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Roche Template Changes to the development pipeline Q3 2020 update New to phase I New to phase II New to phase III New to registration 7 NMEs: 2 NMEs: 4 NMEs: 1 NME: RG6091 UBE3A LNA - Angelman syndrome RG7992 FGFR1 x KLB - NASH RG6107 crovalimab - PNH RG6396 Gavreto (pralsetinib) - RET fusion- RG6286 NME - colorectal cancer CHU Oncolytic Type 5 adenovirus - esophageal RG6413+RG6412 REGN-COV2 - SARS-CoV-2 positive NSCLC RG6315 NME - systemic sclerosis cancer prophylaxis RG6330 KRAS G12C - KRAS-mutant solid tumors RG6171 SERD(3) ER+/HER2 - metastatic breast 2 AIs: RG6418 NLRP3 inhibitor - inflammation 5 AIs: cancer RG3648 Xolair - asthma home use 4D-MT 4D-R125 - X-linked retinitis pigmentosa RG6171 SERD(3) - neoadjuvant HR+ breast 7 AIs: RG6396 Gavreto (pralsetinitb) - RET-mutant CHU CD137 agonist switch antibody - solid tumors cancer RG6058 tiragolumab+Tecentriq - stage III medullary thyroid cancer (MTC) RG6413+RG6412 REGN-COV2 - COVID-19+ unresectable 1L NSCLC 2 AIs: adult – ambulatory RG6058 tiragolumab+Tecentriq - locally adv RG7440 ipatasertib+Tecentriq - prostate cancer RG6413+RG6412 REGN-COV2 - COVID-19+ esophageal cancer previously treated with androgen receptor-targeted adult – hospitalized RG6321 PDS with ranibizumab - diabetic therapy retinopathy RG7446 Tecentriq+Venclexta - maintenance 1L RG7159 Gazyva - lupus nephritis ES-SCLC RG7601 Venclexta - 1L MDS RG7446 Tecentriq+cabozantinib - adv RCC RG7446 Tecentriq+cabozantinib - 2L NSCLC Removed from phase I Removed from phase II Removed from phase III Approvals 2 NMEs: 2 AIs: 3 AIs: 3 NMEs approved in US RG6000 DLK inhibitor - ALS RG7421 Cotellic+Tecentriq+/- taxane - TNBC RG7413 etrolizumab - ulceritis colitis RG7916 Evrysdi - SMA RG7861 anti-S.aureus - infectious diseases RG7596 Polivy - r/r FL* RG7446 Tecentriq+paclitaxel - 1L TNBC RG6168 Enspryng - NMOSD RG7446 Tecentriq+ chemo + Avastin - ovarian RG6396 Gavreto - RET fusion positive NSCLC cancer 1 NME approved in EU RG6268 Rozlytrek - ROS1+ NSCLC 1 AI approved in US RG7421 Cotellic+Zelboraf+Tecentriq - 1L+ BRAFm melanoma 1 AI approved in EU RG6268 Rozlytrek - NTRK+ tumor-agnostic Status as of October 15, 2020 * FL cohort removed, DLBCL continues 1 Roche Group development pipeline Phase I (45 NMEs + 17 AIs) Phase II (21 NMEs + 14 AIs) RG6026 glofitamab combos heme tumors RG7769 PD1 x TIM3 solid tumors RG6171 SERD (3) neoadjuvant HR+ BC RG6058 tiragolumab combos heme & solid tumors RG7802 cibisatamab ± T solid tumors RG6180 iNeST* + pembrolizumab malignant melanoma RG6076 CD19-4-1BBL heme tumors RG7827 FAP-4-1BBL + T solid tumors RG6357 SPK-8011 hemophilia A RG6115 TLR7 agonist (4) HCC RG7828 mosunetuzumab combos heme tumors RG6358 SPK-8016 hemophilia A with inhibitors to factor VIII RG6139 PD1 x LAG3 solid tumors RG7876 selicrelumab combos solid tumors tiragolumab + T NSCLC RG6058 RG6160 FcRH5 x CD3 r/r MM CHU FIXa x FX hemophilia tiragolumab + T cervical cancer RG6171 SERD (3) ER+/HER2- mBC 1L CHU glypican-3 x CD3 solid tumors RG7446 Tecentriq SC NSCLC RG6180 iNeST*± T solid tumors CHU codrituzumab HCC Venclexta + fulvestrant 2L HR+BC RG7601 RG6185 belvarafenib (pan-RAF inh)+Cotellic solid tumors CHU CD137 switch antibody