Newleos Launches with $93.5M to Advance Neuropsychiatric Treatments
Newleos Therapeutics, Inc., a clinical-stage neuroscience company co-founded by Longwood Fund and experienced leaders in CNS drug development, has announced the successful closing of an oversubscribed $93.5 million Series A financing. This significant investment round was led by Goldman Sachs Alternatives, with participation from Novo Holdings A/S, Longwood Fund, DCVC Bio, and Arkin Bio Capital. The company’s clinical-stage pipeline, licensed from Roche, includes multiple oral small molecules aimed at addressing novel mechanisms in various neuropsychiatric disorders, such as generalized anxiety disorder, social anxiety disorder, substance use disorders, and cognitive impairment.
Neuropsychiatry is currently undergoing a transformative period of innovation, with the potential to drastically improve patient outcomes. Anxiety and substance use disorders, in particular, represent some of the most prevalent neuropsychiatric conditions, accounting for over 25% of mental illnesses in U.S. adults and affecting more than 60 million individuals. David Donabedian, Ph.D., Founding CEO of Newleos and Executive Partner at Longwood Fund, emphasized the importance of this financing, stating that the capital will be used to conduct proof-of-concept clinical trials across multiple programs. With a highly experienced team in CNS drug development, Newleos aims to create groundbreaking therapies that address significant unmet medical needs.
The lead clinical program, NTX-1955 (RO7308480), is a first-in-class GABAA-γ1 selective positive allosteric modulator (PAM) designed to treat anxiety disorders. This drug offers a unique mechanism of action, distinguishing it from existing treatments by selectively modulating GABAergic transmission in the anxiety-related brain circuit. Specifically, NTX-1955 targets the γ1 (gamma-1) subunit-containing GABAA receptor, which is highly concentrated in the amygdala. By focusing on this specific modulation, the therapy aims to alleviate anxiety without triggering the safety concerns associated with traditional medications. NTX-1955 has undergone extensive non-clinical evaluations and Phase 1 clinical trials, including single and multiple ascending dose studies, drug-drug interaction assessments, and receptor occupancy studies. These trials have demonstrated that NTX-1955 is well tolerated, brain-penetrant, and highly selective to the GABAA-γ1 receptor. Moving forward, Newleos plans to investigate this promising candidate in proof-of-concept studies for generalized anxiety disorder.
Beyond NTX-1955, Newleos boasts a robust pipeline of additional clinical-stage assets, including NTX-1472 (RO6953958), NTX-2001 (ralmitaront), and NTX-1511 (basmisanil), each targeting different neuropsychiatric disorders through distinct mechanisms of action. NTX-1472 is a selective, brain-penetrant V1a antagonist poised for proof-of-concept studies in social anxiety disorder. The V1a receptor, activated by arginine vasopressin (AVP), plays a key role in social behavior and anxiety modulation. Preclinical studies indicate that blocking V1a reduces anxiety-like behaviors in multiple animal models, highlighting its potential for treating social anxiety disorder.
Another promising candidate, NTX-2001, is a TAAR1 partial agonist that Newleos plans to develop for substance use disorders. The activation of TAAR1 has been shown to inhibit the rewarding and reinforcing effects of various drugs, including psychostimulants, opioids, and alcohol. By modulating this pathway, NTX-2001 may offer a novel approach to addressing addiction and substance abuse.
Additionally, NTX-1511 is a highly selective negative allosteric modulator (NAM) of the α5 (alpha-5) subunit of the GABAA receptor, which holds promise for treating cognitive impairment in rare neurodevelopmental disorders. By selectively targeting the α5 subunit, NTX-1511 aims to enhance cognitive function while minimizing side effects commonly associated with cognitive-enhancing drugs.
The strategic vision of Newleos is backed by a strong leadership team and an esteemed Board of Directors, including Christoph Westphal, M.D., Ph.D., Founding Executive Chairman of Newleos and Founding Partner of 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 at Longwood Fund and Founding CEO of Newleos. As part of the licensing agreement with Roche, Newleos has provided an upfront payment and agreed to milestone-based payments and royalties in exchange for global rights to the clinical-stage assets.
Dr. Westphal highlighted the urgent need for innovation in mental health treatments, noting that existing therapies often fail to meet patient needs. Many individuals with anxiety disorders do not respond to first-line treatments such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Furthermore, benzodiazepines, while effective, pose significant risks, including sedation, cognitive decline, and a high potential for misuse and dependence. Given these limitations, Newleos’ portfolio of novel therapeutics presents a valuable opportunity to redefine neuropsychiatric treatment paradigms.
The investment community has expressed strong confidence in Newleos’ potential to revolutionize neuropsychiatric care. Dr. Cheah underscored the significance of this financing, stating that the field of neuropsychiatry is undergoing substantial innovation, and Newleos represents a compelling opportunity to invest in an attractive pipeline of clinical-stage assets. He emphasized that these programs have the potential to deliver meaningful benefits to patients suffering from underserved neuropsychiatric conditions.
Similarly, Dr. Camahort from Novo Holdings reaffirmed the company’s commitment to supporting novel therapies in neurology and psychiatry. He acknowledged the pressing need for first-in-class and best-in-class treatments for neuropsychiatric diseases and expressed optimism about Newleos’ ability to advance the field. Novo Holdings’ investment reflects a shared vision of bringing much-needed innovative medicines to patients who have long been underserved by existing treatment options.
With this substantial Series A funding, Newleos is well-positioned to execute its ambitious clinical development plans and deliver groundbreaking treatments for neuropsychiatric disorders. As the company moves forward with proof-of-concept clinical trials, the potential impact of its therapies could reshape the landscape of mental health care, offering hope to millions of patients worldwide. By focusing on differentiated mechanisms of action and leveraging cutting-edge science, Newleos aims to address some of the most challenging unmet medical needs in neuropsychiatry.
