Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Investor Presentation (June 2025)
92 slides from Cardiff Oncology's investor presentation, June 2025
Slide 1: Company Overview: The Onvansertib Opportunity
Company Overview The Onvansertib Opportunity
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 sim
Slide 3: Onvansertib properties and specificity
Onvansertib PROPERTIES SPECIFICITY • • •
Slide 4: We shifted our RAS-mutated mCRC program to first-line
We shifted our RAS-mutated mCRC program to the first-line Ph 1b/2 trial KRAS-mut. 24 line mCRC Unexpected clinical finding Sep 12, 2022 Pre-clinical research identifies novel MOA: Onvansertib likely more SECOND-LINE effective in 1% line nt I | I I | I 2022 2023 2024 2025
Slide 5: Encouraged by initial clinical data from CRDF-004
We are encouraged by the initial clinical data from CRDF-004 6 Announced shift from 4 ) nd |i st |j | 2" line to 15 line (CRDF-004) CRDF-004: supported by FDA and Pfizer Ignite initial 1st line data release Aug 7, 2023 Dec 10, 2024 FIRST-LINE — | LL 2024 2025
Slide 6: Our shift to first-line RAS-mutated mCRC
OUR SHIFT TO FIRST-LINE RAS-MUTATED mCRC The strength of our 1st-line program The rationale for our shift from 2nd-line The coming catalysts in 2025
Slide 7: Our lead program targets RAS-mutated metastatic colorectal cancer
Our lead program targets RAS-mutated metastatic colorectal cancer mCRC is BOTH common... 2024 new US cases ('000s)* 0 Breast Prostate Lung Colorectal Melanoma Bladder Renal N-H Lymph. Uterus Pancreas * American Cancer Society Cancer Facts and Figures 2025. 100 200 300 400 ...and challenging to treat
Slide 8: First-line standard of care KRAS G12C
FIRST-LINE STANDARD OF CARE KRAS G12C
Slide 9: Onvansertib's MOA allows targeting all RAS-mutated mCRC
Onvansertib’s MOA allows us to target ALL RAS-mutated mCRC KRAS G12C therapies would address a small part of the need" G12Cc G12D G12V RAS Wild-Type G13D G12S G12A Q61H NRAS G13C ONVANSERTIB addresses 52% of mCRC cases are RAS-mutated! RAS LN ) Wild-Type
Slide 10: CRDF-004 trial design
ENROLLMENT CRITERIA 6 RANDOMIZATION ARMS 28 DAY CYCLE ENDPOINTS *
Slide 11: Enrollment criteria, randomization arms, endpoints
ENROLLMENT CRITERIA 6 RANDOMIZATION ARMS OBJECTIVES OF THE TRIAL ENDPOINTS *
Slide 12: Evaluable patients and time on trial
NUMBER OF EVALUABLE* PATIENTS 6 RANDOMIZATION ARMS TIME ON TRIAL – as of Nov 26, 2024
Slide 13: Date labels for 8-week scan
* Date Labels: estimated date of 8-week scan
Slide 14: ORR higher for experimental arms with both chemo backbones
ORR for the experimental arms is higher with both chemo backbones Best Radiographic Response BY CHEMO BACKBONE*¥ - CRDF-004 as of November 26, 2024 oo Control Arms r Experimental Arms FOLFIRI / bev FOLFOX / bev FOLFIRI / bev / onvansertib FOLFOX / bev / onvansertib 2 25% ORR 40% ORR 50% ORR 66% ORR
Slide 15: Dose response: higher onvansertib dose shows increased ORR
Dose response: Higher onvansertib dose shows increased ORR with deeper responses Best Radiographic Response BY ONVANSERTIB DOSE* — CRDF-004 as of November 26, 2024 oo Control Arms r Experimental Arms SoC SoC plus onvansertib (20mg) SoC plus onvansertib (30mg) 2 33% ORR 50% ORR 64% ORR 2 2 (3 of 9) (
Slide 16: Spider plots show deepening responses at 30mg
Spider plots show deepening responses for onvansertib 30mg dose Radiographic Response over Time* — CRDF-004 as of November 26, 2024 > Control Arms \ la Experimental Arms SoC SoC plus onvansertib (20mg) SoC plus onvansertib (30mg) 33% ORR 50% ORR 64% ORR (3 of 9) (5 of 10) (7 of 11) 20+ Best Response
Slide 17: On treatment best response
> 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 18: ORR consistently higher with onvansertib + SoC
ORR is consistently higher for patients receiving onvansertib + SoC Summary of Objective Response Rates by Cohort* — CRDF-004 as of November 26, 2024 7 CRDF-004 Evaluable Population (N = 30) Historical Controls at Onvansertib Arms Eod of Trial Control Arms All 20mgs onv 30mgs onv (Hecht, et al)** FO
Slide 19: 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 20: CRDF-004 treatment emergent adverse events data
CRDF-004 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_AllGrade
