Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Investor Presentation (January 2025)
92 slides from Cardiff Oncology's investor presentation, January 2025
Slide 1: Company Overview: The Onvansertib Opportunity
Company Overview The Onvansertib Opportunity
Slide 2: dependence upon third parties; and risks related to failure to obtain FDA clearances or
dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber- attacks on our information technology infrastructure, which cou
Slide 3: First-in-class PLK1 inhibitor with robust clinical data
First-in-Class Robust clinical data in Clinical signal from FDA / Pfizer PLK1 inhibitor 2L KRAS-mut mCRC CRDF-004 1L trial • • • • • • • • • We expect additional clinical data from our 1st line RAS-mutated mCRC trial in H1 2025
Slide 4: Our move from 2nd line to 1st line mCRC
Our move from 2nd line to 1st line mCRC CRDF-004 1st line mCRC trial data The onvansertib opportunity
Slide 5: Onvansertib
Onvansertib PROPERTIES SPECIFICITY • • •
Slide 6: Our mCRC journey from second-line to first-line
Our mCRC journey of discovery led us from second-line to first-line FIRST LINE SECOND LINE * ONSEMBLE e Both patients CRDF-004 RAS-mutated mCRC 90 patients, randomized, _—......_ 3 2d ENROLLING 2 aime 2 Gases Pfizer Ignite Ph 1 b/2 KRAS-mutated mCRC CRDF-003 RAS-mutated mCRC 7 66 evaluable patients,
Slide 7: Our mCRC journey from second-line to first-line
Our mCRC journey of discovery led us from second-line to first-line FIRST LINE SECOND Ph 1 b/2 KRAS-mutated mCRC 66 evaluable patients, LINE (URONHOY single arm COMPLETED * ONSEMBLE enrolle
Slide 8: RAS wild-type vs RAS mutated, 1st and 2nd line
RAS Wild-Type 1st LINE 2nd LINE RAS Mutated
Slide 9: RAS wild-type vs RAS mutated, 1st and 2nd line
RAS Wild-Type 1st LINE 2nd LINE RAS Mutated
Slide 10: Phase 1b/2 trial design
ENROLLMENT CRITERIA EFFICACY ENDPOINTS 1 2 28 DAY CYCLE 3
Slide 11: Bev exposed vs bev naive patients
Bev exposed vs bev naïve patients 1st LINE 2nd LINE
Slide 12: Bev naive patients achieved higher response rates
Ph 1b/2 trial bev naive patients achieved higher response rates Best Radiographic Response and Duration of Response* - 66 evaluable patients (as of June 16, 2023) All Bev patients naive N 66 15 ORR 29% (19) 73% (11) 95% Cl (18-41%) (45-92%) mDoR = 12.0mo_ 13.0mo 95% Cl (8.9,-) | (12.0, -) Disease Co
Slide 13: Response by KRAS variant
KRAS G12C Variant CR+PR SD PD PR SD PD Total G12D G12V G13D G12S G12A Q61H G13C
Slide 14: mPFS exceeds historical controls for SoC
Ph 1b/2 trial mPFS exceeds historical controls for SoC Progression free survival* — 66 evaluable patients (as of June 16, 2023) Probability of Survival 1.00 075+ — All patients OB] aaceaceecccenns nd 0.25 0.00 3 6 3 io 5 20 2 Months Characteristic N EventN mPFS (95%C!) 9.3 (78, 14) Overall 66 42 8 P
Slide 15: Univariable and multivariable analysis
Univariable analysis Multivariable Analysis
Slide 16: Scientific basis for clinical findings
Scientific basis for clinical findings
