Newleos Therapeutics Debuts with $93.5 Million Oversubscribed Series A Financing to Transform the Treatment of Neuropsychiatric Disorders through the Advancement of Novel Medicines
Newleos Therapeutics has secured a $93.5 million oversubscribed Series A financing, led by Goldman Sachs Alternatives with participation from Novo Holdings A/S, Longwood Fund, DCVC Bio, and Arkin Bio Capital. The company has in-licensed multiple clinical-stage programs from Roche to develop treatments for neuropsychiatric disorders.
The company's lead program, NTX-1955, is a first-in-class GABAA-γ1 selective positive allosteric modulator designed to treat anxiety disorders. Additional clinical-stage assets include NTX-1472 for social anxiety disorder, NTX-2001 for substance use disorders, and NTX-1511 for cognitive impairment. These programs target various receptors including V1a, TAAR1, and GABAA-α5.
The financing will support proof-of-concept clinical trials across their programs, addressing a significant unmet need in mental health conditions that affect over 60 million individuals in the US.
Newleos Therapeutics ha ottenuto un finanziamento di 93,5 milioni di dollari per la sua oversubscribed Series A, guidata da Goldman Sachs Alternatives con la partecipazione di Novo Holdings A/S, Longwood Fund, DCVC Bio e Arkin Bio Capital. L'azienda ha acquisito in licenza diversi programmi clinici da Roche per sviluppare trattamenti per disturbi neuropsichiatrici.
Il programma principale dell'azienda, NTX-1955, è un modulatore allosterico positivo selettivo per GABAA-γ1 di prima classe progettato per trattare i disturbi d'ansia. Gli ulteriori asset in fase clinica includono NTX-1472 per il disturbo d'ansia sociale, NTX-2001 per i disturbi da uso di sostanze e NTX-1511 per il deterioramento cognitivo. Questi programmi mirano a diversi recettori tra cui V1a, TAAR1 e GABAA-α5.
Il finanziamento supporterà studi clinici di prova di concetto attraverso i loro programmi, affrontando un significativo bisogno insoddisfatto nelle condizioni di salute mentale che colpiscono oltre 60 milioni di individui negli Stati Uniti.
Newleos Therapeutics ha conseguido un financiamiento de 93,5 millones de dólares en su ronda de Series A, liderada por Goldman Sachs Alternatives con la participación de Novo Holdings A/S, Longwood Fund, DCVC Bio y Arkin Bio Capital. La empresa ha licenciado múltiples programas en etapa clínica de Roche para desarrollar tratamientos para trastornos neuropsiquiátricos.
El programa principal de la empresa, NTX-1955, es un modulador alostérico positivo selectivo de GABAA-γ1 de primera clase diseñado para tratar trastornos de ansiedad. Los activos adicionales en etapa clínica incluyen NTX-1472 para el trastorno de ansiedad social, NTX-2001 para trastornos por uso de sustancias y NTX-1511 para el deterioro cognitivo. Estos programas tienen como objetivo diversos receptores, incluyendo V1a, TAAR1 y GABAA-α5.
El financiamiento apoyará ensayos clínicos de prueba de concepto a través de sus programas, abordando una necesidad insatisfecha significativa en las condiciones de salud mental que afectan a más de 60 millones de individuos en los Estados Unidos.
뉴레오스 테라퓨틱스는 골드만삭스 대체투자 부문이 주도하고 노보 홀딩스 A/S, 롱우드 펀드, DCVC 바이오 및 아킨 바이오 캐피탈이 참여한 9350만 달러의 초과 구독된 시리즈 A 자금을 확보했습니다. 이 회사는 로슈로부터 여러 임상 단계 프로그램의 라이센스를 받아 신경정신 장애 치료제를 개발하고 있습니다.
회사의 주요 프로그램인 NTX-1955는 불안 장애를 치료하기 위해 설계된 GABAA-γ1 선택적 양성 알로스테릭 조절제입니다. 추가 임상 단계 자산으로는 사회 불안 장애를 위한 NTX-1472, 물질 사용 장애를 위한 NTX-2001, 인지 장애를 위한 NTX-1511이 포함됩니다. 이 프로그램들은 V1a, TAAR1 및 GABAA-α5를 포함한 다양한 수용체를 표적으로 하고 있습니다.
이 자금은 미국에서 6000만 명 이상의 개인에게 영향을 미치는 정신 건강 상태에서 중요한 충족되지 않은 필요를 해결하기 위해 그들의 프로그램 전반에 걸쳐 개념 증명 임상 시험을 지원할 것입니다.
Newleos Therapeutics a sécurisé un financement de 93,5 millions de dollars pour sa Série A sursouscrite, dirigée par Goldman Sachs Alternatives avec la participation de Novo Holdings A/S, Longwood Fund, DCVC Bio et Arkin Bio Capital. L'entreprise a acquis sous licence plusieurs programmes en phase clinique de Roche pour développer des traitements pour les troubles neuropsychiatriques.
