Lytix Biopharma today released 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:
• 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
• 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
• Clinical Phase II study with LTX- 315 and adoptive T-cell therapy at Herlev hospital in Denmark fully recruited

Business and partnership:
• Strategic partnership established with the US-based veterinary medicine company Aurelius Biotherapeutics for a new group of promising anti-cancer drug candidates
• 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
• Brynjar Forbergskog, Kjetil Hestdal, Jason Rieger, Marie- Louise Fjällskog and Evelina Vågesjö were appointed as new board members

Financial:
• 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
• 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 were presented in a webcast with CEO Øystein Rekdal and CFO Gjest Breistein.
A recording of the presentation is available on https://www.lytixbiopharma.com/investors/overview.html.

The report is available here.

The presentation is available here.