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.

FDA agrees with Lipocine establishing LPCN 1154 pathway to efficacy through a pharmacokinetic (PK) bridge to an approved IV infusion brexanolone Lipocine has demonstrated that the brexanolone exposure of LPCN 1154 is similar to the levels observed in third trimester pregnant women samples A pilot PK bridge study is planned with results expected in 1Q 2023 SALT LAKE CITY , Sept. 15, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products targeting large addressable markets with significant unmet needs to treat central nervous system ("CNS") and metabolic disorders, announced today that the U.S. Food and Drug Administration ("FDA") has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 through a single pivotal pharmacokinetic ("PK") bridge to an approved IV infusion brexanolone via a 505(b)(2) NDA filing.

Lipocine Announces Favorable Regulatory Pathway on Oral LPCN 1154 for Post-Partum Depression (PPD)

SALT LAKE CITY , Aug. 8, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system ("CNS") disorders, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update. Second Quarter Highlights In June, Lipocine's commercial partner Halozyme launched TLANDO™ (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism).

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2022

Phase 2 Photosensitive Epilepsy Study Planned for 2H 2022 SALT LAKE CITY, July 11, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system ("CNS") disorders with high unmet medical needs, announced today that the U.S. Food and Drug Administration ("FDA") has accepted the company's Investigational New Drug Application ("IND") for its neuroactive steroid ("NAS") candidate, LPCN 2101, as a potential treatment for adults with epilepsy.  Lipocine plans to initiate a Phase 2 photosensitive epilepsy ("PSE") study to evaluate the safety, tolerability, and efficacy of oral LPCN 2101.

FDA Clears LPCN 2101 IND for Adult Epilepsy Treatment

SALT LAKE CITY , June 14, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on neuroendocrine and metabolic disorders, today announced that the United States Patent and Trademark Office (USPTO) has granted US patent 11,337,987 for "Compositions and Methods for Treating Central Nervous System (CNS) Disorders" and US patent 11,370,811 for "Testosterone Dodecanoate Compositions and Methods of Preparation and Use".  "We are pleased to have new patents granted in support of our innovative programs to treat liver and CNS disorders," said Dr. Mahesh Patel, Chairman, President, and CEO of Lipocine.

LIPOCINE GRANTED US PATENTS DIRECTED TO CNS AND LIVER PROGRAMS

SALT LAKE CITY , June 6, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, presented "LPCN 2101: An Endogenous Neuroactive Steroid for Epilepsy" today at the 2022 Epilepsy Foundation Pipeline Conference.  The conference is held every two years to bring together decision-makers in the field of epilepsy treatment, therapeutic innovation and development, showcasing the latest developments in the epilepsy pipeline.

LIPOCINE ANNOUNCES PRESENTATION AT 2022 EPILEPSY FOUNDATION PIPELINE CONFERENCE

LPCN 1144 was well tolerated over 72-week exposure with no observed safety signals Liver injury markers were reduced and maintained with extended LPCN 1144 treatment Observed liver histology improvements support further development SALT LAKE CITY , May 12, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology to develop innovative products to treat neuroendocrine and metabolic disorders, announces positive topline results from its Open Label Extension study, OLE.  LPCN 1144 comprises an orally delivered prodrug of testosterone.

Lipocine Announces Positive LPCN 1144 NASH Open Label Extension Study Results

SALT LAKE CITY , May 9, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, today announced financial results for the quarter ended March 31, 2022 and provided a corporate update. Program Highlights TLANDO™ was approved and granted Market Exclusivity by the U.S. Food and Drug Administration ("FDA") for hypogonadism and our licensee expects commercial launch in second quarter of 2022 Lipocine is currently enrolling subjects in a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis, with enrollment in the study expected to be complete by the end of the third quarter of 2022 Lipocine has requested an End of Phase 2 meeting to discuss the Phase 3 study and confirmatory trial design for LPCN 1144 in non-cirrhotic non-alcoholic steatohepatitis ("NASH") An open label extension ("OLE") study in non-cirrhotic NASH has been completed and topline results are expected in May 2022 Board Appointments The company appointed Jill M.

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2022

LIPOCINE ANNOUNCES BOARD of DIRECTOR APPOINTMENTS

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Commercial launch expected in 2Q 2022 SALT LAKE CITY , March 29, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, announced today that Antares Pharma, Inc. issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has approved TLANDO™ (testosterone undecanoate), an oral treatment for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. Lipocine licensed the exclusive U.S. commercialization rights for TLANDO™ to Antares Pharma.

LIPOCINE ANNOUNCES ITS PARTNER RECEIVED FDA APPROVAL OF TLANDO™

SALT LAKE CITY, March 9, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on neuroendocrine and metabolic disorders, today announced financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update. Clinical Program Highlights LPCN 1148 Initiated a Phase 2 proof-of-concept clinical study evaluating LCPN 1148 for the management of decompensated liver cirrhosis in patients on the transplant waitlist We currently expect enrollment in the Phase 2 study to be complete by the end of the second or third quarter of 2022 and top-line 24-week results by the end of 2022 or during the first quarter of 2023.

Lipocine Announces Financial Results for the Year Ended December 31, 2021

SALT LAKE CITY, March 1, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on neuroendocrine and metabolic disorders, today provided an update from the Type C guidance meeting with the U.S. Food and Drug Administration ("FDA") regarding the development path for LPCN 1144. LPCN 1144 is targeted for treatment for nonalcoholic steatohepatitis (NASH) in non-cirrhotic men.

