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NeuroNOS Announces Groundbreaking Research Publication by its CSO Demonstrating Mechanism of Action in Alzheimer’s Disease and Reinforcing Platform’s Strength Across Neurological Disorders

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NeuroNOS, a subsidiary of Beyond Air (NASDAQ: XAIR), announces groundbreaking research publication in Translational Psychiatry demonstrating a novel mechanism in early-stage Alzheimer's disease (AD). The study, led by CSO Prof. Haitham Amal, identifies significant disruptions in nitric oxide (NO)-related pathways and S-nitrosylation across two AD mouse models.

The research reveals the role of nitrosative stress, impaired neurotransmission, and mTOR hyperactivation, suggesting that targeted inhibition of NO production could be a promising therapeutic strategy. The company has filed five patent families and is preparing for clinical trials, with plans to initiate first-in-human autism trials in the US in 2026.

NeuroNOS's platform focuses on treating complex neurological disorders including autism, Alzheimer's, and brain cancers. The company has discovered a common link between autism and AD involving the neuronal nitric oxide synthase (nNOS) enzyme, supporting their strategy of targeting NO pathways across multiple neurological conditions.

NeuroNOS, una filiale di Beyond Air (NASDAQ: XAIR), annuncia la pubblicazione di una ricerca innovativa su Alzheimer in Translational Psychiatry che dimostra un nuovo meccanismo nella fase precoce della malattia. Lo studio, guidato dal CSO Prof. Haitham Amal, identifica significative interruzioni nei percorsi legati al monossido di azoto (NO) e nella S-nitrosilazione in due modelli murini di AD.

La ricerca rivela il ruolo dello stress nitrosativo, della trasmissione sinaptica compromessa e dell'iperattivazione di mTOR, suggerendo che l'inibizione mirata della produzione di NO potrebbe essere una strategia terapeutica promettente. L'azienda ha depositato cinque famiglie di brevetti e si sta preparando per prove cliniche, con piani per avviare i primi trial umani sull'autismo negli Stati Uniti nel 2026.

La piattaforma di NeuroNOS si concentra sul trattamento di disturbi neurologici complessi, tra cui autismo, Alzheimer e tumori cerebrali. L'azienda ha scoperto un legame comune tra autismo e AD che coinvolge l'enzima della sintasi del monossido di azoto neuronale (nNOS), supportando la loro strategia di targeting dei percorsi del NO in diverse condizioni neurologiche.

NeuroNOS, una subsidiaria de Beyond Air (NASDAQ: XAIR), anuncia la publicación de una investigación innovadora en Translational Psychiatry que demuestra un nuevo mecanismo en la etapa temprana de la enfermedad de Alzheimer (AD). El estudio, liderado por el CSO Prof. Haitham Amal, identifica interrupciones significativas en las vías relacionadas con el óxido nítrico (NO) y la S-nitrosilación en dos modelos de ratón de AD.

La investigación revela el papel del estrés nitrosativo, la neurotransmisión alterada y la hiperactivación de mTOR, sugiriendo que la inhibición dirigida de la producción de NO podría ser una estrategia terapéutica prometedora. La empresa ha presentado cinco familias de patentes y se está preparando para ensayos clínicos, con planes de iniciar ensayos en humanos sobre el autismo en EE.UU. en 2026.

La plataforma de NeuroNOS se centra en el tratamiento de trastornos neurológicos complejos, incluyendo el autismo, el Alzheimer y los cánceres cerebrales. La empresa ha descubierto un vínculo común entre el autismo y la AD que involucra la enzima sintetasa de óxido nítrico neuronal (nNOS), apoyando su estrategia de dirigir las vías de NO en múltiples condiciones neurológicas.

NeuroNOS는 Beyond Air (NASDAQ: XAIR)의 자회사로, Translational Psychiatry에 발표된 혁신적인 연구 결과를 통해 초기 단계의 알츠하이머병 (AD)에서 새로운 메커니즘을 보여줍니다. 이 연구는 CSO인 Haitham Amal 교수의 주도로 진행되었으며, 두 개의 AD 쥐 모델에서 질소 산화물 (NO) 관련 경로와 S-니트로실화에서의 중요한 교란을 확인했습니다.

연구는 질소 스트레스, 손상된 신경전달 및 mTOR의 과활성화의 역할을 밝혀내며, NO 생산의 표적 억제가 유망한 치료 전략이 될 수 있음을 시사합니다. 이 회사는 5개의 특허 가족을 출원했으며, 2026년 미국에서 인간을 대상으로 한 자폐증 임상 시험을 시작할 계획을 세우고 있습니다.

