Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (July 2019)
32 slides from Cardiff Oncology's investor presentation, Jul 15, 2019
Slide 1: Forward-Looking Statements
Forward-Looking Statements Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend," or other si
Slide 2: Trovagene Oncology Developing First-in-Class, Third-Generation, Oral PLK1 Inhibitor
Trovagene Oncology Developing First-in-Class, Third-Generation, Oral PLK1 Inhibitor Robust, diversified pipeline with single molecule, onvansertib, addressing multiple cancer indications, each with significant medical need for new treatment options Preclinical data demonstrating efficacy of onvanser
Slide 3: Experienced Management Team
Experienced Management Team Drug Development Expertise + Biomarker Technology Thomas Adams, PhD Chief Executive Officer and Chairman Mark Erlander, PhD Chief Scientific Officer Vicki Kelemen Vice President Clinical Development
Slide 4: Our Vision: Rapidly Advancing Clinical Development Programs
Our Vision Rapidly Advancing Clinical Development Programs 2H 2019 3 clinical-stage programs Safety and efficacy data readouts Clinical data readouts from all 3 programs Phase 2 trials completed Registrational trials initiated Commercialization partner(s) FDA approval of onvansertib in at least 1 in
Slide 5: Demonstrated Operational Stability
Demonstrated Operational Stability Cost-Effective and Efficient Model Raised Capital & Clinical Research Commitment Q1-2, 2019 $8.0 million Cash and Cash Equivalents as of March 31, 2019 $11.3 million Estimated Quarterly Cash Burn $4.0 million Projected Cash Ending Q2, 2019 $10.8 million
Slide 6: Exclusive Global Rights to Onvansertib
Exclusive Global Rights to Onvansertib Licensed from Nerviano Medical Sciences (NMS) in 2017 Largest oncology research and development company in Italy; highly regarded throughout Europe and the U.S. Completed Phase 1 Solid Tumor Trial and IND Excellent R&D Reputation and Track Record Experts in Pro
Slide 7: Optimized Operations and Clinical Development
Optimized Operations and Clinical Development Leveraging Internal Expertise and External Resources 3 INDs in place (1 in each oncology division of the FDA); Orphan Drug Designation in AML Licensed drug with established safety and recommended Phase 2 dose Extensive in-vitro and in-vivo data package p
Slide 8: We Have the Perfect Target
We Have the Perfect Target Onvansertib – Polo Like Kinase 1 (PLK1) Inhibitor PLK1 Inhibitor Over-expressed in most cancers Only oral, first-in-class, third-generation PLK1 in clinical trials Preclinical data to support clinical development across multiple tumor types Proven target for cancer therape
Slide 9: Onvansertib Targets the PLK1 Enzyme
Onvansertib Targets the PLK1 Enzyme A Proven Drug Target and Overexpressed in Most Cancers High selectivity for PLK1, only Tested against >260 kinases; PLK1 only active target (IC50 of 2nM) PLK Member Onvansertib IC50* (M) PLK1 0.002 PLK2 > 10 PLK3 > 10 Small molecule (MW 648.60 Daltons) Selectivity
Slide 10: Onvansertib Benefiting from Class Experience
Onvansertib Benefiting from Class Experience 1st and 2nd generation PLK inhibitors demonstrated clinical activity, but were non-specific for PLK1 and had toxicity issues Product Attributes 1st and 2nd Generation PLK Inhibitors 3rd Generation Onvansertib Selectivity for PLK1 panPLK inhibition of PLK1
Slide 11: Onvansertib
Onvansertib First-in-Class, Third-Generation PLK1 with Best-in-Class Attributes
Slide 12: Diversified Pipeline with Clinical-Stage Programs
Diversified Pipeline with 3 Clinical-Stage Programs Opportunities in Leukemias/Lymphomas and Solid Tumors Preclinical Phase 1 Phase 2 Metastatic Castration-Resistant Prostate (CRPC) Phase 2 trial in combination with Zytiga® (abiraterone acetate)/prednisone - Ongoing Colorectal (CRC) Phase 1b/2 trial
Slide 13: Encouraging Initial Data and Near-Term Readouts
Encouraging Initial Data and Near-Term Readouts TROV-052 AML Phase 1b/2 Completion of 6 dose escalation cohorts with no dose-limiting toxicities Initial data demonstrating efficacy – complete response (CR) Determine recommended Phase 2 dose (Q4 2019) Enroll patients in Phase 2 (Q1-2 2020) TROV-053 m
Slide 14: Onvansertib Synergy May Enhance Efficacy of Standard-of-Care Therapies
Onvansertib Synergy May Enhance Efficacy of Standard-of-Care Therapies1 Acute Myeloid Leukemia Chronic Lymphocytic Leukemia Colorectal T-Cell Lymphoma Colorectal Breast Non-Small Cell Lung Acute Myeloid Leukemia Pancreatic Breast Ovarian Non-Small Cell Lung Leukemias (Acute Myeloid Leukemia) Leukemi
Slide 15: Phase 2 Trial: metastatic Castration-Resistant Prostate Cancer
Phase 2 Trial: metastatic Castration-Resistant Prostate Cancer
Slide 16: Onvansertib Market Opportunity in mCRPC
