PLXP PLx Pharma Inc.

3.23
+0.07  (+2%)
Previous Close 3.16
Open 3.46
52 Week Low 1.8
52 Week High 5.96
Market Cap $29,574,720
Shares 9,156,260
Float 7,460,176
Enterprise Value $33,545,217
Volume 15,039
Av. Daily Volume 13,635
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Upcoming Catalysts

Drug Stage Catalyst Date
VAZALORE 325 mg and 81 mg doses
Aspirin - cardiovascular and stroke patients patients
sNDA Filing
sNDA Filing
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Drug Pipeline

Drug Stage Notes
Locilex
Mild infections of diabetic foot ulcers
Phase 3
Phase 3
Phase 3 top-line data did not meet endpoints - October 25, 2016.

Latest News

  1. 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:

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  2. --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:

    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 

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  3. 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:

     

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  4. 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:

    Source: PLx Pharma Inc.

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  5. -- 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:

    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  
           

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