities and Exchange Commission for the complete terms of the Series B Preferred Stock transaction.

    Fourth Quarter 2019 Financial Results

    The Company recognized revenue of approximately $24,000 for the fourth quarter of 2019 compared to $0.3 million for the fourth quarter of 2018. All the revenue recognized is attributable to work performed under an award of a National Institutes of Health grant, which is nearing completion.

    Research and development expenses were approximately $0.9 million for the fourth quarter of 2019, roughly flat compared to the fourth quarter of 2018. The expenses in both periods include continued development and manufacturing activities for VAZALORE.

    General and administrative expense totaled $2.8 million for the fourth quarter of 2019, compared to $1.9 million for the fourth quarter of 2018. This increase is due to commercial-related activities to support the upcoming launch of VAZALORE, as well as a non-cash increase in stock-based compensation of $0.2 million.

    Other income (expense), net was down $3.7 million to $1.8 million of net other income for the fourth quarter of 2019, primarily attributable to $3.8 million of lower non-cash income from the change in fair value of the warrant liability primarily due to the fluctuation of the Company's common stock price.

    Net loss attributable to common stockholders for the fourth quarter of 2019 was $2.3 million, or ($0.25) per basic and diluted share, compared to net income of $2.9 million, or $0.34 per share, for the fourth quarter of 2018. The fourth quarter of 2019 includes a non-cash gain of $1.9 million, or $0.20 per share compared to a gain of $5.7 million, or $0.65 per share in the fourth quarter of 2018, related to the change in warrant liability. The fourth quarter of 2019 also included $0.3 million, or ($0.03) per share, for preferred stock dividends related to the $15 million Series A convertible preferred stock financing completed in February 2019.

    Full Year 2019 Financial Results

    For the year ended December 31, 2019, total revenues were approximately $0.6 million, compared to $0.8 million for the year ended December 31, 2018. All the revenue recognized is attributable to work performed under an award of a National Institutes of Health grant, which is nearing completion.

    Research and development expense increased to $4.7 million for the year ended December 31, 2019, compared to $3.9 million in the prior year, reflecting continued product development and manufacturing activities for VAZALORE. This increase was due to the manufacture, packaging, stability and analytical costs related to the registration batches, which provide data to be submitted in the Company's sNDA filings.

    General and administrative expense increased to $10.0 million for the year ended December 31, 2019 compared to approximately $7.8 million in the prior year. This increase is due to commercial-related activities to support the upcoming launch of $1.9 million and payments to the University of Texas associated with the patent license agreement of $0.3 million.

    Other income (expense), net was $6.3 million of net other expense for the year ended December 31, 2019, compared to $11.9 million of net other income in the prior year. This change is primarily 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 ($5.7 million of other expense for the year ended December 31, 2019, as compared to $12.7 million of other income in the prior year).

    Net loss attributable to common stockholders for the year ended December 31, 2019 was $34.3 million or ($3.84) per basic and diluted share compared to net income of $0.9 million, or $0.10 per share for the prior year. Full year 2019 included $13.7 million or ($1.54) per share, for the beneficial conversion feature and preferred stock dividends related to the $15 million Series A convertible preferred stock financing completed in February 2019. Full year 2019 also included a non-cash charge of $5.7 million, or ($0.64) per share as a result of a change in the fair value of the warrant liability as compared to income of $12.7 million or $1.45 per share in the prior year.

    As of December 31, 2019, the Company had cash and cash equivalents of $14.0 million. The $8 million Series B Preferred Stock financing should provide a cash runway until the end of the first quarter of 2021. The Company will need additional financing upon submission of the sNDAs. The timing of submissions and the amount of additional capital raised will determine the level of pre-launch marketing spending and commercial inventory build prior to approval of VAZALORE.

    Conference Call

    As previously announced, PLx management will host its fourth quarter 2019 conference call as follows:

    Date:   Friday, March 13, 2020
    Time:   8:30 a.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.

