Kallyope Announces 2026 Strategic Priorities for Migraine and Metabolism Portfolio Based on Novel Neural Circuits Platform

Advancing elismetrep, a novel oral TRPM8 antagonist, towards pivotal studies for the acute treatment of migraine, a disease that affects 1 in 6 adults in the U.S.

Progressing K-554, a potential first-in-class non-incretin peptide for metabolic disease, to Phase 1 studies, with early data expected H2 2026

NEW YORK--(BUSINESS WIRE)--Kallyope, 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, announced the Company’s strategic priorities for 2026. Kallyope’s lead programs target previously unknown drivers of disease in neural signaling pathways.

“2026 is poised to be a transformative year for Kallyope. We recently reported positive results from a Phase 2b study of elismetrep in the acute treatment of migraine as well as our plan to initiate registrational studies and present at a key medical conference in 2026. We are working with great urgency to advance this potentially important new medicine with the opportunity to bring relief to the tens of millions of people who continue to suffer from the debilitating impact of migraines. In metabolic disease, we plan to initiate Phase 1 studies of K-554, a novel, once weekly, non-incretin approach to regulating food intake targeting biology that is distinct from, and likely complimentary to, therapies targeting GLP-1 and amylin receptors. We look forward to reporting early safety, pharmacokinetic, and pharmacodynamic data from the single-ascending dosing portion of the study from this program in H2 2026,” said Jay Galeota, CEO and President, Kallyope.

Program Updates and Anticipated 2026 Milestones:

Elismetrep – An Investigational Oral Drug for the Acute Treatment of Migraine Entering Pivotal Trials

• Elismetrep and TRPM8: Elismetrep is a first-in-class oral antagonist of Transient Receptor Potential Melastatin 8 (TRPM8), an ion channel protein that has a strong genetic association with migraine. TRPM8 is expressed on trigeminal sensory neurons involved in migraine pain signaling and represents a biological pathway distinct from those targeted by existing migraine therapies, including calcitonin gene-related peptide (CGRP) receptor antagonists.
• Positive Phase 2b Proof-of-Concept Data: In December 2025, Kallyope announced positive results from the randomized, double-blinded, placebo-controlled, Phase 2b dose-ranging study of elismetrep, with a design consistent with FDA guidance on migraine studies that analyzed performance across key measures standard for the clinical assessment of migraine medications. In the study, performance across efficacy endpoints was clinically meaningful and competitive with marketed therapies. No safety signals were observed and elismetrep was well tolerated. The large majority of reported adverse events were mild. Kallyope anticipates presenting the full data from the Phase 2b study at a major medical meeting later this year.
• Pivotal Program Expected to Begin in Mid-2026: Kallyope is planning the initiation of registrational trials by mid-2026. Initial data from the pivotal program are expected in 2027.
• Blockbuster Market Potential: The migraine market is estimated to exceed $16 billion by 2033. Currently, one in six adults in the U.S. experience migraines and only around 30% of patients achieve favorable outcomes with any particular medication used in the acute treatment of migraine. This creates a large, highly dissatisfied population that adds or switches between medications to seek relief.

K-554 – A New Mechanism of Action in Obesity with First-in-Class Potential for Robust Efficacy and Improved Tolerability

• Novel, Non-Incretin Therapy: Kallyope’s metabolic lead, K-554, is a first-in-class, once weekly injectable therapeutic candidate targeting a non-incretin peptide receptor. The undisclosed target is at the heart of a novel neural circuit involved in the regulation of feeding. K-554’s biology is distinct from the GLP-1 and amylin pathways, which are the focus of most current drug development efforts in obesity. Kallyope’s novel target is associated with non-aversive satiety signals, suggesting the potential for an attractive and differentiated tolerability profile. Kallyope is also developing an oral small molecule therapy targeting a non-incretin peptide receptor.
• First-in-Human Study and Early Safety Data are Expected in H2 2026: Preparations are underway to initiate Phase 1 first-in-human studies in mid-2026. Data from the single-ascending dosing portion of the study are expected to provide an early read on safety, tolerability and efficacy in H2 2026.
• Blockbuster Market Potential: The global obesity market is estimated to reach at least $120 billion in 2033 due to the significant and growing patient population and need for improved treatment options. Currently, approximately one in three people in the U.S. have metabolic disease or obesity, and only two million people are being treated for metabolic disease with GLP-1-based therapies, signaling an ongoing need for more convenient, cost-effective, well-tolerated mono- and combination therapies.

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 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.

Media Contact:
Ten Bridge Communications
Michael Galfetti
TBCKallyope@tenbridgecommunications.com

Investor Contact:
Kallyope
ir@kallyope.com