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Lytix Biopharma third quarter 2022 results

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Oslo, 17 November 2022. Lytix Biopharma (“Lytix”) (Euronext Growth Oslo: LYTIX), a Norwegian immune-oncology company, today releases its third quarter 2022 results. Highlights include regulatory approval received to expand our ATLAS-IT-05 study to three European countries and the appointment of Stephen Worsley as CBO.  

“We are very pleased to now being able to include patients from Spain, France and Norway in our Phase II study. The expansion of the site network will mitigate recruitment challenges, drive enrollment towards completion and extend the clinical impact field for LTX-315”, says CEO and Co-founder of Lytix Biopharma, Øystein Rekdal.

Highlights from the third quarter 2022:

  • LTX-315
    • Regulatory approval received to expand the ATLAS-IT-05 study to three European countries (Norway, France and Spain)
    • Verrica Pharmaceuticals is in good progress with their Phase II study in BCC, and the conclusion of part 1 of three parts is expected in Q1 2023
  • IND enabling activities required to start a Phase I study with LTX-401 is progressing as planned
  • Stephen Worsley appointed as Chief Business Officer (CBO), and he is already introducing Lytix to KOLs and companies within the industry

Post-period events:

  • Compelling data describing how LTX-315 activates dendritic cells and contributes to anti-cancer immune response was presented at the Society for Immunotherapy of Cancer (SITC)
  • Additional study sites opened in Europe to support ATLAS-IT-05 patient recruitment
  • ATLAS-IT-04 Clinical Study Report completed
    • Proof-of-concept achieved, demonstrating the clinical benefits of LTX-315 in combination with Adoptive Cell Therapy (ACT) in heavily pre-treated sarcoma patients

Financial:

  • Total operating income for Q3 2022 includes NOK 1.4 million in revenue from our licensing partner Verrica. This revenue is for sale of LTX-315 for use in Verrica’s development program. This is the first, and currently only, agreement where Lytix sells LTX-315 to a commercial party.
  • Total operating expenses for the six months that ended September 30 are in line with the same period last year, and as a clinical drug development company, R&D efforts represent the majority of our expenses.
  • A portion of the excess liquidity has been placed in a liquidity fund explaining the increase in short-term financial investments.
  • At the end of the period cash plus short-term financial investments was NOK 172 million.

    Key figures (unaudited):

    Amounts in NOK thousands UnauditedQ3 2022 UnauditedQ3 2021 UnauditedYTD 2022 UnauditedYTD 2021 FY 2021
    Total operating income 2,972 1,907 15,658 25,108 25,827
    Total operating expenses (20,915) (20,703) (57,516) (56,757) (73,844)
    Loss from operations (17,944) (18,796) (41,858) (31,649) (48,017)
    Loss for the period (11,148) (18,906) (26,812) (31,654) (48,049)
    Amounts in NOK thousands Unaudited30.09.2022 Unaudited30.09.2021 31.12.2021
    Assets
    Property, plant and equipment 137 - -
    Trade and other receivables 5,656 4,957 5,680
    Short-term financial investments 49,909 - -
    Cash and cash equivalents 121,671 209,177 197,282
    Total assets 177,374 214,134 202,962
    Shareholder's equity and liabilities
    Total equity 163,883 205,310 189,624
    Total liabilities 13,491 8,825 13,338
    Total equity and liabilities 177,374 214,134 202,962

    Government grants recognized in profit and loss, part of Other operating Income, for Q2 2022 was reported at NOK 805 thousand which was NOK 750 thousand lower than actual. The correct amount is NOK 1,555 thousand. The figures in this report are correct, but the YTD figures will therefore not be reconcilable with the H1 report without adjusting for this error.

    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://channel.royalcast.com/landingpage/hegnarmedia/20221117_4/

    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

About Lytix Biopharma AS

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 therapeutic vaccination principle to boost anti-cancer immunity, with the potential to be the ideal combination partner with other types of immunotherapies. LTX-315 targets  cancer cells and disrupts their cell membranes, causing immunogenic cell death and release of a patient's tumor specific antigens and immune-stimulating molecules. This mode of action allows cytotoxic T cells to recognize, infiltrate, and attack cancer cells.

For more information, visit www.lytixbiopharma.com.

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