    Important Additional Information Will Be Filed With the SEC

    PLx plans to file with the SEC and mail to its stockholders a proxy statement in connection with the Series B Preferred Stock transaction. The proxy statement will contain important information about PLx, the transaction and related matters. Investors and security holders are urged to read the proxy statement carefully when it is available. Investors and security holders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by PLx through the SEC's website at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of the proxy statement from PLx by contacting the Corporate Secretary at (973) 409-6541.

    PLx and its directors and executive officers may be deemed to be participants in the solicitation of proxies with respect to the transactions contemplated by the Series B preferred stock purchase agreement. Additional information regarding interests of such participants is included in PLx's definitive proxy statement filed with the SEC on July 2, 2019, available free of charge as indicated above.

    This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.

    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 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 collecting the data 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.

    PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients 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 the risk of stomach 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, the proposed Series B Preferred Stock and the expected timetable for completing such transaction, 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, PLx's ability to obtain stockholder approval of the Series B Preferred Stock transaction, and the possibility that such transaction will not close or that the closing will be delayed. 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, 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
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.


     

    PLx Pharma Inc.  
    CONSOLIDATED BALANCE SHEETS  
       December 31,     December 31,   
      2019   2018  
    ASSETS        
    CURRENT ASSETS        
    Cash and cash equivalents $ 14,001,304     $ 14,250,267    
    Accounts receivable   18,683       18,234    
    Prepaid expenses and other current assets   263,268       421,933    
    Deferred financing costs   -       174,976    
    TOTAL CURRENT ASSETS   14,283,255       14,865,410    
    NON-CURRENT ASSETS        
    Property and equipment, net   1,466,646       1,394,230    
    Right of use assets   618,158       -    
    Goodwill   2,061,022       2,061,022    
    Security deposit   73,665       67,714    
    TOTAL ASSETS $ 18,502,746     $ 18,388,376    
             
    LIABILITIES, SERIES A CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)        
    CURRENT LIABILITIES        
    Accounts payable and accrued liabilities $ 928,921     $ 687,257    
    Accrued bonuses   1,166,821       1,048,393    
    Accrued interest   34,964       60,366    
    Current portion of term loan, net of discount and fees   3,658,121       2,909,709    
    Other current liabilities   304,603       26,935    
    TOTAL CURRENT LIABILITIES   6,093,430       4,732,660    
    NON-CURRENT LIABILITIES        
    Accrued interest, net of current portion   501,826       309,440    
    Term loan, net of discount, fees and current portion   622,265       4,280,385    
    Warrant liability   8,247,679       2,537,317    
    Accrued dividends   1,058,498       -    
    Other liabilities   409,431       84,281    
    TOTAL LIABILITIES   16,933,129       11,944,083    
             
    Series A convertible preferred stock: $0.001 par value; liquidation value of $15,000,000; 45,000 shares        
    designated, 15,000 and 0 issued and outstanding   13,661,578       -    
             
    STOCKHOLDERS' EQUITY (DEFICIT)        
    Preferred stock; $0.001 par value; 955,000 authorized, none issued and outstanding   -       -    
    Common stock; $0.001 par value; 100,000,000 shares authorized; 9,156,260 and 8,743,950 shares                 
    issued and outstanding   9,156       8,744    
    Additional paid-in capital   74,837,046       72,871,317    
    Accumulated deficit   (86,938,163 )     (66,435,768 )  
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT)   (12,091,961 )     6,444,293    
    TOTAL LIABILITIES, SERIES A CONVERTIBLE PREFERRED STOCK AND                 
    STOCKHOLDERS' EQUITY (DEFICIT) $ 18,502,746     $ 18,388,376    
             



    PLx Pharma Inc.  
    CONSOLIDATED STATEMENTS OF OPERATIONS  
                 
      Three Months Ended December 31,   Year Ended December 31,  
        2019       2018       2019       2018    
    REVENUES:                
    Federal grant $ 23,893     $ 287,662     $ 565,464     $ 753,108    
    TOTAL REVENUES   23,893       287,662       565,464       753,108    
                     
    OPERATING EXPENSES:                
    Research and development   935,513       890,239       4,741,130       3,922,665    
    General and administrative   2,845,953       1,920,855       10,026,627       7,791,600    
    TOTAL OPERATING EXPENSES   3,781,466       2,811,094       14,767,757       11,714,265    
    OPERATING LOSS   (3,757,573 )     (2,523,432 )     (14,202,293 )     (10,961,157 )  
                     
