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LB Pharmaceuticals Inc High - Impact Neuromedicines for Real - World Care August 2026 lb pharmaceuticals
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2 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 and uncertainties, 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. Disclaimer
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3 v Green marketing is a practice whereby companies seek to go above and beyond. Positive registrational Phase 2 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 Building a Fully-integrated Company Focused on Neuropsychiatric Disorders Late-stage trials ongoing in schizophrenia (SCZ), bipolar depression and planned in adjunctive MDD 1. AP, antipsychotic; 2024 sales data from EvaluatePharma; 2. Includes estimated patent term extension (PTE), composition of matter (COM) IP expires 2037
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4 Differentiated Profile Across Neuropsychiatric Disorders Potential for first benzamide long- acting injectable (LAI)1 globally Competitive clinical activity with potential for rapid- onset, sustained response Potentially class-leading tolerability profile Robust effects on cognition, negative symptoms and potentially anhedonia Validated mechanism, once- daily, starting therapeutic dose Potential first benzamide antipsychotic in the U.S.1 1. If approved
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5 Late-Stage Development Pipeline with Multiple Clinical Milestones and Runway Expected beyond 2Q 2029 $327.8 million1 as of June 30, 2026, exclusive of recent $150 million private placement2 LB-102 Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones Psychosis Related Disorders Schizophrenia Topline data expected 1H 2027 Pre-NDA meeting expected 2H 2027 LAI Formulation development in 2026 Mood Disorders Bipolar 1 Depression Topline data expected 1Q 2028 Adjunctive MDD Topline data expected 1H 2029 1. Cash, cash equivalents, and marketable securities as of 6/30/26; 2. gross proceeds
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6 Poor blood-brain barrier (BBB) penetration Requires high doses for SCZ (400-800 mg) increasing systemic exposure Twice daily (BID) dosing creates compliance challenges LB-102 is a Derivative of Amisulpride, an AP with More Than 2 Million Monthly Prescriptions Annually in Europe2 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. Psychopharmacology (Berl). 2009 July 205(1): 119; 4. The Lancet. 2019;394(10209):939–949; 5. Lancet, 2008, 371, 1085-1097 Amisulpride 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 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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7 Improved potency, lowering required dose and reducing systemic exposure – 50 mg LB-102 ≈ 400 mg amisulpride1 Enabled convenient once-daily dosing Supported new chemical entity status and Composition of Matter IP Potential for improved tolerability (e.g., lower EPS) validated by Phase 2 clinical experience Retained CNS receptor binding profile including lack of off-target effects2 LB-102 Was Purpose-Built to Address Amisulpride’s Limitations Designed to improve BBB penetration of amisulpride 1. Neuropsychopharmacology, 2024, 50, 372-377 and PubChem; 2. ACS Omega, 2019, 4, 14151-14154; LB Pharma proprietary data LB-102 Methylation of amisulpride improved lipophilicity, enabling more efficient transport across the BBB and longer residence time in the CNS1 Advantages of LB-102 versus amisulpride
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8 LB-102’s Mechanism, Phase 2 Data, and the Heritage of Amisulpride Support Development in a Wide Range of Indications D2 • Selective binding profile with few off-target effects drives favorable tolerability profile • Potential to preferentially engage presynaptic autoreceptors implicated in mood, anhedonia and cognition at lower doses 1 • LB-102 P2 data demonstrated clinical activity in positive, negative, cognitive symptom domains, and potentially improved tolerability • Amisulpride clinical experience validates potential for broad range of efficacy Psychosis (positive symptoms), mania D3 Depression, cognition, anhedonia, negative symptoms Depression, cognition, anhedonia, negative symptoms 5HT7 1. Danion Am J Psychiatry 1999; 156:610–616; Scatton B, et al Int Clin Psychopharmacol 1997; 12(suppl 2):S29–S36 LB-102 and amisulpride have a distinct CNS receptor binding profile among antipsychotics
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9 Distinct Mechanism of LB-102 and Amisulpride Underlies Efficacy in a Potential Range of Indications Conceptual Illustration; Danion Am J Psychiatry 1999; Schoemaker et al., The Journal of Pharmacology and Experimental Therape utics, 1997; Wong et al., Neuropsychopharmacology, 2024; JAMA Psychiatry, Eramo et al., April 2026 Dopamine Low Dose High Dose Major Depressive Disorder Bipolar Disorder / Negative Symptoms Schizophrenia Physiological Dopamine Levels Dopamine Enhancing (via increased release) Dopamine Suppressing (via receptor blockade) High LevelsLow Levels At high doses, postsynaptic D2/D3 receptor blockade suppresses dopamine signaling, which is overactive in psychosis At low doses, selectivity for presynaptic D2/D3 autoreceptors enhances dopamine signaling, which is underactive in depression
