Lipocine(LPCN) - 2025 Q1 - Quarterly Report

Product Development and Approvals - TLANDO received FDA approval on March 28, 2022, and was commercially launched on June 7, 2022[92][104]. - The company entered into multiple licensing agreements for TLANDO, including an exclusive license with Verity Pharma for the U.S. and Canada, and additional agreements with SPC, Pharmalink, and Aché for other territories[93][94][106][109]. - The company is developing LPCN 1154 for postpartum depression, LPCN 2401 for obesity management, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor, targeting significant unmet medical needs[95][102]. - LPCN 1111, a next-generation oral testosterone replacement therapy, completed a Phase 2b study demonstrating good dose-response relationships and safety[112]. - The company aims to leverage its Lip'ral drug delivery technology platform to develop differentiated products for conditions with large unmet medical needs[98]. - The company is exploring partnerships for its pipeline assets, including LPCN 1144 and LPCN 1148, to advance their development[101]. - The FDA requires an efficacy and safety study of oral LPCN 1154 in the target population for NDA submission, with a Phase 3 study initiated[117]. - LPCN 2101 is being evaluated for women with epilepsy, with promising PK results and plans for a Phase 2 proof-of-concept study[126]. - LPCN 2203 is an oral candidate for managing essential tremor, with successful completion of oral pharmacokinetics and plans for a Phase 2 study[139]. - LPCN 2401 demonstrated a 4.4% increase in lean mass and a 6.7% decrease in fat mass in a Phase 2 study, indicating its potential for obesity management[149]. - LPCN 1148 met its primary endpoint by increasing skeletal muscle index (L3-SMI) relative to placebo (P<.01) in patients with cirrhosis[159]. - LPCN 1107 aims to be the first oral hydroxyprogesterone caproate product for reducing preterm birth risk, addressing an unmet need as approximately 11% of U.S. pregnancies result in preterm birth[179]. Financial Performance and Revenue - The company has generated $53.2 million in revenue from license fees, royalties, and milestone payments since inception through March 31, 2025[185]. - Revenue for the three months ended March 31, 2025, was$93,864, a decrease of $7,523,310 compared to$7,617,174 in the same period of 2024[196]. - Royalty revenue from TLANDO sales was $94,000 for the three months ended March 31, 2025, down from$117,000 in the same period of 2024[197]. - Research and development expenses totaled approximately $155.7 million since inception through March 31, 2025[186]. - Research and development expenses decreased by$1.76 million to $1,061,571 for the three months ended March 31, 2025, compared to$2,818,926 in 2024[198]. - General and administrative expenses decreased by $453,242 to$1,122,477 for the three months ended March 31, 2025, compared to $1,575,719 in 2024[199]. - As of March 31, 2025, the company had$19.7 million in unrestricted cash, cash equivalents, and marketable investment securities, down from $21.6 million at December 31, 2024[203]. Strategic Partnerships and Licensing - Verity Pharma made an initial payment of$2.5 million upon signing the Verity License Agreement, with additional payments totaling $5 million and potential milestone payments of up to$259 million based on sales and development milestones[106]. - The company plans to support its partners in the commercialization of TLANDO, ensuring timely availability to patients while receiving milestone and royalty payments[100]. - The company is responsible for supporting its partners in obtaining regulatory approvals for TLANDO in their respective territories[105]. - The company entered into the Aché License and Supply Agreement in April 2025, granting Aché an exclusive license to commercialize TLANDO in Brazil, with potential fees and royalties based on sales[204]. - The Verity License Agreement, executed in January 2024, includes potential milestone payments of up to $259 million and tiered royalty payments ranging from 12$2.0 million, compared to a cash inflow of $2.4 million for the same period in 2024[219]. - Cash used in investing activities for the three months ended March 31, 2025, was$882,000, significantly lower than $4.1 million in 2024[221]. - No cash was used in financing activities during the three months ended March 31, 2025, while$8,000 was used in the same period in 2024[222]. - The net cash used in operating activities in 2025 was primarily due to ongoing operational support, while the 2024 cash inflow included $7.5 million from the Verity License Agreement[220]. Operational and Market Risks - The company has contractual commitments with clinical research organizations and vendors for clinical trials and research studies, which are generally cancellable obligations[223]. - The lease for the corporate headquarters in Salt Lake City, Utah, was modified and extended through February 28, 2026[224]. - There have been no significant changes in critical accounting policies during the three months ended March 31, 2025, compared to the previous year[226]. - The company is exposed to market risks, including potential losses from adverse changes in interest rates, but does not engage in derivatives for trading purposes[227]. - There were no material changes to the company's market risk during the first three months of 2025[228]. - The company may face dilution of existing stockholders' ownership if additional capital is raised through public or private equity offerings[217].