PLXP PLx Pharma Inc.

3.11
-0.07  -2%
Previous Close 3.18
Open 3.14
52 Week Low 1.8
52 Week High 7.09
Market Cap $28,471,390
Shares 9,156,260
Float 7,613,423
Enterprise Value $36,853,287
Volume 1,566
Av. Daily Volume 16,807
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
VAZALORE
Aspirin - cardiovascular and stroke patients patients
sNDA Filing
sNDA Filing
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

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., 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.

    Primary Logo

    View Full Article Hide Full Article
  2. -- 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  
           

    Primary Logo

    View Full Article Hide Full Article
  3. 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:

    Primary Logo

    View Full Article Hide Full Article
  4. -- 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:

    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
  5. 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:

    Primary Logo

    View Full Article Hide Full Article
View All PLx Pharma Inc. News