LPCN Lipocine Inc.

1.54
-0.03  -2%
Previous Close 1.57
Open 1.55
52 Week Low 0.452
52 Week High 2.42
Market Cap $135,967,601
Shares 88,290,650
Float 86,738,666
Enterprise Value $124,539,354
Volume 1,023,142
Av. Daily Volume 4,010,057
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Upcoming Catalysts

Drug Stage Catalyst Date
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
TLANDO - LPCN 1021
Men with low testosterone (Low T)
Approved
Approved
FDA tentative approval announced December 8, 2020.
LPCN 1148
Liver cirrhosis
Phase 2
Phase 2
Phase 2 trial planned.
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, March 11, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the M Vest LLC and Maxim Group LLC Emerging Growth Virtual Conference and the Lytham Partners Spring 2021 Investor Conference. Both conferences will be held virtually. Presentation details are below.

    M Vest LLC and Maxim Group Emerging Growth Virtual Conference March 18-19

    Presentation time: | March 17, 2021 starting at 9.000 AM ET      

    Investors can register for the conference at https://www.m-vest.com/events/2021-emerging-growth-virtual-conference

    Lytham Partners Spring 2021 Investor Conference Conference March 30-April 1

    Presentation time:      March 30, 2021 5:00 pm ET

    Webcast link:              https://www.webcaster4.com/Webcast/Page/2641/40316  

    The webcasts of these presentations will also be available on Lipocine's corporate website under "Events & Presentations" in the Investors section.  

    About Lipocine Inc.

    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, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  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 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.   

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-to-present-at-m-vest--maxim-conference-and-at-the-lytham-partners-conference-301245203.html

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  2. SALT LAKE CITY, March 11, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the fourth quarter and year ended December 31, 2020, and provided a corporate update.

    "Lipocine had a number of important accomplishments in 2020, most notably the U.S. Food and Drug Administration ("FDA") decision to grant tentative approval to TLANDO, the Company's oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism. We are committed to taking action to receiving final approval to permit the launch of the product," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We also made excellent progress advancing LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH").  We were pleased with the top-line results from our Phase 2 LiFT clinical study, announced in January 2021, which showed that treatment with LPCN 1144 resulted in significant liver fat reduction and improvement of key liver injury markers. The trial is on-going and we expect 36-week biopsy data in July/August 2021."

    Fourth Quarter and Recent Corporate Highlights

    • Granted tentative approval by the FDA for TLANDO, Lipocine's oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone
    • Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects 
      • Both LPCN 1144 treatment arms met the primary endpoint, change in hepatic fat fraction via magnetic resonance imaging proton density fat fraction ("MRI-PDFF"), with statistical significance
      • Statistically significant reduction in markers of liver injury were observed for LPCN 1144 compared to placebo
      • 36-week biopsy data from the LiFT study are expected in July/August 2021 
    • Began enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144 (no placebo arm)
      • The extension will allow the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapy
    • Raised gross proceeds in January 2021 of approximately $28.7 million in a public offering of approximately 16,428,571 million shares of common stock

    Year Ended December 31, 2020 Financial Results

    Lipocine reported a net loss of $21.0 million, or ($0.38) per diluted share, for the year ended December 31, 2020, compared with a net loss of $13.0 million, or ($0.50) per diluted share, for the year ended December 31, 2019.

    Research and development expenses were $9.7 million for the year ended December 31, 2020, compared with $7.5 million for the year ended December 31, 2019. The increase in research and development expenses compared with the prior year was primarily due increases in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study, an increase in commercial manufacturing costs related to TLANDO, an increase in personnel expense, as well as a net increase in other R&D programs and expenses.  Additionally, other costs related to TLANDO had a net decrease which was the result of a decrease in contract research organization expenses, offset by increases in other TLANDO expenses.

    General and administrative expenses were $8.2 million for the year ended December 31, 2020, compared with $5.6 million for the year ended December 31, 2019. The increase in general and administrative expenses compared with the prior year was primarily due to an increase in legal costs, an increase in personnel costs, and an increase in other general and administrative expenses.  These were offset by a decrease in administrative travel expenses and marketing expense.

    As of December 31, 2020, Lipocine had $19.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million as of December 31, 2019. Additionally, as of December 31, 2020 and December 31, 2019 Lipocine had $5.0 million of restricted cash, which was required to be maintained as cash collateral under the Silicon Valley Bank ("SVB") Loan and Security Agreement until TLANDO is approved by the FDA. However, on February 16, 2021, Lipocine and SVB amended the Loan and Security Agreement to, among other things, remove the cash collateral requirement. 

    Subsequent to the end of the year, in January 2021, Lipocine raised gross proceeds of approximately $28.7 million in a public offering before deducting underwriting discounts and commissions and other offering expenses payable by Lipocine.

    About Lipocine Inc.

