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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.


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2021-11-25 07:00:00
Oslo, 25 November 2021. Lytix Biopharma - a Norwegian immune-oncology company -
today releases its third quarter 2021 results. Highlights include opening of the
Phase II study in the US for LTX-315, a first-in-class oncolytic peptide, and
preclinical preparations for the second-generation drug-candidate LTX-401 for
intratumoral treatment of liver cancer. Post quarter, partner Verrica
Pharmaceuticals has announced it expects to initiate its Phase II trial of
LTX-315 in basal cell carcinoma in the first quarter of 2022.

"We continue to see good progression for our lead candidate LTX-315, where the
estimated timeline for the further development program indicates that we will
find LTX-315 in two separate and independent Phase II studies in US in the first
quarter of 2022. Favorable safety data received so far confirms the suitability
of LTX-401 for treatment of liver cancer, and we are planning for a clinical
Phase I trial for this candidate next year", says Dr. Øystein Rekdal, CEO of
Lytix Biopharma.

Highlights from the third quarter 2021:

Product development:
o ATLAS-IT-05, a clinical Phase II study in the US with LTX-315 and
pembrolizumab (Keytruda®) in patients with metastatic solid tumors, were
initiated in July. Screening of patients at MD Anderson Cancer Center has begun,
and late-stage negotiations with other sites are ongoing.
o Two additional patents for LTX-315 were approved in the US. The patents cover
the use of LTX-315 in combination with a chemotherapeutic agent and with the
checkpoint inhibitor ipilimumab.
o Preclinical preparations for LTX-401 as intratumoral treatment of liver cancer
is going as planned, heading for submission of an application for a clinical
Phase I study.

Business and partnership:
o Verrica Pharmaceuticals has in-licensed LTX-315 for dermatology oncology
indications and is progressing towards a Phase II study in the US with LTX-315
as treatment of basal cell carcinoma. The IND for this study was accepted by the
US Food and Drug Administration (FDA) in November 2021, and Verrica expects to
initiate the trial in the first quarter of 2022.

o Third quarter shows higher costs than the previous quarter due to increased
R&D activities
o Lytix maintains a lean organization with low overhead
o NOK 209 million in cash and cash equivalents at the end of third quarter 2021

Key figures (unaudited):

(in NOK thousands) Q3 2021 Q3 2020 YTD Q3 2021 YTD Q3 2020 FY 2020

Total operating income 1,907 3,482 25,108 4,727 6,678
Total operating expense (20,703) 18,775) (56,757) (34,453) (49,050)
Loss from operations (18,796) (15,293) (31,649) (29,726) (42,372)
Loss for the period (18,906) (15,178) (31,654) (29,597) (42,088)

Cash position at the end of the period 209,177 34,532 28,450
Trade and other receivables 4,957 5,672 4,168
Total assets 214,134 40,204 32,617
Total equity 205,310 31,633 19,889
Total liabilities 8,825 8,571 12,728
Total equity and liabilities 214,134 40,204 32,617

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 at https://forms.office.com/r/7FV1WJGZgJ

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:
Øystein Rekdal, CEO: +47 975 73 358
Gjest Breistein, CFO: +47 952 60 512

Lytix Biopharma in brief
Based in Oslo, Norway, Lytix Biopharma is a clinical stage biotech 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 targets cancer cells and disintegrates 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.