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, Aug. 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 disorders, 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
-- 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.
-- 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.
-- 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
-- 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.
-- 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
-- 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.
-- 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
-- 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 formulation and
production of LB-102 for use in our active and planned clinical trials;
(iv) a $4.0 million increase in personnel-related expenses primarily due
to an increase in headcount, an increase in termination benefits, and an
increase in stock compensation expense related to an option modification;
and (v) a $1.3 million increase in preclinical and other direct expenses
related to LB-102.
-- General & Administrative Expenses: General and administrative expenses
were $9.8 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
$7.3 million was primarily due to (i) a $2.8 million increase in
stock-based compensation expense primarily related to stock options
granted and repriced in connection with the IPO, new hire grants, and an
option modification; (ii) a $2.3 million increase in professional,
consulting and public company related expenses; and (iii) a $2.1 million
increase in personnel-related expenses primarily due to an increase in
headcount.
-- Net Loss: Net loss was $51.6 million for the three months ended June 30,
2026, as compared to $4.9 million for the three months ended June 30,
2025.
-- Cash Position: Cash, cash equivalents and marketable securities as of
June 30, 2026 were approximately $327.8 million, which does not include
net proceeds from our $150.0 million private placement in July 2026.
Based on current operating assumptions, the Company anticipates its
current cash, cash equivalents, and marketable securities will support
its planned operations beyond the second quarter of 2029.
Financial Results for the Six Months Ended June 30, 2026
-- Research & Development Expenses: Research and development expenses were
$58.8 million for the six months ended June 30, 2026, compared to $5.8
million for the six months ended June 30, 2025. The increase of $53.0
million was primarily due to (i) a $36.8 million increase in clinical
trial expenses related to our Phase 3 trial of LB-102 in the treatment of
patients with acute schizophrenia; (ii) a $5.7 million increase related
to the conduct of our Phase 2 trial of LB-102 in the treatment of
patients with bipolar depression; (iii) a $3.6 million increase in
expenses related to the formulation and production of LB-102 for use in
our active and planned clinical trials; (iv) a $1.9 million increase in
preclinical and other direct expenses related to LB-102; and (v) a $5.0
million increase in personnel-related expenses primarily due to an
increase in headcount, an increase in termination benefits, and an
increase in stock compensation expense related to an option modification.
-- General & Administrative Expenses: General and administrative expenses
were $17.2 million for the six months ended June 30, 2026, compared to
$5.4 million for the six months ended June 30, 2025. The increase of
$11.8 million was primarily due to (i) a $4.4 million increase in
stock-based compensation expense primarily related to stock options
granted and repriced in connection with the IPO, new hire grants, and an
option modification; (ii) a $4.0 million increase in professional,
consulting and public company related expenses; and (iii) a $3.6 million
increase in personnel-related expenses primarily due to an increase in
headcount.
-- Net Loss: Net loss was $70.7 million for the six months ended June 30,
2026, as compared to $10.2 million for the six months ended June 30,
2025.
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 5-HT7 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. The pivotal Phase 3 NOVA-2
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