Lipocine

Lipocine, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of the delivery of drugs using proprietary delivery technology. The firm is involved in applying oral drug delivery technology for the development of pharmaceutical products focusing on metabolic and endocrine disorders. It offers TLANDO, an oral testosterone replacement therapy. The company was founded in 2011 and is headquartered in Salt Lake City, UT.

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Lipocine, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of the delivery of drugs using proprietary delivery technology. It offers TLANDO, an oral testosterone replacement therapy. The company was founded on October 13, 2011 and is headquartered in Salt Lake City, UT.

SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ -- Under the terms of Agreement Lipocine to receive: Up to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions Commercial sales milestone payments of up to $160.0 million Tiered royalties on net sales of TLANDO from mid-teens up to 20% Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S. Lipocine grants Antares Pharma an option to license TLANDO XR for development and commercialization in the U.S. Upon exercise of the option, Lipocine to receive: An additional $4.0 million in license fees, clinical and regulatory milestone payments of up to $35.0 million, and tiered royalties on net sales from mid-teens up to 20% Antares Pharma to be responsible for all clinical development costs, regulatory filings, commercialization, and post-marketing commitments Lipocine retains all rights for ex-U.S. territories, and non TRT indications for TLANDO and TLANDO XR Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States.  TLANDO is an oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Lipocine And Antares Pharma Enter Into U.S. Licensing Agreement To Commercialize TLANDO®

SALT LAKE CITY, Oct. 5, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the H.C. Wainwright 5th Annual NASH Investor Conference being held virtually on October 12, 2021.

Lipocine to Present at The H.C. Wainwright 5th Annual NASH Investor Conference

SALT LAKE CITY, Sept. 28, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the U.S. Food and Drug Administration ("FDA") has affirmed the resubmission of its New Drug Application ("NDA") for TLANDO®, its oral testosterone product, will be a Class 1 resubmission.

Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO®

SALT LAKE CITY, Sept. 20, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Cantor Fitzgerald Virtual Global Healthcare Conference.

Lipocine to Present at The Cantor Fitzgerald Virtual Global Healthcare Conference

SALT LAKE CITY , Sept. 1, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the H.C.

Lipocine to Present at The H.C. Wainwright 23rd Annual Global Investment Conference

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Lipocine Inc (NASDAQ: LPCN) has announced topline 36-week results from its Phase 2 proof of concept LiFT study investigating LPCN 1144 in Non-Alcoholic Steatohepatitis (NASH). LPCN 1144 comprises an orally delivered prodrug of endogenous testosterone (T).

Lipocine Meets Resolution Regulatory Endpoint In Mid-Stage NASH Trial

SALT LAKE CITY, Aug. 25, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced positive topline 36-week results from its Phase 2 proof of concept LiFT (" Liver  F at intervention with oral  T estosterone") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH. Currently, there are no approved treatments for NASH, a leading cause of liver failure and liver transplantation globally.

Lipocine's LPCN 1144 Met Non-Alcoholic Steatohepatitis ("NASH") Resolution Regulatory Endpoint in Phase 2 LiFT Study

SALT LAKE CITY, Aug. 5, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the second quarter ended June 30, 2021, and provided a corporate update. Recent Corporate Highlights Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects   36-week biopsy data from the LiFT clinical study are expected in August 2021  Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144   Clinical data from the LiFT clinical study were presented at The International Liver Congress™ 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, which took place June 23-26, 2021  Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects LPCN 1144 was shown to improve body composition in biopsy-confirmed NASH patients The U.S. Food and Drug Administration ("FDA") cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults Top-line results from an ongoing pharmacokinetic ("PK") study to assess dose proportionality are expected in the third quarter of 2021 Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021 Entered into a global settlement agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between Lipocine and Clarus, as well as the on-going interference proceeding between the two companies Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA Expect the first subject will be dosed in the proof-of-concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021 Second Quarter Ended June 30, 2021 Financial Results Lipocine reported a net loss of $6.8 million, or ($0.08) per diluted share, for the second quarter ended June 30, 2021, compared with a net loss of $6.4 million, or ($0.13) per diluted share, for the second quarter ended June 30, 2020.

