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1 Lipocine │2026 Corporate Presentation February 2026
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2 Lipocine │2026 Forward-Looking Statements This presentation contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and strategic plans and related development efforts with the FDA, including with respect to LPCN 1154, our current intention to conduct a safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, the timing of our submission of a NDA with the FDA for LPCN 1154, and the potential uses and benefits of our product candidates, the application of our proprietary platform in developing new treatments, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this presentation, except as required by law.
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3 Lipocine │2026 Development Candidates Indication Phase 1 Phase 2 Pivotal Commercial Next Steps/Status Neuroactive Steroids LPCN 1154 (BRLIZIO ) Postpartum Depression (PPD) Phase 3 Topline results early Q2/26 LPCN 2201 Major Depressive Disorder (MDD) Phase 2 POC study LPCN 2203 Essential Tremor (ET) Phase 1 study completed LPCN 2101 Drug Resistant Epilepsy (DRE) Phase 2 POC study Commercial Product Indication Phase 1 Phase 2 Pivotal Commercial Next Steps/Status TLANDO® Testosterone Replacement Therapy Commercialized by partners (Verity Pharma in the U.S.) Out-License Opportunities Indication Phase 1 Phase 2 Pivotal Commercial Next Steps/Status LPCN 1148 Liver Cirrhosis Phase 2 study completed LPCN 2401 Obesity Management – adjunct to GLP-1 Seeking regulatory clarity LPCN 1107 Prevention of Preterm Birth End of Phase 2 meeting completed Lipocine Pipeline
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LPCN 1154 (BRLIZIO TM ) Oral Brexanolone for PPD (Postpartum Depression) BRLIZIO TM is the brand name conditionally approved by FDA
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5 Lipocine │2026 • Better compliance • Scheduling flexibility (e.g. weekend) with minimal family disruption • More amenable to discreet treatment • Quicker return to normal daily activities • Faster management of depression • Reduces the risk of suicidal thoughts and behaviors • Leads to fewer hospitalizations • Positive outcomes in terms of mother and family relationships • Reduces financial burden PPD is a Life-Threatening Condition with Few Existing Treatment Options Rapid relief, short treatment duration, and superior tolerability advantages 1. Mauri et al. Arch Womens Ment Health. 2012; 15(1): 39-47 2. Chin et al. Curr Psychiatry Rep, 2022; 24(4):239-275 3. www.nytimes.com/2025/07/22/health/post-partum-depression-treatment-pill.html Rapid relief benefits Short treatment duration benefits Maternal depression and suicide can have far-reaching consequences for child development, family function, and the nation's economy1-3 • Better treatment adherence • Increase treatment success • Reduced risk of complications and hospitalization • More quality time with family • Less dependence on caregivers Superior tolerability benefits
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6 Lipocine │2026 1. Farr et al. J Womens Health (Larchmt). 2013 Oct 26;23(2):120–128 2. Chin et al. Curr Psychiatry Rep, 2022; 24(4):239-275 3. Mauri et al. Arch Womens Ment Health. 2012; 15(1): 39-47 4. Leerink Center for Pharmacoeconomics, 2025 MEDACorp LLC 5. Foster Rosenblatt market research 2023 (Lipocine internal data) 6. National Vital Statistics Report vol 72, num 1, 2023; Vital Statistics Rapid Release, report 26, 2023 7. Van Niel et al. Cleveland Clinic J of Medicine. 2020;87(5):273-277 8. Cox et al. J Clin Psychiatry. 