Slide 1: Alligator Bioscience AB – Unleashing dendritic cells to cure cancer
ALLIGATOR BIOSCIENCE AB (PUBL) NOVEMBER 2020 UNLEASHING DENDRITIC CELLS TO CURE CANCER 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: Company highlights
Company highlights Public IO biotech with strong innovation track record – 1 5 clinical-stage compounds from proprietary technology platform Focus on two lead products with best-in-class potential - 2 optimized for efficacy and reduced side effects Preclinical and clinical Phase I data support uniqu
Slide 4: Investment case
Investment case > Immuno-oncology (IO) very effective in subset of patients - extensive international efforts to identify new ways to bring effect to more patients > Alligator has leading products within 2 of the key pathways being explored > Each product could generate royalty streams of > 1 billio
Slide 5: Key assets: ATOR-1017 and mitazalimab
Key assets: ATOR-1017 and mitazalimab ATOR-1017 ATOR-1017 Readout Ph I Interim efficacy readout Ph II (H1 2021) 2021 Mitazalimab 2022 Mitazalimab (H2 2022) Interim efficacy readout Ph II Efficacy data Ph II (H2 2021) (H2 2022) 5
Slide 6: ATOR-1017: Designed for optimal efficacy and safety
ATOR-1017: Designed for optimal efficacy and safety 4-1BB antibody with tumor-selective effect Phase I Phase II Phase I readout: H1 2021E > Strong immune activation with Best-in-class • Superior profile vs other 4-1BB antibodies T cell expansion and survival Unique • Unique 4-1BB domain in IgG4 form
Slide 7: ATOR-1017: The optimal 4-1BB mAb
ATOR-1017: The optimal 4-1BB mAb ATOR-1017 is designed to overcome limitations of 1st generation 4-1BB antibodies Toxicity issues Designed for good Poor efficacy MTD ~ 8 mg efficacy & tolerability Well tolerated MTD ≥ 600 mg 7
Slide 8: ATOR-1017: Potential for tumor-selective effect
ATOR-1017: Potential for tumor-selective effect Low activation in the circulation due to FcγR crosslinking-dependency directs the competition for FcγR with endogenous IgG immune activation to the tumor In the circulation In the tumor No immune Immune activation activation ATOR-1017 Endogenous IgG Fc
Slide 9: Tumor-selective immune activation in preclinical models
Tumor-selective immune activation in preclinical models ATOR-1017 activates the immune system in tumors, but not elsewhere in the body ATOR-1017 increases Teff/Treg ratio in tumor …but does not affect systemic cells 25 25 * CD8/Treg ratio in Tumor CD8/Treg ratio in Spleen 20 20 15 15 10 10 5 5 0 0 A
Slide 10: Strong preclinical efficacy data supports best-in-class profile
Strong preclinical efficacy data supports best-in-class profile ATOR-1017 has powerful antitumor effects in preclinical models ATOR-1017 increases survival …and induces long-lasting tumor immunity Survival 100 Survival huIgG4 isotype *** **** ATOR-1017 0.5 mg/kg **** 75 Survival (%) 100 ATOR-1017 5
Slide 11: ATOR-1017: Phase I study overview
ATOR-1017: Phase I study overview > A dose study in patients with metastatic cancer, conducted at three different clinics in Sweden > Uppsala University Hospital > Karolinska University Hospital > Skånes University Hospital, Lund > Patient population: > Solid malignancies > Advanced or refractory, m
Slide 12: ATOR-1017: Phase I study overview
ATOR-1017: Phase I study overview Encouraging safety profile > Dose-escalation ongoing, 100 mg has been cleared, current dose 200 mg > Few drug related AEs, mainly grade 1 or 2, indication of immune activation > Ph I readout H1 2021E, Phase Ib/II efficacy studies to start H2 2021E Patients on study
Slide 13: ATOR-1017: at the forefront of the 2nd generation 4-1BB Abs
ATOR-1017: at the forefront of the 2nd generation 4-1BB Abs 1st generation 4-1BB mAbs 2nd generation 4-1BB mAbs Urelumab ATOR-1017 discontinued Ph I Utomilumab CTX-471 Ph I Ph I ADG-106 Ph I 13
Slide 14: ATOR-1017: Clinical development plan
ATOR-1017: Clinical development plan > Phase I open-label dose-escalation study ongoing, safety data readout H1 2021E > Primary endpoints: safety & tolerability, recommended Phase II dose > Secondary endpoints: pharmacokinetics, immunogenicity and efficacy > Phase II efficacy study planned start H2
