1. SALT LAKE CITY, Sept. 1, 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 H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.

    H.C. Wainwright 23rd Annual Global Investment Conference September 13-15, 2021

    Presentation time: September 13, 2021 starting at 7:00 a.m. EST

    Webcast link: https://journey.ct.events/view/6ad0ee65-750c-40c8-974f-d653d6d67c25

    A webcast of Lipocine's presentation will be available on-demand as of 7:00 am ET, Monday, September 13, 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, LPCN 1107 and LPCN 1154. 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 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  For more information, please visit www.lipocine.com

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    SOURCE Lipocine Inc.

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  2. SALT LAKE CITY, Aug. 25, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced positive topline 36-week results from its Phase 2 proof of concept LiFT ("Liver Fat intervention with oral Testosterone") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH. Currently, there are no approved treatments for NASH, a leading cause of liver failure and liver transplantation globally. LPCN 1144 comprises an orally delivered prodrug of endogenous testosterone ("T").

    The LiFT clinical study, a prospective, multi-center, randomized, double-blind, placebo-controlled, multi-arm, multi-site trial in the United States, enrolled biopsy-confirmed hypogonadal or eugonadal male NASH subjects with stage F1-F3 fibrosis and a NAFLD Activity Score ≥ 4 for a 36-week treatment period.   Subjects with advanced fibrosis (F2-F3) and steatohepatitis (inflammation on liver biopsy) were also eligible.  Subjects were randomized 1:1:1 to one of three arms (Treatment A, a twice daily oral dose of 142 mg testosterone equivalent; Treatment B, a twice daily oral dose of 142 mg testosterone equivalent formulated with 238 mg of d-alpha tocopherol equivalent; and the third arm, a twice daily matching placebo). 

    The primary endpoint of the LiFT clinical study was change in hepatic fat fraction via MRI-PDFF 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. The LiFT clinical study was not powered to assess statistical significance of any of the secondary endpoints. 

    At 12 weeks, treatments with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF, meeting the pre-specific primary endpoint of the LiFT clinical study.  Statistically significant reduction in liver fat was observed compared to placebo: up to a mean of 9.2% absolute reduction and a 46.8% relative reduction in liver fat. 

    Liver biopsies were performed at baseline ("BL") and after 36 weeks of treatment ("EOS"). Prespecified biopsy analyses include NASH Clinical Research Network ("CRN") scoring as well as a continuous paired ("Paired Technique") and digital technique ("Digital Technique-Fibronest").  All biopsy analyses were performed on the same slides and the reads for the three techniques were done independently. Analysis sets included the NASH Resolution Set (all subjects that have BL and EOS biopsy with NASH at BL [NAS ≥4 with lobular inflammation score ≥ 1 and hepatocyte ballooning score ≥1 at BL] (n=37)), the Biopsy Set (all subjects with baseline and EOS biopsies (n=44)), and the Safety Set (all randomized subjects (n=56)).  

    Both LPCN 1144 treatment arms met with statistical significance the pre-specified accelerated approval regulatory endpoint of NASH resolution with no worsening of fibrosis based on NASH CRN scoring.  Additionally, both treatment arms showed substantial improvement of the observed NASH activity in steatosis, inflammation and ballooning.

    Key results are presented in the following table:

    -Histology NASH CRN Scoring Outcomes1



    Placebo

    (n = 11)

    Treatment A

    (n=13)

    Treatment B

    (n=13)

    NASH Resolution responders, n (%) 2

    1 (9%)

    7 (54%)3

    9, (69%)4

    NASH Resolution with No Worsening of Fibrosis responders, n (%)

    0 (0%)

    6 (46%)3

    9 (69%)5



    1 NASH Resolution Set

    2 Improvement in NASH defined as improvement in ballooning or inflammation, and no worsening of ballooning or inflammation

    3 p < 0.05 vs placebo

    4 p < 0.01 vs placebo

    5 p < 0.001 vs placebo

    Both LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis using Paired Technique, which concurred with the NASH CRN scoring findings (per Biopsy Set; NASH Improvement responders: Placebo – 13%, Treatment A – 60%, Treatment B – 57%; NASH Improvement with No Worsening of Fibrosis responders:  Placebo – 13%, Treatment A – 60%, Treatment B – 57%). 

    The treatment effects on fibrosis improvement need confirmation in a larger study.

    Key fibrosis improvement results are presented in the following table:

    Histopathological Assessment TechniquesX



    Placebo

    (n = 15)

    Treatment A

    (n=15)

    Treatment B

    (n=14)

    NASH CRN: Fibrosis Improvement ≥ 1 Stage with No Worsening of NASH, Responders, n (%)

    6 (40%)

    4 (27%)

    2 (14%)

    Paired Technique: Fibrosis Improvement with No Worsening of NASH,Responders, n (%)

    3 (20%)

    6 (40%)

    8 (57%)

    Digital Technique-FibroNest: Fibrosis Improvement,z Responders, n (%)

    5 (33%)

    12 (80%)

    6 (43%)



    x Biopsy Set

    y Fibrosis improvement on paired reads defined as a score of improvement in fibrosis with a score of no worsening of ballooning, inflammation, or steatosis

    z For Digital Reads (FibroNest - http://www.fibronest.com), improvement defined as a decrease in parenchymal tissue normalized phenotypic fibrosis composite score

     One subject in placebo is missing NASH CRN fibrosis score and is treated as a non-responder

    In both treatment arms substantial reductions in markers of liver injury compared to placebo were observed post four weeks of treatment and were sustained through EOS.  Using all available Safety Set data, alanine aminotransferase ("ALT") decreased up to a mean of 23.4 U/L at EOS from all group mean baseline of 51.5 U/L and aspartate aminotransferase ("AST") decreased up to a mean of 13.3 U/L at EOS from all group mean baseline of 31.9 U/L.

    Positive effects in appendicular lean mass and whole-body fat mass, an indicator overall tissue quality, based on dual-energy X-ray absorptiometry scans were noted in both LPCN 1144 treatment arms.

    During the 36 weeks of treatment, LPCN 1144 was well tolerated with an overall safety profile comparable to placebo. Frequency and severity of treatment emergent adverse events, TEAEs, in both treatment arms were comparable to placebo. Study drug related TEAEs were mild to moderate. Four subjects discontinued due to TEAEs in the placebo arm vs one subject in total across the treatment arms. Cardiovascular events were balanced among groups with hematocrit increases averaging <2% in the treatment arms, no observed thromboembolic events, and comparable blood pressure changes in both treatment arms to placebo. 

    There were no reported cases of hepatocellular carcinoma or Drug Induced Liver Injury ("DILI"). Weight change from baseline, GI adverse events and PSA changes were small and comparable among groups. Additionally, no clinically meaningful changes in lipids in treatment groups were noted compared to placebo, and rates of pedal edema were low and similar in all arms.

    Additionally, all subjects had the option to continue with LPCN 1144 treatment 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.

    "The extent of the LPCN 1144 efficacy results in meeting the NASH resolution regulatory endpoint from the LiFT study are striking with no adverse safety signal. These data strongly support further development of this differentiated 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 delighted by the remarkable efficacy results and the overall safety profile of LPCN 1144 in the  LiFT study, which we believe demonstrate the potential for LPCN 1144 to be the "best in class" option for treating NASH with a discerning benefit to risk profile as required for a chronic therapy," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. "Additionally, the unique benefits of LPCN 1144 in improving body composition may fulfill an unmet medical need.  We look forward to meeting with the FDA regarding the path forward for an accelerated approval and Phase 3 study requirements," said Dr. Patel.

