Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Investor Presentation (April 2022)
66 slides from Cardiff Oncology's investor presentation, April 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: PLK1 is hijacked by tumor cells, allowing uncontrolled growth
PLK1 is hijacked by tumor cells, allowing uncontrolled growth DNA Further synthesis cell growth TUMOR Gait, CWGuE Initial Mitosis cell growth M (cell division) <>
Slide 4: PLK1 repairs damaged DNA, enabling tumor cells to proliferate
PLK1 repairs damaged DNA, enabling tumor cells to proliferate Molecular Cell, March 4, 2021 PLK1 repairs dsDNA breaks at broken replication forks
Slide 5: Onvansertib positions Cardiff Oncology to effectively target PLK1
Onvansertib positions Cardiff Oncology to effectively target PLK1 SPECIFICITY PROPERTIES he OPPORTUNITY Exquisitely specific for PLK1 * Small molecule ws PLK1 is over-expressed * Oral dosing a in many cancer types! ENZYME IC5o (uM) * 24-hour half-life me PLK1 0.002 O) ( Breast PLK2 >10 Colorectal PL
Slide 6: What, Why, Where
WHAT Onvansertib has achieved WHY — Onvansertib works WHERE § Cardiff Oncology can go
Slide 7: What Onvansertib has achieved
@) O OOO00 WHAT Onvansertib has achieved O 2 WHY 9 Onvansertib works WHERE Cardiff Oncology can go
Slide 8: Development pipeline
Preclinical IND En. Ph 0/1 Ph 2 Status
Slide 9: Gaps in current mCRC therapies leave a significant unmet need
Gaps in current mCRC therapies leave a significant unmet need 1st LINE 2nd LINE FOLFOX (chemo) + bevacizumab KRAS Nermal + EGFR inhibitor FOLFIRI (chemo) + bevacizumab KRAS Mutant | FOLFOX (chemo) + bevacizumab > KRAS KRAS Normal! Mutant 57.1% WPA 1. Jones R et al. Br J Cancer. 2017 Mar 28;116(7):92
Slide 10: 2nd line historical ORR
2nd LINE HISTORICAL ORR 5% 11.4% 13%
Slide 11: Gaps in KRAS-mutated mCRC therapies leave a significant unmet need
Gaps in KRAS-mutated mCRC therapies leave a significant unmet need KRAS Mutations in mCRC' A G12C Investigational therapies (Amgen; Mirati) address G12D the G12C KRAS mutation only G12V KRAS Normal G13D G12S G12A Q61H G13C 1. Jones R et al. Br J Cancer. 2017 Mar 28;116(7):923-929
Slide 12: Gaps in KRAS-mutated mCRC therapies leave a significant unmet need
Gaps in KRAS-mutated mCRC therapies leave a significant unmet need KRAS Mutations in mCRC' se | 91.1% of patients with KRAS mutations miss out on G12V targeted therapy G13D G12S G12A Q61H G13C 1. Jones R et al. Br J Cancer. 2017 Mar 28;116(7):923-929
Slide 13: Downstream Onvansertib
DOWNSTREAM Onvansertib S G2 G1 M
Slide 14: Ph 1b/2 trial in KRAS-mutated mCRC combines onvansertib with SoC
Our Ph 1b/2 trial in KRAS-mutated mCRC combines onvansertib w/ SoC Sp SoC: FOLFIRI Y + bevacizumab OBO E88 6 7 8 9 10 1 12 13° 14 —ONVANSERTIB— sae SoC: FOLFIRI Y + bevacizumab O)(E)}(P)(O)(O)| 20 || 21 | 22 || 23 || 24 || 25 || 26 || 27 || 28 —ONVANSERTIB—
Slide 15: Trial endpoints measure tumor response and decrease in KRAS burden