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2021

Clarus

Lipocine Inc (NASDAQ: LPCN) has entered into a settlement and license agreement with Clarus Therapeutics to resolve claims in the ongoing intellectual property litigation and interference proceeding.  Under the terms of the settlement, both the companies have agreed to dismiss the litigation presently pending in the District Court for the District of Delaware.

Lipocine Stock Jumps On Litigation Settlement With Clarus Therapeutics

SALT LAKE CITY, July 14, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has entered into a global settlement and license agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies. Under the terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware.

Lipocine Announces Settlement With Clarus Therapeutics

SALT LAKE CITY, July 6, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Ladenburg Thalmann Healthcare Conference. The conference will be held virtually.

Lipocine To Present At The Ladenburg Thalmann Healthcare Conference

SALT LAKE CITY, June 23, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that clinical data will be presented at The International Liver Congress™ 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, on June 23-26, 2021.  1.

Lipocine Announces Presentations at The International Liver Congress™ 2021 Digital Event

SALT LAKE CITY, June 16, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Raymond James Human Health Innovation Conference. The conference will be held virtually.

Lipocine To Present At The Raymond James Human Health Innovation Conference

The FDA has signed off Lipocine Inc's (NASDAQ: LPCN) Investigational New Drug Application (IND) to initiate a Phase 2 study to evaluate LPCN 1154 for the treatment of postpartum depression (PPD) in adults. A pharmacokinetic (PK) study to assess dose proportionality is planned to start in July 2021, with top-line results expected in the third quarter of 2021.

Lipocine To Start Testing Neuro-Steroid Candidate In Postpartum Depression Patients

SALT LAKE CITY, June 14, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults. A pharmacokinetic ("PK") study to assess dose proportionality is planned to start in July 2021 with top-line results expected in the third quarter of 2021.

FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study

SALT LAKE CITY, June 7, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Lytham Partners Summer 2021 Investor Conference. The conference will be held virtually.

Lipocine to Present at the Lytham Partners Summer 2021 Investor Conference

The U.S. District Court for the District of Delaware has granted Clarus Therapeutics' motion for summary judgment against remaining patents in a patent infringement case brought by Lipocine Inc (NASDAQ: LPCN) regarding Clarus's oral testosterone replacement product, Jatenzo. Federal Circuit Judge found all of the asserted Lipocine patents claims invalid.

Clarus Therapeutics Wins Jatenzo Patent Infringement Case Brought By Lipocine

SALT LAKE CITY, May 26, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States District Court for the District of Delaware ("Court") has granted Clarus Therapeutics, Inc.'s ("Clarus") motion for Summary Judgment, finding the asserted claims of Lipocine's U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112.  Clarus still has remaining claims before the Court.

Summary Judgment Ruling in Patent Infringement Lawsuit

NORTHBROOK, Ill., May 25, 2021 /PRNewswire/ -- Today, Federal Circuit Judge William C.

Clarus Therapeutics Defeats Lipocine's Patent Infringement Lawsuit On Summary Judgment

SALT LAKE CITY, May 6, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the first quarter ended March 31, 2021 and provided a corporate update. First Quarter Recent Corporate Highlights Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects Both LPCN 1144 treatment arms met the primary endpoint, change in hepatic fat fraction via magnetic resonance imaging proton density fat fraction ("MRI-PDFF"), with statistical significance 36-week biopsy data from the LiFT study are expected in August 2021 Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144 Announced the publication of results supporting the therapeutic potential of LPCN 1144 in the treatment of non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation Continued to evaluate commercial options for TLANDO, our oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism Posters featuring clinical data on TLANDO™ were presented at the ENDO 2021 Conference Raised gross proceeds of approximately $28.7 million in a public offering of approximately 16.4 million shares of common stock First Quarter Ended March 31, 2021 Financial Results Lipocine reported a net loss of $3.4million, or ($0.04) per diluted share, for the first quarter ended March 31, 2021, compared with a net loss of $5.8 million, or ($0.14) per diluted share, for the first quarter ended March 31, 2020.

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2021

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SALT LAKE CITY, March 11, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the M Vest LLC and Maxim Group LLC Emerging Growth Virtual Conference and the Lytham Partners Spring 2021 Investor Conference. Both conferences will be held virtually.

News for Lipocine Stock (LPCN)