• Enrollment currently scheduled to begin in Q1 2026
• M107 is the first potential disease-modifying drug for the treatment of gastroparesis
• M107’s mechanism of action has been shown to shift pro-inflammatory M1 macrophages towards M2 anti-inflammatory macrophages

Aclipse Therapeutics LLC (“Aclipse” or “the Company”) today announced that it has entered into a clinical collaboration and Know-How Agreement with Mayo Clinic for the Phase 2 clinical development of M107, the Company’s novel small molecule drug candidate being advanced as a potential disease modifying treatment for gastroparesis (i.e., stomach paralysis). The collaboration leverages the combined scientific and clinical expertise of both organizations to target macrophage related inflammation and seeks to address the biological cause of gastroparesis, a chronic and debilitating disease affecting stomach nerves and muscles resulting in stomach paralysis and delayed stomach emptying.

“We are proud to announce this collaboration with Mayo Clinic to bring this potential new treatment to patients,” stated Raymond K. Houck, Chief Executive Officer of Aclipse Therapeutics. Houck continued “M107 is an orally available small molecule drug with anti-inflammatory benefits and a clinically favorable safety profile that has been shown to promote increased expression of M2 macrophages and decreased expression of M1 macrophages, thereby addressing macrophage dysregulation and highlighting its disease-modifying potential in gastroparesis.”

The M107 Phase 2 study, Lobeglitazone for the treatment of idiopathic gastroparesis (the LOGAST trial), is to be conducted under the direction of Principal Investigator Dr. Pankaj Jay Pasricha, MBSS, MD, Chair, Department of Internal Medicine, Mayo Clinic Arizona. The LOGAST trial, expected to begin enrollment during the first quarter of 2026, is slated to involve approximately 10 clinical investigators at three Mayo clinical and research campuses: Rochester, MN, Phoenix, AZ, and Jacksonville, FL. The study is an investigator initiated clinical trial sponsored by Mayo Clinic and supported through a research grant from Aclipse Therapeutics.

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.

About Aclipse Therapeutics

Aclipse Therapeutics develops novel and highly differentiated immunological and anti-inflammatory therapeutics to treat life-threatening and severe diseases. Aclipse focuses on molecular pathways that regulate cellular stress, protein misfolding and inflammation in neuromuscular diseases that are strongly impacted by these molecular pathways. In addition to our M107 program, we are initiating a Phase 1 trial of M102, our NRF2 and HSF1 motor neuron protectant for the treatment of ALS (also known as Lou Gerhig’s or Motor Neuron Disease) in collaboration with the Sheffield Institute for Translational Neuroscience at the University of Sheffield, UK. For more information about Aclipse Therapeutics, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

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