    Conference Call

    Management will host a conference call and webcast today at 8:30 a.m. Eastern time to discuss LPCN 1144 Phase 2 LiFT clinical study key secondary endpoint topline results.  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 September 1, 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 #13722634.  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=146385.  An archive of the webcast will also be available on the webcast page of the Company's website for 90 days.  

    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 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  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 1144 for the treatment of NASH and fibrosis improvement, the timing of additional data, whether LPCN 1144 will be eligible for and 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. There can 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, Aug. 5, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the second quarter ended June 30, 2021, and provided a corporate update.

    Recent Corporate Highlights

    • 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  
    • 36-week biopsy data from the LiFT clinical study are expected in August 2021 
    • Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144  
    • Clinical data from the LiFT clinical study were presented at The International Liver Congress™ 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, which took place June 23-26, 2021 
      • Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects
      • Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects
      • LPCN 1144 was shown to improve body composition in biopsy-confirmed NASH patients
    • The U.S. Food and Drug Administration ("FDA") cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults
      • Top-line results from an ongoing pharmacokinetic ("PK") study to assess dose proportionality are expected in the third quarter of 2021
      • Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021
    • Entered into a global settlement agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between Lipocine and Clarus, as well as the on-going interference proceeding between the two companies
    • Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA
    • Expect the first subject will be dosed in the proof-of-concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021

    Second Quarter Ended June 30, 2021 Financial Results

    Lipocine reported a net loss of $6.8 million, or ($0.08) per diluted share, for the second quarter ended June 30, 2021, compared with a net loss of $6.4 million, or ($0.13) per diluted share, for the second quarter ended June 30, 2020.

    Research and development expenses were $1.5 million for the second quarter ended June 30 2021, compared with $2.3 million for the second quarter ended June 30, 2020. The decrease was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a decrease in personnel expense, which was mainly due to a decrease in stock compensation and bonus expense.  These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

    General and administrative expenses were $1.5 million for the second quarter ended June 30, 2021, compared with $2.0 million for the second quarter ended June 30, 2020. The decrease in general and administrative was primarily related to a decrease in personnel costs, which was mainly due to a decrease in stock compensation and bonus expense, and a decrease in legal expenses. These decreases were offset by increases in corporate insurance and other general and administrative expenses.

    As of June 30, 2021, the Company had $46.6 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.

    Six Months Ended June 30, 2021 Financial Results

    Lipocine reported a net loss of $10.2 million, or ($0.12) per diluted share, for the six months ended June 30, 2021, compared with a net loss of $12.1 million, or ($0.27) per diluted share, for the six months ended June 30, 2020.

    Research and development expenses were $3.0 million for the six months ended June 30, 2021, compared with $4.8 million for the six months ended June 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 the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease in personnel expense, which was mainly due to a decrease in stock compensation expense offset by increases in salaries.  These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

    General and administrative expenses were $3.1 million for the six months ended June 30, 2021, compared with $4.0 million for the six months ended June 30, 2020.  The decrease in general and administrative expenses was primarily due to a decrease in legal costs and a decrease in personnel costs, mainly due a reduction in stock compensation expense. These decreases were offset by an increase in corporate insurance expenses and an increase in other general and administrative expenses.

    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 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 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 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)















    June 30,



    December 31,





    2021



    2020

    Assets











    Current assets:













    Cash and cash equivalents



    $             10,967,713



    $    19,217,382





    Restricted cash



    -



    5,000,000





    Marketable investment securities



    35,672,059



    449,992





    Accrued interest income



    232,568



    391





    Prepaid and other current assets



    283,180



    661,258

















         Total current assets

    47,155,520



    25,329,023















    Other assets



    23,753



    23,753





















         Total assets

    $             47,179,273



    $    25,352,776

































    Liabilities and Stockholders' Equity











    Current liabilities:













    Accounts payable



    $                 906,476



    $      1,597,220





    Accrued expenses



    1,444,188



    1,653,178





    Debt - current portion



    3,957,627



    3,333,333





    Litigation settlement liability - current portion



    2,500,000



    -



















         Total current liabilities



    8,808,291



    6,583,731

















    Debt - non-current portion



    -



    2,257,075



    Warrant liability



    1,125,429



    1,170,051



    Litigation settlement liability - non-current portion



    1,500,000



    -



















         Total liabilities



    11,433,720



    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



    217,986,752



    187,407,634





    Treasury stock at cost, 5,710 shares



    (40,712)



    (40,712)





    Accumulated other comprehensive loss



    (186)



    -





    Accumulated deficit



    (182,209,131)



    (172,032,008)



















         Total stockholders' equity



    35,745,553



    15,341,919































         Total liabilities and stockholders' equity



    $             47,179,273



    $    25,352,776

     

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)







































    Three Months Ended June 30,



     Six Months Ended June 30,













    2021



    2020



    2021



    2020



























    Operating expenses:



















    Research and development



    $            1,464,687



    $           2,268,984



    $      3,045,228



    $            4,780,739



    General and administrative



    1,525,592



    1,953,535



    3,059,544



    4,038,795





    Total operating expenses



    2,990,279



    4,222,519



    6,104,772



    8,819,534































    Operating loss



    (2,990,279)



    (4,222,519)



    (6,104,772)



    (8,819,534)



























    Other income (expense):



















    Interest and investment income



    17,344



    7,177



    27,993



    67,115



    Interest expense



    (57,428)



    (87,847)



    (126,401)



    (221,192)



    Unrealized gain (loss) on warrant liability



    221,322



    (2,066,445)



    26,257



    (3,166,474)



    Litigation settlement



    (4,000,000)



    -



    (4,000,000)



    -





    Total other expense, net



    (3,818,762)



    (2,147,115)



    (4,072,151)



    (3,320,551)































    Loss before income tax expense



    (6,809,041)



    (6,369,634)



    (10,176,923)



    (12,140,085)



























    Income tax expense



    -



    -



    (200)



    (200)































    Net loss



    $           (6,809,041)



    $          (6,369,634)



    $   (10,177,123)



    $         (12,140,285)



























    Basic loss per share attributable to common stock



    $                   (0.08)



    $                  (0.13)



    $             (0.12)



    $                   (0.27)



























    Weighted average common shares outstanding, basic



    88,290,650



    49,769,253



    85,556,110



    45,558,442

    Diluted loss per share attributable to common stock



    $                   (0.08)



    $                  (0.13)



    $             (0.12)



    $                   (0.27)



























    Weighted average common shares outstanding, diluted



    88,290,650



    49,769,253



    85,556,110



    45,558,442



























    Comprehensive loss:





















    Net loss



    $           (6,809,041)



    $          (6,369,634)



    $   (10,177,123)



    $         (12,140,285)





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



    22,273



    (104)



    (186)



    (66)































    Comprehensive loss



    $           (6,786,768)



    $          (6,369,738)



    $   (10,177,309)



    $         (12,140,351)

     

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    SOURCE Lipocine Inc.

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  4. NORTHBROOK, Ill., July 15, 2021 (GLOBE NEWSWIRE) -- Clarus and Lipocine (NASDAQ:LPCN) agreed to settle all outstanding claims in the patent infringement lawsuit brought against Clarus by Lipocine and to further resolve a patent interference between the parties. The action for patent infringement was brought by Lipocine against Clarus arising out of Clarus's marketing of JATENZO®, an oral testosterone replacement product. The interference action involves a Clarus patent application that was pending issuance by the USPTO.

