Slide 1: LPCN 1154 (Brlizio) Oral Brexanolone for Postpartum Depression
LPCN 1154 (BRLIZIO ) TM Oral Brexanolone for Postpartum Depression (PPD) Lipocine │May 2025 1 Brlizio is a brand name conditionally approved by FDA TM
Slide 2: LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Potential as “first line” therapy Brexanolone Mechanism of Action • Brexanolone is a positive allosteric modulator (PAM) of the GABAA receptor Brexanolone (allopregnanolone) Molecular Weight: 318.5 g/mol Lipophilic: Log P ≈ 5.0 Poor aqu
Slide 3: Postpartum Depression (PPD) Market Opportunity
Postpartum Depression (PPD) Market Opportunity Among women reporting PPD symptoms, 64% reported comorbid anxiety symptoms7 • High economic burden Estimated patients in the U.S. with PPD3 • Critical to prevent harm to mother and infant • Negative impact on family/society Pregnancy in the US4 3.6M • S
Slide 4: LPCN 1154 - Compelling advantages over current therapies
LPCN 1154 - Oral Bioidentical NAS for PPD Compelling advantages over current therapies LPCN 1154 SSRIs / SNRIs Zuranolone (Zurzuvae®) (BRLIZIOTM) Off-Label Use Description Bioidentical NAS Synthetic NAS Derivative Synthetic SSRI/SNRI Administration Oral Oral Oral Onset of Action Hours* Days Weeks Tr
Slide 5: LPCN 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission PK Bridge Study Labeling Studies Next Step • Food effect study Positive P3 Safety and • PK study in PPD Results • Metabolite Efficacy Study evaluation Completed Completed Expected patient dosing Q2/25 Lipocine │
Slide 6: PK Bridge Study Results
LPCN 1154 PK Bridge Study Results LPCN 1154 met standard bioequivalence criteria to IV Brexanolone Comparative Exposure • LPCN 1154 was well tolerated • No sedation nor somnolence events observed PK GMR (%) 90% CI LB 90% CI UB • All events were mild to moderate Parameter Test vs. Reference Test vs.
Slide 7: LPCN 1154 Phase 3 Safety and Efficacy Study
LPCN 1154 Phase 3 Safety and Efficacy Study Study design • Two arm, outpatient, randomized, blinded, placebo-controlled in women (≥15 yrs) with postpartum depression • Size: ~80 women with severe PPD • Dosing regimen: 48 hr treatment • Primary endpoint: HAM-D change from baseline at hour 60 • Additi
Slide 8: LPCN 1154 "Best in Class" Oral Treatment for Depression
LPCN 1154 “Best in Class” Oral Treatment for Depression Key takeaways • Significant market opportunity • Differentiated product attributes addressing unmet needs • Streamlined pathway to NDA submission • PK bridge study: completed with positive results • Phase 3 safety & efficacy study: ongoing • To
Slide 9: Business Development Contacts
Business Development Contacts Kong Papangkorn, Ph.D. Business Development Manager kp@lipocine.com