Trial endpoints measure tumor response and decrease in KRAS burden EFFICACY ENDPOINTS Primary: Objective Response Rate (ORR) per RECIST v1.1 in patients who receive =1 cycle of treatment Secondary: Progression-Free Survival (PFS) and Duration of Response (DoR) Exploratory: Decrease in KRAS mutationa
Slide 16: Phase 1b / Phase 2 design
WEEKS 1−2 PHASE 1b PHASE 2 WEEKS 3−4
Slide 17: Historical ORR and mPFS
HISTORICAL ORR* 5% WEEKS 1−2 11.4% 13% 20% WEEKS 3−4 HISTORICAL mPFS* ≥6 mo 4.5−5.7 mo
Slide 18: Historical ORR and PFS vs trial
HISTORICAL ORR 5% WEEKS 1−2 11.4% 13% 20% 35% 34% WEEKS 3−4 HISTORICAL PFS ≥6 mo 9.4mo 4.5−5.7 mo
Slide 19: No major/unexpected toxicities
No major/unexpected toxicities GRADE GRADE TEAEs* 1 2 3 4 All TEAEs* 1 2 3 4 All • • •
Slide 20: 92% of patients achieved disease control
92% of patients achieved disease control (CR + PR + SD) Best Radiographic Response® - all doses (as of Dec 3, 2021) % change in target lesions from baseline 100 0 -30 -100 ™™ Complete Response =m Stable Disease @ Confirmed CR mm Partial Response Confirmed PR * Patients treated at the RP2D mm Progres
Slide 21: 92% of patients achieved disease control
92% of patients achieved disease control (CR + PR + SD) PR confirmation status RP2D 1. Waiting for confirmatory scan; remains on trial 2. Regressed to SD (-31 to -25%); potentially curative surgery All other | 3. Regressed to SD (-32 to -24%); remains on trial doses 4. Discontinued for unrelated AE
Slide 22: Initial PRs up to eight months on treatment
Across all doses we observe initial PRs up to eight months on treatment a tSmginr2 Phib tEmgin’2 Phtb1Smgin*2 Phi ‘amg? 0 hree patients were excluded from the RP2D efficacy evalu fe} ° ° e e e ° e ° °Q ze) ° ° oO soy fo} fe} fo} fe) e ° O=0: ° e ea fe} fe} Q e e e 8 [o} e e ° e Q Q ° sey e e ° ° ° °
Slide 23: Clinical benefits observed
Clinical benefits observed 1 2 3
Slide 24: Response by KRAS variant
KRAS Variant CR+PR SD PD Total 6
Slide 25: Objective response rate exceeds SoC over time
Objective response rate for mCRC trial exceeds SoC over time Onvansertib+SoC ORR over time (as of Dec 3, 2021) RP2D 42% meme 8 of 19 ALL DOSES == 36% ALL DOSES 38% AL DOSES 35% 17 of 487 Historical SoC* ORR 5 of 14 ° 34% RP2D 12 of 35¢ 11.4% 13% 5% EH, f T T T T T T T T 2008 «613017 Jan Apr Jul Oct
Slide 26: Median PFS exceeds SoC over time
Median progression free survival for mCRC trial exceeds SoC over time Progression free survival* — all doses (as of Dec 3, 2021) S 1.00; fa 5 a 6 0.75} 2 S oso----4 Median PFS ----- O° ee ST h Q a 1 Va ~ 0.255 94 XX J 1 1 1 0.00: Vv é 5 10 15 20 Cumulative number of events £ a) 9 17 17 18 : ? ; ” 6
Slide 27: Median PFS exceeds SoC over time
Median progression free survival for mCRC trial exceeds SoC over time Onvansertib+SoC mPFS - all doses (as of Dec 3, 2021) Historical SoC* mPFS (months) == 9.4 months 9.4 months 5.7 5.6 [ : [ 2008 2013 2017 aa Apr Jul Oct Jan t Jan 2022 PFS are interim data as of Dec 3, 2021 from an ongoing trial an
Slide 28: Predictive response biomarker
Predictive response biomarker %Change in KRAS MAF • ✱✱ ✱ 0 • -50 -100 CR+PR SD PD CR+PR SD PD Mean -96 -74 -63
Slide 29: What, Why, Where
WHAT 3 Onvansertib has achieved @) O SION WHY 9 Onvansertib works O e WHERE Cardiff Oncology can go