Slide 17: Combination had superior anti-tumor activity vs single agents
The combination had significant superior anti-tumor activity compared to the single agents SW620 (KRAS G12V) 2500 2000 Tumor volume (mm3) 1500 1000 500 0 0 10 20 30
Slide 18: Tumors from mice treated with onv + bev appear smaller and pale
• • • KRAS-mut mCRC tumors from mice treated with onv + bev appear smaller and pale (less vascularized)
Slide 19: Tumor growth, hypoxia, HIF1α
α Tumor growth Hypoxia HIF1α HIF1a α
Slide 20: Tumor growth, hypoxia, HIF1α, onvansertib, bevacizumab
Tumor growth Hypoxia HIF1α onvansertib α α bevacizumab
Slide 21: Onvansertib inhibited hypoxia-induced HIF1α expression
α In 4 RAS-mutant CRC cell lines1, onvansertib inhibited hypoxia-induced HIF1α expression α α α α PLK1 inhibition using siRNA against PLK1 (siPLK1)2 prevented hypoxia-induced HIF1α expression α α β β α
Slide 22: Clinical and MoA data published in JCO
CONFIDENTIAL Our mCRC clinical and MoA data were published in JCO Ph 1b/2 Bev naive 2L KRAS-mutated mCRC oF Mechanism of Action Onvansertib’s inhibition of the hypoxia response pathway Original Reports | Gastrointestinal Cancer Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-L
Slide 23: Proposed mechanisms of onvansertib and bev combination
Proposed mechanisms of onvansertib and bev combination therapy in bev naïve and bev exposed tumors
Slide 24: Tumor biopsy samples identified
135 tumor biopsy samples identified
Slide 25: Our mCRC journey: ONSEMBLE discontinued
Our mCRC journey of discovery led us from second-line to first-line FIRST LINE SECOND LINE CRDF-003 @ONSEMBLE mCRC Clinical Trial DISCONTINUED RAS-mutated mCRC 23 patients”, randomized, blinded, 3 arms (2 doses + control) 25
Slide 26: ONSEMBLE trial design
ENROLLMENT CRITERIA 28 DAY CYCLE PRIMARY ENDPOINT
Slide 27: ONSEMBLE bev naive patients achieved deeper responses than SoC
ONSEMBLE bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone Best Radiographic Response* — @ONSEMBLE patients (as of February 26, 2024) mCRC Clinical Trial Bev Naive Bev Exposed Onvansertib + FOLFIRI / bev Onvansertib + FOLFIRI / bev FOLFIRI / bev alone FOLFIRI
Slide 28: CRDF-004 1st line mCRC trial data
Our move from 2nd line to 1st line mCRC CRDF-004 1st line mCRC trial data The onvansertib opportunity
Slide 29: CRDF-004 trial design
ENROLLMENT CRITERIA 6 RANDOMIZATION ARMS 28 DAY CYCLE ENDPOINTS *
Slide 30: Enrollment criteria, randomization arms, endpoints
ENROLLMENT CRITERIA 6 RANDOMIZATION ARMS OBJECTIVES OF THE TRIAL ENDPOINTS *
Slide 31: Evaluable patients and time on trial
NUMBER OF EVALUABLE* PATIENTS 6 RANDOMIZATION ARMS TIME ON TRIAL – as of Nov 26, 2024
Slide 32: Date labels: estimated date of 8-week scan
* Date Labels: estimated date of 8-week scan
Slide 33: ORR similar for FOLFIRI and FOLFOX backbones
ORR for control and experimental arms is similar for FOLFIRI and FOLFOX Best Radiographic Response BY CHEMO BACKBONE? - as of November 26, 2024 Best % Change from Baseline 20 -100 Control Arms Experimental Arms FOLFIRI/ bev FOLFOX / bev FOLFIRI / bev / onvansertib FOLFOX / bev / onvansertib 25% ORR
