Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Q4 2023 Earnings Presentation
33 slides from Cardiff Oncology's earnings presentation, Feb 29, 2024
Slide 1: Q4 2023 Financial Results and ONSEMBLE Trial Data
AGENDA Q4 2023 Financial Results and ONSEMBLE Trial Data
Slide 2: Forward-looking statements
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: Agenda
AGENDA 1. 2023 was a transformational year 2. New data release from 2nd line ONSEMBLE trial 3. Review of financial position
Slide 4: August: mCRC, September: beyond mCRC
August: mCRC September: beyond mCRC
Slide 5: Our mCRC journey led us 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 LINE TROV-054) Seam * ONSEMBLE e Both patients CRDF-004 "ENROLLING CRDF-003 © ONSEMBLE mCRC Clinical Trial “DISCONTINUED | RAS-mutated mCRC 90 patients, randomized, 3 arms (2 doses + cont
Slide 6: Phase 1b/2 provided initial efficacy signal in second-line
Our mCRC journey of discovery led us from second-line to first-line FIRST LINE Provided initial signal of efficacy in second-line RAS-mutated mCRC SECOND Ph 1 b/2 KRAS-mutated mCRC 66 evaluable patients, LINE (TROV-054) : single arm COMPLETED
Slide 7: Randomized second-line ONSEMBLE trial discontinued
Our mCRC journey of discovery led us from second-line to first-line FIRST Randomized second-line trial LINE designed to show onvansertib’s contribution to SoC that was discontinued SECOND CRDF-003 RAS-mutated mCRC LINE QONSEMBLE fondomzed blinded, ‘DISCONTINUED —3arms (2 doses + —— control)
Slide 8: Shift to first-line setting
Our mCRC journey of discovery led us from second-line to first-line FIRST Shift to 1s-line setting based on: LINE 1. Phase 1b/2 clinical data 2. New mechanism of action 3. FDA recommendation SECOND LINE CRDF-004 ENROLLING RAS-mutated mCRC 90 patients, randomized, 3 arms (2 doses + control) Pfizer Ig
Slide 9: Existing data, new data, future potential
FIRST LINE FUTURE POTENTIAL SECOND LINE EXISTING NEW DATA DATA
Slide 10: ONSEMBLE trial design and endpoints
NEW DATA ENROLLMENT CRITERIA 28 DAY CYCLE PRIMARY ENDPOINT
Slide 11: ONSEMBLE patient demographics reflect second-line mCRC population
ONSEMBLE’s patient demographics reflect second-line mCRC population | NEW DATA CRDF-003 Enrollment* Number of Patients (N) FOLFIRI and bev Onset ong Onset song te Patients Intent to Treat 8 8 7 23 Treated (included in safety evaluable patients) 7 8 7 22 Evaluable for efficacy 6 8 7 21 Total Patients
Slide 12: Bev exposed vs bev naive patients
NEW DATA Bev exposed vs bev naïve patients 1st LINE 2nd LINE
Slide 13: Bev naive patients achieved deeper responses than SoC alone
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone | NEW DATA CRDF-003 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 al
Slide 14: Best radiographic response: bev naive patients
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone | NEW DATA CRDF-003 Best Radiographic Response*— QONSEMBLE patients (as of February 26, 2024) mCRC Clinical Trial Bev Naive Onvansertib + FOLFIRI / bev FOLFIRI / bev alone 1005 A Sr A . +68% 50 Objective respo
Slide 15: Best radiographic response: bev exposed patients
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone | NEW DATA CRDF-003 Best Radiographic Response*— QONSEMBLE patients (as of February 26, 2024) mCRC Clinical Trial Bev Exposed Onvansertib + FOLFIRI / bev FOLFIRI / bev alone 1005 A . ye 7 mm Partial Response m
Slide 16: Best radiographic response: control arms