    OTHER INCOME (EXPENSE):                
    Interest income   76,176       78,426       405,239       297,800    
    Interest and other expense   (189,832 )     (296,304 )     (994,979 )     (1,145,761 )  
    Change in fair value of warrant liability   1,871,159       5,687,675       (5,710,362 )     12,705,598    
    TOTAL OTHER INCOME (EXPENSE)   1,757,503       5,469,797       (6,300,102 )     11,857,637    
    INCOME (LOSS) BEFORE INCOME TAXES   (2,000,070 )     2,946,365       (20,502,395 )     896,480    
    Income taxes   -       -       -       -    
    NET INCOME (LOSS) $ (2,000,070 )   $ 2,946,365     $ (20,502,395 )   $ 896,480    
                     
    Preferred dividends and beneficial conversion feature   (317,409 )     -       (13,750,806 )     -    
    NET INCOME (LOSS) ATTRIBUTABLE TO COMMON                                 
    STOCKHOLDERS $ (2,317,479 )   $ 2,946,365     $ (34,253,201 )   $ 896,480    
                     
    Net income (loss) per common share - basic $ (0.25 )   $ 0.34     $ (3.84 )   $ 0.10    
    Net income (loss) per common share - diluted $ (0.25 )   $ 0.34     $ (3.84 )   $ 0.10    
                     
    Weighted average shares of common shares - basic   9,129,854       8,741,994       8,916,190       8,733,220    
    Weighted average shares of common shares - diluted   9,129,854       8,741,994       8,916,190       8,733,220    
                     

    Primary Logo

    View Full Article Hide Full Article
  29. SPARTA, N.J., March 03, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing more effective and safer products with its patent-protected PLxGuard™ delivery system, announced today that the Company will release its 2019 fourth quarter and full year financial results on Friday, March 13, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Friday, March 13, 2020
    Time 8:30 a.m. ET
    Toll free (U.S.) (866) 394-2901
    International
    Conference ID
    (616) 548-5567
    4788137
    Webcast (live and replay) www.plxpharma.com

    SPARTA, N.J., March 03, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing more effective and safer products with its patent-protected PLxGuard™ delivery system, announced today that the Company will release its 2019 fourth quarter and full year financial results on Friday, March 13, 2020, before the U.S. financial markets open.

    Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Friday, March 13, 2020
    Time 8:30 a.m. ET
    Toll free (U.S.) (866) 394-2901
    International
    Conference ID
    (616) 548-5567
    4788137
    Webcast (live and replay) www.plxpharma.com under the ‘Investor Relations' section.

    A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 4788137. The archived webcast will be available for 30 days via the aforementioned URL.

    About VAZALORE
    VAZALORE 325 mg is an FDA-approved aspirin product that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy 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 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 more effective and safer 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 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.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E: lwilson@insitecony.com

    Primary Logo

    View Full Article Hide Full Article
  30. SPARTA, N.J., Feb. 21, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing more effective and safer products with its patent-protected PLxGuard™ delivery system, announced today the presentation of an original poster on VAZALORE™ 325 mg at the 2020 International Stroke Conference, the premier meeting dedicated to the science and treatment of cerebrovascular disease and brain health, and the simultaneous publication in the Journal of Thrombosis and Thrombolysis.

    Abstract Title: Bioavailability of Aspirin in Fasted and Fed States of a Novel Formulation of a Pharmaceutical Lipid-Aspirin Complex

    Session Date: Thursday, February 20, 2020, 6:30 PM Pacific…

    SPARTA, N.J., Feb. 21, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company focused on developing more effective and safer products with its patent-protected PLxGuard™ delivery system, announced today the presentation of an original poster on VAZALORE™ 325 mg at the 2020 International Stroke Conference, the premier meeting dedicated to the science and treatment of cerebrovascular disease and brain health, and the simultaneous publication in the Journal of Thrombosis and Thrombolysis.

