Oncolys Biopharma, Inc. · TSE:4588
Oncolys Biopharma — Q2 2019 Earnings Presentation
33 slides from Oncolys Biopharma's earnings presentation, Aug 2, 2019
Slide 1: FY2019 2Q Financial Results
FY2019 2Q Financial Results Oncolys Biopharma Inc. August 2nd, 2019 Copyright(C) 2019, Oncolys Biopharma Inc. All rights reserved. 1
Slide 2: Forward Looking Statements
Forward Looking Statements • This presentation material may contain information which is forward-looking and involves risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. One can identify these forward-looking statements
Slide 3: 2QFY2019 Earnings Overview
1. 2QFY2019 Earnings Overview 2. Telomelysin 3. Next Generation/Super Telomelysin 4. TelomeScan 5. Message from CEO 3 Copyright(C) 2019, OncolysBioPharma Inc. All rights reserved.
Slide 4: 2Q FY2019 achievements
2Q FY2019 achievements Corporate event JPY800 million procurement by 3rd party allotment to Chugai Pharma (TYO: 4519) 1. Chugai ①Japan & Taiwan: exclusive license agreement with sublicensing rights Pharma ②Worldwide ※ : exclusive option agreement 2. Sakigake designation received 3. RT combination P1
Slide 5: 2Q FY2019 financial results
2Q FY2019 financial results JPY million Sales OP CP NP 2Q FY2019 621 △275 △271 △273 (accumulated) 2Q FY2018 90 △643 △639 △641 (accumulated) Difference yr/yr 530 368 368 368 1Q FY2019 572 89 87 86 （rounded down to the nearest million） Sales 1. Upfront payment from Chugai Pharmaceutical based on the l
Slide 6: FY2019 R&D and related costs will be reduced
FY2019 R&D and related costs will be reduced JPY100million 5.0 Chugai license 6.5 Delay in IIT (US) 1.5 13.9 7.4 Budget BOY Budget after revision （※R&D and service operations costs) Budget BOY Budget after revision FY2019 full year forecast remains undisclosed. Copyright(C) 2019, Oncolys Biopharma I
Slide 7: Pipeline overview: Telomelysin
Pipeline overview: Telomelysin As of 02/08/2019 Indication Combination Phase１ Phase２ Phase３ Sakigake Esophageal Designation Radiation Chugai Application cancer Pharma Solid tumors P1a P1b (esophageal Anti-PD-1 antibody P1b in progress cancer) Indication Combination Phase１ Phase２ Phase３ Gastric/gastr
Slide 8: Pipeline overview: other drug candidates
Pipeline overview: other drug candidates As of 02/08/2019 Project Indication exploratory Pre-clinical Phase１ Phase２ Phase３ OBP-702 Solid tumors AMED Suspended: immune checkpoint inhibitor combination Solid tumors therapy in review OBP-801 HDAC inhibitor Opthalmatic Academia Final judgement OBP-601 H
Slide 9: 2. Telomelysin
1. 2QFY2019 Earnings Overview 2. Telomelysin 3. Next Generation/Super Telomelysin 4. TelomeScan 5. Message from CEO 9 Copyright(C) 2019, OncolysBioPharma Inc. All rights reserved.
