Lytix Biopharma Asa · OSL:LYTIX
Lytix Biopharma Asa — Q4 2022 Earnings Presentation
26 slides from Lytix Biopharma Asa's earnings presentation, Feb 16, 2023
Slide 1: Lytix Biopharma AS - Fourth quarter 2022 presentation
Lytix Biopharma AS Addressing the major challenge in cancer therapy Fourth quarter 2022 presentation February 16, 2022
Slide 2: Disclaimer
Disclaimer This presentation (the "Presentation") has been prepared by Lytix Biopharma AS ("Company") exclusively for information purposes. The Presentation is being made only to, and is only directed at, persons to whom such presentation may lawfully be communicated (’relevant persons’). Any person
Slide 3: Presenting team
Presenting team Øystein Rekdal / CEO and co-founder • Dr. Rekdal’s post-doctoral research forms the basis of Lytix Biopharma’s oncolytic molecule platform. • Over the last years Rekdal has been instrumental in the development of intra-tumoral therapy of LTX-315 from preclinical to clinical ‘proof of
Slide 4: Scientifically and commercially validated
Scientifically and commercially validated Unique non-viral oncolytic platform with broad pipeline opportunities Innovative pipeline that addresses major • Lead candidate; one completed challenges in cancer therapy and two ongoing Phase II studies • Tumor heterogeneity • Second generation molecule: •
Slide 5: Lytix Molecules - a new class of immuno-oncology therapies
Lytix Molecules - a new class of immuno-oncology therapies Checkpoint Cancer vaccines Oncolytic viruses Cell therapies modulators Lytix molecules • Address tumor heterogeneity • Ideal for combination with both better than conventional cancer ✓ Cell therapies and vaccines ✓ Checkpoint modulators • Ea
Slide 6: Highlights for the fourth quarter
Highlights for the fourth quarter Countries with active sites Following approval of the clinical trial application (CTA) for ATLAS-IT-05 in Europe in Q3 2022, the Phase II study has expanded from the US to an additional three European countries; Norway, France and Spain Regulatory submission enablin
Slide 7: Post-period events
Post-period events: Verrica Pharmaceuticals has completed treatment in part 1 of three parts of their ongoing Phase II study evaluating LTX-315 in basal cell carcinoma ‒ Part 1 has enrolled 10 patients and demonstrated a favorable safety and tolerability profile with no reported serious adverse even
Slide 8: Clinical/Operational update
Clinical/Operational update
Slide 9: The challenge - the heterogeneity of cancer
The challenge - the heterogeneity of cancer Failing to kill all cancer cells often leads to recurrence of even "harder to treat" tumors Therapy Recurrence Resistant cancer Therapy resistant cells and Primary tumor cancer cells new cancer cells Source: GlobalData High-Prescriber Survey, 2020
Slide 10: Our Solution with oncolytic molecules
Our Solution with oncolytic molecules ▪ Able to kill all types of cancer cells including chemotherapy-resistant cells ▪ Effective exposure of tumor antigens (mutations) from all killed cells ▪ Results in a broad T-cell response towards the tumor
Slide 11: Our solution - kill and kick-start
Our solution - kill and kick-start Oncolytic molecules Exposure of Systemic search for tumor antigens tumor cells Activation of dendritic cells (APCs) T cell A treated activation tumor Other non- treated tumors Activation of a broad repertoire of T cells that can recognize the diversity of tumor cel
Slide 12: ATLAS-IT-05 - expanding into new European sites
ATLAS-IT-05 - expanding into new European sites The clinical trial application approved under EU`s clinical trial regulation ‒ 6 sites are opened in Norway, Spain and France ‒ The sites are recognized for intratumoral immunotherapy expertise, and studies will be led by clinical teams with recognized
Slide 13: Verrica Pharmaceuticals - Phase II study in basal cell carcinoma
Verrica Pharmaceuticals - Phase II study in basal cell carcinoma (BCC) in good progress Verrica has completed treatment in part 1 of three parts of their ongoing Phase II study evaluating LTX-315 in basal cell carcinoma (BCC) Part 2 of the Phase II trial is expected to begin in the second quarter of
Slide 14: Our second-generation oncolytic molecule, LTX-401 - Moving into the clinic
Our second-generation oncolytic molecule, LTX-401 - Moving into the clinic Activities progressing as planned to submit a Clinical Trial Application in 2023 to start a Phase I study Liver cancers represent big cancer segments with a high unmet medical need and low effect with checkpoint inhibitors LT
Slide 15: Pipeline
Pipeline Product Description Indication Discovery Preclinical Phase I Phase II Phase III candidate ATLAS-IT-05 Melanoma patients Pembrolizumab progressed on (Keytruda®) checkpoint inhibitors Phase II by Verrica LTX-315 Pharmaceuticals Basal cell carcinoma (monotherapy) ATLAS-IT-04 Advanced soft tiss
Slide 16: Key figures
Key figures
Slide 17: Key figures – profit and loss
Key figures – profit and loss Unaudited Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q4 2022 Q4 2021 H2 2022 H2 2021 2022 FY 2021 Total operating income 1,615 719 4,587 2,626 17,273 25,827 Total operating expenses (25,453) (17,087) (46,368) (37,790) (82,968) (73,844) Loss from op
Slide 18: Key figures - increased activity
Key figures - increased activity 30 000 20 000 Total operating expense Direct R&D expenses 15 000 20 000 10 000 10 000 5 000 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2022 2021 2022 2021 30 000 Operating expenses 2022 Cash and short term financial investments 250 000 20 000 200 000 150 000 10 000 100 000 0 Q1 Q2
Slide 19: Key figures – balance sheet
Key figures – balance sheet Unaudited Amounts in NOK thousands 31.12.2022 31.12.2021 Assets Property, plant and equipment 124 - Trade and other receivables 6,735 5,680 Short-term financial investments 50,606 - Cash and cash equivalents 94,552 197,282 Total assets 152,017 202,962 Shareholder's equity
Slide 20: Outlook
Outlook
Slide 21: Key objectives moving forward
Key objectives moving forward Clinical development ‒ Expand the clinical impact field for LTX- LTX-315 MONOTHERAPY 315 and drive enrollment in the ATLAS-IT- Local treatment → Abscopal effect 05 Phase II trial towards completion ‒ Continue to support Verrica Pharmaceuticals’ Phase II trial with LTX-3
Slide 22: Q&A
Q&A IR enquiries: [email protected]
Slide 23: Interim Financial Statements
Interim Financial Statements
Slide 24: Condensed Interim statement of profit or loss
Condensed Interim statement of profit or loss Unaudited Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q4 2022 Q4 2021 H2 2022 H2 2021 FY 2022 FY 2021 Revenue - - 1,409 - 1,409 17 Other operating income 1,615 719 3,178 2,626 15,864 25,810 Total operating income 1,615 719 4,587 2,62
Slide 25: Condensed Interim statement of financial position
Condensed Interim statement of financial position Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands 31.03.2022 30.06.2021 30.09.2022 31.12.2022 31.12.2021 Assets Non-current assets Property, plant and equipment 35 132 137 124 - Other receivables - - - - - Total non-current assets 35 1
Slide 26: Condensed Interim statement of cash flows
Condensed Interim statement of cash flows Unaudited Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q4 2022 Q4 2021 H2 2022 H2 2021 FY 2022 FY 2021 Cash flows from operating activities Loss for the period (29,195) (16,395) (40,343) (35,301) (56,006) (48,049) Adjustments for: Depreci