2016;77:9, Beck. AJN. 2006;106:5 9. Sage/Biogen HEOR Claims Analysis 10. Biogen 4th Quarter 2025 Financial Results 11. Sage May 2025 Management Projection Increased awareness and effective therapies are expected to meaningfully expand diagnosis among symptomatic women with PPD PPD – An Expanding Market Opportunity Awareness drives diagnosis - empowering women with PPD through effective therapies • High clinical and economic burden with consequences beyond the mother • Treatment goal is rapid harm reduction for both mother and infant • Meaningful negative impact on family stability, child development, and society • PPD commonly presents with psychiatric comorbidity; 64% report anxiety symptoms 1 • Suicide is a leading cause of maternal death in the first year postpartum 2 − Up to 30% of women with PPD report suicidal ideation 3 • Compelling pharmacoeconomic rationale for early, effective intervention 4 ZURZUVAE® Rx price: $16,377 ZURZUVAE revenue $66M Q4-2510 Projected peak ZURZUVAE® sales of ~$1B11 ~144,000 ~ 240,000 3.6M ~ 600,000 Pregnancies in the US6 Postpartum depression7 Diagnosed PPD patients8 Diagnosed are Rx treated9 ZURZUVAE® is an FDA-approved oral treatment for adults with PPD Estimated patients in the U.S. with PPD5
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7 Lipocine │2026 LPCN 1154 – Poised to Lead the Market and Set the Standard of Care Therapy overview – LPCN 1154 vs. existing options 1. Zulresso label 2. Brexanolone Briefing Book, November 2, 2018 3. In adolescent patients per sNDA 211371 S-007 Multi-disciplinary Review and Evaluation ZULRESSO) 4. Zurzuvae label; Somnolence (36%), dizziness (13%), dose Reduction (14%), and discontinuation (2%), 5. Kristina M. Deligiannidis et al., JAMA Psychiatry. 2021 Sep; 78(9): 1–9 6. Subject to ongoing P3 trial results; all participants have completed dosing with no drug discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reported 7. https://www.uptodate.com/contents/image?imageKey=PSYCH%2F143603 8. IV brexanolone therapy has been discontinued 9. https://www.sciencedirect.com/science/article/pii/S0165032722011570; cumulative response rate Oral Brexanolone (LPCN 1154) Zuranolone (ZURZUVAE®) IV Brexanolone (Zulresso®)8 SSRIs / SNRIs Off-Label Use Description Bioidentical NAS Synthetic NAS Derivative Bioidentical NAS Synthetic SSRI/SNRI CNS depressant AEs TBD6 High4 Serious Moderate7 Onset of Action TBD6 Days Hours Weeks Treatment Duration 48 Hours 14 Days 60 Hours Months Response Rate at Day 3 TBD6 Up to 41% 81%9 N/A Zuranolone (ZURZUVAE®) treatment is associated with frequent CNS depressant effects such as somnolence, dizziness, and sedation. No head-to-head clinical trials have been conducted. Data are derived from published reports of different clinical trials at different points in time, with differences in trial design, size, and patient populations. Response Rate defined as a reduction of HAM-D score of at least 50% compared with baseline *Projected based on Zulresso published reports (Brexanolone Briefing Book, November 2, 2018 and Meltzer-Brody et al. Lancet. 2018 Sep 22;392(10152):1058-1070) LPCN 1154 (Brlizio) is expected to provide more rapid relief of PPD than approved treatments, with only a short (48-hour) treatment requirement. IV Brexanolone (Zulresso®) provides rapid symptom relief and required a 60-hour inpatient IV infusion with intensive monitoring. The therapy has been discontinued. SSRIs / SNRIs have slow onset, longer treatment duration, and lower response rates. Additionally side effects such as sexual dysfunction, changes in sleep pattern and weight gain are common.