solid tumors Venclexta + carfilzomib r/r MM t(11:14) RG6194 HER2 x CD3 BC CHU - .. solid tumors & endometriosis CHU Oncolytic Type 5 adenovirus esophageal cancer RG6279 PD1-IL2v solid tumors SQZ PBMC vaccine solid tumors RG6149 ST2 MAb asthma RG6286 NME colorectal cancer RG6151 - asthma RG6173 anti-tryptase asthma RG6290 MAGE-A4 ImmTAC solid tumors RG6244 - asthma rhPTX-2 (PRM-151) myelofibrosis RG6354 RG6292 CD25 MAb solid tumors RG6287 - IBD rhPTX-2 (PRM-151) . idiopathic pulmonary fibrosis RG6296 BCMA x CD16a r/r MM RG6418 NLRP3 inh inflammation RG7845 fenebrutinib RA RG6323 IL15/IL15Ra-Fc solid tumors RG6315 NME systemic sclerosis RG7880 IL22-Fc inflammatory diseases RG6330 KRAS G12C solid tumors RG7835 IgG–IL2 autoimmune diseases RG6149/RG7880 ST2 MAb or IL22-Fc COVID-19 pneumonia ipatasertib + Taxane + T TNBC RG6084 - HBV NOV TLR4 MAb autoimmune diseases RG7440 ipatasertib + rucaparib mCRPC, solid tumors RG6346 HBV siRNA HBV RG7854+RG7907 TLR7 ago(3) + CpAM (2) HBV ipatasertib .prostate cancer, pretreated RG6091 UBE3A LNA Angelman syndrome RG6413+ REGN-COV2 nAbs . COVID-19+ adult-ambulatory Morpheus platform solid tumors RG6102 brain shuttle gantenerumab Alzheimer’s RG6412 REGN-COV2 nAbs COVID-19+ adult-hospitalised T + Avastin + Cotellic 2/3L CRC RG6237 - neuromuscular disorders RG7992 FGFR1 x KLB MAb NASH T ± Avastin ± chemo HCC, GC, PaC RG7637 - . neurodevelopmental disorders IONIS ASO factor B IgA nephropathy T + anti-CD20 combos heme tumors RG7816 GABA Aa5 PAM autism RG6100 semorinemab Alzheimer’s RG7446 T + K/HP HER2+ BC RG6179 - DME RG6356 microdystrophin (SRP-9001) DMD T + rucaparib ovarian cancer RG6247 4D-R110 choroideremia RG7412 crenezumab familial Alzheimer’s healthy pts T + CD47 MAb r/r AML RG7921 - nAMD RG7906 ralmitaront schizophrenia T + Venclexta maintenance 1L ES-SCLC 4D-MT 4D-R125 X-linked retinitis pigmentosa RG7935 prasinezumab Parkinson's RG7461 simlukafusp alfa combos solid tumors CHU PTH1 recep. ago hypoparathyroidism RG6147 - geographic atrophy Venclexta + AMG176 AML CHU - hyperphosphatemia RG6367 SPK-7001 choroideremia RG7601 Venclexta ± azacitidine r/r MDS RG7774 - retinal disease New Molecular Entity (NME) CardioMetabolism Venclexta + gilteritinib r/r AML Additional Indication (AI) Neuroscience IONIS ASO factor B geographic atrophy *Individualized Neoantigen Specific Immunotherapy; T=Tecentriq Oncology / Hematology Ophthalmology RG-No - Roche/Genentech SQZ - SQZ Biotechnology managed Immunology Other CHU - Chugai managed NOV - Novimmune managed 2 Status as of October 15, 2020 Infectious Diseases IONIS – IONIS managed 4D-MT - 4D-MT managed Roche Group development pipeline Phase III (12 NMEs + 34 AIs) Registration (5 NMEs + 11 AIs) RG6013 Hemlibra mild to moderate hemophilia A RG7446/ Tecentriq bTMB-high RG6264 Phesgo 1 Perjeta + Herceptin FDC SC HER2+ BC 1L NSCLC tiragolumab + T + chemo 1L SCLC RG6268 or entrectinib ROS1+ Gavreto (pralsetinib) 1 RET+ NSCLC RG6396 tiragolumab + T 1L PD-L1+ NSCLC Venclexta r/r MM t(11:14) Gavreto (pralsetinib) 2 RET+ MTC RG6058 RG7601 tiragolumab + T locally advanced esophageal cancer Venclexta + azacitidine 1L MDS Tecentriq Dx+ 1 1L sq + non-sq NSCLC RG7446 tiragolumab + T .stage III unresectable 1L NSCLC RG7853 Alecensa