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2026-08-11
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Earnings documents stored for LBRX.

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Investor releaseQuarter not tagged2026-08-11

LB Pharmaceuticals Inc.: Q2 Earnings Snapshot

Associated Press

NEW YORK (AP) — NEW YORK (AP) — LB Pharmaceuticals Inc. (LBRX) on Tuesday reported a loss of $51.6 million in its second quarter. The New York-based company said it had a loss of $1.71 per share. The results missed Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of 84 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LBRX at https://www.zacks.com/ap/LBRX

Investor releaseQuarter not tagged2026-08-11

LB Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Corporate Update

GlobeNewswire
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…Read full document

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 trial of LB-102 for acute schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression are ongoing, and a Phase 2 trial of LB-102 in adjunctive treatment of MDD is planned. The Company is also pursuing additional expansion opportunities for LB-102 including predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases. About LB Pharmaceuticals LB Pharmaceuticals is a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release 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 “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; the design, objectives, initiation, timing, progress and results of clinical trials of LB-102, including the pivotal Phase 3 NOVA-2 trial in acute schizophrenia, our open label trial (NOVA-3), the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression and the Phase 2 trial for the adjunctive treatment of MDD; the Company’s plan to pursue any additional indications including negative symptoms of schizophrenia and Alzheimer’s disease psychosis/agitation; anticipated cash runway beyond the second quarter of 2029; continued advancement of LB-102 and the Company’s portfolio. 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: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media and Investor Contact: Ellen [email protected]

Investor releaseQuarter not tagged2026-07-22

LB Pharmaceuticals Announces Accelerated Timing of Topline Results from the Phase 3 NOVA-2 Trial of LB-102 in Schizophrenia

GlobeNewswire
NEW YORK, July 22, 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 that based on enrollment projections, it now expects to report topline results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in the first half of 2027 and to schedule a pre-NDA meeting with the FDA thereafter in the second half of 2027. NOVA-2 is a pivotal Phase 3 multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of LB-102 for the treatment of schizophrenia. The trial is designed to enroll approximately 460 patients across 25 sites in the U.S. “Enrollment in our pivotal Phase 3 NOVA-2 trial has been more rapid than we expected, which we believe is a reflection of both the strength of our execution and the level of interest in LB-102 as a potential new treatment for schizophrenia. Based on the pace of enrollment since initiating NOVA-2, we now expect to report topline results in the first half of 2027, ahead of our prior guidance of the second half of 2027, and to schedule a pre-NDA meeting soon thereafter in the second half of 2027,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “We remain well capitalized with a cash runway expected to fund operations into the second quarter of 2029 through multiple clinical readouts, with topline data from the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression expected in the first quarter of 2028, and from the Phase 2 trial of LB-102 in adjunctive MDD in the first half of 2029.” 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 plac…Read full document

NEW YORK, July 22, 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 that based on enrollment projections, it now expects to report topline results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in the first half of 2027 and to schedule a pre-NDA meeting with the FDA thereafter in the second half of 2027. NOVA-2 is a pivotal Phase 3 multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of LB-102 for the treatment of schizophrenia. The trial is designed to enroll approximately 460 patients across 25 sites in the U.S. “Enrollment in our pivotal Phase 3 NOVA-2 trial has been more rapid than we expected, which we believe is a reflection of both the strength of our execution and the level of interest in LB-102 as a potential new treatment for schizophrenia. Based on the pace of enrollment since initiating NOVA-2, we now expect to report topline results in the first half of 2027, ahead of our prior guidance of the second half of 2027, and to schedule a pre-NDA meeting soon thereafter in the second half of 2027,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “We remain well capitalized with a cash runway expected to fund operations into the second quarter of 2029 through multiple clinical readouts, with topline data from the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression expected in the first quarter of 2028, and from the Phase 2 trial of LB-102 in adjunctive MDD in the first half of 2029.” 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. The pivotal Phase 3 NOVA-2 trial of LB-102 for acute schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression are ongoing, 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 LB Pharmaceuticals is a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release 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 “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; the design, objectives, initiation, timing, progress and results of clinical trials of LB-102, including the pivotal Phase 3 NOVA-2 trial in acute schizophrenia, our open label trial (NOVA-3), the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression and the Phase 2 trial for the adjunctive treatment of MDD; and anticipated cash runway into the second quarter of 2029. 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: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media and Investor Contact: Ellen [email protected]

