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High-Impact Neuromedicines for Real-World Care October 27, 2026
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Disclaimer Statements contained in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates, ” "believes, " "expects, " "intends, " “plans, ” “potential, ” "projects, ” “would” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: our expectations regarding our growth, strategy, progress and the design, objectives, expected results and timing of our preclinical studies and clinical trials for LB-102, the potential therapeutic benefits of LB-102; our ability to achieve regulatory approval for LB-102; our financial position, runway and anticipated milestones. Because such statements are subject to risks anduncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: our limited operating history and historical losses; our ability to raise additional funding to complete the development and any commercialization of our product candidates; our dependence on the success of our product candidate, LB-102; that we may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; our ability to obtain, maintain and protect our intellectual property; and our dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in our filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section in the Company’s Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 11, 2026. All forward-looking statements contained in this presentation speak only as of the date on which they were made. Except to the extent required by law, we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. The trademarks included in this presentation are the property of the owners thereof and are used for reference purposes only. 2
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1. AP, antipsychotic; 2024 sales data from EvaluatePharma; 2. Includes estimated patent term extension (PTE), composition of matter (COM) IP expires 2037. 3 Building a Fully Integrated Company Focused on Neuropsychiatric Disorders Late-stage trials ongoing in schizophrenia (SCZ), bipolar depression and planned in adjunctive MDD Positive registrational Phase 2 (NOVA-1) data highlights potential for differentiated profile in $12B branded AP market1 Streamlined path to approval in SCZ with a single Phase 3 trial based on positive FDA feedback Significant expansion potential across psychosis and mood disorders, including long-acting formulations Robust IP portfolio with issued COM protection through ~2041 (including potential PTE)2 Strong balance sheet that supports multiple clinical readouts, and runway beyond 2Q 2029
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1. If approved, LAI = long-acting injectable 4 Competitive clinical activity with potential for rapid-onset, sustained response Differentiated Profile Across Neuropsychiatric Disorders Validated mechanism, once-daily, starting therapeutic dose Potentially class-leading tolerability profile Robust effects on cognition, negative symptoms and potentially anhedonia Potential first benzamide antipsychotic in the U.S.1 Potential for first benzamide LAI1 globally LB-102
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Late-Stage Development Pipeline with Multiple Clinical Milestones and Runway Expected Beyond 2Q 2029 1. Cash, cash equivalents, and marketable securities as of 6/30/26; 2. Gross proceeds 5 Psychosis Related Disorders Indication Product Route of Administration Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones Schizophrenia LB-102 Oral Topline data expected 1H 2027 Pre-NDA meeting expected 2H 2027 LB-102 Long-acting injectable LAI formulation development in 2026 $327.8 million1 as of June 30, 2026, exclusive of recent $150 million private placement2 Mood Disorders Indication Product Route of Administration Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones Bipolar 1 Depression LB-102 Oral Topline data expected 1Q 2028 Adjunctive MDD LB-102 Oral Topline data expected 1H 2029
