Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (January 2014)
28 slides from Curis's investor presentation, Jan 13, 2014
Slide 1: Corporate Overview
Exhibit 99.1 Corporate Overview January 13, 2014 NASDAQ: CRIS 0
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains statements about Curis’ future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results or events could differ
Slide 3: Clinical Pipeline
Clinical Pipeline Novel, Targeted Cancer Therapeutics Program Target Indications Preclinical Phase 1 Phase 2 Phase 3 Market Proprietary Programs Lymphomas and CUDC-907 HDAC/PI3K Phase 1 Multiple Myeloma Breast, Ovarian, CUDC-427 IAP Lymphomas, and Phase 1* Other Cancers Partnered Programs Advanced B
Slide 4: CUDC-907: Potent Inhibitor of HDAC and PI3K Enzymes
CUDC-907: Potent Inhibitor of HDAC and PI3K Enzymes 3
Slide 5: CUDC-907 Summary
CUDC-907 Summary Oral, first-in-class highly potent and selective inhibitor of HDAC and PI3K enzymes Preclinical highlights Inhibition of PI3K, MAPK and JAK/STAT pathways in hematologic tumor models Potential biomarkers predicting CUDC-907 sensitivity Hematological indications clinical highlights Ph
Slide 6: CUDC-907: Dual Activity against HDAC & PI3K
CUDC-907: Dual Activity against HDAC & PI3K HDAC IC50 (nM) PI3K IC50 (nM) 1 1.7 2 5.0 Alpha 19 3 1.8 HDACi Moiety PI3Ki Moiety Delta 39 6 27 Beta 54 10 2.8 CUDC-907 4, 5, 7, 8, 9 >200 Gamma 311 • Full HDAC activity • Full PI3K activity O O R R R R HO H N 2 M1 M2 • ~ 30% PI3K activity as • ~ 80% PI3K
Slide 7: CUDC-907 & M2 Tissue Distribution in Mouse
CUDC-907 & M2 Tissue Distribution in Mouse Informs Clinical PK Model Differential kinetics & distribution of CUDC-907 & M2 metabolite M1 & M2 levels higher in plasma than CUDC-907 levels CUDC-907 is predominantly distributed to tissues Mouse 25 mg/kg Single Dose, PO CUDC-907 M2 6
Slide 8: CUDC-907: Phase 1 Clinical Design
CUDC-907: Phase 1 Clinical Design Phase 1 dose-escalation monotherapy study Relapsed/refractory lymphoma or multiple myeloma patients MSKCC (Anas Younes, MD), SCRI (Jesus Berdeja, MD), MDACC (Yasuhiro Oki, MD) 3+3 design 1o Objective Determination of MTD and recommended Phase 2 dose (RP2D) 2o Object
Slide 9: CUDC-907: Phase 1 Clinical PK
CUDC-907: Phase 1 Clinical PK Plasma levels of CUDC-907 & Metabolites Apparent increase in exposure with higher doses Differential kinetics of CUDC-907 & metabolites Higher M1 & M2 levels compared to CUDC-907 in plasma samples • Model: metabolites are generated from tissue-distributed CUDC-907 Poten
Slide 10: CUDC-907: Phase 1 Clinical Safety
CUDC-907: Phase 1 Clinical Safety Daily dosing schedule Common side effects consistent with target modulation – thrombocytopenia, diarrhea and fatigue MTD at 30mg dose level • Treatment-related AEs & dosing interruptions for thrombocytopenia and/or neutropenia 2 DLTs (G3 diarrhea & G4 hyperglycemia)
Slide 11: CUDC-907: Phase 1 Best Tumor Response
CUDC-907: Phase 1 Best Tumor Response Observed to-Date (Study Ongoing) 11 subjects were evaluable for response (i.e., 1 post-treatment response assessments) 1 subject with mixed FL/DLBCL achieved PR (70% reduction in target lesion) in Cycle 4 (30mg daily dose level) 7 subjects achieved SD 4 subjects
Slide 12: CUDC-907 Summary
CUDC-907 Summary Inhibitor of PI3K alpha, delta, beta and key HDAC enzymes Exclusive worldwide rights Potent activity in lymphoma and multiple myeloma models Phase 1 dose escalation completion projected mid 2014 Clinical PK as predicted from animal model studies Improved tolerability with intermitte
Slide 13: CUDC-427: Antagonist of IAP (Inhibitor of Apoptosis) Proteins
CUDC-427: Antagonist of IAP (Inhibitor of Apoptosis) Proteins 12
Slide 14: CUDC-427: Antagonist of IAP Proteins
CUDC-427: Antagonist of IAP Proteins In-licensed from Genentech, Nov. 2012 Exclusive, worldwide license No “call-back” or “reach-through” provisions Oral small molecule, monovalent SMAC mimetic drug candidate Targets and inhibits IAP proteins – cIAP1, cIAP2, XIAP, ML-IAP Synergy with chemotherapy or
