Quarterly and Recent Highlights
- Announced the acceptance of its 505(b)(2) New Drug Application ("NDA") to the
U.S. Food and Drug Administration ("FDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. TheFDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date ofJune 28, 2016 , for completion of the review of the NDA for LPCN 1021. Additionally, the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021.
- Reported positive top-line results from its multi-dose pharmacokinetic ("PK") dose finding clinical study of LPCN 1107, an oral hydroxyprogesterone caproate ("HPC") product candidate for the prevention of preterm birth. Average steady state HPC levels (Cavg0-24) were comparable or higher for all three LPCN 1107 doses than for injectable HPC (Makena®). HPC levels as a function of daily dose were linear for the three LPCN 1107 doses. With all three LPCN 1107 doses tested, HPC exposure (Cavg0-24) did not fall below 6.4 ng/ml in any study subject, a level considered to be significant based on a previous literature study of injectable HPC1. LPCN 1107 was well tolerated across the three dose levels and no adverse drug reactions, serious adverse events or deaths were reported during the study.
- Initiated the Phase 2b clinical study for LPCN 1111, a novel TRT product candidate for hypogonadal males with potential for once-daily dosing. The study's primary objectives will be to determine the optimal dose, as well as the safety and tolerability, of LPCN 1111 and its metabolites following oral administration of single and multiple doses.
- Presented clinical data for LPCN 1021 at the 21st Annual Meeting of the
Sexual Medicine Society of North America (SMSNA) inLas Vegas, NV.
"During 2015,
Full Year 2015 Financial Results
For the full year of 2015, research and development expenses were
For the full year of 2015, general and administrative expenses were
As of
About
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 relating to Lipocine's common stock, the
1Caritis SN, Venkataramanan R, Thom E, et al. Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth. Am J Obstet Gynecol 2014;210(2):128.
Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||
Years Ending |
|||||||||||||||||
2015 | 2014 | ||||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 12,580,245 | $ | 15,479,446 | |||||||||||||
General and administrative | 5,801,823 | 5,001,368 | |||||||||||||||
Total operating expenses | 18,382,068 | 20,480,814 | |||||||||||||||
Operating loss | (18,382,068 | ) | (20,480,814 | ) | |||||||||||||
Other income, net | 173,890 | 108,338 | |||||||||||||||
Loss before income tax expense | (18,208,178 | ) | (20,372,476 | ) | |||||||||||||
Income tax expense | (200 | ) | (200 | ) | |||||||||||||
Net loss | $ | (18,208,378 | ) | $ | (20,372,676 | ) | |||||||||||
Basic loss per share attributable to common stock | $ | (1.11 | ) | $ | (1.60 | ) | |||||||||||
Weighted average common shares outstanding, basic | 16,470,814 | 12,766,295 | |||||||||||||||
Diluted loss per share attributable to common stock | $ | (1.11 | ) | $ | (1.60 | ) | |||||||||||
Weighted average common shares outstanding, diluted | 16,470,814 | 12,766,295 | |||||||||||||||
Comprehensive loss: | |||||||||||||||||
Net loss | $ | (18,208,378 | ) | $ | (20,372,676 | ) | |||||||||||
Unrealized net loss on available-for-sale securities | (32,900 | ) | - | ||||||||||||||
Comprehensive loss | $ | (18,241,278 | ) | $ | (20,372,676 | ) |
|
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Consolidated Balance Sheets | ||||||||||||||
December 31, 2015 and 2014 | ||||||||||||||
2015 | 2014 | |||||||||||||
Assets | ||||||||||||||
Current assets: | ||||||||||||||
Cash and cash equivalents | $ | 20,007,659 | $ | 27,666,055 | ||||||||||
Marketable investment securities | 24,375,168 | - | ||||||||||||
Accrued interest income | 144,536 | - | ||||||||||||
Prepaid and other current assets | 350,160 | 229,912 | ||||||||||||
Total current assets | 44,877,523 | 27,895,967 | ||||||||||||
Property and equipment, net of accumulated depreciation of | ||||||||||||||
|
75,750 | 73,782 | ||||||||||||
Long-term marketable investment securities | 400,252 | - | ||||||||||||
Other assets | 23,753 | 23,753 | ||||||||||||
Total assets | $ | 45,377,278 | $ | 27,993,502 | ||||||||||
Liabilities and Stockholders' Equity | ||||||||||||||
Current liabilities: | ||||||||||||||
Accounts payable | $ | 507,067 | $ | 306,276 | ||||||||||
Accrued expenses | 2,884,794 | 1,327,256 | ||||||||||||
Total current liabilities | 3,391,861 | 1,633,532 | ||||||||||||
Total liabilities | 3,391,861 | 1,633,532 | ||||||||||||
Commitments and contingencies | ||||||||||||||
Stockholders' equity: | ||||||||||||||
Preferred stock, par value |
||||||||||||||
shares authorized; zero issued and outstanding | - | - | ||||||||||||
Common stock, par value |
||||||||||||||
shares authorized; 18,250,456 and 12,800,382 issued | ||||||||||||||
and 18,244,746 and 12,794,672 outstanding | 1,825 | 1,280 | ||||||||||||
Additional paid-in capital | 128,502,659 | 94,636,479 | ||||||||||||
(40,712 | ) | (40,712 | ) | |||||||||||
Accumulated other comprehensive loss | (32,900 | ) | - | |||||||||||
Accumulated deficit | (86,445,455 | ) | (68,237,077 | ) | ||||||||||
Total stockholders' equity | 41,985,417 | 26,359,970 | ||||||||||||
Total liabilities and stockholders' equity | $ | 45,377,278 | $ | 27,993,502 |