Neuphoria Provides First Quarter 2025 Business Updates
Neuphoria Therapeutics (NASDAQ: NEUP) provided Q1 2025 business updates, highlighting progress in its neuropsychiatric drug development pipeline. The company's lead program, BNC210, is advancing in the Phase 3 AFFIRM-1 trial for Social Anxiety Disorder (SAD), with topline results expected in Q3 2025. BNC210 has shown promising results in previous trials, demonstrating rapid-onset anti-anxiety effects without sedation or addiction risks.
The company is also planning a Phase 2b SYMPHONY trial for BNC210 in PTSD following a successful FDA End-of-Phase 2 meeting. Additionally, Neuphoria's partnered asset MK-1167, an α7 nicotinic acetylcholine receptor PAM, is progressing in a Merck-led Phase 2 trial for Alzheimer's disease. The company maintains a cash runway extending into Q3 2026.
Neuphoria Therapeutics (NASDAQ: NEUP) ha fornito aggiornamenti aziendali per il primo trimestre 2025, evidenziando i progressi nella sua pipeline di sviluppo di farmaci neuropsichiatrici. Il programma principale dell'azienda, BNC210, sta avanzando nella fase 3 dello studio AFFIRM-1 per il Disturbo d'Ansia Sociale (SAD), con risultati preliminari attesi per il terzo trimestre 2025. BNC210 ha mostrato risultati promettenti nei trial precedenti, dimostrando effetti ansiolitici a insorgenza rapida senza sedazione o rischio di dipendenza.
L'azienda sta inoltre pianificando uno studio di fase 2b SYMPHONY per BNC210 nel trattamento del PTSD, a seguito di un incontro positivo con la FDA alla fine della fase 2. Inoltre, il farmaco in collaborazione di Neuphoria, MK-1167, un PAM del recettore α7 nicotinico dell'acetilcolina, sta progredendo in uno studio di fase 2 guidato da Merck per la malattia di Alzheimer. La società dispone di risorse finanziarie sufficienti fino al terzo trimestre 2026.
Neuphoria Therapeutics (NASDAQ: NEUP) presentó actualizaciones comerciales del primer trimestre de 2025, destacando avances en su pipeline de desarrollo de fármacos neuropsiquiátricos. El programa principal de la compañía, BNC210, avanza en el ensayo de fase 3 AFFIRM-1 para el Trastorno de Ansiedad Social (SAD), con resultados preliminares esperados para el tercer trimestre de 2025. BNC210 ha mostrado resultados prometedores en ensayos previos, demostrando efectos ansiolíticos de inicio rápido sin sedación ni riesgos de adicción.
La compañía también planea un ensayo de fase 2b SYMPHONY para BNC210 en TEPT tras una exitosa reunión con la FDA al final de la fase 2. Además, el activo en colaboración de Neuphoria, MK-1167, un PAM del receptor nicotínico α7 de acetilcolina, avanza en un ensayo de fase 2 liderado por Merck para la enfermedad de Alzheimer. La empresa mantiene una liquidez que se extiende hasta el tercer trimestre de 2026.
Neuphoria Therapeutics (NASDAQ: NEUP)는 2025년 1분기 사업 업데이트를 발표하며 신경정신약 개발 파이프라인의 진전을 강조했습니다. 회사의 주력 프로그램인 BNC210은 사회불안장애(SAD)를 위한 3상 AFFIRM-1 임상시험이 진행 중이며, 2025년 3분기에 주요 결과가 발표될 예정입니다. BNC210은 이전 임상에서 빠른 발현의 항불안 효과를 보였으며, 진정이나 중독 위험이 없는 것으로 나타났습니다.
또한 회사는 FDA와의 성공적인 2상 종료 회의 후 PTSD 치료를 위한 BNC210의 2b상 SYMPHONY 시험을 계획하고 있습니다. 아울러 Neuphoria가 파트너십을 맺은 MK-1167은 α7 니코틴성 아세틸콜린 수용체 PAM으로, 머크 주도 하에 알츠하이머병을 위한 2상 시험이 진행 중입니다. 회사는 2026년 3분기까지 운영 자금을 확보하고 있습니다.