    Abstract Title: Bioavailability of Aspirin in Fasted and Fed States of a Novel Formulation of a Pharmaceutical Lipid-Aspirin Complex

    Session Date: Thursday, February 20, 2020, 6:30 PM Pacific Standard Time

    Presenter: Dominick J. Angiolillo, MD, PhD, FACC, FESC, FSCAI, Program Director, Interventional Cardiology Fellowship, Professor of Medicine, Director, Cardiovascular Research, University of Florida College of Medicine-Jacksonville, Jacksonville, FL.

    Study Design
    In this randomized, open label, crossover study, 20 healthy volunteers fasted for at least ten hours and were then randomized as either "fasted," receiving 650 mg of PL-ASA, or as "fed," with a standard high-fat meal and 650 mg of PL-ASA 30 minutes later. After a washout of seven days, participants crossed over to the other arm. The primary outcome was comparison of pharmacokinetic (PK) parameters of the stable aspirin metabolite salicylic acid (SA) between fasted and fed states. The results established that PL-ASA may be co-administered with food without significant impact on aspirin bioavailability.

    "The data presented at the International Stroke Conference demonstrate that VAZALORE, with its novel delivery platform in a liquid-filled capsule, can deliver aspirin reliably irrespective of whether it is taken on an empty stomach or with food. These findings are clinically important since many clinicians recommend that aspirin be taken with food in order to reduce dyspeptic symptoms, a practice that can lead to erratic aspirin absorption, especially with coated aspirin formulations," stated Dr. Angiolillo, the lead author of the Journal of Thrombosis and Thrombolysis publication released simultaneously with the presentation.

    "Aspirin continues to be the cornerstone of lifelong antithrombotic protection for patients with established atherosclerotic cardiovascular disease. The data presented here, and now published, complement previous studies with this lipid-based formulation of aspirin. It is encouraging that a new formulation of aspirin combining both reliable absorption and antiplatelet effect with improved gastrointestinal safety may soon be available for our patients," added Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC, Executive Director of Interventional Cardiovascular Programs Brigham and Women's Hospital Heart & Vascular Center, Professor of Medicine, Harvard Medical School, and Chairman of the PLx Scientific Advisory Board.

    "VAZALORE continues to deliver outstanding results that address important unmet clinical needs of the currently available aspirin formulations. We believe that VAZALORE has the potential to address the long-standing need for a new, better aspirin product, and we will continue our efforts to make VAZALORE available to the millions of high-risk cardiovascular patients who require reliable lifelong vascular protection," concluded Efthymios N. Deliargyris, MD, FACC, FESC, FSCAI, Chief Medical Officer of PLx Pharma.

    About VAZALORE
    VAZALORE 325 mg is an FDA-approved aspirin product developed to provide patients with vascular disease and diabetic patients who are candidates for aspirin therapy 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 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 more effective and safer 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 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, 2018 filed with the SEC on March 8, 2019, 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
    Investor Relations:
    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.

    Primary Logo

    View Full Article Hide Full Article
  31. CARMIEL, Israel, Jan. 30, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it will deliver an oral presentation and three poster presentations on its pegunigalsidase alfa candidate for the treatment of Fabry disease at the 16th Annual WORLDSymposium™ 2020, taking place February 10-13, 2020 at the Hyatt Regency Orlando in Florida.

    Protalix_Biotherapeutics_Logo

    Presentation Details:

    • "Pegunigalsidase alfa, a novel PEGylated ERT, evaluated in Fabry patients with progressing kidney disease, RCT study design," to be presented…

    CARMIEL, Israel, Jan. 30, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it will deliver an oral presentation and three poster presentations on its pegunigalsidase alfa candidate for the treatment of Fabry disease at the 16th Annual WORLDSymposium™ 2020, taking place February 10-13, 2020 at the Hyatt Regency Orlando in Florida.

