Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Investor Presentation (February 2026)
39 slides from Cardiff Oncology's investor presentation, Feb 25, 2026
Slide 1: Company Overview: The Onvansertib Opportunity
Company Overview The Onvansertib Opportunity FEBRUARY 2026
Slide 2: Forward-looking statements
Forward-looking statements Certain statements in this presentation are forward-looking within the dependence upon third parties; and risks related to failure to obtain FDA meaning of the Private Securities Litigation Reform Act of 1995. These clearances or approvals and noncompliance with FDA regula
Slide 3: Unlocking a high-value oncology market: Highly selective PLK1 inhibitor
Unlocking a high-value oncology market: Highly selective PLK1 inhibitor with blockbuster potential in first-line RAS-mutant mCRC Onvansertib: Oral, highly selective Strong efficacy signal in first-line RAS- PLK1 inhibitor mutant mCRC • PLK1: key signaling target that impacts tumor cell • In ITT anal
Slide 4: CRC: High unmet need with limited therapies for RAS-mutated mCRC
CRC: High unmet need with limited therapies for RAS-mutated mCRC COLORECTAL CANCER 3 rd most common cancer worldwide 1st LINE STANDARD of CARE Annually in the United States Remains unchanged for two decades 150,000 55,000 No approvals for RAS-mutated mCRC Chemotherapy Bevacizumab new cases deaths (F
Slide 5: 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., Onvansertib targets ALL RAS-mutated mCRC with 20% present metastatic disease* Blockbuster potential: RAS- RAS 50% mutated Wild Type of first-line mCRC market ~50% ~50% *CDC G12C CRC, colorecta
Slide 6: 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 RAS-mutated MSS/pMMR RAS-mutated Onvansertib is the only program specifically Chemotherapy Onvansertib + FOLFIRI + bev designed for the RAS-mutated p
Slide 7: Onvansertib: First-line RAS-mutated mCRC
ONVANSERTIB FIRST-LINE RAS-MUTATED mCRC Mechanism Supports First-Line Treatment Promising Clinical Benefit in Ongoing CRDF-004 Trial Broader Opportunity for Onvansertib 7
Slide 8: Initially targeted 2nd line KRAS-mutated mCRC based on two known MOAs
Initially targeted 2nd line KRAS-mutated mCRC based on two known MOAs 1 Synthetic lethality in RAS-mut background RAS-mut mCRC tumor cells are hypersensitive to onvansertib 2 Synergy with chemo Onvansertib inhibits repair of chemo-induced DNA damage mCRC, metastatic colorectal cancer; MOA, mechanism
Slide 9: Ph 1b/2 trial in 2nd line KRAS-mut mCRC combined onvansertib with FOLFIRI+bev
Ph 1b/2 trial in 2nd line KRAS-mut mCRC combined onvansertib with FOLFIRI+bev ONVANSERTIB ENROLLMENT CRITERIA 28 27 26 Second-line mCRC 25 Second-line: KRAS+ 24 6 FOLFIRI + bevacizumab 23 7 Unresectable 22 28 DAY CYCLE 8 N=68 21 9 20 Second-line: 10 FOLFIRI + bevacizumab 11 ENDPOINTS 12 13 Primary:
Slide 10: Ph 1b/2 trial: Bev-naïve patients 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 11: Ph 1b/2 trial: Bev-naïve patients achieved higher mPFS
Ph 1b/2 trial: Bev-naïve patients treated with onvansertib + FOLFIRI/bev achieved higher 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
Slide 12: Multiple onvansertib MOAs underlie our focus on RAS-mutated CRC