Slide 34: Higher onvansertib dose shows increased ORR
Dose response: Higher onvansertib dose shows increased ORR with deeper responses Best Radiographic Response BY ONVANSERTIB DOSE* - as of November 26, 2024 Control Arms Experimental Arms SoC SoC plus onvansertib (20mg) SoC plus onvansertib (30mg) 33% ORR 50% ORR 64% ORR 29 (3 of 9) . 5 of 10) (7 of 1
Slide 35: Spider plots show deepening responses at 30mg
Spider plots show deepening responses for onvansertib 30mg dose Radiographic Response over Time* — as of November 26, 2024 Control Arms Experimental Arms SoC SoC plus onvansertib (20mg) SoC plus onvansertib (30mg) 20+ m baseline Best Response — Stable Disease 30+ “100-5 ; . : : 100+» Months — Partia
Slide 36: On treatment best response by patient
> On Treatment Best Response # Confirmed Partial Response # Partial Response # Stable Disease # Progressive Disease # indicates % change from baseline Reason For Discontinuation To Pursue Surgery Adverse Event Progressive Disease Chemotherapy Backbone FOLFIRI FOLFOX
Slide 37: ORR consistently higher with onvansertib + SoC
ORR is consistently higher for patients receiving onvansertib + SoC Summary of Objective Response Rates by Cohort* — as of November 26, 2024 CRDF-004 Evaluable Population (N = 30) Historical Controls at Onvansertib Arms Eod of Trial Control Arms All 20mgs onv 30mgs onv (Hecht, et al)** FOLFIRI 25% 5
Slide 38: Patient demographics
Age (years) Median (range) 56.0 (32, 82) 47.0 (38, 69) 62.0 (39, 75) 55.5 (32, 82) Gender, n (%) Male 6 (66.7) 4 (40.0) 6 (54.5) 16 (53.3) Female 3 (33.3) 6 (60.0) 5 (45.5) 14 (46.7) Race, n (%) White 8 (88.9) 9 (90.0) 11 (100) 28 (93.3) Asian 1 (11.1) 0 0 1 (3.3) Native Hawaiian or Other Pacific Is
Slide 39: Treatment emergent adverse events data
Treatment emergent adverse events (TEAE) data* FOLFIRI/Bev FOLFIRI/Bev/Onv 20mg FOLFIRI/Bev/Onv 30mg FOLFOX/Bev FOLFOX/Bev/Onv20mg FOLFOX/Bev/Onv30mg AliControl Arms All Experimental Arms (N=4) (N-6) (N-6) (N=5) (N=4) (N=5) (N=9) (N=21) N (%of total) AllGrades Gr23 | AllGrades Gr23_AllGrades. © Gr23
Slide 40: mCRC clinical development program agreed with FDA
mCRC clinical development program agreed with FDA at June 2023 Type C meeting • • • • • •
Slide 41: The onvansertib opportunity
Our move from 2nd line to 1st line mCRC CRDF-004 1st line mCRC trial data The onvansertib opportunity
Slide 42: Large TAM: large patient population
Factors driving the large TAM for onvansertib in 1%t line RAS-mut mCRC 1. Large Patient Population: 48,000 new US cases per year (1% line RAS-mut mCRC) Annual eligible US patients* First-line 48k Second-line 23k | All { bev naive bev naive ) mCRC RAS-mut Onvansertib targets all RAS-mutated mCRC" G12
Slide 43: Large TAM: significant unmet need
Factors driving the large TAM for onvansertib in 1%t line RAS-mut mCRC 2. Significant Unmet Need: No new drugs approved in 20 years Standard of Care for 1st / 2"4 line RAS-mutated mCRC includes chemo + bevacizumab FOLFOX (approved 1996) Chemotherapy FOLFIRI (approved 2002) oe /= Antianai . Bevacizum