    Protalix_Biotherapeutics_Logo

    Presentation Details:

    • "Pegunigalsidase alfa, a novel PEGylated ERT, evaluated in Fabry patients with progressing kidney disease, RCT study design," to be presented by Dr. David G. Warnock, of the University of Alabama at Birmingham, a principal investigator in the Company's BALANCE phase III clinical trial of PRX-102 for the treatment of Fabry disease. 
      • Poster presentation is scheduled from 4:30-6:30 PM EST on Wednesday, February 12, 2020 (Poster # 415).
      • Oral presentation is scheduled for Thursday, February 13, 2020 at 8:45 AM EST.
    • "Pegunigalsidase alfa, PEGylated α-Galactosidase-A enzyme in development for the treatment of Fabry disease, shows correlation between renal Gb3 inclusion clearance and reduction of plasma Lyso-Gb3," to be presented by Dr. Derralynn Hughes of University College London in London, UK, a principal investigator in the Company's phase III clinical trial of pegunigalsidase alfa for the treatment of Fabry disease, on Tuesday, February 11, 2020 from 4:30-6:30 PM EST (Poster #176).
    • "Switching from agalsidase alfa to pegunigalsidase alfa for treating Fabry disease : One year of treatment data from BRIDGE, a phase III open label study," to be presented by Dr. Ales Linhart, of Charles University in Praha, Czech Republic, a principal investigator in the Company's phase III clinical trial of PRX-102 for the treatment of Fabry disease. The poster presentation is scheduled from 4:30-6:30 PM EST on Tuesday, February 11, 2020 (Poster # 240).

    Copies of the posters and oral presentation will be made available on the Company's website under the Presentation tab in the Investors section at the time of the poster sessions.

    About Pegunigalsidase Alfa

    Pegunigalsidase alfa (PRX102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, pegunigalsidase alfa has been observed to have a circulatory half-life of approximately 80 hours. The Company designed pegunigalsidase alfa to potentially address the continued unmet clinical need in Fabry patients of continuous disease progression, infusion reactions and immunogenicity.

    About Protalix BioTherapeutics, Inc.

    Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.

    Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.

    Protalix's development pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α-Galactosidase-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    +1-646-627-8390
    chuck@lifesciadvisors.com

    Media Contact
    Doug Russell
    LaVoieHealthScience
    +1-617-953-0120
    drussell@lavoiehealthscience.com

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-participate-in-the-16th-annual-worldsymposium-2020-300996098.html

    SOURCE Protalix BioTherapeutics, Inc.

    View Full Article Hide Full Article
  32. SPARTA, N.J., Jan. 07, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present at the Biotech Showcase 2020 as follows:

    Date: Tuesday, January 14, 2020
    Time: 4:30 p.m. Pacific Standard Time
    Location: Hilton San Francisco Union Square, San Francisco, CA
    Webcast: https://event.webcasts.com/starthere.jsp?ei=1278482&tp_key=654e903f09

    SPARTA, N.J., Jan. 07, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that Natasha Giordano, President and Chief Executive Officer, and Rita O'Connor, Chief Financial Officer, will present at the Biotech Showcase 2020 as follows:

    Date: Tuesday, January 14, 2020
    Time: 4:30 p.m. Pacific Standard Time
    Location: Hilton San Francisco Union Square, San Francisco, CA
    Webcast: https://event.webcasts.com/starthere.jsp?ei=1278482&tp_key=654e903f09

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.plxpharma.com under the News & Events section.

    About VAZALORE
    VAZALORE 325 mg is an FDA-approved aspirin product being developed to provide patients with vascular disease and diabetic patients who are candidates for aspirin therapy 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. Our goal is to begin selling both products in the United States towards the end of 2020, subject to approval by the FDA.

    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 more effective and safer 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 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.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E: lwilson@insitecony.com

    Source: PLx Pharma Inc.

    Primary Logo

    View Full Article Hide Full Article
  33. -- PLx Aligning with the FDA on Data Requirements for VAZALORE 
    -- FDA Approves Labeling for 325 mg -- 
    -- Expect to Launch VAZALORE in late 2020 --

    SPARTA, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the U.S. Food and Drug Administration ("FDA") is providing clarification for the regulatory path forward for VAZALORE.

