Lipocine Inc Stock Price, News & Analysis

Lipocine Inc. (NASDAQ:LPCN) announced the closing of an underwritten public offering of 16,428,571 shares at $1.75 each, generating approximately $28.7 million in gross proceeds. This offering included the full exercise of underwriters' options for 2,142,857 additional shares. The shares were issued under an effective shelf registration statement and the transaction was managed by Raymond James & Associates, Inc. and Ladenburg Thalmann & Co. Inc. Lipocine focuses on metabolic and endocrine disorders and has several drug candidates in its clinical pipeline.

Lipocine (NASDAQ:LPCN) priced a public offering of 14,285,714 shares at $1.75 each, expected to close around January 28, 2021. The offering could generate approximately $25 million in gross proceeds. Underwriters hold a 30-day option for an additional 2,142,857 shares. Proceeds will primarily support general corporate purposes, including working capital. Raymond James is the sole book-running manager, with Ladenburg Thalmann as co-manager. The offering is conducted under an effective registration statement with the SEC.

Lipocine Inc. (NASDAQ: LPCN) announced plans for an underwritten public offering of its common stock. The offering will also allow underwriters a 30-day option to purchase an additional 15% of the shares offered. The net proceeds are intended for general corporate purposes, including working capital and capital expenditures. This offering is made under an effective shelf registration statement previously filed with the SEC. There’s no assurance regarding the completion or specific terms of the offering due to market conditions.

Lipocine Inc. (NASDAQ: LPCN) announced that the USPTO's Patent Trial and Appeal Board declared Interference No. 106,128 involving Lipocine's patent application against Clarus Therapeutics' application. The USPTO withdrew the Clarus application as part of this process. This decision continues a trend of favorable outcomes for Lipocine, following previous interferences that resulted in the cancellation of Clarus patents. Lipocine's CEO, Dr. Mahesh Patel, expressed satisfaction with the PTAB's ruling, which reinforces the strength of Lipocine's patent portfolio.

Lipocine Inc. (NASDAQ: LPCN) reported positive topline results from its Phase 2 LiFT study of LPCN 1144, an oral testosterone prodrug, in male subjects with biopsy-confirmed non-cirrhotic NASH. The study, involving 56 subjects, showed robust liver fat reduction and improved liver injury markers at 12 weeks, with no tolerability issues. LPCN 1144 demonstrated a significant average reduction in liver fat of up to 46.9% and over 63% of patients achieving a >30% reduction. An open label extension study is set to collect additional data up to 72 weeks.

Lipocine Inc. (NASDAQ: LPCN) announced its participation in the H.C. Wainwright BioConnect 2021 Conference, scheduled virtually from January 11-14, 2021. A webcast of their presentation will be accessible on-demand starting 6:00 am ET, January 11, for 90 days.

Lipocine is focused on metabolic and endocrine disorders and has several products in its pipeline, including TLANDO, which has received tentative FDA approval for hypogonadism. Other products under development address conditions like non-cirrhotic NASH and recurrent preterm birth.

Lipocine Inc. (NASDAQ: LPCN) announced the enrollment of patients into an open-label extension of its LPCN 1144 Phase 2 LiFT study. This decision follows significant interest from investigators and patients wishing to continue treatment. The LiFT study focuses on LPCN 1144's effects in non-cirrhotic non-alcoholic steatohepatitis (NASH) patients. The extension allows for up to 72 weeks of therapy to gather additional data on the long-term safety and tolerability of LPCN 1144. All participants in this phase will receive active treatment, eliminating the placebo control.

Lipocine Inc. (NASDAQ: LPCN) announced that the jury trial set for February 8, 2021, in its patent case against Clarus Therapeutics has been postponed due to COVID-19. The trial's rescheduling will depend on when jury trials can safely resume in Delaware. Lipocine claims that Clarus's product JATENZO® infringes on several of its patents. Lipocine's product pipeline includes TLANDO, LPCN 1144, and others, with TLANDO already receiving FDA tentative approval for treating hypogonadism in men.

Lipocine Inc. (NASDAQ: LPCN) announced that the FDA has granted tentative approval for TLANDO, its oral testosterone product for testosterone replacement therapy (TRT) in adult males. This approval follows a comprehensive review of TLANDO's quality, safety, and efficacy. However, TLANDO cannot receive final approval until the exclusivity period for a competing product, Jatenzo®, expires on March 27, 2022. Lipocine plans to pursue final approval and will conduct post-marketing studies regarding risks associated with TLANDO.