Multiple onvansertib MOAs underlie our focus on RAS-mutated CRC Onvansertib attacks RAS-mutated mCRC in three ways 1 Synthetic lethality in RAS-mut background RAS-mut CRC tumor cells are hypersensitive to onvansertib 2 Synergy with chemo Onvansertib inhibits repair of chemo-induced DNA damage 3 Syne
Slide 13: Onvansertib: First-line RAS-mutated mCRC
ONVANSERTIB FIRST-LINE RAS-MUTATED mCRC Mechanism Supports First-Line Treatment Promising Clinical Benefit in Ongoing CRDF-004 Trial Broader Opportunity for Onvansertib 13
Slide 14: Lead program addressing first-line RAS-mut mCRC
Lead program addressing first-line RAS-mut mCRC Ph 1b/2 trial CRDF-004 trial second-line KRAS-mut mCRC first-line RAS-mut mCRC Discovered synergy with First-line trial with bevacizumab support of FDA Sep 2022 Aug 2023 Preclinical research identifies novel MOA: Onvansertib likely more effective in fi
Slide 15: Modest benefit in first-line mCRC setting presents significant commercial opportunity
Modest benefit in first-line mCRC setting presents significant commercial opportunity for onvansertib Data from positive first-line mCRC chemo/bev Phase 3 clinical trials by RAS-mut status* Mechanism Trial Sample ORR PFS (months) Hazard Targeted agent Trial of action population size Exp. vs Ctrl. Ex
Slide 16: CRDF-004: Dose-finding Phase 2 trial in first-line RAS-mutated mCRC
CRDF-004: Dose-finding Phase 2 trial in first-line RAS-mutated mCRC ONVANSERTIB ENROLLMENT CRITERIA 6 RANDOMIZATION ARMS 28 27 1. FOLFIRI/bev 26 First-line mCRC SoC alone 2. FOLFOX/bev 25 First-line SoC: R KRAS+/NRAS+ 24 Chemo + bevacizumab 6 3. FOLFIRI/bev Onv 20mg + 23 7 Unresectable ITT=110 4. FO
Slide 17: CRDF-004 demographics and baseline characteristics
CRDF-004 demographics and baseline characteristics FOLFIRI/bev FOLFIRI/bev/onv 20 FOLFIRI/bev/onv 30 FOLFOX/bev FOLFOX/bev/onv 20 FOLFOX/bev/onv 30 Total Safety Population (Dosed) (n=17) (n=17) (n=18) (n=17) (n=17) (n=18) (n=104) Age (years) Median 53 (32, 81) 52 (30, 78) 60 (34, 81) 57 (34, 82) 66
Slide 18: Onvansertib + FOLFIRI/bev drives improvement in depth of response and ORR
Onvansertib + FOLFIRI/bev drives improvement in both depth of response and ORR in first-line RAS-mut mCRC SoCb Onv 20 mg Onv 30 mg FOLFIRI/bev (FOLFIRI/bev and FOLFOX/bev) +FOLFIRI/bev +FOLFIRI/bev (n=37) (n=19) (n=18) (n=18) Objective Response Rate (per BICR)a as of January 22, 2026- ITT analysis C
Slide 19: Onvansertib + FOLFIRI/bev arms have not yet reached median PFS
Onvansertib + FOLFIRI/bev arms have not yet reached median PFS, with clear dose-dependent efficacy trends and compelling hazard ratios Onv 20 mg Onv 30 mg FOLFIRI/bev +FOLFIRI/bev +FOLFIRI/bev (n=19) (n=18) (n=18) Progression Free Survivala Not Reached Not Reached Median PFS (months, 95% CI) 10.97 (
Slide 20: A few patients achieved deep responses, CR, and surgery referrals
A few patients in onvansertib + FOLFIRI/bev arms achieved deep responses, CR, and surgery referrals* 47-year-old female Achieved CR and went 62-year-old male Achieved CR after 6 Metastatic disease on enrollment. to curative surgery cycles. Referred for Metastatic disease. Right sided Right sided col
Slide 21: CRDF-004 treatment emergent adverse events data
