NeuroNOS Secures $2.0 Million in Funding to Advance Development of an Innovative Autism Therapy
NeuroNOS, a subsidiary of Beyond Air (NASDAQ: XAIR), has secured $2 million in equity financing from private investors to advance its innovative autism therapy development. The funding will accelerate preclinical development of a small-molecule drug designed for injectable and oral treatment of children with autism.
The therapy, based on research by Prof. Haitham Amal at Hebrew University of Jerusalem, targets nitric oxide (NO) regulation in the brain. The research demonstrated elevated NO levels in children with ASD, and inhibiting NO production reversed autism-like phenotypes in multiple models. The findings have been validated in over 700 animals, human stem cell-derived neurons, and blood samples from children with autism.
NeuroNOS has partnered with a U.S.-based contract manufacturer and is in advanced stages of formulation development, initially focusing on subcutaneous injection with plans for an oral formulation. First-in-human studies are anticipated to begin in 2026.
NeuroNOS, una filiale di Beyond Air (NASDAQ: XAIR), ha ottenuto 2 milioni di dollari in finanziamenti azionari da investitori privati per far progredire lo sviluppo della sua innovativa terapia per l'autismo. Il finanziamento accelererà lo sviluppo preclinico di un farmaco a piccole molecole progettato per il trattamento iniettabile e orale dei bambini con autismo.
La terapia, basata sulla ricerca del Prof. Haitham Amal presso l'Università Ebraica di Gerusalemme, mira a regolare il monossido di azoto (NO) nel cervello. La ricerca ha dimostrato livelli elevati di NO nei bambini con ASD, e l'inibizione della produzione di NO ha invertito i fenotipi simili all'autismo in diversi modelli. I risultati sono stati convalidati in oltre 700 animali, neuroni derivati da cellule staminali umane e campioni di sangue di bambini con autismo.
NeuroNOS ha collaborato con un produttore a contratto con sede negli Stati Uniti ed è in fase avanzata di sviluppo della formulazione, concentrandosi inizialmente sull'iniezione sottocutanea con piani per una formulazione orale. Gli studi di prima-in-umano sono previsti per iniziare nel 2026.
NeuroNOS, una subsidiaria de Beyond Air (NASDAQ: XAIR), ha conseguido 2 millones de dólares en financiamiento de capital de inversores privados para avanzar en el desarrollo de su innovadora terapia para el autismo. La financiación acelerará el desarrollo preclínico de un fármaco de moléculas pequeñas diseñado para el tratamiento inyectable y oral de niños con autismo.
La terapia, basada en la investigación del Prof. Haitham Amal en la Universidad Hebrea de Jerusalén, tiene como objetivo regular el óxido nítrico (NO) en el cerebro. La investigación demostró niveles elevados de NO en niños con TEA, y la inhibición de la producción de NO invirtió fenotipos similares al autismo en múltiples modelos. Los hallazgos han sido validados en más de 700 animales, neuronas derivadas de células madre humanas y muestras de sangre de niños con autismo.
NeuroNOS se ha asociado con un fabricante por contrato con sede en EE. UU. y está en etapas avanzadas de desarrollo de formulación, centrándose inicialmente en la inyección subcutánea con planes para una formulación oral. Se anticipa que los estudios en humanos comiencen en 2026.
NeuroNOS는 Beyond Air(NASDAQ: XAIR)의 자회사로, 혁신적인 자폐증 치료 개발을 위해 개인 투자자로부터 200만 달러의 자본금을 확보했습니다. 이 자금은 자폐 아동을 위한 주사 및 경구 치료를 위해 설계된 소분자 약물의 전임상 개발을 가속화할 것입니다.
이 치료법은 예루살렘 히브리 대학교의 Haitham Amal 교수의 연구를 기반으로 하며, 뇌에서 질산화물(NO) 조절을 목표로 합니다. 연구 결과, 자폐 스펙트럼 장애(ASD) 아동에서 NO 수치가 상승했으며, NO 생산 억제가 여러 모델에서 자폐 유사 표현형을 역전시켰습니다. 이 발견은 700마리 이상의 동물, 인간 유래 줄기세포 신경세포 및 자폐 아동의 혈액 샘플에서 검증되었습니다.
NeuroNOS는 미국에 본사를 둔 계약 제조업체와 협력하고 있으며, 초기에는 피하 주사에 집중하고 경구 제형 계획을 세우고 있는 제형 개발의 고급 단계에 있습니다. 인간을 대상으로 한 연구는 2026년에 시작될 것으로 예상됩니다.