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8 Lipocine │2026 LPCN 1154 – Target Product Attributes Addresses Unmet Medical Need Strong potential to set the benchmark for first-line therapy Lipocine | 2025 Oral Dosage Form Comprising Brexanolone 48-hour outpatient dosing Rapid and sustained relief Superior tolerability Identical to endogenous allopregnanolone Fixed dose without titration or taper required
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9 Lipocine │2026 LPCN 1154 – Oral Bioidentical Neuroactive Steroid (NAS) for PPD Overcoming brexanolone oral delivery challenges Brexanolone Source: Giliyar et al. Drug Delivery Technology, Jan 2006, Vol 6 No.1 Molecular Weight: 318.5 g/mol Lipophilic: Log P ≈ 5.0 Poor aqueous solubility: Saq <1.0 µg/mL Oral enablement
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10 Lipocine │2026 LPCN 1154 – Formulation Screening and Dose Finding/Confirmation Studies Seven clinical studies conducted prior to P3 study • Oral bioavailability of LPCN 1154 confirmed • Formulation selected • Linear PK (AUC and Cmax) across all dose strengths evaluated – Single-dose and multi-dose regimens 1. Meltzer-Brody et al. Lancet 2018; 392(10152): 1058-1070. 2. Buchsbaum et al. Biol Psychiatry 1985; 20(8): 832-842. 3. Ibanez et al. Plos One 2014; 9(3): e93159. 4. Huang and Shen Clin Electroencephalography 1994; 24(4): 179-187 5. Biondi et al. Sci Rep 2022; 12(1): 1919. • Dosing regimen for phase 3 study identified based on dosing regimen confirmation study • 24 post-menopausal women • Randomized, crossover design • PK endpoints qEEG provides evidence of target engagement R LPCN 1154 IV Brexanolone Period 1 Study Enrollment First dose Visit 1 Final drug administration LPCN 1154 IV BrexanoloneN=12 N=12 Period 2 First dose Visit 2 Final drug administration Study exit 10 day washout period Randomization N=24 Screening Dosing regimen confirmation study Consistent with therapies effective in managing depression, anxiety, tremor, and seizures 1-5
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11 Lipocine │2026 Bioequivalent to Zulresso PK Parameter LPCN 1154 IV Brexanolone GMR Test vs. Reference (90% CI) Cmax (ng/mL) 120 115 105% (92-118) AUC0-∞ (h*ng/mL) 4884 5019 97% (89-107) AUC0-t (h*ng/mL) 4266 4784 89% (81-98) LPCN 1154 – Dosing Regimen Confirmation Study Results Results inform dosing regimen for Phase 3 safety and efficacy confirmatory study (NCT06979544) n=23; Outlier participant presented PK results for the IV administration period greater than 70 standard deviations away from the PK data set mean for all PK parameters included above GMR = Geometric Mean Ratios, CI = Confidence Interval, t = 100 hours for AUC0-t LPCN 1154 multi-dose regimen resulted in bioequivalent blood levels compared to IV brexanolone administered per label at 90 µg/kg/hr • No sedation or somnolence events observed • All events were mild to moderate • No severe or serious AEs • Reported study related events were venipuncture site related, arthralgia, fatigue, dizziness, headache, back pain, hematoma, and pelvic pain Brexanolone was well tolerated independent of route
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12 Lipocine │2026 LPCN 1154 – Phase 3 Safety and Efficacy Study Based on FDA feedback – outpatient setting with no medical monitoring requirement https://clinicaltrials.gov/study/NCT06979544 Study design • Two arm, outpatient, randomized, blinded, placebo-controlled in women with postpartum depression • Utilizes same dose and regimen as the PK dose confirmation study Inclusion criteria Severe PPD Age ≥15 yrs N= 90 women Endpoints Primary endpoint: HAM-D change from baseline at Hr 60 Additional endpoints: MADRS, HAM-A (anxiety), PGI-C, safety and tolerability, etc. Analysis Timepoints at Hr 12, Hr 36, Hr 60, Day 7, and Day 30 R LPCN 1154 Placebo Primary Analysis Timepoint Treatment period 0 48 60Hour Day 30
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13 Lipocine │2026 LPCN 1154 – Phase 3 Study Updates and Rationale for Success 1. Zulresso MDR, Study 202B • Two DSMB data review meetings complete • Enrollment and dosing complete (N=90) • Expected topline results: Early Q2 2026 Study Updates • Efficacy of brexanolone established in multiple IV infusion (Zulresso) studies • LPCN 1154 has demonstrated bio-equivalent exposure to IV infusion • P3 study population, duration, and size similar to Zulresso® P3 study 1 – Population: women with PPD (Baseline HAM-D 28.3 vs 28.7) – Primary endpoint: HAM-D change from baseline at Hour 60 – Size: Comparable participants dosed per arm as IV brexanolone P3 (~45 vs. ~41) Rationale for Success
