Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Corporate Update (September 2022)
67 slides from Cardiff Oncology's corporate update, Sep 12, 2022
Slide 1: Clinical and Corporate Update
Clinical and Corporate Update SEPTEMBER 12, 2022
Slide 2: Forward-looking statements
2 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 s
Slide 3: Many chemo agents damage a tumor cell's ability to replicate
3 Many chemo agents damage a tumor cell’s ability to replicate DNA synthesis Initial cell growth Further cell growth Mitosis (cell division) S G2 G1 M Irinotecan 5-FU Taxanes
Slide 4: Cancers thrive because they prioritize DNA replication and cell division
4 Cancers thrive because they prioritize DNA replication and cell division
Slide 5: PLK1 is a master regulator of genome integrity during cell replication
5 PLK1 is a master regulator of genome integrity during cell replication DNA synthesis Initial cell growth Further cell growth Mitosis (cell division) S G2 G1 M
Slide 6: PLK1 is a master regulator of genome integrity during cell replication
6 PLK1 is a master regulator of genome integrity during cell replication DNA synthesis Initial cell growth Further cell growth Mitosis (cell division) G2 G1 M S PLK1 plays multiple roles during cell cycle S-Phase Controls the repair of DNA damage G2/M Checkpoint M-Phase
Slide 7: PLK1 is a master regulator of genome integrity during cell replication
7 PLK1 is a master regulator of genome integrity during cell replication DNA synthesis Initial cell growth Further cell growth Mitosis (cell division) G1 M S G2 PLK1 PLK1 plays multiple roles during cell cycle S-Phase Controls the repair of DNA damage G2/M Checkpoint Controls the checkpoint for DNA
Slide 8: PLK1 is a master regulator of genome integrity during cell replication
8 PLK1 is a master regulator of genome integrity during cell replication DNA synthesis Initial cell growth Further cell growth Mitosis (cell division) G2 G1 S M PLK1 plays multiple roles during cell cycle S-Phase Controls the repair of DNA damage G2/M Checkpoint Controls the checkpoint for DNA quali
Slide 9: Onvansertib shuts down PLK1's cell-preservation mechanisms
9 PLK1 is a master regulator of genome integrity during cell replication onvansertib shuts down PLK1’s cell- preservation mechanisms, enhancing the efficacy of cell- damaging cancer therapies ONVANSERTIB INHIBITS PLK1
Slide 10: Onvansertib positions Cardiff Oncology to effectively target PLK1
10 Onvansertib positions Cardiff Oncology to effectively target PLK1 • Small molecule • Oral dosing • 24-hour half-life ENZYME IC50 (µM) PLK1 0.002 PLK2 >10.000 PLK3 >10.000 CK2 0.400 FLT3 0.400 CDK1/CycB >10.000 42 other kinases and >140 in the Millipore panel >10.000 Exquisitely specific for PLK1
Slide 11: Two goals drive our near-term clinical development program
11 Two goals drive our near-term clinical development program 1 Validate prior mCRC data with a randomized trial 2 Demonstrate clinical POC in additional indications 2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 GOALS
Slide 12: Today we'll see where we are, and where we're going
12 Today we’ll see where we are, and where we’re going Accelerating our mCRC program Additional onvansertib programs Initial trial: phase 1b/2 Next trial
Slide 13: Today we'll see where we are, and where we're going
13 Today we’ll see where we are, and where we’re going Accelerating our mCRC program Additional onvansertib programs Pancreatic cancer (mPDAC) Triple negative breast cancer (TNBC) Small cell lung cancer (SCLC) Prostate cancer (mCRPC)
Slide 14: Accelerating our mCRC program
14 Initial trial: phase 1b/2 Next trial Accelerating our mCRC program Additional onvansertib programs
Slide 15: There are no targeted therapies available for KRAS/NRAS mutations
15 There are no targeted therapies available for KRAS/NRAS mutations 1. Jones R et al. Br J Cancer. 2017 Mar 28;116(7):923-929 1st LINE 2nd LINENormal Mutated Standard Targeted FOLFIRI + bevacizumabFOLFOX + bevacizumab + EGFR inhibitor KRAS/NRAS mutatedNormal NONE Standard Targeted FOLFOX + bevacizu