Slide 21: First-line RAS-mutated mCRC clinical development program
First-line RAS-mutated mCRC clinical development program Agreed with FDA June 2023 Type C meeting CRDF-00 4 CRDF-00 5
Slide 22: Our shift to first-line RAS-mutated mCRC
OUR SHIFT TO FIRST-LINE RAS-MUTATED mCRC The strength of our 1st-line program The rationale for our shift from 2nd-line The coming catalysts in 2025
Slide 23: Second-line phase 1b/2 trial generated a novel finding
Our second-line phase 1b/2 trial generated a novel finding Ph 1b/2 trial KRAS-mut. 24 line mCRC Unexpected clinical finding Sep 12, 2022 SECOND-LINE | I I I 2022 2023 2024 2025 23
Slide 24: Phase 1b/2 trial design
ENROLLMENT CRITERIA EFFICACY ENDPOINTS 1 2 28 DAY CYCLE 3
Slide 25: Ph1b/2 trial added onvansertib to SoC in second line
Our Ph1b/2 trial added onvansertib to SoC in the 2" line setting Patients who came to our second-line trial not having received bev in first-line are called, “bev naive” 1st LINE Standard of Care FOLFOX chemotherapy Bev (optional) Yes No “bev naive" - Qnd LINE Cardiff Oncology Phase 1b/2 trial FOLFI
Slide 26: 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* r Historical controls** 66 evaluable patients (as of June 16, 2023) s—<— Bev Bev . naive exposed Bev naive: 15 of 66 patients (23%) Bev exposed: 51 of 66 (77%) 73% ORR 16% ORR ORR 23-
Slide 27: 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) $ 1.004 2 i] wn me} Pan] £0.75, 2 o 2 fe} a 0.50; ---------------b------------4 Lj Bey naive 0.254 Bev exposed 0,00- 25 Months mPFS (mo) Historical controls** Bev naive 6.9-8
Slide 28: Univariable and multivariable analysis
n ORR (Odds Ratio) p-value PFS (Hazard Ratio) p-value Univariable analysis of baseline characteristics for ORR and PFS indicate superior clinical benefit for bev naïve patients and for patients without metastatic disease at time of diagnosis Multivariable Analysis was performed with these two charac
Slide 29: Unexpected clinical findings prompted new pre-clinical research
Unexpected clinical findings prompted new pre-clinical research Ph 1b/2 trial KRAS-mut. 2" line mCRC Unexpected clinical finding Sep 12, 2022 Pre-clinical research identifies novel MOA: Onvansertib likely more SECOND-LINE effective in 1% line et I | I I | I 2022 2023 2024 2025
Slide 30: Onvansertib + bev inhibits tumor growth more than either alone
Onvansertib + bev inhibits tumor growth greater than either agent alone HCT-116 (KRAS G13D) 2500 2000 — Vehicle = Bev only 1500 > 1000 Onv only : * a oe E | The combination had significant = 500 as: t Onv + bev superior anti-tumor activity —T | compared to the single agents | o- T 1 0 10 20 30 Onv:
Slide 31: Onvansertib + bev inhibits tumor growth in multiple models
Onvansertib + bev inhibits tumor growth greater than either agent alone HCT-116 (KRAS G13D) Onv: 45mg/kg PO, QD Bev: 10mg/kg, IP, BIW — Vehicle — Bev only — Onv only — Onv + bev LoVo (KRAS G13D) t 0 10 20 30 Days Onvansertib 45mg/kg PO, QD Bev 5mg/kg, IP, BIW SW620 (KRAS G12V) tek t 0 10 20 30 Days
Slide 32: Onvansertib's antiangiogenesis role complements bev
Onvansertib’s independent role in antiangiogenesis complements bev LoVo (KRAS G13D)* SW620 (KRAS G12V)* ‘eee Control (vehicle) 4 Roche drug Avastin” 8* largest global drug in 2019 ($7.1B sales) Bevacizumab Onvansertib << KRAS-mut mCRC tumors from mice treated with onv + bev appear smaller and pale (
Slide 33: Tumor growth, hypoxia, HIF1α
α Tumor growth Hypoxia HIF1α HIF1a α
Slide 34: Tumor growth, hypoxia, bevacizumab
Tumor growth Hypoxia HIF1α α bevacizumab
Slide 35: Tumor growth, hypoxia, onvansertib
Tumor growth Hypoxia HIF1α onvansertib α α bevacizumab
Slide 36: PLK1 inhibition in LoVo RAS-mutant CRC cell lines
α PLK1 inhibition in LoVo RAS-mutant CRC cell lines1 α α α β α β α
Slide 37: Onvansertib inhibits hypoxia signaling by downregulating HIF1α
Onvansertib inhibits the hypoxia signaling pathway by downregulating HIF 1a expression In 4 RAS-mutant LoVo HCT-116 SW-620 DLD1 CRC cell lines', onvansertib inhibited 0, 20% 1% 0, 20% 1% _ 0, 20% 1% 0, 20% 1% | hypoxia-induced Onv - + - + On - + - + On - + - + Ow - + - + HIF 1a expression HIF1a | 11
Slide 38: JCO published our clinical data and MOA
