Neuphoria Therapeutics Provides Update on AFFIRM-1 Phase 3 Trial Evaluating BNC210 for the Acute Treatment of Social Anxiety Disorder
Neuphoria Therapeutics (Nasdaq: NEUP) announced on October 20, 2025 that the AFFIRM-1 Phase 3 trial of BNC210 for acute treatment of social anxiety disorder (SAD) did not meet its primary endpoint or secondary endpoints.
The company said safety and tolerability remained favorable. Neuphoria will discontinue the SAD program, begin a strategic review of its portfolio and operations, and evaluate BNC210 for PTSD given prior positive chronic-dosing data. Neuphoria expects to provide an update by year-end.
The company highlighted a partnership with Merck (Merck-funded MK-1167 Phase 2 in Alzheimer’s) with up to $450 million of potential milestone payments plus royalties. As of June 30, 2025 cash and equivalents were $14.2 million, sufficient to fund operations through Q2 2027.
Neuphoria Therapeutics (Nasdaq: NEUP) ha annunciato il 20 ottobre 2025 che lo studio di fase 3 AFFIRM-1 di BNC210 per il trattamento acuto dell disturbo d'ansia sociale (SAD) non ha raggiunto l'obiettivo primario né gli obiettivi secondari.
L'azienda ha comunicato che la sicurezza e la tollerabilità sono rimaste favorevoli. Neuforia interromperà il programma SAD, avvierà una revisione strategica del proprio portafoglio e delle operazioni, e valuterà BNC210 per PTSD data la precedente evidenza di dosaggio cronico positiva. Neuphoria prevede di fornire un aggiornamento entro la fine dell'anno.
L'azienda ha sottolineato una partnership con Merck (MK-1167 di Merck nel 2° in Alzheimer) con fino a $450 milioni di potenziali milestone e royalties. Al 30 giugno 2025 la liquidità e equivalenti ammontavano a $14,2 milioni, sufficienti a finanziare le operazioni fino al Q2 2027.
Neuphoria Therapeutics (Nasdaq: NEUP) anunció el 20 de octubre de 2025 que el ensayo de fase 3 AFFIRM-1 de BNC210 para el tratamiento agudo del trastorno de ansiedad social (SAD) no alcanzó su endpoint primario ni los secundarios.
La compañía indicó que la seguridad y la tolerabilidad siguieron siendo favorables. Neuphoria parará el programa SAD, iniciará una revisión estratégica de su cartera y operaciones, y evaluará BNC210 para PTSD dado el dato previo de dosificación crónica positiva. Neuphoria espera proporcionar una actualización antes de fin de año.
La empresa destacó una asociación con Merck (MK-1167 de Merck en la segunda fase para demencia) con posibles pagos por hitos de hasta $450 millones más regalías. A 30 de junio de 2025, la caja y equivalentes eran de $14,2 millones, suficientes para financiar las operaciones hasta el segundo trimestre de 2027.
네우로피아 테라퓨틱스(나스닥: NEUP)는 2025년 10월 20일에 BNC210의 급성 사회 불안 장애(SAD) 치료를 위한 AFFIRM-1 3상 시험이 1차 평가점수 및 2차 평가점수를 충족하지 못했다고 발표했습니다.
회사는 안전성과 내약성이 양호하게 유지되었다고 말했습니다. Neuforia는 SAD 프로그램을 중단하고 포트폴리오 및 운영의 전략적 검토를 시작하며, 이전의 긍정적 만성 투여 데이터에 비추어 PTSD에 대해 BNC210을 평가할 예정입니다. 연말까지 업데이트를 제공할 것으로 예상합니다.
또한 회사는 Merck와의 파트너십을 강조했습니다( Merck가 자금을 지원하는 MK-1167 알츠하이머 파이프라인 2상). 최대 $450백만의 잠재적 마일스톤 지급과 로열티가 포함됩니다. 2025년 6월 30일 현재 현금 및 현금성자산은 $14.2백만으로 2027년 2분기까지 운영 자금이 충분합니다.
Neuphoria Therapeutics (Nasaq : NEUP) a annoncé le 20 octobre 2025 que l’essai de phase 3 AFFIRM-1 de BNC210 pour le traitement aigu de l’anxiété sociale (SAD) n’a pas atteint son critère principal ni ses critères secondaires.