Slide 16: The prognosis for second-line mCRC patients is poor
16 The prognosis for second-line mCRC patients is poor * Bennouna et al., Lancet Oncol 2013; 14: 29–37; Giessen et al., Acta Oncologica, 2015, 54: 187-193; Cremolini et al., Lancet Oncol 2020, 21: 497–507; Antoniotti et al., Correspondence Lancet Oncol June 2020. mCRC: metastatic colorectal cancer 2
Slide 17: Adding onvansertib to SoC could address the unmet need
17 Adding onvansertib to SoC could address the unmet need 2nd LINE FOLFIRI + bevacizumab NONE FOLFIRI + bevacizumab 1st LINENormal Mutated Standard Targeted FOLFOX + bevacizumab + EGFR inhibitor Standard Targeted FOLFOX + bevacizumab NONE ONVANSERTIB Onvansertib has the potential to fill this gap
Slide 18: Gaps in KRAS-mutated mCRC therapies leave a significant unmet need
18 G12C G12D G12V G13D G12S G12A Q61H G13CNRAS Normal Gaps in KRAS-mutated mCRC therapies leave a significant unmet need 1. Jones R et al. Br J Cancer. 2017 Mar 28;116(7):923-929 3.8% Investigational therapies (Amgen; Mirati) address the G12C KRAS mutation only KRAS/NRAS Mutations in mCRC1
Slide 19: Gaps in KRAS-mutated mCRC therapies leave a significant unmet need
19 Gaps in KRAS-mutated mCRC therapies leave a significant unmet need 1. Jones R et al. Br J Cancer. 2017 Mar 28;116(7):923-929 of patients with KRAS/NRAS mutations miss targeted therapy 93%G12C G12D G12V G13D G12S G12A Q61H G13CNRAS Normal KRAS/NRAS Mutations in mCRC1
Slide 20: Onvansertib is positioned to address gaps in KRAS-mutated mCRC
20 Onvansertib is positioned to address gaps in KRAS-mutated mCRC MOA In KRAS-mutated mCRC, onversertib has two mechanisms of action 1. Jones R et al. Br J Cancer. 2017 Mar 28;116(7):923-929 Synergy with 2nd-line SoC2 Synthetic lethality in KRAS mutants1G12C G12D G12V G13D G12S G12A Q61H G13CNRAS No
Slide 21: Our Ph1/2b trial combined onvansertib with the current SoC
21 2nd-Line SoC: FOLFIRI + bevacizumab 2nd-Line SoC: FOLFIRI + bevacizumab 28 DAY CYCLE Our Ph1/2b trial combined onvansertib with the current SoC 6 7 8 9 10 11 12 13 14 20 21 22 23 24 25 26 27 28 O N V A N S E R T I B O N V A N S E R T I B KRAS+ Unresectable 2nd line mCRC ENROLLMENT CRITERIA N=50 (
Slide 22: Our Ph1/2b trial assessed safety, efficacy and response biomarker
22 2nd-Line SoC: FOLFIRI + bevacizumab 2nd-Line SoC: FOLFIRI + bevacizumab 28 DAY CYCLE 6 7 8 9 10 11 12 13 14 20 21 22 23 24 25 26 27 28 O N V A N S E R T I B O N V A N S E R T I B KRAS+ Unresectable 2nd line mCRC ENROLLMENT CRITERIA N=50 (48 evaluable) Can we get a signal that onvansertib compleme
Slide 23: Patients achieved a strong, durable response with onvansertib + SoC
23 Patients achieved a strong, durable response with onvansertib + SoC * Waterfall plot and table reflect interim data as of July 25, 2022 from an ongoing trial and unlocked database Best Radiographic Response* – all doses (as of July 25, 2022) All Doses RP2D Objective Response Rate* (CR + PR) 34% (
Slide 24: We observe initial PRs up to eight months on treatment
24 We observe initial PRs up to eight months on treatment * Swimmer plot and table reflect interim data as of July 25, 2022 from an ongoing trial and unlocked database Evaluable Patients – all doses 48 Time of initial PR 8-week scan 16-week scan 24-week scan 32-week scan 8 3 5 1 Swimmer plot* – all
Slide 25: Patients achieved responses across several KRAS mutations
25 Patients achieved responses across several KRAS mutations Evaluable Patients – all doses 48 Time of initial PR 8-week scan 16-week scan 24-week scan 32-week scan 8 3 5 1 Swimmer plot* – all doses (as of July 25, 2022) months KRAS Variant CR+PR SD PD Total G12D 6 7 1 14 G12V 1 8 1 10 G13D 4 3 7 G1
Slide 26: Objective Response Rate for mCRC trial exceeds SoC over time
