Lytix Biopharma Asa · OSL:LYTIX
Lytix Biopharma Asa — Q1 2022 Earnings Presentation
50 slides from Lytix Biopharma Asa's earnings presentation, May 12, 2022
Slide 1: Lytix Biopharma First quarter 2022 presentation
Lytix Biopharma AS Addressing the major challenge in cancer therapy with Oncolytic Molecules First quarter 2022 presentation May 12, 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: Today's presenters
Today's presenters 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
Slide 4: Lytix Biopharma in brief
Lytix Biopharma in brief Lytix is a biotech company headquartered in Oslo, Norway. The company was listed at Euronext Growth in June 2021. Lytix has developed a unique and proprietary technology platform for in situ vaccination. Lytix aims to accelerate progression of this unique platform, building
Slide 5: Why is it so difficult to cure cancer?
Why is it so difficult to cure cancer ? Time Normal Tumor cells cell Tumor New mutations occur during cancer evolution leading to different cancer cells in a tumor = heterogeneity
Slide 6: Each tumor is unique
Each tumor is unique Intratumoral heterogeneity Intermetastatic heterogeneity Interpatient heterogeneity
Slide 7: Tumor heterogeneity is the major challenge in current cancer immunotherapy
Tumor heterogeneity is the major challenge in current cancer immunotherapy Source: GlobalData High-Prescriber Survey (Dec. 2020)
Slide 8: Failing to kill all cancer cells often leads to recurrence
Failing to kill all cancer cells often leads to recurrence of even "harder to treat" tumors Therapy Recurrence Therapy resistant Primary tumor cancer cells Resistant cancer cells New cancer cells
Slide 9: Oncolytic molecules kill all cancer cells
Oncolytic molecules kill all cancer cells 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 10: Oncolytic molecules address tumor heterogeneity
Oncolytic molecules address tumor heterogeneity TREATED TUMOR Exposure of mutations (tumor antigens) from all dead cancer cells LYMPH NODE Generating T cells that recognize the different mutations (tumor antigens) BLOOD VESSELS T cells enter the blood stream searching for cancer cells NON-TREATED TU
Slide 11: Highlights of the first quarter 2022
Highlights of the first quarter 2022 First patient in Verrica Pharmaceutical’s study with LTX-315 screened in March and dosed on April 4th ‒ Triggered a milestone payment of 1m USD to Lytix ATLAS-IT-05 – Expanding site network to highly recognized sites with expertise within intratumoral immunothera
Slide 12: Clinical/operational update
Clinical/operational update
Slide 13: Verrica Pharmaceuticals shows progress with Phase II study
Lytix` license partner Verrica Pharmaceuticals Inc shows progress with their Phase II study First patient in Verrica`s Phase II study was screened in March and dosed on April 4th - evaluating LTX-315 for the treatment of Basal Cell Carcinoma (BCC, skin cancer) Approximately 66 patients with Basal Ce
Slide 14: Phase II study with LTX-315 (ATLAS-IT-05)
Phase II study with our lead cancer drug candidate LTX- 315 (ATLAS-IT-05) A Phase II combination study evaluating LTX-315 and pembrolizumab in patients with solid tumors The study protocol has been amended to narrow its focus to patients with advanced melanoma Objective for the study ‒ Document whet
Slide 15: Expanding the global reach
Expanding the global reach Site network ‒ US sites have been impacted by Covid-19 ‒ To quickly expand our access to patients in the US we added Oncobay in February 2022 ‒ To mitigate recruitment challenges, the study is expanding to Europe Added operational expertise ‒ Jackie Earabino recruited as H
Slide 16: LTX-315 with adoptive T-cell therapy in sarcoma
LTX-315 in combination with adoptive T-cell therapy in a Phase II study for patients with sarcoma Adoptive T cell therapy 5. T-cell ‒ A method to isolate and expand the infusion 1. LTX-315 patient`s own T cell before they are given back to the patient to combat the tumor Soft tissue sarcoma 4. T-cel
Slide 17: LTX-315 with adoptive T-cell therapy in sarcoma: objectives and status
LTX-315 in combination with adoptive T-cell therapy in a Phase II study for patients with sarcoma Objectives ‒ Does LTX-315 induce T-cell infiltration in 5. T-cell 1. LTX-315 infusion sarcoma patients? ‒ Are the T cells generated specific for the patient`s tumor cells? ‒ Is there any correlation bet
Slide 18: LTX-401 - Phase I ready end of 2022
LTX-401 - Activities are on track with the aim to be Phase I ready end of 2022 COMMENTARY Hepatocellular carcinoma and liver cancer metastases are two big cancer segments with high unmet medical need and significant market potential LTX-401 is a small oncolytic High incidence with poor standard trea
Slide 19: Key company objectives for 2022
Key company objectives for 2022 Expand the clinical impact field for LTX-315 and complete enrollment in the ATLAS-IT-05 Phase II trial by the end of 2022 Provide API to and support our commercial partner Verrica Pharmaceuticals in their Phase II trial in BCC Analyze and present data from the ATLAS-I