Slide 44: >380 patients dosed with onvansertib, well tolerated
>380 patients have been dosed with onvansertib and it has been well- tolerated across multiple 28 DAY CYCLE indications
Slide 45: Line of therapy, trials and combinations
Line of Therapy Trial IIT* Ph2 Ph3 Combination with:
Slide 46: Pfizer Breakthrough Growth Initiative and Ignite
PFIZER BREAKTHROUGH GROWTH INITIATIVE PFIZER Ignite • • • • •
Slide 47: First-in-class PLK1 inhibitor with robust clinical data
First-in-Class Robust clinical data in Clinical signal from FDA / Pfizer PLK1 inhibitor 2L KRAS-mut mCRC CRDF-004 1L trial • • • • • • • • • We expect additional clinical data from our 1st line RAS-mutated mCRC trial in H1 2025
Slide 48: Appendix: Additional mCRC Data
Appendix Additional mCRC Data
Slide 49: CRDF-004 FOLFIRI/Bev control arm TEAEs
CRDF-004 FOLFIRI/Bev Treatment Emergent Adverse Effects (TEAEs) N (% of total) Grade 1 Grade 2 Grade 4 Total Any Adverse Events 4 (100.0) 2(50.0) 0( 00) 4 (100.0) Fatigue 1(25.0) 1 (25.0) 0( 00) 2(50.0) Nausea 2(50.0) 0( 00) 0( 00) 2(50.0) Neutrophil count decreased 1(25.0) 2( 50.0) 0( 00) 4 (100.0)
Slide 50: CRDF-004 FOLFIRI/Bev/Onv 20mg TEAEs
CRDF-004 FOLFIRI/Bev/Onvansertib 20mg Treatment Emergent Adverse Effects (TEAEs) N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total Any Adverse Events 6 (100.0) 6 (100.0) 4(667) 0( 00) 6 (100.0) Fatigue 2(33.3) 1(167) 0( 00) 0( 00) 3(50.0) Nausea 2(33.3) 3( 50.0) 0( 0.0) 0( 00) 5 (83.3) Neutrophil
Slide 51: CRDF-004 FOLFIRI/Bev/Onv 30mg TEAEs
CRDF-004 FOLFIRI/Bev/Onvansertib 30mg Treatment Emergent Adverse Effects (TEAEs) N Sof total Grade 1 Grade 2 Grade 3 Grade 4 Total Any Adverse Events 6 (100.0) 5 (83.3) 5 (83.3) 2(33.3) 6 (100.0) Fatigue 3( 50.0) 0( 0.0) 0( 0.0) 0( 0.0) 350.0) . Nausea 2(333) 0( 0.) 0( 00) 0( 09) 2(333) Experimental
Slide 52: CRDF-004 FOLFOX/Bev control arm TEAEs
CRDF-004 FOLFOX/Bev Treatment Emergent Adverse Effects (TEAEs) N (% of total) Grade 1 Grade 2 Grade 4 Total Any Adverse Events 4 (80.0) 5 (100.0) 1(20.0) 5 (100.0) Fatigue 3( 60.0) 0( 00) 0( 00) 4(80.0) Nausea 1(20.0) 2( 40.0) 0( 00) 3(60.0) Neutrophil count decreased 0( 00) 0( 00) 1(200) 2( 40.0) N
Slide 53: CRDF-004 FOLFOX/Bev/Onv 20mg TEAEs
CRDF-004 FOLFOX/Bev/Onvansertib 20mg Treatment Emergent Adverse Effects (TEAEs) N (% of total) Grade 1 Grade 2 Grade 4 Total Any Adverse Events 4 (100.0) 4 (100.0) 0( 00) 4 (100.0) Fatigue 2(50.0) 1 (25.0) 0( 00) 3(75.0) Nausea 2(50.0) 2(50.0) 0( 00) 4 (100.0) Neutrophil count decreased 2(50.0) 0( 0
Slide 54: CRDF-004 FOLFOX/Bev/Onv 30mg TEAEs
CRDF-004 FOLFOX/Bev/Onvansertib 30mg Treatment Emergent Adverse Effects (TEAEs) N (% of total) Grade 1 Grade2 Grade 4 Any Adverse Events 5 (100.0) 4 (80.0) 0( 0.0) Fatigue 3( 60.0) 0( 00) 0( 00) Nausea 1(20.0) 1(20.0) 0( 00) Neutrophil count decreased 1(20.0) 0( 00) 0( 00) Neutropenia 0( 00) 0( 00)
Slide 55: Ph 1b/2 patient demographics