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LB-102 is a Structural Modification of Amisulpride, an AP with More Than 2 Million Monthly Prescriptions Annually in Europe2 6 Approved ex-U.S. for SCZ, (-) symptoms of SCZ and dysthymia1 with extensive use in mood disorders and anxiety2 Not available in the U.S. for psychosis-related or mood disorders 1. Solian label, dysthymia is a form of depression; 2. Proprietary Company data from Germany, Italy, Spain, France, and 12 other continental European countries, Rx/year = prescriptions per year; 3. Abbas AI, et al. Psychopharmacology (Berl). 2009 4. Huhn M, et al. Lancet. 2019; 5. Kahn RS, et al. Lancet. 2008 • Poor blood-brain barrier (BBB) penetration • Requires high doses for SCZ (400-800 mg), increasing systemic exposure • Twice daily (BID) dosing creates compliance challenges Amisulpride • Selectively inhibits D2, D3, and 5HT7 receptors with few off-target effects (e.g., 5HT2C, H1, α1)3 • Among the highest effect sizes (0.73) compared with approved APs4 • Favorable tolerability profile with one of the lowest all-cause discontinuation rates4,5 Advantages of Amisulpride Limitations of Amisulpride
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77 LB-102 Was Purpose-Built to Address Amisulpride’s Limitations Designed to improve BBB penetration of amisulpride NCE = new chemical entity; BBB = blood, brain barrier; 1. Neuropsychopharmacology, 2024 and PubChem; 2. ACS Omega, 2019; LB Pharma proprietary data Potential advantages of LB-102 resulting from methylation of amisulpride Improved potency, lowering required dose and reducing systemic exposure – 50 mg LB-102 ≈ 400 mg amisulpride1 Enabled convenient once-daily dosing NCE status and wholly-owned issued composition of matter IP Potential for improved tolerability (e.g., lower EPS) consistent with NOVA-1 clinical experience Retained CNS receptor binding profile including lack of off-target effects2
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LB-102’s Mechanism, NOVA-1 Data, and the Heritage of Amisulpride Support Clinical Development in a Wide Range of Indications 8 LB-102 and amisulpride have a distinct CNS receptor binding profile among antipsychotics 1. Danion Am J Psychiatry 1999; Scatton B, et al Int Clin Psychopharmacol 1997 A dopamine receptor associated with psychosis (positive symptoms) and mania A dopamine receptor associated with pathways related to depression, cognition, anhedonia, and negative symptoms A serotonin receptor associated with pathways involved in depression, cognition, anhedonia, and negative symptoms D2 D3 5HT7 • Selective binding profile with few off-target effects contributes to the favorable tolerability profile seen in our NOVA-1 study • Potential to preferentially engage presynaptic autoreceptors implicated in mood, anhedonia and cognition at lower doses 1
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Low Dose Bipolar Disorder/Negative SymptomsMajor Depressive Disorder Distinct Mechanism of LB-102 and Amisulpride Provides Opportunity in a Range of Indications Conceptual Illustration Danion JM, et al. Am J Psychiatry. 1999; Schoemaker H, et al. J Pharmacol Exp Ther. 1997; Wong DF, et al. Neuropsychopharmacology. 2024; Eramo A, et al. JAMA Psychiatry. 2026 9 At low doses, selectivity for presynaptic D2/D3 autoreceptors enhances dopamine signaling, which is underactive in depression At high doses, postsynaptic D2/D3 receptor blockade suppresses dopamine signaling, which is overactive in psychosis Schizophrenia High Dose Low Levels High Levels Physiological Dopamine Range
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Established Antipsychotic Development Path Unlocks Multi-Indication Value 10 Development of APs typically starts in schizophrenia to anchor dose and premium pricing; enables efficient expansion to bipolar depression and MDD, increasing the addressable market by ~10x 1. https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics#:~:text=Approximately%201%25%20of%20Americans%20 are,late%20teens%20or%20early%2020s; 2. https://www.nimh.nih.gov/health/statistics/bipolar-disorder; 3. https://www.nimh.nih.gov/health/statistics/major- depression#:~:text=disorders%2C%20or%20medication.-Prevalence%20of%20Major%20Depressive%20Episode%20Among%20Adults,more)%20races%20(13.9%25); 2025 sales data from EvaluatePharma. SCZ ~3M patients1 BPD ~7M patients2 MDD ~20M patients3 Numerous Blockbuster Products 2025 U.S. sales Vraylar $3.6B Rexulti $1.9B Abilify $1.1B High-Value Acquisitions Intra-Cellular acquired for $14.6B
