Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (June 2017)
25 slides from Curis's investor presentation, Jun 7, 2017
Slide 1: Corporate Presentation June 2017
Corporate Presentation June 2017 Exhibit 99.1
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements about Curis, Inc. (“we,” “us,” or the “Company”) that are intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Words such as “expect(s),”
Slide 3: Mission: Innovative Medicines to Treat Cancer Effectively
Mission: Innovative Medicines to Treat Cancer Effectively Precision Oncology Oncology-Focused Biotech Pipeline of differentiated small molecule cancer drug candidates Developing and intend to commercialize oncology drugs Partnerships: Aurigene, Genentech/Roche Immuno-oncology
Slide 4: Pipeline: Immuno-oncology and Precision Oncology
Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL MYC-Driven Solid Tumors CA-170 * PD-L1 / VISTA Solid Tumors & Lymphomas CA-327 * PD-L1 / TIM3 Cancers CA-4948 * IRAK4 Hematologic malignancies Erivedge® ** Smoothened Advanced
Slide 5: CUDC-907 has the potential to become a treatment for MYC-altered cancers
CUDC-907 has the potential to become a treatment for MYC-altered cancers CUDC-907 Phase 2 drug candidate to treat MYC-driven cancers Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL MYC-Driven Solid Tumors
Slide 6: CUDC-907: oral inhibitor of HDAC and PI3K enzymes
HDACi PI3Ki CUDC-907 Oral, small molecule inhibitor of HDAC & PI3K enzymes Down-regulates MYC mRNA and protein levels Phase 1 heme study completed (88 patients) – relapsed/ refractory (R/R) lymphoma or multiple myeloma Objective responses (multiple CRs and PRs) in certain patients with R/R DLBCL, in
Slide 7: CUDC-907 Phase 1 Efficacy: responses correlated with MYC alterations in DLBCL
CUDC-907 Phase 1 Efficacy Monotherapy responses correlated with MYC alterations in DLBCL Data as of March 15, 2016 -- presented at 2016 EHA 18 of 25 R/R DLBCL patients treated with monotherapy were evaluable for assessment (2 CR, 6 PR, 4 SD) MYC status assessed by FISH or IHC MAXIMUM CHANGE IN TUMOR
Slide 8: CUDC-907 Phase 2 Trial: monotherapy in MYC-altered relapsed/refractory DLBCL
CUDC-907 Phase 2 Trial Monotherapy in MYC-altered relapsed/refractory DLBCL Open label study to evaluate the efficacy and safety of CUDC-907 monotherapy in patients with relapsed/refractory (R/R) DLBCL – after 2 prior treatments Primary endpoint: ORR, based on up to 60 MYC-altered R/R DLBCL patients
Slide 9: CA-170 is a first-in-class oral small molecule immune checkpoint inhibitor
CA-170 is a first-in-class oral small molecule immune checkpoint inhibitor In Phase 1 clinical development CA-170 Oral, small molecule checkpoint inhibitor – PDL1 and VISTA Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-170 PD-L1 / VISTA Solid Tumors & Lympho
Slide 10: Small Molecule Checkpoint Inhibitors
Small Molecule Checkpoint Inhibitors Oral, small molecules designed to bind inhibitory checkpoints Common folding structure in the extracellular domain PD-L1Expressed on immune and tumor cells VISTAExpressed on myeloid cells, including MDSCs TIM3Co-expressed with PD-1 on highly exhausted CD8+ T cell
Slide 11: CA-170 is a Checkpoint Inhibitor
CA-170 Concentration (log nM) Activation (%) CA-170 is a Checkpoint inhibitor Ex-vivo and in vivo T cell activation and anti-tumor activity Increase in Activated CD8+ T cells In vivo Activation of PDL1 or VISTA-inhibited T cells Activation (%) CA-170 Concentration (log nM) Anti-Tumor Activity In viv
Slide 12: CA-170 Phase 1 Trial: dose escalation stage
CA-170 Phase 1 Trial Dose escalation stage Patient Population Patients with advanced solid tumors or lymphoma Study sites in US, EU, and Asia Objectives Safety/Tolerability, PK, PD, Recommended Phase 2 Dose (RP2D), anti-cancer activity Treatment Oral, once daily, dosing in continuous 21-day cycles D