Slide 30: Onvansertib's safety profile
Onvansertib’s safety profile
Slide 31: MOA 1 and MOA 2
KRAS HYPERSENSITIVITY1 SYNERGY WITH CHEMO S G2 G1 M MOA 1 MOA 2
Slide 32: MOA 1: KRAS hypersensitivity
KRAS HYPERSENSITIVITY1 MOA 1
Slide 33: MOA 1 and MOA 2
KRAS HYPERSENSITIVITY1 SYNERGY WITH CHEMO S G2 G1 M MOA 1 MOA 2
Slide 34: DNA replication phase
DNA REPLICATION PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 35: DNA replication and cell growth phase
DNA REPLICATION PHASE CELL GROWTH PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 36: Cell growth phase
CELL GROWTH PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 37: Cell growth phase
CELL GROWTH PHASE S G2 TUMOR CELL CYCLE G1 M
Slide 38: Onvansertib + Irinotecan in HCT-116
Onvansertib + Irinotecan1 in HCT-116 (with G13D KRAS mutation)
Slide 39: What, Why, Where
WHAT 3 Onvansertib has achieved WHY 9 Onvansertib works OOO00 WHERE (Cardiff Oncology can go O5°O°
Slide 40: DNA damaging agents, microtubule targeting, epigenetics
DNA DAMAGING AGENTS MICROTUBULE TARGETING EPIGENETICS
Slide 41: Pipeline and partners
Preclinical IND En. Ph 0/1 Ph 2 Status Partners
Slide 42: Clinical programs and other combinations
CLINICAL OTHER PROGRAMS COMBINATIONS • • •
Slide 43: Pfizer Breakthrough Growth Initiative
Pfizer BREAKTHROUGH GROWTH INITIATIVE SUMMARY TERMS • • • • •
Slide 44: Cardiff Oncology at a glance
Cardiff Oncology at a glance Clinical-stage biotech company developing onvansertib, an oral, highly-selective PLK1 inhibitor, across a range of cancers Exchange Nasdaq: CRDF Cash, Cash Equivalents and Investments! $140.8M Cash used in Operating Activities’ (FY 2021) $23.0M Headquarters San Diego, CA
Slide 45: KRAS-Mutated Metastatic Colorectal Cancer (mCRC)
KRAS-Mutated Metastatic Colorectal Cancer (mCRC)
Slide 46: Phase 1b/2 mCRC trial patient enrollment and demographics
Phase 1b/2 mCRC trial patient enrollment and demographics 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 Treated 6 6 6
Slide 47: % change in target lesions from baseline
% change in target lesions from baseline
Slide 48: Change in target lesions: CR+PR and SD patients
% change in target lesions from baseline Patients achieving CR+PR % change in target lesions from baseline Patients achieving SD
Slide 49: Summary of onvansertib mCRC Ph1b/2 trial data over time
Summary of onvansertib mCRC Ph1b/2 trial data over time ASCO Gl ASCO Gl KOL Event Jan 2022 Investor Webcast Jan 2021 Sept 2021 Jan 2022 Abstract Poster Dec 3, 2021 + Data Cutoff Date | Nov 1, 2020* July 2, 2021* Sep 16, 2021 Dec 3, 2021 efficacy follow up through Jan. 18 All Doses a RP2D All Doses R
Slide 50: KRAS-mutated mCRC: Cardiff Oncology's next steps
KRAS-mutated mCRC: Cardiff Oncology’s next steps Cardiff Oncology management has decided to expand the activated Phase 2 trial and enroll ~40-50 additional patients as we prepare for initiation of the pivotal trial * Obtain additional patient data: — Safety — Efficacy — Pharmacokinetic/oharmacodynam
Slide 51: Historical reference PFS and OS