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10 Established Antipsychotic Development Path Unlocks Multi-Indication Value 1. https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics#:~:text=Approximately%201%25%20of%20Americans%20are,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 Numerous Blockbuster Products High Value Acquisitions 2025 U.S. sales Vraylar $3.6B Rexulti $1.9B Abilify $1.1B Intra-Cellular acquired for $14.6B SCZ ~3M patients1 BPD ~7M patients2 MDD ~20M patients3 Development of APs typically starts in SCZ to anchor dose and premium pricing; enables efficient expansion to bipolar depression and MDD, increasing the addressable market by ~10x
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. Schizophrenia
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12 Schizophrenia Remains a High-Burden Disease with Persistent Treatment Gaps 1. Schizophrenia Statistics in the U.S. 2025 | Facts about Schizophrenia – The Global Statistics; 2. Robinson DG et al., American Journal of Psychiatry, 1999; 3. Correll et al., Neuropsychiatr Dis Treat. 2020 Feb 21;16:519-534; 4. Lieberman et al., N Engl J Med. 2005 Sep 22;353(12); 5. Harvey et al., Schizophr Res Cogn. 2022;29:100249 ~3M people in the US with schizophrenia1 Schizophrenia is a Prevalent and Debilitating Disease with No Cure Persistent Symptoms and Treatment Limitations Continue to Drive Disability and Switching, Hinder Adherence ~80% of patients experience cognitive impairment, a significant driver of functional disability5 ~60% experience persistent negative symptoms not adequately addressed by current treatments3 ~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) BID BID dosing, food effects, need for titration hinder adherence
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13 Successful Phase 2 Acute SCZ Trial Has Potential to Be One of Two Pivotal Trials Required for Approval JAMA Psychiatry, Eramo et al., April 2026 1. Exploratory dose 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 FDA noted, in writing, that our Phase 2 trial appeared to have many of the characteristics of an adequate and well- controlled trial – providing an opportunity for approval with one successful Phase 3 trial N = 359 25 sites U.S. Only 50 mg (n = 107) 75 mg (n = 108) 100 mg1 (n = 36) Placebo (n = 108) NOVA -1 Phase 2 Trial Design 4-Week Treatment Period
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14 Statistically Superior Clinical Activity to Placebo at All Three Doses Clinically meaningful PANSS reduction in 4-week SCZ trial (baseline PANSS of 94) JAMA Psychiatry, Eramo et al., April 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 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) Pbo -9.3 LS Means in PANSS Total Score Change from Baseline Treatment Group LB-102 50 mg LB-102 75 mg LB-102 100 mg Placebo Baseline Day 8 Day 15 Day 21 Day 28 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 Rapid onset at ~1 week with sustained benefit
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15 Dose Effect Size vs Placebo (completers) Effect Size vs Placebo (MMRM) LB-102 (Phase 2) 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 ES for 100 mg dose are in the range of those previously reported for amisulpride ES for 100 mg dose across both methods are greater than those reported for Cobenfy (0.56)2 Results demonstrate statistical robustness of Phase 2 trial and provide confidence heading into Phase 3 Compelling Treatment Effect at Doses Planned for Phase 3 1. The Lancet. 2019;394(10209):939–949; 2. European Neuropsychopharmacology. 2025;92;62-73; 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
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16 • Significant, dose-dependent improvement in cognition consistent with LB-102 mechanism • Magnitude of benefit represents a significant potential advantage over existing therapies • High rate of satisfactory completion of tests demonstrates reliability of data • Broad patient population without enriching for severe cognitive impairment at baseline • Cognitive deficits are highly prevalent with significant unmet need spanning SCZ, bipolar depression and MDD 2 Robust, Dose-Dependent Effect on Cognition in Phase 2, a Key Unmet Need Global composite effect1: psychomotor function, memory, attention, working memory and executive function 1. Cognition was evaluated as an exploratory endpoint in our Phase 2 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 Dose Effect Size vs. Placebo P-value LB-102 50 mg (n=90) 0.26 0.0476 75 mg (n=83) 0.41 0.0027 100 mg (n=23) 0.66 0.0018
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17 Favorable Adverse Event (AE) Profile in Phase 2 • Most AEs were mild or moderate in severity and similar to placebo • 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 neutrality 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
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18 • 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 lower than amisulpride despite 70-80% RO for LB-102 Total EPS Observed in LB-102 Phase 2 Trial Number of subjects (% of treatment group) 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%) Potentially Class Leading Low Rate of EPS (Including Akathisia) Among D2 Antagonists and Partial Agonists EPS related adverse events were generally mild to moderate in severity. One event of dystonia (75 mg LB-102) was considered an SAE.
