Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Investor Presentation (September 2020)
36 slides from Cardiff Oncology's investor presentation, Sep 22, 2020
Slide 1: Turning the Tide on Cancer
Turning the Tide on Cancer September 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: Cardiff Oncology At-A-Glance
Cardiff Oncology At-A-Glance Exchange Nasdaq: CRDF Cash & Clinical Trial Funding* $30.5M Common Stock Outstanding** 25.0M Clinical-stage biotech company, • Convertible Preferred 3.5M • Outstanding Options – weighted avg. exercise 1.9M developing onvansertib, an oral, price / share $7.65 highly-selec
Slide 4: Investment Highlights
Investment Highlights 3rd Generation, 1st-in-class, Strong Lead Program in Integrated Biomarker Diversified Pipeline Across Oral PLK1 Inhibitor KRAS-mutated mCRC Strategy Numerous Cancers Onvansertib overcomes the Supported by compelling preliminary Circulating Tumor DNA: changes in Clinical data fr
Slide 5: Experienced Management Team With Drug Development and Biomarker Technology Expertise
Experienced Management Team With Drug Development and Biomarker Technology Expertise Mark Erlander, PhD Vicki Kelemen Chief Executive Officer Chief Operating Officer Brigitte Lindsay Vice President of Finance 2020 Corporation Presentation I 5
Slide 6: Pipeline and Upcoming Catalysts
Pipeline and Upcoming Catalysts Indication Preclinical Phase 1b Phase 2 Next Milestone Onvansertib + FOLFIRI/Avastin® in Second-Line KRAS- Q1 2021 mCRC Mutated Metastatic Colorectal Cancer ASCO-GI Onvansertib Solid Tumor Programs ® Q1 2021 mCRPC Onvansertib + Zytiga (abiraterone)/prednisone in Zytig
Slide 7: Onvansertib
Onvansertib 3rd generation, 1st in class, oral and highly selective Polo-like Kinase 1( PLK1) inhibitor addressing unmet needs across a broad range of cancer indications
Slide 8: PLK1 is a Proven Therapeutic Target that is Overexpressed in Most Cancers
PLK1 is a Proven Therapeutic Target that is Overexpressed in Most Cancers • PLK1 is a serine/threonine kinase and master regulator of cell-cycle progression • PLK1 controls G2/mitosis (G2/M) checkpoint • Inhibition of PLK1 causes mitotic arrest and subsequent cell death • Emerging data demonstrate t
Slide 9: Onvansertib has Best-in-class Drug Properties and Synergistically Combines with Standard-of-Care Therapies
Onvansertib has Best-in-class Drug Properties and Synergistically Combines with Standard-of-Care Therapies Synergistic in Combination with Standard-of- Best-in-Class Drug Properties Care Chemo and Targeted Therapies High Selectivity Zytiga® For PLK1 (abiraterone) Taxol® Avastin® (paciltaxel) (bevaci
Slide 10: Second-Line Treatment of KRAS-Mutated mCRC
Second-Line Treatment of KRAS-Mutated mCRC Phase 1b/2 open-label trial of onvansertib + FOLFIRI/bevacizumab Trial Sites: USC Norris Comprehensive Cancer Center; Mayo Clinic Cancer Centers Principal Investigator: Dr. Heinz-Josef Lenz
Slide 11: New Second-Line Therapies are Needed to Improve Response and Increase Progression-Free Survival
New Second-Line Therapies are Needed to Improve Response and Increase Progression-Free Survival 50% of patients with mCRC Prognosis is poor with a five- Other drugs currently in development have a KRAS mutation year survival rate of 10% do not address the most prevalent KRAS mutations in mCRC 4% Res
Slide 12: Synthetic Lethality: Cells with KRAS Mutations are Hypersensitive to Inhibition of PLK1
Synthetic Lethality: Cells with KRAS Mutations are Hypersensitive to Inhibition of PLK1 The output of the RAS-mutated pathway activates PLK1, which is inhibited by onvansertib Onvansertib Addresses KRAS Mutation Cell Viability in Onvansertib-Treated KRAS Mutant Subtypes in mCRC and Wild Type Isogeni
Slide 13: Synergy: Onvansertib in Combination with SOC Irinotecan and 5-FU
