Alligator Bioscience Ab · OMXSTO:ATORX
Alligator Bioscience Ab — Invest Securities BioMed 2020
31 slides from Alligator Bioscience Ab's conference presentation, Jan 28, 2020
Slide 1: Alligator Bioscience AB (publ) – Invest Securities BioMed 2020
ALLIGATOR BIOSCIENCE AB (PUBL) INVEST SECURITIES BIOMED 2020 28 January 2020 1
Slide 2: Disclaimer
Disclaimer FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements that provide Alligator’s expectations or forecasts of future events such as new product developments, regulatory approvals and financial performance. Such forward looking statements are subject to risks, unce
Slide 3: Alligator Bioscience: Tumor-directed immunotherapy
Alligator Bioscience: Tumor-directed immunotherapy > Broad portfolio of immuno-oncology assets > Four drug candidates in clinical development > Listed on Nasdaq Stockholm (mid cap) > Cash on hand approx. USD 31 million (Sep 30, 19) 3
Slide 4: ALLIGATOR GOLD®
ALLIGATOR GOLD® Antibody library established. ATOR-1015 Clinical development Clinical development of ADC-1013 ‘The Swedish MPA approves start of phase | study. The first phase | clinical study of ADC-1013 started. Milestone payment from Janssen USD 6 million milestone received in January. License ag
Slide 5: Tumor-directed immuno-oncology
Tumor-directed immuno-oncology GENERAL IMMUNE-ACTIVATION TUMOR-DIRECTED IMMUNE-ACTIVATION General immune activation is associated with risk of Selective activation of tumor-specific immune cells severe adverse effects results in systemic immunity with limited toxicity 5
Slide 6: Pipeline in the context of the cancer-immunity cycle
Pipeline in the context of the cancer-immunity cycle Mitazalimab ATOR-1015 Discovery T cell ATOR-1017 ALG.APV-527 ATOR-1144 Tumor cell 6
Slide 7: Solid technology platforms and capabilities
Solid technology platforms and capabilities ALLIGATOR-GOLD® library FIND® protein optimization Increased tumor retention Increased affinity & potency Decreased antigenicity Improved developability diversity >1010 Bispecific antibody formats CMC – GMP enabling capability Cell line development
Slide 8: Mitazalimab
Mitazalimab bioscience
Slide 9: Mitazalimab: Phase II ready CD40 antibody
Mitazalimab: Phase II ready CD40 antibody Phase II ready CD40 agonist antibody Clinical status - Potential for efficacy in PD-1 resistant indications Regulatory Preclinical and clinical data package of Pharma quality Clinical development material secured Drug supply - GMP material up until Phase III
Slide 10: CD40 - Boosts vaccines and makes cold tumors hot
CD40 - Boosts vaccines and makes cold tumors hot CD40 increases T-cell response in vaccination CD40 increases cold tumors’ response rates ORR NP=nab-paclitaxel 60 60 60 40 40 40 20 20 20 0 0 0 1 1 40 em em D PD D +P G G +C + P+ em 40 em N G D G P+ +C P+ N em N Van Hoff et al O´Hara et al Wainberg et
Slide 11: Mitazalimab: Competitive safety clinical data
Mitazalimab: Competitive safety clinical data > Positive Phase I data presented at ASCO 2019 > 95 patients enrolled > Up to 1200 µg/kg i.v without premedication, and up to 2000 µg/kg with premedication safe and tolerable > Early evidence on clinical activity: > Partial response (9 months) observed i
Slide 12: Mitazalimab: Strong competitive position
Mitazalimab: Strong competitive position Compound Company Phase APX005M Apexigen II Mitazalimab Alligator I/II Selicrelumab Roche I/II CDX-1140 Celldex I/II ABBV-927 Abbvie I > Five CD40-targeting MAbs in clinical development > Mitazalimab has potential to be first-in- Selective CD40 activation Gene
Slide 13: Mitazalimab: Possible launch 2026 in pancreatic cancer
Mitazalimab: Possible launch 2026 in pancreatic cancer > Quickest route to market, pancreatic cancer - potential for first line > Start mitazalimab Phase II combination study H2 2020E > Potential for parallel development in combination with neoantigen vaccines or adoptive cell transfer 2019 2020 202
Slide 14: ATOR-1015
ATOR-1015 bioscience
Slide 15: ATOR-1015: First-in-class tumor-localizing CTLA-4 antibody
ATOR-1015: First-in-class tumor-localizing CTLA-4 antibody Dual binding to CTLA-4 and OX40 5 mutations were introduced → Affinity increased 100-fold Anti-OX40 Anti-CTLA-4 ATOR-1015 15
Slide 16: ATOR-1015 unleashes T-cells
ATOR-1015 unleashes T-cells 16
