Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (May 2017)
23 slides from Cardiff Oncology's investor presentation, May 1, 2017
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 sim
Slide 2: About Trovagene
About Trovagene Precision medicine biotechnology company developing therapeutics to improve cancer care by leveraging our proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics Industry leader in urine and blood based tumor genomic diagnostics Broad intellectual property and pro
Slide 3: Trovagene Product Pipeline
Trovagene Product Pipeline CANDIDATE DEVELOPMENT STAGE R&D PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PCM-075 Acute Myeloid Leukemia (AML) PCM-075 Safety / Solid Tumors PCM-075 Other Cancers Therapeutics CANDIDATE DEVELOPMENT STAGE R&D VALIDATION MARKETED Trovera™ EGFR, KRAS, BRAF NSCLC, CRC, Melanoma, Pan
Slide 4: PCM-075: A PLK1 Inhibitor
PCM-075: A PLK1 Inhibitor PCM-075 is an oral, highly-selective polo-like kinase 1 (PLK1) inhibitor Licensed exclusive global development and commercialization rights from Nerviano Medical Sciences, S.r.l. Nerviano Medical Sciences: largest oncology-focused R&D company in Italy, highly regarded in Eu
Slide 5: PCM-075 Licensing Terms
PCM-075 Licensing Terms Trovagene has exclusive global development and commercialization rights to PCM-075 Nerviano receives: Upfront payment of $2.0 million Milestones Development: Phase 3 Regulatory: NDA submission Commercial Launch Tiered royalty payments up to and over $1.0 billion Trovagene has
Slide 6: Polo-Like Kinase
Polo-Like Kinase PLK1, PLK2, PLK3 are members of a family of serine/threonine kinases that are important regulators of cell-cycle progression1–5 PLK1 is a master regulator of mitotic progression and is the only family member expressed exclusively in dividing cells1–5 PLK1 regulates multiple steps of
Slide 7: PLK1 As a Cancer Target
PLK1 As a Cancer Target 1Nature Reviews Molecular Cell Biology; 2Translational Oncology, Feb 2017 Inhibition of PLK1 Results in Cell Death1 Overexpression of PLK1 Observed in Numerous Cancer Types2 PLK1 blocking
Slide 8: PCM-075 Attributes
PCM-075 Attributes Highly Selective Short Half-Life Acceptable Safety Profile Broad Applicability Orally Available
Slide 9: PCM-075 Biochemical Profile
PCM-075 Biochemical Profile Selective, adenosine triphosphate (ATP) competitive PLK1 inhibitor Selectivity driven by polar interaction with the carboxyl side chain of Glutamate 140 position of PLK1 Polo-like kinase 1 (PLK1) inhibitor * IC50 is the half-maximal concentration at which PCM-075 inhibits
Slide 10: PCM-075 Mechanism of Action
PCM-075 Mechanism of Action Induces a cellular phenotype of G2/M, leading to cell death Clear evidence of in-vitro pathway modulation in AML Mitotic inhibitor demonstrating anti-proliferative activity* AML-NS8 Patient-Derived Cells Treated with 200 nM PCM-075 for 24 Hrs1 * In numerous human cel line
Slide 11: PCM-075 In-Vivo Activity
PCM-075 In-Vivo Activity Response observed in various xenograft models as a single agent and in combination Compound Median Survival Time (days) %TGI Placebo 28 Cytarabine 38 128.6 PCM-075 62 221.4 In Vivo Disseminated Leukemia Model (AML-NS8 Cells) Treatment with PCM-075 Started 20 Days Post-Inocul
Slide 12: PLK Inhibition in AML
PLK Inhibition in AML Pan-PLK inhibitor demonstrated increased response rates, improvements in event-free survival, and overall survival benefit in combination with low-dose cytarabine (LDAC) Adverse events observed in Phase 3 study, potentially due to drug accumulation and pan-PLKi activity Opportu
Slide 13: AML Market Opportunity
AML Market Opportunity AML: aggressive hematologic malignancy Incidence: 20,000 new cases and 10,400 deaths annually in the U.S. Prognosis: 5 year survival rate is 25% Treatment options vary based on patient condition / age, but can include: Chemotherapy Radiation Stem cell transplant Genetic landsc
Slide 14: PCM-075 Clinical Development Plan
PCM-075 Clinical Development Plan Active IND for PCM-075 with clinical and regulatory organization engaged Phase 1/2 study planned with first patient to be dosed in 2017 Dose-escalation with PCM-075 as single agent and then in combination with chemotherapy agents to assess patient response and explo
Slide 15: Milestones
Milestones Q2 Launch of NextCollect™ Q2 FDA filing of IND for Phase 1/2 AML trial Q2 Pharma services collaborations Q3 Phase 1 solid tumor trial published Q3 FDA acceptance of IND for Phase 1/2 trial Q4 PCM-075 AML biomarker panel Q4 ASH Presentations Q4 First patient dosed in Phase 1/2 AML trial
Slide 16: PCM-075: Broad Clinical Opportunities
PCM-075: Broad Clinical Opportunities Extensive preclinical data supportive of: Hematologic cancers (leukemias and lymphomas) Solid tumor cancers (breast, colon, ovarian, lung) Mol Cancer Ther; 11(4) April 2012 IC50 values for inhibition of cell proliferation after treatment with PCM-075 in a panel
Slide 17: Trovagene ctDNA PCM Technology
Trovagene ctDNA PCM Technology Proprietary ctDNA technology allows us to uniquely measure, with high clinical sensitivity, circulating genetic fragments of cancer tumors Over 120 patents issued and 60 pending Only liquid biopsy company with ctDNA technology compatible in both urine and blood for pre
Slide 18: NextCollect
NextCollect™ Infectious Disease Transplant Urology Genetics Oncology First of its kind urine collection and DNA preservation system Comprehensive analysis of cell-free and cellular DNA Research use only (RUO) Opportunity for global distribution Urine collection and DNA preservation system
Slide 19: Monitoring of Cancer concordant with radiographic response
Monitoring of Cancer concordant with radiographic response Trovagene’s ctDNA tests can be effectively used to monitor therapeutic response NSCLC 3rd Generation TKI/EGFR T790M1 Histiocytic Tumor/BRAF Inhibitor2 1 Multiple peer-reviewed studies including Husain, Kurzrock et al, World Lung Conference,
Slide 20: AML Biomarker Strategy
AML Biomarker Strategy Trovagene to develop AML biomarker panel for clinical study NPM1 patent for diagnosis and monitoring of patient response owned by Trovagene Most other markers already assessed with ctDNA PCM technology Patient selection pre and post response to therapy Patel J, et al. Prognost
Slide 21: Summary
Summary PCM-075 Oral and highly-selective PLK1 inhibitor Favorable 24-hour half-life for AML treatment therapy with reversible hematologic toxicities Phase 1/2 trial planned for PCM-075 with first patient to be dosed in 2017 PCM diagnostic technology Development of PCM-075 AML biomarker panel Launch
Slide 22: Thank you
Thank you for more information, please email ir@trovagene.com
Slide 23: Thank you
6 TS Thank you ee for more information, please email ir@trovagene.com