    On May 25, 2021, Clarus's request for summary judgement of invalidity with respect to all of Lipocine's asserted patent claims in the lawsuit was granted. Under terms of the settlement announced today, Lipocine and Clarus…

    NORTHBROOK, Ill., July 15, 2021 (GLOBE NEWSWIRE) -- Clarus and Lipocine (NASDAQ:LPCN) agreed to settle all outstanding claims in the patent infringement lawsuit brought against Clarus by Lipocine and to further resolve a patent interference between the parties. The action for patent infringement was brought by Lipocine against Clarus arising out of Clarus's marketing of JATENZO®, an oral testosterone replacement product. The interference action involves a Clarus patent application that was pending issuance by the USPTO.

    On May 25, 2021, Clarus's request for summary judgement of invalidity with respect to all of Lipocine's asserted patent claims in the lawsuit was granted. Under terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v. Clarus Therapeutics, Inc., Civil Action No. 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware. Additionally, both parties have reached an agreement on the interference, captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 and presently pending in the USPTO. The terms of the settlement remain confidential but do not involve any payment by Clarus to Lipocine.

    About Clarus Therapeutics, Inc.

    Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus's first commercial product, JATENZO, was launched in early 2020. For more information, visit www.clarustherapeutics.com and www.jatenzo.com

    Forward-Looking Statements

    Certain statements made in this press release are "forward-looking statements" within the meaning of the federal securities laws, including statements about the parties' ability to close the proposed business combination and related transactions, the anticipated benefits of the proposed business combination, and the financial condition, results of operations, earnings outlook and prospects of Blue Water and/or the proposed business combination and related transactions and may include statements for the period following the consummation of the proposed business combination and related transactions. In addition, any statements that refer to projections (financial or otherwise), forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as "plan," "believe," "expect," "anticipate," "intend," "outlook," "estimate," "forecast," "project," "continue," "could," "may," "might," "possible," "potential," "predict," "should," "would" and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking.

    The forward-looking statements are based on the current expectations of the management of Blue Water and Clarus Therapeutics, as applicable, and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Clarus Therapeutics' ability to increase sales of JATENZO, secure favorable reimbursement coverage for such sales and expand its product offerings to include a pipeline of androgen and metabolic therapies for men and women, including orphan indications; the ability to complete the proposed business combination and to obtain approval from Blue Water's stockholders or satisfy other closing conditions in the definitive merger agreement; the outcome of any legal proceedings that may be instituted against Blue Water or Clarus related to the merger agreement or the proposed transaction; the ability to maintain the listing of Blue Water's securities on a national securities exchange; the amount of any redemptions by existing holders of Blue Water's common stock; the ability to recognize the anticipated benefits of the business combination; other risks and uncertainties included under the header "Risk Factors" in the registration statement on Form S-4 to be filed by Blue Water, in the final prospectus of Blue Water for its initial public offering dated December 16, 2020 and in Blue Water's other filings with the SEC.

    Clarus Investor Relations Contact:

    Kara Stancell

    Clarus Therapeutics, Inc.

    555 Skokie Blvd., Suite 340

    Northbrook, IL 60062

    (847) 562-4300 X206

    kstancell@clarustherapeutics.com

      ###

    About JATENZO

    Indication

    JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

    Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

    Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

    Limitation of use

    Safety and efficacy of JATENZO in males less than 18 years old have not been established.

    IMPORTANT SAFETY INFORMATION

    WARNING: INCREASES IN BLOOD PRESSURE

    • JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
    • Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.
    • Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
    • Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

    CONTRAINDICATIONS

    JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

    WARNINGS AND PRECAUTIONS

    • Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently.
    • Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
    • Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management.
    • Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
    • Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO.
    • Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated.
    • Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
    • Gynecomastia may develop and persist in patients being treated for hypogonadism.
    • Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease.
    • Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy.
    • Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients.
    • Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
    • Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials.

    ADVERSE EVENTS

    The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

    These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at www.jatenzo.com.

    © 2021 Clarus Therapeutics, Inc. All rights reserved.

     



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  5. SALT LAKE CITY, July 14, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has entered into a global settlement and license agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies.

    Under the terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware.   Additionally, both parties have reached an agreement on the interference proceedings captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 presently pending in the U.S. Patent and Trademark. The terms of the settlement remain confidential.

    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 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  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 timing and results of ongoing litigation and our responses thereto and our ability to maintain and utilize our intellectual property. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, risks related to ongoing litigation relating to our intellectual property 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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  6. SALT LAKE CITY, July 6, 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 Ladenburg Thalmann Healthcare Conference. The conference will be held virtually. Presentation details are below.

    Ladenburg Thalmann Healthcare Conference July 13-14

    Presentation time:      July 13, 2021 starting at 11:00am ET

    Webcast:     https://wsw.com/webcast/ladenburg7/lpcn/2414031 

    The webcast of this presentation 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, 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 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  For more information, please visit www.lipocine.com.   

     

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  7. SALT LAKE CITY, June 23, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that clinical data will be presented at The International Liver Congress™ 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, on June 23-26, 2021. 

    1. Title: Oral LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects: Results of a Phase 2 randomized controlled study Low Testosterone in Males may Warrant Liver Health Assessment Intervention

    Session Type: Poster Session

    Category: NAFLD: Therapy

    Date: June 23, 2021 8:00 a.m. E.T. to 6:00 p.m. C.E.T

    ePoster Session: June 25, 2021 11:30 a.m. C.E.T.



    2. Title: High prevalence of low normal or overtly hypogonadal levels of testosterone observed in histologically established NASH subjects in LiFT Study

    Session Type: Poster Session

    Category: NAFLD: Therapy

    Date: June 23, 2021 8:00 a.m. E.T. to 6:00 p.m. C.E.T



    3. Title: LPCN 1144 improves body composition in biopsy-confirmed NASH patients

    Session Type: Poster Session

    Category: Late Breaker: General Hepatology

    Date: June 23, 2021 8:00 a.m. E.T. to 6:00 p.m. C.E.T

    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 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 1154 is an oral neurosteroid targeted for the treatment of depressive disorders. 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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  8. SALT LAKE CITY, June 16, 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 Human Health Innovation Conference. The conference will be held virtually. Presentation details are below.

    Raymond James Human Health Innovation Conference June 21-23

    Presentation time:       June 21, 2021 starting at 12:40 PM ET         

    Webcast link:              https://kvgo.com/rj-health/lipocine-inc-june-2021

    The webcast of this presentation 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, 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 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  For more information, please visit www.lipocine.com.   

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  9. SALT LAKE CITY, June 14, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults.

    A pharmacokinetic ("PK") study to assess dose proportionality is planned to start in July 2021 with top-line results expected in the third quarter of 2021.  Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to occur with the first subject dosed in the fourth quarter of 2021.

    PPD, a major depressive disorder that is under diagnosed in US, impacts approximately 1 in 7 women after giving birth. PPD can lead to devastating consequences for a woman, her newborn and her family. Currently, there is no oral therapy approved for the treatment of PPD. The active moiety in LPCN 1154 is an endogenous positive allosteric modulator of γ-aminobutyric acid ("GABAA") receptor. LPCN 1154 is expected to be an "at home" treatment with easier treatment access than the current standard of care invasive option that requires hospitalization with significant limitations. Moreover, LPCN 1154 is expected to provide the required level of privacy for a mother, avoiding bonding/breast feeding interruptions due to the required hospitalizations for the current option.

    "We are eager to leverage our unique oral-enabling technology platform to embark upon a program in neuroendocrinology for a leading neuropsychiatric indication with a high unmet need," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. "We believe LPCN 1154 has the potential to provide a suitable option for all women in need of PPD therapy, including breastfeeding mothers."