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11 Schizophrenia
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Persistent Symptoms and Treatment Limitations Continue to Drive Disability and Switching, Hinder Adherence Schizophrenia Remains a High-Burden Disease with Persistent Treatment Gaps 1. The Global Statistics, Schizophrenia Statistics in the U.S. 2025 | Facts about Schizophrenia; 2. Robinson DG, et al. American Journal of Psychiatry, 1999; 3. Correll CU, et al. Neuropsychiatr Dis Treat. 2020; 4. Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223; 5. Harvey PD, et al. Schizophr Res Cogn. 2022 12 Schizophrenia is a Prevalent and Debilitating Disease with No Cure ~3M people in the US with schizophrenia1 ~80% of patients relapse within 5 years2 ~74% discontinue medications within 18 months due to lack of efficacy or burdensome side effects4 (e.g., sedation, EPS, GI effects) ~60% experience persistent negative symptoms not adequately addressed by current treatments3 BID BID dosing, food effects, need for titration hinder adherence ~80% of patients experience cognitive impairment, a significant driver of functional disability5
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NOVA -1 Trial Design Successful NOVA-1 Acute Schizophrenia Trial Has Potential to Be One of Two Pivotal Trials to Support FDA Approval 13Eramo et al., JAMA Psychiatry, April 2026; 1. Exploratory dose N = 359 25 sites U.S. Only 4-Week Treatment Period 50 mg (n = 107) 75 mg (n = 108) 100 mg1 (n = 36) Placebo (n = 108) FDA noted, in writing, that our NOVA-1 trial appeared to have many of the characteristics of an adequate and well-controlled trial – opportunity to seek approval with one additional successful registrational trial Primary Endpoint: PANSS Δ from baseline at day 28 Secondary Endpoints: CGI-S, PANSS positive and negative subscales, Marder factor Exploratory Endpoint: Cognition Designed trial to be potentially pivotal with large sample size, robust statistical analyses, conservative imputation of missing data
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-20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0 LS Means in PANSS Total Score Change from Baseline Treatment Group LB-102 50 mg LB-102 75 mg LB-102 100 mg Placebo Eramo A, et al. JAMA Psychiatry. 2026; (p-values) for 50, 75 and 100 mg at Day 8 (<.0001, 0.0032, 0.0181); Day 15 (0.0006, 0.0344, 0.0276); Day 21 (0.0006, 0.0025, 0.0050); LS Mean = least squared mean; SEM = standard error of the mean; PANSS Δ is defined as change in PANSS from baseline to Day 28; Demographics and baseline characteristics were similar across treatment arms and reflective of an inpatient schizophrenia population. 14 Clinically meaningful PANSS reduction in 4-week schizophrenia trial (baseline PANSS of 94) Statistically Superior Clinical Activity to Placebo at All Three Doses Numerous measures implemented to control placebo rate, including screening to exclude professional patients, use of central raters, scale minimization, and close oversight of sites and CROs PANSS Δ from baseline (Δ vs. Placebo at Day 28) 50 mg -14.3 (-5.0 vs. Pbo) (p=0.0009) 75 mg -14.0 (-4.7 vs. Pbo) (p=0.0022) 100 mg -16.1 (-6.8 vs. Pbo) (p=0.0017) Placebo -9.3 Baseline Day 8 Day 15 Day 21 Day 28 Effect observed as early as week 1 with sustained benefit
