Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Investor Presentation (November 2022)
78 slides from Cardiff Oncology's investor presentation, November 2022
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: Many chemotherapy agents damage a cancer cell's ability to replicate
Many chemotherapy agents damage a cancer cell’s ability to replicate DNA Further synthesis cell growth Initial Mitosis cell growth (cell division)
Slide 4: Cancers thrive because they prioritize DNA replication and cell division
Cancers thrive because they prioritize DNA replication and cell division
Slide 5: PLK1 is a master regulator of genome integrity
PLK1 is a master regulator of genome integrity during cell replication DNA Further synthesis cell growth Initial cell growth (cell division)
Slide 6: PLK1 plays multiple roles during cell cycle
PLK1 plays multiple roles S G2 during cell cycle S-Phase G1 M G2/M Checkpoint M-Phase
Slide 7: PLK1 plays multiple roles during cell cycle
PLK1 plays multiple roles S G2 during cell cycle S-Phase G1 M G2/M Checkpoint M-Phase
Slide 8: PLK1 plays multiple roles during cell cycle
PLK1 plays multiple roles S G2 during cell cycle S-Phase G1 M G2/M Checkpoint M-Phase
Slide 9: Onvansertib inhibits PLK1
PLK1 is a master regulator of genome integrity during cell replication ONVANSERTIB INHIBITS PLK1 onvansertib shuts down “OL PLK1's cell- HN preservation ion mechanisms, enhancing the efficacy of cell- damaging cancer therapies
Slide 10: Onvansertib positions Cardiff Oncology to effectively target PLK1
Onvansertib positions Cardiff Oncology to effectively target PLK1 PROPERTIES * Small molecule * Oral dosing ¢ 24-hour half-life SPECIFICITY Exquisitely specific for PLK1 ENZYME ICs (uM) PLK1 0.002 PLK2 >10 PLK3 >10 CK2 0.4 FLT3 0.4 CDK1/CycB >10 42 other kinases >10 and >140 in the Millipore panel 1
Slide 11: What, Why, Where
Scaraitt Oncology” Onvansertib has achieved Onvansertib works Cardiff Oncology can go
Slide 12: What: Onvansertib has achieved
Scarditt Oncology~ OO0O00 WHAT Onvansertib has achieved 05°52 WHY 9 Onvansertib works WHERE Cardiff Oncology can go
Slide 13: 1st line / 2nd line mCRC treatment
Normal 1st LINE 2nd LINE Mutated
Slide 14: 1st line / 2nd line historical ORR
Normal 1st LINE 2nd LINE HISTORICAL* ORR 5% Mutated 11.4% 13%
Slide 15: 1st line / 2nd line mCRC treatment
Normal 1st LINE 2nd LINE Mutated
Slide 16: KRAS/NRAS Mutations in mCRC
KRAS/NRAS Mutations in mCRC1
Slide 17: KRAS/NRAS Mutations in mCRC
KRAS/NRAS Mutations in mCRC1 93%
Slide 18: KRAS/NRAS Mutations in mCRC: MOA
KRAS/NRAS Mutations in mCRC1 MOA 1 2
Slide 19: Trial design: single arm, 28 day cycle
ENROLLMENT CRITERIA SINGLE ARM TRIAL 28 DAY CYCLE
Slide 20: Trial design: single arm, 28 day cycle
ENROLLMENT CRITERIA SINGLE ARM TRIAL 28 DAY CYCLE 1 2 3
Slide 21: Patients achieved a strong, durable response with onvansertib + SoC
Patients achieved a strong, durable response with onvansertib + SoC Best Radiographic Response® -— all doses (as of July 25, 2022) 100 All ° mm Complete Response mm Partial Response mim Stable Disease Doses RP2D 3 @ Confirmed CR @ Confirmed PR: m= Progressive Disease . . & %* Patients treated at the
