LPCN Lipocine Inc.

1.62
-0.03  -2%
Previous Close 1.65
Open 1.67
52 Week Low 0.301
52 Week High 2.39
Market Cap $106,411,563
Shares 65,686,150
Float 64,134,166
Enterprise Value $93,968,880
Volume 1,818,059
Av. Daily Volume 2,835,259
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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, Jan. 14, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office ("USPTO") declared Interference No. 106,128 between Lipocine, Inc. ("the Senior Party") owned U.S. Patent Application and Clarus Therapeutics, Inc. ("the Junior Party") owned U.S. Patent Application. In preparation for the Interference, the USPTO withdrew the Clarus Application from issue.

    This follows the pattern of previous Interferences as shown below:

    • Interference No. 106,045 decided in Lipocine's favor and resulted in the cancellation of Clarus patent 8,828,428.
    • Interference No. 106,120 decided in Lipocine's favor and resulted in the cancellation of Clarus application 15/723,976.

    "We are pleased with the actions and judgements ordered by the PTAB which validates the strength of Lipocine's patent portfolio," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.

    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. 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, the potential uses and benefits of our product candidates, our product development efforts, the timing of processes related to intellectual property, and the timing of ongoing litigation. 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, 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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  2. SALT LAKE CITY, Jan. 12, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced positive topline results from its LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study (NCT04134091), investigating LPCN 1144 in biopsy-confirmed non-cirrhotic non-alcoholic steatohepatitis ("NASH") male subjects. Currently, there are no approved treatments for NASH, a silent killer that affects ~30 million Americans. LPCN 1144 is an oral prodrug of endogenous testosterone. 

    In the ongoing randomized, double-blind, placebo-controlled 36-week treatment LiFT study, subjects with F1-F3 fibrosis were randomized 1:1:1 to one of three arms (Treatment A is a twice daily oral dose of 142 mg testosterone equivalent, Treatment B is a twice daily oral dose of 142 mg testosterone equivalent formulated with 217 mg of d-alpha tocopherol equivalent, and the third arm is twice daily matching placebo). The primary endpoint is change in hepatic fat fraction via Magnetic Resonance Imaging Proton Density Fat Fraction ("MRI-PDFF") and exploratory liver fat/marker end points post 12 weeks of treatment. Additionally, key secondary endpoints post 36 weeks of treatment include assessment of histological change for NASH resolution and/or fibrosis improvement as well as liver fat data.

    Subjects will have access to LPCN 1144 through an open label extension study (NCT04685993). The extension study will enable the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapy

    Treatments with LPCN 1144 post 12 weeks of treatment resulted in robust liver fat reduction, assessed by MRI-PDFF, and showed improvement of liver injury markers with no observed tolerability issues. Inclusion of d-alpha tocopherol formulated with the testosterone prodrug resulted in additional liver benefits, notably improved key liver markers without compromising tolerability.

    Key results are presented in the following tables:

    Table 1. Mean absolute liver fat using MRI-PDFF in all subjects (n=56)* at Week 12.

    Treatment

    Change from baseline (CBL)

    Placebo-adjusted CBL

    %

    p-value

    %

    p value

    A (n = 18)

    -7.7

    <0.0001

    -6.1

    0.0001

    B (n = 19)

    -9.2

    <0.0001

    -7.5

    <0.0001

    Placebo (n = 19)

    -1.7

    NS

    n/a

    n/a

    * Missing data was obtained using Multiple Imputation

    NS: Not significant (p > 0.05)

    Table 2. Mean relative liver fat using MRI-PDFF at Week 12 in subjects (n=52) with liver fat ≥ 5% at baseline.* 

    Treatment

    Change from baseline (CBL)

    Placebo-adjusted CBL

    %

    p value

    %

    p value

    A (n = 17)

    -40.0

    <0.0001

    -30.0

    0.0002

    B (n = 17)

    -46.9

    <0.0001

    -37.0

    <0.0001

    Placebo (n = 18)

    -9.9

    NS

    n/a

    n/a

    * Based on available data.