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14 Lipocine │2026 With over 100 unique participants exposed to LPCN 1154 across eight clinical studies, no reports of excessive sedation, loss of consciousness, or drug- related SAEs • All reported nervous system disorders AEs were mild to moderate in severity • No reports of drug discontinuations • Unlike IV brexanolone (Zulresso ), no reported cases of: – Excessive sedation – Loss of consciousness – Drug-related SAEs Phase 3 Study1 Safety Update (Blinded) LPCN 1154 – Safety Update Favorable safety profile 1. NCT06979544 2. Excessive sedation (ES) is characterized by impaired alertness and attention or difficulty following simple instructions, which precludes the participant from completing daily tasks. Participant is frequently drowsy and may fall asleep during activities (e.g., conversation, eating)
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15 Lipocine │2026 LPCN 1154 – Development Status Streamlined 505(b)(2) pathway to NDA submission targeted mid 2026 Food effect study PK study in PPD Metabolite evaluation Labeling Clinical Studies Ongoing P3 StudyDosing Regimen Confirmation Study Positive Results Dosing completed Two DSMB data review meetings complete o Topline results – Early Q2-26
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16 Lipocine │2026 LPCN 1154 – Potential “Game Changer” for Fast Acting Depression Therapy Key takeaways • Large, attractive market opportunity • Differentiated product profile addressing unmet needs • Rapid relief, short treatment duration, superior tolerability • Clear, streamlined path to NDA submission • Dosing regimen confirmed • Phase 3 safety and efficacy study ongoing • Topline data expected early Q2 2026 • Planned NDA filing mid-2026 • Issued and pending patent protection globally • Issued patent terms extending to 2044+ • Platform potential for expansion into additional depressive indications Treatment Duration LPCN 1154 (Brlizio) 48 Hours Zurzuvae 14 Days SSRI Months
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LPCN 2201 Oral Brexanolone for Major Depressive Disorder (MDD)
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18 Lipocine │2026 MDD Market Potential Total annual burden of medication-treated MDD among the US population was $92.7 billion1 1. J Clin Psychiatry 2021;82(2):20m13699 2. https://www.nimh.nih.gov/health/statistics/major-depression 3. Cai et al. J Affect Disord. 2021 Oct 1:293:148-158 4. Adv Ther. 2023 Jul 31;40(10):4460–4479 5. https://www.investor.jnj.com/investor-news/news-details/2025/Johnson--Johnson-Reports- Q3-2025-Results-Raises-2025-Sales-Outlook/default.aspx 6. Axsome Corporate Presentation November 2025 7. https://www.mordorintelligence.com/industry-reports/antidepressants-market *Induction, $4,000 for 1st month + maintenance ~ $1,000 per month SPRAVATO® Rx cost: ~ $15,000 annually*, $405M in Q3 20255 AUVELITY® Rx Cost: ~$15,000 annually, $136 M in Q3 20256 Significant Unmet Needs in Depression Disorders Adequate and durable remission/response; treat anxiety comorbidity Robust Efficacy Minimal CNS depressant effects, no dissociation, no sexual dysfunction or weight gain side effects, no withdrawal side effects upon discontinuation Good Tolerability Hours/Days, especially for severe MDDRapid Relief Outpatient or at home useUnrestricted Access Market expected to reach $31B by 20307 Severe MDD is strongly linked to significant difficulty in work, social, and home activities 61% received treatment2 ~13M 38% with suicidal ideation3 ~8M ~33% severe MDD4 ~6.6M MDD prevalence 8.4% of population2 ~21M