Ph 1b/2 trial’s patient demographics reflect 2"¢ line mCRC population Enrollment* Number of Patients (N) Phase 1b, Dose Level 0 Phase 1b, Dose Level +1 Phase 1b, Dose Level +2 Phase 2 RP2D Total Patients Onvansertib 12 mg/m? Onvansertib 15 mg/m? Onvansertib 18 mg/m? Onvansertib 15 mg/m? All Doses Tr
Slide 56: Bev naive patients experienced more durable responses
Ph 1b/2 trial bev naive patients experienced more durable responses Swimmer plot* - 66 evaluable patients (as of June 16, 2023) All Bev Bev patients naive exposed Pursued surgery / ablation 18% (12/66) 53% (8/15) 8% 4/51) Initial PR at 8 week scan 9 8 1 Initial PR at 16+ week scan 10 3 7 a | oo 0 0
Slide 57: Ph 1b/2 treatment emergent adverse events
• TEAE GR1 GR2 GR3 GR4 TOTAL TEAE GR1 GR2 GR3 GR4 TOTAL Fatigue 24 22 7 0 53 78% Cough 11 0 0 0 11 16% • Neutropenia 1 18 23 7 49 72% Pyrexia 8 1 1 0 10 15% Nausea 29 13 4 0 46 68% Dyspnea 7 3 0 0 10 15% • Diarrhea 21 13 4 0 38 56% AST Increase 7 2 1 0 10 15% Leukopenia 9 14 5 1 29 43% Lymphocytopen
Slide 58: ONSEMBLE bev naive change in tumor size
ONSEMBLE bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone Change in tumor size from baseline* — QONSEMBLE bev naive patients (as of February 26, 2024) mCRC Clinical Trial Bev naive: onvansertib + FOLFIRI/bev arm Bev naive: FOLFIRI/bev (control) arm 100+ 100+
Slide 59: ONSEMBLE bev naive onvansertib arm
ONSEMBLE bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone Change in tumor size from baseline* — QONSEMBLE bev naive patients (as of February 26, 2024) mCRC Clinical Trial Bev naive: onvansertib + FOLFIRI/bev arm 100+ Best response of: —PR Lesion was later bi
Slide 60: ONSEMBLE bev exposed patients showed no responses
ONSEMBLE bev exposed patients, with or without onvansertib, showed no responses Change in tumor size from baseline* — @ONSEMBLE bev exposed patients (as of February 26, 2024) mCRC Clinical Trial Bev exposed: onvansertib + FOLFIRI/bev arm Bev exposed: FOLFIRI/bev (control) arm 100+ 100+ © Best respon
Slide 61: ONSEMBLE swimmer plot
ONSEMBLE swimmer plot Bev Naive Bev Naive Bev Exposed Bev Exposed lung lesion, which was later biopsy- Swimmer plot* — ONSEMBLE mCRC Clinical Trial patients (as of February 26, 2024) fe] fe] e ie) ° e te) e e io] oO oO oO o e o fo) e a 0 10 12 Months fe] fe} fe} ° ° ce) Ke} fe} fe] > fe] (0) fe} fe)
Slide 62: ONSEMBLE patient demographics
ONSEMBLE’s patient demographics reflect second-line mCRC population Enrollment* Number of Patients (N) FOLFIRI and bev Intent to Treat 8 Treated (included in safety evaluable patients) 7 Evaluable for efficacy 6 Total Patients N=22 Median [range] or n (%) Age (years) 53 [35-81] Sex Male 12 (54%) Fem
Slide 63: ONSEMBLE control arm TEAEs
ONSEMBLE Control Arm: Treatment Emergent Adverse Effects (TEAEs) N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total Control arm Any Adverse Events 6 (85.7) 6 (85.7) 3 (42.9) 0( 0.0) 6 (85.7) Diarrhea 3 (42.9) 1 (14.3) 0( 0.0) 0( 0.0) 4 (57.1) (N=7) Nausea 2 ( 28.6) 1 (14.3) 1 (14.3) 0( 0.0) 4 (57.
