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Lipocine Inc. (LPCN) SEC Filing 10-K Annual report for the fiscal year ending Thursday, December 31, 2015

Lipocine Inc.

CIK: 1535955 Ticker: LPCN

 

Exhibit 99.1

 

 

 

 

For Immediate Release

 

LIPOCINE ANNOUNCES FINANCIAL AND OPERATIONAL RESULTS FOR THE FULL YEAR OF 2015

 

SALT LAKE CITY (March 10, 2016

) – Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced financial results for the full year ended December 31, 2015.

 

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. The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 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) in Las Vegas, NV.

 


The following information was filed by Lipocine Inc. (LPCN) on Thursday, March 10, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets [parenthetical]
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Stockholders' Equity
Consolidated Statements Of Operations And Comprehensive Loss
401(k) Plan
401(k) Plan (details Textual)
Accounting Pronouncements Issued Not Yet Adopted
Agreement With Spriaso, Llc
Agreement With Spriaso, Llc (details Textual)
Collaborative Agreements
Collaborative Agreements (details Textual)
Commitments And Contingencies
Description Of Business
Income Taxes
Income Taxes (details 1)
Income Taxes (details 2)
Income Taxes (details 3)
Income Taxes (details Textual)
Income Taxes (details)
Income Taxes (tables)
Leases
Leases (details Textual)
Leases (details)
Leases (tables)
Marketable Investment Securities
Marketable Investment Securities (details 1)
Marketable Investment Securities (details Textual)
Marketable Investment Securities (details)
Marketable Investment Securities (tables)
Property And Equipment
Property And Equipment (details Textual)
Property And Equipment (details)
Property And Equipment (tables)
Stockholders' Equity
Stockholders' Equity (details 1)
Stockholders' Equity (details 2)
Stockholders' Equity (details Textual)
Stockholders' Equity (details)
Stockholders' Equity (tables)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (details 1)
Summary Of Significant Accounting Policies (details 2)
Summary Of Significant Accounting Policies (details 3)
Summary Of Significant Accounting Policies (details 4)
Summary Of Significant Accounting Policies (details Textual)
Summary Of Significant Accounting Policies (details)
Summary Of Significant Accounting Policies (policies)
Summary Of Significant Accounting Policies (tables)
Ticker: LPCN
CIK: 1535955
Form Type: 10-K Annual Report
Accession Number: 0001144204-16-087232
Submitted to the SEC: Thu Mar 10 2016 4:31:22 PM EST
Accepted by the SEC: Thu Mar 10 2016
Period: Thursday, December 31, 2015
Industry: Pharmaceutical Preparations

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