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19 Lipocine │2026 Product Attribute* LPCN 2201 (Neuroactive Steroid) SPRAVATO (Esketamine)1 AUVELITY (Dextromethorphan + bupropion)2 SSRI/SNRI Mechanism of Action Positive GABAA modulator NMDA receptor antagonist NMDA receptor antagonist + norepinephrine/dopamine reuptake inhibitor Serotonin reuptake inhibition (SSRI) or serotonin + norepinephrine reuptake inhibition (SNRI) Route Oral Intranasal Oral Oral Onset of Efficacy Hours to days Hours to days 1-2 weeks 4-8 weeks Key AEs TBD Psychological effects (61-84%) including dissociation, dizziness (29%), nausea (28%), sedation (23%), vertigo (23%) Dizziness (16%), nausea (13%), dry mouth, somnolence Sexual dysfunction, weight gain, GI upset Monitoring/ Administration Setting Not expected/At home REMS/In-clinic observation (≥2 hrs post-dose) None required/At home None required/At home LPCN 2201 – Targeted Attribute-Based Product Differentiation Potential Rapid Acting Anti-depressant (RAAD) *No head-to-head clinical trials have been conducted. Data are derived from published reports of different clinical trials at different points in time, with differences in trial design, size, and patient populations. 1. https://www.spravatohcp.com/trd-efficacy-safety/ 2. Auvelity label
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20 Lipocine │2026 LPCN 2201 – Oral RAAD for Major Depression Disorders Potential to set rapid relief benchmark for MDD Attributes LPCN 2201 Rapid Relief Convenient Oral At-Home Use Favorable Safety Profile High unmet need for oral RAAD; large market potential Leverage expertise/credibility and investment/value in oral NAS created to date Streamlined development Issued and pending patent claims for MDD indication
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LPCN 2203 Oral Brexanolone for Essential Tremor
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22 Lipocine │2026 • Tremor is highly disabling and stigmatizing • Stress can aggravate tremor in social setting • Major impact on activities of daily living leading to unemployment, anxiety and depression2 − Most common impacts on activities of daily living are pouring liquids and writing/typing (100%) and grooming/hygiene, drinking, dressing, eating, and reading (80-85%) − 90% of participants indicated the emotional impact of ET − 75% reported tremor-related worry or anxiety • Majority of patients require caregiving2 Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption Essential Tremor (ET) 1. Louis ED, Ottman R. Tremor Other Hyperkinet Mov (N Y). 2014;4:259 2. Gerbasi et al. Patient experiences in essential tremor: Mapping functional impacts to existing measures using qualitative research. MDS 2023. *indicative pricing ~ $10K/patient/year $3.6B* Diagnosed 40% 65% in need of 2nd line treatment 20% peak adoption360 K 1.8 M ~7 M 2.8 M Estimated prevalence 2.2 % of population1
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23 Lipocine │2026 Competitive Landscape Standard of Care LimitationsUnmet Need Unfavorable benefit to risk profile3 • Most patients are intolerant or have an inadequate response to first line propranolol or primidone • 33% experienced no benefit from propranolol and 35% discontinued due to side effects • 17% reported no benefit from primidone and 23% discontinued due to side effects Superior benefit to risk profile • Improve efficacy • Fewer side effects • Somnolence • Dizziness • Constipation • Address anxiety/depression comorbidity • Disease-modifying effects • Propranolol is the first line therapy • 65% in need of second line treatment • ~44% of diagnosed patients treated with propranolol or primidone2 • Ulixacaltamine: Positive P3 results4 • Discontinuation rate 36-38% • TEAEs ≥ 10%: Constipation (25- 29%), dizziness (24-26%), brain fog (12-19%), paraesthsia (10-12%), fatigue (9-10%), insomnia (8-12%), and headache (8-13%) Essential Tremor Management – No New Drugs Approved In 50+ Years Daytime efficacy and improved tolerability remain an unmet need 1. Louis ED, Ottman R. Tremor Other Hyperkinet Mov (N Y). 2014;4:259 2. Vetterick et al. Adv Ther. 2022; 39(12): 5546–5567 3. Clinical Parkinsonism & Related Disorders 5 (2021) 100101 4. Praxis Corporate Presentation Jan 2026
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LPCN 2101 Treatment of Epilepsy
