Neuphoria Provides a Review of 2024 and Highlights 2025 Plans
Neuphoria Therapeutics (NASDAQ: NEUP) has provided an update on its 2024 achievements and 2025 plans. The company reached significant milestones in its clinical programs, including:
The advancement of BNC210 to Phase 3 AFFIRM-1 trial for Social Anxiety Disorder (SAD), with topline results expected in Q3 2025. Additionally, Merck initiated a Phase 2 trial of MK-1167 for Alzheimer's disease treatment.
Key financial developments include receiving a US$15M milestone payment from Merck in March 2025, extending cash runway to Q3 2026. The company is eligible for up to $450M in additional milestone payments plus royalties from Merck, and AUS$117M from Carina Biotech for their partnered programs.
For 2025, Neuphoria plans to initiate a Phase 2b dose-ranging study of BNC210 in PTSD in Q4, following the SAD trial results. The company successfully re-domiciled from Australia to the United States in December 2024.
Neuphoria Therapeutics (NASDAQ: NEUP) ha fornito un aggiornamento sui risultati raggiunti nel 2024 e sui piani per il 2025. L'azienda ha raggiunto importanti traguardi nei suoi programmi clinici, tra cui:
Il passaggio di BNC210 alla fase 3 dello studio AFFIRM-1 per il Disturbo d'Ansia Sociale (SAD), con risultati preliminari attesi per il terzo trimestre 2025. Inoltre, Merck ha avviato una sperimentazione di fase 2 con MK-1167 per il trattamento dell'Alzheimer.
Tra gli sviluppi finanziari principali, la ricezione di un pagamento milestone di 15 milioni di dollari USA da Merck a marzo 2025, che estende la liquidità fino al terzo trimestre 2026. L'azienda potrà ricevere fino a 450 milioni di dollari in ulteriori pagamenti milestone più royalties da Merck, oltre a 117 milioni di dollari australiani da Carina Biotech per i programmi in collaborazione.
Per il 2025, Neuphoria prevede di avviare nel quarto trimestre uno studio di fase 2b con dosaggi variabili di BNC210 per il PTSD, a seguito dei risultati dello studio sul SAD. A dicembre 2024, l'azienda ha completato con successo il trasferimento della propria sede dall'Australia agli Stati Uniti.
Neuphoria Therapeutics (NASDAQ: NEUP) ha proporcionado una actualización sobre sus logros en 2024 y sus planes para 2025. La compañía alcanzó hitos significativos en sus programas clínicos, incluyendo:
El avance de BNC210 a la fase 3 del ensayo AFFIRM-1 para el Trastorno de Ansiedad Social (SAD), con resultados principales esperados para el tercer trimestre de 2025. Además, Merck inició un ensayo de fase 2 con MK-1167 para el tratamiento del Alzheimer.
Entre los desarrollos financieros clave, recibió un pago por hitos de 15 millones de dólares estadounidenses de Merck en marzo de 2025, extendiendo la liquidez hasta el tercer trimestre de 2026. La compañía es elegible para recibir hasta 450 millones de dólares adicionales en pagos por hitos más regalías de Merck, y 117 millones de dólares australianos de Carina Biotech por sus programas asociados.
Para 2025, Neuphoria planea iniciar un estudio de fase 2b con dosis variables de BNC210 en TEPT en el cuarto trimestre, tras los resultados del ensayo de SAD. En diciembre de 2024, la compañía completó exitosamente su traslado de Australia a Estados Unidos.
Neuphoria Therapeutics (NASDAQ: NEUP)는 2024년 성과와 2025년 계획에 대한 업데이트를 제공했습니다. 회사는 임상 프로그램에서 중요한 이정표를 달성했으며, 주요 내용은 다음과 같습니다:
BNC210을 사회불안장애(SAD) 대상 3상 AFFIRM-1 시험으로 진전시켰으며, 주요 결과는 2025년 3분기에 발표될 예정입니다. 또한, Merck는 알츠하이머 치료제 MK-1167의 2상 시험을 시작했습니다.
주요 재무 발전으로는 2025년 3월 Merck로부터 1,500만 달러의 마일스톤 지급금을 수령하여 현금 유동성이 2026년 3분기까지 연장되었습니다. 회사는 Merck로부터 최대 4억 5천만 달러의 추가 마일스톤 지급금과 로열티, 그리고 Carina Biotech로부터 공동 프로그램에 대해 호주 달러 1억 1,700만 달러를 받을 자격이 있습니다.
2025년 계획으로는 SAD 시험 결과에 이어 4분기에 PTSD 대상 BNC210의 용량 범위 2b상 시험을 시작할 예정입니다. 회사는 2024년 12월 호주에서 미국으로 본사를 성공적으로 이전했습니다.
Neuphoria Therapeutics (NASDAQ : NEUP) a communiqué une mise à jour sur ses réalisations en 2024 et ses projets pour 2025. L'entreprise a atteint des étapes importantes dans ses programmes cliniques, notamment :
La progression de BNC210 vers l'essai de phase 3 AFFIRM-1 pour le trouble d'anxiété sociale (SAD), avec des résultats préliminaires attendus au troisième trimestre 2025. Par ailleurs, Merck a lancé un essai de phase 2 de MK-1167 pour le traitement de la maladie d'Alzheimer.
