LB Pharmaceuticals Reports 3Q 2025 Financial Results and Recent Corporate Updates
LB Pharmaceuticals (Nasdaq: LBRX) reported 3Q 2025 results and corporate updates on Nov 6, 2025. The company completed an upsized IPO of 21,850,000 shares at $15.00 raising $327.8M gross and held $314.5M cash, projected to fund operations into Q2 2028. LB-102 Phase 2 NOVA1 data showed dose-dependent cognitive effect sizes vs placebo of 0.26 (50 mg), 0.41 (75 mg) and 0.66 (100 mg). The company plans a Phase 3 acute schizophrenia trial (sample size increased from ~400 to ~460) starting in Q1 2026 with topline in H2 2027, and a potentially registrational Phase 2 bipolar depression trial starting Q1 2026 with topline in Q1 2028.
LB Pharmaceuticals (Nasdaq: LBRX) ha riportato i risultati del 3Q 2025 e aggiornamenti aziendali il 6 novembre 2025. L'azienda ha completato un IPO ampliato di 21.850.000 azioni a 15,00 USD, raccogliendo 327,8 milioni di USD lordi e detenendo 314,5 milioni di USD in contanti, previsti per finanziare le operazioni fino al Q2 2028. I dati della LB-102 fase 2 NOVA1 hanno mostrato effetti cognitivi dipendenti dalla dose rispetto al placebo di 0,26 (50 mg), 0,41 (75 mg) e 0,66 (100 mg). L'azienda prevede uno studio di fase 3 sull'acute schizophrenia (campione aumentato da circa 400 a circa 460) che inizierà nel Q1 2026 con i dati principali nel H2 2027, e uno studio di fase 2 potenzialmente registrazionale per la bipolar depression che inizierà nel Q1 2026 con i dati principali nel Q1 2028.
LB Pharmaceuticals (Nasdaq: LBRX) reportó resultados del 3T 2025 y actualizaciones corporativas el 6 de noviembre de 2025. La empresa completó una IPO ampliada de 21.850.000 acciones a 15,00 USD, recaudando 327,8 millones de USD brutos y manteniendo 314,5 millones de USD en efectivo, proyectados para financiar operaciones hasta el Q2 2028. Los datos de LB-102 fase 2 NOVA1 mostraron tamaños de efecto cognitivo dependientes de la dosis frente a placebo de 0,26 (50 mg), 0,41 (75 mg) y 0,66 (100 mg). La empresa planea un ensayo de fase 3 para esquizofrenia aguda (el tamaño de muestra aumentó de ~400 a ~460) que comenzará en el Q1 2026 con datos principales en la H2 2027, y un ensayo de fase 2 potencialmente registracional para bipolar depression que podría comenzar en el Q1 2026 con datos principales en el Q1 2028.
LB Pharmaceuticals (Nasdaq: LBRX)가 2025년 11월 6일 3Q 2025 실적 및 기업 업데이트를 발표했습니다. 회사는 15.00 USD에 21,850,000주를 상장하는 확대된 IPO를 완료하여 총 3억 2,780만 USD의 매출을 올렸고, 현금 보유액은 3억 1,450만 USD이며 운영 자금을 2028년 2분기까지 충당할 것으로 예상됩니다. LB-102 Phase 2 NOVA1 데이터는 위약 대비 용량 의존적 인지 효과 크기를 0.26 (50 mg), 0.41 (75 mg) 및 0.66 (100 mg)로 보였습니다. 회사는 ~400에서 ~460으로 증가한 샘플 크기를 가진 급성 조현병 3상 시험을 2026년 1분기에 시작하고 2027년 하반기에 topline를 발표하며, 2026년 1분기에 시작하여 2028년 1분기에 topline를 발표할 수 있는 양극성 우울증의 잠재적 등록 가능성 있는 2상 시험을 계획하고 있습니다.
