SEC 8-K filings with transcript text
Aug 11, 2026
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Exhibit 99.1
LB Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Corporate Update
Announced accelerated timing of topline data readout from the pivotal Phase 3 NOVA-2 trial of LB-102 in schizophrenia in the first half of 2027
Announced plans for pipeline expansion of LB-102 into new neuropsychiatric indications with strong
mechanistic rationale and validating clinical and real-world experience from amisulpride
Cash, cash equivalents, and marketable securities of $327.8 million as of June 30, 2026, and proceeds from recent $150.0 million private placement to fund pipeline expansion, expected to fund operations beyond Q2 2029, through multiple clinical milestones
NEW YORK, August 11, 2026 (GLOBE NEWSWIRE) – LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases, today announced financial results for the second quarter ended on June 30, 2026 and provided a corporate update.
“We are taking meaningful steps to maximize the full potential of LB-102, leveraging clinically validated biology with purposeful innovation as the foundation for an expanded pipeline,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “We recently announced a private placement of $150 million with participation from new and existing investors to expand the development of LB-102 into new indications where unmet needs align with the emerging clinical profile of LB-102. We are looking forward to our first pivotal trial readout and recently announced that, based on enrollment in our pivotal NOVA-2 trial in schizophrenia being more rapid than expected, we now project topline data readout in the first half of 2027, ahead of our prior guidance, and plan to schedule a pre-NDA meeting with the FDA soon thereafter in the second half of 2027. We are well positioned to advance multiple clinical programs and continue to expect topline data from our Phase 2 trial of LB-102 in bipolar depression in the first quarter of 2028 as well as data from our Phase 2 trial of LB-102 in adjunctive MDD in the first half of 2029.”
Second Quarter 2026 and Recent Highlights
The Company’s lead asset, LB-102, is a novel benzamide in late-stage clinical development for psychosis and mood disorders. LB-102 has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.
LB-102 in Schizophrenia
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Based on enrollment projections in the pivotal Phase 3 NOVA-2 trial evaluating the efficacy and safety of LB-102 in patients with acute schizophrenia, topline data is expected in the first half of 2027. The Company expects to schedule a pre-NDA meeting with the FDA thereafter in the second half of 2027.
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The 52-week open-label safety and tolerability trial (NOVA-3), evaluating the long-term safety and tolerability of LB-102 in patients with stable schizophrenia, is enrolling eligible patients who have completed NOVA-2, as well as de novo patients.
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Published results from the Phase 2 NOVA-1 trial of LB-102 in schizophrenia in JAMA Psychiatry.
LB-102 in Mood Disorders: Bipolar Depression and Adjunctive Treatment of MDD
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The Phase 2 ILLUMINATE-1 trial evaluating the efficacy and safety of LB-102 in patients with bipolar 1 depression is enrolling patients, with topline data expected in the first quarter of 2028.
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Initiation of the Phase 2 trial in the adjunctive treatment of MDD is expected in early 2027, with topline data expected in the first half of 2029.
Corporate Updates
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In July 2026, the Company announced a private placement of $150.0 million with participation from new and existing institutional investors. The proceeds are intended to fund expansion of LB-102 into new indications, potentially including negative symptoms of schizophrenia and Alzheimer’s disease psychosis/agitation, and for general corporate purposes.
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In June 2026, the Company announced the appointment of Christopher Zergebel as Senior Vice President, Clinical Operations. Mr. Zergebel is a seasoned biotechnology executive with more than 25 years of global development operations experience.