Neuphoria Therapeutics (NASDAQ : NEUP) a publié des mises à jour commerciales pour le premier trimestre 2025, mettant en avant les progrès réalisés dans son pipeline de développement de médicaments neuropsychiatriques. Le programme principal de la société, BNC210, progresse dans l'essai de phase 3 AFFIRM-1 pour le trouble d'anxiété sociale (SAD), avec des résultats principaux attendus au troisième trimestre 2025. BNC210 a montré des résultats prometteurs lors d'essais précédents, démontrant des effets anxiolytiques à action rapide sans sédation ni risque de dépendance.
La société prévoit également un essai de phase 2b SYMPHONY pour BNC210 dans le PTSD après une réunion réussie de fin de phase 2 avec la FDA. Par ailleurs, l'actif en partenariat de Neuphoria, MK-1167, un PAM du récepteur nicotinique α7 de l'acétylcholine, progresse dans un essai de phase 2 dirigé par Merck pour la maladie d'Alzheimer. La société dispose d'une trésorerie suffisante jusqu'au troisième trimestre 2026.
Neuphoria Therapeutics (NASDAQ: NEUP) gab Geschäftsaktualisierungen für das erste Quartal 2025 bekannt und hob Fortschritte in seiner Entwicklungspipeline für neuropsychiatrische Medikamente hervor. Das Hauptprogramm des Unternehmens, BNC210, befindet sich in der Phase-3-Studie AFFIRM-1 zur Behandlung der sozialen Angststörung (SAD), wobei die wichtigsten Ergebnisse im dritten Quartal 2025 erwartet werden. BNC210 zeigte in früheren Studien vielversprechende Ergebnisse mit schnellen angstlösenden Effekten ohne Sedierung oder Abhängigkeitsrisiko.
Das Unternehmen plant zudem eine Phase-2b-Studie SYMPHONY für BNC210 bei PTBS nach einem erfolgreichen FDA-Ende-Phase-2-Meeting. Zusätzlich schreitet das Partnerschaftsprojekt MK-1167, ein α7-nikotinerger Acetylcholinrezeptor-PAM, in einer von Merck geleiteten Phase-2-Studie zur Alzheimer-Krankheit voran. Das Unternehmen verfügt über finanzielle Mittel bis ins dritte Quartal 2026.
- Strong cash position with runway extending into Q3 2026
- Lead drug BNC210 demonstrated rapid-onset anti-anxiety effects without sedation or addiction risks
- Successful FDA End-of-Phase 2 meeting for BNC210 in PTSD indication
- Strategic partnership with Merck for MK-1167 in Alzheimer's disease
- Phase 2b SYMPHONY trial for PTSD indication contingent on meeting capital requirements
- Multiple clinical trials running simultaneously may strain resources
Insights
Neuphoria demonstrates promising progress with BNC-210 in anxiety disorders with strong cash position into Q3 2026.
Neuphoria's Q1 2025 update reveals solid operational execution with their lead candidate BNC-210 progressing on schedule in the Phase 3 AFFIRM-1 trial for Social Anxiety Disorder (SAD), with
The company's clinical strategy is particularly compelling because BNC-210 has shown differentiated clinical attributes - specifically rapid onset of action and meaningful anti-anxiety effects without the concerning side effects that plague current treatments (sedation, cognitive impairment, and addiction potential). This pharmacological profile addresses significant unmet needs in anxiety treatment.
Their cash runway extending into Q3 2026 provides sufficient operational flexibility through multiple clinical readouts, most importantly the upcoming Phase 3 data. The successful End-of-Phase 2 meeting with FDA for BNC-210 in PTSD indicates regulatory alignment on development plans, though the company appropriately prioritizes capital allocation by making the SYMPHONY trial contingent on meeting the next program milestone.