Slide 22: We observe initial PRs up to eight months on treatment
We observe initial PRs up to eight months on treatment oO oO o oO e a cy 3 8 oe = Swimmer plot* — all doses (as of July 25, 2022) oO fo} fo} fo} oO oO 2 re} e oe fo} ce} re} ro} . 3 0 ¢ Evaluable Patients — all doses 48 S 2 oO 2 o <a : o o ie} n ert = Time of initial PR o o o ‘On Trial On Follow Up
Slide 23: KRAS Variant response
KRAS Variant CR+PR SD PD Total
Slide 24: Objective Response Rate for mCRC trial exceeds SoC over time
Objective Response Rate for mCRC trial exceeds SoC over time Onvansertib+SoC ORR over time RP2D % mmm 8 of 19 42% ° ALL DOSES m= 36% ALL DOSES 38% phase 35% 17 of 487 . . Ol Historical SoC* ORR 5 of 14 34% RP2D 12 of 35+ 11.4% 13% 5% TP if T T T T T T T 2008 13 ‘17 Jan Apr Jul Oct Jan * 2008: Bennou
Slide 25: Progression Free Survival for mCRC trial exceeds SoC over time
Progression Free Survival for mCRC trial exceeds SoC over time Onvansertib+SoC mPFS - as of July 25, 2022 ALL DOSES Historical SoC* mPFS (mo) ==9 4 mot ==9 4 mot 9.3 mot RP2D 2008 2013 2017 oI: Jan Apr Jul Oct t Onvansertib mPFS are interim data from an ongoing trial and unlocked database * 2008: Be
Slide 26: Why: Onvansertib works
fe) Os Cardiff Oncology~ WHAT 3 Onvansertib has achieved Oe OC Oo) WHY =§ Onvansertib works O92 WHERE Cardiff Oncology can go
Slide 27: Onvansertib's safety profile
Onvansertib’s safety profile
Slide 28: MOA 1: KRAS hypersensitivity; MOA 2: synergy with chemo
KRAS HYPERSENSITIVITY1 SYNERGY WITH CHEMO S G2 G1 M MOA 1 MOA 2
Slide 29: MOA 1: KRAS hypersensitivity
KRAS HYPERSENSITIVITY1 MOA 1
Slide 30: MOA 1 and MOA 2
KRAS HYPERSENSITIVITY1 SYNERGY WITH CHEMO S G2 G1 M MOA 1 MOA 2
Slide 31: DNA replication phase
DNA REPLICATION PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 32: DNA replication and cell growth phase
DNA REPLICATION PHASE CELL GROWTH PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 33: Cell growth phase
CELL GROWTH PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 34: Cell growth phase
CELL GROWTH PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 35: Where Cardiff Oncology can go
WHAT 3 Onvansertib has achieved WHY 9 Onvansertib works OOO00 WHERE (Cardiff Oncology can go O5°O°
Slide 36: Goals 2023-2025
2023 2024 2025 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 GOALS 1 2
Slide 37: Demonstrate, Confirm, Position, Operate
DEMONSTRATE CONFIRM POSITION OPERATE
Slide 38: Randomized trial design: 28 day cycle
ENROLLMENT CRITERIA 28 DAY CYCLE
Slide 39: Enrollment criteria and endpoints
ENROLLMENT CRITERIA ENDPOINTS Primary Key Secondary Other Secondary
Slide 40: Combination with investigator-initiated trials and preclinical
Combination with: Preclinical Ph1/2 Ph2/3 Status Investigator-initiated trials Investigator
Slide 41: Pfizer Breakthrough Growth Initiative summary terms
Pfizer BREAKTHROUGH GROWTH INITIATIVE SUMMARY TERMS • • • • •
Slide 42: Targets with and without oncogenic alterations
Targets with Targets without oncogenic oncogenic alterations alterations
Slide 43: We have multiple important catalysts over the next two years