NeuroNOS의 플랫폼은 자폐증, 알츠하이머 및 뇌암을 포함한 복잡한 신경학적 장애 치료에 중점을 두고 있습니다. 이 회사는 자폐증과 AD 간의 공통 연결 고리를 발견했으며, 이는 신경성 질소 산화물 합성효소(nNOS) 효소와 관련이 있어 여러 신경학적 질환에서 NO 경로를 표적으로 삼는 전략을 지원합니다.

NeuroNOS, une filiale de Beyond Air (NASDAQ: XAIR), annonce la publication d'une recherche révolutionnaire dans Translational Psychiatry démontrant un nouveau mécanisme dans la phase précoce de la maladie d'Alzheimer (AD). L'étude, dirigée par le CSO Prof. Haitham Amal, identifie d'importantes perturbations dans les voies liées au monoxyde d'azote (NO) et la S-nitrosylation à travers deux modèles murins d'AD.

La recherche révèle le rôle du stress nitrosatif, de la neurotransmission altérée et de l'hyperactivation de mTOR, suggérant que l'inhibition ciblée de la production de NO pourrait constituer une stratégie thérapeutique prometteuse. L'entreprise a déposé cinq familles de brevets et se prépare à des essais cliniques, avec des plans pour initier des essais cliniques sur l'autisme aux États-Unis en 2026.

La plateforme de NeuroNOS se concentre sur le traitement des troubles neurologiques complexes, y compris l'autisme, Alzheimer et les cancers du cerveau. L'entreprise a découvert un lien commun entre l'autisme et l'AD impliquant l'enzyme synthase du monoxyde d'azote neuronal (nNOS), soutenant ainsi leur stratégie de ciblage des voies NO dans plusieurs conditions neurologiques.

NeuroNOS, eine Tochtergesellschaft von Beyond Air (NASDAQ: XAIR), kündigt die Veröffentlichung bahnbrechender Forschung in Translational Psychiatry an, die einen neuartigen Mechanismus in der frühen Phase der Alzheimer-Krankheit (AD) demonstriert. Die Studie, geleitet von CSO Prof. Haitham Amal, identifiziert erhebliche Störungen in den mit Stickstoffmonoxid (NO) verbundenen Signalwegen und der S-Nitrosylierung in zwei AD-Mausmodellen.

Die Forschung zeigt die Rolle von nitrosativem Stress, beeinträchtigter Neurotransmission und mTOR-Hyperaktivierung und legt nahe, dass die gezielte Hemmung der NO-Produktion eine vielversprechende therapeutische Strategie sein könnte. Das Unternehmen hat fünf Patentfamilien angemeldet und bereitet klinische Studien vor, mit dem Ziel, 2026 in den USA die ersten klinischen Studien zu Autismus zu starten.

Die Plattform von NeuroNOS konzentriert sich auf die Behandlung komplexer neurologischer Störungen, einschließlich Autismus, Alzheimer und Gehirntumoren. Das Unternehmen hat eine gemeinsame Verbindung zwischen Autismus und AD entdeckt, die das neuronale Stickstoffmonoxid-Synthase (nNOS)-Enzym betrifft, und unterstützt damit ihre Strategie, NO-Signalwege über mehrere neurologische Erkrankungen hinweg zu zielen.

Positive
  • Publication in prestigious Nature journal validates scientific approach
  • Novel mechanism discovered for early-stage Alzheimer's treatment
  • Five patent families filed protecting NO modulation platform
  • Advanced stages of formulation development and manufacturing preparation
  • Platform shows potential across multiple neurological conditions
Negative
  • Clinical trials yet to begin - earliest human trials planned for 2026
  • Operating in highly competitive brain therapeutics market
  • No current revenue-generating products

Insights

NeuroNOS's publication in Translational Psychiatry represents important scientific validation of their nitric oxide (NO) modulation platform. The research identifies disruptions in NO-related pathways as a potential mechanism in early-stage Alzheimer's disease, suggesting targeted inhibition of NO production as a therapeutic approach.

This strengthens Beyond Air's strategic positioning in the CNS space through its NeuroNOS subsidiary. The company has built intellectual property protection with five patent families while establishing manufacturing partnerships for API and formulation development. Their platform approach targeting NO pathways across multiple neurological disorders (Alzheimer's, autism, brain cancer) creates potential for pipeline diversification.

From a development perspective, the timeline targeting first-in-human autism trials in 2026 indicates we're still in early research stages with lengthy clinical development ahead. While the company cites collaborations with international partners and academic institutions, specific partnership economics or funding commitments remain undisclosed.