Slide 15: CUDC-427 and Apoptosis Induction
CUDC-427 and Apoptosis Induction Extrinsic Oral small molecule drug Monovalent SMAC mimetic TNF Intrinsic Non- Canonical canonical Pathway Pathway Bid cIAPs cIAPs Bax/Bak Caspase-8 Mitochondria CUDC 427 Cytochrome C Caspase-9 Smac NF-kB Caspase-3, -7 XIAP ML-IAP Synergy with apoptosis- inducing agen
Slide 16: CUDC-427 Phase 1 Trial Summary
CUDC-427 Phase 1 Trial Summary Phase 1 monotherapy trial executed by Genentech Design Dose-escalation study in patients with refractory solid tumors or lymphoma 42 patients in 11 cohorts 5mg to 600mg once daily dosing, 14 days “on” and 7 days “off” schedule Results Dose proportional PK with no evide
Slide 17: CUDC-427 Phase 1 Trial – Clinical Activity
CUDC-427 Phase 1 Trial – Clinical Activity Two patients had complete response MALT lymphoma (300 mg): CR by PET let in Cycle 5 (off study – patient choice) Ovarian cancer (450 mg): CR end of Cycle 2 (off study due to AE, rash) Sustained CR per imaging Feb 2013 April 18, 2012 July 31, 2012 16
Slide 18: CUDC-427 Clinical Development Status
CUDC-427 Clinical Development Status Curis-initiated Phase 1 study using monotherapy continuous bi-daily administration schedule – July 2013 1 patient death due to liver failure – October 2013 FDA partial clinical hold – November 2013 Response to FDA in final preparation; submission shortly Further
Slide 19: CUDC-427 Summary
CUDC-427 Summary Potent antagonist of IAP proteins Exclusive worldwide rights Orally available small molecule drug Preclinical efficacy and synergy with chemotherapy or TNF Phase 1 monotherapy studies Discontinuous daily regimen well tolerated – (formal MTD not reached) • Clinical benefit observed i
Slide 20: Erivedge: First-in-class Hedgehog Pathway Inhibitor
Erivedge®: First-in-class Hedgehog Pathway Inhibitor 19
Slide 21: Erivedge Developed Under Collaboration
Erivedge® Developed Under Collaboration Genentech and Roche Erivedge (vismodegib) Oral inhibitor of Hedgehog signaling pathway Discovered under broad pathway collaboration formed in 2003 Approved for treatment of advanced basal cell carcinoma (BCC) Genentech/Roche-sponsored trial completed in less s
Slide 22: Erivedge Launched in Multiple Countries
Erivedge® Launched in Multiple Countries Genentech and Roche Marketed in the U.S. for the treatment of advanced BCC Roche recorded ~ $51 million net sales first 9 months 2013 • 32% growth 3Q ($21.4 million) vs. 2Q ($16.2 million) Anticipated continued sales growth in 2014 Near-term Erivedge royaltie
Slide 23: Roche Continues to Invest in Erivedge
Roche Continues to Invest in Erivedge Initiated Phase 1b/2 study of Erivedge in patients with AML and high-risk MDS in October 2013 Study design Approx. 60 patients across 2 cohorts • Cohort 1: 150 mg Erivedge daily • Cohort 2: 150 mg Erivedge daily + cytarabine for 10 days Primary endpoint: ORR aft
Slide 24: Debio 0932: Second Generation, Oral HSP90 Inhibitor
Debio 0932: Second Generation, Oral HSP90 Inhibitor Phase 1/2 DebioPharm 23
Slide 25: Debio 0932
Debio 0932 Oral Small Molecule Hsp90 Inhibitor Second generation oral small molecule Hsp90 inhibitor Exclusive worldwide license with Debiopharm $90 million in potential payments ($13 million received to-date) Royalties on net sales; share of certain sublicensing payments Clinical development status
Slide 26: CUDC-101 and EGFR Discovery Program
CUDC-101 and EGFR Discovery Program CUDC-101: EGFR/Her2 and HDAC inhibitor Strong preclinical evidence of synergistic inhibition of multiple signaling pathways Phase 1 and Phase 1b studies completed using intravenous administration • 71 patients as monotherapy – activity in liver cancer patients • 1
Slide 27: Summary Financial Data
Summary Financial Data September 30, 2013 (000’s) Cash, cash equivalents, investments (1) $ 67,100 Erivedge® secured debt (non-recourse to Curis) $ 30,600 Basic shares outstanding 84,100 Fully-diluted shares outstanding (2) 96,000 Net loss through September 30, 2013 $ (8,100) (1) Curis received an a
Slide 28: NASDAQ: CRIS
NASDAQ: CRIS 27