Le programme phare de l'entreprise, NTX-1955, est un modulateur allostérique positif sélectif de GABAA-γ1 de première classe conçu pour traiter les troubles anxieux. Les actifs supplémentaires en phase clinique comprennent NTX-1472 pour le trouble d'anxiété sociale, NTX-2001 pour les troubles liés à l'usage de substances et NTX-1511 pour le déficit cognitif. Ces programmes ciblent divers récepteurs, notamment V1a, TAAR1 et GABAA-α5.
Le financement soutiendra des essais cliniques de preuve de concept à travers leurs programmes, répondant à un besoin important non satisfait dans les conditions de santé mentale qui touchent plus de 60 millions d'individus aux États-Unis.
Newleos Therapeutics hat eine überzeichnete Series-A-Finanzierung in Höhe von 93,5 Millionen Dollar gesichert, die von Goldman Sachs Alternatives geleitet wurde, mit Beteiligung von Novo Holdings A/S, Longwood Fund, DCVC Bio und Arkin Bio Capital. Das Unternehmen hat mehrere klinische Programme von Roche lizenziert, um Behandlungen für neuropsychiatrische Störungen zu entwickeln.
Das Hauptprogramm des Unternehmens, NTX-1955, ist ein selektiver positiver allosterischer Modulator für GABAA-γ1 der ersten Klasse, der zur Behandlung von Angststörungen entwickelt wurde. Weitere klinische Vermögenswerte umfassen NTX-1472 für soziale Angststörungen, NTX-2001 für Substanzgebrauchsstörungen und NTX-1511 für kognitive Beeinträchtigungen. Diese Programme zielen auf verschiedene Rezeptoren ab, darunter V1a, TAAR1 und GABAA-α5.
Die Finanzierung wird klinische Nachweisstudien über ihre Programme hinweg unterstützen und ein erhebliches unerfülltes Bedürfnis im Bereich der psychischen Gesundheit ansprechen, das über 60 Millionen Menschen in den USA betrifft.
- Secured substantial $93.5 million Series A financing
- Multiple clinical-stage assets already licensed from Roche
- Lead program NTX-1955 has completed Phase 1 trials with positive safety profile
- Targeting large market opportunity with over 60 million affected individuals in US
- Early-stage company with no approved products
- Success-based milestone payments and royalties owed to Roche
- Operating in highly competitive neuropsychiatric drug development space
Insights
Goldman Sachs Alternatives' lead investment in Newleos Therapeutics represents a strategic move into the rapidly expanding neuropsychiatric therapeutics market, estimated to reach
The investment thesis is particularly compelling for several reasons:
- The acquisition of multiple clinical-stage assets from Roche significantly de-risks the development pathway, as these compounds have already demonstrated safety profiles and mechanism validation
- The lead program, NTX-1955, targets the GABAA-γ1 receptor with a novel mechanism that could potentially capture market share from both SSRIs and benzodiazepines, representing a
$15 billion addressable market - The portfolio approach with four clinical-stage programs diversifies risk while maintaining upside potential across multiple large market opportunities
From Goldman Sachs' perspective, this investment aligns with the growing institutional interest in mental health therapeutics, particularly as traditional treatments show limitations. The deal structure, including milestone payments and royalties to Roche, suggests a capital-efficient approach to drug development that could accelerate returns for Goldman's alternative investment portfolio.
The participation of sophisticated healthcare investors like Novo Holdings and Longwood Fund validates the investment thesis and provides strategic support for clinical development. This transaction positions Goldman Sachs to potentially capture value from both the growing mental health market and the broader trend of pharmaceutical companies increasingly sourcing innovation through biotech acquisitions.
-Newleos aims to develop first-in-class and best-in-class therapies to address the need for safer and more efficacious treatment options for major mental health conditions-
-Multiple clinical-stage programs licensed from Roche, ready for proof-of-concept studies in general anxiety, social anxiety, substance use disorders, and cognitive impairment-
-Founded by Longwood Fund and seasoned leaders in CNS drug development-
-Series A Financing led by Goldman Sachs Alternatives-
“Anxiety and substance use disorders represent some of the most prevalent neuropsychiatric indications with high unmet need, representing over 25 percent of mental illnesses in US adults and impacting over 60 million individuals,” commented David Donabedian, Ph.D., Founding CEO, Newleos and Executive Partner, Longwood Fund. “With a seasoned, founding team that has extensive company creation and CNS drug development experience, Newleos will use this capital to conduct proof-of-concept clinical trials across our programs.”