ASCO's flagship publication, JCO, published our clinical data and MOA Journal of Clinical Oncology’ Ph 1b/2 Bev naive 2"4 line KRAS-mutated mCRC trial MOA Onvansertib’s inhibition of the hypoxia response pathway Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of
Slide 39: Proposed MOA of onv+bev in bev naive / exposed tumors
Proposed MOA of onv+bev therapy in bev naive / bev exposed tumors Journal of Clinical Oncology’ MOA Onvansertib’s inhibition of the hypoxia response pathway (A) In bev naive tumors, the combination of onvansertib and bev effectively inhibits cell survival, proliferation, and angiogenesis (8) In bev
Slide 40: Biopsies: bev naive vs bev exposed
135 biopsies: Bev naïve Bev exposed
Slide 41: Our shift to first-line RAS-mutated mCRC
OUR SHIFT TO FIRST-LINE RAS-MUTATED mCRC The strength of our 1st-line program The rationale for our shift from 2nd-line The coming catalysts in 2025
Slide 42: Additional clinical data expected from first-line trial in H1 2025
First-in-Class 2nd line KRAS-mut. Clinical signal from Shift to 1st line PLK1 inhibitor mCRC program CRDF-004 1st trial • • • • • We expect additional clinical data from our 1st line RAS-mutated mCRC trial in H1 2025
Slide 43: Line of therapy trials
Line of Therapy Trial IIT* Ph2 Ph3 Combination with:
Slide 44: Pfizer Ignite
PFIZER BREAKTHROUGH GROWTH INITIATIVE PFIZER Ignite • • • • •
Slide 45: Appendix: Additional mCRC Data
Appendix Additional mCRC Data
Slide 46: CRDF-004 FOLFIRI/Bev 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 47: CRDF-004 FOLFIRI/Bev/Onvansertib 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 48: CRDF-004 FOLFIRI/Bev/Onvansertib 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 49: CRDF-004 FOLFOX/Bev 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 50: CRDF-004 FOLFOX/Bev/Onvansertib 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 51: CRDF-004 FOLFOX/Bev/Onvansertib 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 52: Ph 1b/2 patient demographics reflect second-line mCRC
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 53: KRAS variant response
KRAS Variant CR+PR SD PD PR SD PD Total
Slide 54: 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 55: Treatment emergent adverse events summary
• 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 56: ONSEMBLE trial design
ENROLLMENT CRITERIA 28 DAY CYCLE PRIMARY ENDPOINT
Slide 57: ONSEMBLE bev naive patients achieved deeper responses
ONSEMBLE bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone Best Radiographic Response* — go NSEMBLE patients (as of February 26, 2024) mCRC Clinical Trial Bev Naive Bev Exposed Onvansertib + FOLFIRI / bev Onvansertib + FOLFIRI / bev FOLFIRI / bev alone FOLFIR
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 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, onvansertib
Tumor growth Hypoxia HIF1α onvansertib α α bevacizumab
Slide 67: Hypoxia gene expression log2FoldChange
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, 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 first-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 first-line mPDAC
mPDAC mPDAC CRDF-001 Ph 2 Second-Line Trial Biomarker Discovery Trial (IIT) • • Path forward: Move to 1st line mPDAC •
Slide 75: CRDF-001 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: Onvansertib+SoC 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 first-line mPDAC
mPDAC mPDAC CRDF-001 Ph 2 Second-Line Trial Biomarker Discovery Trial (IIT) • • Path forward: Move to 1st line mPDAC •
Slide 81: Biomarker trial 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 first-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 (SCLC)
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: SCLC preliminary safety and efficacy
ENROLLMENT CRITERIA PRELIMINARY SAFETY (N=6) PRELIMINARY EFFICACY (N=7)
Slide 88: Radiographic scans for patient with confirmed PR in SCLC
Radiographic scans for patient with a confirmed PR in SCLC Baseline Scan Restaging after Cycle 2
Slide 89: Appendix: Investigator-Initiated Trial Triple Negative Breast Cancer (TNBC)
Appendix: Investigator-Initiated Trial Triple Negative Breast Cancer (TNBC)
Slide 90: Onvansertib + paclitaxel superior to single agent therapy
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