La société a déclaré que la sécurité et la tolérance restaient favorables. Neuphoria va interrompre le programme SAD, lancer une revue stratégique de son portefeuille et de ses opérations, et évaluer BNC210 pour le PTSD compte tenu des données positives de dosage chronique préalables. Neuphoria prévoit de fournir une mise à jour d’ici la fin de l’année.
La société a mis en avant un partenariat avec Merck (MK-1167 en phase 2 dans l’Alzheimer financé par Merck) avec jusqu'à 450 millions de dollars de paiements potentiels de jalons en plus des royalties. Au 30 juin 2025, la trésorerie et équivalents étaient de 14,2 millions de dollars, suffisants pour financer les opérations jusqu’au 2e trimestre 2027.
Neuphoria Therapeutics (Nasdaq: NEUP) gab am 20. Oktober 2025 bekannt, dass die AFFIRM-1-Phase-3-Studie von BNC210 zur akuten Behandlung der sozialen Angststörung (SAD) ihre primären und sekundären Endpunkte nicht erreicht hat.
Das Unternehmen sagte, Sicherheit und Verträglichkeit blieben vorteilhaft. Neuphoria wird das SAD-Programm einstellen, eine strategische Überprüfung seines Portfolios und der Operationen einleiten und BNC210 aufgrund der bisherigen positiven Langzeitdosierungsdaten auf PTSD evaluieren. Neuphoria erwartet ein Update bis Ende des Jahres.
Das Unternehmen hob eine Partnerschaft mit Merck hervor (Merck-finanzierte MK-1167 Phase-2 in Alzheimer) mit potenziellen Meilensteinzahlungen von bis zu 450 Millionen USD plus Royaltyzahlungen. Zum 30. Juni 2025 betrugen Kasse und Äquivalente 14,2 Millionen USD, ausreichend, um die Operationen bis ins 2. Quartal 2027 zu finanzieren.
Neuphoria Therapeutics (ناسداك: NEUP) أعلنت في 20 أكتوبر 2025 أن تجربة AFFIRM-1 من المرحلة 3 لـ BNC210 لعلاج فوري لاضطراب القلق الاجتماعي (SAD) لم تحقق الهدف الرئيسي ولا الأهداف الثانوية.
قالت الشركة إن السلامة والتحمل ظلتا مواتيَين. سيتوقف Neuphoria عن برنامج SAD، وستبدأ مراجعة استراتيجية لمحفظتها وعملياتها، وتقيِّم BNC210 لـ PTSD بناءً على بيانات الجرعات المزمنة الإيجابية السابقة. تتوقع Neuphoria تقديم تحديث بحلول نهاية العام.
أبرزت الشركة شراكة مع Merck (MK-1167 في المرحلة 2 لمرض الزهايمر ممول من Merck) مع حتى 450 ملايين دولار كمدفوعات معلمية محتملة بالإضافة إلى العوائد. حتى 30 يونيو 2025 بلغت النقدية وما يعادلها 14.2 مليون دولار، وهو ما يكفي لتمويل العمليات حتى الربع الثاني من 2027.
Neuphoria Therapeutics (纳斯达克：NEUP) 于 2025年10月20日宣布，针对急性治疗社交焦虑障碍（SAD）的 AFFIRM-1 第3阶段试验的 BNC210 未达到主要终点也未达到次要终点。
公司表示安全性和耐受性仍然良好。Neuphoria 将停止 SAD 计划，启动对其投资组合和运营的战略审查，并在此前的正向慢性剂量数据基础上评估 BNC210 是否用于 PTSD。Neuphoria 预计在年底前提供更新。
公司强调与 Merck 的伙伴关系（Merck 出资的 MK-1167 阿尔茨海默病研究的二期）可能带来高达 4.5亿美元 的里程碑付款及 royalties。截止 2025年6月30日 的现金及等价物为 1420万美元，足以支持运营至 2027年第二季度。
- Safety and tolerability profile remained favorable
- Merck-funded MK-1167 Phase 2 program ongoing
- Eligible for up to $450 million in Merck milestones plus royalties
- Cash and equivalents of $14.2M as of June 30, 2025
- Reported cash runway through Q2 2027
- AFFIRM-1 failed primary endpoint for SUDS performance-phase change
- Secondary endpoints in AFFIRM-1 showed no significant differences
- Company will discontinue the SAD program
- Immediate hold on program investment pending strategic review
Insights
Phase 3 failed to meet primary and secondary endpoints; SAD program stopped, safety profile unchanged.
