LPCN Lipocine Inc.

1.31
+0.08  (+7%)
Previous Close 1.23
Open 1.23
52 Week Low 0.301
52 Week High 3.45
Market Cap $62,722,144
Shares 47,879,499
Float 46,327,515
Enterprise Value $49,663,719
Volume 1,753,649
Av. Daily Volume 1,603,406
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Upcoming Catalysts

Drug Stage Catalyst Date
TLANDO - LPCN 1021
Men with low testosterone (Low T)
PDUFA
PDUFA
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LPCN 1144
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
LPCN 1148
Liver cirrhosis
Phase 2
Phase 2
Phase 2 trial to be initiated 4Q 2020 or 1Q 2021.
LPCN 1107
Prevention of preterm birth ("PTB").
Phase 3
Phase 3
Conduct food/fact effect study in preparation for Phase 3 trial.
LPCN 1111
Oral testosterone product
Phase 2b
Phase 2b
Phase 2b top-line data released September 2016. Seeking feedback from FDA regarding Phase 3 design.

Latest News

  1. SALT LAKE CITY, May 15, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that clinical data for lead candidate TLANDO™ will be presented at the American Urological Association ("AUA") Virtual Experience, to take place May 15-17, 2020.  TLANDO is an oral testosterone replacement therapy ("TRT") product candidate being developed for adult males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

    1. Abstract Number: MP45-14 
      Title: Impact of a new oral testosterone undecanoate on blood pressure and cardiovascular risk
      Presenter: Mohit Khera, MD 
      Session Type: Poster Session
      Session Title: Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II
       
    2. Abstract Number: MP45-15
      Title: A novel oral testosterone therapy restores testosterone to eugonadal levels without dose titration
      Presenter: Martin Miner, MD
      Session Type:
      Poster Session
      Session Title:
      Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II 

    3. Abstract Number: PD26-05 
      Title:
       Effects of a new oral testosterone undecanoate (TLANDO) therapy on liver
      Presenter: Irwin Goldstein, MD
      Session Type:
      Oral Podium Session
      Session Title:
      Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy I

    The abstracts, posters and podium slides are published today on the AUA website.

    About Lipocine
    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements
    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, risk related to on-going litigation and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-announces-presentations-on-tlando-at-aua-virtual-experience-2020-301059647.html

    SOURCE Lipocine Inc.

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  2. SALT LAKE CITY, May 13, 2020 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the results of a pre-clinical study of LPCN 1144. LPCN 1144 is an oral prodrug of bioidentical testosterone ("testosterone undecanoate" or "TU"). The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet ("HFD")-induced, rabbit animal model of NASH and hepatic fibrosis.

    In the pre-clinical study, the HFD induced histological NASH features with fibrosis, altered key biomarkers, and lowered serum testosterone levels. Expectedly, treatment with LPCN 1144 increased testosterone levels in rabbits with HFD-induced low testosterone. Histological and biomarker analyses also demonstrate that LPCN 1144 improved HFD-induced NASH features and hepatic fibrosis. LPCN 1144 treatment reduced HFD-induced visceral fat increase and insulin resistance. LPCN 1144 treatment-related reduction in key liver inflammation and fibrosis markers was comparable to that reported for obeticholic acid ("OCA") under a similar pre-clinical methodology (Vignozzi et al., Mol Cell Endocrinol, 2014). Lipocine plans to present the results at an upcoming scientific conference. 

    LPCN 1144 is currently being studied in the LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 paired biopsy clinical study in patients with confirmed non-cirrhotic NASH.

    "We are encouraged by these pre-clinical study results," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "Pending confirmation in the on-going LiFT clinical trial, these findings suggest therapeutic potential of LPCN 1144 in the treatment of NASH and hepatic fibrosis," Dr. Patel added.    

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's  product candidates and related pre-clinical and clinical trials, the timing of completion of clinical trials, the potential uses and benefits of our product candidates, the use and benefits of LPCN 1144 in the treatment of NASH and hepatic fibrosis, our product development efforts, and future discussions and potential future actions by the FDA related to TLANDO including the PDUFA date. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, pre-clinical, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, risk related to on-going litigation and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/treatment-potential-of-lpcn-1144-demonstrated-in-a-pre-clinical-nash-and-hepatic-fibrosis-model-301058242.html

    SOURCE Lipocine Inc.