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25 Lipocine │2026 DRE is defined by ILAE as the failure of two appropriate anti-seizure medications (ASMs) to achieve sustained seizure freedom Drug-Resistant Epilepsy (DRE) A significant clinical challenge in epilepsy care with high social and occupational limitations1 1. Pharmacol Rev. 2020 Jul;72(3):606–638 2. Front Neurol. 2022 Nov 3;13:1023832. 3. https://www.epilepsy.com/treatment/medicines/drug-resistant-epilepsy? 4. Epilepsia. 2022;63(8):2144–2154 5. JAMA Neurol. 2017 Dec 26;75(3):279–286 Affects 30-40% of epilepsy patients in the U.S. 2 Increased risk of injury, hospitalization, mortality, and mental health issues1 Contributes heavily to the $24.5 billion annual epilepsy-related healthcare costs4 Limited success with medications and need for early identification Probability of achieving seizure freedom diminishes substantially with each subsequent AED regimen tried 5 Prevalence Clinical Impact Economic Burden Treatment Challenges
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26 Lipocine │2026 Unmet Needs in DRE Seizure freedom without adverse effects, while improving the patient's quality of life Ioannou et al. Brain Behav. 2022 Sep;12(9):e2589 Mesraoua et al. J Neurol Sci. 2023 Sep 15:452:120766 Limitations of Current Options • 30–40% of patients still do not achieve freedom from seizures, despite being on multiple medications • Many patients with DRE go through multiple ASMs with limited success • Rescue treatments (primarily benzodiazepines) do not prevent future seizures, they only stop the current episode • High risk of seizure recurrence within hours or days after a cluster • Seizures may cause physical injuries, and a minority may last long (status epilepticus) or recur in clusters and can be life-threatening Unmet Needs • Medications with novel mechanism of action, especially for patients who experience recurrent seizure clusters or DRE • Minimal cognitive, mood, or systemic side effects • Address associated comorbidities like depression, anxiety, and cognitive impairment • Transition effectively to maintenance therapy and sustain seizure control after acute treatment • Prevent status epilepticus and prevent patients from using emergency room for seizure management
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27 Lipocine │2026 LPCN 2101 – Eltanolone for Epilepsy Treatment Positive Allosteric Modulator (PAM) of the GABAA receptor 1) Kokate et al., 1996. Neuropharmacology. 2) Carver and Reddy, JPET 2016. 3) Ekaminski et al. epilepsia, 2004. 45(7): p. 864-7. 4)Bruun et al., 2015 Neuropharmacology. 5) Chuang and Redy, 2020, J Pharmacol Exp Ther. 6) Kokate et al., JPET, 1998. *horizontal screen test Lipocine | 2025 • Effective in most of the tonic and/or clonic, focal, and generalized seizure animal models1-3 • Maintained effectiveness upon chronic dosing 6 • Potentially synergistic with benzodiazepines 4,5 0 10 20 30 40 0 4 8 12 16 20 24 Time (hr) From separate studies in post-menopausal women with Lip’ral based oral dosage forms • Novel MOA specifically addressing DRE • Active molecule is bioidentical to endogenous NAS • Potential to address psychiatric comorbidities (depression, anxiety, sleep disorders) Product Candidate Differentiation Anti-Seizure Activity in Preclinical Models First Oral Enablement Phase 1 Results Mean Plasma Concentration (ng/mL)
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28 Lipocine │2026 LPCN 2101 Development Status Phase 2 ready Chronic administration was safe and well tolerated Preclinical Toxicity Phase 1 StudiesPreclinical PK First oral enablement demonstrated Achieved ~10x of estimated highest target therapeutic level IND cleared Confirmed oral enablement Well-tolerated Next Steps o Initiate P2 study
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TLANDO® Testosterone Replacement Therapy (TRT)
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30 Lipocine │2026 TLANDO® – FDA-Approved Oral Testosterone Replacement Therapy Established commercialization partnerships in multiple territories First and only oral testosterone replacement therapy (TRT) option that does not require dose titration TRT is a large and growing market with ~8M annual prescriptions in the U.S. and ~650,000 in Canada TLANDO® licensed to Verity Pharma in January 2024 for commercialization in the U.S. • $11 million upfront payment to Lipocine • Entitled to receive tiered royalty payments ranging from 12% up to 18% on net sales of TLANDO franchise TLANDO® licensed to 5 territories including US and Canada FDA labeling changes for testosterone products • Removal of Boxed Warning related to an increased risk of adverse cardiovascular outcomes • Include results from required post market ambulatory blood pressure (ABPM) studies Approved product utilizing Lip’ral technology IMPORTANT SAFETY INFORMATION www.tlando.com/