CRDF-004 treatment emergent adverse events (TEAE) data as of July 8, 2025* Safety Population (Dosed) FOLFIRI/bev FOLFIRI/bev/onv 20mg FOLFIRI/bev/onv 30mg FOLFOX/bev FOLFOX/bev/onv 20mg FOLFOX/bev/onv 30mg (n=17) (n=17) (n=18) (n=17) (n=17) (n=18) N (% of total) All Grades Gr >=3 All Grades Gr >=3 A
Slide 22: CRDF-004 trial (ongoing): key takeaways
CRDF-004 trial (ongoing): key takeaways Data summary: onvansertib + FOLFIRI/bev o Confirmed ORR of 72% in 30 mg arm, 30% No significant added toxicity improvement over FOLFIRI SoC CRDF-004 data support selection of 30 mg o Median PFS not yet reached in either the 20 mg or onvansertib dose for combin
Slide 23: 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-mut status* Mechanism Trial Sample ORR PFS (months) Hazard Targeted agent Trial of action population size Exp. vs Ctrl. Exp. vs Ctrl. ratio Onvansertib Onv + FOLFIRI/bev
Slide 24: Mechanistic synergy between FOLFIRI, onvansertib, and bev supports combination rationale
Mechanistic synergy in anti-angiogenic affects between FOLFIRI, onvansertib, and bev supports combination rationale FOLFIRI Onvansertib Bevacizumab Topoisiomerase I PLK1 inhibition VEGFA blockade inhibition ↓ HIF1α expression Direct inhibition of ↓ HIF1α expression and and downstream angiogenesis do
Slide 25: Multiple onvansertib MOAs underlie our focus on RAS-mutated CRC
Multiple onvansertib MOAs underlie our focus on RAS-mutated CRC Onvansertib attacks RAS-mutated mCRC in three ways 1 Synthetic lethality in RAS-mut background RAS-mut CRC tumor cells are hypersensitive to onvansertib 2 Synergy with FOLFIRI chemo Onvansertib inhibits repair of chemo-induced DNA damag
Slide 26: CRDF-004 data positions onvansertib for registrational trial
CRDF-004 data positions onvansertib for registrational trial First-line RAS-mutated mCRC clinical development program Agreed with FDA June 2023 Type C meeting CRDF-00 4 CRDF-00 5 PHASE 2 DOSE-CONFIRMATION TRIAL PHASE 3 REGISTRATIONAL TRIAL Data support selection of 30 mg onvansertib dose Preliminary
Slide 27: CRDF-005: preliminary trial design in first-line RAS-mutated mCRC
Phase 3 CRDF-005: preliminary trial design in first-line RAS-mutated mCRC ENROLLMENT CRITERIA FOLFIRI + First-line mCRC Key Assumptions (to be Bevacizumab + Onvansertib 30 mg finalized after FDA Randomize KRAS+/NRAS+ discussions) CRDF-005 1:1 • 2 arm study (combine Unresectable Standard of Care (SOC
Slide 28: Pfizer is providing clinical execution for CRDF-004
Pfizer is providing clinical execution for CRDF-004 Cardiff Oncology retains full economic ownership and control of onvansertib PFIZER PFIZER BREAKTHROUGH GROWTH INITIATIVE Ignite $15M investment; Pfizer representative Serves as CRO partner for the clinical serves on Scientific Advisory Board execut
Slide 29: Onvansertib: Broader Opportunity
ONVANSERTIB FIRST-LINE RAS-MUTATED mCRC Mechanism Supports First-Line Treatment Promising Clinical Benefit in Ongoing CRDF-004 Trial Broader Opportunity for Onvansertib 29
Slide 30: Our pipeline opens many attractive opportunities for onvansertib
Our pipeline opens many attractive opportunities for onvansertib Line of Therapy Trial IIT* Ph1 Ph2 Ph3 Combination with: FOLFIRI/bev mCRC 1st line CRDF-004 (w/Pfizer) randomized and FOLFOX/bev (RAS-mut) 2nd line Ph 1b/2 completed FOLFIRI/bev CMML Rochester, 2nd line Ph 1 Minnesota expansion ongoing
