Lytix Biopharma ASA · OSL:LYTIX
Lytix Biopharma ASA — Q4 2023 Earnings Presentation
32 slides from Lytix Biopharma ASA's earnings presentation, Feb 29, 2024
Slide 1: Lytix Biopharma AS Fourth quarter 2023 presentation
Lytix Biopharma AS Promising efficacy signal in two ongoing Phase II trials Fourth quarter 2023 presentation February 29, 2024
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 Graeme Currie - CDO • Dr. Rekdal’s post-doctoral research forms the basis of Lytix • Over 30 years of drug development experience in both Biopharma’s technology platform. pharmaceutical and biotechnology companies • Over the last years Rekdal has b
Slide 4: Lytix is addressing a major challenge in cancer therapy
Lytix is addressing a major challenge in cancer therapy Each tumor has several different unique mutations making it difficult to treat Lytix’s technology overcomes this major challenge by generating broad tumor-specific immune responses in each patient 4
Slide 5: Lytix Biopharma at glance
Lytix Biopharma at glance Dedicated to being part of tomorrow’s cancer treatment Company overview Product candidates and portfolio RESULTS PRODUCT DESCRIPTION INDICATION PROGRESS EXPECTED Clinical-stage, immuno-oncology company Melanoma (mole) Atlas-IT-05 Listed and headquartered in Oslo patients Pe
Slide 6: High revenue potential for Lytix molecules
High revenue potential for Lytix molecules - monotherapy and in combination therapies - multiple cancer indications INCREASING GROWTH PROSPECTS FOR OTHER IMMUNOTHERAPIES The global market value for cancer immunotherapies has increased sharply over the past 10 years Other immuno- This growth is drive
Slide 7: Highlights for the fourth quarter
Highlights for the fourth quarter - and post-period events Verrica Pharmaceuticals’ Phase II study in basal cell carcinoma – Positive early results ‒ Verrica presented positive early results in August 2023. ‒ In January 2024, Verrica reported that all patients have been dosed with LTX-315. • This is
Slide 8: Highlights for the fourth quarter
Highlights for the fourth quarter - and post-period events Clinical results published in high profiled journal ‒ A paper entitled “LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes generate tumor specific T cells in patients with metastatic soft tissue sarcoma” published in the
Slide 9: Clinical/Operational update
Clinical/Operational update
Slide 10: Encouraging early results from Phase II study in basal cell carcinoma
Encouraging early results from Phase II study in basal cell carcinoma Part 1 ‒ Of the 6 patients treated with LTX- 315 (VP-315) at the highest dose, complete histological clearance was observed in 4 injected lesions, 95% and 30% clearance in two other injected lesions Enrollment completed January 20
Slide 11: ATLAS-IT-05: Enrollment of 20 patients completed
ATLAS-IT-05: Enrollment of 20 patients completed Recruitment of 20 patients completed August US sites 2023 Late-stage melanoma patients that have previously failed to respond to PD-(L)1 inhibitor therapy European sites Enrolled patients had failed ≤3 prior lines of treatment, including dual checkpoi
Slide 12: Promising results in a challenging patient population
12 Promising results in a challenging patient population - Disease stabilization in approximately half of the patients Interim data from all patients have been collected and analyzed ‒ Durable responses with stable Best overall response n (%) disease up to one year ‒ One partial response so far Part
Slide 13: Several patients with prolonged clinically relevant response
Several patients with prolonged clinically relevant response - Some patients still in early stage of the study 250% 004-002 200-013 200% 202-001 200-006 150% 200-014 400-001 PD 002-002 100% 001-006 201-003 301-001 50% 400-003 202-004 SD 0% 301-003 004-003 202-003 -50% 004-001 PR 200-003 001-007 -100
Slide 14: Evidence of effects in non-injected lesions
Evidence of effects in non-injected lesions A number of patients showed shrinkage of non-injected lesions ‒ Shrinkage ranging from 93% to 9% Case study ‒ 75-year-old male with Stage IVm1a melanoma (BRAF positive) ‒ Multiple metastases in lymph nodes and gluteal muscle ‒ Prior treatment: nivolumab (a
Slide 15: Responses in injected lesions
Responses in injected lesions Complete regression of lesions on a forearm • Complete regression obtained in a number of injected lesions • Injected lesions with complete regression ranging between 3-15 mm (mean diameter) Patient 400-002 14 12 Mean LPD (mm) Complete regression of lesion behind the kn
Slide 16: Summary of interim results (ATLAS-IT-05)