    Table 3. Responders with > 30% Relative Reduction in Liver Fat at Week 12, Intent to Treat Dataset (n=56)*.

    Treatment

    Responder

    (% of subjects)

    p value

    vs Placebo

    A (n = 18)

    66.7

    0.0058

    B (n = 19)

    63.2

    0.0026

    Placebo (n = 19)

    15.8



    * Subjects with missing data are considered non-responders

    Table 4. Average changes in key serum liver injury markers ALT and AST at Week 12 (n=52)*.



    ALT (U/L)

    AST (U/L)

    Treatment

    Absolute

    Placebo-Adjusted

    Absolute

    Absolute

    Placebo-Adjusted

    Absolute

    CBL

    p value

    vs BL

    CBL

    p value

    vs Placebo

    CBL

    p value

    vs BL

    CBL

    p value

    vs Placebo

    A (n = 16)

    -9.4

    0.0054

    -11.1

    0.0164

    -4.9

    0.0402

    -7.7

    0.0216

    B (n = 19)

    -22.4

    <0.0001

    -24.1

    <0.0001

    -10.4

    <0.0001

    -13.2

    0.0001

    Placebo (n = 17)

    1.8

    NS

     n/a

    n/a

    2.8

    NS

    n/a

    n/a

    * All available data

    During the 12 weeks of treatment, the observed rate and severity of Treatment Emergent Adverse Events ("TEAEs") in both the treatment arms were comparable to the placebo arm. Three subjects in the placebo group and one subject in the combined treatment arms discontinued study drug due to TEAEs.

    "The LiFT study provides the first proof of concept that LPCN 1144 improves both liver fat and markers of liver injury in patients with biopsy proven NASH with fibrosis, with the majority of patients experiencing greater than 30% reduction in liver fat.  The addition of d-alpha tocopherol appears to further reduce liver injury in this population.  These data appear to support the potential for this novel approach as a treatment of NASH," said Dr. Arun Sanyal, Professor in the Virginia Commonwealth University ("VCU") Department of Internal Medicine and Education Core Director in the VCU Center for Clinical and Translational Research

    "We are pleased by the top-line results from our LiFT study, which we believe demonstrate the potential for oral LPCN 1144's to be used in treating NASH," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. "Additionally, NASH patients are likely to have compromised androgen signaling with associated sarcopenia, skeletal fragility, sexual/mood disorder, and anemia. Therefore, we believe LPCN 1144 therapy has the potential to provide additional benefits such as improved bone density and muscle mass as well as improvement in sexual/mental disorders. We look forward to sharing 36-week biopsy data from the LiFT study in mid-2021," said Dr. Patel. 

    Conference Call

    Management will host a conference call and webcast today at 8:30 a.m. Eastern time to discuss topline Phase 2 results from its LPCN 1144 ongoing LiFT study in biopsy-confirmed non-cirrhotic NASH subjects.  To participate in the conference call, please dial 1-877-451-6152 from the U.S. or 1-201-389-0879 from outside the U.S.  In addition, following the completion of the call, a telephone replay will be accessible until January 19, 2021, by dialing 1-844-512-2921 from the U.S. or 1-412-317-6671 from outside the U.S. and entering conference ID #13715019.  Those interested in listening to the conference call live via the internet may do so by using the following link: http://public.viavid.com/index.php?id=143020.  An archive of the webcast will also be available on the webcast page of the Company's website for 90 day.  

