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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.
2021-08-27 07:00:00
Oslo, 27 August 2021. Lytix Biopharma - a Norwegian immune-oncology company -
today releases its first half and second quarter 2021 results. Highlights
include the approval and opening of clinical phase II studies in the US, a
successful financing round of NOK 225 million with subsequent listing at
Euronext Growth and a strengthening of the management team and board of
directors.

"We have reached several important milestones during the first half of the year.
Lytix Biopharma is now fueled to target the US - the world's largest market for
cancer treatment", says Dr. Øystein Rekdal, CEO of Lytix Biopharma.

The FDA's approval of Lytix Biopharma's Investigational New Drug application
(IND) for lead candidate LTX-315 in January clears a path for further clinical
development towards market approval in the US. In July the first clinical site
was opened at world-renowned MD Anderson Cancer Center in Texas.

"To kick off the clinical studies, we have strengthened the company in several
ways, through both new management executives and new board members with industry
and capital markets experience. In parallel with the studies in the US, we are
progressing with our second-generation drug candidate, LTX-401, which is
developed for treatment of deep-seated tumors, including liver cancer," says
Rekdal.

More than 800 000 people are diagnosed every year worldwide with liver cancer.
LTX-401 is in a pre-clinical development and should be ready for a Phase I
clinical trial next year.

In the first half of 2021, Lytix Biopharma received a milestone payment of NOK
19.3 million, following the exclusive worldwide agreement entered with US-based
Verrica Pharmaceuticals in August 2020. The partnership aims to develop and
commercialize LTX-315 for skin cancer diseases.

"The partnership with Verrica is a commercial validation of Lytix` technology
platform, in addition to an agreement which provides income from day 1. We
strongly believe that partnerships like this will be essential for Lytix' way to
commercializing our product candidates", he states.


Highlights for the second quarter and first half of 2021:
Product development:
o Data from a Phase I clinical trial published in Clinical Cancer Research
showing that Lytix' lead candidate LTX-315 has an acceptable safety profile, is
clinically active and enhances the number of T-cells in the majority of the
treated cancer patients
o In mid-July, Lytix announced the opening of the first clinical US site, MD
Anderson Cancer Center, in a Phase II clinical trial investigating the safety
and efficacy of intratumoral injection of LTX-315 in a combination with
pembrolizumab (Keytruda®) in patients with solid tumors
o Clinical Phase II study with LTX- 315 and adoptive T cell therapy at Herlev
hospital in Denmark fully recruited

Business and partnership:
o Strategic partnership established with the US-based veterinary medicine
company Aurelius Biotherapeutics for a new group of promising anti-cancer drug
candidates
o Gry Stensrud (former VP at Photocure) joined Lytix as Chief Technical Officer
(CTO) and Graeme Currie (former Dynavax, Regeneron, Sepracor, PDL Biopharma and
BioClin) was hired as a consultant Chief Development Officer (CDO) to lead
Lytix' clinical program
o Brynjar Forbergskog, Kjetil Hestdal, Jason Rieger, Marie- Louise Fjällskog and
Evelina Vågesjö were appointed as new board members

Financial:
o Lytix successfully completed a private placement following a national
offering, raising gross proceeds of approximately NOK 225m, through the
allocation of 12 511 893 new shares at a subscription price of NOK 18 per share
o Milestone payment of NOK 19.3m (USD 2.25m) from Verrica Pharmaceuticals
related to FDA's approval of Lytix' Investigational New Drug (IND) application
for LTX-315 in January

Key figures:
(in NOK thousands) Q2 2021 Q2 2020 H1 2021 H1 2020 FY 2020
Total operating income 1,640 1,111 23,201 1,245 6,678
Total operating expense (14,041)(9,377) (36,054)(15,678)(49,050)
Loss from operations (12,401)(8,266) (12,853)(14,433)(42,372)
Loss for the period (12,392)(8,216) (12,748)(14,419)(42,088)

Cash position at the end of the period 70,950 42,279 28,450
Trade and other receivables 162,792 5,459 4,168
Total assets 233,742 47,738 32,617
Total equity 223,030 39,863 19,889
Total liabilities 10,712 7,875 12,728
Total equity and liabilities 233,742 47,738 32,617



The results will be presented in a webcast with CEO Øystein Rekdal and CFO Gjest
Breistein today at 08.00 a.m. CEST. The presentation and subsequent Q&A session
will be held in English and may be viewed live at
https://forms.office.com/r/5WTFatrdsN

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, Chief Executive Officer: +47 975 73 358
Gjest Breistein, Chief Financial Officer: +47 952 60 512

Lytix Biopharma in brief
Based in Oslo, Norway, Lytix Biopharma is a clinical stage immune-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 peptide that has
demonstrated superior abilities to induce polyclonal t-cell responses.