Investor releaseQuarter not tagged2026-05-13

LB Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Corporate Update

GlobeNewswire
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 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. 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 schizophre…Read full document

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 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. 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 Published results from the Phase 2 NOVA-1 trial of LB-102 in schizophrenia in The Journal of the American Medical Association (JAMA) Psychiatry. 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 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. 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 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. 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 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 clinical trials; (iii) a $0.5 million increase in preclinical and other direct expenses primarily related to preclinical testing of LB-102; (iv) a $0.9 million increase in personnel-related expenses primarily due to an increase in headcount; and (v) a $0.6 million increase in other research and development expenses, primarily due to increased use of consultants. General & Administrative Expenses: General and administrative expenses were $7.5 million for the three months ended March 31, 2026, compared to $3.0 million for the three months ended March 31, 2025. The increase of $4.5 million was due to (i) a $1.5 million increase in personnel-related expenses primarily due to an increase in headcount; (ii) a $1.6 million increase in stock-based compensation expense primarily related to stock options granted and repriced in connection with the IPO, as well as new hire grants; and (iii) a $1.4 million increase in professional fees, including accounting and legal fees and consulting fees. Net Loss: Net loss was $19.1 million for the three months ended March 31, 2026, as compared to $5.3 million for the three months ended March 31, 2025. Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were approximately $365.6 million. Based on current operating assumptions, the Company anticipates its current cash, cash equivalents, and marketable securities will support its planned operations into the second quarter of 2029. 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. The pivotal Phase 3 NOVA-2 trial of LB-102 for acute schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression 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 LB Pharmaceuticals is a late-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release 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 “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; the design, objectives, initiation, timing, progress and results of clinical trials of LB-102, including the pivotal Phase 3 NOVA-2 trial in acute schizophrenia, our open label trial (NOVA-3), the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression and the Phase 2 trial for the adjunctive treatment of MDD; anticipated cash runway into the second quarter of 2029 and use of proceeds; the Company’s ability to advance its strategy to build a fully integrated neuropsychiatric company; continuing advancement of LB-102 and the Company’s portfolio. 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: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media and Investor Contact: Ellen Rose [email protected]

Investor releaseQuarter not tagged2026-05-13

LB Pharmaceuticals Inc.: Q1 Earnings Snapshot

Associated Press

NEW YORK (AP) — NEW YORK (AP) — LB Pharmaceuticals Inc. (LBRX) on Tuesday reported a loss of $19.1 million in its first quarter. The New York-based company said it had a loss of 67 cents per share. The results topped Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 75 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LBRX at https://www.zacks.com/ap/LBRX

Investor releaseQuarter not tagged2026-04-23

LB Pharmaceuticals Announces Publication in JAMA Psychiatry of Results from Phase 2 NOVA-1 Trial of LB-102 in Schizophrenia

GlobeNewswire
Pivotal Phase 3 NOVA-2 trial in schizophrenia ongoing, topline data expected in 2H 2027 LB-102 has potential to be the first benzamide approved for schizophrenia in the U.S. NEW YORK, April 22, 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 major depressive disorder (MDD), and other neuropsychiatric diseases, today announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled “Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial.” LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT-7 receptors that is being advanced as a potential first benzamide in the U.S. for the treatment of neuropsychiatric disorders. “We are pleased to publish the positive results from the Phase 2 NOVA-1 trial in this prestigious, peer-reviewed journal, which we believe underscores the potential for LB-102, if approved, to become an important new treatment option for patients with schizophrenia,” commented Anna Eramo, MD, Chief Medical Officer of LB Pharmaceuticals. “Based on LB-102’s unique mechanism and these compelling clinical results, we have advanced LB-102 into the pivotal Phase 3 NOVA-2 trial for patients with schizophrenia the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression and plan to initiate a Phase 2 trial in adjunctive MDD in early 2027.” The positive data from the NOVA-1 trial were first announced in early 2025. In this four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia, 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 domains of neuropsychiatric disease. LB-102 is currently being evaluated in the pivotal Phase 3 NOVA-2 trial in patients with acute schizophrenia…Read full document

