LPCN Lipocine Inc.

0.89
-0.05  -5%
Previous Close 0.94
Open 0.95
52 Week Low 0.9301
52 Week High 2.42
Market Cap $78,675,798
Shares 88,290,650
Float 86,149,561
Enterprise Value $43,149,292
Volume 1,017,275
Av. Daily Volume 521,948
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Upcoming Catalysts

Drug Stage Catalyst Date
TLANDO (LPCN 1021)
Men with low testosterone (Low T)
NDA Filing
NDA Filing
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LPCN 1148
Liver cirrhosis
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
LPCN 1144 - (LiFT)
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 top-line change in liver fat data met primary endpoint January 12, 2021. Phase 2 36-week data met with primary endpoint of NASH resolution with no worsening of fibrosis based on NASH CRN scoring. Both treatment arms showed improvement of the observed NASH activity in steatosis, inflammation and ballooning, August 25, 2021. Phase 2 data reported statistically significant reductions of ALT and AST; up to a mean of 24.5 U/L decrease in ALT, and 12.3 U/L decrease in AST, noted November 16, 2021.
LPCN 1154
Postpartum Depression
Phase 1
Phase 1
Phase 2 trial planned. Dosing to commence 4Q 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, Jan. 5, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that one abstract has been selected for podium presentation and three abstracts have been selected for poster presentations during the upcoming 2022 NASH-TAG Conference in Park City, Utah on January 6-8, 2022.

    Presentation Details:



    Session Title:

    Distinguished Abstract Presentation and Poster

    Abstract Number:

    #29

    Presentation Title:

    "LPCN 1144 Therapy Demonstrates Histologic Benefits in the Phase 2 LiFT Study in Nonalcoholic Steatohepatitis (NASH) Subjects"

    Presentation Time:

    Podium Presentation – January 7th at 10:15 a.m. MT



    Poster Presentation – January 6th at 6 p.m. MT – January 8th at 9 p.m. MT





    Session Title:

    Distinguished Abstract Poster

    Abstract Number:

    #30

    Presentation Title:

    "LPCN 1144 Improves Body Composition in Biopsy-Confirmed NASH Patients"

    Presentation Time:

    Poster Presentation – January 6th at 6 p.m. MT – January 8th at 9 p.m. MT





    Session Title:

    Distinguished Abstract Poster

    Abstract Number:

    #31

    Presentation Title:

    "Safety and Tolerability of LPCN 1144 Treatment in Biopsy-Confirmed NASH Subjects in the Phase 2 LiFT Study"

    Presentation Time:

    Poster Presentation – January 6th at 6 p.m. MT – January 8th at 9 p.m. MT

    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, LPCN 1154, 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 Phase 2 clinical study demonstrating 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 or twice daily, TLANDO XR met the typical primary and secondary endpoints. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  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, the timing and completion of regulatory reviews, 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 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.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-to-present-clinical-data-on-lpcn-1144-at-2022-nash-tag-conference-301454125.html

    SOURCE Lipocine Inc.

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  2. SALT LAKE CITY, Dec. 22, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the first patient has been dosed in its Phase 2 proof-of-concept clinical study (NCT04874350) for the management of liver cirrhosis. The Phase 2 study is a multi-center, randomized, placebo-controlled 52-week study in sarcopenic cirrhotic patients that are on the liver transplant list. The primary endpoint is change from baseline in Skeletal Muscle Index ("SMI") via computed tomography in LPCN 1148 treated subjects compared to placebo at week 24, and key secondary endpoints include measures of frailty (liver frailty index), change in waitlist events, myosteatosis…

    SALT LAKE CITY, Dec. 22, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the first patient has been dosed in its Phase 2 proof-of-concept clinical study (NCT04874350) for the management of liver cirrhosis. The Phase 2 study is a multi-center, randomized, placebo-controlled 52-week study in sarcopenic cirrhotic patients that are on the liver transplant list. The primary endpoint is change from baseline in Skeletal Muscle Index ("SMI") via computed tomography in LPCN 1148 treated subjects compared to placebo at week 24, and key secondary endpoints include measures of frailty (liver frailty index), change in waitlist events, myosteatosis, rate of hospital admissions, all-cause mortality, and decompensation events (including all cause and liver related mortalities and clinically significant worsening) and rates of breakthrough hepatic encephalopathy. Primary endpoint topline results are expected in the second half of 2022.  