Slide 31: Investigator-initiated Phase 1 trial in CMML: encouraging early activity
Investigator-initiated Phase 1 trial in CMML: onvansertib shows encouraging early activity as monotherapy in orphan disease Chronic Myelomonocytic Leukemia (CMML) • Aggressive hematologic malignancy (median age ~76; median survival <3 years) 10 • Overlapping features of MDS and MPN; marked by monocy
Slide 32: Upcoming Milestones
Upcoming Milestones 1H 2026 • Report detailed CRDF-004 Phase 2 data in first-line RAS-mutated mCRC • Announce registrational strategy and Phase 3 trial design following consultation with FDA Clinical & Regulatory 2H 2026 • Initiate registrational program / Phase 3 trial in first-line RAS-mutated mCR
Slide 33: Appendix: Additional CRDF-004 data
Appendix Additional CRDF-004 data 33
Slide 34: Deeper tumor regression observed with onvansertib+SoC
Deeper tumor regression observed with onvansertib+SoC- July 8, 2025 Best Radiographic Response BY ONVANSERTIB DOSE* Intent-to-treat (ITT) (SoC alone) Control Onv 20mg + SoC Onv 30mg + SoC Confirmed ORR1 30% 42% 49% ORR2 43% 50% 59% Control Arm (SoC) Experimental Arms (SoC + onvansertib) Control Arm
Slide 35: Deeper tumor regression with onvansertib on either chemo backbone vs SoC alone
Deeper tumor regression observed when adding onvansertib to either chemo backbone vs SoC alone- July 8, 2025 Best Radiographic Response BY CHEMO BACKBONE* Intent-to-treat FOLFIRI FOLFOX (ITT) Control SoC + Onv Control SoC + Onv Confirmed ORR1 26% 44% 33% 46% ORR2 47% 50% 39% 59% 100 100 FOLFIRI Arms
Slide 36: Higher number of 30mg onvansertib patients remain on trial vs. control
Higher number of 30mg onvansertib patients remain on trial vs. control- July 2025 Radiographic Response over Time* Time on Trial by Best Response CR/PR Control Onv 20mg Onv 30mg 1005-004 OX 1007-005 IR 1005-026 IR 1025-030 OX SD Control arms Safety Population (Dosed) (SoC alone) + SoC + SoC 1008-008
Slide 37: Greater number of onvansertib 30mg patients achieved Early Tumor Shrinkage
Greater number of onvansertib 30mg dose patients achieved Early Tumor Shrinkage – July 8, 2025 Previous Ph3 1st Line mCRC Trials1 % of patients TRIBE CRYSTAL OPUS CRDF-004 with ETS RAS WT/mut. RAS WT RAS WT RAS mut. Early Tumor Control Shrinkage (ETS) 52% 49% 46% 41% Arm (11/27) ≥20% reduction Onv 2
Slide 38: Tumor regression vs. baseline is deeper over time with onv 30mg dose
Tumor regression vs. baseline is deeper over time with onv 30mg dose- July 8, 2025 Control Arm (SoC) SoC + onvansertib 20 mg SoC + onvansertib 30 mg Radiographic Response over Time* 100 Control Arms Experimental Arms SoC Onvansertib 20mg + SoC1 Onvansertib 30mg + SoC Best Response lesions from basel
Slide 39: Depth of Response is deeper for the onv 30mg dose arm
Depth of Response is deeper for the onv 30mg dose arm- July, 8 2025 Previous Ph3 1st Line mCRC Trials1 % Tumor TRIBE CRYSTAL OPUS CRDF-004 Shrinkage RAS WT/mut. RAS WT RAS WT RAS mut. Depth of Control Response (DpR) 38% 33% 31% 32% Arm Maximum tumor Experimental Onv 20mg Onv 30mg shrinkage at Arm 43
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