SALT LAKE CITY, May 8, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced financial results for the quarter ended March 31, 2019, and provided a corporate update.
First Quarter and Recent Corporate Highlights
- Announced findings from the Ambulatory Blood Pressure Monitoring clinical study (NCT03868059) ("ABPM Study") designed to study TLANDO's effects on blood pressure. The results appear in line with recently approved testosterone replacement therapy.
- Announced top-line results from the 16-week Liver Fat Imaging Study ("Liver Fat Study") with LPCN 1144, designed to assess the therapeutic potential of LPCN 1144 in non-alcoholic steatohepatitis ("NASH"). Treatment results demonstrated that 48% of the treated subjects had NAFLD resolution at the end of the study. Additionally, 100% of the subjects experiencing NAFLD resolution had at least a 35% relative liver fat reduction from baseline with a relative mean liver fat reduction of 55% in this group.
- LPCN 1144 featured in late-breaker presentation at the EASL International Liver Conference, demonstrating reduction of liver fat (measured using magnetic resonance imaging, proton density fat fraction or "MRI-PDFF") and improvement in key serum biomarkers typically associated with NASH.
- Poster highlighting therapeutic potential of LPCN 1144 in NAFLD and NASH presented at ENDO 2019 meeting.
- Received clearance by the U.S. Food and Drug Administration ("FDA") for an Investigational New Drug ("IND") application to initiate a Phase 2 clinical study of LPCN 1144 in patients with biopsy confirmed NASH.
- Filed suit against Clarus Therapeutics, Inc. ("Clarus") in the United States District Court alleging that Clarus's JATENZO® product infringes six of Lipocine's U.S. patents.
"We achieved important milestones in Lipocine's most advanced clinical programs during the first quarter of 2019, and in recent weeks," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. Dr. Patel further stated, "With the successful completion of the ABPM study for TLANDO, we look forward to resubmitting our NDA for TLANDO in May 2019. We announced positive 16-week results from the Liver Fat Study of LPCN 1144 and have received clearance from the FDA to initiate a Phase 2 clinical study of LPCN 1144 in patients with biopsy confirmed NASH."
First Quarter Ended March 31, 2019 Financial Results
Lipocine reported a net loss of $3.2 million, or ($0.14) per diluted share, for the quarter ended March 31, 2019, compared with a net loss of $2.7 million, or ($0.13) per diluted share, in the quarter ended March 31, 2018.
Research and development expenses were $1.9 million for the quarter ended March 31, 2019, compared with $1.4 million for the quarter ended March 31, 2018. The increase in research and development expenses was primarily due to increased contract research organization costs for TLANDO in connection with the ABPM Study, offset by decreases in outside service costs primarily related to the January 2018 TLANDO BRUDAC meeting, decreases in contract manufacturing costs related to LPCN 1107, and decreases in personnel costs.
General and administrative expenses were $1.2 million for the quarter ended March 31, 2019, compared with $1.7 million for the quarter ended March 31, 2018. The decrease in general and administrative expenses was primarily due to decreased personnel costs, decreased professional fees offset by an increase in other administrative costs related to overhead.
As of March 31, 2019, the Company had unrestricted and restricted cash, cash equivalents and marketable securities aggregating $22.5 million, compared to $20.3 million at December 31, 2018. The $5.0 million of restricted cash, cash equivalents and marketable securities becomes unrestricted upon approval of TLANDO by the FDA.
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 four development programs: TLANDO, LPCN 1144, LPCN 1111 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone comprised of testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1144, an oral product of bioidentical testosterone comprised of testosterone undecanoate, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of NASH. 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.
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
Cash and cash equivalents
Marketable investment securities
Accrued interest income
Prepaid and other current assets
Total current assets
Property and equipment, net of accumulated depreciation of $1,128,561 and $1,124,700, respectively
Liabilities and Stockholders' Equity
Debt - current portion
Total current liabilities
Debt - non-current portion
Commitments and contingencies
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; 24,580,663 and 21,737,196 issued and 24,574,953 and 21,731,486 outstanding
Additional paid-in capital
Treasury stock at cost, 5,710 shares
Accumulated other comprehensive income (loss)
Total stockholders' equity
Total liabilities and stockholders' equity
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
Three Months Ended March 31,
Research and development
General and administrative
Total operating expenses
Other income (expense):
Interest and investment income
Total other expense, net
Loss before income tax expense
Income tax expense
Basic loss per share attributable to common stock
Weighted average common shares outstanding, basic
Diluted loss per share attributable to common stock
Weighted average common shares outstanding, diluted
Net unrealized gain (loss) on available-for-sale securities
SOURCE Lipocine Inc.