    "We are excited to have this Phase 2 study underway as LPCN 1148 targets a serious unmet need with a strong pharmaco-economic justification as a potential treatment for the management of liver cirrhosis," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. "In addition to being a unique treatment option with a compelling rationale, we plan to apply for Orphan Drug Designation ("ODD") with LPCN 1148 for regressing decompensation events including Hepatic Encephalopathy," said Dr. Patel.

    About Liver Cirrhosis: Decompensated liver cirrhosis is estimated to affect more than 630,000 Americans, with men affected at twice the rate as women, and results in approximately 45,000 deaths every year. The only cure, liver transplant, has a high economic burden (~$812,500/transplant).  The hypothalamus-pituitary-gonadal axis is profoundly altered in advanced cirrhotic patients, leading to endocrine dysfunction. Testosterone levels fall progressively with increased chronic liver disease severity. Low testosterone levels, reported in the majority of male cirrhotic patients, is known to be associated with increased rates of adverse outcomes including varices in the gastrointestinal tract with internal bleeding, ascites, major infections, hepatic decompensation, and worsening of quality of life while awaiting transplant.

    About Compromised Muscle in Cirrhosis: The presence of sarcopenia (loss of muscle mass/area) in 40-70% of cirrhotic men and frailty (a state of decreased physiological reserve/functionality) are associated with increased risk of hospitalization and hepatic decompensation events, a two-fold increase in waitlist mortality, and poor post-transplant outcomes. Moreover, myosteatosis (an excess of fat in muscle tissue) is recognized to negatively correlate with muscle mass, strength, and mobility, an increased MELD score, worse median survival, and higher rates of mortality in cirrhotic patients.

    About Hepatic Encephalopathy ("HE"): HE is a metabolically induced, potentially reversible, functional disturbance of the brain condition leading to "brain fog" due to the liver's (primary organ) and muscle's (secondary organ) inability to eliminate myo/neuro toxic ammonia from the systemic circulation and is a significant decompensation event associated with cirrhosis. HE is the most potent risk factor for hospitalization, accidental trauma, and mortality. Clinically overt HE is significantly more prevalent in cirrhotic patients with muscle depletion or decreased muscle strength. Reports suggest low testosterone and fat-free mass depletion are predictors of HE in cirrhotic liver transplant candidates.

    About LPCN 1148: LPCN 1148 is a novel prodrug of testosterone, testosterone laurate ("TL"), for oral administration with compelling potential unique mode of action to improve liver and muscle function, resulting in improved Quality of Life (QOL) while awaiting transplant, decreased hospital admissions, and prevention of progression of decompensation events.

    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, LPCN 1154, 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 Phase 2 clinical study demonstrating 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 or twice daily, TLANDO XR met the typical primary and secondary endpoints. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  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 and completion of additional clinical trials and studies, the potential uses and benefits of LPCN 1148 for the management of symptoms associated with liver cirrhosis, the timing of additional data 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. There can be no assurance that we will choose, or have the ability, to conduct further clinical trials with respect to LPCN 1148 and, ultimately, apply for and receive approval from the FDA to market LPCN 1148 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.

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-patient-dosed-in-its-phase-2-study-with-lpcn-1148-for-management-of-liver-cirrhosis-301449215.html

    SOURCE Lipocine Inc.

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  3. SALT LAKE CITY, Nov. 10, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update.

