Lipocine Inc. (NASDAQ:LPCN) is a biopharmaceutical company focused on leveraging its proprietary Lip'ral platform to develop differentiated products through the oral delivery of previously difficult to deliver molecules, with a focus on treating Central Nervous System (CNS) disorders. The company has a diverse pipeline of product candidates targeting high unmet needs in areas such as postpartum depression, epilepsy, essential tremor, and chronic weight management.
Business Overview
Lipocine's primary development programs are based on oral delivery solutions for poorly bioavailable drugs. The company's proprietary Lip'ral technology is designed to improve patient compliance and safety through orally available treatment options. Lipocine's pipeline includes several differentiated innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver diseases, and hormone supplementation.The company's most advanced product candidate is LPCN 1154, a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the treatment of postpartum depression (PPD). Lipocine has also made progress with other CNS-focused candidates, including LPCN 2101 for epilepsy and LPCN 2203 for essential tremor.
In addition to its clinical development pipeline, Lipocine has assets for which it is seeking partnerships to enable further development, including TLANDO for territories outside of North America, LPCN 1148 for the management of decompensated cirrhosis, LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH), and LPCN 1107 for the prevention of recurrent preterm birth.
Financial Performance
For the full year 2023, Lipocine reported annual net income of -$16.4 million, annual revenue of $110.0 million, annual operating cash flow of -$11.9 million, and annual free cash flow of -$11.9 million.In the first quarter of 2024, the company generated revenue of $7.6 million, a significant increase from the $55,000 in revenue reported in the same period of 2023. This revenue growth was primarily driven by $7.5 million in licensing revenue received from the company's Verity License Agreement. Research and development expenses decreased to $2.8 million in Q1 2024 from $3.1 million in Q1 2023, while general and administrative expenses increased to $1.6 million from $1.3 million over the same period.
Lipocine ended the first quarter of 2024 with $24.6 million in unrestricted cash, cash equivalents, and marketable investment securities, compared to $22.0 million at the end of 2023. The company believes its existing capital resources will be sufficient to meet its projected operating requirements through at least May 9, 2025.
Verity License Agreement
In January 2024, Lipocine entered into a license agreement with Verity Pharmaceuticals Inc. (Verity), granting Verity an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize Lipocine's TLANDO product for testosterone replacement therapy (TRT) in the U.S. and Canada.Under the terms of the agreement, Verity paid Lipocine an initial payment of $2.5 million upon signing, followed by an additional $5 million payment on February 1, 2024. Lipocine is also eligible to receive up to $259 million in potential milestone payments, as well as tiered royalty payments ranging from 12% to 18% of net sales of all products licensed to Verity.
The Verity License Agreement also provides Verity with a license to develop and commercialize LPCN 1111, Lipocine's potential once-daily oral product candidate for TRT, in the U.S. and Canada. Lipocine retains the rights to TLANDO and LPCN 1111 outside of the U.S. and Canada, as well as development and commercialization rights for applications outside of the TRT field.
Pipeline Updates
LPCN 1154 (Postpartum Depression)
Lipocine's most advanced CNS candidate, LPCN 1154, is a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone that the company is developing for the treatment of postpartum depression (PPD). In March 2024, Lipocine completed enrollment and dosed the first cohort of patients in its pivotal PK study for LPCN 1154. The company expects to have top-line results from this study in the second quarter of 2024.LPCN 2101 (Epilepsy)
Lipocine is also evaluating LPCN 2101, an additional neuroactive steroid (NAS) candidate, for the treatment of epilepsy in women. The company has completed pre-clinical and Phase 1 studies for LPCN 2101, which demonstrated promising pharmacokinetic results, safety, and tolerability. Lipocine plans to initiate a Phase 2 proof-of-concept study for LPCN 2101, subject to resource prioritization.LPCN 2203 (Essential Tremor)
Lipocine is developing LPCN 2203, an oral candidate for the management of essential tremor, comprising a bioidentical GABA modulating NAS. The company has successfully completed oral pharmacokinetic studies with the bioidentical GABA modulating NAS and is planning to submit a protocol for a proof-of-concept Phase 2 study for essential tremor.LPCN 1148 (Decompensated Cirrhosis)
Lipocine is evaluating LPCN 1148, comprising testosterone laurate, for the management of decompensated cirrhosis. In July 2023, the company announced that the Phase 2 study of LPCN 1148 met the primary endpoint of increased skeletal muscle index relative to placebo in patients with cirrhosis. The study also demonstrated improvements in clinical outcomes such as prevention of new decompensation events, including hepatic encephalopathy, rates of hospitalizations, and patient-reported outcomes. Lipocine plans to request a Type C meeting with the FDA to discuss the clinical development plan for LPCN 1148 in mid-2024.LPCN 1144 (NASH)
Lipocine has completed a Phase 2 clinical study (the LiFT study) evaluating LPCN 1144, an oral prodrug of bioidentical testosterone, for the treatment of non-cirrhotic NASH. Both LPCN 1144 treatment arms met the pre-specified accelerated approval regulatory endpoint of NASH resolution with no worsening of fibrosis. The company had a written response from the FDA for a Type C meeting in January 2022, where the agency agreed that the NDA submission of LPCN 1144 would be via the 505(b)2 regulatory pathway and acknowledged the improvements in key components associated with NASH histopathology after 36-weeks of treatment. Lipocine is exploring partnership opportunities for the continued development and/or marketing of LPCN 1144.LPCN 2401 (Chronic Weight Management)
Lipocine is developing LPCN 2401, an oral formulation of a proprietary combination of an anabolic androgen receptor agonist and α-alpha tocopherol, as an adjunct therapy to incretin mimetics for chronic weight management. The company plans to request a meeting with the FDA to discuss the study design for a proof-of-concept Phase 2 study for LPCN 2401 and may explore partnership opportunities.LPCN 1107 (Preterm Birth Prevention)
Lipocine believes LPCN 1107, an oral hydroxyprogesterone caproate product candidate, has the potential to become the first oral treatment indicated for the reduction of risk of preterm birth in women with a history of singleton spontaneous preterm birth. The company has completed a multi-dose pharmacokinetic dose selection study in pregnant women and is exploring partnership opportunities for the continued development and/or marketing of LPCN 1107.