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Results demonstrate statistical robustness of NOVA-1 trial and provide confidence heading into Phase 3 Compelling Treatment Effect at Doses Planned for Phase 3 Dose Effect Size (completers) Effect Size (MMRM) LB-102 (NOVA-1) 50 mg 0.61 0.50 100 mg 0.83 0.64 Results for LB-102 are near the top of effect size (ES) reported for approved first-line APs1,2 ES for 100 mg dose are in the range of those previously reported for amisulpride 15 Effect size is calculated by taking the difference in average PANSS change between two groups (an active treatment arm and placebo) and dividing it by the pooled standard deviation. Completer analysis includes observed data from patients who received the protocol specified four weeks of treatment; MMRM refers to Mixed Model for Repeated Measures. MMRM analysis includes observed and imputed data from all patients with at least one post baseline PANSS assessment; 100 mg was exploratory dose. Descriptive comparison of point estimates from separate trials. Not based on a head-to-head comparison. Differences in study populations, designs, assessment time points, and statistical methods may affect comparability 1. Huhn M, et al. Lancet. 2019; 2. Fabiano, N, et al, European Neuropsychopharmacology. 2025
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1. Cognition was evaluated as an exploratory endpoint in our NOVA-1 clinical trial utilizing the CogState Computerized Schizophrenia Battery of Tests, a well validated measure of cognitive ability in subjects with schizophrenia. Effect size versus placebo was calculated in a post hoc analysis after excluding certain outliers that did not meet the test performance pass quality control metric; 2. Horan et al., 2025 Schizophrenia Bulletin, 51 (2) , 262–273; Nominal p-values 16 Global composite effect1: psychomotor function, memory, attention, working memory and executive function Robust, Dose-Dependent Effect on Cognition in NOVA-1, a Key Unmet Need Dose Effect Size p-value LB-102 (NOVA-1) 50 mg (n=90) 0.26 0.0476 75 mg (n=83) 0.41 0.0027 100 mg (n=23) 0.66 0.0018 • Significant, dose-dependent improvement in cognition consistent with LB-102 mechanism • Magnitude of observed benefit is considered clinically meaningful • High rate of satisfactory completion of tests demonstrates reliability of data • Broad patient population; effect observed without enriching analysis for severe cognitive impairment at baseline • Cognitive deficits are highly prevalent with significant unmet need spanning schizophrenia, bipolar depression and MDD2
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Favorable Adverse Event (AE) Profile in NOVA-1 Adverse Events Reported in ≥5% of Patients Number of subjects (% of treatment group) 50 mg (n=107) 75 mg (n=108) 100 mg (n=36) Placebo (n=108) Insomnia 27 (25.2%) 23 (21.3%) 14 (38.9%) 24 (22.2%) Headache 12 (11.2%) 9 (8.3%) 2 (5.6%) 10 (9.3%) Anxiety 10 (9.3%) 9 (8.3%) 4 (11.1%) 9 (8.3%) Agitation 11 (10.3%) 6 (5.6%) 4 (11.1%) 10 (9.3%) Weight increase 13 (12.1%) 8 (7.4%) 3 (8.3%) 4 (3.7%) Hyperprolactinemia 11 (10.2%) 8 (7.5%) 6 (16.6%) 0 Blood creatine phosphokinase increased 4 (3.7%) 1 (0.9%) 2 (5.6%) 3 (2.8%) Alanine aminotransferase increased 3 (2.8%) 1 (0.9%) 2 (5.6%) 1 (0.9%) Somnolence 1 (0.9%) 4 (3.7%) 2 (5.6%) 0 Constipation 4 (3.7%) 1 (0.9%) 2 (5.6%) 0 • AEs leading to discontinuation were reported at the following rates: 50 mg (1.9%), 75 mg (2.8%), 100 mg (8.3%), Pbo (1.9%) • Serious Adverse Events (SAE) occurred at the following rates: 50 mg (less than 1%), 75 mg (less than 1%), 100 mg (2.8%), Pbo (1.9%) • Comorbid conditions at entry influenced reporting of TEAEs which were defined as any AE that began on or after the first dose , or any pre-existing condition that reappeared during treatment or follow up. As a result, AEs such as insomnia appear elevated • Weight gain reflects any increase without a threshold. We observed ~1.6 kg placebo adjusted weight gain while preserving metabolic status1 Most AEs were mild or moderate in severity and similar to placebo 17
