LPCN: Trial Results Improve Outlook
NASDAQ:LPCN
READ THE FULL LPCN RESEARCH REPORT
2Q:23 Financial and Operational Results
Two clinical trial readouts dominated Lipocine Inc.’s (NASDAQ:LPCN) news flow year to date: The pharmacokinetic (PK) study for LPCN 1154, which is in development for postpartum depression (PPD) and topline results from the Phase II study for LPCN 1148 in adult men with cirrhosis of the liver and sarcopenia. The bridge study for -1154 demonstrated comparable PK to the approved IV-administered brexanolone and identified the dose that will be used in a confirmatory pivotal PK study required for a new drug application (NDA) filing. The proof-of-concept study for -1148 demonstrated a statistically significant improvement in skeletal muscle and was associated with fewer severe hepatic encephalopathy (HE) events relative to placebo. In addition to the two positive readouts for pipeline assets, Lipocine attended scientific and investor conferences since the prior quarter update.
On August 10, 2023 Lipocine (NASDAQ: LPCN) filed its 2Q:23 Form 10-Q and posted its earnings release for the quarter ending June 30, 2023.
Highlights for 2023 include:
➢ First subject dosed in LPCN 1154 PK trial – April 2023
➢ 1:17 reverse stock split – May 12, 2023
➢ Topline results from LPCN 1154 PK trial – May 2023
➢ Topline results from LPCN 1148 proof of concept trial – July 2023
Lipocine generated no revenues during 2Q:23 and posted a net loss of ($3.5) million, or ($0.68) per share. For the quarter ending June 30, 2023 and versus the same period in the prior year:
➢ Research & Development expense totaled $2.5 million, down 13% from $2.9 million. The decline was attributable to a decrease in LPCN 1154 clinical study activity, lab supplies, small equipment and other related costs, contract research organization expense and outside consulting costs related to the completion of the LPCN 1144 LiFT study in 2022. Other contributors include lower costs for food effect studies for LPCN 1107 and scale up costs. Offsetting trends include an increase in contract research organization expense related to the LPCN 1148 trial, personnel related costs and TLANDO related costs;
➢ General & Administrative expenses were $1.4 million, up 28% from $1.1 million primarily due to higher professional and legal fees related to the reverse stock split and other general and administrative expenses, estimated franchise taxes resulting from the reverse stock split, business development fees, personnel salaries and benefits, market research activities and director fees. These increases were offset by lower professional fees incurred in the recruitment of additional directors in 2022 and corporate insurance expense;
➢ Total other income came from interest and investment sources, due to higher interest rates and imputed interest on the Antares agreement;
➢ Net loss was ($3.5) million or ($0.68) per share compared with net loss of ($2.6) million or ($0.51) per share, respectively.1
At quarter’s end, marketable securities, cash and equivalents totaled $25.8 million. Cash burn for 2Q:23 was ($3.3) million, compared with 2Q:22 consumption of ($3.1) million. ($5,000) of cash was used in financing related to the costs of the at the market (ATM) offering. Lipocine holds sufficient cash and equivalents to fund operations until at least August 2024.
Product Candidates
Lipocine’s primary research and development efforts in the CNS pipeline focus on lead candidate LPCN 1148 for management of decompensated cirrhosis and hepatic encephalopathy, LPCN 1154 for post-partum depression (PPD) and LPCN 2101 for women with epilepsy. See our full report for details on topline results for LPCN 1148 and LPCN 1154.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
________________________
1. Prior year earnings per share are adjusted for the May 2023 reverse share split.