    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 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression.  For more information, please visit www.lipocine.com.   

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products including LPCN 1154, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials including the Phase 2 clinical study with LPCN 1154, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, risk related to on-going litigation and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

     

     

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  10. SALT LAKE CITY, June 7, 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 Lytham Partners Summer 2021 Investor Conference. The conference will be held virtually. Presentation details are below.

    Lytham Partners Summer 2021 Investor Conference June 14-16

    Presentation time:

    June 14, 2021 starting at 3:30 PM ET

    Webcast link:

    https://www.webcaster4.com/Webcast/Page/2641/41460

    The webcast of this presentation 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.   

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  11. SALT LAKE CITY, May 26, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States District Court for the District of Delaware ("Court") has granted Clarus Therapeutics, Inc.'s ("Clarus") motion for Summary Judgment, finding the asserted claims of Lipocine's U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112.  Clarus still has remaining claims before the Court.

    "We are extremely disappointed in the court's decision and believe the ruling is contrary to the established law of Section 112.  We continue to believe in the strength and validity of our intellectual property," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.  "We are in the process of evaluating the court's decision and determining next steps."

    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 the timing and results of ongoing litigation and our responses thereto and our ability to maintain and utilize our intellectual property. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, risks related to ongoing litigation relating to our intellectual property 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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  12. NORTHBROOK, Ill., May 25, 2021 /PRNewswire/ -- Today, Federal Circuit Judge William C. Bryson, a Senior Circuit Judge of the U.S. Court of Appeals for the Federal Circuit, sitting by designation in the U.S. District Court for the District of Delaware, granted Clarus's motion for summary judgment against Lipocine, Inc. ((", Lipocine", , NASDAQ:LPCN) for failure to provide adequate written description of Lipocine's asserted patent claims.  In his decision, which gives Clarus an unequivocal win, Judge Bryson found all of the asserted Lipocine patent claims invalid.  Clarus's defense of inequitable conduct, to be tried before Judge Bryson, remains pending, and its disposition is expected to be addressed by Clarus and the Court at a future date…

    NORTHBROOK, Ill., May 25, 2021 /PRNewswire/ -- Today, Federal Circuit Judge William C. Bryson, a Senior Circuit Judge of the U.S. Court of Appeals for the Federal Circuit, sitting by designation in the U.S. District Court for the District of Delaware, granted Clarus's motion for summary judgment against Lipocine, Inc. ((", Lipocine", , NASDAQ:LPCN) for failure to provide adequate written description of Lipocine's asserted patent claims.  In his decision, which gives Clarus an unequivocal win, Judge Bryson found all of the asserted Lipocine patent claims invalid.  Clarus's defense of inequitable conduct, to be tried before Judge Bryson, remains pending, and its disposition is expected to be addressed by Clarus and the Court at a future date. 

    The action for patent infringement was brought by Lipocine against Clarus on April 2, 2019, arising out of Clarus's marketing of JATENZO, an oral testosterone replacement product approved by the FDA in March of 2019, and launched in March of 2020. Lipocine previously dismissed infringement allegations against Clarus on two other Lipocine patents. 

    "Judge Bryson's decision is extremely gratifying and completely disposes of Lipocine's infringement claims, which Clarus viewed from Day 1 as being without merit," said Dr. Robert Dudley, Clarus's Chairman, CEO, and President. "We thank the Court for its carefully reasoned judgment in favor of Clarus."

    "Clarus is focused on dedicating all of our resources to the evolution of medicines that empower people to live their best every day," added Dr. Dudley. "With this decision, Clarus continues to move forward with its marketing of JATENZO and broadening its pipeline beyond men's health."

    About Clarus Therapeutics, Inc.

    Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus's first commercial product, JATENZO, was launched in early 2020. For more information, visit www.clarustherapeutics.com and www.jatenzo.com

    Forward-Looking Statements

    Certain statements made in this press release are "forward-looking statements" within the meaning of the federal securities laws, including statements about the parties' ability to close the proposed business combination and related transactions, the anticipated benefits of the proposed business combination, and the financial condition, results of operations, earnings outlook and prospects of Blue Water and/or the proposed business combination and related transactions and may include statements for the period following the consummation of the proposed business combination and related transactions. In addition, any statements that refer to projections (financial or otherwise), forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as "plan," "believe," "expect," "anticipate," "intend," "outlook," "estimate," "forecast," "project," "continue," "could," "may," "might," "possible," "potential," "predict," "should," "would" and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking.

    The forward-looking statements are based on the current expectations of the management of Blue Water and Clarus Therapeutics, as applicable, and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Clarus Therapeutics' ability to increase sales of JATENZO, secure favorable reimbursement coverage for such sales and expand its product offerings to include a pipeline of androgen and metabolic therapies for men and women, including orphan indications; the ability to complete the proposed business combination  and to obtain approval from Blue Water's stockholders or satisfy other closing conditions in the definitive merger agreement; the outcome of any legal proceedings that may be instituted against Blue Water or Clarus related to the merger agreement or the proposed transaction; the ability to maintain the listing of Blue Water's securities on a national securities exchange; the amount of any redemptions by existing holders of Blue Water's common stock; the ability to recognize the anticipated benefits of the business combination; other risks and uncertainties included under the header "Risk Factors" in the registration statement on Form S-4 to be filed by Blue Water, in the final prospectus of Blue Water for its initial public offering dated December 16, 2020 and in Blue Water's other filings with the SEC.

    Media Contact:

    Russo Partners

    David Schull

    12 West 27th Street, 4th Floor

    New York, NY 10001

    (858) 717-2310

    david.schull@russopartnersllc.com

    Clarus Investor Relations Contact:

    Ric Peterson

    Clarus Therapeutics, Inc.

    555 Skokie Blvd., Suite 340

    Northbrook, IL  60062

    (847) 562-4300

    rpeterson@clarustherapeutics.com

    About JATENZO

    Indication

    JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

    Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

    Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

    Limitation of use

    Safety and efficacy of JATENZO in males less than 18 years old have not been established.

    IMPORTANT SAFETY INFORMATION

    WARNING: INCREASES IN BLOOD PRESSURE

    • JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
    • Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.
    • Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
    • Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

    CONTRAINDICATIONS

    JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer.  JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

    WARNINGS AND PRECAUTIONS

    • Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently.
    • Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
    • Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management.
    • Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
    • Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO.
    • Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated.
    • Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
    • Gynecomastia may develop and persist in patients being treated for hypogonadism.
    • Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease.
    • Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy.
    • Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients.
    • Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
    • Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials.

    ADVERSE EVENTS

    The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

    These are not all of the risks associated with JATENZO.  For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.  You can also obtain information regarding Jatenzo at www.jatenzo.com.

    © 2021 Clarus Therapeutics, Inc. All rights reserved.

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    SOURCE Clarus Therapeutics

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  13. 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.   

     

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    SOURCE Lipocine Inc.

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  14. 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)

     

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    SOURCE Lipocine Inc.

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  15. 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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  16. 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.

     

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  17. 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.   

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  18. SALT LAKE CITY, Jan. 28, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the closing of an underwritten public offering of 16,428,571 shares of its common stock, offered at a price of $1.75 to the public, which included the exercise in full by the underwriters of their option to purchase 2,142,857 additional shares of common stock at the public offering price. Gross proceeds to Lipocine were approximately $28.7 million before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

    Raymond James & Associates, Inc. acted as sole book-running manager and Ladenburg Thalmann & Co. Inc. acted as co-manager for the public offering.