Parmi les développements financiers clés, la réception d'un paiement d'étape de 15 millions de dollars US de Merck en mars 2025, prolongeant la trésorerie jusqu'au troisième trimestre 2026. L'entreprise est éligible à jusqu'à 450 millions de dollars supplémentaires en paiements d'étape ainsi qu'à des redevances de Merck, et à 117 millions de dollars australiens de Carina Biotech pour leurs programmes partenaires.
Pour 2025, Neuphoria prévoit de lancer une étude de phase 2b avec différents dosages de BNC210 dans le trouble de stress post-traumatique (PTSD) au quatrième trimestre, suite aux résultats de l'essai SAD. En décembre 2024, la société a réussi son transfert de siège de l'Australie vers les États-Unis.
Neuphoria Therapeutics (NASDAQ: NEUP) hat ein Update zu seinen Erfolgen im Jahr 2024 und den Plänen für 2025 veröffentlicht. Das Unternehmen erreichte bedeutende Meilensteine in seinen klinischen Programmen, darunter:
Den Fortschritt von BNC210 in die Phase-3-Studie AFFIRM-1 zur Behandlung der Sozialen Angststörung (SAD), mit den Topline-Ergebnissen erwartet im dritten Quartal 2025. Außerdem startete Merck eine Phase-2-Studie mit MK-1167 zur Alzheimer-Behandlung.
Wesentliche finanzielle Entwicklungen umfassen den Erhalt einer Meilensteinzahlung von 15 Mio. US-Dollar von Merck im März 2025, wodurch die Liquidität bis zum dritten Quartal 2026 verlängert wurde. Das Unternehmen hat Anspruch auf bis zu 450 Mio. US-Dollar an weiteren Meilensteinzahlungen sowie Lizenzgebühren von Merck und 117 Mio. AUD von Carina Biotech für die gemeinsamen Programme.
Für 2025 plant Neuphoria die Einleitung einer Phase-2b-Dosisfindungsstudie mit BNC210 bei PTSD im vierten Quartal, nach den Ergebnissen der SAD-Studie. Im Dezember 2024 erfolgte die erfolgreiche Verlegung des Firmensitzes von Australien in die USA.
- Received US$15M milestone payment from Merck, extending cash runway to Q3 2026
- Phase 3 AFFIRM-1 trial in SAD progressing with topline results expected Q3 2025
- Merck advanced partnered program to Phase 2 trial in Alzheimer's disease
- Eligible for up to $450M additional milestone payments plus royalties from Merck
- Successfully completed US re-domiciliation, strengthening corporate structure
- Delayed PTSD program progression, moving to additional Phase 2b study before Phase 3
- Reducing BNC210 dosage in PTSD program from 900mg to 450mg BID
- Additional capital requirements needed for continued program development
Insights
Neuphoria's pipeline is demonstrating meaningful progression with multiple clinical catalysts approaching. The advancement of their partnered α7 nicotinic acetylcholine receptor PAM (MK-1167) to Phase 2 in Alzheimer's disease by Merck represents significant external validation of their scientific approach beyond their lead candidate.
The company's lead program, BNC210, continues to show promise across multiple CNS indications. Their SAD program has reached Phase 3 with topline results expected in Q3 2025 - a major near-term catalyst. The strategic decision to pursue a lower dose (450mg BID vs 900mg BID) Phase 2b study in PTSD following extensive PK/PD analysis is particularly noteworthy, as it could potentially maintain efficacy while improving tolerability.
The publications in NEJM Evidence and Psychiatry Research provide critical peer validation of BNC210's clinical data. These are prestigious journals with rigorous review processes, suggesting the scientific community views their data favorably.
The FDA alignment on registrational pathways for both SAD and PTSD significantly de-risks their regulatory strategy. Overall, Neuphoria's pipeline demonstrates rational development planning with a disciplined approach to capital allocation by staging critical studies and leveraging partnerships to extend runway.
Neuphoria's $15M milestone payment from Merck materially strengthens their financial position, extending their cash runway to Q3 2026. This runway now covers their critical Phase 3 AFFIRM-1 readout in SAD, removing near-term financing risk during this pivotal period.
The company has structured significant potential future economics through partnerships - up to $450M in milestones plus royalties from Merck and approximately AUS$117M from Carina Biotech. These risk-sharing agreements provide capital-efficient development while maintaining significant upside.
The re-domiciliation from Australia to the US positions Neuphoria for improved access to capital markets and institutional investors. Their staged development approach for BNC210 - prioritizing the Phase 3 SAD trial before initiating the Phase 2b PTSD dose-ranging study - demonstrates disciplined capital allocation.