The Merck-partnered MK-1167 program targeting α7 nicotinic acetylcholine receptors for Alzheimer's represents a valuable pipeline diversification strategy. Having a major pharmaceutical partner advancing this asset reduces development risk for Neuphoria while maintaining potential upside exposure to the enormous Alzheimer's market.
- Cash runway into Q3 2026
- AFFIRM-1 Phase 3 clinical trial of BNC-210 in social anxiety disorder on track for topline readout in Q3 2025
- α7 nicotinic acetylcholine receptor PAM MK-1167 partnered with Merck and in Phase 2 clinical trial in Alzheimer’s
BURLINGTON, Mass., May 20, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today provides business updates for the First Quarter of 2025.
“The first quarter of 2025 marked steady progress across our pipeline,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “Our lead internal program BNC210 continues to enroll into the AFFIRM-1 Phase 3 study in Social Anxiety Disorder, and we are planning to release topline data in Q3 this year. We’re also very pleased to see our partnered asset, MK-1167, continue its momentum in the Merck-led Phase 2 trial in Alzheimer’s disease.”
Recent Highlights
Clinical Programs
- Phase 3 AFFIRM-1 with BNC210 for the acute, as-needed treatment of anxiety in social anxiety disorder (SAD) trial is proceeding with topline results anticipated in Q3 2025.
- BNC210 has demonstrated rapid-onset, broad and meaningful anti-anxiety effects in completed clinical trials in panic attacks, generalized anxiety disorder (GAD) and social anxiety disorder (SAD) without evidence of sedation, impairments in cognition or addiction potential.
- Planning for a Phase 2b (SYMPHONY) trial for BNC210 in PTSD is underway following a successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA). The proposed SYMPHONY trial is being designed to help identify a second (lower) dose for BNC210 in order to further de-risk the program prior to advancing onto a Phase 3 trial, contingent on meeting capital requirements for the next program milestone (Ph3 AFFIRM-1 SAD trial read-out).
FOR FURTHER INFORMATION PLEASE CONTACT:
| General Spyridon (Spyros) Papapetropoulos info@neuphoriatx.com | Investor Relations Kevin Gardner kgardner@lifesciadvisors.com | |
About Neuphoria Therapeutics Inc.
Neuphoria (Nasdaq: NEUP) is a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. Neuphoria is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute, “as needed” treatment of social anxiety disorder (SAD) and for chronic treatment of post-traumatic stress disorder (PTSD). BNC210 is a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. In addition, Neuphoria has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Neuphoria's pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs, both in the lead optimization development stage.
Forward-Looking Statements
Neuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs, plans, burn rate and expectations. Certain forward-looking statements, including (without limitation) about (1) Neuphoria’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement and/or completion of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Neuphoria’s financial resources, and (4) assumptions underlying any such statements. The inclusion of forward-looking statements should not be regarded as a representation by Neuphoria that any of its plans will be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. Certain forward-looking statements involve contracts, licenses and arrangements involving third parties and their respective clinical trial and research and development projects that are out of our control, including our agreements with Merck and Carina. They may terminate or delay any or all such projects in their discretion pursuant to the terms of our agreements with them, which could result in the Company not realizing any further milestone payments or further progress on the respective product pathways. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q, each filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Neuphoria undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Neuphoria’s filings with the SEC, copies of which are available from the SEC’s website (www.sec.gov) and on Neuphoria’s website (www.neuphoriatx.com) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Neuphoria expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.
FAQ
When will Neuphoria (NEUP) release topline results for BNC210 Phase 3 trial in Social Anxiety Disorder?
What are the key advantages of Neuphoria's BNC210 drug for anxiety treatment?
How long can Neuphoria (NEUP) operate with its current cash reserves?
What is the status of Neuphoria's partnership with Merck?
What are Neuphoria's plans for BNC210 in PTSD treatment?
