Slide 1: LPCN 2101: An Endogenous Neuroactive Steroid for Epilepsy
LIPOCIN= ENHANCING HEALTH LPCN 2101: An Endogenous Neuroactive Steroid for Epilepsy Benjamin Bruno, PharmD, PhD Director, Clinical Development lipocine, Inc.
Slide 2: Forward-looking statements
A pro of LPCN fates, FDA’s approval of TLANDO’, the expected timing of Phase 3 trials for LPCN d regulatory processes and objectives, potential benefits of the Company's Actual results may differ materially from the forward-looking statements ‘made in connection with, this presentation. Several fact
Slide 3: Innovative Oral Candidates for Neuroendocrine and Metabolic Disorders
Innovative Oral Candidates for Neuroendocrine and Metabolic Disorders PRE- Candidate (Indication) qUpTON PHASE 1 PHASE 2 PHASE 3 Approved* Commercial Partner TLANDO® U.S.: Antares Pharma (Testosterone Replacement Therapy) EX-US: Available LPCN 1111 (TLANDO XR) (Once Daily Testosterone Replacement Th
Slide 4: Women with Epilepsy (WWE) of Childbearing Age
Women with Epilepsy (WWE) of Childbearing Age 900,000 childbearing age women suffer from active epilepsy in the United States Seizure Control Pre-Pregnancy Pregnancy Comorbidities ¢ Drug-drug interaction ¢ Planned pregnancy ¢ Fetal/neonatal toxicity ¢ Anxiety ~ AED selection e Adherence to AEDs ¢ De
Slide 5: 2101: Positive Allosteric Modulator (PAMs) of the GABA-A Receptor
LPCN 2101: Positive Allosteric Modulator (PAMs) of the GABA, Receptor Lipocine Endogenous Oral Neurosteroid Has Potential to Address Unmet Needs presynaptic terminal Low (if any) fetal toxicity risk Comorbidity benefits Improve drug adherence relative to synthetics CYP interaction advantage Potentia
Slide 6: 2101: Preclinical Study
LPCN 2101: Preclinical Study Safety and blood levels with oral delivery * Sixteen female dogs were randomly assigned to one of four groups: o Vehicle, low, mid, or high dose LPCN 2101 orally administered once daily for 14 days Groups | Female (LPCN 2101) | Dogs (N) ne aT os ae Vehicle Low Dose 4 0.3
Slide 7: 2101 Pharmacokinetic Study
LPCN 2101 Pharmacokinetic Study Single-dose study in post-menopausal women Single-Dose AUC 100 80 Fed = || Fasted 40 2 oO Low Mid High High Dose AUC,., (h*ng/mL) 8 * Exposure comparable under fed and fasting conditions * Linear dose response for drug exposure LIPOCIN= ENHANCING HEALTH
Slide 8: Planned Proof-of-Concept Study for LPCN 2101
Planned Proof-of-Concept Study for LPCN 2101 Photosensitive Epilepsy Subjects with photoparoxysmal response (PPR) Positive results predict anticonvulsant efficacy Can aid in dose selection for future studies w, Phase 2, randomized, crossover, double-blind, placebo-controlled, dose-ranging study ¢ Ch