Slide 15: Mitazalimab: Phase II ready CD40 antibody
Mitazalimab: Phase II ready CD40 antibody Unleashing the power of dendritic cells Phase I complete Phase II/III, pancreatic cancer Other indications: cold tumors, renal, bladder T cell Clinical Phase II ready CD40 agonist antibody status > Cold tumors, having few T cells, are resistant to PD-1 Regul
Slide 16: Pancreatic cancer: clinical validation for CD40
Pancreatic cancer: clinical validation for CD40 > The 2nd leading cause of cancer-related CD40 increases response in pancreatic cancer deaths in the US in 2020E Overall response rate (ORR) NP=nab-paclitaxel > Quickest route to market with potential 60 60 60 for first line 40 40 40 > Estimated sales:
Slide 17: OPTIMIZE-1: Mitazalimab in Pancreatic Cancer
OPTIMIZE-1: Mitazalimab in Pancreatic Cancer Establish safety and efficacy with Folfirinox Dosing regimen: Folfirinox 2 days before mitazalimab > Run-in part to demonstrate safety of mitazalimab in combination with standard of care > Expansion at selected dose (RP2D) with an additional 20 patients f
Slide 18: Strong benchmark to competitor CD40 antibodies
Strong benchmark to competitor CD40 antibodies CD40 agonists: CD40 superagonists: Mitazalimab vs APX005M*: equal CD40 efficacy demonstrated Selective CD40 activation General CD40 activation FcgRIIb FcγR dependent FcγR independent 30 mitazalimab Fold induction (RLU) Ph I/II APX-005M analogue* Ph I/II
Slide 19: Mitazalimab: Clinical development path
Mitazalimab: Clinical development path > Current status: Phase I completed, Phase II ready > Phase II combination with chemotherapy, mFOLFIRINOX, in pancreatic cancer with planned CTA Q4 2020. PD-1 to be added upon efficacy response. > Interim readout H2 2021E > Efficacy readout H2 2022 2020 2021 20
Slide 20: Neo-X-Prime: Novel concept within immuno-oncology
Neo-X-Prime: Novel concept within immuno-oncology Overcoming resistance to immunotherapy of cancer > Majority of cancer patients are resistant to anti-PD-1 immunotherapy. A key reason is poor T cell priming to tumor neoantigens > Neo-X-Prime solves this by bringing tumor-neoantigens to dendritic cel
Slide 21: Neo-X-Prime: outstanding efficacy
Neo-X-Prime: outstanding efficacy Neo-X-Prime outperformes monospecific antibodies Anti-CD40 Discovery Preclinical development 80 Complete responders (%) Discovery Preclinical development 60 Anti-TAA* 40 CD40 x TAA bispecific antibodies Compounds 20 Based on proprietary RUBY™ format Effective T cell
Slide 22: Outlook: Two key clinical assets in Phase II 2021
Outlook: Two key clinical assets in Phase II 2021 ATOR-1017 Mitazalimab Q3 2020 Q3 2020 2021 Start of Phase II Full Phase I clinical readout study and first interim data in and start of Phase II efficacy study pancreatic cancer patients 22
Slide 23: We fight cancer through the immune system
We fight cancer through the immune system 23
Slide 24: Appendix
Appendix 24 joscience
Slide 25: Financials as End of September 2020
Financials as End of September 2020 QUARTER YTD (MSEK) Q3 2020 Q3 2019 Jan-Sep 2020 Jan-Sep 2019 Net Sales 0 4.3 4.4 4.4 Operating result -30.6 -58.5 -110.2 -155.2 Net Result -30.8 -56.6 -108.8 -150.3 R&D costs % of operating cost 75% 83% 73% 79% Liquidity at end of the period (incl bonds) 137.0 302
Slide 26: Largest shareholders July 2020
Largest shareholders 31 July 2020 Shareholder % Banque Internationale à Luxembourg SA 19.2 Sunstone Life Science Ventures Fund II K/S 8.1 Lars Spånberg 4.5 Johnson & Johnson Innovation 3.8 Försäkringsbolaget Avanza pension 3.7 Fjärde AP-fonden 3.2 Öhman fonder 2.8 Magnus Petersson 2.3 Mikael Lönn 2.
Slide 27: Superior profile vs main competitors
Superior profile vs main competitors Mitazalimab APX-005M ABBV-927 SEA-CD40 Selicrelumab CDX-1140 Fc IgG1 IgG1 IgG1 IgG1 IgG2 IgG2 Fc-mod. (S267E) Fc-mod.(V273Y), Fc-mod., increased Improved FcgRIIb, reduced ADCC ADCC reduced ADCC FcγR-dependent Yes Yes Yes Yes No No Dose (MTD) 1.2 mg/kg 0.1-0.3 mg/