    Over the last year, the Company has refined and optimized its formulation, resulting in…

    -- PLx Aligning with the FDA on Data Requirements for VAZALORE 
    -- FDA Approves Labeling for 325 mg -- 
    -- Expect to Launch VAZALORE in late 2020 --

    SPARTA, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"™), announced today that the U.S. Food and Drug Administration ("FDA") is providing clarification for the regulatory path forward for VAZALORE.

    Over the last year, the Company has refined and optimized its formulation, resulting in a high-quality and stable product. VAZALORE will deliver better absorption and improved GI safety for millions of patients at a high risk for cardiovascular events. In the Company's recent interactions with the FDA, PLx agreed to provide some additional data on VAZALORE 325 mg dose strength to bridge the new formulation to the original approved formulation, and expects to meet with the FDA to finalize the data modeling components shortly. In addition, PLx gained alignment with the FDA on the necessary data required for approval for the 81 mg dose. PLx anticipates completing the data modeling and the submissions for both the 325 mg and 81 mg simultaneously in the second quarter of 2020. It is projected that this will shift the timing of the launch of both dosages of VAZALORE in the United States towards the end of 2020.

    Additionally, the FDA has approved updated labeling for 325 mg dose strength, and the Company will apply the approved 325 mg labeling to the 81 mg labeling in the CMC submission planned for second quarter 2020.

    "We believe this valuable feedback from the FDA will result in a stronger submission with a higher likelihood of approval. The approval of our labeling for VAZALORE 325 mg is a great accomplishment and is vital to our continuing commercialization efforts," said Natasha Giordano, President and Chief Executive Officer of PLx Pharma.

    About VAZALORE
    VAZALORE 325 mg is an FDA-approved aspirin product being developed to provide patients with vascular disease and diabetic patients who are candidates for aspirin therapy 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. Our goal is to begin selling both products in the United States towards the end of 2020, subject to approval by the FDA.

    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 more effective and safer 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 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, 2018 filed with the SEC on March 8, 2019, 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.

    Primary Logo

    View Full Article Hide Full Article
  34. SPARTA, N.J., Nov. 08, 2019 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer 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, 2019.

    Highlights of, and certain events subsequent to, the third quarter of 2019 include:

    • Net income attributable to common shareholders totaled $1.4 million, or $0.09 per basic and diluted share, compared to net loss of $3.4 million, or ($0.39) per basic and…

    SPARTA, N.J., Nov. 08, 2019 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) ("PLx" or the "Company"), a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide more effective and safer 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, 2019.

    Highlights of, and certain events subsequent to, the third quarter of 2019 include:

    • Net income attributable to common shareholders totaled $1.4 million, or $0.09 per basic and diluted share, compared to net loss of $3.4 million, or ($0.39) per basic and diluted share, for the third quarter of 2018.  2019 includes a non-cash gain of $5.5 million, or $0.55 per share compared to a charge of $0.4 million, or ($0.05) per share in 2018, related to the change in warrant liability;

    • Presented an abstract entitled Pharmacokinetic and pharmacodynamic assessment of a lipid-based aspirin formulation: results of a prospective, randomized, crossover study at the European Society of Cardiology (ESC) Congress and published the study in the Journal of Thrombosis and Thrombolysis;

    • Expanding our medical education effort by sponsoring a Continuing Medical Education (CME) symposium on aspirin in partnership with the Cardiovascular Research Foundation at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference addressing the critical role of aspirin therapy in the treatment of vascular disease;

    • Continued to collect stability data on the manufactured registration batches to be included in the Company's supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) planned for the end of this year;

    • Initiating commercial planning with several large retailers that have indicated strong interest in VAZALORE;
       
    • Developing consumer-focused educational marketing campaigns; and
       
    • Tracking on all significant milestones, with the goal of launching VAZALORE in mid-2020.           

    "Aspirin therapy has received a significant amount of attention recently and is a topic of interest in every cardiology conference we attended this year. It is clear the market is in need of a better aspirin. VAZALORE's better anti-platelet efficacy and improved GI safety profile offers the opportunity to become the new standard of care.  As specialists learn more about the unique benefits for patients who require life-long aspirin therapy, VAZALORE is garnering a great deal of enthusiasm among clinicians."

