Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (January 2020)
30 slides from Cardiff Oncology's investor presentation, Jan 13, 2020
Slide 1: Trovagene Oncology Investor Presentation January 2020
Trovagene Oncology Investor Presentation January 2020
Slide 2: 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 3: Company At-A-Glance
Company At-A-Glance Clinical-stage oncology therapeutics company, developing onvansertib, an oral and highly- selective Polo-like Kinase 1 (PLK1) inhibitor San Diego, CA • Selectively targets PLK1, a proven therapeutic target; overexpressed in most cancers Nasdaq: TROV • Stops division of cancer cel
Slide 4: Investment Highlights
Investment Highlights Ovansertib 1st-in-class, 3rd-generation, safe and well-tolerated, oral PLK1 inhibitor that selectively targets the PLK1 enzyme and blocks cancer cell division Clinical Efficacy Demonstrated 3 ongoing clinical trials with demonstrated efficacy in patients who have developed resi
Slide 5: Significant Value Creation in 2020
Significant Value Creation in 2020 Efficacy From 3 Ongoing In 2020 Data Phase 2 Trials 5
Slide 6: 2020 Key Inflection Points
2020 Key Inflection Points 1H2020 Key Inflection Points Event Timing Colorectal Cancer: Phase 1b Safety and Efficacy Data January 25th Prostate Cancer: Phase 2 Efficacy Data February 13th Acute Myeloid Leukemia: Biomarker Data April 24th – 29th Prostate Cancer: Phase 2 and Correlative Biomarker Data
Slide 7: Onvansertib is a Platform for Value Creation
Onvansertib is a Platform for Value Creation ► Clinical Programs Based on Scientific Rationale: supported by preclinical and synergy data, and integration of biomarkers to rapidly assess response to treatment ► Addressing Significant Medical Needs: – overcome resistance to standard-of care drugs – e
Slide 8: Onvansertib Mechanism of Action
Onvansertib Mechanism of Action Inhibition of PLK1 causes arrest of cell Synergistic in combination with division and subsequent cell death1 chemotherapies and targeted therapeutics Zytiga® (abiraterone) ® Taxol® Avastin (paclitaxel) (bevacizumab) Venclexta® Cytarabine (venetoclax) Camptosar® Onvans
Slide 9: Optimal Attributes for a Safe and Effective Drug
Optimal Attributes for a Safe and Effective Drug 9
Slide 10: Indication: metastatic KRAS-Mutated Colorectal Cancer (mCRC)
Indication: metastatic KRAS-Mutated Colorectal Cancer (mCRC)
Slide 11: Improving Response and Progression-Free Survival in mCRC
Improving Response and Progression-Free Survival Metastatic Colorectal Cancer (mCRC) Establishing a Successful Path Forward: • Positive results from Phase 1b/2 trial may ► Only a 5% response rate to provide an opportunity for Phase 2b 1 standard-of-care FOLFOX/FOLFIRI registrational trial and Fast T
Slide 12: Rationale for Onvansertib + FOLFIRI/Avastin in KRAS-Mutated mCRC
Rationale for Onvansertib + FOLFIRI® /Avastin® in KRAS-Mutated Metastatic CRC ► Synthetic Lethality – CRC tumor cells harboring KRAS mutation are more Onvansertib Targets KRAS Mutations Through vulnerable to cell death with PLK1 inhibition Downstream Effects on Tumor Cell Division – Tumor cell viabi
Slide 13: Demonstrating Clinical Benefit in KRAS-Mutated CRC as Second-Line Treatment
Demonstrating Clinical Benefit in KRAS-Mutated CRC as New Second-Line Treatment Trial Design: Phase 1b/2, multi-center, open label trial in mCRC Onvansertib administered orally, Onvansertib + FOLFIRI®/ Phase 1b (n=18) days 1-5 every 14-days (2 courses Avastin® (bevacizumab) Phase 2 (n=26) of treatme
Slide 14: Clinical Data Shows Onvansertib Effectively Targets KRAS Mutations in CRC
Clinical Data Shows Onvansertib Effectively Targets KRAS Mutations in CRC Colorectal Cancer 1% G12D ► To-date, KRAS mutation decreased in all 6 patients st 6% 6% G12V completing their 1 cycle of onvansertib treatment 8% 39% G13D ► Mutations identified in these patients account for nearly 18% G12C 10
Slide 15: Decreases in Plasma KRAS Mutation Shown in All Patients
Decreases in Plasma KRAS Mutation Shown in All Patients Treated with Onvansertib 02-004 – KRAS G13D- 12mg/m2 02-005- KRAS G12V -12mg/m2 01-006- KRAS G12V – 12 mg/m2 50.0% 1.0% 0.20% 40.0% 0.8% 0.15% 30.0% 0.6% 0.10% 20.0% 0.4% 0.05% 10.0% 0.2% KRAS G13D MAF(%) KRAS G12V KRAS MAF(%) G12V KRAS MAF(%)