    The shares were offered pursuant to an effective shelf registration statement on Form S-3 (No. 333-250072) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 23, 2020. A prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's web site at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at prospectus@raymondjames.com.

    About Lipocine Inc.

    Lipocine Inc. ("Lipocine") 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 U.S. Food and Drug Administration (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 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.

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  19. SALT LAKE CITY, Jan. 26, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the pricing of an underwritten public offering of 14,285,714 shares of its common stock, offered at a price of $1.75 to the public. Additionally, the Company has granted the underwriters a 30-day option to purchase up to an additional 2,142,857 shares of common stock. All of the shares in the offering are being offered by the Company. The offering is expected to close on or about January 28, 2021, subject to customary closing conditions. The gross proceeds to the Company from this offering are expected to be approximately $25.0 million, before deducting underwriting…

    SALT LAKE CITY, Jan. 26, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the pricing of an underwritten public offering of 14,285,714 shares of its common stock, offered at a price of $1.75 to the public. Additionally, the Company has granted the underwriters a 30-day option to purchase up to an additional 2,142,857 shares of common stock. All of the shares in the offering are being offered by the Company. The offering is expected to close on or about January 28, 2021, subject to customary closing conditions. The gross proceeds to the Company from this offering are expected to be approximately $25.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. This amount assumes no exercise of the underwriters' option.

    The Company intends to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include additions to working capital and capital expenditures. The Company has not yet determined the amount of net proceeds to be used specifically for any particular purpose or the timing of these expenditures.

    Raymond James & Associates, Inc. is acting as sole book-running manager and Ladenburg Thalmann & Co. Inc. is acting as co-manager for the public offering.

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-250072) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 23, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's web site at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, and when available, copies of the final prospectus supplement and accompanying prospectus may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at prospectus@raymondjames.com

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Lipocine Inc.

    Lipocine Inc. ("Lipocine") 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 U.S. Food and Drug Administration (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 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, including statements regarding the closing of the proposed offering of securities, our intended use of proceeds and other statements that are not historical facts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the offering of common stock may not close, the funds raised are uncertain, the funds raised, if any, may not meet our needs and the terms may not be advantageous to us, 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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  20. SALT LAKE CITY, Jan. 25, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it intends to offer shares of its common stock for sale in an underwritten public offering. In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering solely to cover over-allotments, if any. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Lipocine.

    SALT LAKE CITY, Jan. 25, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it intends to offer shares of its common stock for sale in an underwritten public offering. In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering solely to cover over-allotments, if any. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Lipocine.

    We intend to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include additions to working capital and capital expenditures.

    Raymond James & Associates, Inc. is acting as sole manager for the public offering.

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-250072) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 23, 2020. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at prospectus@raymondjames.com. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Lipocine

    Lipocine Inc. ("Lipocine") 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 U.S. Food and Drug Administration (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 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, including statements regarding Lipocine's announced offering of securities, expected proceeds from such offering, its intended use of proceeds and other statements that are not historical facts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the offering of common stock may not close, the funds raised are uncertain, the funds raised, if any, may not meet our needs and the terms may not be advantageous to us, 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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  21. 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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  22. 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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  23. 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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  24. 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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  25. 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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  26. SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: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 tentative approval to TLANDO, its oral testosterone product for testosterone replacement therapy ("TRT") 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).  In granting tentative approval, the FDA has concluded that TLANDO has met all required quality, safety and efficacy standards necessary for approval, but TLANDO has not received final approval…

    SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: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 tentative approval to TLANDO, its oral testosterone product for testosterone replacement therapy ("TRT") 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).  In granting tentative approval, the FDA has concluded that TLANDO has met all required quality, safety and efficacy standards necessary for approval, but TLANDO has not received final approval and is not eligible for final approval and marketing in the U.S. until the expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo®, which expires on March 27, 2022. Lipocine is currently reviewing FDA's tentative approval of TLANDO and remains committed to taking appropriate actions with the goal of receiving final approval to permit the launch of TLANDO.  The FDA has also required Lipocine to conduct certain post-marketing studies to (i) assess patient understanding of key risks relating to TLANDO and (ii) evaluate development of adrenal insufficiency with chronic TLANDO therapy.

    "We are pleased to have received this tentative approval for TLANDO. The tentative approval is supported by a strong clinical and CMC data package. This is an important step towards getting our oral TRT no-titration option to patients. We are committed to working towards obtaining final approval of TLANDO," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.  Dr. Patel further stated, "We believe that TLANDO represents a differentiated TRT for treating hypogonadism in men, with the potential to both improve patient compliance and overcome inadvertent testosterone transference and pulmonary oil micro-embolism risks, effects often associated with existing non-oral treatments."

    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 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, 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 timing and receipt of final approval of TLANDO, the expiration of exclusivity rights of third party products, the timing of completion of clinical trials and other studies, the regulatory approval process 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 grant final approval for TLANDO, that the FDA will not approve any of our products, risks related to exclusivity granted by the FDA to competing 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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  27. SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that an independent contractor posted on Lipocine's website (www.lipocine.com), without authorization from Lipocine, statements suggesting that TLANDO was approved by the U.S. Food and Drug Administration ("FDA"). TLANDO has not received final approval from the FDA. Upon learning of the unauthorized posting to its website, Lipocine deleted the incorrect posting.

     

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  28. SALT LAKE CITY, Dec. 4, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it is continuing to work towards taking action on the TLANDO New Drug Application ("NDA") during the week of December 7, 2020.  However, the Company cannot assure that the FDA will act in that time frame. 

    TLANDO is the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and it is currently under review by the FDA.  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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials, the expected timing of an FDA decision with regards to TLANDO, and 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 act on TLANDO in the time frame expected and the risk that the FDA will not approve TLANDO or 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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  29. SALT LAKE CITY, Nov. 10, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    Third Quarter and Recent Corporate Highlights

    • Completed patient enrollment in the LPCN 1144 Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, a paired-biopsy study in confirmed pre-cirrhotic NASH subjects
      • Top-line results for change in liver fat data measured by MRI-PDFF (primary endpoint) expected in January 2021 and 36-week biopsy and MRI-PDFF data expected mid-2021
    • Announced the peer-reviewed publication of LPCN 1144 Liver Fat Study results, "LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease in Hypogonadal Males" in Hepatology Communications
    • Presented two abstracts at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America ("SMSNA")
      • A study on the potential use of oral testosterone in COVID-19 highlighted key clinical evidence suggesting that low testosterone levels may play an important role on clinical outcomes
      • Results from a 24-day, open-label, single-arm, multicenter study confirming the validity of a fixed dose approach to orally administering TLANDO™ in hypogonadal men without the need for dose titration.

    Ongoing Activities and Upcoming Milestones

    • Presenting results from a preclinical study investigating LPCN 1144 treatment on hepatic fibrosis and non-alcoholic steatohepatitis ("NASH") features will be presented at The Liver Meeting Digital Experience™, hosted by the American Association for the Study of Liver Diseases ("AASLD") on November 13, 2020
    • Announcing decision from U.S. Food and Drug Administration ("FDA") on the New Drug Application ("NDA") for TLANDO™

    Third Quarter Ended September 30, 2020 Financial Results

    Lipocine reported a net loss of $4.3 million, or ($0.07) per basic and diluted share, for the quarter ended September 30, 2020, compared with a net loss of $3.1 million, or ($0.12) per basic and diluted share, in the quarter ended September 30, 2019.