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18 Potential for a Class Leading Rate of EPS (Including Akathisia) Preferred Term 50 mg (n=107) 75 mg (n=108) 100 mg (n=36) Placebo (n=108) Dystonia 0 3 (2.8%) 1 (2.8%) 1 (0.9%) Akathisia 1 (0.9%) 2 (1.9%) 0 1 (0.9%) Extrapyramidal disorder 0 1 (0.9%) 1 (2.8%) 2 (1.9%) Total EPS 1 (1.0%) 6 (5.6%) 2 (5.6%) 4 (3.7%) • EPS is generally correlated with dopamine receptor occupancy (RO) rate • EPS rates (including akathisia) observed with other D2 antagonists and partial agonists can reach more than 30% • EPS rates with LB-102 were low despite 70-80% RO Total EPS Observed in LB-102 NOVA-1 Trial Number of subjects (% of treatment group) EPS related adverse events were generally mild to moderate in severity. One event of dystonia (75 mg LB-102) was considered an SAE Descriptive comparison of point estimates from separate trials. Not based on a head-to-head comparison. Differences in study populations, designs, assessment time points, and statistical methods may affect comparability
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Low Rates of Other Adverse Events of Interest Support the Potential for a Class Leading Safety Profile Adverse events of interest were generally mild to moderate in severity. QTcF = Fridericia-corrected QT interval. The QT interval is the time between the start of the Q wave and the end of the T wave on an ECG, representing the time it takes for ventricular depolarization and repolarization; Stopping criteria were defined per FDA guidance of an increase of more than 60 ms or an absolute QT interval of more than 500 ms 19 Prolactin-related AEs Low rate (~1-5.6%); AEs were mild to moderate and did not result in discontinuation Sedation Single case of sedation among 251 patients exposed to LB-102 in NOVA-1 trial QTc Prolongation Minimal QT prolongation (4.3-5.4 ms); no patients met pre-specified stopping criteria
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LB-102’s Robust Registrational Program is Underway in Schizophrenia Phase 3 NOVA-2 topline data read out expected in 1H 2027 N ~ 460 1:1:1 randomization ~ 25 sites U.S. Only 6-Week Treatment Period 50 mg 100 mg Placebo Phase 3 (Inpatient) • Low execution risk: Similar in scope to NOVA-1 • Primary changes: 6-week duration; 3 versus 4 arms • Doses selected to inform use in commercial setting Open Label Extension (Outpatient) • ~900 patients – rollover from Phase 3 trial + new patients • Supports accrual of safety database for approval • Subset analyses: cognition and negative symptoms Primary Endpoint: PANSS Δ from baseline at day 42 (6 weeks) Secondary Endpoints: CGI-S, PANSS positive and negative subscales, Marder factors, cognition, Personal and Social Performance Scale (PSP) Phase 3 Trial Design 20
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LB-102 has Potential to be the Branded AP of Choice in Schizophrenia 21 Potential first benzamide in the U.S. for the treatment of schizophrenia Compelling Evidence of Clinical Activity in NOVA-1 • Effect observed as early as week 1 • Clinically meaningful PANSS reduction across all doses at each week • Strong treatment effect Potential for a Class Leading Safety Profile • Low EPS (including akathisia), QTc prolongation, negligible sedation • No expected food effect or DDIs • Few GI side effects Potential for Differentiated Effects in Negative and Cognitive Symptoms • Significant effect on negative symptoms at 50 mg dose • Robust, dose dependent treatment effect on cognition Simple once-daily dosing, starting therapeutic dose without titration, if approved
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22 Mood Disorders: Bipolar Depression and Adjunctive Major Depressive Disorder
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1. North America Sales: Includes U.S. and Canada. Converted from JPY to USD based on exchange rate of 1 JPY to 0.00638 USD on 12/31/25; 2. 2025 revenue is comprised of J&J-reported Caplyta sales for Q2–Q4 2025 and Wall Street consensus estimates for Intra-Cellular Therapies’ Q1 2025 Caplyta revenue. Intra-Cellular did not report Q1 2025 results amidst its acquisition by J&J, completed on April 2, 2025. Source: SEC filings, company reports, Wall Street research, EvaluatePharma; Approved indications from individual product labels in the U.S. 23 Achieving Blockbuster Status Typically Requires Expansion Beyond SCZ 2025 Branded AP Sales in U.S.: ~$12B Four branded APs account for ~60% of sales Vraylar 30% ($3.6B) Rexulti1 15% ($1.9B) Abilify1 9% ($1.1B) Caplyta2 8% ($0.9B) All Other Antipsychotics 38% ($4.6B) • Vraylar Approvals: SCZ, Bipolar Mania, BPD, MDD • Rexulti Approvals: SCZ, MDD, Alzheimer’s agitation • Abilify Approvals: SCZ, Bipolar Mania, MDD, Autism, Tourette’s • Caplyta Approvals: SCZ, BPD, MDD