    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, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  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 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 clinical trials, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risk 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, 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

    Consolidated Balance Sheets

    December 31, 2020 and 2019

























    2020



    2019

    Assets









    Current assets:









          Cash and cash equivalents



    $  19,217,382



    $    9,728,523

          Restricted cash



    5,000,000



    5,000,000

          Marketable investment securities



    449,992



    4,340,041

          Accrued interest income



    391



    16,522

          Prepaid and other current assets



    661,258



    545,887











                Total current assets



    25,329,023



    19,630,973











    Property and equipment, net of accumulated depreciation

       of $1,143,697 and $1,140,143, respectively











    -



    3,554

    Other assets



    23,753



    23,753











                Total assets



    $  25,352,776



    $  19,658,280





















    Liabilities and Stockholders' Equity









    Current liabilities:









          Accounts payable



    $    1,597,220



    $    1,182,241

          Accrued expenses



    1,653,178



    449,303

          Debt - current portion



    3,333,333



    3,333,333











                Total current liabilities



    6,583,731



    4,964,877











          Debt - non-current portion



    2,257,075



    3,814,407

          Warrant liability



    1,170,051



    4,591,200











                Total liabilities



    10,010,857



    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; 70,041,967 and 37,655,175

              issued and 70,036,257 and 37,649,465 outstanding



    7,005



    3,766

    Additional paid-in capital



    187,407,634



    157,391,969

    Treasury stock at cost, 5,710 shares



    (40,712)



    (40,712)

    Accumulated other comprehensive loss



    -



    (38)

    Accumulated deficit



    (172,032,008)



    (151,067,189)











                Total stockholders' equity



    15,341,919



    6,287,796





















                Total liabilities and stockholders' equity



    $  25,352,776



    $  19,658,280

     

    LIPOCINE INC. AND SUBSIDIARIES

    Consolidated Statements of Operations and Comprehensive Loss

    Years Ended December 31, 2020 and 2019





















    2020



    2019











    Revenues:









       License revenue



    $                -



    $      164,990

          Total revenues



    -



    164,990











    Operating expenses:









       Research and development



    9,748,469



    7,468,210

       General and administrative



    8,247,795



    5,597,070

          Total operating expenses



    17,996,264



    13,065,280











          Operating loss



    (17,996,264)



    (12,900,290)











    Other income (expense)









       Interest and investment income



    75,650



    423,491

       Interest expense



    (386,618)



    (766,745)

       Gain on extinguishment of debt



    234,802



    -

       Unrealized gain (loss) on warrant liability



    (2,892,189)



    236,400

             Total other expense, net



    (2,968,355)



    (106,854)











             Loss before income tax expense



    (20,964,619)



    (13,007,144)











    Income tax expense



    (200)



    (200)

            Net loss



    $ (20,964,819)



    $ (13,007,344)











    Basic loss per share attributable to common stock



    $          (0.38)



    $          (0.50)











    Weighted average common shares outstanding, 



    55,688,085



    25,882,273

    basic









    Diluted loss per share attributable to common stock 



    $          (0.38)



    $          (0.50)











    Weighted average common shares outstanding, diluted



    55,688,085



    25,882,273





















    Comprehensive loss:









          Net loss



    $ (20,964,819)



    $ (13,007,344)

          Unrealized net gain on available-for-sale securities



    38



    925

          Comprehensive loss



    $ (20,964,781)



    $ (13,006,419)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-year-ended-december-31-2020-301245232.html

    SOURCE Lipocine Inc.

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  3. SALT LAKE CITY, March 4, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the publication of preclinical results supporting the therapeutic potential of LPCN 1144 in the treatment of and non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis. The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation (https://doi.org/10.1007/s40618-021-01522-7).

    SALT LAKE CITY, March 4, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the publication of preclinical results supporting the therapeutic potential of LPCN 1144 in the treatment of and non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis. The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation (https://doi.org/10.1007/s40618-021-01522-7).

    About Lipocine Inc.

    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, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  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 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 clinical trials, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risk 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, 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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    SOURCE Lipocine Inc.

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  4. SALT LAKE CITY, March 3, 2021- /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 ENDO 2021 Conference, to take place March 20-23, 2021.  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. Title: Low Testosterone in Males may Warrant Liver Health Assessment Intervention

      Session Type: Poster Session

      Session: P12 - Cardiovascular Endocrinology

      DateMarch 20, 2021 11:00 a.m. E.T., On-Demand

      Linkhttps://www.abstractsonline.com/pp8/#!/9188/presentation/3323



    2. Title: Efficacy and Safety of TLANDO, a Novel Oral Easy to Prescribe and Use TRT Option

      Session Type: Poster Session

      Session: P25 – Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications

      DateMarch 20, 2021 11:00 a.m. E.T., On-Demand

      Linkhttps://www.abstractsonline.com/pp8/#!/9188/presentation/1912



    3. Title: TLANDO, a Novel Oral TRT, Improves Sexual and Mental Domain Outcomes in Hypogonadal Men

      Session Type: Poster Session

      Session: P25 – Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications

      DateMarch 20, 2021 11:00 a.m. E.T., On-Demand

      Linkhttps://www.abstractsonline.com/pp8/#!/9188/presentation/1915

    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, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  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 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 clinical trials, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risk 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, 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-endo-2021-conference-301239253.html

    SOURCE Lipocine Inc.

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  5. SALT LAKE CITY, Feb. 26, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Raymond James 42nd Annual Institutional Investors Conference and the H.C. Wainwright Global Life Sciences Conference. Both conferences will be held virtually. Presentation details are below.

    Raymond James 42nd Annual Institutional Investors Conference March 1-3

    Presentation time: 

     March 1, 2021 at 11:40 AM EST      

    Webcast link: 

     https://kvgo.com/rjinstitutionalinvestors/lipocine-march-2021

    H.C. Wainwright Global Life Sciences Conference March 9-10

    Presentation time:

     March 9, 2021 starting at 7:00 am EST

    Webcast link:

     https://journey.ct.events/view/22b189ab-7ea3-489c-a91d-e387ee47c4d6 

    The session time is on-demand and will be archived for 90 days.

    The webcasts of these presentations will also be available on Lipocine's corporate website under "Events & Presentations" in the Investors section.  

    About Lipocine Inc.

    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, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study.  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 indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information. For more information, please visit www.lipocine.com.   

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-to-present-at-two-upcoming-investor-conferences-301236245.html

    SOURCE Lipocine Inc.

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