    Research and development expenses were $2.5 million for the quarter ended September 30, 2020, compared with $1.7 million for the quarter ended September 30, 2019. The increase in research and development expenses during the three months ended September 30, 2020 was primarily due to a $280,000 increase in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a $278,000 increase in commercial manufacturing costs related to TLANDO, a $160,000 increase in personnel expense, as well as increases in other R&D expenses of $56,000.

    General and administrative expenses were $1.9 million for the quarter ended September 30, 2020, compared with $1.4 million for the quarter ended September 30, 2019. The increase in general and administrative expenses during the three months ended September 30, 2020 was primarily due to a $259,000 increase in legal costs, a $240,000 increase in personnel costs, and a $4,000 increase in other general and administrative expenses. These increases were offset by a $28,000 decrease marketing expense and a $17,000 decrease in administrative travel expenses.

    As of September 30, 2020, we had $18.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million at December 31, 2019. Additionally, as of September 30, 2020 and December 31, 2019 we had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA.

    Nine Months Ended September 30, 2020 Financial Results

    Lipocine reported a net loss of $16.5 million, or ($0.32) per basic and diluted share, for the nine months ended September 30, 2020, compared with a net loss of $9.7 million, or ($0.40) per basic and diluted share, for the nine months ended September 30, 2019.

    Research and development expenses were $7.3 million for the nine months ended September 30, 2020, compared with $5.6 million for the nine months ended September 30, 2019. The increase in research and development expenses during the nine months ended September 30, 2020 was primarily due to a $2.9 million increase in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a $430,000 increase in personnel expense, and a $50,000 increase in other research and development expenses. These increases were offset by a $1.7 million decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study in the first half of 2019, a $50,000 decrease in contract manufacturing costs for LPCN 1107, and a $46,000 decrease in costs for TLANDO XR.

    General and administrative expenses were $5.9 million for the nine months ended September 30, 2020, compared with $4.0 million for the nine months ended September 30, 2019. The increase in general and administrative expenses during the nine months ended September 30, 2020 was primarily due to a $1.9 million increase in legal costs and a $228,000 increase in personnel costs. These increases were offset by a $77,000 decrease in administrative travel expense, a $68,000 decrease in marketing expense and a $43,000 decrease in other general and administrative expenses.

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO. 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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the FDA's review of our NDA related to TLANDO, 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.

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

    (Unaudited)































    September 30,



    December 31,













    2020



    2019

    Assets









    Current assets:













    Cash and cash equivalents



    $             12,938,186



    $      9,728,523





    Restricted cash



    5,000,000



    5,000,000





    Marketable investment securities



    5,861,797



    4,340,041





    Accrued interest income



    11,216



    16,522





    Prepaid and other current assets



    915,575



    545,887



























    Total current assets



    24,726,774



    19,630,973



















    Property and equipment, net of accumulated depreciation of









       $1,142,540 and $1,140,143, respectively



    1,157



    3,554

    Other assets



    23,753



    23,753



























    Total assets



    $             24,751,684



    $    19,658,280





































    Liabilities and Stockholders' Equity









    Current liabilities:













    Accounts payable



    $               1,047,729



    $      1,182,241





    Accrued expenses



    1,534,495



    449,303





    Debt - current portion



    3,206,290



    3,333,333



























    Total current liabilities



    5,788,514



    4,964,877



















    Debt - non-current portion



    3,151,010



    3,814,407

    Warrant liability



    1,303,859



    4,591,200



























    Total liabilities



    10,243,383



    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; 65,691,860 and 37,655,175 issued















    and 65,686,150 and 37,649,465 outstanding



    6,569



    3,766





    Additional paid-in capital



    182,062,701



    157,391,969





    Treasury stock at cost, 5,710 shares



    (40,712)



    (40,712)





    Accumulated other comprehensive gain (loss)



    475



    (38)





    Accumulated deficit



    (167,520,732)



    (151,067,189)



























    Total stockholders' equity



    14,508,301



    6,287,796













































    Total liabilities and stockholders' equity



    $             24,751,684



    $    19,658,280

     

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)







































    Three Months Ended September 30,



    Nine Months Ended September 30,













    2020



    2019



    2020



    2019



























    Revenues:





















    License revenue



    $                          -



    $              164,990



    $                   -



    $               164,990





    Total revenues



    -



    164,990



    -



    164,990



























    Operating expenses:



















    Research and development



    $            2,487,861



    $           1,713,417



    $      7,268,599



    $            5,627,383



    General and administrative



    1,887,195



    1,427,261



    5,925,991



    3,989,645





    Total operating expenses



    4,375,056



    3,140,678



    13,194,590



    9,617,028































    Operating loss



    (4,375,056)



    (2,975,688)



    (13,194,590)



    (9,452,038)



























    Other income (expense):



















    Interest and investment income



    5,614



    98,988



    72,729



    348,833



    Interest expense



    (84,293)



    (183,500)



    (305,485)



    (611,864)



    Gain (loss) on warrant liability



    140,477



    -



    (3,025,997)



    -





    Total other expense, net



    61,798



    (84,512)



    (3,258,753)



    (263,031)































    Loss before income tax expense



    (4,313,258)



    (3,060,200)



    (16,453,343)



    (9,715,069)



























    Income tax expense



    -



    -



    (200)



    (200)































    Net loss



    $           (4,313,258)



    $          (3,060,200)



    $   (16,453,543)



    $           (9,715,269)



























    Basic loss per share attributable to common stock



    $                   (0.07)



    $                  (0.12)



    $             (0.32)



    $                   (0.40)



























    Weighted average common shares outstanding, basic



    64,833,714



    24,911,908



    52,030,431



    24,301,045

    Diluted loss per share attributable to common stock 



    $                   (0.07)



    $                  (0.12)



    $             (0.32)



    $                   (0.40)



























    Weighted average common shares outstanding, diluted



    64,833,714



    24,911,908



    52,030,431



    24,301,045



























    Comprehensive loss:





















    Net loss



    $           (4,313,258)



    $          (3,060,200)



    $   (16,453,543)



    $           (9,715,269)





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



    579



    (2,656)



    513



    1,224































    Comprehensive loss



    $           (4,312,679)



    $          (3,062,856)



    $   (16,453,030)



    $           (9,714,045)

     

     

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  30. SALT LAKE CITY, Nov. 6, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it is working towards taking action on the TLANDO New Drug Application ("NDA") on or about the week of  November 30, 2020. However, the Company cannot assure that the FDA will act in that time frame. 

    TLANDO is the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and it is currently under review by the FDA.  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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials, the expected timing of an FDA decision with regards to TLANDO, and 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 act on TLANDO in the time frame expected and the risk that the FDA will not approve TLANDO or 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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  31. SALT LAKE CITY, Nov. 5, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present a poster with results from a preclinical study investigating LPCN 1144 treatment on hepatic fibrosis and non-alcoholic steatohepatitis ("NASH") features at The Liver Meeting Digital Experience™, hosted by the American Association for the Study of Liver Diseases ("AASLD"). The poster will be available virtually on Friday, November 13, 2020, Room 1970 between 6:00 AM - 11:55 PM ET.

    "It has been shown that low testosterone levels in men are independently associated with the presence and severity of NASH," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. Dr. Patel further stated, "These preclinical data add to our understanding of the effects of oral testosterone on the liver, showing that LPCN 1144 improved high fat diet induced hepatic fibrosis and NASH features."

    Lipocine recently announced completion of enrollment in its LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study, a paired-biopsy study investigating LPCN 1144 in confirmed NASH subjects.  The Company expects to report top-line change in liver fat data measured by MRI-PDFF (primary endpoint) in January 2021.  Subsequently, 36-week biopsy and MRI-PDFF data are expected mid-2021.  For more information, refer to NCT04134091.