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Appendix
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LPCN 1148 Management of Liver Cirrhosis • Overt Hepatic Encephalopathy (OHE) • Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
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33 Lipocine │2026 LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets Positive POC Phase 2 results in treatment of sarcopenia and OHE in cirrhosis POC = Proof of concept; SOC = Standard of care; ARA = Androgen receptor agonist Overt Hepatic Encephalopathy (OHE) Positive P2 results with background SOC Validated regulatory pathway A commercially successful surrogate Sparse competitors in development Unique ARA with patent protection through 2044 0 50 100 150 200 250 300Sales ($M) Analogue (Rifaximin) Sales BofA Global Research, Pharmaceutical Scripts/Sales Data Report 21 January 2025 Sarcopenia in Cirrhosis Positive P2 results in sarcopenia FDA granted Fast Track Designation Acceptable endpoints on sarcopenia No competition in development Unique ARA with patent protection through 2044
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34 Lipocine │2026 ~9% increase in L3-SMI at week 24 33% of patients had resolution of sarcopenia* at week 24 LPCN 1148 Phase 2 Results – Sarcopenia Primary Endpoint Met Resolution for sarcopenia and significantly increased skeletal muscle mass index (SMI) LS mean (SE), † P<0.01 for change from baseline; ‡ p<0.01 vs. Week 24 placebo; L3-SMI = L3 skeletal muscle index *Using protocol-defined sarcopenia thresholds. All data is LOCF -5 0 5 10 15 20 25% CBL L3-SMI Week LPCN 1148 Placebo Placebo to 1148 ‡ ‡‡ ‡ ‡ †
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35 Lipocine │2026 Through Week 24 Week 24 to EOS Parameter Placebo N=14 LPCN 1148 N=15 LPCN 1148 N=11 LPCN 1148 switch from placebo N=8 History of HE prior to randomization (n) 11 (79%) 11 (73%) 7 (64%) 6 (75%) Recurrent Overt HE (events) 6 1* 1 1 Time to first recurrent event (days) 35 114 294 140 LPCN 1148 Phase 2 Results – HE Endpoint Met Fewer overt hepatic encephalopathy events OHE is defined as an adverse event of HE with CTCAE severity > grade 1. * P<0.05 vs placebo HE events post study drug discontinuation for liver transplant excluded
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36 Lipocine │2026 LPCN 1148 Phase 2 Results Safety Data Overall LPCN 1148 was well tolerated Safety set; includes all participants who received study drug in a given stage. Post-transplant AEs excluded. Severe AEs: CTCAE severity ≥ Grade 3 • Rates and severities of AEs similar to those in Stage 1 with placebo • Fewer participants experienced severe AEs when switched from placebo to LPCN 1148 Parameter Placebo (Through Week 24) N=14 LPCN 1148 (Through Week 24) N=15 LPCN 1148 (Week 24 to EOS) N=11 LPCN 1148 switch from placebo (Week 24 to EOS) N=8 Total AEs 9 (64%) 9 (60%) 7 (64%) 7 (88%) Serious AEs 5 (36%) 5 (33%) 5 (45%) 1 (13%) Severe AEs 4 (29%) 4 (27%) 3 (27%) 1 (13%) Deaths 2 (14%) 0 1 (9%) 0
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LPCN 2401 Obesity Management – adjunct to GLP-1
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38 Lipocine │2026 Unprecedented Demand and Usage of GLP-1 Receptor Agonists 1-3 GLP-1 market trending toward oral once daily dosing 1. https://www.biospace.com/drug-development/7-indications-for-glp-1s-beyond-weight-loss 2. https://www.pwc.com/us/en/services/consulting/business- model-reinvention/glp-1-trends-and-impact-on-business-models.html 3. https://www.nature.com/articles/s41574-024-01066-9 4. Novo Nordisk SEC filing 2025 5. Eli Lilly SEC filing 2025 6. https://jamanetwork.com/journals/jama/article-abstract/2819949 7. https://www.globenewswire.com/news-release/2025/03/18/3044263/28124/en/ T2DM Weight management Cardiovascular disease Chronic kidney disease Sleep apnea FDA approved indications Expanding clinical indications1 Semaglutide: $30 billion sales in the US in 20244 Tirzepatide: $14 billion sales in the US in 20245 As of 2024, around 12 percent of U.S. adults reported having used a GLP-1 medication at some point6 Over 150 GLP-1 drug candidates in development for multiple indications7