Financial Results for the Three Months Ended June 30, 2026
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Research & Development Expenses: Research and development expenses were $44.1 million for the three months ended June 30, 2026, compared to $2.4 million for the three months ended June 30, 2025. The increase of $41.7 million was primarily due to (i) a $32.1 million increase in expenses primarily related to our Phase 3 clinical trial of LB-102 in the treatment of patients with acute schizophrenia; (ii) a $2.7 million increase in expenses related to the conduct of our Phase 2 clinical trial of LB-102 in the treatment of patients with bipolar depression; (iii) a $2.0 million increase in expenses related to the
May 12, 2026
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Exhibit 99.1
LB Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Corporate Update
Initiated two late-stage clinical trials of LB-102: the pivotal Phase 3 NOVA-2 trial in
schizophrenia and the Phase 2 ILLUMINATE-1 trial in bipolar depression
Published results from the Phase 2 NOVA-1 trial of LB-102 in schizophrenia in The Journal of
the American Medical Association (JAMA) Psychiatry
Expanded pipeline following $100 million private placement with plans to initiate a Phase 2 trial
of LB-102 in adjunctive treatment of major depressive disorder (MDD) in early 2027
Cash, cash equivalents, and marketable securities of $365.6 million as of March 31, 2026
expected to fund operations into Q2 2029, through multiple clinical milestones
NEW YORK, May 12, 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 first quarter ended on March 31, 2026 and provided a corporate update.
“With multiple clinical trials ongoing, our focus is on execution to support several clinical readouts over the next three years that have the potential to unlock tremendous value of LB-102 in both psychosis and mood disorder indications,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “We remain on track for topline data from NOVA-2 in schizophrenia in the second half of 2027, from ILLUMINATE-1 in bipolar depression in the first quarter of 2028 and in adjunctive MDD in the first half of 2029. Our recent successful financing supports the expansion of our pipeline and positions us to advance our strategy of building a fully integrated neuropsychiatric company.”
First Quarter 2026 and Recent Highlights
The Company is building a pipeline that leverages the broad therapeutic potential of LB-102, which has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.
LB-102 in Schizophrenia
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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.
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Initiated the 52-week open-label safety and tolerability trial (NOVA-3) to evaluate the long-term safety and tolerability of LB-102 in patients with stable schizophrenia
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Published results from the Phase 2 NOVA-1 trial of LB-102 in schizophrenia in The Journal of the American Medical Association (JAMA) Psychiatry.
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Presented new data from the Phase 2 NOVA-1 trial at the 2026 Annual Congress of the Schizophrenia International Research Society (SIRS) in March 2026. A poster presentation highlighted a post hoc analysis designed to assess whether the improvement in cognitive performance demonstrated in the Phase 2 NOVA-1 trial, as measured by the Global Cognition composite score, was a direct effect of LB-102 or an indirect consequence of the effect of LB-102 on total schizophrenia symptoms. Results of the analysis demonstrated that the cognitive benefit was primarily, and statistically significantly, a direct effect of LB-102.
LB-102 in Mood Disorders: Bipolar Depression and Adjunctive Treatment of MDD
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Initiated the Phase 2 ILLUMINATE-1 trial 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.
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Announced the further expansion of the LB-102 development program in mood
disorders, with plans to initiate a Phase 2 trial in the adjunctive treatment of MDD in early 2027, with topline data expected in the first half of 2029.
Corporate Updates
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The Company further strengthened its board, with the appointment of Robert Lenz, M.D., Ph.D., and its executive team with several key hires to support the advancement of LB-102.
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In February 2026, the Company announced a private placement of $100 million with participation from new and existing institutional investors. Net proceeds were approximately $93.8 million, after deducting financial advisory fees and other financing expenses.
Financial Results for First Quarter 2026
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Research & Development Expenses: Research and development expenses were $14.6 million for the three months ended March 31, 2026, compared to $3.4 million for the three months ended March 31, 2025. The increase of $11.2 million was primarily due to a (i) $7.6 million increase in clinical trial expenses related to the conduct of our Phase 2 trial of LB-102 in the treatment of patients with bipolar 1 depression and our Phase 3 trial of LB-102 in the treatment of patients with acute schizophrenia; (ii) a $1.7 million increase in expenses related to the formulation and production of LB-102 for use in our active and planned
Mar 26, 2026
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Exhibit 99.1
LB Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
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
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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.
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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.
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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.
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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
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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.
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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
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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.
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Over the course of 2025 and early 2026, the
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