Product Development and Licensing - TLANDO received FDA approval on March 28, 2022, and was commercially launched on June 7, 2022[102][112]. - The company entered into a license agreement with Verity Pharma for TLANDO, receiving an initial payment of $2.5 million and an additional $5 million on February 1, 2024, with potential milestone payments of up to $259 million[114]. - The company has licensed TLANDO to SPC for commercialization in South Korea and to Pharmalink for the Gulf Cooperation Council (GCC) region[103][106]. - LPCN 1154 is being developed as a fast-acting oral antidepressant for postpartum depression, with a focus on CNS conditions[105][109]. - LPCN 1111, a next-generation oral TRT candidate, completed a Phase 2b study showing good dose-response relationships and was well tolerated[120]. - The company is exploring partnerships for LPCN 1144 and LPCN 1148, targeting liver diseases and non-cirrhotic NASH[108][109]. - The proprietary Lip'ral technology enhances the absorption of poorly bioavailable drugs, improving patient compliance and safety[110]. - The company aims to support its licensees in the commercialization of TLANDO, emphasizing the need for a differentiated oral TRT option[106]. - The company is actively seeking licensing agreements for TLANDO outside the current licensed territories, although no agreements have been finalized[118]. - The company plans to continue developing its pipeline candidates targeting significant unmet needs in CNS disorders[109]. - LPCN 2101 is being evaluated for women with epilepsy, with promising PK results and safety demonstrated in pre-clinical and Phase 1 studies[131]. - The company plans to initiate a Phase 2 IND opening proof-of-concept study for LPCN 2101, subject to resource prioritization[131]. - LPCN 2203 is an oral candidate for managing essential tremor, with successful completion of oral pharmacokinetics and plans for a proof-of-concept Phase 2 study[144]. - LPCN 2401 demonstrated a 4.4% increase in lean mass and a 6.7% decrease in fat mass in a Phase 2 study, with a 4.1% reduction in android fat and a 2.8% increase in bone mineral content[153]. - LPCN 1148 met its primary endpoint by increasing skeletal muscle index (L3-SMI) relative to placebo (P<.01) in patients with cirrhosis[161]. - LPCN 1148 treatment resulted in fewer observed OHE events and a longer time to the first recurrent OHE event compared to placebo[162]. - The LiFT Phase 2 clinical study for LPCN 1144 enrolled 56 biopsy-confirmed NASH male subjects, randomized into three treatment arms[168]. - LPCN 1144 treatments resulted in robust liver fat reduction assessed by MRI-PDFF after 12 weeks[170]. - LPCN 1144 treatment arms achieved statistical significance in NASH resolution with no worsening of fibrosis, showing substantial improvement in steatosis, inflammation, and ballooning[173]. - LPCN 1144 was well tolerated over 72 weeks with no observed safety signals, and liver injury markers were reduced and maintained[174]. - LPCN 1107 is being explored for partnership opportunities, with the potential to become the first oral product for the prevention of preterm birth[177]. - LPCN 1107 has shown comparable or higher average steady-state HPC levels than injectable HPC in a multi-dose PK study[179]. - The FDA granted orphan drug designation to LPCN 1107, qualifying the company for various development incentives[182]. Financial Performance - As of September 30, 2024, the company generated $49.6 million in revenue from license fees, royalties, and milestone payments since inception[184]. - Research and development expenses totaled approximately $153.5 million since inception through September 30, 2024[185]. - The company did not recognize any revenue during the three months ended September 30, 2024, and recorded a non-cash revenue reversal of $3.1 million related to the termination of the Antares License Agreement[198]. - General and administrative expenses for the three months ended September 30, 2024, were $1,045,240, slightly increasing from $1,042,572 in the same period of 2023[197]. - Revenue for the nine months ended September 30, 2024, was $7.7 million, a significant increase of $10.8 million compared to $3.1 million for the same period in 2023[204]. - Research and development expenses decreased by $2.2 million to $6.3 million for the nine months ended September 30, 2024, compared to $8.5 million in 2023[203]. - General and administrative expenses increased by $358,090 to $4.1 million for the nine months ended September 30, 2024, compared to $3.8 million in 2023[203]. - Interest and investment income decreased by $153,777 to $913,784 for the nine months ended September 30, 2024, compared to $1.1 million in 2023[203]. - The company had $19.8 million in unrestricted cash and marketable securities as of September 30, 2024, down from $22.0 million at December 31, 2023[210]. - The company recorded gains of approximately $138,000 on warrant liability for the three months ended September 30, 2024, compared to $75,000 in 2023[202]. - The company expects to continue incurring operating losses as it advances the clinical development of multiple product candidates[209]. - No common stock warrants from the November 2019 Offering were exercised during the three or nine months ended September 30, 2024, or 2023[202]. - The company expects its existing capital resources to meet projected operating requirements through at least November 7, 2025, including ongoing clinical studies for LPCN 1154 and other product candidates[219]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $2.9 million, a significant decrease from $9.8 million for the same period in 2023[224]. - Cash provided by investing activities decreased from $10.4 million in the nine months ended September 30, 2023, to $1.7 million in the same period of 2024[226]. - The company raised approximately $209,000 from financing activities in the nine months ended September 30, 2024, compared to $410,000 in the same period of 2023[227]. - Cash provided by the Verity License Agreement contributed $7.5 million to offset operating expenses during the nine months ended September 30, 2024[225]. - The company may need to delay or reduce the scope of clinical studies if adequate financing is not obtained[222]. - Capital expenditures for the nine months ended September 30, 2024, were approximately $80,000, compared to $4,000 in the same period of 2023[226]. - The company has no current commitments or agreements for acquisitions or investments in businesses, products, or technologies[221]. - The company is assessing the impact of the new accounting standards issued in November 2023 on its financial statements[233]. Market Needs and Opportunities - Approximately 600,000 women in the U.S. are affected by postpartum depression (PPD) annually, highlighting a significant unmet medical need for effective treatments[125]. - Essential tremor affects an estimated 7 million people in the U.S., with significant unmet needs in treatment efficacy and tolerability[145]. - Approximately 74% of US adults aged 20 and older are either obese or overweight, with an estimated 30% having a BMI ≥ 30 kg/m²[155]. - The total number of GLP-1 users in the U.S. is projected to reach 30 million by 2030, representing about 9% of the overall population[156]. - NASH affects approximately 20% to 30% of the U.S. population, with 15% to 20% of that group progressing to a more severe state[166]. - The economic burden of liver transplants is approximately $812,500 per transplant, with over 500,000 people living with decompensated cirrhosis in the U.S.[163]. - LPCN 2401 has the potential to improve body composition while preserving lean mass, addressing a significant unmet need in obesity management[158].

