Post-quarter-end brought a surge of positive news for Lytix's first asset, ruxotemitide (formerly LTX-315), with two key clinical results in both neoadjuvant melanoma and basal cell carcinoma (BCC). These findings, outlined below, have prompted the company to accelerate its development plan, focusing on the fastest route to bring the groundbreaking drug to patients.

Q3 2025 highlights and developments

• Licensing partner Verrica Pharmaceuticals previously announced strong clinical results from their Phase II study with ruxotemitide, including a 97% calculated objective response rate and a 51% complete histologic clearance rate
• New data from the ongoing Phase II study was announced on November 10, 2025, at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting in National Harbor, which included:
  • Histologic assessment in non-injected lesions suggests a potential abscopal-like effect
  • A strong increase in the density of CD4+, CD8+ T-cells and B cells, all of which support a local anti-tumor response within the tumors
• On November 14, 2024, Verrica announced that the FDA confirmed alignment with their plan for the Phase 3 program to include two placebo-controlled studies, each involving approximately 100 subjects, with a primary endpoint of complete clearance assessed at week 14. Based on discussions with the FDA, Verrica expects these studies will be sufficient to support a New Drug Application (NDA) filing, with long-term follow-up studies to be conducted as post-approval commitments
• On November 11, 2025, Dr. Henrik Jespersen's team presented an interim update at the Nordic Melanoma Meeting on the Phase II NeoLIPA study
  • 44% pathological complete response (pCR) and 55% major pathological response (MPR) among the first nine evaluable patients
  • Overall pathological response seen in 88% of patients, with a favorable safety profile
  • No relapses reported to date
• Lytix is in the final stages of developing LTX-401, a proprietary asset, and is currently evaluating clinical development strategies to determine the best timing and approach for advancing into clinical trials
• Cash and short-term financial investments amounted to NOK 90 million as of September 30, 2025
• A non-cash share option expense of NOK 11.9 million related to the new option program launched in September temporarily increases the reported net loss

Ruxotemitide is advancing commercialization through two strategic avenues: our internal work on neoadjuvant melanoma via the NeoLIPA study and a close partnership with Verrica Pharmaceuticals for the non-surgical treatment of basal cell carcinoma. These dual initiatives offer near- and mid-term opportunities to create significant market value in superficial tumors.

At the same time, Lytix is expanding into deep-seated tumors with LTX-401. Backed by strong pre-clinical data and positive regulatory feedback, we are developing a strategic plan for this asset.

While Lytix is progressing ruxotemitide toward market approval, the company remains open to valuable partnerships that can speed up development, maximize the global potential of the program, and ensure patients gain access to this drug as quickly as possible. With a focused pipeline and disciplined financial management, Lytix is well-positioned for 2026.

Webcast details:

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

Date: Tuesday, November 18th, 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/20251118_1/

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