Slide 13: CA-170 Oral Exposure in Patients
CA-170 Oral Exposure in Patients 50mg – 800mg dose – continuous once daily dosing PK profile in patients is similar to PK observed in non-clinical models Cmax and AUC at 50mg starting dose in patients is similar to 10mg/kg dose in mouse (active dose) Dose proportional increase in exposure with incre
Slide 14: CA-170 is a Checkpoint Inhibitor in Patients
CA-170 is a Checkpoint Inhibitor in Patients Increase in T cells in Tumor Increase in CD8+ T cells in patient tumor biopsies after CA-170 treatment Assessed after first cycle of CA-170 treatment at 600mg dose (21 days) Patient with colorectal cancer, 5 prior treatments; immunotherapy treatment-naïve
Slide 15: CA-170 Phase 1b Trial: dose expansion design and plans
CA-170 Phase 1b Trial Dose expansion design and plans Melanoma NSCLC RCC HL TNBC HNSCC CRC Bladder Gastric + Etc CA-170 Treatment Clinical Parameters Tumor and Immune Profile Parameters Tumor shrinkage Duration on treatment AE / irAE profile Tumor infiltrate profile Gene expression profile Expressio
Slide 16: CA-327 is an oral, small molecule immune checkpoint inhibitor
CA-327 is an oral, small molecule immune checkpoint inhibitor IND filing expected in 2H 2017 CA-327 Oral, small molecule checkpoint inhibitor – PDL1 and TIM3 Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-327 PD-L1 / TIM3 Cancers
Slide 17: CA-327 Is a Checkpoint Inhibitor
CA-327 Is a Checkpoint Inhibitor Selectively targets PDL1 and TIM3 CA-327 Vehicle Blood CD8+/CD69+ T cells Vehicle Control Anti-PD1 Antibody 1mg/kg CA-327 Tumor CD8+/CD69+ T cells Vehicle Control Anti-PD1 Antibody 1mg/kg CA-327 Tumor Model Treatment % TGI at Dose (mg/kg) 1 3 10 B16F10 melanoma CA-32
Slide 18: CA-4948 is an oral, small molecule inhibitor of IRAK4
CA-4948 is an oral, small molecule inhibitor of IRAK4 IND filing expected in 3Q 2017 (Phase 1 trial in Non-Hodgkin’s Lymphoma) CA-4948 Oral, small molecule inhibitor of IRAK4 Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-4948 IRAK4 Heme malignancies
Slide 19: IRAK4 kinase in TLR and IL-1R signaling pathways
IRAK4 kinase is a critical component of toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways – implicated in certain cancers IRAK4 kinase, through IRAK1 is critical for NF-kB activation for cytokine secretion & cell survival Recruitment of IRAK4 to TLR/ IL-1R mediated by MY
Slide 20: Prevalence of Oncogenic MYD88 Mutations
Prevalence of Oncogenic MYD88 Mutations Non-Hodgkin lymphomas Indication MYD88-L265P Diffuse Large B-cell Lymphoma (ABC-DLBCL) 15-29% Immune-privileged DLBCL (IP-DLBCL) 50-80% Waldenstrom’s Macroglobulinemia (WM) 95-97% Lymphoplasmacytic Lymphoma (LPL) 79% Splenic Marginal Zone Lymphoma (SMZL) 6-10%
Slide 21: CA-4948 Exhibits Significant In vivo Activity
CA-4948 Exhibits Significant In vivo Activity MyD88-mutant DLBCL tumor models CA-4948 is a potent and selective IRAK4 inhibitor In vivo anti-tumor activity in multiple MYD88-mutant (MyD88-L265P) vs. MYD88-wt DLBCL tumor models
Slide 22: Immuno-oncology and Precision Oncology pipeline
Immuno-oncology and Precision Oncology Orally available small molecules * Licensed from Aurigene **Developed and marketed by Genentech (Curis receives royalty income) Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL MYC-Drive
Slide 23: 2017 Projected Milestones
CA-170 Phase 1 initial data, Clinical profilen Q3 2017 CUDC-907 Phase 2 interim data (ORR)n Q3 2017 CA-4948 IND filing n Q3 2017 CA-327 IND filing n Q4 2017 2017 Projected Milestones
Slide 24: Summary of Financials as of March 31, 2017
$60.8MCash & Marketable Securities 143.7MShares Outstanding - Basic 162.4MShares Outstanding - Fully Diluted* *Diluted Shares = 143.7M basic shares + 18.7M options Summary of Financials As of March 31, 2017
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