Lytix Biopharma Asa · OSL:LYTIX
Lytix Biopharma Asa — Q2 2024 Earnings Presentation
33 slides from Lytix Biopharma Asa's earnings presentation, Aug 29, 2024
Slide 1: Lytix Biopharma AS Q2 and H1 2024 presentation
Lytix Biopharma AS Q2 and H1 2024 presentation August 29th, 2024 Øystein Rekdal Gjest Breistein CEO, Co-founder CFO
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: Developing the future of cancer treatment
Developing the future of cancer treatment Clinical-stage, immune- Fighting cancer through Three ongoing phase II Licensing deal with Nobel prize winner in oncology company local killing of tumor cells studies in Europe and the Nasdaq-listed Verrica immune oncology developing a new class of and activ
Slide 4: Lytix's solution through two phases; killing tumors locally and activating immune response
Lytix’s solution through two phases; Killing tumors locally and activating a broad immune response systemically Directly injecting the cancer drug into the tumor Broad activation of immune cells to target remaining tumors Untreated tumor Activating the immune cells to target other, non-injected tumo
Slide 5: Highlights for the second quarter
Highlights for the second quarter - And post quarter end Verrica Pharmaceuticals’ Phase II study in basal cell carcinoma – Positive preliminary results • Positive top-line Phase II results in basal cell carcinoma (BCC)- the largest skin cancer disease globally • 86 percent overall reduction of tumor
Slide 6: Highlights for the second quarter
Highlights for the second quarter - And post quarter end A superior new formulation for LTX-401 • Could potentially represent a game-changer for Lytix’s second lead candidate • Strong effects in two “hard to treat” preclinical cancer models compared to “old” LTX-401 formulation • A PCT patent applic
Slide 7: Clinical/Operational update
Clinical/Operational update 1 Phase II study: Basal cell carcinoma (Verrica Pharmaceuticals) 2 Phase II study: Late stage melanoma (ATLAS-IT-05) 3 New phase II study: Early stage melanoma (NeoLIPA) 4 LTX-401
Slide 8: Lead drug candidate shows great potential in the largest cancer disease globally
Lytix’s lead drug candidate shows great potential in the largest cancer disease globally The skin cancer disease basal cell carcinoma is the largest cancer indication globally Lytix’s lead cancer drug is addressing this large and growing market expected to grow to USD 11.5bn in 2028 A licensing deal
Slide 9: Strong preliminary results in Phase II trial
Strong preliminary results in Phase II trial LTX-315 named VP-315 in Verrica Pharmaceuticals study KEY RESULTS SUMMARY – 90 PATIENTS 86% 51% 71% Overall reduction Complete clearance Reduction in tumor of tumor size rate of basal cell size on patients with carcinomas residual carcinomas No serious ad
Slide 10: BCC represents a multi-billion-dollar global market
BCC represents a multi-billion-dollar global market • BCC is the most common cancer (3.6 mill US cases diagnosed per year), with increasing incidence rates worldwide • More than one out of every three new cancers are skin cancers, and the vast majority are BCCs(1) • Diagnosed BCC patients have a 35%
Slide 11: LTX-315: First line treatment potential, less invasive for patients
Current treatment options are invasive LTX-315: First line treatment potential, less invasive for patients Before After BCCs are typically found in skin more exposed to the sun, with ~80% located on the face and head ~95 % of BCC patients are treated with surgery. Surgery often cause scarring that a
Slide 12: Commercially validated through partnering with Verrica Pharmaceuticals
About Verrica Pharmaceuticals Commercially validated through partnering with Verrica Pharmaceuticals → US-based (Nasdaq: VRCA) dermatology therapeutics company developing medications for skin diseases requiring THE PARTNERSHIP medical interventions → With a strong focus on addressing unmet • Verrica
Slide 13: Verrica aims to complete the Phase II study and continue VP-315 development
Verrica Pharmaceuticals aims to complete the Phase II study with a strategy of continuing the development of VP-315 Q3 Q4 Q1 H1 ‘24 ‘24 ‘25 ‘25 Database lock1 Clinical study Genomic and T- FDA End-of-Phase report cell (immune II meeting response) data2 1. Finalization of the completed data set, and
Slide 14: Clinical/Operational update: Late stage melanoma (ATLAS-IT-05)
Clinical/Operational update 2 Phase II study: Late stage melanoma (ATLAS-IT-05)
Slide 15: ATLAS-IT-05 (ongoing): Promising effects of LTX-315 in late-stage melanoma
ATLAS-IT-05 (ongoing): Promising effects of LTX-315 in heavily pre-treated patients with late-stage melanoma Complete regression in injected tumor lesions • LTX-315 and anti PD-1 inhibitor pembrolizumab are being tested in late-stage melanoma patients that have previously failed to respond to PD-(L)