    Third Quarter and Recent Corporate Highlights

    • Entered into a license agreement with Antares Pharma to commercialize TLANDO in the US
      • Lipocine to receive up to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions
      • Lipocine is entitled to commercial sales milestone payments of up to $160.0 million and tiered royalties on net sales of TLANDO from mid-teens up to 20%
      • Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S.
      • Antares Pharma was also granted an option to license TLANDO XR for development and commercialization in the U.S. for additional licensing fees ($4.0 million), clinical and regulatory milestone payments ($35.0 million), sales milestone payments and royalties (mid-teens up to 20%)
    • The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH")
    • The FDA has affirmed that the resubmission of the New Drug Application ("NDA") for TLANDO will be a Class 1 resubmission, with a two-month FDA review goal period
      • The FDA previously granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
      • The product is not eligible for final approval and marketing in the U.S. until the expiration of the FDA's Orange Book listed exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo®, which expires on March 27, 2022
    • Announced positive topline 36-week results from its Phase 2 proof-of-concept Liver Fat intervention with oral Testosterone ("LiFT") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH
      • Study met its primary endpoint. At 12 weeks, treatment with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF
      • Both LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis
      • Efficacy and safety results from the LiFT study have been accepted for late-breaking presentations at the American Association for the Study of Liver Diseases ("AASLD") The Liver Meeting® on November 12-15, 2021
      • Company intends to meet with the FDA regarding the path forward for an accelerated approval and to discuss Phase 3 study requirements

    Third Quarter Ended September 30, 2021 Financial Results

    Lipocine reported a net loss of $3.1 million, or ($0.03) per diluted share, for the third quarter ended September 30, 2021, compared with a net loss of $4.3 million, or ($0.07) per diluted share, for the third quarter ended September 30, 2020.

    Research and development expenses were $2.4 million for the third quarter ended September 30, 2021, compared with $2.5 million for the third quarter ended September 30, 2020. The decrease for the third quarter of 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study as well as decrease costs related to TLANDO.  These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs. 

    General and administrative expenses were $1.2 million for the third quarter ended September 30, 2021, compared with $1.9 million for the third quarter ended September 30, 2020. The decrease in general and administrative was primarily related to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense. 

    As of September 30, 2021, the Company had $38.7 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

    Subsequent to the end of the third quarter, the Company received an $11.0 million upfront license fee as part of the licensing agreement with Antares Pharma to commercialize TLANDO. 

    Nine Months Ended September 30, 2021 Financial Results

    Lipocine reported a net loss of $13.3 million, or ($0.15) per diluted share, for the nine months ended September 30, 2021, compared with a net loss of $16.5 million, or ($0.32) per diluted share, for the nine months ended September 30, 2020.

    Research and development expenses were $5.4 million for the nine months ended September 30, 2021, compared with $7.3 million for the nine months ended September 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study, a decrease in costs related to TLANDO and a decrease in personnel costs primarily related to reduced stock compensation expense.  These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

    General and administrative expenses were $4.3 million for the nine months ended September 30, 2021, compared with $5.9 million for the nine months ended September 30, 2020.  The decrease in general and administrative expenses was primarily due to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense.  These decreases were offset by an increase in corporate insurance expense.  

    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, LPCN 1154, 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 Phase 2 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 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  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 the receipt of final FDA approval of TLANDO, the timing and amount of sales and development milestone payments and royalties under the License Agreement, the exercise of Antares' option with respect to TLANDO XR, the costs and timing of any post-marketing studies of TLANDO and clinical studies relating to TLANDO XR, our ability to compete in the TRT market, the degree to which TLANDO will gain market share in the TRT market, if at all, Antares Pharma's ability to successfully commercialize TLANDO, the benefits to Lipocine and Antares Pharma under the License Agreement, the potential benefits of TLANDO to patients, Lipocine's product candidates and related clinical trials, 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.