    About NASH

    NASH is a more advanced state of non-alcoholic fatty liver disease ("NAFLD") and can progress to a cirrhotic liver and eventually hepatocellular carcinoma/liver cancer. Twenty to thirty percent of the U.S. population is estimated to suffer from NAFLD and fifteen to twenty percent of this group progress to NASH, which is a substantially large population that lacks effective therapy. Currently, there are no FDA approved treatments for NASH. Approximately 50% of NASH patients are in adult males and the number of NASH cases is projected to increase 63% from 16.5 million cases in 2015 to 27.0 million cases in 2030. NAFLD/NASH is becoming more common due to its strong correlation with obesity and metabolic syndrome, including components of metabolic syndrome such as diabetes, cardiovascular disease and high blood pressure. In men, especially with comorbidities associated with NAFLD/NASH, testosterone deficiency has been associated with an increased accumulation of visceral adipose tissue and insulin resistance, which could be factors contributing to NAFLD/NASH.

    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.

    Cautionary and 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, including week-36 data for the LiFT Phase 2 clinical study, 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. In addition, while we believe the top-line results from the LiFT study are positive, there can be no assurance at this stage that LPCN 1144 will provide the benefits indicated at this stage in the study, that later data will continue to support such benefits, or that the rate and severity of TEAEs will not change as the study continues. There can also be no assurance that we will choose, or have the ability, to conduct Phase 3 trials with respect to LPCN 1144 and, ultimately, apply for and receive approval from the FDA to market LPCN 1144 for the indications described in this press release. 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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  3. SALT LAKE CITY, Jan. 4, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced that the Company will participate in the H.C. Wainwright BioConnect 2021 Conference, being held virtually on January 11-14, 2021.

    Presentation Details 

    Date: 

    January 11-14, 2021

    Webcast:

    https://journey.ct.events/view/b1061a87-a495-4b51-a6d2-6afb7693e59f 

    A webcast of Lipocine's presentation will be available on-demand as of 6:00 am ET, Monday, January 11, 2021, thorough the H.C. Wainwright conference portal, on Lipocine's website under "Events & Presentations" in the Investors section or using the webcast link above.  The webcast will be available on the Lipocine's website for 90 days. 

    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 product 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.   

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  4. SALT LAKE CITY, Dec. 30, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it is enrolling patients into an open label extension to the ongoing LPCN 1144 Phase 2 LiFT study based on investigator and patient interest in continuing treatment. The LiFT ("Liver Fat intervention with oral Testosterone") clinical study is a paired-biopsy study investigating LPCN 1144 in confirmed non-cirrhotic non-alcoholic steatohepatitis ("NASH") subjects. 

    In the initial, double-blind part of the LiFT study, patients were randomized to receive one of two treatments of LPCN 1144 or placebo over 36 weeks. Patients who complete this portion will now have the option to enter the 36-week open label extension study, which is designed to evaluate the long-term safety and tolerability of LPCN 1144 treatment. There is no placebo arm in the open label extension study, and all patients will be treated with LPCN 1144.

    "This extension to our ongoing LiFT clinical study will allow us to collect additional data on LPCN 1144 for up to a total of 72 weeks of therapy," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "Patients who may have received placebo during the initial, randomized part of the trial now have the opportunity to receive active drug."

    For more information on LiFT, refer to NCT04134091. For more information on this open label extension study, refer to NCT04685993.

    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 product 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

    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, including the LIFT clinical study, 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 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, 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, Dec. 29, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that Judge William C. Bryson of the United States District Court of Delaware has postponed the February 8, 2021 jury trial scheduled to hear arguments in the patent litigation case of Lipocine Inc. vs. Clarus Therapeutics Inc. due to the ongoing effects of the COVID-19 pandemic. The jury trial will be rescheduled once it becomes clear when jury trials will resume in the District of Delaware.  

    In the pending suit against Clarus Therapeutics, Inc. ("Clarus") Lipocine is alleging that Clarus's JATENZO® product infringes Lipocine's U.S. patents: 9,034,858; 9,205,057; 9,480,690; and 9,757,390. 

    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 product 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.   

    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, including the LIFT clinical study, the potential uses and benefits of our product candidates, our product development efforts, and timing of ongoing litigation. 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, 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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