Slide 16: Indication: metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Indication: metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Slide 17: Overcoming Resistance and Extending Efficacy in mCRPC
Overcoming Resistance and Extending Efficacy Metastatic Castrate-Resistant Prostate Cancer (mCRPC) 1 Establishing a Successful Path Forward: • Positive results from Phase 2 trial may provide an opportunity for a Phase 2b registrational trial ► Resistance develops to standard-of- care therapy, Zytiga
Slide 18: Rationale for Onvansertib + Zytiga in mCRPC
Rationale for Onvansertib + Zytiga® in Metatstatic Castrate-Resistant Prostate Cancer (mCRPC) Onvansertib + Zytiga® (abiraterone) demonstrates synergy in mCRPC model (C4-2)1 Onvansertib + Zytiga® (abiraterone) significantly increases mitotic arrest1 A B Mitotic cells C Apoptotic cells Abi alone Abi
Slide 19: Overcoming Resistance and Extending Efficacy: Trial Design
Overcoming Resistance and Extending Efficacy Trial Design: Phase 2 multi-center, open label trial in mCRPC Cohort 1 (n=32) Efficacy Endpoint Onvansertib 18mg/m2 Days 1-5 (14-Day Cycle) 6 Cycles = 12 Weeks Onvansertib + Zytiga® Cohort 2 (n=32) Efficacy Endpoint Onvansertib 12mg/m2 Days 1-14 (21-Day C
Slide 20: Efficacy Demonstrated by PSA Disease Control and Radiographic Scan
Efficacy Demonstrated by PSA Disease Control and Confirmed by Radiographic Scan Best PSA Response ► Threshold for demonstrating e 20 n i l AR-V7 positive onvansertib efficacy: e s 0 a b AR-V7 negative – ≥20% of patients achieve primary m -20 o Met primary r f efficacy endpoint efficacy endpoint of P
Slide 21: Indication: Acute Myeloid Leukemia (AML)
Indication: Acute Myeloid Leukemia (AML)
Slide 22: Addressing the Need for New Treatment Options in Relapsed AML
Addressing the Need for New Treatment Options Relapsed Acute Myeloid Leukemia (AML) Establishing a Successful Path Forward: • Positive results from Phase 2 trial and Orphan Drug Designation may provide an 1 ► 5-year survival rate of only 25% opportunity for a Phase 2b registrational trial ► Standard
Slide 23: Providing a New, Safe and Effective Treatment
Providing a New, Safe and Effective Treatment Trial Design: Phase 2 multi-center, open label trial in AML Relapsed or Refractory Onvansertib 60mg/m2 Days 1-5 Onvansertib +Decitabine Patients (n=32) (21-28 Day Cycle) Efficacy Endpoint Primary: safety and preliminary efficacy Correlative Biomarker: As
Slide 24: Phase 1b Completed Trial Efficacy Summary
Phase 1b Completed Trial Efficacy Summary Patients Treated with ≥ 1 Cycle (n=36) Decitabine Arm 18 mg/m2 27 mg/m2 2 m / g m 2 1 2 m / Ongoing g m 8 1 CR 2 m / CRi g 2 m ► At the 4 higher dose levels (27 to 90 mg/m ), 7 CRp 2 CR/CRi was observed in: 2 MLFS m / g PR – 5 of 16 (31%) patients in the dec
Slide 25: Corporate
Corporate Bo * trovagene ONCOLOGY
Slide 26: Strong Patent Portfolio
Strong Patent Portfolio ► Core Technology: 3 Issued Patents to 2030 in US, Europe and Asia with extension to 2035 in US – Compound (onvansertib): US 8614220 – Salt forms of onvansertib: US 8648078 – Combinations with anti-neoplastic compounds: US 8927530 ► Evergreening: Combination Therapy – Exclusi
Slide 27: Business Development Strategy
Business Development Strategy Objective: Joint Development and Commercialization Partnerships Current Co-Research Collaboration ► Financial and clinical support for ► Co-research agreement with Nektar company-sponsored and/or investigator Therapeutics to evaluate onvansertib in sponsored (IST) studi
Slide 28: Financials
Financials 2019 Raised Capital & Clinical Research Commitment • $14.5 million • Q4’18 = $11.5M Quarter Ending Cash and Cash Equivalents • Q1’19 = $11.3M • Q2’19 = $10.8M • Q3’19 = $ 9.0M Estimated Quarterly Cash Burn • ~$4.0M 28
Slide 29: 2020 Key Inflection Points
2020 Key Inflection Points 1H2020 Key Inflection Points Event Timing Colorectal Cancer: Phase 1b Safety and Efficacy Data January 25th Prostate Cancer: Phase 2 Efficacy Data February 13th Acute Myeloid Leukemia: Biomarker Data April 24th – 29th Prostate Cancer: Phase 2 and Correlative Biomarker Data
Slide 30: Thank You
Thank You For additional information please contact: ir@trovagene.com 30