Lytix Biopharma Q4 2024: Solid clinical results strengthen the path to Phase III and further advancements in 2025

13 Feb 2025 08:00 CET

Lytix Biopharma today published the results for the fourth quarter of 2024. The
year ended with strong clinical results, a validated technology addressing the
major shortcomings in today’s cancer treatment alternatives, and a robust
capital base setting the stage into a pivotal 2025 for the company.

During the quarter, licensing partner Verrica Pharmaceuticals reported an
impressive 97 percent calculated objective response rate in treating patients
with basal cell carcinoma, the most common cancer type globally. This
demonstrates the strength and efficacy of LTX-315 as a potential first-line
therapy. Verrica is preparing for FDA discussions in H1 2025 to outline the path
toward a Phase III trial.

"The exceptional clinical results reinforce our confidence in LTX-315’s
potential. With growing validation from our clinical studies, Lytix Biopharma is
closer than ever to achieving a milestone few Norwegian oncology companies have
reached – advancing into Phase III trials," says Dr. Øystein Rekdal, CEO of
Lytix Biopharma.

Lytix's lead drug candidate, LTX-315, is currently being evaluated in three
Phase II studies. Alongside the Verrica-led study in BCC patients, the
ATLAS-IT-05 trial, which focuses on late-stage, heavily pre-treated patients, is
expected to conclude in H2 2025. Additionally, a new study (NeoLIPA) has
commenced at Oslo University Hospital, Radiumhospitalet, targeting early-stage
melanoma patients.

In the promising NeoLIPA study, the first melanoma patient was treated with
LTX-315 at Radiumhospitalet, Oslo in November 2024. The study evaluates LTX-315
in combination with the standard of care immune checkpoint inhibitor
(pembrolizumab) prior to surgery, in early-stage patients with a responsive
immune system.

“Melanoma patients often experience relapse following surgery when treated with
the standard of care today. Our technology arms the immune system and
complements today’s treatment options to prevent the cancer from spreading and
recurring at a later stage, in addition to kill cancer cells in the locally
treated lesions”, says Rekdal.

He continues, “Dr. Jespersen and his team at Oslo University Hospital are well
underway recruiting new patients to the study. The potential for LTX-315 in this
patient population is significant as they have a strong immune system. Being one
of the most severe cancer types, this skin cancer disease also represents a
significant commercial opportunity for Lytix. We look forward to the interim
results after the summer.”

Lytix strengthened its financial position in December, securing NOK 111 million
through a private placement and a PrimaryBid offering. This funding, backed by
strong investor support, provides a solid cash runway to advance key clinical
milestones. Cash amounts to NOK 131 million at the end of Q4.

Highlights from Q4 2024 and post-period events:

Operational
- Phase II BCC study: 97% objective response rate; Next step is Verrica’s
end-of-phase-II meeting with FDA to discuss Phase III (H1 2025)
- NeoLIPA study: Patient recruitment ongoing; targets early-stage melanoma
patients with strong immune system
- ATLAS-IT-05: 40% disease control in late-stage melanoma, with response lasting
up to 22 months; study concludes H2 2025
- LTX-401: New superior formulation with enhanced anticancer effects and
extended patent life; clinical trials planned for 2026

Business & financial
- US patent secured for LTX-315 with PD-1 inhibitors
- Successful capital raise of NOK 111m to fund key milestones
- Strengthened management team with Mette Husbyn appointed as new CTO
- Increased focus on late-stage development & partnerships

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/20250213_13/

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

638545_Lytix Biopharma Q4 2024_Press Release.pdf
638545_2024-H2 - Lytix - Interim Report - IFRS - 2024-02-13 - Final.pdf
638545_2024-Q4 - Lytix Biopharma_Quarterly_Presentation - Final.pdf