Bev naive patients treated with onvansertib + SoC achieved deeper responses than SoC alone | NEW DATA CRDF-003 % change in target lesions from baseline Best Radiographic Response*— QONSEMBLE patients (as of February 26, 2024) 100 50 -50 -100 * Radiographic r mCRC Clinical Trial Bev Naive Bev Exposed
Slide 17: Best response by patient
NEW DATA Best response of: PR SD PD
Slide 18: Best response by patient
NEW DATA Best response of: PR SD PD
Slide 19: Two independent trials demonstrate the bev naive finding
Two independent clinical trials demonstrate the bev naive finding | NEW DATA CRDF-003 Objective Response Rate (ORR) by Cohort* N Bev Naive Bev Exposed QONSEMBLE Onvansertib 15 50% 0% coysomd + S0C ota oot Control 6 0% 0% (SoC alone) (0 of 3) (0 of 3) Phase 1b/2 Onvansertib 66 73% 16% Single-arm + So
Slide 20: Tumor growth, hypoxia and HIF1α
α Tumor growth Hypoxia HIF1α HIF1a α
Slide 21: Onvansertib and bevacizumab mechanism
Tumor growth Hypoxia HIF1α HIF1a onvansertib α α bevacizumab
Slide 22: Future potential
FIRST LINE FUTURE POTENTIAL SECOND LINE EXISTING NEW DATA DATA
Slide 23: Our lead program targets first-line RAS-mutated mCRC
Our lead program targets first-line RAS-mutated mCRC | FUTURE POTENTIAL CRDF-004 mCRC is common... 2024 new US cases ('000s)* © 100 200 300 Breast Lung Colorectal 9 Melanoma [iN Bladder [0 Renal [i N-H Lymph. [i Uterus [i Pancreas [ij * American Cancer Society Cancer Facts and Figures 2024, and comp
Slide 24: Standard of Care
FUTURE POTENTIAL Standard of Care
Slide 25: CRDF-004 trial design and endpoints
FUTURE POTENTIAL ENROLLMENT CRITERIA 28 DAY CYCLE ENDPOINTS PFIZER IGNITE
Slide 26: Our financial position is strong as of Q4 2023
Our financial position is strong as of Q4 2023 Summary financial information as of December 31, 2023 December 31, 2023 cash and investments* $74.8M Q4 2023 net cash used in Operating Activities* $7.1M Runway with current cash extends into 3Q 2025 4 We expect to release data from our first-line RAS m
Slide 27: ONSEMBLE second-line data support CRDF-004 first-line strategy
ONSEMBLE second-line data support our CRDF-004 first-line strategy Efficacy signal in bev naive patients No SoC signal in the control arm Signal in both 20mg & 30mg dose Results from G ONSEMBLE Second-line RAS-mut mCRC Objective responses observed only in bev naive patients that received onvansertib
Slide 28: Appendix: Additional ONSEMBLE data
Appendix Additional ONSEMBLE data
Slide 29: Bev naive and bev exposed
NEW DATA Bev Naïve Bev Naïve Bev Exposed Bev Exposed
Slide 30: Best response by patient
NEW DATA Best response of: PR SD PD
Slide 31: Control arm: treatment emergent adverse events
Control Arm: Treatment Emergent Adverse Effects (TEAEs) | NEW DATA CRDF-003 N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Any Adverse Events 6 (85.7) 6 (85.7) 3 (42.9) 0( 0.0) Control arm Diarrhea 3 (42.9) 1 (14.3) 0( 0.0) 0( 0.0) (N=7) Nausea 2 ( 28.6) 1 (14.3) 1 (14.3) 0( 0.0) . . Fatigue 3 (42.9
Slide 32: Onvansertib 30mg arm TEAEs
Onvansertib 30mg Arm TEAEs: Onvansertib in combination with FOLFIRI+bev is well-tolerated | NEW DATA CRDF-003 fi...» N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total E . l Any Adverse Events 7 (100.0) 7 (100.0) 4 (57.1) 0( 0.0) 7 (100.0) xperimental arm Diarrhea 1 (143) 1(143) 2( 28.6) 0( 0.0) 4
Slide 33: Onvansertib 20mg arm TEAEs
Onvansertib 20mg Arm TEAEs: Onvansertib in combination with FOLFIRI+bev is well-tolerated | NEW DATA CRDF-003 N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total : Any Adverse Events 8 (100.0) 7 (87.5) 2( 25.0) 225.0) 8 (100.0) Experimental arm Diarrhea 4 (50.0) 3(37.5) 0( 0.0) 0( 0.0) 7 (87.5) Onv