Pivotal Phase 3 NOVA-2 trial in schizophrenia ongoing, topline data expected in 2H 2027 LB-102 has potential to be the first benzamide approved for schizophrenia in the U.S. NEW YORK, April 22, 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 major depressive disorder (MDD), and other neuropsychiatric diseases, today announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled “Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial.” LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT-7 receptors that is being advanced as a potential first benzamide in the U.S. for the treatment of neuropsychiatric disorders. “We are pleased to publish the positive results from the Phase 2 NOVA-1 trial in this prestigious, peer-reviewed journal, which we believe underscores the potential for LB-102, if approved, to become an important new treatment option for patients with schizophrenia,” commented Anna Eramo, MD, Chief Medical Officer of LB Pharmaceuticals. “Based on LB-102’s unique mechanism and these compelling clinical results, we have advanced LB-102 into the pivotal Phase 3 NOVA-2 trial for patients with schizophrenia the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression and plan to initiate a Phase 2 trial in adjunctive MDD in early 2027.” The positive data from the NOVA-1 trial were first announced in early 2025. In this four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia, 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 domains of neuropsychiatric disease. LB-102 is currently being evaluated in the pivotal Phase 3 NOVA-2 trial in patients with acute schizophrenia. NOVA-2 is a double-blind placebo-controlled trial that is 6 weeks in duration and designed to enroll approximately 460 patients across 25 sites in the United States. Topline results from NOVA-2 are anticipated in the second half of 2027 and if positive, the Company expects to hold a pre-NDA meeting with FDA thereafter. About LB-102 LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders. A methylated derivative of amisulpride, a widely used antipsychotic outside the U.S., LB-102 was developed to retain amisulpride’s benefits while addressing its limitations. LB-102 is a 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 domains of neuropsychiatric disease. A Phase 3 clinical trial (NOVA-2) of LB-102 for schizophrenia and a Phase 2 clinical trial (ILLUMINATE-1) of LB-102 for bipolar depression have been initiated, and a Phase 2 trial 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 LB Pharmaceuticals is a late-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, the adjunctive treatment of MDD, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, adjunctive MDD, and other neuropsychiatric diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release 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 “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102;and the design, objectives, initiation, timing, progress and results of current and future clinical trials of LB-102, including the Phase 2 NOVA-1 trial, the Phase 3 NOVA-2 trial and the Phase 2 ILLUMINATE-1 trial. 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: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media and Investor Contact: Ellen Rose [email protected]

Investor releaseQuarter not tagged2026-03-27

LB Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

GlobeNewswire
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.…Read full document

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 LB Pharmaceuticals is a late-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release 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 “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; the design, objectives, initiation, timing, progress and results of clinical trials of LB-102, including the pivotal Phase 3 NOVA-2 trial in acute schizophrenia, the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression and the Phase 2 trial for the adjunctive treatment of MDD; anticipated cash runway into the second quarter of 2029 and use of proceeds; continuing advancement of LB-102 and the Company’s portfolio. 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: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media and Investor Contact: Ellen Rose [email protected]

Investor releaseQuarter not tagged2026-03-27

LB Pharmaceuticals Inc.: Q4 Earnings Snapshot

Associated Press Finance

NEW YORK (AP) — NEW YORK (AP) — LB Pharmaceuticals Inc. (LBRX) on Thursday reported a loss of $11.5 million in its fourth quarter. On a per-share basis, the New York-based company said it had a loss of 45 cents. The results met Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was also for a loss of 45 cents per share. For the year, the company reported a loss of $25.2 million, or $3.13 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LBRX at https://www.zacks.com/ap/LBRX

