Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Investor Presentation (October 2026)
34 slides from Cardiff Oncology's investor presentation, October 2026
Slide 1: Company Overview: The Onvansertib Opportunity
Company Overview The Onvansertib Opportunity OCTOBER 2026
Slide 2: Forward-looking statements
Forward-looking statements Certain statements in this presentation are forward-looking within dependence on key personnel; limited experience in marketing and the meaning of the Private Securities Litigation Reform Act of 1995. sales; substantial competition; uncertainties of patent protection and T
Slide 3: Onvansertib: Highly selective oral PLK1 inhibitor for first-line RAS-mutated mCRC
Onvansertib: Highly selective oral PLK1 inhibitor for first-line RAS-mutated metastatic colorectal cancer Strong Efficacy in Practice Changing Clear Registrational Path RAS-mutated mCRC Potential 72% ORR in randomized first- Large commercial opportunity Successful EOP2 FDA meeting: line Ph 2 trial,
Slide 4: Positioned to address the first-line RAS-mutated mCRC market
Positioned to address the first-line RAS-mutated mCRC market ~150,000 newly diagnosed CRC patients in U.S.; 20% present metastatic disease* 1st Line Standard-of-Care Remains Unchanged for Two Decades Blockbuster potential: Chemotherapy Bevacizumab (FOLFOX/FOLFIRI/FOLFOXIRI) Onvansertib RAS- RAS (Ava
Slide 5: Onvansertib: First-line RAS-mutated mCRC
ONVANSERTIB FIRST-LINE RAS-MUTATED mCRC Mechanistic Rationale for FOLFIRI/bev Combination Positive Data from the Phase 2 CRDF-004 Trial Broader Opportunity 5
Slide 6: Multiple MOAs underlie onvansertib activity in RAS-mutated mCRC
Multiple MOAs underlie onvansertib activity in RAS-mutated mCRC Two clinical studies demonstrate improved outcomes with FOLFIRI/bev in bev-naïve patients, validating combination synergy Onvansertib targets RAS-mutated mCRC in three potential ways 1 Synthetic lethality in RAS-mut background RAS-mut m
Slide 7: Onvansertib: First-line RAS-mutated mCRC
ONVANSERTIB FIRST-LINE RAS-MUTATED mCRC Mechanistic Rationale for FOLFIRI/bev Combination Positive Data from the Phase 2 CRDF-004 Trial Broader Opportunity 7
Slide 8: CRDF-004 Phase 2 trial: key goals/endpoints achieved
CRDF-004 Phase 2 trial: key goals/endpoints achieved Primary Goal: Primary Endpoint: Secondary Endpoint: DOSE + CHEMO SELECTION ORR PFS 30% absolute Median PFS not yet 30 mg onvansertib improvement reached vs SoC + FOLFIRI/bev in ORR Efficacious and tolerable 30 mg onvansertib + 9 of 14 patients rem
Slide 9: CRDF-004: dose-finding, randomized, controlled Phase 2 trial design
CRDF-004: dose-finding, randomized, controlled Phase 2 trial in first-line patients with RAS-mutated mCRC INCLUSION CRITERIA 6 RANDOMIZATION ARMS ONVANSERTIB 28 27 FOLFIRI + bev 26 • First-line mCRC FOLFIRI + bev + Onv 20mg 25 First-line SoC: • KRAS+/NRAS+ FOLFIRI + bev + Onv 30mg 24 Chemo + 6 • No
Slide 10: Demographics and baseline characteristics
Demographics and baseline characteristics Onv 20 mg + Onv 30 mg + Onv 20 mg + Onv 30 mg + FOLFIRI/bev FOLFOX/bev FOLFIRI/bev FOLFIRI/bev FOLFOX/bev FOLFOX/bev (N=19) (N=18) (N=18) (N=18) (N=18) (N=19) Age (years) Mean (SD) 55.41 (14.34) 52.41 (13.13) 59.67 (12) 56.24 (12.04) 59.41 (14.5) 60.11 (14.1
Slide 11: As of March 18, 2026 data cut-off, 13 of 14 remaining patients continue
As of the March 18, 2026 data cut-off, 13 of 14 remaining patients continue on onvansertib + SoC chemo/bev Onv 20mg + Onv 30mg + Onv 20mg + Onv 30mg + Population, n FOLFIRI/bev FOLFOX/bev Total FOLFIRI/bev FOLFIRI/bev FOLFOX/bev FOLFOX/bev Intent-to-treat (ITT) 19 18 18 18 18 19 110 Safety populatio
Slide 12: Onv 30 mg + FOLFIRI/bev delivers superior ORR and depth of response
Onv 30 mg + FOLFIRI/bev delivers superior ORR & depth of response: 30% improvement in ORR over FOLFIRI/bev Objective Response Rate (per BICR) - ITT Analysis Onv 20 mg/Onv 30 mg + FOLFIRI/bev (n=36) Combined ORR: 58.3% (21) FOLFIRI/bev Onv 20 mg + FOLFIRI/bev Onv 30 mg + FOLFIRI/bev (n=19) (n=18) (n=
Slide 13: Onv 30 mg + FOLFIRI/bev demonstrates longer duration of treatment
Onv 30 mg + FOLFIRI/bev demonstrates longer duration of treatment 9 of 10 remaining patients on onv + FOLFIRI/bev > (FOLFIRI/bev) Control Arm (n=19) Time on Trial by Best Confirmed Response Complete Response Partial Response Stable Disease > On Treatment > > First Response Scan > > FOLFIRI/bev Onv 2
Slide 14: Onv 30 mg + FOLFIRI/bev demonstrates deep and durable tumor shrinkage
Onv 30 mg + FOLFIRI/bev demonstrates deep and durable tumor shrinkage over time Control Arm (FOLFIRI/bev) Onv 20 mg + FOLFIRI/bev Onv 30 mg + FOLFIRI/bev (n=19) (n=18) (n=18) Best Confirmed % Change in target lesions from baseline Response Complete Response Partial Response Stable Disease > > > On T
Slide 15: Onv (20 & 30 mg) + FOLFIRI/bev shows improved PFS vs SoC
Onv (20 & 30 mg) + FOLFIRI/bev shows improved PFS vs SoC (FOLFIRI/bev & FOLFOX/bev) BICR Assessment Investigator Assessment Onv (30mg & 20mg) + FOLFIRI/bev Onv (30mg & 20mg) + FOLFIRI/bev Combined SoC (FOLFIRI/bev & FOLFOX/bev) Combined SoC (FOLFIRI/bev & FOLFOX/bev) No. at risk No. at risk FOLFIRI/
Slide 16: Onv 30 mg + FOLFIRI/bev shows improved PFS vs FOLFIRI/bev
Onv 30 mg + FOLFIRI/bev shows improved PFS vs FOLFIRI/bev BICRAssessment BICR Assessment Investigator InvestigatorAssessment Assessment Onv 30 mg + FOLFIRI/bev Onv 30 mg + FOLFIRI/bev FOLFIRI/bev FOLFIRI/bev Onv 30 mg + Onv 30 mg + FOLFIRI/bev FOLFIRI/bev FOLFIRI/bev FOLFIRI/bev N 19 18 N 19 18 Medi
Slide 17: Consistent ORR (BICR) benefit across subgroups
Consistent ORR (BICR) benefit across subgroups with Onv 30 mg + FOLFIRI/bev Onv 30 mg + FOLFIRI/bev vs FOLFIRI/bev Level N Difference in ORR (95% CI) Favors treatment group Favors control group 17 STAGE I at initial diagnosis excluded due to too few patients to meaningfully analyze.
Slide 18: Trends in PFS benefit across subgroups
Trends in PFS benefit* across subgroups with Onv 30 mg + FOLFIRI/bev Onv 30 mg + FOLFIRI/bev vs FOLFIRI/bev Level N Hazard ration (95% CI) * Progressive disease events were based on events of BICR and Investigator assessments. The earliest reported date was used for a conservative estimate STAGE I a
Slide 19: Onvansertib adds no consistent meaningful benefit to FOLFOX/bev
Onvansertib adds no consistent meaningful benefit to FOLFOX/bev Objective Response Rate (per BICR)a - ITT Analysis FOLFOX/bev Onv 20 mg + FOLFOX/bev Onv 30 mg + FOLFOX/bev (n=18) (n=18) (n=19) 44.4% (8) 55.6% (10) 47.4% (9) Confirmed ORR (n) Best confirmed Response CR Best % Change from Baseline PR
Slide 20: No unexpected, overlapping, or new toxicities with FOLFIRI/bev or FOLFOX/bev
Onvansertib shows no unexpected, overlapping, or new toxicities when added to FOLFIRI/bev or FOLFOX/bev Onv 20 mg + Onv 30 mg + Onv 20 mg + Onv 30 mg + FOLFIRI/bev FOLFOX/bev FOLFIRI/bev FOLFIRI/bev FOLFOX/bev FOLFOX/bev (N=17) (N=17) (N=17) (N=18) (N=17) (N=18) Number (%) of Participants: Any Grade
Slide 21: Mechanistic rationale for onvansertib's synergy with FOLFIRI but not FOLFOX
Mechanistic rationale for onvansertib's synergy with FOLFIRI but not FOLFOX Onvansertib may complement irinotecan via HIF1α suppression and inhibition of DNA repair pathways Topoisomerase I inhibitors (Irinotecan/SN38) Oxaliplatin + Onvansertib + Onvansertib Both suppress HIF1α → dual anti-angiogeni
Slide 22: Onvansertib study compares favorably to previous mCRC studies
Onvansertib study compares favorably to previous mCRC studies Data from positive first-line mCRC chemo/bev clinical trials by RAS-mutated status ORR PFS (months) Hazard Targeted agent Trial Trial population Exp. vs Ctrl. Exp. vs Ctrl. ratio Onvansertib Onv 30 mg + FOLFIRI/bev vs FOLFIRI/bev RAS muta
Slide 23: CRDF-004 Phase 2 trial: key goals/endpoints achieved
CRDF-004 Phase 2 trial: key goals/endpoints achieved Primary Goal: Primary Endpoint: Secondary Endpoint: DOSE + CHEMO SELECTION ORR PFS 30% absolute Median PFS not yet 30 mg onvansertib improvement reached vs SoC + FOLFIRI/bev in ORR Efficacious and tolerable 30 mg onvansertib + 9 of 14 patients rem
Slide 24: CRDF-005: Proposed pivotal trial in first-line RAS-mutated mCRC
CRDF-005: Proposed pivotal trial in first-line RAS-mutated mCRC FDA End-of-Phase 2 meeting completed in 2Q 2026 ENROLLMENT CRITERIA Onvansertib 30 mg + FOLFIRI/bevacizumab • First-line mCRC Randomized CRDF-005 1:1 • KRAS+/NRAS+ • No BRAF-V600 or MSI- H/dMMR • Unresectable FOLFIRI/bevacizumab • No pr
Slide 25: Competitive landscape: Onvansertib's unique position in first-line RAS-mutated mCRC
Competitive landscape: Onvansertib’s unique position in first-line RAS-mutated mCRC Current Standard of Care (FDA approved) Ongoing/planned Phase 3 in first-line mCRC RAS-mutated Onvansertib is the only program Chemotherapy Onvansertib + FOLFIRI + bev specifically for pan RAS-mut mCRC (FOLFOX/FOLFIR
Slide 26: Onvansertib: First-line RAS-mutated mCRC
ONVANSERTIB FIRST-LINE RAS-MUTATED mCRC Mechanistic Rationale for FOLFIRI/bev Combination Positive Data from the Phase 2 CRDF-004 Trial Broader Opportunity 26
Slide 27: Attractive pipeline opportunities for onvansertib
Attractive pipeline opportunities for onvansertib Onvansertib in combination with: Ph1 Ph2 Ph3 IIT sponsor Company-Sponsored Trials 1L mCRC FOLFIRI/bev (RAS-mut) and FOLFOX/bev Investigator-Initiated Trials* Rochester, R/R CMML Monotherapy Minnesota 1L mPDAC NALIRIFOX 2L SCLC Monotherapy 2L TNBC Pac
Slide 28: Encouraging early activity as monotherapy in relapsed/refractory CMML
Encouraging early activity as monotherapy in relapsed/refractory CMML Chronic Myelomonocytic Leukemia (CMML) • Aggressive hematologic malignancy (median age ~76; median survival <3 years) 10 • Overlapping features of MDS and MPN; marked by monocytosis, cytopenias, and bone marrow dysplasia 9 WBC Res
Slide 29: Upcoming key milestones
Upcoming key milestones 1H 2026 Reported detailed CRDF-004 Phase 2 data in first-line RAS-mutated mCRC • Announced registrational strategy and Phase 3 trial design following consultation with FDA Clinical & 2H 2026 • Feedback on registrational program from European Medicines Agency expected Regulato
Slide 30: Upcoming key milestones
Upcoming key milestones 1H 2026 Reported detailed CRDF-004 Phase 2 data in first-line RAS-mutated mCRC • Announced registrational strategy and Phase 3 trial design following consultation with FDA 2H 2026 Clinical & • Resolution of Nerviano dispute Regulatory • Feedback on registrational program from
Slide 31: Appendix: Ph 1b/2 trial in second-line KRAS-mutated mCRC
Appendix Ph 1b/2 trial in second-line KRAS-mutated mCRC 31
Slide 32: Ph 1b/2 trial in second-line KRAS-mutated mCRC combined onvansertib with FOLFIRI+bev
Ph 1b/2 trial in second-line KRAS-mutated mCRC combined onvansertib with FOLFIRI+bev ONVANSERTIB ENROLLMENT CRITERIA 28 27 26 Second-line mCRC 25 Second-line: 24 6 KRAS+ FOLFIRI + bevacizumab 23 7 Unresectable 22 28 DAY CYCLE 8 N=68 21 9 20 Second-line: 10 FOLFIRI + bevacizumab 11 ENDPOINTS 12 13 Pr
Slide 33: Bev-naïve patients treated with onvansertib + FOLFIRI/bev achieved higher response rates
Ph 1b/2 trial: Bev-naïve patients treated with onvansertib + FOLFIRI/bev achieved higher response rates Best Radiographic Response and Duration of Response* Historical controls** 66 evaluable patients (as of June 16, 2023) Bev- Bev- naïve exposed Bev-naïve: 15 of 66 patients (23%) Bev-exposed: 51 of
Slide 34: Bev-naïve patients treated with onvansertib + FOLFIRI/bev achieved longer mPFS
Ph 1b/2 trial: Bev-naïve patients treated with onvansertib + FOLFIRI/bev achieved longer mPFS Progression-free survival* Historical controls** 66 evaluable patients (as of June 16, 2023) Bev Bev naïve exposed mPFS (mo) 6.9−8.5 4.5−6.7 Bev-naïve mPFS 7.8 mo 15.0 mo Bev-exposed *Onvansertib mPFS are i
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