Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Corporate Update (August 2023)
48 slides from Cardiff Oncology's corporate update, Aug 7, 2023
Slide 1: mCRC Program Update and Clinical Development Plan
mCRC Program Update and Clinical Development Plan A U G U ST 7 , 2 0 2 3
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: Clinical data from 1st line RAS-mutated mCRC trial expected mid-2024
We expect clinical data from our 1st line RAS-mutated mCRC trial in mid-2024 PFIZER
Slide 4: mCRC clinical development program agreed with FDA
mCRC clinical development program agreed with FDA • • • • • •
Slide 5: Annual eligible U.S. patients
Annual eligible U.S. patients (’000s)* 50 48 40 23 15 12 5 3 0
Slide 6: Investigator-initiated trials by line of therapy
Line of Therapy Trial Ph2 Ph3 Combination with: Investigator-initiated trials
Slide 7: Onvansertib clinical development plan in mCRC
Onvansertib clinical development plan in mCRC CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD
Slide 8: Onvansertib clinical development plan in mCRC
Onvansertib clinical development plan in mCRC CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD
Slide 9: Onvansertib
Onvansertib PROPERTIES SPECIFICITY • • •
Slide 10: 1st line and 2nd line RAS mutated mCRC
Normal 1st LINE 2nd LINE RAS Mutated
Slide 11: 1st line and 2nd line RAS mutated mCRC
Normal 1st LINE 2nd LINE RAS Mutated
Slide 12: RAS-mutations in mCRC and MOA
RAS-mutations in mCRC1 MOA 1 2
Slide 13: Trial design: enrollment criteria and efficacy endpoints
ENROLLMENT CRITERIA EFFICACY ENDPOINTS 1 2 28 DAY CYCLE 3
Slide 14: We enrolled 50 initial patients and an additional 18 patients
We enrolled 50 PHASE 1b PHASE 2 TOTAL initial patients, and then an additional 18 patients, in our trial ITT population (N) 50 68 Evaluable population* (N) 48 66
Slide 15: Bev exposed vs bev naive patients
Bev exposed vs bev naïve patients 1st LINE 2nd LINE
Slide 16: Bev naive patients achieved higher response rate with onvansertib+SoC
Bev naive patients achieved higher response rate with onvansertib+SoC 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, -) Dise
Slide 17: Bev naive patients experienced more durable responses
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% 12/60) 53% (g/15) 8% 4/51) Initial PR at 8 week scan 9 8 1 Initial PR at 16+ week scan 10 3 7 o e@ eee ee eo ew ew 8 le
Slide 18: KRAS variant responses
KRAS G12C Variant CR+PR SD PD Total G12D G12V G13D G12S G12A Q61H G13C
Slide 19: PFS exceeds historical controls for SoC, particularly in bev naive patients
PFS exceeds historical controls for SoC, particularly in bev naive patients Progression free survival* — 66 evaluable patients (as of June 16, 2023) 3 1.00 3 1.004 g 5 a a ° 8 Bojs. Bors, . iad I O76 — Bev naive 8 — All patients 4 £ P & — Bev exposed 050) - 22-22 eee- eee 77 ee ieee 0.25: 0.25- 5.0
Slide 20: 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 21: Onvansertib clinical development plan in mCRC
Onvansertib clinical development plan in mCRC CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD
Slide 22: Findings establish scientific basis of bev naive clinical finding
Our findings establish the scientific basis of our bev naïve clinical finding
Slide 23: Combination had superior anti-tumor activity compared to 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 24: KRAS-mut tumors treated with onv + bev appear smaller and pale
KRAS-mut tumors from mice treated with onv + bev appear smaller and pale (less vascularized)
Slide 25: Hypoxia: a hallmark of cancer
Hypoxia: a hallmark of cancer In response to hypoxia, cancer cells activate the hypoxia- inducible factor (HIF) pathway, which can promote tumorigenesis through multiple means: ° Angiogenesis Cell proliferation and survival Highly immunosuppressive and invasive tumor microenvironment * Hypoxia-induc
Slide 26: Onvansertib inhibited hypoxia-induced HIF1a expression in RAS-mutant CRC cells
In 4 RAS-mutant CRC cell lines*, onvansertib inhibited hypoxia-induced HIF1a expression PLK1 inhibition using siRNA against PLK1 (siPLK1) prevented hypoxia-induced HIF1a expression
Slide 27: New MOA inhibits a survival switch of tumorigenesis
This new MOA, which inhibits a “survival switch” of tumorigenesis, may underlie the increased efficacy observed clinically
Slide 28: Prior bev treatment modulates gene pathways conferring resistance