Synergy: Onvansertib in Combination with SOC Irinotecan and 5-FU Onvansertib works synergistically in combination with standard-of-care FOLFIRI (irinotecan and 5-FU) Synergy in Combination with Irinotecan Synergy in Combination with 5-FU SOC: Standard-of-care 2020 Corporation Presentation I 13
Slide 14: Phase 1b/2 Open Label Trial of Onvansertib + FOLFIRI/bevacizumab
Phase 1b/2 Open Label Trial of Onvansertib + FOLFIRI/bevacizumab Trial Design 1 CYCLE = 28 Days Treatment Course = 14 Days Treatment Course = 14 Days 1 2 3 4 5 6 - 14 1 2 3 4 5 6 - 14 Onvansertib Onvansertib FOLFIRI + bevacizumab FOLFIRI + bevacizumab Efficacy Endpoints What is Clinical Trial Succes
Slide 15: Response to Treatment Confirmed by Radiographic Scan
Response to Treatment Confirmed by Radiographic Scan Compelling Preliminary Efficacy Data Best Radiographic Response • 10 of 11 (91%) patients had clinical benefit: ‐ 5 (45%) patients achieved a partial response (PR) ‐ 4 patients had a confirmed PR (≥ 30% tumor shrinkage) with 1 patient going on to
Slide 16: Response to Treatment Confirmed by Progression-Free Survival
Response to Treatment Confirmed by Progression-Free Survival Durability of Response Response Appears Durable • 8 (73%) patients had durable responses of >6 months (range 6 12 to >12 months); 4 patients remain on treatment; median PFS has not yet been reached 15 • Only 1 patient progressed in <6 18 m
Slide 17: Serial Monitoring of KRAS is Predictive of Radiographic Scan Response
Serial Monitoring of KRAS is Predictive of Radiographic Scan Re Monitoring KRAS mutations in plasma ctDNA may enable rapid predictions of therapeutic response • KRAS mutant allelic frequency (MAF) was measured by digital droplet PCR (ddPCR) at baseline and at the end of Cycle 1 – 9 of 11 patients ha
Slide 18: KRAS-Mutated mCRC Expanded Access Program (EAP)
KRAS-Mutated mCRC Expanded Access Program (EAP) • Program initiated in June 2020 for a total of 20 patients • 11 sites participating across the US • Eligibility criteria includes: – Patients not meeting clinical trial inclusion criteria – Patients who have received 2 or more lines of prior treatment
Slide 19: Catalysts and Milestones: KRAS-Mutated mCRC
Catalysts and Milestones: KRAS-Mutated mCRC Positive Phase 1b/2 results may provide an opportunity for a Phase 2b registrational trial May 2020: Fast Track September 2020: ESMO January 2021: ASCO-GI Q1 2021: FDA meeting to Designation presentation data presentation (planned) discuss regulatory path
Slide 20: Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer Phase 2 open-label trial of onvansertib + abiraterone Trial Sites: Beth Israel Deaconess, Dana Farber, Mass General Principal Investigator: Dr. David Einstein
Slide 21: New Therapeutic Options are Needed to Overcome Resistance to SOC Androgen Receptor Signaling Inhibitors
New Therapeutic Options are Needed to Overcome Resistance to SOC Androgen Receptor Signaling Inhibitors (ARSi) Resistance develops to treatment with ARSi’s offer a median overall survival No effective treatment options are standard of care androgen receptor signaling (mOS) benefit of only ~4 months1
Slide 22: Onvansertib Extends the Response to Androgen Receptor Signaling Inhibitors
Onvansertib Extends the Response to Androgen Receptor Signaling Inhibitors Onvansertib works synergistically in combination with abiraterone and significantly increases mitotic arrest Onvansertib + Abiraterone Demonstrate Synergy in Onvansertib + Abiraterone Significantly Increase mCRPC model (C4-2)
Slide 23: Phase 2 Open Label Trial of Onvansertib + Abiraterone
Phase 2 Open Label Trial in of Onvansertib + Abiraterone Disease Control Assessed by PSA Stabilization Trial Design: Dosing Schedule Duration Efficacy Endpoint Onvansertib 24mg/m2 Days 1-5 (21-day Disease Control Cohort 1 (n = 24) 4 Cycles = 12 Weeks cycle) + Zytiga® (Abiraterone) (PSA Stabilization
Slide 24: Phase 2 Data Demonstrate the Efficacy of Onvansertib in mCRPC