Investor releaseQuarter not tagged2025-11-06

LB Pharmaceuticals Reports 3Q 2025 Financial Results and Recent Corporate Updates

GlobeNewswire
NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX) today announced financial results for the third quarter ended on September 30, 2025 and provided recent corporate updates. “Following our recent initial public offering, we are well-positioned to continue executing on our strategy to advance LB-102 into a Phase 3 trial in acute schizophrenia, as well as a Phase 2 trial in bipolar depression,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “The robust and statistically significant results recently reported from our potentially registrational Phase 2 trial in acute schizophrenia confirm the meaningful clinical impact and differentiated tolerability of LB-102, which we believe has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. Our team is focused on advancing LB-102 towards FDA approval to expand treatment options for underserved patients.” Recent Corporate Updates In September 2025, the Company announced the pricing of its upsized initial public offering of 21,850,000 shares of its common stock at a price of $15.00 per share. The aggregate gross proceeds to LB Pharmaceuticals from the offering were $327.8 million. In October 2025, the Company presented three posters featuring new and previously reported analyses from its Phase 2 NOVA1 clinical trial of LB-102 in acute schizophrenia at the 38th European College of Neuropsychopharmacology (“ECNP”) Congress, which took place in Amsterdam, The Netherlands, from October 11-14, 2025. Using a validated battery of cognitive tests in its Phase 2 acute schizophrenia trial, a post-hoc analysis 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. The treatment effect size versus placebo was 0.26 (p=0.0476) at the 50 mg dose, 0.41 (p=0.0027) at the 75 mg dose and reached 0.66 (p=0.0018) at the 100 mg dose. Significant effect sizes of the magnitude reported in this trial provide early evidence that LB-102 may positively impact cognitive deficits—an area of significant unmet need that spans across schizophrenia and mood disorders. The Company presented two additional posters at ECNP, which included an enc…Read full document

NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX) today announced financial results for the third quarter ended on September 30, 2025 and provided recent corporate updates. “Following our recent initial public offering, we are well-positioned to continue executing on our strategy to advance LB-102 into a Phase 3 trial in acute schizophrenia, as well as a Phase 2 trial in bipolar depression,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “The robust and statistically significant results recently reported from our potentially registrational Phase 2 trial in acute schizophrenia confirm the meaningful clinical impact and differentiated tolerability of LB-102, which we believe has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. Our team is focused on advancing LB-102 towards FDA approval to expand treatment options for underserved patients.” Recent Corporate Updates In September 2025, the Company announced the pricing of its upsized initial public offering of 21,850,000 shares of its common stock at a price of $15.00 per share. The aggregate gross proceeds to LB Pharmaceuticals from the offering were $327.8 million. In October 2025, the Company presented three posters featuring new and previously reported analyses from its Phase 2 NOVA1 clinical trial of LB-102 in acute schizophrenia at the 38th European College of Neuropsychopharmacology (“ECNP”) Congress, which took place in Amsterdam, The Netherlands, from October 11-14, 2025. Using a validated battery of cognitive tests in its Phase 2 acute schizophrenia trial, a post-hoc analysis 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. The treatment effect size versus placebo was 0.26 (p=0.0476) at the 50 mg dose, 0.41 (p=0.0027) at the 75 mg dose and reached 0.66 (p=0.0018) at the 100 mg dose. Significant effect sizes of the magnitude reported in this trial provide early evidence that LB-102 may positively impact cognitive deficits—an area of significant unmet need that spans across schizophrenia and mood disorders. The Company presented two additional posters at ECNP, which included an encore presentation of the primary efficacy and safety results from the NOVA1 trial, and a post-hoc analysis focused on the effects of LB-102 on negative symptoms in a subset of patients with prominent negative symptoms at baseline. Collectively, these analyses further reinforce LB-102’s balanced clinical profile, which is characterized by clinically meaningful reduction in Positive and Negative Syndrome Scale (“PANSS”) scores, a generally favorable and potentially class-leading tolerability profile and differentiated clinical activity across multiple symptom domains. To increase the statistical power of its planned Phase 3 clinical trial in acute schizophrenia, the Company plans to increase the sample size of this trial from approximately 400 patients to approximately 460 patients. The Company is planning to initiate this trial in the first quarter of 2026 and continues to expect to report topline data for this trial in the second half of 2027. The Company also plans to initiate a potentially registrational Phase 2 trial in bipolar depression in the first quarter of 2026 and expects to report topline data for this trial in the first quarter of 2028. New Team Appointments In September 2025, the Company announced the appointments of William Kane and Rekha Hemrajani to its Board of Directors. These new Board members add valuable expertise in finance, business development, CNS product commercialization, and corporate strategy. In October 2025, LB Pharmaceuticals announced the appointment of James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs. Throughout his career, Dr. Rawls has led or contributed to more than a dozen successful regulatory filings and product approvals in the United States, Europe, and Japan, with specific experience in neuropsychiatric diseases. Financial Results for the Three Months ended September 30, 2025 Research & Development Expenses: Research and development expenses were $2.4 million for the third quarter of 2025, as compared to $10.7 million in the third quarter of 2024. The decrease was primarily due to a decrease in clinical trial expenses related to the conduct of our Phase 2 clinical trial of LB-102 in acute schizophrenia in 2024. General & Administrative Expenses: General and administrative expenses were $2.8 million for the third quarter of 2025, as compared to $5.4 million for the third quarter of 2024. The decrease was primarily due to the write-off of deferred financing costs in 2024. Net Loss: Net loss was $3.6 million for the third quarter of 2025, as compared to a net loss of $14.2 million for the third quarter of 2024. Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2025 were approximately $314.5 million following the Company’s initial public offering in September. Based on current operating assumptions, the Company anticipates its current cash, cash equivalents and marketable securities will support its planned operations into the second quarter of 2028. Financial Results for the Nine Months ended September 30, 2025 Research & Development Expenses: Research and development expenses were $8.3 million for the nine months ended September 30, 2025, as compared to $50.8 million for the nine months ended September 30, 2024. The decrease was primarily due to a decrease in clinical trial expenses related to the conduct of our Phase 2 clinical trial of LB-102 in acute schizophrenia in 2024. General & Administrative Expenses: General and administrative expenses were $8.3 million for the nine months ended September 30, 2025, as compared to $8.5 million for the nine months ended September 30, 2024. Net Loss: Net loss was $13.7 million for the nine months ended September 30, 2025, as compared to $58.0 million for the nine months ended September 30, 2024. About LB-102 LB-102 is a Phase 3-ready oral, small molecule and a methylated derivative of amisulpride. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. The Phase 2 trial demonstrated statistically significant benefit versus placebo at all doses studied, a potentially class leading safety profile among D2 antagonists and partial agonists, and positive effects on negative symptoms and cognition. LB-102 is advancing into a Phase 3 clinical trial for acute schizophrenia and a Phase 2 clinical trial for bipolar depression. Additional expansion opportunities for LB-102 could include major depressive disorder (MDD), predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as bipolar mania and cognitive impairment associated with schizophrenia. About LB Pharmaceuticals LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release 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 “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the design, objectives and timing of the Phase 3 trial in acute schizophrenia and the Phase 2 trial in bipolar depression; the expected regulatory pathway and therapeutic benefits of LB-102 and continuing advancement of LB-102 and the Company’s portfolio; and anticipated cash runway into the second quarter of 2028. 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: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”) and its other documents to be subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts Media: Michael Tattory LifeSci Communications [email protected] Investor Relations: Joyce Allaire LifeSci Advisors [email protected]

Investor releaseQuarter not tagged2025-11-06

LB Pharmaceuticals Inc.: Q3 Earnings Snapshot

Associated Press Finance

NEW YORK (AP) — NEW YORK (AP) — LB Pharmaceuticals Inc. (LBRX) on Thursday reported a loss of $3.6 million in its third quarter. On a per-share basis, the New York-based company said it had a loss of 61 cents. The results fell short of Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 57 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LBRX at https://www.zacks.com/ap/LBRX

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook