Lytix Biopharma presents first half and second quarter 2023 results

Building a Phase II evidence base

Oslo, 31 August 2023. Lytix Biopharma – Lytix Biopharma AS (“Lytix”) (Euronext Growth Oslo: LYTIX), a clinical stage immuno-oncology company, today releases its first half and second quarter 2023 results.

Chief Executive Officer of Lytix Biopharma, Dr. Øystein Rekdal, commented: “We have continued to make positive progress as we build a clinical Phase II evidence base for our lead compound LTX-315. Earlier this month we received strong data from Part 1 of Verrica Pharmaceuticals’ ongoing clinical Phase II study and more recently we announced the recruitment of all 20 patients into the ATLAS-IT-05 trial. Furthermore, today we announce that a second melanoma study will commence in 1H 2024, with LTX-315 being tested in combination with pembrolizumab in a neoadjuvant Phase II setting. Given this study will include patients with earlier stage disease, we expect to see an improvement in the response rates due to patients enrolled in this study having healthier immune system.”

Highlights from the second quarter 2023, and post-period events:

• Verrica Pharmaceuticals’ positive Phase II study evaluating LTX-315 for the treatment of basal cell carcinoma (BCC):
  • Complete clearance observed in four lesions, 95% clearance in one lesion and 30% clearance in one lesion.
  • Based on the stronger than expected activity observed in patients receiving LTX-315, Verrica has decided to accelerate the clinical development of LTX-315 and to complete the entire Phase II study in H1 2024.
• ATLAS-IT-05:
  • All 20 patients have been recruited in the study.
  • Interim results from the study will be presented at the European Society for Medical Oncology (ESMO) Congress in October 2023. 
• Neoadjuvant study in earlier stage melanoma patients:
  • Lytix will support an investigator led Phase II study at Oslo University Hospital, Radiumhospitalet.
  • The study is expected to commence in H1 2024 and will enroll 27 melanoma patients.
• LTX-401:
  • Decision made to refocus resources and generate additional clinical efficacy data on LTX-315, resulting in the postponement of the start of the planned Phase I safety study with LTX-401.

Key figures (unaudited):

Profit and loss:

 Balance sheet:

CEO Øystein Rekdal, CDO Graeme Currie and CFO Gjest Breistein will host a webcast for investors and analysts today at 14.30 CEST, which will be made available within the Investors section of the Company's website: www.lytixbiopharma.com. A recording of the presentation will be made available after the event.

The presentation and subsequent Q&A session will be held in English and may be viewed live by registering here: https://forms.office.com/e/FPEmPcUjX1