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

    (Unaudited)































    September 30,



    December 31,













    2021



    2020

    Assets









    Current assets:













    Cash and cash equivalents



    $               4,517,105



    $    19,217,382





    Restricted cash



    -



    5,000,000





    Marketable investment securities



    34,145,380



    449,992





    Accrued interest income



    159,230



    391





    Prepaid and other current assets



    1,543,641



    661,258



























    Total current assets



    40,365,356



    25,329,023



















    Other assets



    23,753



    23,753



























    Total assets



    $             40,389,109



    $    25,352,776





































    Liabilities and Stockholders' Equity









    Current liabilities:













    Accounts payable



    $                 725,552



    $      1,597,220





    Accrued expenses



    1,571,012



    1,653,178





    Debt - current portion



    3,135,979



    3,333,333





    Litigation settlement liability - current portion



    1,000,000



    -



























    Total current liabilities



    6,432,543



    6,583,731



















    Debt - non-current portion



    -



    2,257,075

    Warrant liability



    645,478



    1,170,051

    Litigation settlement liability - non-current portion



    500,000



    -



























    Total liabilities



    7,578,021



    10,010,857





































    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; 88,296,360 and 70,041,967 issued















    and 88,290,650 and 70,036,257 outstanding



    8,830



    7,005





    Additional paid-in capital



    218,136,818



    187,407,634





    Treasury stock at cost, 5,710 shares



    (40,712)



    (40,712)





    Accumulated other comprehensive loss



    (3,420)



    -





    Accumulated deficit



    (185,290,428)



    (172,032,008)



























    Total stockholders' equity



    32,811,088



    15,341,919













































    Total liabilities and stockholders' equity



    $             40,389,109



    $    25,352,776

     

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)































    Three Months Ended September 30,



    Nine Months Ended September 30,









    2021



    2020



    2021



    2020























    Revenues:



















    License revenue



    $                 54,994



    $                         -



    $          54,994



    $                          -





    Total revenues



    54,994



    -



    54,994



    -























    Operating expenses:



















    Research and development



    $            2,366,521



    $           2,487,861



    $      5,411,748



    $            7,268,599



    General and administrative



    1,222,146



    1,887,195



    4,281,690



    5,925,991





    Total operating expenses



    3,588,667



    4,375,056



    9,693,438



    13,194,590



























    Operating loss



    (3,533,673)



    (4,375,056)



    (9,638,444)



    (13,194,590)























    Other income (expense):



















    Interest and investment income



    17,264



    5,614



    45,257



    72,729



    Interest expense



    (44,839)



    (84,293)



    (171,241)



    (305,485)



    Unrealized gain (loss) on warrant liability



    479,951



    140,477



    506,208



    (3,025,997)



    Litigation settlement



    -



    -



    (4,000,000)



    -





    Total other income (expense), net



    452,376



    61,798



    (3,619,776)



    (3,258,753)



























    Loss before income tax expense



    (3,081,297)



    (4,313,258)



    (13,258,220)



    (16,453,343)























    Income tax expense



    -



    -



    (200)



    (200)



























    Net loss



    $           (3,081,297)



    $          (4,313,258)



    $   (13,258,420)



    $         (16,453,543)























    Basic loss per share attributable to common stock



    $                   (0.03)



    $                  (0.07)



    $             (0.15)



    $                   (0.32)























    Weighted average common shares outstanding, basic



    88,290,650



    64,833,714



    86,477,640



    52,030,431

    Diluted loss per share attributable to common stock 



    $                   (0.03)



    $                  (0.07)



    $             (0.15)



    $                   (0.32)























    Weighted average common shares outstanding, diluted



    88,290,650



    64,833,714



    86,477,640



    52,030,431























    Comprehensive loss:





















    Net loss



    $           (3,081,297)



    $          (4,313,258)



    $   (13,258,420)



    $         (16,453,543)





    Net unrealized gain (loss) on available-for-sale securities



    (3,234)



    579



    (3,420)



    513



























    Comprehensive loss



    $           (3,084,531)



    $          (4,312,679)



    $   (13,261,840)



    $         (16,453,030)

     

     

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-third-quarter-ended-september-30-2021-301419241.html

    SOURCE Lipocine Inc.