NeuroNOS, une filiale de Beyond Air (NASDAQ: XAIR), a sécurisé 2 millions de dollars de financement par actions auprès d'investisseurs privés pour faire avancer le développement de sa thérapie innovante pour l'autisme. Ce financement accélérera le développement préclinique d'un médicament à petites molécules conçu pour le traitement injectable et oral des enfants autistes.
La thérapie, basée sur les recherches du Prof. Haitham Amal à l'Université hébraïque de Jérusalem, vise à réguler le monoxyde d'azote (NO) dans le cerveau. Les recherches ont montré des niveaux élevés de NO chez les enfants atteints de TSA, et l'inhibition de la production de NO a inversé des phénotypes similaires à l'autisme dans plusieurs modèles. Les résultats ont été validés sur plus de 700 animaux, des neurones dérivés de cellules souches humaines et des échantillons de sang d'enfants autistes.
NeuroNOS a établi un partenariat avec un fabricant sous contrat basé aux États-Unis et est dans des phases avancées de développement de formulation, se concentrant initialement sur l'injection sous-cutanée avec des plans pour une formulation orale. Les études de première ligne sur l'homme devraient commencer en 2026.
NeuroNOS, eine Tochtergesellschaft von Beyond Air (NASDAQ: XAIR), hat 2 Millionen Dollar an Eigenkapitalfinanzierung von privaten Investoren gesichert, um die Entwicklung ihrer innovativen Therapie für Autismus voranzutreiben. Die Finanzierung wird die präklinische Entwicklung eines kleinen Molekülmedikaments beschleunigen, das für die injizierbare und orale Behandlung von Kindern mit Autismus entwickelt wurde.
Die Therapie basiert auf der Forschung von Prof. Haitham Amal an der Hebräischen Universität Jerusalem und zielt darauf ab, die Regulation von Stickstoffmonoxid (NO) im Gehirn zu steuern. Die Forschung hat erhöhte NO-Spiegel bei Kindern mit ASD gezeigt, und die Hemmung der NO-Produktion hat autismusähnliche Phänotypen in mehreren Modellen umgekehrt. Die Ergebnisse wurden in über 700 Tieren, aus menschlichen Stammzellen abgeleiteten Neuronen und Blutproben von autistischen Kindern validiert.
NeuroNOS hat mit einem US-amerikanischen Auftragshersteller zusammengearbeitet und befindet sich in fortgeschrittenen Phasen der Formulierungsentwicklung, wobei zunächst der Schwerpunkt auf subkutanen Injektionen liegt, mit Plänen für eine orale Formulierung. Erste Studien am Menschen werden voraussichtlich 2026 beginnen.
- Secured $2 million initial funding with potential for additional capital raise
- Advanced stage of formulation development with multiple delivery methods in development
- Strong preclinical validation across 700 animals and human stem cell samples
- Partnership with top-tier U.S. contract manufacturer established
- Human trials not starting until 2026, indicating long timeline to potential commercialization
- Additional capital needed beyond initial $2 million funding
- No FDA-approved drugs currently targeting ASD's biological mechanisms, suggesting potential regulatory challenges
Insights
The $2 million funding secured by NeuroNOS represents a modest but positive development for Beyond Air's subsidiary pipeline. While this capital injection will accelerate preclinical development of their nitric oxide-regulating autism therapy, investors should contextualize this as an early milestone in what will be a lengthy and capital-intensive development process.
The scientific approach targeting nitric oxide dysregulation in autism appears well-validated through multiple preclinical models - including three mouse models, human stem cell-derived neurons, and blood samples from children with ASD. This multi-faceted validation strategy strengthens the biological rationale but doesn't eliminate the significant translational risks inherent to CNS drug development.
Timeline expectations point to first-in-human studies in 2026, positioning this as a long-term value driver rather than near-term catalyst. The engagement of a contract manufacturer and advanced formulation work demonstrates appropriate development progression, yet the
For XAIR investors, this news confirms advancement of their subsidiary's pipeline in a high-unmet-need indication where currently no FDA-approved therapies target underlying biology. The substantial autism prevalence creates meaningful market potential, though revenue realization remains years away given the early development stage.