Slide 10: Pipeline overview: Telomelysin
Pipeline overview: Telomelysin As of 02/08/2019 Indication Combination Phase１ Phase２ Phase３ Sakigake Esophageal Designation Radiation Chugai Application cancer Pharma Solid tumors P1a P1b (esophageal Anti-PD-1 antibody P1b in progress cancer) Indication Combination Phase１ Phase２ Phase３ Gastric/gastr
Slide 11: Strategic changes in development of Telomelysin
Strategic changes in development of Telomelysin Oncolys decided to terminate melanoma Phase 2 study in the US from strategic standpoint. 1. Patient enrollment severely delayed due to unexpectedly harsh competition. 2. Needs for melanoma treatment in clinical settings are increasingly met as new drug
Slide 12: Telomelysin-radiation phase study for esophageal cancer
Telomelysin-radiation phase 1 study for esophageal cancer 1. Licensing/capital tie-up agreement concluded with Chugai Pharma 2. Telomelysin adopted as innovative drug candidate for SAKIGAKE designation, a government-supported fast-track system. Copyright(C) 2019, Oncolys Biopharma Inc. All rights re
Slide 13: Licensing and capital tie-up agreement with Chugai Pharma
Licensing and capital tie-up agreement with Chugai Pharma Global exclusive rights for development, manufacturing and marketing of Telomelysin are fully licensed out IF option rights granted to Chugai Pharma are executed. Area Licensee Agreement type Deal size Japan/Taiwan Exclusive license Total lic
Slide 14: Strategic cooperation with Chugai Pharma
Strategic cooperation with Chugai Pharma ＜Chugai Pharma＞ 1. Lead phase 2 clinical study in combination with radiation New Drug Application 2. Look to “combine Telomelysin with cancer immunotherapy” in the future ※ 3. Will have world-wide exclusive rights of Telomelysin IF Chugai exercises option rig
Slide 15: Clinical trial in combination with anti-PD-(L)1 antibody
Clinical trial in combination with anti-PD-(L)1 antibody 15 Copyright(C) 2019, OncolysBioPharma Inc. All rights reserved.
Slide 16: Anti PD-1 antibody combination study in Japan
Anti PD-1 antibody combination study in Japan 1. NCCHE / Okayama University RR(%) 33.3% 2. Solid tumors; stage IV 35 (3/9) 30 3. Phase１b 25 4. 19 patients to be enrolled 20 13.1% 15 (41/314) Phase 1a Phase 1b 6.7% 9 pts 10 pts 10 (21/314) 5 Telomelysin (1course) 0 Max. 3 courses may be added P1a int
Slide 17: Anti PD-(L)1 antibody combination study in US
Anti PD-(L)1 antibody combination study in US 1. Cornell University 1. Cornell University, Johns Hopkins University 2. Gastric and GEJ cancer; stage IV 2. Progressive head and neck cancer 3. Phase２ 3. Phase２ 4. Up to 37 patients 4. Up to 54 patients 5. Primary endpoint: efficacy and safety 5. Primar
Slide 18: Aiming to expand indications further
Aiming to expand indications further Esophageal Lung cancer cancer Japan Gastric/gastro- Breast cancer esophageal junction cancer Cornell University HCC Head & neck cancer US Intraoral Rectal cancer cancer （under consideration） With Radiation Copyright(C) 2019, Oncolys Biopharma Inc. All rights rese
Slide 19: Business alliance: Jiangsu Hengrui
Business alliance: Jiangsu Hengrui Development of Telomelysin in China 1. Possible IND application to NMPA (ex-CFDA) by the end of 2020 2. Telomelysin already produced in accordance with GMP in China ※ 3. CFDA approved Hengrui’s anti-PD-1 antibody, Camrelizumab (SHR-1210) for Hodgkin's lymphoma trea
Slide 20: HCC clinical trial in Taiwan and Korea
HCC clinical trial in Taiwan and Korea Administration of Telomelysin to the last patient has started in Aug 2019, with 18 patients enrolled in total. Cohort 5 2 x 1012vp x 3 ３＋３ Cohort ４ 2 x 1011vp ３ Cohort ３ 1 x 1012vp ３ Cohort ２ 1 x 1011vp ３ Cohort １ 1 x 1010vp 40.36 mm ３ Copyright(C) 2019, Oncoly
Slide 21: 3. Next Generation/Super Telomelysin
1. 2QFY2019 Earnings Overview 2. Telomelysin 3. Next Generation/Super Telomelysin 4. TelomeScan 5. Message from CEO 21 Copyright(C) 2019, OncolysBioPharma Inc. All rights reserved.
