Newleos Therapeutics Raises $93.5 Million in Oversubscribed Series A to Transform Neuropsychiatric Disorder Treatments
Newleos Therapeutics, Inc., a clinical-stage neuroscience company co-founded by Longwood Fund and experienced leaders in CNS drug development, has successfully closed an oversubscribed $93.5 million Series A financing. The round was led by Goldman Sachs Alternatives, with contributions from Novo Holdings A/S, Longwood Fund, DCVC Bio, and Arkin Bio Capital. Newleos’ clinical-stage pipeline, which was in-licensed from Roche, features several oral small molecules targeting innovative mechanisms for treating a variety of conditions, including generalized anxiety, social anxiety, substance use disorders, and cognitive impairment.
Newleos Therapeutics, Inc. is an emerging biotechnology company focused on developing innovative therapies for neuropsychiatric disorders. The company has a robust clinical-stage pipeline featuring first- and best-in-class treatments for various conditions, including anxiety, social anxiety, substance use disorders, and cognitive impairment. Recently, Newleos secured a $93.5 million Series A financing, which will help advance its clinical programs and bring much-needed solutions to patients facing mental health challenges.
One of Newleos’ lead clinical programs is NTX-1955 (RO7308480), a first-in-class GABAA-γ1 selective positive allosteric modulator (PAM). NTX-1955 was designed to address anxiety disorders with a differentiated mechanism of action compared to current treatments. The drug focuses on modulating GABAergic transmission in the brain’s anxiety circuit by targeting the γ1 subunit-containing GABAA receptor, which is abundant in the amygdala, the brain region involved in regulating fear and anxiety. By specifically regulating GABAA receptors in the amygdala, NTX-1955 has the potential to reduce anxiety without affecting other brain networks that could lead to safety concerns, such as sedation or cognitive decline, which are common side effects of existing treatments.
The drug has already undergone an extensive non-clinical evaluation and is currently being studied in Phase 1 clinical trials. These trials include single and multiple ascending dose studies, drug-drug interaction assessments, and receptor occupancy studies. Preliminary results have shown that NTX-1955 is safe, well-tolerated, brain-penetrant, and selective to the GABAA-γ1 receptor. With these encouraging results, Newleos plans to advance NTX-1955 into proof-of-concept clinical studies for the treatment of generalized anxiety disorder.
Newleos’ pipeline also includes several other promising clinical-stage assets. One of these, NTX-1472 (RO6953958), is a selective V1a receptor antagonist aimed at treating social anxiety disorder. The V1a receptor is activated by arginine vasopressin (AVP), a neuropeptide that plays a significant role in social behavior and anxiety. Preclinical studies have demonstrated that blocking the V1a receptor can reduce anxiety-like behavior, making NTX-1472 a promising candidate for social anxiety treatment. This drug is expected to enter proof-of-concept studies soon.
Another asset in the pipeline is NTX-2001 (ralmitaront), a TAAR1 partial agonist that Newleos plans to study for its potential to treat substance use disorders. TAAR1 activation is known to inhibit the rewarding and reinforcing effects of drugs like psychostimulants, opioids, and alcohol, making NTX-2001 a potential breakthrough treatment for addiction.
NTX-1511 (basmisanil), a selective negative allosteric modulator (NAM) of the α5 subunit of the GABAA receptor, rounds out Newleos’ clinical-stage portfolio. This drug has the potential to address cognitive impairment, particularly in rare neurodevelopmental disorders. Cognitive decline is a common and debilitating symptom of many neuropsychiatric disorders, and NTX-1511 could provide relief to patients suffering from conditions such as fragile X syndrome or other rare neurodevelopmental diseases.
The company’s leadership team includes Christoph Westphal, M.D., Ph.D., who serves as the Founding Executive Chairman of Newleos Therapeutics and is a Founding Partner at Longwood Fund. Other key members of the board include Ming Cheah, Ph.D., Vice President at Goldman Sachs Alternatives, and Ray Camahort, Ph.D., Partner at Novo Holdings US. The Newleos team is supported by Longwood Fund, which played a crucial role in co-founding the company alongside experts Federico Bolognani, M.D., Ph.D., and William Martin, Ph.D.
Dr. Westphal commented, “We recognize that current treatments for mental health conditions, such as anxiety and substance use disorders, are inadequate. Many patients do not respond to SSRIs and SNRIs, and benzodiazepines carry significant risks. Newleos’ portfolio offers a differentiated approach to treating these disorders, potentially leading to better outcomes for patients.”
Dr. Cheah of Goldman Sachs added, “We are excited to lead the Series A funding for Newleos. The company’s pipeline presents an exciting opportunity to invest in therapies that could have a meaningful impact on underserved neuropsychiatric disorders.”
Dr. Camahort from Novo Holdings emphasized the importance of advancing innovative treatments in the field of neuropsychiatry, stating, “We believe Newleos has the potential to significantly improve outcomes for patients with neuropsychiatric conditions.”
In summary, Newleos Therapeutics is advancing a promising portfolio of novel therapeutics aimed at transforming the treatment landscape for neuropsychiatric disorders. With its clinical-stage pipeline targeting anxiety, substance use disorders, and cognitive impairment, Newleos is positioning itself to bring meaningful relief to millions of patients suffering from these conditions. The company’s focus on precision medicine and innovative drug development, backed by a strong leadership team and significant investment, sets it on a path to become a leader in the field of neuropsychiatry.