26 2008 ‘13 ‘17 Objective Response Rate for mCRC trial exceeds SoC over time 42% RP2D Onvansertib+SoC ORR† over time 38% ALL DOSES Historical SoC* ORR 8 of 19 12 of 32 5% 11.4% 13% 20222021 Jan Apr Jul Oct Jan 35% RP2D34% ALL DOSES 12 of 35 17 of 4836% 5 of 14 ALL DOSES * 2008: Bennouna et al., Lanc
Slide 27: Progression Free Survival for mCRC trial exceeds SoC over time
27 Progression Free Survival for mCRC trial exceeds SoC over time * 2008: Bennouna et al., Lancet Oncol 2013; 14: 29–37; 2013: Giessen et al., Acta Oncologica, 2015, 54: 187-193; 2017: Cremolini et al., Lancet Oncol 2020, 21: 497–507; and Antoniotti et al., Correspondence Lancet Oncol June 2020. SoC
Slide 28: Progression Free Survival for mCRC trial exceeds SoC over time
28 Progression Free Survival for mCRC trial exceeds SoC over time † Onvansertib mPFS are interim data from an ongoing trial and unlocked database * 2008: Bennouna et al., Lancet Oncol 2013; 14: 29–37; 2013: Giessen et al., Acta Oncologica, 2015, 54: 187-193; 2017: Cremolini et al., Lancet Oncol 2020
Slide 29: Onvansertib in combination with FOLFIRI-bev is well-tolerated
29 Onvansertib in combination with FOLFIRI-bev is well-tolerated * Data are interim as of July 25, 2022 from an ongoing trial and unlocked database. N: number of patients (total N=50); events shown occurred in ≥10% of patients; numbers indicate number of patients experiencing the event, (regardless
Slide 30: The trial's patient demographics reflects 2nd line mCRC population
30 The trial’s patient demographics reflects 2nd line mCRC population * Data are interim as of July 25, 2022 from an ongoing trial and unlocked database, for the first 50 subjects. Number of Patients (N) Phase 1b, Dose Level 0 Onvansertib 12 mg/m2 Phase 1b, Dose Level +1 Onvansertib 15 mg/m2 Phase 1
Slide 31: Anti-angiogenics, like bevacizumab, combine with 1st and 2nd line SoC
31 Anti-angiogenics, like bevacizumab, combine with 1st and 2nd line SoC Normal RAS Mutated 1st LINE FOLFOX + bevacizumab + EGFR inhibitor FOLFOX + bevacizumab 2nd LINE FOLFIRI + bevacizumab FOLFIRI + bevacizumab N=50 (48 evaluable) Do 2nd line patients naïve to bev show better efficacy than 2nd lin
Slide 32: 1st line use of bev in prior trials has minimal impact on 2nd line efficacy
32 1st line use of bev in prior trials has minimal impact on 2nd line efficacy 1. Hansen et al., Cancers 2021, 13, 1031; 2. Tabernaro et al. Eur J Cancer, 2014, 50, 320-332; 3. Bennouna et al., Lancet Oncol. 2013, 14, 29–37; 4. Van Cutsem et al., J. Clin. Oncol. 2012, 30,3499–3506; 5. Tabenaro et al
Slide 33: Ph 1b/2 trial bev naïve patients had unexpectedly high ORR and mPFS
33 Ph 1b/2 trial bev naïve patients had unexpectedly high ORR and mPFS 1. Hansen et al., Cancers 2021, 13, 1031; 2. Tabernaro et al. Eur J Cancer, 2014, 50, 320-332; 3. Bennouna et al., Lancet Oncol. 2013, 14, 29–37; 4. Van Cutsem et al., J. Clin. Oncol. 2012, 30,3499–3506; 5. Tabenaro et al, Lancet
Slide 34: ORR is consistently greater for bev naïve patients across characteristics
34 80% 80% 80% 75% 71% 70% 69% 67% 67% 67% 63% 60% 56% 50% 16% 27% 31% 14% 23% 26% 23% 25% 20% 23% 16% 23% 21% 25% RP2D No surgery Female No liver mets Only liver lesions Left or right colon tumor All patients Lesions (liver only) Had surgery Lesions (liver+) Male FOLFOX in the metastatic setting Me
Slide 35: The potential onvansertib bevacizumab synergy is a new opportunity
35 The potential onvansertib bevacizumab synergy is a new opportunity * Onvansertib ORR and mPFS are interim data as of July 25, 2022 from an ongoing trial and unlocked database. 10 5 11 5 16 4 7 7 13 10 19 13 35 9 28 6 15 6 22 8 19 10 35 9 34 6 4 No (naïve) Yes (exposed) All Patients 23% ORR69% ORR
Slide 36: Early KRAS MAF ctDNA decrease correlates w/ radiographic response
36 Early KRAS MAF ctDNA decrease correlates w/ radiographic response Onvansertib KRAS MAF are interim data as of July 25, 2022 from an ongoing trial and unlocked database. 0 -50 -100 CR+PR SD PD % C ha ng e in K RA S M A F -96 -73 -63 * ** * KRAS MAF measured by droplet digital PCR (ddPCR) at baseli