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39 Lipocine │2026 Drawbacks of Approved GLP-1 Receptor Agonists Rapid loss of lean mass and functionality in elderly GLP-1 users 1. The data were adapted from Veru Corporate Presentation Jones Healthcare and Technology Innovation Conference, April 8-9, 2025 2. Wegovy label (Revised 03/2024) 3. https://investor.regeneron.com/news-releases/news-release-details/interim-results-ongoing-phase-2-courage-trial-confirm-potential Low Quality Weight Loss1 -4.7kg -3.2kg -1.5kg -5 -4 -3 -2 -1 0 Weight Loss (kg) Fat loss (%) Lean mass Loss (%) Mean change from Baseline -4.1% Weight Loss Fat Loss Lean Mass Loss -8.6% Semaglutide Significant weight loss is from lean mass loss in 16 weeks1 The median percentage of total body weight loss that is due to lean mass: 32% in 16 weeks 1 (elderly 60+) 35% in 24 weeks3 (adults 18-80) Lean Mass Loss1 32% 68% Lean mass Fat mass 0 1 2 3 Age ≥ 75 % Subjects with Fracture Semaglutide Placebo Fracture Risk2,3 Patients on semaglutide had significantly more fractures of the hip and pelvis 2 43% of elderly (60+) lost ≥10% Stair Climb Power from baseline in 16 weeks of GLP-1 use 1 Functionality Loss1 43%
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40 Lipocine │2026 Proprietary androgen receptor agonist, testosterone ester(s), targeted for once-a-day treatment - “LPCN 2401” • Androgen receptor agonist with α-tocopherol for once-a-day treatment – “LPCN 2401+E” • A bioidentical to physiological regulator of myostatin that indirectly inhibits its expression and signaling LPCN 2401 Once Daily Oral as An Adjunct to GLP-1 Treatment Proven potential to improve body composition - quality weight loss with quality fat loss Product Candidate Attributes 1. Biochimie,87(1):39-43, 2005 2. J Endocr Soc. 2019 Jan 1; 3(1): 91–107 3. J Clin Endocrinol Metab, 104(6): 2094–2102, 2019 4. Clin. Interv. Aging 2016, 11, 1317–1324 5. Horm. Metab. Res. 2004, 36, 674–678 Androgen Receptor Agonist Targeted Mechanism of Actions Muscle • Stimulates muscle satellite activator, FGF23 • Modulates muscle growth suppressors MRF4 and myostatin (GDF8) expression in skeletal muscle 3 Bone • Acts directly on osteoblasts and consequently promotes bone formation 4 • Increases AR expression level in osteoblasts 4,5 Fat • Induces lipolysis1 • Lowers lipogenesis1 • Inhibits expression of adipocytokines (e.g., leptin, TNF-α, IL-6, IL-1) 2
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41 Lipocine │2026 LPCN 2401 – Clinical Data Show Significant Improvement in Body Composition Phase 2 results demonstrate increased lean mass and decreased fat mass at Week 20 *p<0.05 vs placebo Phase 2 clinical trial - NCT04134091 n=12 for LPCN 2401; n=13 for LPCN 2401+E; n=13 for placebo 1.6 0.7 1.9 0.8 -1.3 -0.9 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 Lean Mass (kg) Appendicular Lean Mass (kg) CBL (kg) Lean Mass * * * * Fat Mass -2.0 -2.6 1.2 -4 -2 0 2 Total Fat Mass (kg) CBL (kg) * -0.9 -1.4 0.9 -2 -1 0 1 Trunk Fat Mass (kg) CBL (kg) * * *
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42 Lipocine │2026 LPCN 2401 Novel Oral Treatment for Obesity Management Target benefits to improve weight loss and functionality LPCN 2401 + GLP-1 agonist treatment Amplify fat loss More abdominal fat loss LPCN 2401 treatment post GLP-1 cessation Maintain/improve functionality Sustain HbA1c improvement Attenuate functionality loss Quality Weight Loss Preserve lean mass Primarily fat loss Improve bone health Improve lean mass Maintain Weight Loss Minimize fat regain Minimize weight regain
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LPCN 1107 Prevention of Preterm Birth (PTB)
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44 Lipocine │2026 LPCN 1107 for Prevention of Preterm Birth Product candidate highlights Potential to be SOC in prevention of preterm birth Oral dosage form comprising 17-hydroxyprogesterone caproate >$2B market potential with no approved drug Strong pharmaco-economic justification Oral, a Major Contribution to Patient Care (MC to PC), including no injection site reaction Phase 3 ready with compelling efficacy rationale Accelerated approval pathway and ODD (Orphan Drug Designation)