HISTORICAL REFERENCE PFS OS 5.7 11.2 4.5 11.5 5.6 —
Slide 52: Metastatic Pancreatic Adenocarcinoma (mPDAC)
Metastatic Pancreatic Adenocarcinoma (mPDAC)
Slide 53: Ph trial in KRAS-mutated mPDAC combines onvansertib with SoC
Our Ph 2 trial in KRAS-mutated mPDAC combines onvansertib w/ SoC Eo] 2nd-Line SoC: Nal-IRI Y + Leucovorin + 5-FU FOIA OOAO) | 1 || 12) 13) 4 ONVANSERTIB Eo 2nd-Line SoC: Nal-IRI Y + Leucovorin + 5-FU HOO OCOOCOOO #22 ONVANSERTIB
Slide 54: mPDAC trial efficacy endpoints
Our Ph 2 trial in KRAS-mutated mPDAC combines onvansertib w/ SoC EFFICACY END POINTS (1) Primary: Objective Response Rate (ORR) in patients who receive =28-days of treatment (2) Secondary: Duration of Response (DOR) * and median overall survival (mOS) Exploratory: Identification of biomarkers L 3 )
Slide 55: Historical response rate and PFS
HISTORICAL RESPONSE RATE WEEKS 1−2 7.7% 20% PROGRESSION-FREE SURVIVAL WEEKS 3−4 3.1 mo ≥6 mo
Slide 56: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Slide 57: Ph study in mCRPC combines onvansertib with abiraterone
Our Ph 2 study in mCRPC combines onvansertib with abiraterone onvansertib abiraterone prednisone abiraterone prednisone One cycle = 21 days 15 16 17 18 19 20 21 8 11 12 13 14 57
Slide 58: Key eligibility and exclusion criteria
Key Eligibility Criteria Arm A (n=24) Arm B (n=32) Arm C (n=32) • Key Exclusion Criteria • •
Slide 59: Endpoints measure disease control and time to PSA progression
Endpoints measure disease control and time to PSA progression EFFICACY ENDPOINTS Ps Primary: Proportion of patients achieving 1 disease control after 12-weeks of treatment, / as defined by lack of PSA progression (per PCWG53 criteria) 9) Secondary: Radiographic response (per (2) RECIST v1.1); time t
Slide 60: Historical resistance to ARSi
HISTORICAL RESISTANCE TO ARSi 9-15 mo WEEKS 1−2 30% disease control rate OVERALL SURVIVAL BENEFIT WEEK ~4 mo3 ≥6 mo
Slide 61: Onvansertib + Abiraterone demonstrate synergy in preclinical model
Onvansertib + Abiraterone Demonstrate Synergy in Onvansertib + Abiraterone Significantly Increases Abi-Resistant Model (LVCaP2CR)1 Apoptotic Cell Death1 25 Vehicle to baseline (mean +/-SEM) Onvansertib Tumor volume relative 20 Abiraterone 15 Combination 10 * 5 * *** * * *** *** ** 0 0 3 7 10 14 17 2
Slide 62: Arm C provides the greatest disease control
Arm C of our Phase 2 trial provides the greatest disease control Efficacy Across Arms A, B, and C for Evaluable Patients (02-Feb-22) Arm A Arm B (onv days 1-5 / 21-day cycle) (onv days 1-5 / 14-day cycle) Evaluable for efficacy* 17 19 Disease control / PSA Stabilization at 12 weeks** 5 (29%) 8 (42%)
Slide 63: Probability of Progression
TROV053_PFS_Feb2-2022 Probability of Progression Arm A (5+16) 100 Arm B (5+9) Arm C (14+7) 50 0 0 20 40 60 80 100 Time (weeks)
Slide 64: PARPi Pre-Clinical Data
O00 . Lo. OOO PARP Pre-Clinical Data Ooo
Slide 65: Onvansertib + PARP inhibitors
Onvansertib + PARP inhibitors
Slide 66: Onvansertib + PARP inhibitors: Probability of Survival
Onvansertib + PARP inhibitors* Probability of Survival
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