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

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)
  • An 86% overall reduction in tumor size was observed, with complete clearance achieved in 51% of patients.
  • LTX-315 demonstrates the potential as a first-line treatment option for BCC.
  • 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
  • 40% of patients experienced disease control, with stabilization lasting up to 20 months.
  • Sustained partial response obtained in two patients.
• The first patient has been treated in the new phase II NeoLIPA study
  • This study examines the impact of Lytix's lead drug candidate, LTX-315, in early-stage melanoma patients.
  • 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.
  • This new formulation of LTX-401 has demonstrated substantially improved anticancer effects, with the added benefit of extending patent life.
  • Lytix is preparing to seek scientific advice from European regulatory authorities to strategically advance this formulation into clinical development.
• Financials
  • 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.