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  4. SALT LAKE CITY, Nov. 4, 2021 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis ("NASH"). LPCN 1144, an oral prodrug of bioidentical testosterone, was recently studied in the Liver Fat intervention with oral Testosterone ("LiFT ") Phase 2 paired biopsy clinical study in patients with confirmed NASH.  Treatments with LPCN 1144 in the LiFT clinical study resulted in robust liver fat reduction, assessed by magnetic resonance imaging, proton density fat fraction ("MRI-PDFF") technique, and showed…

    SALT LAKE CITY, Nov. 4, 2021 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis ("NASH"). LPCN 1144, an oral prodrug of bioidentical testosterone, was recently studied in the Liver Fat intervention with oral Testosterone ("LiFT ") Phase 2 paired biopsy clinical study in patients with confirmed NASH.  Treatments with LPCN 1144 in the LiFT clinical study resulted in robust liver fat reduction, assessed by magnetic resonance imaging, proton density fat fraction ("MRI-PDFF") technique, and showed improvement of liver injury markers with no observed tolerability issues. Additionally, key secondary endpoint results after 36 weeks of treatment in the LiFT clinical study demonstrated that treatments with LPCN 1144 met the NASH resolution regulatory endpoint, showed positive effects in appendicular lean mass and whole-body fat mass and continued to show substantial reductions in markers of liver injury compared to placebo.

    "The granting of Fast Track Designation represents an important recognition by the FDA of LPCN 1144's potential to address a significant unmet need in the treatment of NASH," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We believe the Fast Track Designation will enable us to work closely with the FDA on our development program for NASH, including the design of the Phase 3 program."

    The Fast Track program is designed to accelerate the development and expedite the review of products, such as LPCN 1144, which are intended to treat serious diseases and for which there is an unmet medical need.  Fast Track designation lends eligibility for some, or all, of the following:

    • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
    • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
    • Eligibility for Accelerated Approval and Priority Review if relevant criteria are met
    • Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed

    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-five to thirty percent of the U.S. population is estimated to suffer from NAFLD.  NASH afflicts three to twelve percent of the U.S. population, 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, LPCN 1154, 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 Phase 2 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 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  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 and completion of additional clinical trials and studies, the potential uses and benefits of LPCN 1144 for the treatment of NASH, the timing of additional data, our ability to take advantage of the benefits of Fast Track Designation for LPCN 1144,whether LPCN 1144 will receive accelerated approval from the FDA for LPCN 1144, 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.

     

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  5. SALT LAKE CITY, Nov. 1, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that three abstracts have been selected for poster presentations during the upcoming The Liver Meeting® 2021, organized by the American Association for the Study of Liver Diseases (AASLD) to take place November 12-15, 2021.

    Presentation Details:

    Session Title:

    Late-Breaking Abstract Posters

    Publication Number:     

    LP46

    Poster Title:                

    "LPCN 1144 Therapy Demonstrates Histologic Benefits In The Phase 2 LiFT Study in Non-Alcoholic Steatohepatitis (NASH) Subjects"





    Session Title:            

    Late-Breaking Abstract Posters

    Publication Number:    

    LP47

    Poster Title:                  

    "Safety And Tolerability Of LPCN 1144 Treatment In Biopsy Confirmed NASH Subjects In The Phase 2 LiFT Study"





    Session Title:                 

    NAFLD and NASH: Experimental: Clinical

    Publication Number:     

    1876

    Poster Title:                  

    "LPCN 1144 Improves Body Composition In Biopsy-Confirmed NASH Patients"

    The abstracts will be available for viewing by attendees of The Liver Meeting® 2021 on the AASLD website and the online planner of The Liver Meeting® app November 1, 2021 at 10:00 am ET and will be published in the December issue of HEPATOLOGY.

    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, LPCN 1154, 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 Phase 2 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 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  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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