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2024-11-14 Kvartalsrapport 2024-Q3
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Beskrivning

LandNorge
ListaEuronext Growth Oslo
SektorHälsovård
IndustriBioteknik
Lytix Biopharma är ett bioteknikbolag i kliniskt stadium som utvecklar nya cancerimmunterapier. Bolagets teknik bygger på forskning inom antimikrobiella peptider, ett försvar riktade mot patogener. Lytix Biopharmas huvudprodukt, LTX-315, är en onkolytisk peptid med syftet att personalisera immunterapi. Bolaget bedriver sin forskning och verksamhet i Oslo, Norge.
2024-02-29 08:00:00
Oslo, 29 February 2024. Lytix Biopharma ("Lytix") (Euronext Growth Oslo: LYTIX),
a Norwegian immuno-oncology company dedicated to being part of tomorrow's cancer
treatment, today releases its fourth quarter and second half 2023 results.

During the fourth quarter, the company reached important clinical progress
through positive interim results from both its phase II studies on different
types of skin cancer with its lead product candidate LTX-315. Early results from
the partnership study on basal cell carcinoma (regular skin cancer) with
Nasdaq-listed Verrica Pharmaceuticals were positive, with complete clearance of
cancer cells in four out of six patients treated with the highest dose of Lytix'
LTX-315. The entire study is set to be completed in H1 2024.

"Lytix is maturing with two highly promising clinical studies approaching
conclusion, providing a solid foundation for our further clinical development.
Our unique cancer drug is injected directly into the tumor and combined with
other treatments activating the body's immune system, we are well positioned to
solve the shortcomings of today's cancer treatment. In addition, we are looking
forward to initiating a Phase II study in earlier-stage cancer patients with a
more robust immune system and a larger commercial potential", says Dr. Øystein
Rekdal, CEO of Lytix Biopharma.

Highlights from Q4 and H2 2023 and post-period events:

Partnership:
o Verrica Pharmaceuticals' Phase II study in basal cell carcinoma - Positive
early results.
o Verrica reported positive early results from Part 1 of its ongoing Phase
II trial in August 2023.
o Complete clearance of basal cell carcinoma cells in four out of
six patients treated with the highest LTX-315 dose.
o In January 2024, Verrica reported that all patients have been dosed in
their Phase II trial and that they will complete the entire study in H1 2024.

R&D:
o ATLAS-IT-05 study ongoing - Encouraging interim data from 20 melanoma
patients.
o In August, Lytix announced complete enrollment of 20 patients.
o Clinical interim data obtained from all patients.
o Disease control in approximately half of the patients with durable
responses up to one year and one patient with partial response.
o LTX-315 in combination with pembrolizumab was well tolerated.
o Expanding to earlier-stage melanoma patients with a stronger immune system
o Investigator-led neoadjuvant Phase II study at Oslo University Hospital,
Radiumhospitalet planned to start in H1 2024.
o The study protocol was presented at the 15th Nordic Melanoma Meeting in
October 2023.
o In December 2023, the clinical trial application for the NeoLIPA trial
was submitted to the regulatory authorities for approval.
o Clinical results generating attention in highly profiled journals
o Results from the ATLAS-IT-04 study were published in a paper entitled
"LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes generate
tumor-specific T cells in patients with metastatic soft tissue sarcoma". The
paper was published in OncoImmunology, a high-profile, open-access journal.
o A paper describing LTX-315 unique way of activating immune cells that
are critical for T cell priming has been accepted for publication in the high
profiled journal Frontiers of Cancer.
o Strengthening intellectual property
o Two Patent Corporation Treaty (PCT) applications were filed in December
2023 to secure additional IP protection.

Business and Financial:
o In October the Research Council of Norway approved Lytix's application for up
to NOK 14.3m (US$1.3m) of non-dilutive financial support from the 'SkatteFUNN'
R&D tax incentive scheme for a project in respect of its lead program:
'Intratumoral LTX-315 in advanced melanoma'.

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 15.00 CET. As part of the webcast, the
KOL Dr. Robert Andtbacka will share his perspective on our clinical development
program and strategy.

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/veVZgFKk2C

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

For more information, please contact:
Gjest Breistein, CFO
+47 952 60 512
gjest.breistein@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.