Slide 22: Next generation Telomelysin (OBP-702)
Next generation Telomelysin (OBP-702) 1996 The first clinical research for cancer gene therapy with tumor- suppressor gene Ad-p53 was filed to the MHLW. P53: tumor suppressor gene 1999 Ad-p53 Phase１ clinical trial for lung cancer started p53 p53 Normal Ad-p53 2006 Telomelysin Phase１clinical trial fo
Slide 23: Next generation Telomelysin (OBP-702) tumor volume
Next generation Telomelysin (OBP-702) Day 0 Day 28 8 PBS Mean tumor volume (cm3) PBS 7 Ad-p53 6 Telomelysin OBP-301 Ad-p53 5 OBP-702 * 4 3 Telomelysin 2 1 OBP-702 0 0 7 14 21 28 Transplanted human osteosarcoma cell line Days after treatment － ＋ ＋ ＋ (Hasei et al, Mol Cancer Ther, 12:314-325, 2013) Co
Slide 24: Super Telomelysin
Super Telomelysin Super Telomelysin T cell Immunotherapy lymphocyte-stimulating molecule Cancer cell Systemic PD-L1 administration PD-L1 molecule Cancer cell Oncolysis Virus particle 24 Copyright(C) 2019, Oncolys Biopharma Inc. All rights reserved. 24
Slide 25: 4. TelomeScan
1. 2QFY2019 Earnings Overview 2. Telomelysin 3. Next Generation/Super Telomelysin 4. TelomeScan 5. Message from CEO 25 Copyright(C) 2019, OncolysBioPharma Inc. All rights reserved.
Slide 26: TelomeScan
TelomeScan TelomeScan is a genetically engineered adenovirus which replicates and expresses GFP only in telomerase-positive cancer cells hTERTp IRES CMVp E1A E1B GFP ⊿E1 ⊿E3 Normal cell Adenovirus Type-5 Genome Telomerase - TeｌomeScan (OBP-401) TelomeScan Infection GFP expression Tumor cell Telomera
Slide 27: CTC and cancer metastasis process
CTC and cancer metastasis process 1. Currently cancer diagnostic marker’s detection rates are 30-40%. 2. Cancer cell larger than 1cm can be detected using PET and MRI. 3. Circulating tumor cell (CTC) of less than 1 cm are undetectable by PET/MRI. Primary tumor Tumor cells are carried about in blood
Slide 28: Ongoing projects for TelomeScan
Ongoing projects for TelomeScan Study Indication Purpose University of Pennsylvania Lung cancer Therapeutic efficacy monitoring NRG (MD Anderson, etc.) Lung cancer Therapeutic efficacy monitoring New York University Uterocervical cancer CTC／HPV detection Juntendo University Lung cancer CTC／PD-L1 det
Slide 29: Deciphera
Deciphera CTC Macrophage Primary tumor TMEM : Tumor Microenvironment of Metastasis V : vehicle (control) Rb : Rebastinib c-kit/TIE2 Metastasis/r Blood ecurrence vessel Inhibition of TIE2 influences tumor microenvironment of metastatic tumor （ref: Allison S. H. et al., Mol Cancer Ther (2017)） Copyrig
Slide 30: TelomeScan development direction
TelomeScan development direction Licensing New Drug Application Prognosis Therapeutic efficacy NRG (MD Anderson, etc. ) Deciphera University of Pennsylvania Breast cancer Lung cancer Juntendo University Osaka University New York University Osaka Police Hospital Uterocervical cancer Pancreatic cancer
Slide 31: 5. Message from CEO
1. 2QFY2019 Earnings Overview 2. Telomelysin 3. Next Generation/Super Telomelysin 4. TelomeScan 5. Message from CEO 31 Copyright(C) 2019, OncolysBioPharma Inc. All rights reserved.
Slide 32: Our mission: Powering Future Oncotherapy
Our mission “Powering Future Oncotherapy” Copyright(C) 2019, Oncolys Biopharma Inc. All rights reserved. 32
Slide 33: Thank you very much!
Thank you very much! 33 Copyright(C) 2019, Oncolys Biopharma Inc. All rights reserved.