Clinically meaningful data establishes proof of concept for elismetrep as a promising therapeutic candidate for migraine and its progression into registrational studies anticipated to initiate mid-2026

Data validate novel TRPM8 migraine-associated channel blocker (MACB) and demonstrate a clinical profile competitive with leading approved therapeutics for migraine

Kallyope is a late-stage biotechnology company focused on developing innovative migraine and metabolic disease therapies for health challenges faced by hundreds of millions of people globally. Today the Company announced that it will present results from a Phase 2b dose-ranging study of its novel therapy elismetrep in an oral presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting being held April 18-22, 2026 in Chicago, IL. Elismetrep is the only TRPM8 migraine-associated channel blocker (MACB) in late-stage clinical studies for the treatment of migraine.

“Elismetrep has demonstrated the potential to become a much needed new class of migraine medication for the tens of millions of people who suffer from significant migraine symptoms, despite available treatments,” said Brett Lauring, MD, PhD, Chief Medical Officer, Kallyope. “We are looking forward to rapidly advancing registrational studies this year to bring desperately needed symptom relief to migraine patients.”

AAN Presentation Information:

• Title: TRPM8 Antagonism with Elismetrep: A Novel Approach for Treating Migraine
• Presenter: Brett Lauring, MD, PhD
• Abstract Number: 1676
• Date and Time: Wednesday, April 22^nd at 11:15 AM CT/12:15 PM ET

About Transient Receptor Potential Melastatin 8 (TRPM8)
Migraine is increasingly understood as a disorder of trigeminal sensory neuron hyperexcitability, in which trigeminal sensory pathways become sensitized, leading to sensory hypersensitivity and amplified pain signaling. TRPM8 is a polymodal sensory ion channel on a distinct subset of trigeminal sensory neurons relevant to migraine pain signaling. In the context of migraine, TRPM8 activity is associated with trigeminal sensory neuron pathway activation, contributing to pain onset and heightened, sustained pain signaling. TRPM8 is a mechanistically distinct therapeutic target from current migraine treatments, including calcitonin gene-related peptide (CGRP) receptor antagonists and serotonergic (5-HT)-based agents and is the only TRP channel with an established genetic association to migraine in genome-wide association studies.

About Elismetrep
Elismetrep (K-304) is an investigational, novel, oral, TRPM8 migraine-associated channel blocker (MACB) that is highly selective for TRPM8 versus other TRP channels. Specifically designed to block TRPM8 activity, elismetrep has been shown to reduce migraine pain. The Phase 2b dose-ranging trial for elismetrep for the acute treatment of migraine in adults demonstrated clinically meaningful efficacy that is competitive with the current leading marketed therapies. Registrational trials for elismetrep for the acute treatment of migraine are planned to initiate by mid-2026. Elismetrep is an investigational product and has not been approved by the FDA or any other regulatory agency.

About Kallyope
Kallyope is a late-stage biotechnology company focused on developing innovative migraine and metabolic therapies for health challenges faced by hundreds of millions of people globally. Kallyope’s lead programs target previously unknown drivers of disease in neural signaling pathways. The Company’s most advanced candidate, elismetrep (K-304), is poised to begin pivotal development for the acute treatment of migraine. The metabolism pipeline includes candidates against a novel target for weight loss identified and validated by the Company’s Klarity™ platform, as well as oral small molecule approaches to the highly validated amylin pathway for the treatment of obesity. Kallyope was founded by world-leading neuroscientists and continues to explore the role of neural circuits in driving disease.

For more information, visit www.kallyope.com.

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