Lytix Biopharma Q3 2024: Positive clinical results and strategic advancements strengthen path to commercialization

19 Nov 2024 07:00 CET

Oslo, 19 November 2024. Lytix Biopharma (“Lytix”) (Euronext Growth Oslo: LYTIX),
a Norwegian immuno-oncology company dedicated to being part of tomorrow’s cancer
treatment, today releases its third quarter 2024 results. Lytix achieved
substantial progress in its clinical pipeline, progressing towards
commercialization.

“Our progress this quarter underscores Lytix’s potential to deliver
transformative treatments for cancer patients,” said Øystein Rekdal, CEO of
Lytix Biopharma. “The positive data from our ongoing studies, especially in
basal cell carcinoma and melanoma, reinforce the value of our technology. We now
have clinical results that supports our vision of making Lytix’s innovative
therapies accessible to patients worldwide.”

Lytix Biopharma’s studies are addressing patients with different types of skin
cancer diseases, basal cell carcinoma and melanoma, and its technology shows
promising features also for other large cancer indications.

Several upcoming milestones
Lytix’ lead drug candidate LTX-315 is currently studied in three ongoing phase
II studies; ATLAS-IT-05 in late-stage melanoma patients, the treatment of basal
cell carcinoma in partnership with Verrica Pharmaceuticals, and the newly
initiated study in early-stage melanoma patients at Radiumhospitalet in Norway
(NeoLipa).

“We are approaching the end of 2024 with great optimism. Looking ahead, we have
several potential value inflecting milestones coming up, including Verrica’s
end-of-phase II meeting with FDA during the 1st half of 2025 and interim results
from the NeoLIPA study in melanoma patients with a stronger immune system than
those previously treated. We’re confident this patient group will respond even
better to the unique properties of LTX-315, showcasing the strength of our
technology,” continues Rekdal.

Highlights from Q3 2024 and post-period events:
• Promising top-line results achieved in Phase II study in basal cell carcinoma
(BCC)
o An 86% overall reduction in tumor size was observed, with complete clearance
achieved in 51% of patients.
o LTX-315 demonstrates the potential as a first-line treatment option for BCC.
o The positive top-line results were presented at the 2024 Fall Clinical
Dermatology Conference (October 24-27th).

• ATLAS-IT-05 – Encouraging new interim data from 20 late-stage and heavily
pre-treated melanoma patients
o 40% of patients experienced disease control, with stabilization lasting up to
20 months.
o Sustained partial response obtained in two patients.

• The first patient has been treated in the new phase II NeoLIPA study
o This study examines the impact of Lytix’s lead drug candidate, LTX-315, in
early-stage melanoma patients.
o Melanoma, the most severe type of skin cancer with increasing global
incidence, is projected to reach a global market size of USD 11 billion by 2030.

• The new superior formulation of LTX-401 may represent a significant
advancement for Lytix’s second lead candidate.
o This new formulation of LTX-401 has demonstrated substantially improved
anticancer effects, with the added benefit of extending patent life.
o Lytix is preparing to seek scientific advice from European regulatory
authorities to strategically advance this formulation into clinical development.

• Financials
o Cash at the end of the period amounted to NOK 43.5 million. The cash runway is
expected to take Lytix into 2025.

The results will be presented in a webcast with CEO Øystein Rekdal and CFO Gjest
Breistein today at 10.30 CEST.

The presentation and subsequent Q&A session will be held in English and may be
viewed live by registering here:
https://channel.royalcast.com/landingpage/hegnarmedia/20241119_7/

A recording of the presentation will be made available on
https://www.lytixbiopharma.com/investors/financial-reports.html (after the
presentation).

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, 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

632574_Press Release - Lytix Q3 2024 - 2024-11-19.pdf
632574_2024-Q3 - Lytix Biopharma_Quarterly_Presentation_Q3.pdf