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Bipolar Disorder and MDD Have Unmet Needs that Align Well with the Profile of LB-102 Bipolar Disorder MDD Efficacy Unmet Needs: Residual symptoms are poorly addressed by current treatments and significantly impact function Safety/Tolerability Unmet Needs: Poor tolerability drives suboptimal dosing, poor adherence, discontinuation, relapse, switching 1. Whitton AE, et al. Curr Top Behav Neurosci. 2022; 2. Tsapekos D, et al. BMC Psychiatry. 2023; 3. Culpepper L, et al. J Clin Psychiatry. 2017; Serretti A. Clin Psychopharmacol Neurosci. 2023; 4. LB Proprietary Market Research; 5. Luo et al., 2020; Jain et al., 2022; Zhu et al., 2022; McIntyre, Weiller 2015) ADT = antidepressant therapy. 24 LB-102 has potential for market-competitive efficacy, a favorable tolerability profile and a unique opportunity to significantly improve residual symptoms ~60% have anhedonia1 or cognitive deficits2 ~60% of patients switch therapy due to safety or efficacy4 45 – 70% experience anhedonia or cognitive deficits3 45% of patients use adjunctive therapy to an ADT5
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Supportive Results from LB-102 Phase 2 Schizophrenia Trial Strong Mechanistic Rationale Validating Clinical and Real-World Experience with Amisulpride Multiple Lines of Evidence Support the Development of LB-102 in Bipolar Depression and Adjunctive MDD 25 High POS in planned Phase 2 trials
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• Selectivity for presynaptic autoreceptors at low doses increases dopamine signaling, which is underactive in depression • D3 / 5HT7 also implicated in cognition and depression • Lower doses also minimize potential for D2-mediated AEs common to APs, supporting effective dosing, improved tolerability and long-term use LB-102’s Multimodal Mechanism Underlies Potential for Efficacy in Depression, Anhedonia, and Cognitive Impairment 26 Strong Mechanistic Rationale Validating Clinical and Real-World Experience with Amisulpride Supportive Results from LB-102 Phase 2 Schizophrenia Trial
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• Approvals in dysthymia and negative symptoms of schizophrenia • As good or better than Paxil, Zoloft and significantly better than Pbo1 • Significant benefit vs. Pbo in negative symptoms of schizophrenia • >2 million monthly prescriptions in EU in 2023, including 20% for mood disorders2 Historical Amisulpride Data and Current Use Strongly Support LB-102’s Potential in Mood Disorders 1. Cassano GB, et al. Int Clin Psychopharmacol. 2002; Amore M, et al. Int Clin Psychopharmacol. 2001; 2. Proprietary Company data from Austria, Germany, Italy, Romania, Belgium, Greece, Luxembourg, Slovakia, Czech Republic, Hungary, Poland, Spain, France, Ireland, Portugal, Switzerland. 27 Strong Mechanistic Rationale Validating Clinical and Real-World Experience with Amisulpride Supportive Results from LB-102 Phase 2 Schizophrenia Trial
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• Market-competitive clinical activity with rapid onset as early as week 1 • Robust effects on cognition and negative symptoms1 • Favorable tolerability profile with low EPS (including akathisia), minimal sedation, and few GI side effects1 • Efficacy data that demonstrates ability to prevent emergence of bipolar mania • Safety dataset for schizophrenia approval reduces cost and timeline to bipolar depression and adjunctive MDD approvals Results from LB-102 Phase 2 SCZ Trial Further Support Potential to Achieve Differentiated Profile in Mood Disorders 1. LB Pharmaceuticals Phase 2 trial results in schizophrenia 28 Strong Mechanistic Rationale Supportive Results from LB-102 Phase 2 Schizophrenia Trial Validating Clinical and Real-World Experience with Amisulpride
