Lytix Biopharma presents fourth quarter and second half 2022 results

Oslo, 16 February 2023. Lytix Biopharma (“Lytix”) (Euronext Growth Oslo: LYTIX), a Norwegian immuno-oncology company, today releases its fourth quarter and second half 2022 results – Steady progress towards improving cancer treatment outcomes.

“Our molecules have a unique dual mode of action and can kill cancer cells in a way that activates a broad T-cell response that has the potential to target all cancer cells within heterogeneous tumors and thereby increase the number of patients responding to immunotherapy. We have seen very promising effects in cancer patients and are now eagerly looking forward to receiving the results from the clinical Phase II studies with our lead candidate”, says Dr. Øystein Rekdal, CEO of Lytix Biopharma.

Highlights from the fourth quarter and second half 2022 and post period events:

Business and Partnership:

• Verrica Pharmaceuticals recently completed treatment in Part 1 of their ongoing Phase II study evaluating LTX-315 in basal cell carcinoma. Part 1 has enrolled 10 patients and demonstrated a favorable safety and tolerability profile with no reported serious adverse events. Patients receiving the higher range of dosing experienced a consistent response of clinical tumor necrosis.
• Lytix Biopharma appointed Stephen Worsley as Chief Business Officer as part of the company’s strong focus on exploring commercial opportunities for its drug candidates. Stephen brings a great track record of successful deals in oncology on assets in development and is now introducing Lytix’ assets to key opinion leaders and companies within the industry.

R&D:

• Following approval of the clinical trial application (CTA) for ATLAS-IT-05 in Europe in Q3 2022, the Phase II study in the US has expanded to an additional three European countries; Norway, France and Spain. All sites are open and recruiting patients with the aim of completing enrollment by mid-2023.
• Activities are ongoing to prepare for a regulatory submission, which is required to start a Phase I study with LTX-401.
• The Clinical Study Report for ATLAS-IT-04 has been completed. ATLAS-IT-04 showed encouraging data demonstrating that LTX-315 improved the outcome of adoptive cell transfer treatment, stabilizing the disease in patients with progressive metastatic soft tissue sarcoma.

• Compelling data from Lytix’ collaboration with research groups at National Cancer Institute and Weill Cornell Medicine were presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting.

Financial:

• Total operating expenses for the six months that ended 31 December 2022 was NOK 46.4 million compared to NOK 37.8 million in the same period in 2021. Compared to the six months ending 31 December 2021, there has been an increase in activities in connection to the ongoing ATLAS-IT-05 trial in the US and EU and the preclinical development of LTX-401. The important expansion of ATLAS-IT-05 to the EU has been driving costs during this period. In parallel, personnel expenses have decreased.
• Cash position at the end of the period was NOK 94.6 million compared to NOK 197.3 million as of 31 December 2021. In addition to the cash position, Lytix has NOK 50.6 million placed in a liquidity fund as of 31 December 2022. In total Lytix has NOK 145.2 in cash and short-term financial investments at the end of the year.

Key figures (unaudited):

The full report is linked to this press release (and together with a presentation available at https://www.lytixbiopharma.com/investors/financial-reports.html).

The results will be presented in a webcast with CEO Øystein Rekdal, CDO Graeme Currie and CFO Gjest Breistein today at 14.30 CEST.

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/q06xRZSrBV

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

For more information, please contact:

Gjest Breistein, CFO: gjest.breistein@lytixbiopharma.com

Ole Peter Nordby, Head of IR & Communication Manager: ole.peter.nordby@lytixbiopharma.com

Lytix in brief:

Based in Oslo, Norway, Lytix Biopharma is a clinical stage immuno-oncology company developing novel cancer immunotherapies, an area within cancer therapy that is aimed at activating the patient’s immune system to fight cancer. The Company’s technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. Lytix Biopharma’s lead product, LTX-315, is a first-in-class oncolytic molecule representing a new and superior in situ therapeutic vaccination principle to boost anti-cancer immunity, with the potential to be the ideal combination partner with other types of immunotherapy. LTX-315 target cancer cells and disintegrate their cell membranes, causing immunogenic cell death and release of a patient’s tumor specific antigens.  This mode of action allows cytotoxic T cells to recognize, infiltrate, and attack cancer cells. The Company was listed on Euronext Growth in Oslo in June 2021, following a private placement covered by investors such as PBM Capital, a US based, healthcare-focused investment firm.