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19 Low Rates of Other Adverse Events of Interest Support Potentially 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 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 Phase 2 trial QTc Prolongation Minimal QT prolongation (4.3-5.4 ms); no patients met pre-specified stopping criteria
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20 Primary Endpoint: PANSS Δ from baseline at day 42 (6 weeks) Secondary Endpoints: CGI-S, PANSS positive and negative subscales, Marder factor, cognition, Personal and Social Performance Scale Robust Phase 3 Program for LB-102 in Schizophrenia N ~ 460 1:1:1 randomization ~ 25 sites U.S. Only 50 mg 100 mg Placebo 6-Week Treatment Period Phase 3 (Inpatient) • Low execution risk: Similar in scope to Phase 2 • 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 Phase 3 topline data read out expected in 1H 2027 Phase 3 Trial Design
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21 LB-102 has Potential to be the Branded AP of Choice in SCZ Potential first-in-class benzamide in the U.S. for the treatment of SCZ • Rapid-onset at week 1, clinically meaningful PANSS reduction across all three tested dose levels • Strong treatment effect (e.g., ES) at both 50 and 100 mg • 6-week Phase 3 trial has potential to further improve PANSS reduction • Low EPS (including akathisia), QTc prolongation, negligible sedation • No expected food effect or DDIs • Few GI side effects, no orthostasis • Simple QD dosing, starting therapeutic dose without titration Potentially Class Leading Safety Profile + Simple Dosing • Robust, dose dependent treatment effect on cognition • Significant effect on negative symptoms at 50 mg dose • Additional supporting data from Phase 3 and OLE available at launch Differentiated Effects in Cognition and Negative Symptoms Compelling Evidence of Clinical Activity
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Mood Disorders: Bipolar Depression and Adjunctive Major Depressive Disorder
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23 Achieving Blockbuster Status Typically Requires Expansion Beyond SCZ (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, Evaluate Pharma; Approved indications from individual product labels in the U.S. Vraylar 30% ($3.6B) Rexulti1 15% ($1.9B) Abilify1 9% ($1.1B) Caplyta2 8% ($0.9B) All Other Antipsychotics 38% ($4.6B) 2025 Branded AP Sales in U.S.: ~$12B Four Branded APs Account for ~60% of Sales 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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24 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 Bipolar Disorder and MDD Have Unmet Needs that Align Well with the Profile of LB-102 LB-102 has potential for market competitive efficacy, favorable tolerability profile and unique opportunity to significantly improve residual symptoms 1. Whitton et al. Curr Topics Behav Neurosci (2022) 58: 111–128; 2. Tsapekos et al. BMC Psychiatry (2023) 23:842; 3. 5. Culpepper et al., J Clin Psychiatry 78:9, November/December 2017. 6. Serretti. A Clin Psychopharmacol Neurosci. 2023 Aug 31;21(3):401– 409.; 4. LB Proprietary Market Research 5. Luo et al., 2020; Jain et al., 2022; Zhu et al., 2022; McIntyre, Weiller 2015); ADT = Antidepressant Therapy ~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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25 Multiple Lines of Evidence Support the Development of LB-102 in Bipolar Depression and Adjunctive MDD High POS in planned Phase 2 trials Strong Mechanistic Rationale Validating Clinical and Real-World Experience with Amisulpride Supportive Results from LB-102 Phase 2 Schizophrenia Trial
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26 LB-102’s Multi-Modal Mechanism Underlies Potential for Efficacy in Depression, Anhedonia, and Cognitive Impairment • 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 Strong Mechanistic Rationale Validating Clinical and Real-World Experience with Amisulpride Supportive Results from LB-102 Phase 2 Schizophrenia Trial
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27 Validating Clinical and Real-World Experience with Amisulpride Historical Amisulpride Data and Current Use Strongly Support LB-102 Potential in Mood Disorders • Approvals in dysthymia and negative symptoms of SCZ • As good or better than Paxil, Zoloft and significantly better than Pbo1 • Significant benefit vs. Pbo in negative symptoms of SCZ • >2 million monthly prescriptions in EU in 2023, including 20% for mood disorders2 1. Cassano GB, et al. Int Clin Psychopharmacol. 2002;17(1):27-32.; Amore M, et al. Int Clin Psychopharmacol. 2001;16(6):317-324 2. Proprietary Company data from Austria, Germany, Italy, Romania, Belgium, Greece, Luxembourg, Slovakia, Czech Republic, Hungary, Poland, Spain, France, Ireland, Portugal, Switzerland Supportive Results from LB-102 Phase 2 Schizophrenia Trial Strong Mechanistic Rationale