LB Pharmaceuticals (Nasdaq : LBRX) a publié les résultats du 3e trimestre 2025 et des mises à jour d’entreprise le 6 novembre 2025. La société a bouclé une IPO amplifiée de 21 850 000 actions à 15,00 USD, levant 327,8 millions de USD bruts et détenant 314,5 millions de USD en trésorerie, prévus pour financer les opérations jusqu’au Q2 2028. Les données de LB-102 phase 2 NOVA1 ont montré des tailles d’effet cognitif dépendantes de la dose par rapport au placebo de 0,26 (50 mg), 0,41 (75 mg) et 0,66 (100 mg). La société prévoit un essai de phase 3 pour la schizophrénie aiguë (la taille de l’échantillon entre environ 400 et environ 460) qui débutera au 1er trimestre 2026 avec des résultats préliminaires au 2e semestre 2027, et un essai de phase 2 potentiellement enregistrable pour la dépression bipolaire, débutant au 1er trimestre 2026 avec des résultats préliminaires au 1er trimestre 2028.
LB Pharmaceuticals (Nasdaq: LBRX) berichtete am 6. November 2025 über die Ergebnisse des 3Q 2025 und Unternehmensaktualisierungen. Das Unternehmen schloss einen vergrößerten IPO von 21.850.000 Aktien zu 15,00 USD ab und erzielte dabei 327,8 Mio. USD brutogewinn, hält 314,5 Mio. USD an Bargeld und rechnet damit, die operativen Mittel bis zum 2. Quartal 2028 zu finanzieren. Die LB-102 Phase-2 NOVA1-Daten zeigten dossengesteuerte kognitive Effekte gegenüber Placebo von 0,26 (50 mg), 0,41 (75 mg) und 0,66 (100 mg). Das Unternehmen plant eine Phase-3-Studie zur akuten Schizophrenie (Stichprobengröße von ca. 400 auf ca. 460 erhöht), die im 1. Quartal 2026 beginnt, mit Topline-Daten im 2. Halbjahr 2027, sowie eine potenziell registrierungsrelevante Phase-2-Studie zur bipolaren Depression, die im 1. Quartal 2026 beginnt und Topline-Daten im 1. Quartal 2028 liefert.
LB Pharmaceuticals (Nasdaq: LBRX) أصدرت نتائج الربع الثالث من 2025 وتحديثات الشركة في 6 نوفمبر 2025. أكملت الشركة عملية اكتتاب عام أولي موسّع لــ 21,850,000 سهم بسعر 15.00 دولار للسهم، محققة إجمالي قدره 327.8 مليون دولار وباحتياطي نقدي قدره 314.5 مليون دولار، ومن المتوقع أن يمول التشغيل حتى الربع الثاني من 2028. أظهرت بيانات LB-102 المرحلة 2 NOVA1 تأثيرات معرفية مرتبطة بالجرعة مقارنةً بالدواء الوهمي بقيم 0.26 (50 mg)، 0.41 (75 mg) و0.66 (100 mg). تخطط الشركة لإجراء تجربة المرحلة 3 لاضطراب الفصام الحاد (زيادة حجم العينة من نحو 400 إلى نحو 460) ستبدأ في الربع الأول من 2026 مع نتائج رئيسية في النصف الثاني من 2027، وتجربة المرحلة 2 التي قد تكون مسجّلة رسمياً للاكتئاب ثنائي القطب، ستبدأ في الربع الأول من 2026 مع نتائج رئيسية في الربع الأول من 2028.
- IPO proceeds of $327.8M
- Cash balance of $314.5M expected to fund into Q2 2028
- Phase 2 cognitive effect sizes: 0.26/0.41/0.66 (50/75/100 mg)
- Planned Phase 3 sample increase from ~400 to ~460 to boost power
- Plans to initiate Phase 3 and Phase 2 bipolar trials in Q1 2026
- Net loss of $3.6M in 3Q 2025 (though improved vs prior year)
- R&D spend declined to $2.4M in 3Q 2025 from $10.7M in 3Q 2024 (reflects lower trial activity)
- Nine‑month net loss of $13.7M through Sept 30, 2025
Insights
Well‑funded company advancing a Phase 3 in acute schizophrenia after promising Phase 2 signals; near‑term milestones and cash runway are clear.
LB Pharmaceuticals shows a clear development path for LB‑102 backed by an upsized IPO that generated
The company reports statistically significant, dose‑dependent cognitive and symptom improvements in the Phase 2 completer population, including reported treatment effect sizes versus placebo of 0.26 (p=0.0476) at 50 mg, 0.41 (p=0.0027) at 75 mg, and 0.66 (p=0.0018) at 100 mg. Reported near‑term risks depend on successful enrollment, maintaining the reported tolerability profile in larger populations, and meeting protocol timelines; the company cites planned topline timing for the Phase 3 in Concrete items to watch include initiation of both trials in
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.