Newleos’ lead clinical program, NTX-1955 (RO7308480), is a first-in-class GABAA-γ1 selective positive allosteric modulator (PAM) designed to treat anxiety disorders with a differentiated mechanism of action without the side effects of currently available treatments. NTX-1955 was designed to specifically modulate GABAergic transmission in the anxiety brain circuit by targeting the γ1 (gamma-1) subunit-containing GABAA receptor, which is highly enriched in the amygdala. By focusing on GABAA regulation in the amygdala, NTX-1955 has the potential to reduce anxiety while sparing other brain networks associated with safety liabilities. NTX-1955 has completed a comprehensive non-clinical package and has been in Phase 1 trials, including single and multiple ascending dose studies, drug-drug interaction and receptor occupancy studies, demonstrating that it is safe, well tolerated, brain penetrant and selective to GABAA-γ1. Newleos plans to investigate NTX-1955 in proof-of-concept clinical studies for the treatment of generalized anxiety disorder.
Newleos’ additional clinical-stage assets include NTX-1472 (RO6953958), NTX-2001 (ralmitaront), and NTX-1511 (basmisanil), which target V1a, TAAR1 and GABAA-α5 receptors, respectively. NTX-1472 is a selective, brain-penetrant V1a antagonist poised to enter proof-of-concept studies targeting social anxiety disorder. A well-understood pathway, the V1a receptor is activated by arginine vasopressin (AVP), a nanopeptide structurally related to oxytocin. Preclinical studies have shown that blocking V1a reduces anxiety-like behavior in multiple animal models. NTX-2001 is a TAAR1 partial agonist, which Newleos intends to study in substance use disorders. TAAR1 activation inhibits the rewarding and reinforcing effects of drugs from different classes including psychostimulants, opioids and alcohol. NTX-1511 is a highly selective negative allosteric modulator (NAM) of the α5 (alpha-5) subunit of the GABAA receptor with the potential to address cognitive impairment in rare-neurodevelopmental indications.
The Newleos Board of Directors includes Christoph Westphal, M.D., Ph.D., Founding Executive Chairman, Newleos Therapeutics and Founding Partner, Longwood Fund; Ming Cheah, Ph.D. Vice President, within Life Sciences Investing at Goldman Sachs Alternatives; Ray Camahort, Ph.D., Partner in the Venture Investments group at Novo Holdings US; and David Donabedian, Ph.D., Executive Partner, Longwood Fund, and Founding CEO, Newleos. As part of the licensing agreement, Roche received an upfront payment and is eligible to receive success-based milestones and royalties in exchange for granting Newleos worldwide rights to the clinical stage assets.
“The Partners at Longwood Fund have long recognized that currently available treatments fall short of meeting the needs of patients with mental health conditions. A majority of anxiety patients fail to respond to first line therapy with SSRIs and SNRIs, and benzodiazepines are not recommended for long term use due to side effects such as sedation, potential for misuse and dependence, and cognitive decline,” commented Dr. Westphal. “Newleos’ portfolio of clinical stage candidates provides an exciting opportunity to advance truly differentiated medicines for some of the most prevalent indications like anxiety and substance use disorders.”
“We believe the field of neuropsychiatry is going through a period of robust innovation, with the potential to dramatically improve outcomes for patients,” commented Dr. Cheah. “We are pleased to lead the Series A for Newleos as a differentiated opportunity to invest in an attractive portfolio of clinical-stage programs that may deliver meaningful benefit to the lives of patients with underserved neuropsychiatric disorders. We look forward to partnering with the Newleos team to advance its pipeline of novel therapeutics.”
“Novo Holdings is committed to advancing innovative solutions for neurological and psychiatric conditions, a therapeutic area that urgently needs best-in-class and novel first-in-class therapies that could meaningfully improve patient outcomes,” commented Dr. Camahort. “We believe Newleos’ pipeline has the potential to advance the treatment of neuropsychiatric diseases across multiple indications and Novo Holdings is excited to support the Newleos team on this journey to bring much needed novel medicines to patients with neuropsychiatric disorders.”
About Newleos Therapeutics, Inc.
Newleos Therapeutics is dedicated to providing a new dawn or "eos" for patients with mental health conditions by developing next generation, first- and best-in-class therapies. Over 100 million patients in
About Longwood Fund
Longwood Fund is a venture capital firm dedicated to creating and investing in novel healthcare companies that develop important treatments to help patients while generating significant value for investors. The Longwood team has a long history of successfully launching and building important life science companies while providing operational leadership and strategic guidance. Collectively, the Partners at Longwood Fund have co-founded 25 companies with over 20 launched or marketed drugs and therapies, as well as over two dozen clinical stage assets, all focused on helping patients in need. Companies founded by Longwood Fund, or its principals prior to the founding of the Firm, as lead investor and CEO/CBO include Acceleron, Momenta, Alnylam, Vertex, Sirtris, TScan, Pyxis Oncology, Immunitas, Be Biopharma, Photys, Carbon Biosciences, DEM BioPharma and Solu Therapeutics. For more information, please visit www.longwoodfund.com.
About Goldman Sachs Alternatives
Goldman Sachs (NYSE: GS) is one of the leading investors in alternatives globally, with over
About Novo Holdings A/S
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S (Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth,
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Media:
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Source: Newleos Therapeutics, Inc.
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