Lytix Biopharma Q2/H1 2025: Preparing for a milestone-rich second half with advancing clinical programs and strengthened organization

28 Aug 2025 07:00 CEST

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.

More information:
Access the news on Oslo Bors NewsWeb site

654030_2025-H1 - Lytix Biopharma - Interim Report - IFRS - 2025-06-30 - Final.pdf
654030_Lytix Biopharma Q2 2025_Press Release - Final.pdf
654030_2025-Q2 - Lytix Biopharma - Quarterly Presentation - 2025-06-30 - Final.pdf