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Lipocine Regains Complinace With Nasdaq Minimum Bid Price Requirement

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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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SOURCE Lipocine Inc.

Lipocine Inc

NASDAQ:LPCN

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Pharmaceutical Preparation Manufacturing
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Health Technology, Pharmaceuticals: Other, Manufacturing, Pharmaceutical Preparation Manufacturing
US
Salt Lake City

About LPCN

lipocine inc., a specialty pharmaceutical company, develops and commercializes pharmaceutical products. the company develops drugs based on hydroance, a drug delivery technology. it primarily focuses on developing oral versions of several hormones for use in men and women health. the company’s lipid-based technology platform offers non-invasive delivery solutions for small polar organics and macromolecules. it also offers custom drugs for pharmaceutical/biotechnology companies. lipocine inc. was founded in 1997 and is headquartered in salt lake city, utah.