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• Inclusion criteria: Patients with ongoing depressive episodes associated with bipolar 1 disorder • 25 mg fixed dose (first 3 weeks), flexible dose of 25 or 50 mg (Weeks 4-6) • Primary endpoint: MADRS-10 at Week 6, all LB-102-treated patients vs Placebo • Secondary endpoints: MADRS-6, CGI-BP , Cognition, Anhedonia, Safety, and Tolerability • Two-arm and flexible dose design mitigate placebo effect1 Bipolar Depression: Potentially Registrational Phase 2 Trial Design 29 Topline data readout expected in 1Q 2028 ; 1. Kahn A, et al. Neuropsychopharmacology. 2003; CGI-BP refers to the Clinical Global Impression-Bipolar Illness (CGI-BP) scale. 6-Week Outpatient Treatment Period LB-102 25-50 mg QD (Flexible Dose) Week 1 Week 2 Week 5Week 3 Week 4 Week 6 CGI-BP Score LB-102 25 mg QD (Fixed Dose) n ≈ 160 Placebo QD (n ≈ 160) N ~ 320 Randomized 1:1
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• Inclusion criteria: Inadequate response to 1-2 prior trials with standard antidepressants • 15 mg fixed dose (first 3 weeks), flexible dose of 15 or 25 mg (Weeks 4-6) • Primary endpoint: MADRS-10, all LB-102-treated patients vs Placebo • Secondary endpoints: CGI-I/CGI-S, Anhedonia, Function, Cognition, Safety and Tolerability • Two-arm and flexible dose design mitigate placebo effect1 Adjunctive MDD: Potentially Registrational Phase 2 Trial Design 30 Topline data readout expected in 1H 2029 6-Week Outpatient Treatment Period ADT + LB-102 15-25 mg QD (Flexible Dose) Week 1 Week 2 Week 5Week 3 Week 4 Week 6 CGI-I Score ADT + LB-102 15 mg QD (Fixed Dose) ADT + Placebo QD N ~ 380 Randomized 1:1 1. Kahn A, et al. Neuropsychopharmacology. 2003; CGI-I refers to the Clinical Global Impression-Improvement (CGI-I) scale, ADT = antidepressant therapy.
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31 Future Directions
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We are Pursuing Additional High Value, Clinically Validated Expansion Opportunities with Strong Clinical Rationale 1. Boyer P, et al. Br J Psychiatry. 1995; Danion JM, et al. Am J Psychiatry. 1999; Loo H, et al. Br J Psychiatry. 1997; 2. Solian label; 3. Alzheimer’s Association Report. Alzheimers Dement. 2023; 4. Oguma T, Jino K. Chem Pharm Bull (Tokyo). 2024; 5. Reeves S, et al. J Clin Psychiatry. 2017; 6. Howard R, et al. Lancet Psychiatry. 2018 32 Predominantly Negative Symptoms of SCZ Rationale: • Amisulpride outperformed placebo in three independent studies for negative symptoms1 • Approved for SCZ with negative symptoms in the UK and Australia2 Next Steps: • On track to receive FDA feedback by end of 2026 • Exploring label-enabling Phase 3b trial designs • Potential for trial initiation in 2H 2027 (subject to regulatory feedback) Alzheimer’s Disease (AD) Psychosis/Agitation Rationale: • 40% of ~7M Americans with AD experience psychosis or agitation3,4 • Amisulpride demonstrated clinical benefit in AD psychosis5 and was well-tolerated in elderly patients6 Next Steps: • Elderly HV Phase 1 trial (safety/PK) • Registrational-quality Phase 2 in AD psychosis/agitation (design TBD, based on outcome of HV trial)
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LAIs reduce risk of relapse by offering the potential for: Compelling Lifecycle Opportunity with LAI Formulation LB-102 LAI • Potential first-in-class benzamide LAI globally • Supports global market expansion in SCZ and bipolar disorder • Formulation development planned in 2026 1. Third party company financials and analyst reports; 2. Schizophrenia. 2023;9. 33 ~$6B market globally1 Improved compliance Reduced hospitalization and improved functional outcomes earlier in the disease2 Consistent drug exposure
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A Compelling Sequence of Clinical Milestones Anticipated Near-Term Catalysts 2026 2027 2028 2029 Schizophrenia Initiated P3 trial (Q1) Pre-NDA meeting (2H) Bipolar Depression Initiated P2 trial (Q1) Adjunctive MDD Initiation of P2 trial (early 2027) 34 Cash runway expected to fund operations beyond Q2 2029 Topline data (1H) Topline data (1Q) Topline data (1H)
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Thank you For more information, please contact ir@lbpharma.com