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  3. SALT LAKE CITY, May 7, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.

    First Quarter and Recent Corporate Highlights

    • Resubmitted New Drug Application ("NDA") for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males with hypogonadism
      • The U.S. Food and Drug Administration ("FDA") acknowledged receipt of resubmission and established August 28, 2020 as the target Prescription Drug User Fee Act ("PDUFA") goal date
    • Received FDA clearance on Investigational New Drug ("IND") application for Phase 2 clinical study with LPCN 1148 for the treatment of non-alcoholic steatohepatitis ("NASH") in cirrhotic patients 
    • Raised $6.0 million in gross proceeds in a registered direct offering of common stock and warrants in February 2020
    • Received decision from the U.S. Court of Appeals for the Federal Circuit affirming the decision of the United States Patent and Trademark Office ("USPTO") in the patent interference case between Lipocine and Clarus Therapeutics

    First Quarter Ended March 31, 2020 Financial Results
    Lipocine reported a net loss of $5.8 million, or ($0.14) per diluted share, for the quarter ended March 31, 2020, compared with a net loss of $3.2 million, or ($0.14) per diluted share, for the quarter ended March 31, 2019.

    Research and development expenses were $2.5 million for the quarter ended March 31, 2020, compared with $1.9 million for the quarter ended March 31, 2019. The increase in research and development expenses during the three months ended March 31, 2020 was primarily due to increased contract research organization and outside consulting and manufacturing costs for the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects of $1.7 million, a $50,000 increase in costs for TLANDO XR and a $56,000 increase in personnel expense.  These increases were offset by a $1.2 million decrease in costs incurred relating to TLANDO, including the completion of the ABPM study and the filing of the NDA in the first half of 2019 and a $12,000 decrease in contract manufacturing costs for LPCN 1107.

    General and administrative expenses were $2.1 million for the quarter ended March 31, 2020, compared with $1.2 million for the quarter ended March 31, 2019. The increase in general and administrative expenses during the three months ended March 31, 2020 was primarily due to a $1.0 million increase in legal costs associated with the lawsuit filed against Clarus for patent infringement in April 2019 in addition to costs associated with interference cases filed against Clarus, offset by a $59,000 decrease in personnel costs and a $26,000 decrease in administrative travel expenses.

    As of March 31, 2020, Lipocine had $15.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million at December 31, 2019.  Additionally, the Company had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA. The Company believes that its existing capital resources will be sufficient to meet its projected operating requirements through at least February 15, 2021. 

    About Lipocine
    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements
    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's  product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, risk related to on-going litigation and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

    (Unaudited)








    March 31,


    December 31,



    2020


    2019

    Assets





    Current assets:





        Cash and cash equivalents


    $            15,134,789


    $     9,728,523

        Restricted cash


    5,000,000


    5,000,000

        Marketable investment securities


    448,077


    4,340,041

        Accrued interest income


    9,212


    16,522

        Prepaid and other current assets


    373,370


    545,887

          Total current assets


    20,965,448


    19,630,973






    Property and equipment, net of accumulated depreciation of

       $1,140,942 and $1,140,143, respectively


    2,755


    3,554

    Other assets


    23,753


    23,753






          Total assets


    $            20,991,956


    $   19,658,280











    Liabilities and Stockholders' Equity





    Current liabilities:





        Accounts payable


    $              1,654,909


    $     1,182,241

        Accrued expenses


    738,280


    449,303

        Debt - current portion


    1,666,666


    3,333,333






          Total current liabilities


    4,059,855


    4,964,877






    Debt - non-current portion


    4,688,136


    3,814,407

    Warrant liability


    5,691,229


    4,591,200






          Total liabilities


    14,439,220


    13,370,484











    Commitments and contingencies










    Stockholders' equity:





         Preferred stock, par value $0.0001 per share, 10,000,000

         shares authorized; zero issued and outstanding


    -


    -

         Common stock, par value $0.0001 per share, 100,000,000

         shares authorized; 47,860,209 and 37,655,175 issued

         and 47,854,499 and 37,649,465 outstanding


    4,786


    3,766

    Additional paid-in capital


    163,426,502


    157,391,969

    Treasury stock at cost, 5,710 shares


    (40,712)


