Lutris Pharma to Present Updated Data from Its Phase 2 Trial of LUT014 Gel for the Treatment of Patients With EGFRI-Induced Acneiform Rash at the EADV Congress

Lutris Pharma, a clinical stage biopharmaceutical company focused on improving the quality of life and drug adherence for patients treated with anti-cancer therapies by mitigating dermatological toxicities, today announced the presentation of updated results from its phase 2, randomized, double-blind, placebo-controlled clinical trial of lead compound LUT014. LUT014 is a novel topical B-Raf inhibitor designed to reduce or prevent worsening of dermatological toxicities caused by anti-cancer drugs that target the MAPK pathway through paradoxical MAPK reactivation. The updated clinical data will be released in an oral presentation during a Free Communications Session at the 35 th European Academy of Dermatology and Venereology (EADV) Congress, being held September 30 through October 3 in Vienna, Austria.

Presentation Title: Acneiform Rash from EGFR Inhibitor Therapy: Durable, Mechanism-Directed Reduction with Topical LUT014 (B-Raf Inhibitor) in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Presenting Author: Anisha Patel, MD, professor of Dermatology at The University of Texas MD Anderson Cancer Center, Houston, TX Abstract ID: AS-1328 Session Title: Free Communication 6: Pruritus/Adverse Drug Reactions Session Date: Friday October 2, 2026 Presentation Time: 11:25 – 11:35 am CET Session Location: Hall N

About MAPK inhibitor-Induced Rash Inhibitors of the MAP Kinase (MAPK) pathway are a class of drugs used to treat certain cancers. EGFR inhibitors are among the targeted therapies that inhibit MAPK pathway signaling. EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin and the EGFR signaling pathway is critical in regulating growth, survival, proliferation, and differentiation of cells. B-Raf is a protein that is a key regulator of the MAPK pathway. Oncogenic EGFR constitutively signals through the MAPK pathway, leading to uncontrolled cell proliferation in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers. EGFR inhibitors can block the EGFR signal responsible for cell growth and are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors lead to many adverse reactions, with the majority of patients experiencing dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014 LUT014 is a proprietary, first-in-class, novel small molecule, topical B-Raf inhibitor designed to reduce or prevent worsening of dermatological toxicities caused by anti-cancer drugs that target the MAPK pathway through paradoxical MAPK reactivation. LUT014 is formulated as a gel and designed to be applied to the affected areas of the skin. When a MAPK inhibitor that acts upstream of B-Raf is used for cancer treatment (e.g., EGFR inhibitors and RAS inhibitors), the MAPK pathway reduces or stops signaling. This causes cell death in both the cancer cells and normal cells. While the death of cancer cells is the desired effect, the death of non-cancer cells, such as those of the skin, is not desired and leads to side effects such as acneiform rash. In cells where the MAPK is inhibited, when the B-Raf protein is also inhibited, the MAPK signaling becomes reactivated. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 gel harnesses this paradoxical effect to rescue the skin cells. Due to its overwhelmingly local penetration, LUT014's activity is restricted to the skin. To date, LUT014 has shown favorable safety and clinical benefit in a completed a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor-induced acneiform ...