We have multiple important catalysts over the next two years mPDAC TNBC mCRC data readout data readout randomized data readout SCLC data readout Gg ONSEMBLE mCRC Clinical Trial 39 23 15 0 lJ mCRC mPDAC TNBC SCLC 2L K/N-mut 2b 2Linvasive Salvage
Slide 44: At September 30, 2022, our financial position is robust
At September 30, 2022, our financial position is robust mPDAC TNBC mCRC data readout data readout randomized data readout SCLC data readout QONSEMBLE mCRC Clinical Trial September 30, 2022 cash and investments® $114.3M Net cash used in Operating Activities” (Rolling two-quarter period ending Sept. 3
Slide 45: KRAS-Mutated Metastatic Colorectal Cancer (mCRC)
KRAS-Mutated Metastatic Colorectal Cancer (mCRC)
Slide 46: Summary of onvansertib mCRC Ph1b/2 trial data over time
Summary of onvansertib mCRC Ph1b/2 trial data over time Data Cutoff Date Evaluable Patients ORR (CR+PR) Confirmed CR/PRs Duration of Response mPFS Disease control rate (CR+PR+SD) * Data releases include certain follow up data and reflect interim data from an ongoing trial and unlocked database ASCO
Slide 47: No major/unexpected toxicities
GRADE GRADE No major/unexpected toxicities TEAEs* 1 2 3 4 All TEAEs* 1 2 3 4 All • • •
Slide 48: Phase 1b/2 trial design
ENROLLMENT CRITERIA SINGLE ARM TRIAL PHASE 1b PHASE 2 28 DAY CYCLE
Slide 49: Progression Free Survival for mCRC trial exceeds SoC over time
Progression Free Survival for mCRC trial exceeds SoC over time Progression free survival® — all doses (as of July 25, 2022) gs 1.00 5 2 a nn Historical SoC* mPFS (mo) 4 0.75 4 5.6 4 _/ 45 2 0.504 a i 0.25 5 2008 2013 2017 0.00 ~ Median PFS: 93 0 5 10 15 20 Months * mPFS is interim data from an ongoi
Slide 50: Predictive response biomarker
% KRAS Mutant Allelic Frequency (MAF)* Predictive response biomarker • • •
Slide 51: Early changes in KRAS MAF predicts clinical response
Early Changes in KRAS MAF predicts clinical response ORR (%) KRAS RESPONDERS 64% 14 of 22 KRAS NON-RESPONDERS 9% 2 of 23 mPFS (mo) KRAS RESPONDERS 12.6 mo KRAS NON-RESPONDERS 6.0 mo Probability of Survival 1.005 0.50 + 0.25 5 0.00 ~' Onvansertib ORR and mPFS are interim data as of July 25, 2022 from
Slide 52: Historical reference PFS and OS
HISTORICAL REFERENCE PFS OS 5.7 11.2 4.5 11.5 5.6 —
Slide 53: Trial design and statistics
ENROLLMENT CRITERIA DESIGN • • • • STATS • • •
Slide 54: KRAS-Mutated mCRC Bevacizumab Subgroup Data
KRAS-Mutated Metastatic Colorectal Cancer Bevacizumab Subgroup Data
Slide 55: The trial's patient demographics reflect mCRC population
The trial’s patient demographics reflects 24 line mCRC population Enrollment* Number of Patients (N) Treated Currently on treatment Total Patients N=50 Age (years) Sex Male Female ECOG 0 1 Primary tumor site Colon Rectum Other * Data are interim as of July 25, Phase 1b, Dose Level 0 Onvansertib 12 m
Slide 56: 1st line / 2nd line mCRC Ph1b/2 trial
1st LINE 2nd LINE Normal mCRC Ph1b/2 trial RAS Mutated
Slide 57: 2nd line efficacy data from historical trials in mCRC
2nd LINE EFFICACY DATA FROM HISTORICAL TRIALS IN mCRC Normal 2nd Line ORR3-6 2nd Line mPFS (mo)1-2 2nd Line mOS (mo)1-2 RAS Mutated
Slide 58: Historical controls vs onvansertib Ph1b/2 data
2nd LINE HISTORICAL CONTROLS VS ONVANSERTIB* Ph 1b/2 DATA Normal 2nd Line ORR3-6 2nd Line mPFS (mo)1-2 RAS Mutated