Phase 2 Data Demonstrate the Efficacy of Onvansertib in mCRPC Arm A: 17 patients were evaluable for efficacy Treatment Response and Duration • 5 (29%) patients achieved disease control (DC) • 9 (53%) had radiographic stable disease (SD) including s s s 4 with durable SD (range 8 months – 1.7 years)
Slide 25: Onvansertib-Induced Circulating Tumor Cell Decrease is Associated with Progression-Free Survival
Onvansertib-Induced Circulating Tumor Cell Decrease is Associated with Progression-Free Survival Circulating tumor cell (CTC) count, reported as favorable or unfavorable (<5 versus ≥5 CTC/7.5mL of blood, respectively) is a prognostic factor for survival in CRPC – conversion from unfavorable to favor
Slide 26: Catalysts and Milestones: mCRPC
Catalysts and Milestones: mCRPC Positive Phase 2 results may provide an opportunity for a Phase 2b registrational trial October 2020: Prostate February 2021: ASCO-GU April 2021: AACR Q3 2021: FDA meeting to Cancer Foundation (PCF) presentation (planned) presentation (planned) discuss regulatory path
Slide 27: New Clinical Programs Planned
New Clinical Programs Planned Chronic Myelomonocytic Leukemia (CMML) Pancreatic Ductal Adenocarcinoma (PDAC)
Slide 28: Phase 2 Study to Evaluate Onvansertib in RAS-pathway Mutant CMML
Phase 2 Study to Evaluate the Safety and Efficacy of Onvansertib in RAS-pathway Mutant CMML Study Rationale • Proliferative CMML is enriched for activating RAS pathway Activating RAS Pathway Can Be Therapeutically mutations such as NRAS, KRAS, CBL, PTPN11 and NF1, Targeted with PLK1 Inhibitors all o
Slide 29: Phase 2 Two-Arm Randomized Trial of Onvansertib +/- Decitabine in RAS-Pathway Mutated CMML
Phase 2 Two-Arm Randomized Trial of Onvansertib +/- Decitabine in RAS- Pathway Mutated CMML Determine the safety and overall response rate (ORR) of onvanserib, a novel oral PLK1 inhibitor in RAS- pathway mutant chronic myelomonocytic leukemia Trial Design: Dosing Schedule Duration Efficacy Endpoint
Slide 30: Phase 2 Study of Onvansertib in Combination with 5-FU and Nal-IRI for Second Line PDAC
Phase 2 Study of Onvansertib in Combination with 5-FU and Nal-IRI for Second Line Treatment of KRAS-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Study Rationale • KRAS is the most common oncogene mutated in Mutant KRAS is Essential for PDAC Growth – pancreatic adenocarcinoma, which is
Slide 31: Phase 2 Open Label Trial of Onvansertib + 5-FU and Nanoliposomal Irinotecan in KRAS-Mutated PDAC
Phase 2 Open Label Trial of Onvansertib + 5-FU and Nanoliposomal Irinotecan in KRAS-Mutated PDAC Trial Design (35 patients): 1 CYCLE = 14 Days Treatment Course (Days) 1 2 3 4 5 6 - 14 Onvansertib 18mg/m2 5-FU + Nanoliposomal Irinotecan (nal-IRI) Eligibility Criteria What is Clinical Trial Success •
Slide 32: Corporate
& Cardiff Oncology” Corporate
Slide 33: Strong Patent Portfolio
Strong Patent Portfolio Core Technology: 3 Issued Patents Evergreening: Combination Evergreening: Biomarkers to 2030 in US, Europe and Asia, Therapy with anticipated extension to 2035 Method for assessing PLK1 target Exclusive license from MIT for 2 US issued phosphorylation status for identifying C
Slide 34: Cardiff Oncology At-A-Glance
Cardiff Oncology At-A-Glance Exchange Nasdaq: CRDF Cash & Clinical Trial Funding* $30.5M Common Stock Outstanding** 25.0M Clinical-stage biotech company, • Convertible Preferred 3.5M • Outstanding Options – weighted avg. exercise 1.9M developing onvansertib, an oral, price / share $7.65 highly-selec
Slide 35: Investment Highlights
Investment Highlights 3rd Generation, 1st-in-class, Strong Lead Program in Integrated Biomarker Diversified Pipeline Across Oral PLK1 Inhibitor KRAS-mutated mCRC Strategy Numerous Cancers Onvansertib overcomes the Supported by compelling preliminary Circulating Tumor DNA: changes in Clinical data fr
Slide 36: Thank You
Thank You for more information contact: ir@cardiffoncology.com
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