    "This is an exciting time for PLx as we progress toward obtaining regulatory approval for VAZALORE and moving our commercialization efforts forward to bring our innovative product to market," said Natasha Giordano, President and Chief Executive Officer of PLx Pharma.

    Third Quarter 2019 Financial Results

    The Company recognized revenue of approximately $41,000 in the third quarter of 2019 compared to $0.2 million in the third quarter of 2018. All the revenue recognized is attributable to work performed under an award of a National Institutes of Health grant which is approaching completion.

    Research and development expenses were approximately $1.2 million for the third quarter of 2019 and 2018. The expenses in both periods include continued development and manufacturing activities for VAZALORE.

    General and administrative expense totaled $2.5 million in the third quarter of 2019, compared to $1.8 million in the third quarter of 2018. This increase is due to commercial related activities to support the upcoming launch of VAZALORE.

    Other income (expense), net was $5.4 million of net other income in the third quarter of 2019, compared to $0.6 million of net other expense in the third quarter of 2018. This 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 ($5.5 million of other income in the three months ended September 30, 2019, compared to $0.4 million of other expense in the comparable 2018 period).

    Net income attributable to common shareholders for the third quarter of 2019 was $1.4 million, or $0.09 per basic and diluted share, compared to net loss attributable to common shareholders of $3.4 million, or ($0.39) per basic and diluted share, for the third quarter of 2018. This includes a non-cash gain of $5.5 million, or $0.55 per share compared to a charge of $0.4 million, or ($0.05) per share in 2018, related to the change in warrant liability. The third quarter of 2019 also included $0.3 million, or ($0.03) per share, for preferred stock dividends related to the $15 million Series A convertible preferred stock financing completed in February 2019.

    Nine Months Ended September 30, 2019 Financial Results

    For the nine months ended September 30, 2019, net revenue was approximately $0.5 million, roughly unchanged from the same period in 2018. All the revenue recognized is attributable to work performed under an award of a National Institutes of Health grant.

    Research and development expense increased to $3.8 million for the nine months ended September 30, 2019, compared to $3.0 million for the first nine months of 2018, reflecting continued product development and manufacturing activities for VAZALORE. This increase was due to the manufacture, packaging, stability and analytical costs related to the registration batches, which provide data to be submitted in our sNDA filing.

    General and administrative expense increased to $7.2 million for the nine months ended September 30, 2019 from $5.9 million for the first nine months of 2018. This increase is due to commercial-related activities to support the upcoming launch of $1.1 million and a payment to the University of Texas associated with the patent license agreement of $0.2 million.

    Other income (expense), net was $8.1 million of net other expense for the nine months ended September 30, 2019, compared to $6.4 million of net other income for the first nine months of 2018. This 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 ($7.6 million of other expense in the nine months ended September 30, 2019, as compared to $7.0 million of other income in the comparable 2018 period).

    Net loss attributable to common shareholders for the nine months ended September 30, 2019 was $31.9 million or ($3.60) per basic and diluted share compared to net loss attributable to common shareholders of $2.0 million, or ($0.23) per basic and diluted share, for the first nine months of 2018. The first nine months of 2019 included $13.4 million or ($1.52) per share, for the beneficial conversion feature and preferred stock dividends related to the $15 million Series A convertible preferred stock financing completed in February 2019. 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 compared to income of $7.0 million or $0.80 per share in the first nine months of 2018.

    As of September 30, 2019, the Company had cash and cash equivalents of $18.5 million.

    Conference Call

    As previously announced, PLx management will host its third quarter 2019 conference call as follows:

    Date Friday, November 8, 2019
    Time 8:30 a.m. EST
    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 VAZALORE
    VAZALORE 325 mg is an FDA-approved aspirin product being developed to provide patients with vascular disease and diabetic patients who are candidates for aspirin therapy 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. Our goal is to begin selling both products in the United States by mid-2020, subject to approval by the FDA.