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28 Results from LB-102 Phase 2 SCZ Trial Further Support Potential to Achieve Differentiated Profile in Mood Disorders • 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 SCZ approval reduces cost and timeline to bipolar depression and adjunctive MDD approvals 1. LB Pharmaceuticals Phase 2 trial results in SCZ Strong Mechanistic Rationale Validating Clinical and Real-World Experience with Amisulpride Supportive Results from LB-102 Phase 2 Schizophrenia Trial
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29 Bipolar Depression: Potentially Registrational Phase 2 Trial Design 1. SAFER refers to a clinician-rated a interview tool. The acronym stands for interview’s attention to the following criteria: State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps (pervasive, persistent, and pathological -- Desseilles et al, Harv Rev Psych 2013, Freeman et al, J Clin Psychopharm 2017; 2. Kahn et al, Neuropsychopharmacology 2003 Mar;28(3):552-7; CGI-BP-I refers to the Clinical Global Impression-Bipolar Illness (CGI-BP) scale, • Inclusion criteria: Patients with ongoing depressive episodes associated with bipolar 1 disorder utilizing SAFER criteria1 • 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 effect2 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 (~30 US sites) Topline data readout expected in 1Q 2028
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30 Adjunctive MDD: Potentially Registrational Phase 2 Trial Design 1. SAFER refers to a clinician-rated interview tool. The acronym stands for interview’s attention to the following criteria: State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps (pervasive, persistent, and pathological -- Desseilles et al, Harv Rev Psych 2013, Freeman et al, J Clin Psychopharm 2017; 2. Kahn et al, Neuropsychopharmacology 2003 Mar;28(3):552-7; CGI-I refers to the Clinical Global Impression-Improvement (CGI-I) scale, ADT, antidepressant therapy • Inclusion criteria: Inadequate response to 1-2 prior trials with standard antidepressants utilizing SAFER 1 • 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 effect2 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 (~ 50 US/EU sites) Topline data readout expected in 1H 2029
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. Future Directions
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32 We are Pursuing Additional High Value, Clinically Validated Expansion Opportunities with Strong Clinical Rationale 1. Boyer et al, British Journal of Psychiatry (1995), 166, 68-72; Danion et al, Am J Psychiatry 1999; 156:610-616; Loo et al Br J Psychiatry. 1997 Jan:170:18-22; 2. Solian label; 3. Alzheimer’s & Dementia, 2023;19;1598-1695; 4. Chem. Pharm. Bull, 2024;72;610-617; 5. J. Clin. Psych., 2017;78;e844-e851; 6.Lancet Psychiatry, 2018;5:553-563 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) 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) Predominantly Negative Symptoms of SCZ Alzheimer’s Disease (AD) Psychosis / Agitation
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33 Compelling Lifecycle Opportunity with LAI Formulation 1. Schizophrenia, 2023, 9; 2. Third party company financials and analyst reports Potential first-in-class benzamide LAI globally Supports global market expansion in SCZ and bipolar disorder Formulation development planned in 2026 LAI’s reduce risk of relapse by offering the potential for: LB-102 LAI ~$6B market globally2Improved compliance Consistent drug exposure Reduced hospitalization and improved functional outcomes earlier in the disease1
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34 A Compelling Sequence of Clinical Milestones Anticipated Near- Term Catalysts 2026 20 27 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) 2026 2027 2028 2029 Topline data (1H) Topline data (1Q) Topline data (1H) Cash runway expected to fund operations beyond Q2 2029
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35 LB Pharmaceuticals Inc Thank you! For more information, please contact ir@lbpharma.us