    LPCN 1144 Treatment Potential Assessment in a High Fat Diet Induced Rabbit Model of Hepatic Fibrosis and NASH (Kilyoung Kim et al)

    The goal of this study was to evaluate the treatment potential of daily LPCN 1144 on histological and biochemical features of NASH and fibrosis using a high fat diet ("HFD")-induced NASH model. Male rabbits were randomly assigned to 5 groups: regular diet ("RD"), HFD, HFD+LPCN 1144 vehicle ("VEH"), HFD+LPCN 1144, and HFD+LPCN 1144+a-tocopherol ("LPCN 1144+AT). The study duration was 12 weeks.

    Both the LPCN 1144 and LPCN 1144+AT arms improved mean histological scores of NASH with fibrosis compared to HFD arm. Importantly, the fibrosis percentage (in sampled liver tissue area) was significantly improved in both the LPCN 1144 (p<0.05) and LPCN 1144+AT (p=0.05) treatment arms vs the HFD arm. Both LPCN 1144 and LPCN 1144+AT arms also reduced HFD-induced elevated liver mRNA inflammation and fibrosis markers. Furthermore, LPCN 1144 concomitant treatment improved insulin resistance, visceral adiposity, and low testosterone (metabolic dysfunctions) induced by HFD.

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO. 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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related 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.

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  32. SALT LAKE CITY, Oct. 14, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present results from studies suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men as well as the safety and efficacy of TLANDO™, an oral testosterone replacement therapy without a dose titration requirement, at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America ("SMSNA"). Lipocine will outline the possible mechanisms and clinical evidence that suggests men with low testosterone have poor COVID-19 outcomes, and the rationale of using an oral testosterone therapy for…

    SALT LAKE CITY, Oct. 14, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present results from studies suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men as well as the safety and efficacy of TLANDO™, an oral testosterone replacement therapy without a dose titration requirement, at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America ("SMSNA"). Lipocine will outline the possible mechanisms and clinical evidence that suggests men with low testosterone have poor COVID-19 outcomes, and the rationale of using an oral testosterone therapy for men with COVID-19. Results from the previously completed dose validation ("DV") study of a fixed dose TLANDO in hypogonadal males will also be presented at the meeting.  The presentations will take place virtually on November 9, 2020 from 7:00 p.m.9:00 p.m. EST during Session 2 (Androgens and Ejaculation/Orgasm Disorders). 

    https://www.smsna.org/V1/2020/program/scientific-program?where_person=44

    https://www.smsna.org/V1/2020/program/scientific-program?where_person=42

    "We know that while COVID-19 infection rates are comparable between men and women, men are developing severe symptoms and dying at a significant higher rate than women. Furthermore, men with comorbidities commonly associated with lower testosterone are at greater risk for severe disease and death," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc.  "The presentation on COVID-19 highlight key clinical evidences suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men. Based on the published data, the use of oral testosterone with the goal of achieving physiological testosterone levels should be evaluated in clinical trials of COVID-19."

    Dr. Anthony DelConte, Chief Medical Director of Lipocine further stated, "TLANDO will be the first oral testosterone for treatment hypogonadism without titration requirement. It is expected to be easy to prescribe and use." Dr. DelConte added, "The SMSNA presentation on TLANDO highlights the key safety and efficacy data from multiple clinical studies supporting TLANDO's ability to effectively restore testosterone levels in hypogonadal men without need for any dose adjustment."

    Is Oral Testosterone a Potential Treatment for COVID-19 in Men? (Benjamin J. Bruno et al)

    The authors performed a literature search to understand the possible mechanisms and clinical evidence concerning testosterone levels in COVID-19 patients.  A recent clinical study investigating testosterone levels in men with COVID-19 found 80% of men who died due to COVID-19 had low total or bioavailable testosterone levels at the time of hospital admission. Those with severe Acute Respiratory Distress Syndrome ("ARDS") had acutely depressed total testosterone compared to patients who did not exhibit severe ARDS. The mean total testosterone levels for men who required invasive ventilation was 29 ng/dL (normal range ~300-1100 ng/dL), whereas those who were discharged from the ICU had mean total T of 254 ng/dL at the time of ICU admission.

    In comparison to other routes of testosterone administration, oral testosterone therapy may be the most convenient and suitable for acute treatment of COVID-19 in both inpatient and outpatient settings. Oral testosterone can rapidly increase the transiently reduced hormone. This may prevent unfavorable COVID-19 outcomes through multiple mechanisms of action and its effects on the lung, immune cells, and liver.

    TLANDO, Oral Testosterone Replacement Therapy Without Dose Titration Requirement (Anthony DelConte et al)

    The authors reviewed a 24 day, open-label, single-arm, multicenter study (NCT03242590) which was designed to assess whether TLANDOTM, an oral TRT , can safely and effectively restore testosterone levels in hypogonadal men without the need for any dose adjustment.  Ninety-five subjects were enrolled and received 225 mg TLANDO orally twice a day, with 94 of these subjects completing the study.  A majority (81%) of hypogonadal subjects achieved average testosterone levels within the normal range post ~3 weeks of treatment without dose adjustment (95% CI 72% - 88%).  The results confirm the validity of a fixed dose approach without the need for dose titration to orally administering TLANDO.

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO. 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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related 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.

     

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  33. SALT LAKE CITY, Sept. 29, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, will provide an update on LPCN 1144, an oral product of bioidentical testosterone being evaluated for the treatment of non-cirrhotic, NASH at the H.C. Wainwright 4th Annual NASH Investor Conference, being held virtually on October 5, 2020.

    Presentation Details

    Date:               Monday, October 5

    Time:               3:30pm4:00pm Eastern Time

    Webcast:         https://journey.ct.events/view/edcdaa3d-4910-4583-81d2-9d4c0fe165cd

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and is awaiting FDA decision on its NDA. 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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

     

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  34. SALT LAKE CITY, Sept. 21, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the last patient has been enrolled in its LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study, a paired-biopsy study investigating LPCN 1144 in confirmed non-cirrhotic non-alcoholic steatohepatitis ("NASH") subjects. LPCN 1144 is an oral prodrug of endogenous testosterone. To date LPCN 1144 therapy has shown meaningful reductions of liver fat in our proof of concept liver fat imaging study in hypogonadal males and has demonstrated treatment potential in a pre-clinical NASH and hepatic fibrosis rabbit model. Moreover, no notable tolerability…

    SALT LAKE CITY, Sept. 21, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the last patient has been enrolled in its LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study, a paired-biopsy study investigating LPCN 1144 in confirmed non-cirrhotic non-alcoholic steatohepatitis ("NASH") subjects. LPCN 1144 is an oral prodrug of endogenous testosterone. To date LPCN 1144 therapy has shown meaningful reductions of liver fat in our proof of concept liver fat imaging study in hypogonadal males and has demonstrated treatment potential in a pre-clinical NASH and hepatic fibrosis rabbit model. Moreover, no notable tolerability issues have been seen in 700+ hypogonadal subjects with up to 52-week exposure.

    There is a growing body of preclinical and clinical evidence supporting the relationship between testosterone deficiency and NAFLD/NASH. The majority of biopsy-confirmed NASH male patients reportedly have low testosterone and the levels of free T decrease significantly with increased fibrosis.