Slide 17: Continued strong sales increase
Continued strong sales increase I-O sales forecast* CTLA-4 (Yervoy) 45,000 > Yervoy sales 2018: USD 1.33 40,000 billion (PD-1~USD 16 billion) 35,000 30,000 > Approved in melanoma, renal cancer (RCC) and colorectal Sales (MUSD) 25,000 20,000 cancer (MSIhighCRC) 15,000 10,000 5,000 0 2018 2019(F) 2020
Slide 18: Anti-CTLA-4 increases survival in melanoma
Anti-CTLA-4 increases survival in melanoma > 5-year overall survival in metastatic melanoma > 50% in combination with PD-1 > Unique depth & durability of response with potential for long- term survival > CTLA-4 limited by severe immune-related adverse effects cNIVO (1 mg/kg Q3W) + IPI (3 mg/kg Q3W);
Slide 19: Medical need for improved CTLA-4 antibodies
Medical need for improved CTLA-4 antibodies > Current dosing limited to 4 doses due to Severe immune-related adverse events1, 2 toxicities3 neuropathy > 59% grade 3-4 adverse events (ipi + nivo) endocrinopathy pneumonitis > A safer CTLA-4 therapy may increase utility and reduce discontinuation4 hepa
Slide 20: ATOR-1015: Clinical development path
ATOR-1015: Clinical development path > Phase I safety ongoing, readout autumn 2020E > Phase II H2 2020E: combination with anti-PD-1 in Melanoma > Additional Phase II studies to be initiated in Renal Cell Carcinoma and MSIhigh Colorectal Cancer > First Efficacy readout H1 2022E 2019 2020 2021 2022 Ph
Slide 21: ATOR-1017
ATOR-1017 bioscience
Slide 22: ATOR-1017 Mode of action
ATOR-1017 Mode of action > ATOR-1017 activates 4-1BB expressing effector T cells and NK cells > 4-1BB highly expressed on tumor infiltrating effector T cells > The agonistic effect of ATOR-1017 is dependent on FcγR mediated crosslinking > ATOR-1017 induces tumor-directed immune activation in tumors
Slide 23: ATOR-1017 – the optimal 4-1BB mAb
ATOR-1017 – the optimal 4-1BB mAb Toxicity issues Good efficacy Poor efficacy MTD ~ 0.1 mg/kg Good tolerability Well tolerated MTD≥10 mg/kg 23
Slide 24: ATOR-1017
ATOR-1017 4-1BB targeting mAb (IgG4) with cross-linking Survival Positioning dependency leading tumor directed activation of T 100 cells 75 Survival (%) Drug supply Clinical material available for Ph I and start of Ph II 50 25 0 Clinical Phase I: first patient dosed in Dec 2019 0 25 50 75 100 Time a
Slide 25: ATOR-1017: First patient dosed in Dec 2019
ATOR-1017: First patient dosed in Dec 2019 Phase I study > First-in-human, open label, dose escalation study > Up to 50 patients with metastatic cancer > Three clinics in Sweden > Principal investigator Dr Gustav Ullenhag, Uppsala University Hospital > Primary endpoint safety & tolerability, recomme
Slide 26: Two Additional Projects Advancing
Two Additional Projects Advancing ALG.APV-527 looking for clinical development partner AC101 first patient dosed 26
Slide 27: Financials as of September 2019
Financials as of September 2019 QUARTER YEAR TO DATE (MUSD) Q3 2019 Q3 2018 2019 2018 Net Sales 0.4 0.0 0.4 0.1 Operating result -6.0 -4.1 -15.8 -12.6 Net Result -5.8 -4.0 -15.3 -12.2 R&D costs % of operating cost 83% 76% 79% 76% Liquidity at end of the period (incl bonds) 30.8 48.8 Equity per share
Slide 28: Major shareholders as of December 31, 2019
Major shareholders as of December 31, 2019 Shareholder % > Market cap: Total Banque Intl. Luxembourg 20.6 USD 80 million Sunstone Life Science fund 8.1 > Ticker: Lars Spånberg 4.5 ATORX Johnson & Johnson Innovation 3.8 > Volume per day Avanza pension 3.7 (avg YTD 19): 170,000 shares 4th AP-fund 3.1
Slide 29: Experienced Management Team
Experienced Management Team Per Norlén Anu Balendran Malin Carlsson Peter Ellmark Christina Furebring Charlotte A. Russell Per-Olof – born 1970, CEO – born 1975, VP – born 1968, Chief – born 1973, VP – born 1964, Senior – born 1964, Chief Schrewelius since 2015 – MD, Business Operating Officer Disco
Slide 30: Expected Significant Events 2020
Expected Significant Events 2020 mitazalimab ATOR-1015 ATOR-1017 ALG-APV-527 Start clinical Clinical Phase I Clinical Phase I Start clinical Phase II read-out dose escalation Phase I with a combo in Start Ph II part completed partner pancreatic PD-1 combo in in solid tumors (H2 2020) cancer melanoma
Slide 31: We fight cancer through the immune system.
We fight cancer through the immune system. A revolution for life. www.alligatorbioscience.com 31