    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 more effective and safer 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 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, 2018 filed with the SEC on March 8, 2019, 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,
    2019
      December 31,
    2018
    ASSETS      
    CURRENT ASSETS      
    Cash and cash equivalents $   18,509,487     $   14,250,267
    Accounts receivable     -          18,234
    Prepaid expenses and other current assets     250,363          421,933
    Deferred financing costs     -          174,976
    TOTAL CURRENT ASSETS     18,759,850         14,865,410
    NON-CURRENT ASSETS      
    Property and equipment, net     1,392,206         1,394,230
    Lease assets     699,996          - 
    Goodwill      2,061,022         2,061,022
    Security deposit     73,666         67,714
    TOTAL ASSETS $    22,986,740     $   18,388,376
           
    LIABILITIES, SERIES A CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)    
    CURRENT LIABILITIES      
    Accounts payable and accrued liabilities $    1,290,839     $   687,257
    Accrued bonus and severance     907,130         1,048,393
    Accrued interest      40,508          60,366
    Current portion of term loan, net of discount and fees     3,626,168         2,909,709
    Other current liabilities      309,239         26,935
    TOTAL CURRENT LIABILITIES     6,173,884         4,732,660
    NON-CURRENT LIABILITIES      
    Accrued interest, net of current portion      462,708         309,440
    Term loan, net of discount, fees and current portion     1,548,864          4,280,385
    Warrant liability      10,118,838         2,537,317
    Accrued dividends     741,089         - 
    Other liabilities      488,599         84,281
    TOTAL LIABILITIES     19,533,982         11,944,083
           
    Series A convertible preferred stock: $0.001 par value; liquidation value of $15,000,000; 45,000 shares designated, 15,000 and 0 shares issued and outstanding     13,661,578         - 
           
    STOCKHOLDERS' EQUITY (DEFICIT)      
    Preferred stock; $0.001 par value; 955,000 authorized, none issued and outstanding     -          - 
    Common stock; $0.001 par value; 100,000,000 shares authorized; 9,122,990 and 8,743,950 shares issued and outstanding     9,123         8,744
    Additional paid-in capital     74,720,150         72,871,317
    Accumulated deficit     (84,938,093 )       (66,435,768
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT)     (10,208,820 )       6,444,293
    TOTAL LIABILITIES, SERIES A CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) $   22,986,740     $   18,388,376
           


    PLx Pharma Inc.
    UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
               
      Three Months Ended September 30,   Nine Months Ended September 30,
        2019       2018       2019       2018  
    REVENUES:              
    Federal grant $   41,106     $    216,530     $   541,571     $   465,446  
    TOTAL REVENUES     41,106         216,530         541,571         465,446  
                   
    OPERATING EXPENSES:              
    Research and development      1,214,029         1,219,144         3,805,617         3,032,426  
    General and administrative     2,503,314         1,800,159         7,180,674         5,870,745  
    TOTAL OPERATING EXPENSES     3,717,343         3,019,303         10,986,291         8,903,171  
    OPERATING LOSS      (3,676,237 )       (2,802,773 )       (10,444,720 )       (8,437,725 )
                   
    OTHER INCOME (EXPENSE):              
    Interest income     111,621         77,276         329,063         219,374  
    Interest and other expense     (230,053 )       (290,773 )       (805,147 )       (849,457 )
    Change in fair value of warrant liability      5,498,391         (408,803 )       (7,581,521 )       7,017,923  
    TOTAL OTHER INCOME (EXPENSE)     5,379,959         (622,300 )       (8,057,605 )       6,387,840  
    INCOME (LOSS) BEFORE INCOME TAXES      1,703,722         (3,425,073 )       (18,502,325 )       (2,049,885 )
    Income taxes     -          -          -          -   
    NET INCOME (LOSS) $   1,703,722     $   (3,425,073 )   $   (18,502,325 )   $   (2,049,885 )
                   
    Preferred dividends and beneficial conversion feature     (311,136 )       -          (13,433,397 )       -   
    NET INCOME (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS $   1,392,586     $   (3,425,073 )   $   (31,935,722 )   $   (2,049,885 )
                   
    Net income (loss) per common share - basic $   0.09     $   (0.39 )   $    (3.60 )   $   (0.23 )
    Net income (loss) per common share - diluted $   0.09     $   (0.39 )   $   (3.60 )   $   (0.23 )
                   
    Weighted average shares of common shares - basic