Slide 16: Several patients with prolonged clinically relevant response
Several patients with prolonged clinically relevant response - Some patients still in early stage of the study PD SD PR Each line in the figure represent one patient PD: progressive disease, SD: stable disease, PR: partial response, CR; complete response 16
Slide 17: Clinical/Operational update: Early stage melanoma (NeoLIPA)
Clinical/Operational update 3 New phase II study: Early stage melanoma (NeoLIPA)
Slide 18: NeoLIPA – Expanding to earlier-stage melanoma patients
Study: NeoLIPA – Expanding to earlier-stage NeoLIPA Initiating melanoma patients with a stronger immune system Study start – Q3 2024 Study details • Encouraging results from Phase II studies in BCC and late-stage patients opens for study in earlier-stage patients • LTX-315 and pembrolizumab will be
Slide 19: Clinical/Operational update: LTX-401
Clinical/Operational update 4 LTX-401
Slide 20: LTX-401 – a small oncolytic molecule with large commercial potential
LTX-401 – a small oncolytic molecule with a large commercial potential in deep seated cancer Small molecule Small oncolytic molecule Similar mode-of-action as LTX-315 in development with superior effects in liver cancer models • Increased commercial interest with a clinical Significant commercial va
Slide 21: Superior efficacy with LTX-401 in new formulation
Superior efficacy with LTX-401 in new formulation compared to “old” LTX-401 in «hard to treat» cancer models Improved survival with LTX-401 new formulation 100% survival with LTX-401 new formulation Control 100 Acetate buff LTX-401 90 100 Control LTX-401 Alt. formulation Chitosan (0/ Acetate buffer
Slide 22: Key figures
Key figures DC lytix
Slide 23: Key figures – profit and loss
Key figures – profit and loss Unaudited Unaudited Amounts in NOK thousands Q2 2024 Q2 2023 FY 2023 Total operating income - 74 3,991 Total operating expenses (21,540) (34,209) (100,776) Loss from operations (21,540) (34,135) (96,785) Loss for the period (21,435) (31,427) (87,897) • Total operating e
Slide 24: Maintaining strict cost control while prioritizing clinical activities
Maintaining strict cost control 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 2024 2023 2024 2023 Operating expenses/Direct R&D expenses for Q1 2024 on this slide is
Slide 25: Key figures – balance sheet
Key figures – balance sheet Unaudited Unaudited Amounts in NOK thousands 30.06.2024 30.06.2023 31.12.2023 Assets Property, plant and equipment 76 144 110 Right-of-use assets 2,998 888 438 Trade and other receivables 14,410 5,959 12,777 Short-term financial investments - 41,961 23,183 Cash and cash e
Slide 26: Outlook
Outlook DC lytix
Slide 27: Clinical roadmap: Exciting times ahead
Clinical roadmap: Exiting times ahead Product candidate Study/partner Indication Discovery Phase I Phase II Phase III Next milestones Melanoma patients progressed on Interim data H2 2024 ATLAS-IT-05 checkpoint inhibitors Phase II in progress Final data H1 2026 In combination with Keytruda® Verrica F
Slide 28: Executing on our strategy – upcoming events
Executing on our strategy – upcoming events Verrica - BCC ‒ Clinical Study Report (Q4 2024) ‒ Analysis of Immune responses (Q1 2025) ‒ FDA- End of Phase 2 meeting (H1 2025) Lytix Clinical Development ‒ Initiation of NeoLIPA study (Q3 2024) ‒ Interim results from NeoLIPA (2025) ‒ LTX-401 meeting with
Slide 29: Q&A
Q&A IR enquiries: [email protected]
Slide 30: Interim Financial Statements
Interim Financial Statements
Slide 31: Condensed interim statement of comprehensive income
Condensed interim statement of comprehensive income Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q2 2024 Q2 2023 H1 2024 H2 2023 FY 2023 Revenue - 74 10,526 74 3,991 Total operating income - 74 - 74 3,991 Payroll and related expenses (4,715) (7,417) (10,378) (12,557) (24,344) Dep
Slide 32: Condensed interim statement of financial position
Condensed interim statement of financial position Unaudited Unaudited Amounts in NOK thousands 30.06.2024 30.06.2023 31.12.2023 Assets Non-current assets Property, plant and equipment 76 144 110 Right-of-use assets 2,998 888 438 Total non-current assets 3,074 1,032 548 Current assets Trade and other
Slide 33: Condensed interim statement of cash flows
Condensed Interim statement of cash flows Unaudited Unaudited Unaudited Unaudited Amounts in NOK thousands Q2 2024 Q2 2023 H1 2024 H12023 FY 2023 Cash flows from operating activities Loss for the period (21,435) (31,427) (39,617) (51,095) (87,897) Adjustments for: Depreciation of property, plant and