Slide 59: No single patient characteristic explains observed ORR difference
No single patient characteristic explains observed ORR difference No Yes (naïve) (exposed) N=
Slide 60: Actions and opportunity
How should we respond ACTIONS to this observation? No Yes (naïve) (exposed) OPPORTUNITY
Slide 61: Bev naive patients durability
All Doses RP2D Bev naïve patients Durability
Slide 62: No prior bev exposure vs bev exposure in 1st line
No prior bev exposure (naïve) Bev exposure in 1st line Best response of: CR/PR SD PD
Slide 63: We observe initial PRs up to eight months on treatment
We observe initial PRs up to eight months on treatment ‘oo 294 90000869 oO 090 9° loo, 12] #ePPPonceeto09g0G 95) Pog ,° 999900" jop000090%0g ie} > 3 fe} su ° e o io} o o 8 > ° 5 > ° a ° 8 > ry e e 1 > ie} 9969 g e ie) D0 e— eee, © 080 0° Cogehs ° erie ee [ele} eee e On Trial (On Follow Up On Treatme
Slide 64: Metastatic Pancreatic Adenocarcinoma (mPDAC)
Metastatic Pancreatic Adenocarcinoma (mPDAC)
Slide 65: mPDAC trial design: 14 day cycle
ENROLLMENT CRITERIA SINGLE ARM TRIAL 14 DAY CYCLE
Slide 66: mPDAC trial design: 14 day cycle
ENROLLMENT CRITERIA SINGLE ARM TRIAL 1 14 DAY CYCLE 2 3
Slide 67: Enrollment criteria and historical response rate
ENROLLMENT CRITERIA HISTORICAL RESPONSE RATE* SINGLE ARM TRIAL 7.7% ORR 14 DAY 20% CYCLE HISTORICAL mPFS* 3.1 mo ≥6 mo
Slide 68: Early data from our mPDAC trial is encouraging
Early data from our mPDAC trial data is encouraging Swimmer plot* — as of August 30, 2022 Change in tumor size from baseline* [e) [e) {e) a [e) fe) Oo 6 @ 04-012 fe) fe) > g 20 (a! H [ a o 2 0 2 4 6 Months 7 E a t 704-008! < 05-014 © ¢<-——_-»—______e 05.009 0 2.5 5.0 7.5 Months 2 «a -20 aang On Trea
Slide 69: Investigator-Initiated Trial: Triple Negative Breast Cancer (TNBC)
Investigator-Initiated Trial Triple Negative Breast Cancer (TNBC)
Slide 70: Onvansertib + paclitaxel is superior to single agent therapy
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 _ control (n=8) =) 3 800 > IS) 600 paclitaxel (
Slide 71: TNBC trial design: enrollment and primary endpoints
ENROLLMENT CRITERIA PRIMARY ENDPOINTS − 28 DAY CYCLE
Slide 72: TNBC trial endpoints
ENROLLMENT CRITERIA PRIMARY ENDPOINTS − 28 DAY CYCLE SECONDARY ENDPOINT
Slide 73: Investigator-Initiated Trial: Small Cell Lung Cancer (SCLC)
Investigator-Initiated Trial Small Cell Lung Cancer (SCLC)
Slide 74: Onvansertib demonstrates single-agent activity in SCLC
Onvansertib demonstrates single-agent activity in SCLC TRIAL RATIONALE In vivo efficacy of onvansertib monotherapy (SCLC xenografts)* Onvansertib monotherapy CISPLATIN RESISTANT CISPLATIN SENSIVITVE showed significant tumor = 2000 2000 growth inhibition against € con. platinum-sensitive and “> -resi
Slide 75: SCLC trial design: 21 day cycle
ENROLLMENT CRITERIA PRIMARY ENDPOINT SECONDARY ENDPOINTS 21 DAY CYCLE
Slide 76: PARPi Pre-Clinical Data
O00 . Lo. OOO PARP Pre-Clinical Data Ooo
Slide 77: Onvansertib + PARP inhibitors
Onvansertib + PARP inhibitors
Slide 78: Onvansertib + PARP inhibitors: Probability of Survival
Onvansertib + PARP inhibitors* Probability of Survival
Cardiff Oncology — Investor Presentation (November 2022) on 6ix