Neuphoria reported that the AFFIRM-1 Phase 3 trial of BNC210 did not meet its primary endpoint on SUDS nor show statistically significant secondary endpoint differences. The company will discontinue the social anxiety disorder program and is pausing investment as part of a strategic review.
The safety and tolerability profile remained consistent with prior studies, which limits immediate safety concerns but does not alter the efficacy outcome. The decision to stop SAD work is an evidence-based response to a failed pivotal study and removes a near-term path to approval for that indication.
Watch for the company update by
Failed Phase 3 plus portfolio pause triggers strategic review; cash runway to Q2 2027 guides near-term options.
Neuphoria will evaluate all strategic options after AFFIRM-1 missed endpoints and will conserve cash immediately. The company reported
The ongoing Merck partnership remains active and could deliver up to
AFFIRM-1 trial did not meet primary endpoint or secondary endpoints
Company to conduct strategic review of portfolio and business operations
BURLINGTON, Mass., Oct. 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 announced that the AFFIRM-1 Phase 3 trial of BNC210 for the acute treatment of social anxiety disorder (SAD) did not meet its primary endpoint of change from baseline to the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale (SUDS) scores. In addition, analyses of secondary endpoints did not demonstrate statistically significant differences. The safety and tolerability profile of BNC210 continued to be favorable and was consistent with previously reported studies.
“We are grateful to the AFFIRM-1 trial participants and their families, as well as the investigators and our staff, who contributed to our SAD program over the years,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “We plan to immediately take action to conserve our cash position by holding further investment in our programs and evaluating all options for Neuphoria’s path forward through a strategic review, with the goal of maximizing value for shareholders.”
Business Update and Outlook
Based on the results from the AFFIRM-1 trial, Neuphoria will discontinue further development of its SAD program. Given previous positive data with chronic daily dosing, Neuphoria also plans to evaluate next steps for further development of BNC210 in post-traumatic stress disorder (PTSD). The company plans to conduct a full strategic review of its operations and portfolio and to provide an update by year-end.
The Company has an ongoing partnership with Merck & Co., Inc. (Merck). MK-1167, one of two positive allosteric modulator (PAM) candidates being advanced in the strategic partnership with Merck, is currently being evaluated in a Merck-led Phase 2 trial in Alzheimer’s disease. Merck is responsible for all costs of this program, and through the partnership, Neuphoria is eligible to receive up to
As of June 30, 2025, Neuphoria’s cash and cash equivalents were
About AFFIRM-1
The AFFIRM-1 Phase 3 clinical trial was a multi-center, double-blind, two-arm, parallel group, placebo-controlled trial evaluating the safety and efficacy of a single, acute dose of 225 mg of BNC210 versus placebo. Participants in the trial were randomized 1:1 to receive a single dose of 225 mg BNC210 or matched placebo. One hour after dosing, participants were introduced to a public speaking challenge and had two minutes to prepare for the speech (anticipation phase) before delivering a five-minute speech in front of a small audience (performance phase). The primary endpoint of the trial was the change from baseline to the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale (SUDS) scores. Secondary endpoints included change in SUDS score from baseline to the average of the anticipation phase, changes in the Clinical Global Impression – Severity (CGI-S) scale, self-assessment with the State Trait Anxiety Inventory (STAI-State) and the Patient Global Impression – Improvement (PGI-I) scale. A follow-up visit occurred one week after the public speaking challenge.
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’s lead drug candidate is BNC210, a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, potentially providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. In addition, Neuphoria has strategic partnerships with Merck & Co., Inc. (Merck; known as MSD outside the United States and Canada) for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions; and with Carina Biotech, to develop a legacy oncology program. MK-1167, one of two positive allosteric modulator (PAM) candidates being advanced in the partnership with Merck, is currently being evaluated in a Merck-led Phase 2 trial in Alzheimer’s disease. 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.
| FOR FURTHER INFORMATION PLEASE CONTACT: | |
| General Spyridon (Spyros) Papapetropoulos spyros@neuphoriatx.com | IR & PR Argot Partners neuphoria@argotpartners.com |
FAQ
What did Neuphoria (NEUP) announce about the AFFIRM-1 Phase 3 trial on October 20, 2025?
Will Neuphoria continue developing BNC210 for social anxiety disorder (NEUP)?
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