    (40,712)

    Accumulated other comprehensive loss


    -


    (38)

    Accumulated deficit


    (156,837,840)


    (151,067,189)






          Total stockholders' equity


    6,552,736


    6,287,796











          Total liabilities and stockholders' equity


    $            20,991,956


    $   19,658,280

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)




    Three Months Ended March 31,



    2020


    2019






    Operating expenses:





      Research and development


    2,511,754


    1,949,821

      General and administrative


    2,085,261


    1,175,927

        Total operating expenses


    4,597,015


    3,125,748






        Operating loss


    (4,597,015)


    (3,125,748)






    Other income (expense):





      Interest and investment income


    59,938


    125,265

      Interest expense


    (133,345)


    (223,789)

        Total other expense, net


    (73,407)


    (98,524)

    Unrealized loss on warrant liability


    (1,100,029)


    -






        Loss before income tax expense


    (5,770,451)


    (3,224,272)






    Income tax expense


    (200)


    (200)






        Net loss


    $          (5,770,651)


    $         (3,224,472)






    Basic loss per share attributable to common stock


    $                  (0.14)


    $                 (0.14)






    Weighted average common shares outstanding, basic


    41,347,631


    23,383,008






    Diluted loss per share attributable to common stock 


    $                  (0.14)


    $                 (0.14)






    Weighted average common shares outstanding, diluted


    41,347,631


    23,383,008






    Comprehensive loss:





      Net loss


    $          (5,770,651)


    $         (3,224,472)

      Net unrealized gain on available-for-sale securities


    38


    2,352






      Comprehensive loss


    $          (5,770,613)


    $         (3,222,120)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-announces-first-quarter-2020-financial-and-operational-results-301054618.html

    SOURCE Lipocine Inc.

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  4. SALT LAKE CITY, May 5, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food & Drug Administration ("FDA")  has accepted the Company's Investigational New Drug application ("IND") to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for the treatment of liver cirrhosis in adult male cirrhotic patients. The planned Phase 2 clinical study is a prospective, multi-center, randomized, placebo-controlled 52-week study in male cirrhotic patients that are on the liver transplant list. Contingent upon available funding, Lipocine projects study…

    SALT LAKE CITY, May 5, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food & Drug Administration ("FDA")  has accepted the Company's Investigational New Drug application ("IND") to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for the treatment of liver cirrhosis in adult male cirrhotic patients. The planned Phase 2 clinical study is a prospective, multi-center, randomized, placebo-controlled 52-week study in male cirrhotic patients that are on the liver transplant list. Contingent upon available funding, Lipocine projects study initiation in the fourth quarter of 2020 or the first quarter of 2021.

    Liver cirrhosis is estimated to affect in excess of 600,000 Americans, with men affected at twice the rate of women, and results in approximately 45,000 deaths every year. Due to a lack of available organs, only a third of waitlisted patients receive liver transplants, and patients who do receive a transplant are increasingly being described as frail. Low testosterone affects up to 90% of cirrhotic men, and is a predictor of mortality and increased adverse events including ascites, hepatic encephalopathy, and clinically significant portal hypertension.

    "We are excited the FDA has accepted the LPCN 1148 Phase 2 clinical protocol to test our potential treatment in cirrhotic patients," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. "We believe LPCN 1148 has the potential to improve survivability and quality of life for cirrhotic patients."

    About Lipocine
    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements
    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products including LPCN 1148, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials including the Phase 2 clinical study with LPCN 1148, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, risk related to on-going litigation and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

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  5. SALT LAKE CITY, April 17, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019.  Specifically, the FDA declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding how the FDA should review and make approval decisions on any pending or future oral T-ester products.

    Clarus originally filed the Citizens Petition with the FDA requesting the FDA issue "clear, written guidance regarding the safety and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy" and requested the FDA not to approve "any pending [new drug application ("NDA")] for an oral T-ester to treat male hypogonadism that fails to meet the standards for approval set forth in [the] petition."

    About Lipocine
    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH.  TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements
    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding potential future actions and decisions by the FDA. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, risk related to on-going litigation and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

     

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