The Alzheimer's market represents significant unmet need (55 million patients globally with $1+ trillion economic burden), but this space has historically been challenging with numerous clinical failures. NeuroNOS's approach targeting an underlying mechanism shared across neurological conditions is scientifically intriguing but will require substantial clinical validation.

The research identifying S-nitrosylation disruptions across multiple Alzheimer's disease models represents a potentially significant contribution to our understanding of disease mechanisms. By demonstrating consistent early molecular changes in two established mouse models (P301S and 5xFAD), the work suggests nitric oxide pathway dysregulation may play a foundational role in pathogenesis.

Particularly notable is the identification of nitrosative stress, impaired neurotransmission, and mTOR hyperactivation as interrelated processes. This aligns with emerging research suggesting Alzheimer's pathology begins decades before clinical symptoms appear, highlighting the potential value of targeting these early mechanisms.

The connection drawn between Alzheimer's and autism through neuronal nitric oxide synthase (nNOS) impairment is scientifically interesting as it supports the concept of shared molecular vulnerabilities across seemingly distinct neurological conditions. However, translating these findings into effective therapeutics remains challenging given the complexity of brain disorders and the blood-brain barrier limitations.

While this research provides mechanistic insights, significant hurdles remain in developing NO-modulating therapies with sufficient specificity, safety, and brain penetration. The timeline to clinical trials (2026 for autism) reflects these challenges, and success will depend on whether the company can develop compounds that selectively target disease-related NO pathways without disrupting normal physiological functions.

BOSTON, April 01, 2025 (GLOBE NEWSWIRE) -- NeuroNOS, a pioneering biopharmaceutical company developing transformative treatments for complex neurological disorders, including Autism Spectrum Disorder (ASD), brain cancers, and Alzheimer’s disease, and a subsidiary of Beyond Air (NASDAQ: XAIR), proudly announces the publication of breakthrough research by its Chief Scientific Officer, Prof. Haitham Amal, in Translational Psychiatry, a peer-reviewed medical journal published by Nature Publishing Group. The article, which is titled, “Shared Early Molecular Mechanisms Revealed in P301S and 5xFAD Alzheimer's Disease Mouse Models,” presents compelling evidence of a novel mechanism in the early stages of Alzheimer’s disease (AD), offers new hope for the development of effective therapies for this devastating condition. A copy of the article is available on Translational Psychiatry website at (click here).

Alzheimer’s disease is one of the most common and costly neurodegenerative disorders globally, affecting over 55 million people and imposing a staggering economic burden exceeding $1 trillion annually. Beyond its financial toll, AD devastates families, progressively eroding the identity and autonomy of those afflicted. Despite decades of research, there remains no truly effective treatment capable of halting or reversing the disease’s progression.

The research discussed in the article identifies significant disruptions in nitric oxide (NO)-related pathways, particularly in S-nitrosylation, a key post-translational modification mediated by NO. The research demonstrates early and consistent molecular changes across two established AD mouse models, highlighting the role of nitrosative stress, impaired neurotransmission, and mTOR hyperactivation. Importantly, the data suggest that targeted inhibition of NO production may serve as a promising therapeutic strategy in early-stage Alzheimer’s disease.

“The results of this study validate a key component of our scientific vision,” said Prof. Amal. “We have demonstrated, for the first time, a shared mechanism in Alzheimer’s models rooted in nitric oxide dysregulation. These results strengthen our confidence in the potential of NO modulation as a therapeutic approach and further establish the robustness of our CNS drug development platform.”

“NeuroNOS is a young and radically innovative company, built to think differently and move fast,” added Amir Avniel, CEO of NeuroNOS. “In a remarkably short time, we have transitioned from scientific vision to tangible reality—decoding one of the most critical mechanisms in brain diseases and constructing a drug development platform around it. We are already in advanced stages of formulation development and manufacturing, preparing for clinical trials. The brain disease arena is in dire need of breakthroughs, and we have embraced the unique mission to lead this innovative development of brain therapeutics.”

NeuroNOS has undertaken one of the most ambitious challenges in biotechnology: building a drug development platform tailored to the most complex and underserved brain disorders, including autism, Alzheimer’s disease, and brain cancers. The company has filed five patent families protecting its novel approach and is collaborating with leading international partners for the production of active pharmaceutical ingredients and advanced formulations. These latest results in Alzheimer’s disease join the company’s recent success in autism, where compelling preclinical data were disclosed, underscoring the consistency and power of NeuroNOS’s platform. The company remains on track with its roadmap to initiate first-in-human clinical trials for autism in the United States in 2026.