With multiple shots on goal across different neuropsychiatric indications and mechanisms, Neuphoria's pipeline diversification reduces binary risk typical of single-asset biotechs. The Alzheimer's program, now in Phase 2 with Merck, adds particular value given the significant market opportunity and Merck's extensive CNS development expertise and resources.
The company's current market cap of ~$9M appears disconnected from their clinical stage, partnerships, and extended cash position, suggesting potential revaluation opportunities as clinical milestones approach.
- Initiation by Merck of a Phase 2 trial in Alzheimer’s disease with partnered α7 nicotinic acetylcholine receptor PAM MK-1167 highlights company’s pipeline diversification beyond BNC210
- US
$15M milestone payment from Merck extends company’s cash runway to Q3 2026 - Phase 3 AFFIRM-1 trial of BNC210 in social anxiety disorder (SAD) is progressing as planned with topline readout anticipated in Q3 2025
- A Phase 2b dose ranging study with a lower dose of BNC210 in post-traumatic stress disorder (PTSD) is planned to follow the read-out of the Phase 3 study in social anxiety disorder SAD.
BURLINGTON, Mass., April 15, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today provided a review of 2024 and highlighted plans for 2025.
“2024 and the first quarter of 2025 were transformational for our pipeline; Our internal BNC210 program entered Ph3 in Social Anxiety Disorder with robust enrollment, and our partnered α7 nicotinic acetylcholine receptor positive allosteric modulator (PAM) program with Merck for the treatment of the symptoms of Alzheimer’s disease dementia advanced to Phase 2,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “We are now beginning a promising 2025 as we look to deploy our resources on programs that have the highest chance of providing the greatest benefit to patients and generating the greatest value to shareholders.”
Recent Highlights and 2025 Plans
Clinical Programs
- Initiated the Phase 3 AFFIRM-1 trial with 225mg BNC210 for the acute, as-needed treatment of anxiety in social anxiety disorder (SAD) in July 2024.
- The Phase 3 AFFIRM-1 trial is progressing as planned with enrollment being on-track for topline results anticipated in Q3 2025.
- Agreement with the U.S. Food and Drug Administration (FDA) on the design of BNC210’s registrational program in social anxiety disorder (SAD) has been reached during an End-of-Phase 2 (EoP2) held in Q3 2023.
- 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.
- Held a successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA) in July 2024, providing a potential registrational path for BNC210 in PTSD.
- A Phase 2b trial of BNC210 in PTSD is being planned to help identify a second (lower) dose for BNC210 further de-risking the program before progressing to Phase III while reducing short- and mid-term capital requirements to the next program milestone.
- Based on extensive pharmacokinetic and pharmacodynamic analysis of existing datasets, BNC210 450 mg BID (lower dose) is expected to provide clinically meaningful efficacy similar to that observed with 900mg BID in the ATTUNE Phase 2b trial while improving the overall safety and tolerability profile.
- The Phase 2b study in PTSD is scheduled to begin in Q4 2025, following the release of topline results from the ongoing Phase 3 AFFIRM-1 trial in social anxiety disorder (SAD).
- Published the clinically meaningful improvements seen with BNC210 across several key PTSD symptoms in NEJM Evidence in December 2024 (https://doi.org/10.1056/evidoa2400380).
- The results of the Phase 3-enabling PREVAIL Phase 2 study of BNC210 in social anxiety disorder (SAD) published in Psychiatry Research, in February 2025 (https://doi.org/10.1016/j.psychres.2025.116387).
- Initiation by Merck (known as MSD outside the United States and Canada) of a Phase 2 clinical trial to evaluate the safety and efficacy of MK-1167, a partnered α7 nicotinic acetylcholine receptor positive allosteric modulator (PAM) program, for the treatment of the symptoms of Alzheimer’s disease dementia (NCT06721156).
Corporate Highlights
- Successfully re-domiciled from Australia to the United States in December 2024.
- A private placement in May 2024 enabled the Company to continue executing its late-stage clinical programs.
- Received a milestone payment of AUS
$1M in November 2024 from Carina Biotech for BNC101, a partnered legacy oncology program.- Based on the agreement with Carina, Neuphoria is eligible to receive up to approximately AUS
$117 million in additional payments for certain development, regulatory and commercial milestones if Carina Biotech fully develops and markets the new therapy.
- Based on the agreement with Carina, Neuphoria is eligible to receive up to approximately AUS
- Received a milestone payment of US
$15M in March 2025 from Merck for our α7 nicotinic acetylcholine receptor PAM partnered CNS program enabling continuing execution of our pipeline and extending company’s runway to Q3 2026.- Under the agreement with Merck, Neuphoria is eligible to receive up to
$450M in additional milestone payments for certain development and commercial milestones associated with the progress of multiple candidates plus royalties on net sales of any licensed medicines.
- Under the agreement with Merck, Neuphoria is eligible to receive up to
Dr. Papapetropoulos concluded: “We started 2025 strong and with a focus on efficiently advancing our pipeline and increasing shareholder value through leveraging capital generated through our long-term partnerships with Merck and Carina Biotech. We look forward to sharing updates across our portfolio throughout the year.”
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
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