ALK+ NSCLC adj Tecentriq+ Avastin 1 1L HCC RG6107 crovalimab PNH RG1569 Actemra COVID-19 pneumonia RG7601 Venclexta + azacitidine 1L AML RG6114 mPI3K alpha inh 1L HR+ mBC RG1569 Actemra + remdesivir COVID-19 pneumonia RG7853 Alecensa 1LNSCLC Dx+ RG6171 SERD (3) ER+/HER2- mBC RG3648 Xolair food allergy Xolair 3 nasal polyps RG3648 ipatasertib + abiraterone 1L CRPC RG7159 Gazyva lupus nephritis Xolair 2 asthma home use ipatasertib + chemo 1L TNBC/HR+ BC RG7413 etrolizumab Crohn’s Xofluza 1 influenza RG7440 ipatasertib + fulvestrant + palbociclib 1L HR+ mBC Xofluza influenza, hospitalized pts Xofluza 1 influenza, high risk RG6152 ipatasertib + Tecentriq + taxane 1L TNBC RG6152 Xofluza influenza, pediatric (0-1 year) Xofluza influenza post exposure prophylaxis RG7596 Polivy 1L DLBCL Xofluza influenza direct transmission Xofluza 2 influenza, pediatric (1-12 yrs) RG6413+ 3 Tecentriq NSCLC adj REGN-COV2 nABs SARS-CoV2 prophylaxis RG1594 Ocrevus short infusion RMS & PPMS RG6412 Tecentriq NMIBC, high risk RG6168 Enspryng (satralizumab) 1 NMOSD RG1450 gantenerumab Alzheimer’s Tecentriq RCC adj RG7916 Evrysdi (risdiplam) 1 SMA RG6042 tominersen Huntington’s Tecentriq + cabozantinib advanced RCC port delivery system with ranibizumab . wAMD Tecentriq + cabozantinib 2L NSCLC 1 RG6321 port delivery system with ranibizumab . DME Approved in US, filed in EU T ± chemo SCCHN adj RG7446 port delivery system with ranibizumab DR 2 Filed in US Tecentriq HER2+ BC neoadj faricimab DME 3 T + capecitabine or carbo/gem 1L TNBC RG7716 Filed in US, approved in EU faricimab wAMD T + paclitaxel TNBC adj New Molecular Entity (NME) CardioMetabolism T + nab-paclitaxel TNBC neoadj Additional Indication (AI) Neuroscience T + Avastin HCC adj Oncology / Hematology Ophthalmology Immunology Other T ± chemo 1L mUC Infectious Diseases T=Tecentriq 3 Status as of October 15, 2020 NME submissions and their additional indications Projects in phase II and III Port Delivery System tiragolumab + TLR7 ago (3) RG7907+ RG6321 with ranibizumab RG6058 Tecentriq (T) + CpAM (2) RG7854 wAMD 1L PD-L1+ cervical ca HBV Xofluza ✓ rhPTX-2 RG6413+ REGN-COV2 Crovalimab tiragolumab + T FGFR1 x KLB MAb RG6152 influenza, pediatric RG6107 RG6058 RG7992 RG6354 (PRM-151) SARS-CoV2 prophylaxis PNH 1L PD-L1+ NSCLC NASH (1-12 yrs) RG6412 IPF Xofluza ✓ REGN-COV2 tiragolumab + T rhPTX-2 RG6413+ tominersen ralmitaront RG6152 influenza post-exposure COVID-19+ RG6042 RG6058 locally adv esophageal RG7906 RG6354 (PRM-151) RG6412 Huntington’s schizophrenia prophylaxis adult-ambulatory cancer myelofibrosis REGN-COV2 tiragolumab + T microdystrophin Evrysdi (risdiplam) RG6413+ gantenerumab ST2 MAb RG7916 COVID-19+ RG1450 RG6058 Stage III unresectable 1L RG6356 SRP-9001 RG6149 SMA (EU) RG6412 Alzheimer‘s asthma adult-hospitalized NSCLC DMD Gavreto Xofluza semorinemab etrolizumab mPI3K alpha inh Anti-tryptase RG6396 (pralsetinib) ✓ RG6152 influenza, pediatric RG7413 RG6114 RG6100 (Tau MAb ) RG6173 Crohn’s 1L HR+ BC asthma RET+ NSCLC (0-1 year) Alzheimer’s Gavreto Xofluza Xofluza iNeST** prasinezumab fenebrutinib RG6396 (pralsetinib) ✓* RG6152 RG6152 RG6180 RG7935 RG7845 influenza, hospitalized direct transmission
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