Oslo, Norway, August 28, 2025 - Lytix Biopharma AS, a clinical-stage immuno-oncology company, today announced its results for the second quarter and first half of 2025.

The first half of the year has been a period of steady clinical progress and preparation. Lytix advanced across clinical, regulatory and organizational priorities, building a stronger foundation for the decisive period ahead.

-          Over the past years, we have validated Lytix technology across several cancer types and indications with strong results in a variety of patient populations. Our technology has demonstrated proof-of-concept across various skin cancers, highlighting a significant and urgent need for new treatment alternatives. The gap in today's treatment options is positioning Lytix and our drug candidates at the forefront for cancer treatment of tomorrow, said Dr. Øystein Rekdal, CEO of Lytix Biopharma.  
 

At the center of this progress is Ruxotemitide (formerly LTX-315). The program has matured with the assignment of its international nonproprietary name (INN), a successful End-of-Phase II FDA meeting for basal cell carcinoma through partner Verrica, and completion of patient treatment in the ATLAS-IT-05 trial in advanced melanoma. In parallel, enrollment is progressing in the NeoLIPA study in early-stage melanoma, with interim results expected in November 2025.

These clinical steps are complemented by a strengthened leadership team and board, reflecting Lytix's transition from clinical exploration toward late-stage development, partnering, and future commercialization.
 

-          We are moving step by step toward patients. With the completion of our advanced melanoma trial and progress in early-stage melanoma, Ruxotemitide is transitioning into earlier disease settings where therapeutic potential is greater. Alongside our partner Verrica's preparations for Phase III in basal cell carcinoma, the coming months will be a milestone-rich period for Lytix, said Rekdal.

H1 2025 highlights and developments

• Licensing partner Verrica Pharmaceuticals had a successful end-of-phase II FDA meeting for Ruxotemitide in basal cell carcinoma; alignment on advancing to Phase III
• Verrica plans to present a comprehensive update on the clinical development plan with Ruxotemitide in BCC program, including genomic and immune response data, at a scientific conference later in 2025
• Completion of patient treatment in the ATLAS-IT-05 Phase II trial in advanced melanoma, with disease control in ~40% of patients and systemic immune responses observed
• Ongoing enrollment in the NeoLIPA study in early-stage melanoma (around one third of patients treated); interim results expected November 11, 2025 at the Nordic Melanoma Meeting
• Strengthened board and executive team to support commercial readiness and partnerships
• Cash and short-term investments totaled NOK 100.3 million as of June 30, 2025
• ATLAS-IT-05 accruals reduced by NOK 10.2 million due to lower trial drug costs (non-cash adjustment)

With data updates from Verrica, interim NeoLIPA results, and Phase III preparations in basal cell carcinoma, Lytix enters the second half of 2025 with multiple upcoming catalysts and a clear path toward broader clinical impact and future commercialization.

Webcast details:

The results will be presented in a webcast with CEO Øystein Rekdal and CFO Gjest Breistein today.

Date: Thursday, August 28th, 2025

Time: 10:00 AM CEST

Questions may be submitted in advance to: post@lytixbiopharma.com

The presentation and Q&A session will be conducted in English. You can view the live event by registering here: https://channel.royalcast.com/landingpage/hegnarmedia/20250828_5/

A recording will be available after the event at: https://www.lytixbiopharma.com/financial-reports

For more information, please contact:

Gjest Breistein, CFO
+47 952 60 512
gjest.breistein@lytixbiopharma.com

About Lytix:

Based in Oslo, Norway, Lytix Biopharma is a clinical-stage biotech company with a highly novel technology based on world leading research in host-defense peptide-derived molecules. Lytix Biopharma's lead product, Ruxotemitide (formerly LTX-315), is a first-in-class oncolytic molecule representing a new principle to boost anti-cancer immunity. Lytix Biopharma has a pipeline of molecules that can work in many different cancer indications and treatment settings, both as mono- and combination therapy.