First-in-human studies anticipated to begin in 2026
Engaged a top tier U.S. based contract manufacturer to ensure the highest standards of quality
Currently in the advanced stages of formulation development for subcutaneous injection, with plans for an oral formulation
BOSTON, March 24, 2025 (GLOBE NEWSWIRE) -- NeuroNOS, a pioneering biopharmaceutical company focused on developing transformative treatments for Autism Spectrum Disorder (ASD) and other complex neurological conditions, including Alzheimer’s disease and brain cancers, and a subsidiary of Beyond Air (NASDAQ: XAIR), has secured an initial
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“Autism is a complex condition with limited treatment options,” added Prof. Haitham Amal, BScPharm, Ph.D., Chief Scientific Officer of NeuroNOS. “The promising preclinical data from the research completed to date have demonstrated that by addressing nitric oxide imbalances in the brain, we can create a truly novel approach to improving both behavior and underlying brain function. These positive preclinical data provide us with strong confidence in the potential for this therapy.”
The NeuroNOS drug under development stems from the innovative discoveries of Prof. Amal during his research at the School of Pharmacy at the Hebrew University of Jerusalem (HUJI) and currently a visiting professor at Harvard University. This research was published in the prestigious journal Advanced Science. His research showed that children with ASD exhibit elevated NO levels. Moreover, inhibiting NO production in neurons reversed autism-like phenotypes in ASD mouse models and in stem cell-derived neurons from children with ASD.
These findings, which are the basis for the partnership established between NeuroNOS and the Hebrew University, have been validated in over 700 animals in three mouse models, with human stem cell-derived neurons, and blood samples from children with autism, provide biological evidence of how NO dysregulation contributes to ASD. The loss of dendritic spines, particularly in brain regions associated with social behavior and cognitive development, is believed to be a key driver of the social and developmental impairments seen in children with autism.
By targeting and regulating NO levels, NeuroNOS’s drug aims to restore normal brain signaling, prevent synaptic dysfunction, and ultimately improve both behavioral and cognitive function in children with ASD.
To ensure the efficient production of its innovative drug, NeuroNOS is working with a U.S. based contract manufacturer. This partnership is instrumental in scaling production and ensuring the highest standards of quality.
In parallel, NeuroNOS is in the advanced stages of formulation development. The company is currently optimizing the drug’s delivery mechanism, with the first phase focusing on a subcutaneous (under-the-skin) injection to ensure optimal bioavailability and patient compliance. Future formulations, including an oral formulation, are also being explored to expand accessibility for pediatric patients.
The Growing Autism Prevalence and the Need for Innovative Solutions
ASD is a complex neurodevelopmental condition affecting millions of children worldwide. Many individuals with ASD experience severe social, cognitive, and developmental challenges, which can significantly impact their quality of life and ability to integrate into society. In the past 20 years, autism rates in the United States have risen dramatically, which has intensified the urgency to develop effective treatments. Despite the growing prevalence of ASD, there are currently no FDA-approved drugs that directly target the biological mechanisms underlying the condition. NeuroNOS is committed to addressing this critical gap by developing a transformative therapy aimed at improving both the behavioral and biological aspects of ASD.
About NeuroNOS
NeuroNOS is a pioneering biopharmaceutical company developing a novel drug for Autism Spectrum Disorder (ASD) and other neurological conditions. The company’s small-molecule therapy is based on a technology from the Hebrew University. It is designed for subcutaneous injection or oral administration and aims to regulate nitric oxide (NO) levels in the brain, a mechanism that has shown significant promise in preclinical studies. NeuroNOS has demonstrated that balancing NO levels can lead to both behavioral and biological improvements in animal models of autism. The company is actively advancing its preclinical research, with plans to enter a Phase 1 human clinical trial in 2026.
For more information about NeuroNOS and investment opportunities, visit https://www.neuro-nos.com or contact the company’s investor relations team (listed below).
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” concerning the expected closing date of the NeuroNOS equity financing; the anticipated use of proceeds from the equity financing; the therapeutic potential of the NO regulating therapy; and the potential impact on patients and anticipated benefits associated with the NO regulating therapy product candidate. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “anticipates,” “expects,” “intends,” “impacts,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: NeuroNOS’s ability to successfully close the larger round of equity financing; NeuroNOS’s ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials concerning the NO regulating therapy; the FDA potentially requiring additional clinical trials or data; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for the NO regulating therapy; our approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; NeuroNOS’s ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates and the NO regulating therapy product candidate; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating history and other risks identified and described in more detail in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.
Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
FAQ
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