-Seasoned clinical and medical experts join to propel potential first- and best-in-class programs in anxiety, substance use disorders and cognitive impairment-

-Strategic corporate appointments enhance operational capabilities-

Newleos Therapeutics, Inc., a clinical-stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development, today announced the expansion of its leadership team with the appointment of experienced professionals across clinical, medical, and corporate functions.

Sondra Smyrnios has been appointed as Senior Vice President, Clinical and Technical Operations, with over 30 years of pharmaceutical industry experience in roles spanning clinical operations, data sciences, and global study execution. Adam Simmons joins as Vice President, Clinical Development and Operations, contributing his expertise in neuropharmacology, global clinical development and operational management. Additionally, Newleos welcomes Chris Jepsen as Vice President of Quality and Tiffany Lago, M.D., as Executive Medical Director, further strengthening the company’s clinical and medical leadership team.

In corporate functions, Newleos has appointed Lea Hachigian, Ph.D., as Vice President, Corporate Strategy and Operations, Kyle Audi as Vice President, Finance, and Brian Shea as Vice President, Head of Legal. These strategic hires will support the company’s ambitious growth trajectory and drive operational excellence.

"I am delighted to welcome this group of accomplished professionals to the Newleos team,” commented David Donabedian, Ph.D., Founding CEO of Newleos and Executive Partner at Longwood Fund. “Their collective experience and leadership will be instrumental as we advance what we believe are truly differentiated clinical candidates for some of the most prevalent neuropsychiatric indications, including anxiety and substance use disorders."

Newleos' lead clinical program, NTX-1955, 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 has completed a comprehensive non-clinical package as well as 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 later this year.

The company's additional clinical-stage assets include NTX-1472, NTX-2001 (ralmitaront), and NTX-1511 (basmisanil), which target V1a, TAAR1, and GABAA-α5 receptors, respectively. NTX-1472 is poised to enter proof-of-concept studies targeting social anxiety disorder, NTX-2001 is intended for studies in substance use disorders, and NTX-1511 has the potential to address cognitive impairment in rare neurodevelopmental indications.

Full biographies for Newleos’ leadership team are available on the Newleos website.

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 the United States are affected by neuropsychiatric disorders, with anxiety and substance use disorders among the largest areas of unmet medical need. The company’s clinical-stage pipeline was licensed from Roche and includes oral small molecules targeting GABA_A-γ1, V1a, TAAR1 and GABA_A-α5 with broad potential in general anxiety, social anxiety, substance use disorders and cognitive impairment. Newleos was co-founded by Longwood Fund, Federico Bolognani, M.D., Ph.D., and William Martin, Ph.D., seasoned experts in company creation and CNS drug development.

For more information visit www.newleos.com.

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