Lytix Biopharma presents fourth quarter and second half 2022 results

16 Feb 2023 08:00 CET

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 with the potential to target all
cancer cells within heterogeneous tumors and thereby increasing the number of
patients responding to immunotherapy. We have seen very promising effects in
cancer patients so far and are 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.


The full report and a presentation are linked to this press release (and
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.

More information:
Access the news on Oslo Bors NewsWeb site

582616_Q4 2022_presentation.pdf
582616_Lytix Biopharma_Q4 2022 results_16 Feb 2023.pdf
582616_Q4 and 1H 2022_report.pdf