Lipocine Announces Regulatory Guidance on LPCN 1144 in Non-cirrhotic NASH

SALT LAKE CITY, Feb. 3, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on developing innovative products for metabolic and endocrine disorders, today announced that Antares Pharma, Inc. issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has accepted its New Drug Application ("NDA") resubmission for TLANDO® (testosterone undecanoate).  The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act (PDUFA).

LIPOCINE ANNOUNCES ITS PARTNER RECEIVED FDA ACCEPTANCE OF NDA RESUBMISSION FOR TLANDO®

SALT LAKE CITY , Jan. 27, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the peer-reviewed publication of positive Phase 3 clinical data from the Dosing Validation ("DV") study which evaluated the fixed-dose oral testosterone undecanoate, TLANDO, for the treatment of hypogonadism. As previously disclosed, the DV study met its primary endpoint, with TLANDO restoring testosterone levels to the normal range in hypogonadal males.

Lipocine Announces Peer-Reviewed Publication of Phase 3 Study Results for TLANDO®

SALT LAKE CITY, Jan. 5, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that one abstract has been selected for podium presentation and three abstracts have been selected for poster presentations during the upcoming 2022 NASH-TAG Conference in Park City, Utah on January 6-8, 2022. Presentation Details: Session Title: Distinguished Abstract Presentation and Poster Abstract Number: #29 Presentation Title: "LPCN 1144 Therapy Demonstrates Histologic Benefits in the Phase 2 LiFT Study in Nonalcoholic Steatohepatitis (NASH) Subjects" Presentation Time: Podium Presentation – January 7th at 10:15 a.m.

Lipocine to Present Clinical Data on LPCN 1144 at 2022 NASH-TAG Conference

SALT LAKE CITY, Dec. 22, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the first patient has been dosed in its Phase 2 proof-of-concept clinical study (NCT04874350) for the management of liver cirrhosis. The Phase 2 study is a multi-center, randomized, placebo-controlled 52-week study in sarcopenic cirrhotic patients that are on the liver transplant list.

LIPOCINE ANNOUNCES PATIENT DOSED IN ITS PHASE 2 STUDY WITH LPCN 1148 FOR MANAGEMENT OF LIVER CIRRHOSIS

Lipocine has obtained positive results in a phase 2 study using its drug LPCN1144 for the treatment of patients with NASH.

Lipocine Is One To Watch Based On Possible FDA Approval Of TLANDO And NASH Data

SALT LAKE CITY, Nov. 10, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update. Third Quarter and Recent Corporate Highlights Entered into a license agreement with Antares Pharma to commercialize TLANDO in the US 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 Lipocine is entitled to commercial sales milestone payments of up to $160.0 million and 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. Antares Pharma was also granted an option to license TLANDO XR for development and commercialization in the U.S. for additional licensing fees ($4.0 million), clinical and regulatory milestone payments ($35.0 million), sales milestone payments and royalties (mid-teens up to 20%) The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH") The FDA has affirmed that the resubmission of the New Drug Application ("NDA") for TLANDO will be a Class 1 resubmission, with a two-month FDA review goal period The FDA previously granted tentative approval to TLANDO 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) The product is not eligible for final approval and marketing in the U.S. until the expiration of the FDA's Orange Book listed exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo®, which expires on March 27, 2022 Announced positive topline 36-week results from its Phase 2 proof-of-concept Liver Fat intervention with oral Testosterone ("LiFT") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH Study met its primary endpoint.

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2021

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SALT LAKE CITY, Nov. 4, 2021 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis ("NASH"). LPCN 1144, an oral prodrug of bioidentical testosterone, was recently studied in the Liver Fat intervention with oral Testosterone ("LiFT ") Phase 2 paired biopsy clinical study in patients with confirmed NASH.

Lipocine Announces FDA Grants Fast Track Designation to LPCN 1144 for Treatment of Non-Cirrhotic NASH

SALT LAKE CITY, Nov. 1, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that three abstracts have been selected for poster presentations during the upcoming The Liver Meeting® 2021, organized by the American Association for the Study of Liver Diseases (AASLD) to take place November 12-15, 2021. Presentation Details: Session Title: Late-Breaking Abstract Posters Publication Number:      LP46 Poster Title:                  "LPCN 1144 Therapy Demonstrates Histologic Benefits In The Phase 2 LiFT Study in Non-Alcoholic Steatohepatitis (NASH) Subjects" Session Title:             Late-Breaking Abstract Posters Publication Number:     LP47 Poster Title:                    "Safety And Tolerability Of LPCN 1144 Treatment In Biopsy Confirmed NASH Subjects In The Phase 2 LiFT Study" Session Title:                  NAFLD and NASH: Experimental: Clinical Publication Number:      1876 Poster Title:                   "LPCN 1144 Improves Body Composition In Biopsy-Confirmed NASH Patients" The abstracts will be available for viewing by attendees of The Liver Meeting® 2021 on the AASLD website and the online planner of The Liver Meeting® app November 1, 2021 at 10:00 am ET and will be published in the December issue of HEPATOLOGY.

Lipocine Announces Multiple Poster Presentations at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2021

Lipocine Inc (NASDAQ: LPCN) has entered into an exclusive licensing agreement with Antares Pharma Inc (NASDAQ: ATRS) to commercialize Tlando in the U.S.  Tlando is an oral testosterone product for testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone.

Lipocine, Antares Ink Licensing Pact For Testosterone Replacement Therapy In US

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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.

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