Slide 64: ONSEMBLE onvansertib 30mg arm TEAEs
ONSEMBLE onvansertib 30mg Arm TEAEs: Onvansertib in combination with FOLFIRI+bev is well-tolerated N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total . Any Adverse Events 7 (100.0) 7 (100.0) 4 (57.1) 0( 0.0) 7 (100.0) Experimental arm Diarrhea 1 (143) 1(143) 2( 28.6) 0( 0.0) 4(57.1) Onv 30mg (N=7)
Slide 65: ONSEMBLE onvansertib 20mg arm TEAEs
ONSEMBLE onvansertib 20mg Arm TEAEs: Onvansertib in combination with FOLFIRI+bev is well-tolerated Thrombocytopenia N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total : Any Adverse Events 8 (100.0) 7 (87.5) 2 (25.0) 2(25.0) 8 (100.0) Experimental arm Diarrhea 4 (50.0) 3 (37.5) 0 ( 0.0) 0( 0.0) 7 (
Slide 66: Tumor growth, hypoxia, bevacizumab
Tumor growth Hypoxia HIF1α onvansertib α α bevacizumab
Slide 67: Gene expression in hypoxia, HCT116 and SW620 cells
Hx_DMS0_4h vs Nx_DMSO_4h: HCT116 and SW620 cells Hx_ONV2_4h vs Hx_DMSO_4h: HCT116 and SW620 cells 4 1 DDIT4 SLC2A3 ADM BHLHE40 PLAUR KDM3A 2 0 SAP30 INHA CDKN1C XPNPEP1 log2FoldChange in SW620 log2FoldChange in SW620 PNRC1 ANGPTL4 STBD1 PFKP NFIL3 PFKFB3 STC2 BNIP3L SLC25A1 AK4 GBE1 PDK1 CCNG2 HOXB9
Slide 68: Vehicle, Bev, Onv combinations
Vehicle Bev – Onv Onv+Bev – Bev+Irin *** Onv+Irin ** Onv+Bev+Irin *
Slide 69: Onvansertib and bev reduce tumor vascularization
The combination of onvansertib and bev reduces tumor vascularization marker CD31 vascularization - 20 O 15 8 % 10 oO a Oo 5 0 we $W620 xenograft model is shown. CD31 scoring: for each sample 5 fields of view at 100 um magnification were randomly selected in the tumor area. CD Mean score SEM for each
Slide 70: KRAS G12D and G12C models treatment
C1143 (KRAS G12D) 600 Vehicle 400 Onvansertib Irinotecan 200 200 Onv+Irino 150 100 *** 50 ** 0 0 5 10 15 20 -50 Treatment time (days) C1144 (KRAS G12C) 250 200 **** 150 100 ** 50 0 0 5 10 15 20 Treatment time (days)
Slide 71: KRAS G12C, G12D and G13D models treatment
B8239 (KRAS G12C) C1143 (KRAS G12D) 800 300 600 200 400 *** 100 200 **** *** * 0 0 5 10 15 20 0 5 10 15 20 Treatment time (days) Treatment time (days) C1138 (KRAS G13D) 300 200 *** 100 ** 0 0 5 10 15 20 Treatment time (days)
Slide 72: Appendix: Metastatic Pancreatic Adenocarcinoma (mPDAC)
Appendix: Metastatic Pancreatic Adenocarcinoma (mPDAC)
Slide 73: Path forward: Move to 1st line mPDAC
mPDAC mPDAC CRDF-001 Ph 2 Second-Line Trial Biomarker Discovery Trial (IIT) • • Path forward: Move to 1st line mPDAC •
Slide 74: Path forward: Move to 1st line mPDAC
mPDAC mPDAC CRDF-001 Ph 2 Second-Line Trial Biomarker Discovery Trial (IIT) • • Path forward: Move to 1st line mPDAC •
Slide 75: mPDAC trial design
ENROLLMENT CRITERIA OBJECTIVE PRIMARY ENDPOINT 14 DAY SECONDARY ENDPOINT CYCLE
Slide 76: Onvansertib+SoC higher efficacy than historical controls
Onvansertib+SoC has higher efficacy than 2" line historical controls Best Radiographic Response - 21 evaluable patients (as of September 13, 2023)* 100 a © Historical controls! £ 2 50 24 \ine 15 line 4 CRDF-001 mPDAC mPDAC Best Response : | 9, 6 PD ORR is 77% 23% $8 0 O 0 @ O (4/21) 2 | ia 2 is 8 Su
Slide 77: Stable disease patients converted to partial responses