    The LiFT Phase 2 clinical study is a 38-week, prospective, multi-center, randomized, double-blind, placebo-controlled, three-arm study of LPCN 1144 in biopsy-confirmed male NASH subjects (based on NAFLD activity score) with grade F1-F3 fibrosis.  The study randomized 56 subjects 1:1:1 to two test arms and one placebo arm. Lipocine expects to report top-line change in liver fat data measured by MRI-PDFF (primary endpoint), in January 2021.  Subsequently, 36-week biopsy and MRI-PDFF data are expected mid-2021.  For more information, refer to NCT04134091.

    "We are pleased to have completed enrollment in the LiFT trial, especially during the current COVID-19 crisis, and look forward to sharing primary endpoint results," stated Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.  Dr. Patel further stated, "Considering the possible benefit to risk profile, we are excited to investigate LPCN 1144 for the treatment of biopsy-confirmed NASH patients."

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and it is currently under review. 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 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 standard TRT primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of liver cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related 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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  35. SALT LAKE CITY, Sept. 8, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it will provide a corporate update at the 22nd HC Wainwright Annual Global Investment Conference. The conference will take place virtually September 14 – 16, 2020.

    Presentation details:

    Date:

    Monday, September 14

    Time:

    12 noon Eastern Time

    Webcast:

    https://wsw.com/webcast/hcw7/lpcn/1604613

    To register in advance for the conference, refer to https://hcwevents.com/

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and had a PDUFA date of August 28, 2020 which was delayed by a few weeks. 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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related 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.

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  36. SALT LAKE CITY, Aug. 28, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO's New Drug Application ("NDA") and is committed to taking action as expeditiously as possible.  The anticipated Prescription Drug User Food Act ("PDUFA") goal date was August 28, 2020 for TLANDO. Although the FDA did not provide a timeline on a new action date, the FDA informed the Company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional data and the Company has provided the…

    SALT LAKE CITY, Aug. 28, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO's New Drug Application ("NDA") and is committed to taking action as expeditiously as possible.  The anticipated Prescription Drug User Food Act ("PDUFA") goal date was August 28, 2020 for TLANDO. Although the FDA did not provide a timeline on a new action date, the FDA informed the Company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional data and the Company has provided the FDA with all information requested to date.

    TLANDO is the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and had a PDUFA date of August 28, 2020 which was delayed by a few weeks. 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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related 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.

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  37. SALT LAKE CITY, Aug. 3, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the peer reviewed publication of LPCN 144 Liver Fat Study ("LFS") results, "LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease In Hypogonadal Males" in Hepatology Communications. Drs. Somaya Albhaisi and Arun Sanyal, from Virginia Commonwealth University, and Dr. Michael Charlton, from the University of Chicago, coauthored the publication. LPCN 1144 is an oral prodrug of bioidentical testosterone ("testosterone undecanoate" or "TU"). The publication can be accessed via:

    https://aasldpubs.onlinelibrary.wiley.com/doi/full/10.1002/hep4.1571

    The study aims were: (1) to determine the prevalence of NAFLD within a population of hypogonadal males and the relationship of circulating testosterone levels with the presence and severity of NAFLD, (2) to evaluate the impact of LPCN 1144 on hepatic steatosis and markers of liver injury in hypogonadal men, and (3) to assess the safety and tolerability of LPCN 1144 in this population.

    "We are encouraged by the NAFLD resolution experienced with LPCN 1144 in hypogonadal men and look forward to results from our on-going Phase 2a LiFT clinical study in biopsy confirmed NASH subjects which are expected by the end of 2020," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer 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, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH.  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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials, 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.

     

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  38. SALT LAKE CITY, July 31, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that Wajda v. Patel, et al., Case: 2019-0122-JTL, a putative shareholder derivative action, was dismissed by Vice Chancellor Laster of the Chancery Court of Delaware. The derivative action was filed on February 15, 2019 against the Lipocine Inc.'s board of directors, and Lipocine as a nominal defendant.  The Court granted Lipocine's motion to dismiss, holding that the plaintiff had failed to allege demand futility as required under Delaware Chancery Rule 23.1.  

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's commercial and 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 FDA marketing approval 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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials, the potential uses and benefits of our product candidates, our product development efforts and litigation outcomes. 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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  39. SALT LAKE CITY, July 13, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has received a letter from The Nasdaq Stock Market LLC ("Nasdaq") on July 9, 2020 indicating that Lipocine has regained compliance with Nasdaq's minimum bid price for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) ("Min Bid Price Listing Rule").  

    About Lipocine

    Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH.  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, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of 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)























    March 31,



    December 31,









    2020



    2019















    Current assets:











    Cash and cash equivalents



    $              15,134,789



    $      9,728,523



    Restricted cash



    5,000,000



    5,000,000



    Marketable investment securities



    448,077



    4,340,041



    Accrued interest income



    9,212



    16,522



    Prepaid and other current assets



    373,370



    545,887



















    Total current assets

    20,965,448



    19,630,973















    Property and equipment, net of accumulated depreciation of









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



    2,755



    3,554

    Other assets



    23,753



    23,753



















    Total assets



    $              20,991,956



    $    19,658,280











































    Current liabilities:











    Accounts payable



    $                1,654,909



    $      1,182,241



    Accrued expenses



    738,280



    449,303



    Debt - current portion



    1,666,666



    3,333,333



















    Total current liabilities

    4,059,855



    4,964,877















    Debt - non-current portion



    4,688,136



    3,814,407

    Warrant liability



    5,691,229



    4,591,200



















    Total liabilities

    14,439,220



    13,370,484





























    Commitments and contingencies (notes 7, 8 and 10)























    Stockholders' equity:











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













    shares authorized; zero issued and outstanding



    -



    -



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













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













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



    4,786



    3,766



    Additional paid-in capital



    163,426,502



    157,391,969



    Treasury stock at cost, 5,710 shares



    -40,712



    -40,712



    Accumulated other comprehensive loss



    -



    -38



    Accumulated deficit



    -156,837,840



    -151,067,189



















    Total stockholders' equity

    6,552,736



    6,287,796

































    Total liabilities and stockholders' equity

    $              20,991,956



    $    19,658,280















    See accompanying notes to unaudited condensed consolidated financial statements





     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)























    Three Months Ended March 31,









    2020



    2019















    Operating expenses:











    Research and development



    2,511,754



    1,949,821



    General and administrative



    2,085,261



    1,175,927





    Total operating expenses



    4,597,015



    3,125,748



















    Operating loss



    -4,597,015



    -3,125,748















    Other income (expense):











    Interest and investment income



    59,938



    125,265



    Interest expense



    -133,345



    -223,789





    Total other expense, net



    -73,407



    -98,524

    Unrealized loss on warrant liability



    -1,100,029



    -



















    Loss before income tax expense



    -5,770,451



    -3,224,272















    Income tax expense



    -200



    -200



















    Net loss



    $(5,770,651)



    $(3,224,472)















    Basic loss per share attributable to common stock



    ($0.14)



    ($0.14)















    Weighted average common shares outstanding, basic



    41,347,631



    23,383,008















    Diluted loss per share attributable to common stock 



    ($0.14)



    ($0.14)















    Weighted average common shares outstanding, diluted



    41,347,631



    23,383,008















    Comprehensive loss:













    Net loss



    $(5,770,651)



    $(3,224,472)





    Net unrealized gain on available-for-sale securities



    38



    2,352



















    Comprehensive loss



    $(5,770,613)



    $(3,222,120)

     

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

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

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

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

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

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

     

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

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

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

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

    About Lipocine

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

    Forward-Looking Statements

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

     

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    SOURCE Lipocine Inc.

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

    First Quarter and Recent Corporate Highlights

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

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

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

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

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

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

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

     

    LIPOCINE INC. AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

    (Unaudited)








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