Prior bev treatment modulates gene pathways that can confer resistance to bev and onvansertib Method: KRAS-mutant mCRC patients 1* line treatment je) (} FOLFOX (n=71) FOLFOX + bev (n=64) * Bev exposed tumors showed up-regulation of pathways associated with: — Hypoxia - G2/M checkpoint and mitosis +
Slide 29: RAS-mutations in mCRC and MOA
RAS-mutations in mCRC1 MOA 1 2 3
Slide 30: Onvansertib clinical development plan in mCRC
Onvansertib clinical development plan in mCRC CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD
Slide 31: FDA agreed with proposed 1st line clinical program
FDA suggested we consider moving to …and FDA agreed with Cardiff Oncology’s a 1st line clinical development path… proposed 1st line clinical program 2nd line 1st line mCRC mCRC • • •
Slide 32: Clinical, regulatory and commercial transition from 2L to 1L
• • • Clinical Regulatory • • • • Transition Commercial • from • 2L to 1L
Slide 33: Enrollment criteria and endpoints
ENROLLMENT CRITERIA ENDPOINTS Primary Secondary Benchmark of success
Slide 34: 2nd line and 1st line mCRC
2nd Line mCRC 1st line mCRC 2nd Line mCRC 1st line mCRC
Slide 35: Pfizer Breakthrough Growth Initiative
PFIZER BREAKTHROUGH GROWTH INITIATIVE PFIZER Ignite • • • • •
Slide 36: Multiple near-term clinical data read outs
We have multiple near-term clinical data read outs st |j mPDAC TNBC Wiling meRe data readout data readout d ata readout SCLC data readout June 30, 2023 cash and investments Net cash used in Operating Activities (Rolling two-quarter period ending June 30, 2023) $89.4M $15.8M 36
Slide 37: Clinical data from 1st line RAS-mutated mCRC trial expected mid-2024
We expect clinical data from our 1st line RAS-mutated mCRC trial in mid-2024 PFIZER
Slide 38: Appendix: Additional Ph 1b/2 Clinical Data
Appendix: Additional Ph 1b/2 Clinical Data
Slide 39: Expansion cohort replicated improved responses in bev naive patients
As an independent cohort in the Ph 1b/2 trial, the expansion cohort replicated the finding of improved responses from the bev naïve patients
Slide 40: Bev naive patients responded better than bev exposed
Bev naive patients responded better than bev exposed Swimmer plot* — 18 expansion cohort patients (as of June 16, 2023) Pursued surgery / ablation All patients 17% (3/18) Bev naive 50% (2/4) Bev exposed 7% (1/14) Bev naive Bev exposed Oo 0 0 00 [ommre) o°oee oeeee O00 ¢ of 10 15 20 Months Reason for
Slide 41: Expansion cohort patients replicated prior bev naive finding
Expansion cohort patients replicated the prior bev naive finding Progression free survival* — 18 expansion cohort patients (as of June 16, 2023) Probability of Survival 0.50 0.0 Characteristic N Event N mPFS (95%Cl) Overall 18 8 8.4 (4.8, —) — All patients 5 2 Months Probability of Survival 0.50 0.0
Slide 42: mCRC Ph 1b/2 subgroup data compares favorably to SoC
mCRC Ph 1b/2 trial subgroup data compares favorably to SoC Objective response rates (%) and mPFS (mo) in our Ph1b/2 trial varied considerably by subgroup Bev naive Bev exposed Total Ph1b/2 (N=48) 82% (9 of 11) 14.0 mo 23% of patients 22% (8 of 37) 7.8 mo 77% of patients 35% (17 of 48) 9.3 mo 100% of
Slide 43: Bev naive patients experienced deeper tumor regression
Bev naive patients experienced deeper tumor regression Change in tumor size from baseline* — all doses (as of June 16, 2023) Bev naive Bev exposed Best response of: Median best response Median best response 2 - ss % change: % change: 3 a, All patients -39% All patients -3% Frogressive Ss € m= PD CR/
Slide 44: No single patient characteristic explains difference in response rates
No single patient characteristic explains the difference in response rates by prior bev status
Slide 45: Appendix: Additional Preclinical Data
Appendix: Additional Preclinical Data
Slide 46: C1143 (KRAS G12D) and C1144 (KRAS G12C) 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 47: B8239, C1143 and C1138 KRAS models
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 48: Onvansertib inhibits vascularization in vitro
Onvansertib inhibits vascularization in vitro Tube formation assay: HUVEC endothelial cells seeded onto a 3D extracellular matrix form tube-like structures upon stimulation with the angiogenic factor VEGFA, simulating the formation of new blood vessels Treatment with onvansertib (25, 100 and 400nM)