Stable disease patients have converted to partial responses over time Swimmer plot — 23 evaluable patients (as of September 13, 2023)* [e) {e) fe} io} ie] (o} ® o} [e} oO fe} fo} e e@ fe] [o} fe) o fe} [e} fe} oO fo} fo} e ry fe} [e} t fe) oe te) 1 e e (eo) e Oo 0 4 8 12 Months an ongoing trial and
Slide 78: Patient responses can deepen over time
Patient responses to onvansertib+SoC can deepen over time Spider plot - 21 evaluable patients (as of September 13, 2023)* 100+ ( mPFS for SoC is 3.1 months | A T = i} 3 ! i} 6 I - 2 20+ i} Best Response 2 of — Partial Response a — Progressive Disease 5 — Stable Disease © 20+ @ Confirmed PR 3, ! © Wa
Slide 79: Longer median PFS than historical controls
Onvansertib+SoC has longer median PFS than 2"9 line historical controls Progression-free survival — 23 evaluable patients (as of September 13, 2023)* Historical controls! 2r9 line CRDF-001 mPDAC mPFS 5.0mos 3.1 mos 16 week progression- 56% van free? available 1% line mPDAC 5.5 mos 48% 1,004 Probabil
Slide 80: Path forward: Move to 1st line mPDAC
mPDAC mPDAC CRDF-001 Ph 2 Second-Line Trial Biomarker Discovery Trial (IIT) • • Path forward: Move to 1st line mPDAC •
Slide 81: Enrollment criteria and objectives
ENROLLMENT CRITERIA OBJECTIVES • •
Slide 82: Tumor responder vs non-responder patients
• • Patient 28 (tumor responder) Patient 33 (tumor non-responder)
Slide 83: Path forward: Move to 1st line mPDAC
mPDAC mPDAC CRDF-001 Ph 2 Second-Line Trial Biomarker Discovery Trial (IIT) • • Path forward: Move to 1st line mPDAC •
Slide 84: Appendix: Investigator-Initiated Trial Small Cell Lung Cancer
Appendix: Investigator-Initiated Trial Small Cell Lung Cancer (SCLC)
Slide 85: Onvansertib demonstrates single-agent activity in SCLC
Onvansertib demonstrates single-agent activity in SCLC TRIAL RATIONALE Onvansertib monotherapy showed significant tumor growth inhibition against platinum-sensitive and -resistant models Tumor volume (mm?) SCLC * Mice were implanted with SCLC PDX and treated with vehicle, 2000 1500 7 1000 | 500 4 0
Slide 86: SCLC trial design
ENROLLMENT CRITERIA OBJECTIVE PRIMARY ENDPOINT 21 DAY CYCLE SECONDARY ENDPOINTS
Slide 87: Preliminary safety and efficacy
ENROLLMENT CRITERIA PRELIMINARY SAFETY (N=6) PRELIMINARY EFFICACY (N=7)
Slide 88: Scans for patient with confirmed PR in SCLC
Radiographic scans for patient with a confirmed PR in SCLC IIT Baseline Scan Restaging after Cycle 2
Slide 89: Appendix: Investigator-Initiated Trial Triple Negative Breast Cancer
Appendix: Investigator-Initiated Trial Triple Negative Breast Cancer (TNBC)
Slide 90: Onvansertib + paclitaxel superior to single agent
Preclinical: Onvansertib + paclitaxel is superior to single agent therapy TRIAL RATIONALE In vivo efficacy of onvansertib in combination with paclitaxel Tp53-Mutant SUM159 xenografts* The combination of onvansertib + paclitaxel *~ 1200- showed significant synergy S e 1000 + control (n=8) =) 2 8004 |
Slide 91: TNBC trial design
ENROLLMENT CRITERIA PRIMARY ENDPOINTS − 28 DAY CYCLE
Slide 92: TNBC trial endpoints
ENROLLMENT CRITERIA PRIMARY ENDPOINTS − 28 DAY CYCLE SECONDARY ENDPOINT
Cardiff Oncology — Investor Presentation (January 2025) on 6ix