Slide 20: Financials
Financials
Slide 21: Key figures – profit and loss
Key figures – profit and loss Unaudited Unaudited Amounts in NOK thousands Q1 2022 Q1 2021 FY 2021 Total operating income 1,509 21,561 25,821 Total operating expenses (16,182) (22,012) (73,844) Loss from operations (14,673) (452) (48,017) Loss for the period (15,231) (356) (48,049) The decrease in o
Slide 22: Key figures – balance sheet
Key figures – balance sheet Unaudited Unaudited Amounts in NOK thousands 31.03.2022 31.03.2021 31.12.2021 Assets Property, plant and equipment 35 - - Trade and other receivables 7,242 6,190 5,680 Cash and cash equivalents 180,666 22,582 197,282 Total assets 187,942 28,772 202,962 Shareholder's equit
Slide 23: Company presentation
Company presentation
Slide 24: First in class entering Phase II studies in U.S.
FIRST IN CLASS ENTERING PHASE II VALIDATED STUDIES IN U.S. Nobel Price winner at Unique therapeutic LTX-315 in Phase II the advisory board approach development in US led by with universal # 1 cancer hospital Commercial deal within mechanism of action globally skin cancer Promising efficacy signals V
Slide 25: Tumor heterogeneity is the major challenge in current cancer immunotherapy
Tumor heterogeneity is the major challenge in current cancer immunotherapy Source: GlobalData High-Prescriber Survey (Dec. 2020)
Slide 26: T cells may be the only solution to combat tumor heterogeneity
T cells may be the only solution to combat tumor heterogeneity Each T cell can only fight one type of cancer cells Each person has a repertoire of 10x10 different T cells T cells need to see tumor antigens to be activated
Slide 27: Oncolytic molecules generate a broad T cell response
Oncolytic molecules address the major challenges with tumor heterogeneity by generating a broad T cell response
Slide 28: LTX-315 generates many different T cells in mouse melanoma
The oncolytic peptide LTX-315 generates a high number of different T cells in mouse melanoma Different T cells in tumor Different T cells in tumor Different T cells in blood Different T cells in blood Effective exposure of tumor antigens leads to activation of a broad T cell response : One type of T
Slide 29: LTX-315 is effective in hard to treat cancer models
LTX-315 is effective in “hard to treat” cancer models B16F10 MELANOMA BRAF MUTATED MELANOMA No effect of chemotherapy or immune checkpoint inhibitors in the BRAF mutated melanoma model Liao, Cell Stress, 2019
Slide 30: LTX-315 generates novel T cells in a breast cancer patient
LTX-315 also generates new high number of novel T cells in a breast cancer patient 126 different T cells increased significantly in numbers after treatment
Slide 31: Broad T cell response induced in cancer patients
Broad T cell response induced in cancer patients with different types of cancer Sarcoma patient Sarcoma patient Sarcoma #3 Desmoid patient Melanoma patient T cell clones after treatment Breast Cancer #5 Breast Cancer patient Melanoma Melanoma #4 patient Breast Cancer Breast patient Cancer T cell clo
Slide 32: Proof of Principle – T cells attack non-treated tumors
Proof of Principle – T cells generated by LTX-315 are able to attack and reduce size of non-treated tumors Two tumors treated on Local treatment generated right side T cells reduce size of other distant non-treated tumors 39 % reduction 82 % reduction Spicer, Clin. Cancer Res., 2021
Slide 33: Best response in distant non-treated lesions
Proof of Principle – T cells generated by LTX-315 are able to attack and reduce size of non-treated tumors Best response in distant non-treated lesions REDUCED SIZE Results from dose escalating trials with suboptimal dosing Spicer, Clin. Cancer Res., 2021
Slide 34: Oncolytic molecules are ideal for combining with checkpoint inhibitors
Oncolytic molecules are ideal for being combined with immune checkpoint inhibitors Oncolytic molecules generate T cells that recognize different cancer cells + Immune checkpoint inhibitors keeps the brakes off and make the T cells work more efficiently
Slide 35: Case study: LTX-315 + checkpoint inhibitor in breast cancer patient
Case study: Proof of Principle - LTX-315 + checkpoint inhibitor showed effects not obtained with same checkpoint inhibitor alone in breast cancer patient The checkpoint inhibitor pembrolizumab alone • No effect in liver metastasis • Chemotherapy 2. 5 % overall response rate (ORR) LTX-315 + pembroliz
Slide 36: Large commercial opportunities for T cell activators in metastatic cancer
Large commercial opportunities for T cell activators in metastatic cancer Immune checkpoint inhibitors cure some patients Responders Failures MALIGNANT 60-89% Global market for MELANOMA Immune checkpoint inhibitors TRIPLE NEGATIVE 82-95% BREAST CANCER $25bn HEAD & NECK 82-87% Oncolytic molecules hav
Slide 37: First in class entering Phase II studies in U.S.
