Received a Complete Response Letter (“CRL”) from the United States Food and Drug Administration (“FDA”) regarding the New Drug Application (“NDA”) for TLANDO™, 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.
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SALT LAKE CITY, Aug. 7, 2018 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced financial results for the three and six months ended June 30, 2018. Second Quarter and Recent Corporate Highlights
"We continue to believe that, as an oral drug, TLANDO offers significant benefits to hypogonadal patients compared to topical gels and injections. Following receipt of the CRL we remain committed to working with the FDA to arrive on a path forward for the potential approval of TLANDO," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. "We recently initiated an ambulatory blood pressure monitoring study, designed to address one of the concerns raised by the FDA, and we expect data from this study in the first quarter of 2019." Second Quarter 2018 Financial Results Lipocine reported a net loss of $3.3 million, or ($0.15) per diluted share, for the quarter ended June 30, 2018, compared with a net loss of $6.1 million, or ($0.31) per diluted share, in the quarter ended June 30, 2017. Research and development expenses were $1.5 million in the quarter ended June 30, 2018, compared with $4.1 million in the quarter ended June 30, 2017. The decrease in research and development expenses was primarily due to reduced contract research organization costs related to on-going clinical development of TLANDO as well as less contract manufacturing costs in 2018. General and administrative expenses were $1.7 million in the quarter ended June 30, 2018, compared with $2.0 million in the quarter ended June 30, 2017. The decrease in general and administrative expenses was primarily due to decreased professional fees in 2018 associated with legal, intellectual property and commercial activities as well as decreased personnel, office and overhead costs. As of June 30, 2018, the Company had cash, cash equivalents, and marketable securities of $20.1 million, compared to cash, cash equivalents, and marketable securities of $21.5 million at December 31, 2017. Additionally, as of June 30, 2018 we had $5.0 million of restricted cash. Six Months Ended June 30, 2018 Financial Results Lipocine reported a net loss of $6.0 million, or ($0.28) per diluted share, for the six months ended June 30, 2018, compared with a net loss of $11.0 million, or ($0.58) per diluted share, in the six months ended June 30, 2017. Research and development expenses were $2.9 million in the six months ended June 30, 2018, compared with $7.2 million in the six months ended June 30, 2017. The decrease in research and development expenses was primarily due to reduced contract research organization costs related to on-going clinical development of TLANDO, reduced personnel costs and less contract manufacturing costs for LPCN 1107 offset by an increase in outside services associated with the TLANDO BRUDAC meeting in January 2018. General and administrative expenses were $3.4 million in the six months ended June 30, 2018, compared with $3.9 million in the six months ended June 30, 2017. The decrease in general and administrative expenses was primarily due to decreased personnel costs related to a reduced headcount in 2018. Additionally, professional fees decreased in 2018 associated with legal, intellectual property and commercial activities as well as decreased office and overhead costs. About Lipocine Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes three development programs TLANDO, LPCN 1111 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. TLANDO received a Complete Response Letter from the FDA on May 8, 2018. LPCN 1111, 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 and is currently in Phase 2 testing. 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. An End of Phase 2 meeting with the FDA has been completed. 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 and the FDA review process relating to its product candidates, the timing of completion of clinical trials including the ABPM study for TLANDO, the path to approvability by the FDA of Lipocine's development programs, 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,
2018 2017
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Assets
Current assets:
Cash and cash
equivalents $1,602,079 $3,210,749
Restricted cash 5,000,000 -
Marketable
investment
securities 18,488,756 18,257,321
Accrued interest
income 46,687 23,067
Litigation insurance
recovery - 3,319,927
Prepaid and other
current assets 113,250 408,227
Total current assets 25,250,772 25,219,291
Property and equipment, net of accumulated depreciation
of $1,115,811 and $1,121,080, respectively 27,886 75,070
Other assets 23,753 30,753
Total assets $25,302,411 $25,325,114
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Liabilities and
Stockholders'
Equity
Current liabilities:
Accounts payable $406,540 $598,070
Litigation
settlement payable - 4,250,000
Accrued expenses 886,980 1,497,056
Debt -current
portion 1,549,485 -
Total current liabilities 2,843,005 6,345,126
Debt - non-current portion 8,580,447 -
Total liabilities 11,423,452 6,345,126
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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; 21,270,249
and 21,270,249 issued
and 21,264,539 and
21,264,539 outstanding 2,127 2,127
Additional paid-in
capital 146,304,446 145,423,012
Treasury stock at
cost, 5,710 shares (40,712) (40,712)
Accumulated other
comprehensive loss (11,608) (4,616)
Accumulated deficit (132,375,294) (126,399,823)
Total stockholders' equity 13,878,959 18,979,988
---------- ----------
Total liabilities and
stockholders' equity $25,302,411 $25,325,114
=========== ===========
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended June 30, Six Months Ended June 30,
--------------------------- -------------------------
2018 2017 2018 2017
---- ---- ---- ----
Revenues:
License revenue $ - $ - $428,031 $ -
Total revenues - - 428,031 -
--- --- ------- ---
Operating expenses:
Research and
development 1,482,378 4,106,897 2,859,905 7,190,636
General and
administrative 1,682,032 2,033,721 3,369,522 3,858,897
Total operating
expenses 3,164,410 6,140,618 6,229,427 11,049,533
--------- --------- --------- ----------
Operating loss (3,164,410) (6,140,618) (5,801,396) (11,049,533)
---------- ---------- ---------- -----------
Other income (expense):
Interest and
investment income 120,403 50,852 230,585 99,208
Interest expense (211,494) - (403,960) -
Total other
income
(expense), net (91,091) 50,852 (173,375) 99,208
Loss before
income tax
expense (3,255,501) (6,089,766) (5,974,771) (10,950,325)
Income tax expense - - (700) (700)
Net loss $(3,255,501) $(6,089,766) $(5,975,471) $(10,951,025)
=========== =========== =========== ============
Basic loss per share attributable to common stock $(0.15) $(0.31) $(0.28) $(0.58)
====== ====== ====== ======
Weighted average common shares outstanding, basic 21,264,539 19,372,625 21,264,539 19,043,759
========== ========== ========== ==========
Diluted loss per share attributable to common stock $(0.15) $(0.31) $(0.28) $(0.58)
====== ====== ====== ======
Weighted average common shares outstanding, diluted 21,264,539 19,372,625 21,264,539 19,043,759
========== ========== ========== ==========
Comprehensive loss:
Net loss $(3,255,501) $(6,089,766) $(5,975,471) $(10,951,025)
Net unrealized gain
(loss) on
available-for-
sale securities 8,043 5,174 (6,992) 7,881
Comprehensive
loss $(3,247,458) $(6,084,592) $(5,982,463) $(10,943,144)
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Company Codes: NASDAQ-SMALL:LPCN |