Onvansertib Market Opportunity in mCRPC Significant Disease Burden - Need for More Effective Treatment Options Disease Burden Treatment Opportunity 1 of 6 men will be diagnosed with prostate cancer2 25,000 men die from metastatic prostate cancer annually2 5-year survival rate is 37%2 Standard-of-car
Slide 17: Phase 2 Clinical Trial in mCRPC
Phase 2 Clinical Trial in mCRPC Disease Control Assessed by PSA Stabilization or Decline Dosing Schedule Duration Efficacy Endpoint Efficacy Endpoints: Effect of onvansertib in combination with Zytiga®/prednisone on disease control assessed by prostate-specific antigen (PSA) decline or stabilization
Slide 18: Early PSA Response Observed
Early PSA Response Observed Addition of Onvansertib to Daily Zytiga® 6 patients have completed 4 cycles (3 months) of treatment with onvansertib + abiraterone 2 of 6 patients had observed declines in PSA levels after dosing with onvansertib To-date, 1 patient in Arm A has achieved the efficacy endpo
Slide 19: Phase 1b/2 Trial: metastatic Colorectal Cancer
Phase 1b/2 Trial: metastatic Colorectal Cancer
Slide 20: Onvansertib Market Opportunity in mCRC
Onvansertib Market Opportunity in mCRC Only 5% Response to Current Second-Line Therapies Disease Burden Treatment Opportunity 140,000 new cases of CRC in 20181 65% 5-year survival1 ~51,000 deaths per year from mCRC1 Tumor biomarkers drive therapy decisions for 1st-line mCRC therapy2 ~50% mCRC has RA
Slide 21: Synergy in Combination with Irinotecan
Synergy in Combination with Irinotecan Preclinical Data Demonstrates Reduced Tumor Growth Combination of onvansertib with irinotecan (FOLFIRI) significantly reduces tumor growth compared to either drug alone In 3 independent models tested, onvansertib induced maximal tumor regression of ~84% compare
Slide 22: Phase 1b/2 Clinical Trial in mCRC
Phase 1b/2 Clinical Trial in mCRC Objective Response Rate (ORR) in Second-Line Treatment Phase 1b: Dose escalation to assess safety and identify recommended Phase 2 dose Administered orally, once-daily on Days 1-5 every 14-days (2 courses per 28-day cycle) 12 mg/m2 15 mg/m2 18 mg/m2 Phase 2: Assess
Slide 23: Phase 1b/2 Trial: Acute Myeloid Leukemia
Phase 1b/2 Trial: Acute Myeloid Leukemia
Slide 24: Onvansertib Market Opportunity in AML
Onvansertib Market Opportunity in AML Providing a New Treatment for Relapsed/Refractory Patients Disease Burden Treatment Opportunity 20,000 new cases annually 5-year survival rate of only 25%1 Aggressive blood cancer that usually occurs in the elderly1 Today’s standard-of-care for elderly AML patie
Slide 25: Phase 1b/2 Clinical Trial in AML
Phase 2: Assess safety and preliminary antitumor activity Efficacy Endpoints: Rate of complete response (CR + CRi) defined as morphologic leukemia-free state (MLF) Exploratory Endpoints: Evaluation of pharmacodynamic and correlative biomarkers Phase 1b/2 Clinical Trial in AML Onvansertib + Low-Dose
Slide 26: Patients Achieving Complete Response
Patients Achieving Complete Response Onvansertib is Safe and Well Tolerated Of the 26 patients evaluable for safety, 19 had an evaluable bone marrow biopsy to assess efficacy Preliminary efficacy in the evaluable population includes 3 patients achieving complete response (CR) and 1 patient achieving
Slide 27: Biomarker Evaluates Inhibition of PLK1
Biomarker Evaluates Inhibition of PLK1 Identifies Patients Most Likely to Respond to Treatment Blood test examines the extent that onvansertib inhibits PLK1 enzymatic activity (target engagement) by assessing the phosphorylated status of TCTP within circulating leukemic blast cells TCTP antibody (ca
Slide 28: Biomarker to Assess Inhibition of PLK1
Biomarker to Assess Inhibition of PLK1 Correlation of Biomarker+ Patients with Treatment Response PLK1 inhibition can be monitored in patients through pTCTP status to determine target engagement of onvansertib with PLK1 pTCTP as a marker of PLK1 activity: PLK1 phosphorylates the translational contro
Slide 29: Biomarker-Positive Patients Significantly Correlated with Treatment Response
Biomarker-Positive Patients Significantly Correlated with Treatment Response PLK1 inhibition by onvansertib (target engagement) is correlated with higher response to treatment Patients with target-engagement had a significantly greater decrease in BM blasts compared to patients with no target-engage
Slide 30: Trovagene Oncology Developing First-in-Class, Third-Generation, Oral PLK1 Inhibitor
Trovagene Oncology Developing First-in-Class, Third-Generation, Oral PLK1 Inhibitor Robust, diversified pipeline with single molecule, onvansertib, addressing multiple cancer indications, each with significant medical need for new treatment options Preclinical data demonstrating efficacy of onvanser
Slide 31: Thank You
Thank You For additional information please contact: ir@trovagene.com
Slide 32: Thank You
Thank You Bo : trova g e Al e For additional information please ONCOLOGY contact: ir@trovagene.com