Summary of interim results (ATLAS-IT-05) The combination of LTX-315 and anti-PD-1 therapy (pembrolizumab) show effects in patients that have previously failed to respond to anti-PD-(L)-1 therapy Enrolled patients had generally poor prognostic factors and some patients had also failed on dual checkpo
Slide 17: LTX-315's strong ability to generate broad tumor specific T-cell responses
LTX-315`s strong ability to generate broad tumor specific T-cell responses makes it ideal for earlier-stage cancer 1. High number of T cells 2. Broad repertoire of T cells 3. Patient specific T cells Proof of principle from Before treatment previous studies 1. Infiltration of T cells in majority of
Slide 18: Planned neoadjuvant study with LTX-315 in earlier stage melanoma patients (NeoLipa)
Planned neoadjuvant study with LTX-315 in earlier stage melanoma patients (NeoLipa) LTX-315 added to the currently recommended neoadjuvant treatment (immune checkpoint inhibitor, pembrolizumab) before surgery for resectable stage III/IV melanoma Principal investigator, dr. Henrik Jespersen, Head of
Slide 19: LTX-401: optimized for deep-seated solid tumors
LTX-401: optimized for deep-seated solid tumors Robust effects in several pre-clinical cancer models, including liver cancer Safe and well tolerated in preclinical safety studies Synergy with checkpoint inhibitors High potency (can be administered in high doses and over longer time) • Small oncolyti
Slide 20: A perspective view on ATLAS-IT-05 interim data and Lytix's focus on earlier stage cancer
A perspective view on ATLAS-IT-05 interim data and Lytix`s focus on earlier stage cancer By Robert Andtbacka
Slide 21: Introduction to Dr. Robert Andtbacka
Introduction to Dr. Robert Andtbacka Internationally renowned surgical oncologist with more than over 25 years of experience in immuno-oncology clinical research and development and a highly reputed leader in melanoma and intratumoral immuno-oncology Has led over 50 clinical studies evaluating the a
Slide 22: Key figures
Key figures
Slide 23: Key figures – profit and loss
Key figures – profit and loss Unaudited Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q4 2023 Q4 2022 H2 2023 H2 2022 FY 2023 FY 2022 Total operating income 5,125 1,615 9,417 4,587 10,241 17,273 Total operating expenses (24,729) (25,453) (47,665) (46,368) (107,118) (82,968) Loss f
Slide 24: Strict cost discipline while prioritizing clinical activities
Strict cost discipline while prioritizing clinical activities 40 000 30 000 Total operating expense Direct R&D expenses 25 000 30 000 20 000 20 000 15 000 10 000 10 000 5 000 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2023 2022 2023 2022 40 000 Operating expenses 22/23 Cash and short term financial investments 200
Slide 25: Key figures – balance sheet
Key figures – balance sheet Unaudited Amounts in NOK thousands 31.12.2023 31.12.2022 Assets Property, plant and equipment 110 124 Trade and other receivables 12,777 6,735 Short-term financial investments 23,183 50,606 Cash and cash equivalents 27,365 94,552 Total assets 63,436 152,017 Shareholder's
Slide 26: Outlook
Outlook
Slide 27: Key objectives
Key objectives Clinical development ‒ ATLAS-IT-05 study • Looking forward to report additional data from the patients still in the study ‒ Verrica Pharmaceutical`s Phase II trial in BCC • Final results mid 2024 ‒ Neoadjuvant phase II study in earlier stage melanoma • Interim data H1 2025 • Represent
Slide 28: Q&A
Q&A IR enquiries: [email protected]
Slide 29: Interim Financial Statements
Interim Financial Statements
Slide 30: Condensed Interim statement of profit and loss
Condensed Interim statement of profit and loss Unaudited Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q4 2023 Q4 2022 H2 2023 H2 2022 FY 2023 FY 2022 Revenue - - 3,917 1,409 3,991 1,409 Other operating income 5,125 1,615 5,500 3,178 6,250 15,864 Total operating income 5,125 1,615
Slide 31: Condensed Interim statement of financial position
Condensed Interim statement of financial position Unaudited Unaudited Unaudited Amounts in NOK thousands 30.06.2023 30.09.2023 31.12.2023 31.12.2022 Assets Non-current assets Property, plant and equipment 144 127 110 124 Total non-current assets 144 127 110 124 Current assets Trade and other receiva
Slide 32: Condensed Interim statement of cash flows
Condensed Interim statement of cash flows Unaudited Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q4 2023 Q4 2022 H2 2023 H2 2022 FY 2023 FY 2022 Cash flows from operating activities Loss for the period (18,580) (29,195) (36,828) (40,343) (87,937) 56,006) Adjustments for: Deprecia