- 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.
- 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
Mtattory@lifescicomms.com
Investor Relations:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
| LB Pharmaceuticals Inc Condensed Balance Sheets (In thousands, except share and per share data) (Unaudited) | ||||||||
| As of | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 269,744 | $ | 22,978 | ||||
| Marketable securities | 44,735 | 5,021 | ||||||
| Prepaid expenses and other current assets | 1,922 | 880 | ||||||
| Total current assets | 316,401 | 28,879 | ||||||
| Operating lease right-of-use assets, net | 2,198 | 2,298 | ||||||
| Property and equipment, net | 1,635 | 1,859 | ||||||
| Restricted cash | 512 | 498 | ||||||
| Total assets | $ | 320,746 | $ | 33,534 | ||||
| Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,590 | $ | 2,320 | ||||
| Accrued expenses | 3,327 | 5,302 | ||||||
| Operating lease liability, current | 730 | 487 | ||||||
| Total current liabilities | 6,647 | 8,109 | ||||||
| Derivative liability - warrants | 942 | 2,504 | ||||||
| Operating lease liability, noncurrent | 2,936 | 3,216 | ||||||
| Total liabilities | 10,525 | 13,829 | ||||||
| Commitments and contingencies | ||||||||
| Redeemable convertible preferred stock | ||||||||
| Series Seed preferred stock, | — | 435 | ||||||
| Series A preferred stock, | — | 6,179 | ||||||
| Series B preferred stock, | — | 580 | ||||||
| Series C preferred stock, | — | 107,065 | ||||||
| Stockholders’ equity (deficit) | ||||||||
| Common stock, | 3 | 1 | ||||||
| Additional paid-in capital | 428,327 | 9,657 | ||||||
| Accumulated deficit | (118,056 | ) | (104,323 | ) | ||||
| Accumulated other comprehensive (loss) income | (53 | ) | 111 | |||||
| Total stockholders’ equity (deficit) | 310,221 | (94,554 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders’ deficit | $ | 320,746 | $ | 33,534 | ||||
| LB Pharmaceuticals Inc Condensed Statements of Operations (in thousands, except share and per share data) (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 2,419 | $ | 10,664 | $ | 8,261 | $ | 50,795 | ||||||||
| General and administrative | 2,827 | 5,419 | 8,273 | 8,496 | ||||||||||||
| Total operating loss | (5,246 | ) | (16,083 | ) | (16,534 | ) | (59,291 | ) | ||||||||
| Non-operating income (expense) | ||||||||||||||||
| Interest income | 707 | 384 | 1,120 | 1,423 | ||||||||||||
| Realized gain on sale of marketable securities, net | — | 503 | 119 | 593 | ||||||||||||
| Gain (loss) on change in fair value of derivative instruments | 983 | 1,015 | 1,562 | (756 | ) | |||||||||||
| Total non-operating income | 1,690 | 1,902 | 2,801 | 1,260 | ||||||||||||
| Loss before income tax | (3,556 | ) | (14,181 | ) | (13,733 | ) | (58,031 | ) | ||||||||
| Income tax provision | — | — | — | — | ||||||||||||
| Net loss | $ | (3,556 | ) | $ | (14,181 | ) | $ | (13,733 | ) | $ | (58,031 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.61 | ) | $ | (39.49 | ) | $ | (6.26 | ) | $ | (162.15 | ) | ||||
| Weighted average shares outstanding used in calculating net loss per share, basic and diluted | 5,806,862 | 359,079 | 2,195,199 | 357,891 | ||||||||||||
FAQ
What were LB Pharmaceuticals' IPO proceeds and share count in September 2025 (LBRX)?
How much cash did LBRX have on September 30, 2025 and how long will it fund operations?
What Phase 2 NOVA1 cognitive results did LB Pharmaceuticals report for LB-102?
When will LBRX start its Phase 3 acute schizophrenia trial and what is the planned sample size?
What is LBRX's timeline for the bipolar depression trial for LB-102?
How did LB Pharmaceuticals' R&D and net loss change in 3Q 2025 (LBRX)?