Core Points - Lipocine Inc. has entered into a license, development, and supply agreement with SPC Korea for exclusive rights to market TLANDO® in South Korea [1][2] - The agreement includes an upfront payment, regulatory and sales milestone payments, and royalties on net commercial sales for Lipocine [2] - SPC Korea will be responsible for obtaining regulatory approval in South Korea [2] Company Overview - Lipocine is a biopharmaceutical company focused on enhancing therapeutics through effective oral delivery using its proprietary technology platform [5] - TLANDO is a testosterone replacement therapy approved by the US FDA for adult males with conditions related to endogenous testosterone deficiency [4][6] - The company is developing various drug candidates targeting significant unmet medical needs, including treatments for postpartum depression, epilepsy, essential tremor, chronic weight management, and liver cirrhosis [6]

Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABAA modulation Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders SALT LAKE CITY, Oct. 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary ...

SALT LAKE CITY, Sept. 30, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that it will present and meet with investors at the H.C. Wainwright 8th Annual MASH Investor Conference, to take place virtually on October 7, 2024. Presentation Details Time: 2:00 to 2:30pm ET Date: Monday, October 7, 2024 Webcast Link: https://journey.ct.events/view/c252f9f3-ea24-4af7 ...

Study evaluated LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity SALT LAKE CITY, Sept. 5, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that a poster featuring Phase 2 data on LPCN 2401 will be presented at the Obesity Society's Annual ObesityWeek® conference to be held November 3 – ...

SALT LAKE CITY, Aug. 27, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that Dr. Mahesh V. Patel, President and Chief Executive Officer, will present and meet with investors at the H.C. Wainwright 26th Annual Global Investment Conference being held in-person and virtually on September 9-11, 2024. Presentation Details Time: Available from 7:00 a.m. EDT onward ...

SALT LAKE CITY, Aug. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the second quarter ended June 30, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression (PPD) In June 2024, Lipocine announced positive topline study results from the NDA enabling study of LPCN 1154. LPCN 1154 treatment was well tolerated with no ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended June 30, 2024 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ________ to ________. (Exact name of registrant as specified in its charter) Commission File Number: 001-36357 LIPOCINE INC. (Registrant's telephone number, including area code) ...

| --- | --- | --- | --- | |--------------|--------------------|--------------------|--------------------| | PK Parameter | GMR (%) | 90% CI LB | 90% CI UB | | | Test vs. Reference | Test vs. Reference | Test vs. Reference | | Cmax | 105 | 92 | 120 | | AUC0-∞ | 97 | 88 | 107 | | AUC0-t | 88 | 80 | 99 | LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observed. All events were mild to moderate, and no severe or serious adverse events occurred. Reported study related events were ve ...

SALT LAKE CITY, June 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8, in Milan, Italy. The presentation "Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week phase 2 randomized clinical trial" was presente ...