Lipocine — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported total revenue of $2.3 million for the quarter ended September 30, 2026, compared to $115,000 in the same period in 2025.
• Q3 2026 revenue consisted of $2.1 million in license and collaboration revenue and $190,000 in royalty revenue from TLANDO sales.
• Reported a net loss of $0.7 million ($0.08 per diluted share) for Q3 2026, compared to a net loss of $3.2 million ($0.59 per diluted share) in Q3 2025.
• Research and development expenses were $2.1 million for Q3 2026, down from $2.7 million in Q3 2025, driven by lower costs for the LPCN 2401 study and reduced LPCN 1154 clinical costs.
• General and administrative expenses were $1.1 million for Q3 2026, up from $0.8 million in Q3 2025, primarily due to higher personnel costs and legal fees.
• Interest and investment income was $0.2 million for both Q3 2026 and Q3 2025.
• For the nine months ended September 30, 2026, reported revenue of $2.6 million compared to $831,000 in the prior year period.
• Nine-month net loss was $7.0 million ($0.90 per diluted share) compared to $7.3 million ($1.35 per diluted share) in the prior year.
• Nine-month R&D expenses were $6.9 million, up from $5.9 million, reflecting higher LPCN 1154 study costs and personnel expenses.
• Nine-month G&A expenses were $3.3 million, up from $2.8 million, driven by legal fees and personnel costs.
• As of September 30, 2026, unrestricted cash, cash equivalents, and marketable investment securities totaled $21.5 million, compared to $14.9 million at December 31, 2025.
• As of November 4, 2026, unrestricted cash, cash equivalents, and marketable investment securities were approximately $28.5 million.
• Deferred revenue remained constant at $320,000 between December 31, 2025, and September 30, 2026.
• Total liabilities were $2.0 million as of September 30, 2026, down from $2.5 million as of December 31, 2025.

Business Segments and Product Lines:

• Initiated the BLOOM Phase 3 placebo-controlled outpatient study for LPCN 1154 (BRLIZIO™) for Postpartum Depression (PPD) in September 2026, expected to enroll approximately 120 participants.
• FDA feedback confirmed the NDA submission package is complete for a 505(b)(2) pathway submission, contingent on a single positive and well-controlled Phase 3 trial.
• Plans to submit a Phase 2 protocol to the FDA for LPCN 2201 (Major Depressive Disorder) and may initiate a study subject to resource prioritization.
• Completed oral pharmacokinetic studies for LPCN 2203 (Essential Tremor) and plans to submit a proof-of-concept Phase 2 protocol to the FDA, subject to resource prioritization.
• Health Canada approved TLANDO® for testosterone replacement therapy in adult males in September 2026; partner Verity Pharma plans a Canadian launch in early 2027.
• Pharmalink received product marketing authorization for TESTYRA® (TLANDO) in the United Arab Emirates in July 2026, with a launch planned for early 2027.
• Continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, GCC countries, and Brazil.
• Explores business partnerships for the development, approval, and commercialization of BRLIZIO™.

Other Key Points:

• The company has no debt reported in the balance sheet; total liabilities consist of accounts payable, accrued expenses, and deferred revenue.
• Stockholders' equity increased to $21.2 million as of September 30, 2026, from $14.5 million at December 31, 2025.
• The company holds $18.9 million in marketable investment securities as of September 30, 2026, compared to $9.7 million at December 31, 2025.
• Forward-looking statements include risks regarding clinical trial success, FDA approval, capital sufficiency, and the ability to secure strategic partnerships.