Reported positive results from potentially registrational Phase 2 trial of

LB-102 in schizophrenia

Advanced LB-102 into late-stage development in multiple indications with initiation of

a pivotal Phase 3 NOVA-2 trial in schizophrenia, and Phase 2 ILLUMINATE-1 trial

in bipolar depression

Announced pipeline expansion with plans to initiate a Phase 2 trial of LB-102 for the

adjunctive treatment of major depressive disorder (MDD) in early 2027

Cash, cash equivalents, and investments of $295.2 million as of December 31, 2025,

and proceeds from recent $100 million private placement, expected to provide cash runway into Q2 2029

NEW YORK, March 26, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc ("LB Pharmaceuticals" or the "Company") (Nasdaq: LBRX), a late-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, adjunctive treatment of MDD, and other neuropsychiatric diseases, today announced financial results for the fourth quarter and full year ended on December 31, 2025 and provided a corporate update.

"2025 was a transformative year for LB. It began with the presentation of positive Phase 2 trial results of LB-102 in acute schizophrenia that support the potential of LB-102 to offer patients with neuropsychiatric disease a differentiated and balanced clinical activity and tolerability profile and culminated with our successful initial public offering in September," said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. "Continuing our momentum, in 2026 we initiated the Phase 3 NOVA-2 trial of LB-102 in schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression. Our recently announced $100 million private placement enables us to further expand the development of LB-102 in mood disorders, and we plan to initiate a Phase 2 trial in adjunctive MDD in early 2027. Based on our current plans, our strong balance sheet from the initial public offering and private placement provides extended runway into the second quarter of 2029 and positions us to advance LB-102 through multiple clinical readouts in both psychosis and mood disorders."

Fourth Quarter 2025 and Recent Highlights

The Company is building a pipeline that leverages the broad therapeutic potential of LB-102, which has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.

LB-102 in Schizophrenia

   -- Reported positive results in January 2025 from a robust 359 patient Phase 
      2 trial (NOVA-1) of LB-102 in acute schizophrenia. The trial met the 
      primary endpoint, demonstrating statistically significant reduction from 
      baseline in the Positive and Negative Syndrome Scale (PANSS) total score 
      at 4 weeks at all dose levels compared to placebo. In this trial, LB-102 
      was observed to be generally well-tolerated. 
 
   -- Presented additional positive data in March 2025 from the Phase 
      2 trial at the 2025 Annual Congress of the Schizophrenia International 
      Research Society (SIRS) demonstrating that treatment with LB-102 resulted 
      in a positive shift in disease severity as measured by mean change from 
      baseline in Clinical Global Impression of Severity (CGI-S) scores. 
 
   -- Presented three posters in October 2025 featuring new and previously 
      reported analyses from the Phase 2 clinical trial of LB-102 in acute 
      schizophrenia at the 38th European College of Neuropsychopharmacology 
      (ECNP) Congress. A post-hoc analysis evaluating the effects of LB-102 on 
      cognition in patients with acute schizophrenia in the Phase 2 trial 
      demonstrated that after four weeks of treatment with LB-102, a robust, 
      dose-dependent, and significant treatment effect size was identified in a 
      completer population for all doses of LB-102 compared with placebo. 
 
   -- Initiated the pivotal Phase 3 (NOVA-2) trial evaluating the efficacy and 
      safety of LB-102 in patients with acute schizophrenia in March 2026, with 
      topline data expected in the second half of 2027. 

LB-102 in Mood Disorders: Bipolar Depression and Adjunctive Treatment of MDD

   -- Initiated the Phase 2 trial (ILLUMINATE-1) evaluating the efficacy and 
      safety of LB-102 in patients with bipolar 1 depression in January 2026, 
      with topline data expected in the first quarter of 2028. 
 
   -- Announced plans to initiate a Phase 2 trial of LB-102 for the adjunctive 
      treatment of MDD in early 2027, with topline data expected in the first 
      half of 2029. 

Corporate Updates

   -- In September 2025, the Company announced the pricing of an upsized 
      initial public offering of 21,850,000 shares of common stock at a price 
      of $15.00 per share, including full exercise of the underwriters' 
      overallotment option to purchase additional shares. The aggregate gross 
      proceeds to LB Pharmaceuticals from the offering were $327.8 million. 
 
   -- Over the course of 2025 and early 2026, the Company announced the 
      appointments of William Kane, Rekha Hemrajani, and Dr. Robert Lenz to its 
      Board of Directors, further strengthening the board with expertise in 
      finance, business development, CNS product development and 
      commercialization, and corporate strategy. The Company also strengthened 
      the executive team with several key hires to support the advancement of 
      LB-102. 
 
   -- In February 2026, the Company announced a private placement of $100 
      million with participation from new and existing institutional investors. 
      The proceeds are intended to fund a Phase 2 trial for LB-102 as an 
      adjunctive treatment for MDD, and for general corporate purposes. 

Financial Results for Fourth Quarter 2025

   -- Research & Development Expenses: Research and development expenses were 
      $8.5 million for the three months ended December 31, 2025, as compared to 
      $0.4 million for the three months ended December 31, 2024. The increase 
      was primarily due to an increase in start-up expenses related to the 
      Phase 2 clinical trial of LB-102 in patients with bipolar depression and 
      its Phase 3 clinical trial of LB-102 in patients with acute 
      schizophrenia. 
 
   -- General & Administrative Expenses: General and administrative expenses 
      were $5.4 million for the three months ended December 31, 2025, as 
      compared to $5.2 million for the three months ended December 31, 2024. 
 
   -- Net Loss: Net loss was $11.5 million for the three months ended December 
      31, 2025, as compared to $5.1 million for the three months ended December 
      31, 2024. 
 
   -- Cash Position: Cash, cash equivalents and marketable securities as of 
      December 31, 2025 were approximately $295.2 million. Based on current 
      operating assumptions, the Company anticipates its current cash, cash 
      equivalents and marketable securities, which includes proceeds from 
      a $100 million private placement in February 2026, will support its 
      planned operations into the second quarter of 2029. 

Financial Results for Year End 2025

   -- Research & Development Expenses: Research and development expenses were 
      $16.7 million for the year ended December 31, 2025, as compared to $51.2 
      million for the year ended December 31, 2024. The decrease was primarily 
      due to a decrease in expenses related to the conduct of the Phase 2 
      clinical trial of LB-102 in patients with acute schizophrenia, the 
      majority of which took place in 2024. 
 
   -- General & Administrative Expenses: General and administrative expenses 
      were $13.7 million for the years ended December 31, 2025 and 2024. 
 
   -- Net Loss: Net loss was $25.2 million for the year ended December 31, 
      2025, as compared to $63.1 million for the year ended December 31, 2024. 

About LB-102

LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the United States for the treatment of neuropsychiatric disorders. A methylated derivative of amisulpride, a widely used antipsychotic outside the United States, LB-102 was developed to retain amisulpride's benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5HT-7 receptors with few off-target effects and broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB-102's potential to address multiple dimensions of neuropsychiatric illness. A Phase 3 clinical trial (NOVA-2) of LB-102 --for acute schizophrenia and a Phase 2 clinical trial of LB-102 for bipolar 1 depression (ILLUMINATE-1) have been initiated, and a Phase 2 trial of LB-102 in adjunctive treatment of MDD is planned. Additional expansion opportunities for LB-102 include predominantly negative symptoms of schizophrenia, Alzheimer's disease psychosis and agitation, as well as other neuropsychiatric diseases.

About LB Pharmaceuticals

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