In recent years, NeuroNOS has demonstrated a significant link between autism and Alzheimer’s disease, revealing a common denominator involving impairment of the neuronal nitric oxide synthase (nNOS) enzyme, which is responsible for regulating nitric oxide (NO) molecules in the brain. This discovery suggests that both conditions may share underlying molecular mechanisms, further supporting NeuroNOS’s strategy of targeting NO pathways across multiple neurological indications.

The company’s scientific team includes Nobel laureates and autism experts from top hospitals in the United States. Additionally, the Hebrew University of Jerusalem, particularly its School of Pharmacy, is a central partner in NeuroNOS’s research and development efforts, contributing to the advancement of innovative therapies for neurological disorders.

The global brain therapeutics market represents a substantial and growing opportunity. Key drivers of this growth include an aging population, increasing prevalence of neurological disorders, and significant unmet medical needs. NeuroNOS’s innovative approach positions the company to capitalize on this expanding market by addressing critical gaps in treatment options for complex brain diseases.

The success of this study follows previous preclinical breakthroughs by NeuroNOS in autism and glioblastoma models, reinforcing the versatility and power of its nitric oxide modulation platform for targeting unmet needs in the brain. The company remains focused on translating these findings into effective therapies.

About NeuroNOS

NeuroNOS is a biopharmaceutical company developing novel treatments for neurological conditions based on modulation of nitric oxide (NO) levels in the brain. Originating from the Hebrew University of Jerusalem, the company’s small-molecule drug candidates are designed for subcutaneous or oral administration. Preclinical studies have demonstrated behavioral and biological improvements in models of autism and other CNS disorders. NeuroNOS is a subsidiary of Beyond Air, Inc. (NASDAQ: XAIR).

About Beyond Air, Inc.

Beyond Air (NASDAQ: XAIR) is a commercial-stage medical device and biopharmaceutical company harnessing the power of endogenous and exogenous Nitric Oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The company has received FDA approval and CE Mark for LungFit® PH, a groundbreaking system for treating neonatal hypoxic respiratory failure. Beyond Air is also advancing additional LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia (such as COVID-19) and nontuberculous mycobacteria (NTM). Additionally, Beyond Air has partnered with The Hebrew University of Jerusalem to drive forward preclinical research into Autism Spectrum Disorder (ASD) and other neurological conditions. For more information, visit www.beyondair.net.

About the Hebrew University of Jerusalem (HUJI)
The Hebrew University of Jerusalem is Israel’s leading academic and research institution. Serving 24,000 students from 80 countries, it produces a third of Israel’s civilian research and is ranked 12th worldwide in biotechnology patent filings and commercial development. Faculty and alumni of the Hebrew University have won eight Nobel Prizes and a Fields Medal. For more information about the Hebrew University, please visit http://new.huji.ac.il/en.

About Yissum
Yissum is the technology transfer company of the Hebrew University of Jerusalem. Founded in 1964, it serves as a bridge between cutting-edge academic research and a global community of entrepreneurs, investors, and industry. Yissum’s mission is to benefit society by converting extraordinary innovations and transformational technologies into commercial solutions that address our most urgent global challenges. Yissum has registered over 11,500 patents globally, licensed over 1,140 technologies and has spun out more than 245 companies. Yissum’s business partners span the globe and include companies such as Boston Scientific, ICL, Merck and many more. For further information please visit www.yissum.co.il.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of U.S. securities laws. Such statements include, but are not limited to, expectations regarding financing, clinical trials, regulatory approvals, and commercialization. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. More detailed information about these risks is available in Beyond Air’s filings with the U.S. Securities and Exchange Commission. NeuroNOS and Beyond Air undertake no obligation to update forward-looking statements, except as required by law.

Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577


FAQ

What is the key finding of NeuroNOS's research on Alzheimer's disease (XAIR)?

The research identified disruptions in nitric oxide-related pathways and S-nitrosylation as key mechanisms in early-stage Alzheimer's, suggesting targeted NO inhibition as a potential therapeutic strategy.

When will NeuroNOS (XAIR) begin human clinical trials for autism treatment?

NeuroNOS plans to initiate first-in-human clinical trials for autism in the United States in 2026.

How many patent families has NeuroNOS (XAIR) filed for their NO modulation platform?

NeuroNOS has filed five patent families protecting their novel approach to treating neurological disorders.

What is the connection between autism and Alzheimer's discovered by NeuroNOS (XAIR)?

NeuroNOS found that both conditions share a common link involving impairment of the neuronal nitric oxide synthase (nNOS) enzyme, which regulates NO molecules in the brain.

What is the current global impact of Alzheimer's disease addressed by NeuroNOS (XAIR)?

Alzheimer's affects over 55 million people globally with an economic burden exceeding $1 trillion annually.
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