FIRST IN CLASS ENTERING PHASE II VALIDATED STUDIES IN U.S.
Slide 38: Pipeline
Pipeline Product Combination Population Preclinical Phase I Phase II Phase III Collaborations candidate partner ATLAS-IT-05 Patients progressed Pembrolizumab on checkpoint (Keytruda®) inhibitors ATLAS-IT-04 Advanced soft tissue LTX-315 Adoptive T-cell sarcoma therapy Verrica Pharmaceuticals Basal ce
Slide 39: First in class entering Phase II studies in U.S.
FIRST IN CLASS ENTERING PHASE II VALIDATED STUDIES IN U.S.
Slide 40: Verrica has started Phase II study in most common skin cancer
Verrica Pharmaceuticals has started their Phase II study in the most common form of skin cancer Approximately 3-4 million patients diagnosed with basal cell carcinoma in US each year and high unmet need for new treatment options First patient in Verrica Pharmaceutical’s study treated Regulatory mile
Slide 41: Nobel laureate Jim Allison is a member of our scientific advisory board
Nobel laureate Jim Allison, who discovered the first immune checkpoint inhibitor, is a member of our scientific advisory board “The ability of an activated immune response to generate a diverse T-cell repertoire that adapts to heterogeneous and genetically unstable tumors (…) make it absolutely esse
Slide 42: Science behind Lytix technology documented by leading institutions
Science behind Lytix’technology documented by world leading cancer research institutions 50+ peer reviewed scientific publications, demonstrating the potential of oncolytic molecules
Slide 43: Lytix investor PBM Capital
Lytix investor - the US healthcare specialist PBM Capital invest in game changing technologies
Slide 44: Summary
Summary
Slide 45: Why we will succeed
Why we will succeed UNIQUE APPROACH SCIENCE VALIDATION EXECUTION Lytix’s molecules Science confirmed by Commercial deal within Management represent the missing top notch US and skin cancer Board piece European cancer Advisory Board research institutions US health specialist Competent investors Ideal
Slide 46: Interim Financial Statements
Interim Financial Statements
Slide 47: Interim statement of profit or loss
Interim statement of profit or loss Unaudited Unaudited Amounts in NOK thousands Q1 2022 Q1 2021 FY 2021 Revenue - 17 17 Other operating income 1,509 21,544 25,810 Total operating income 1,509 21,561 25,827 Payroll and related expenses (3,700) (13,834) (31,605) Depreciation and amortization expenses
Slide 48: Interim statement of financial position
Interim statement of financial position Unaudited Unaudited Amounts in NOK thousands 31.03.2022 31.03.2021 31.12.2021 Assets Non-current assets Property, plant and equipment 35 - - Total non-current assets 35 - - Current assets Trade and other receivables 7,242 6,190 5,680 Cash and cash equivalents
Slide 49: Interim statement of cash flows
Interim statement of cash flows Unaudited Unaudited Amounts in NOK thousands Q1 2022 Q1 2021 FY 2021 Cash flows from operating activities Loss for the period (15,231) (356) (48,049) Adjustments for: Depreciation of property, plant and equipment - - - Share-based payment expense 281 1,168 4,055 Incre
Slide 50: Q&A
Q&A IR enquiries: ole.peter.nordby@lytixbiopharma.com