Slide 37: Early Changes in KRAS MAF predicts clinical response
37 Early Changes in KRAS MAF predicts clinical response Onvansertib ORR and mPFS are interim data as of July 25, 2022 from an ongoing trial and unlocked database. ORR (%) 9% 2 of 23 KRAS NON-RESPONDERS 64% 14 of 22 KRAS RESPONDERS 12.6 mo mPFS (mo) 6.0 mo KRAS RESPONDERS KRAS NON-RESPONDERS P = 0.01
Slide 38: Accelerating our mCRC program
38 Initial trial: phase 1b/2 Next trial Accelerating our mCRC program Additional onvansertib programs
Slide 39: We believe that onvansertib complements and improves SoC
39 We believe that onvansertib complements and improves SoC * Bennouna et al., Lancet Oncol 2013; 14: 29–37; Giessen et al., Acta Oncologica, 2015, 54: 187-193; Cremolini et al., Lancet Oncol 2020, 21: 497–507; Antoniotti et al., Correspondence Lancet Oncol June 2020. mCRC: metastatic colorectal can
Slide 40: We approach our next trial with four clear objectives
40 We approach our next trial with four clear objectives DEMONSTRATE onvansertib’s contribution to SoC CONFIRM optimal dosing POSITION for possible accelerated approval opportunity OPERATE with capital efficiency
Slide 41: Our ONSEMBLE Ph2 trial is designed to demonstrate efficacy
41 2nd-Line SoC: FOLFIRI + bevacizumab 2nd-Line SoC: FOLFIRI + bevacizumab 28 DAY CYCLE Our ONSEMBLE Ph2 trial is designed to demonstrate efficacy SoC (FOLFIRI + Bev) SoC + onvansertib (20mg) SoC + onvansertib (30mg) 6 7 8 9 10 11 12 13 14 20 21 22 23 24 25 26 27 28 O N V A N S E R T I B O N V A N S
Slide 42: Our ONSEMBLE Ph2 trial is designed to demonstrate efficacy
42 Our ONSEMBLE Ph2 trial is designed to demonstrate efficacy ENDPOINTS Primary Key Secondary Other Secondary Objective Response Rate: CR + PR Progression-Free Survival Disease Control Rate: CR + PR + SD Duration of Response: DoR Overall Survival: OS Reduced MAF association with ORR, PFS, DCR, DoR,
Slide 43: Our ONSEMBLE Ph2 trial will be statistically robust
43 Our ONSEMBLE Ph2 trial will be statistically robust ENROLLMENT CRITERIA KRAS+/NRAS+ Unresectable 2nd line mCRC N=150 1:1:1 R • Randomized with control group exclusively the SoC • Examine two doses of onvansertib for safety/efficacy • Stratification within randomization for bev-naïve vs bev expose
Slide 44: We are optimistic that randomized data will create substantial value
44 We are optimistic that randomized data will create substantial value 2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 mCRC randomized data readout Opportunity to create value • Rigorous demonstration of onvansertib’s role in increasing efficacy in mCRC vs. SoC alone • Position for possible acce
Slide 45: Additional onvansertib programs
45 Pancreatic cancer (mPDAC) Prostate cancer (mCRPC) Triple negative breast cancer (TNBC) Small cell lung cancer (SCLC) Accelerating our mCRC program Additional onvansertib programs
Slide 46: Our mPDAC Ph2 trial combines onvansertib with standard-of-care
46 Our mPDAC Ph2 trial combines onvansertib with standard-of-care 10 9 8 7 6 2nd-Line SoC: Nal-IRI + Leucovorin + 5-FU 14 DAY CYCLE 11 12 13 14 O N V A N S E R T I B Failed 1st Line Gemcitabine / Abraxane ENROLLMENT CRITERIA 43 patients planned Can we get a signal that onvansertib complements and im
Slide 47: The endpoints measure tumor response and duration of response
47 The endpoints measure tumor response and duration of response 10 9 8 7 6 2nd-Line SoC: Nal-IRI + Leucovorin + 5-FU 14 DAY CYCLE 11 12 13 14 O N V A N S E R T I B Failed 1st Line Gemcitabine / Abraxane ENROLLMENT CRITERIA N=6/43 Here’s what we’re trying to gain from this trial SINGLE ARM TRIALEFFI
Slide 48: mPDAC trial is designed to demonstrate onvansertib's efficacy vs SoC
48 mPDAC trial is designed to demonstrate onvansertib’s efficacy vs SoC 10 9 8 7 6 2nd-Line SoC: Nal-IRI + Leucovorin + 5-FU 14 DAY CYCLE 11 12 13 14 O N V A N S E R T I B Failed 1st Line Gemcitabine / Abraxane ENROLLMENT CRITERIA N=6/43 Here’s what we’re trying to gain from this trial SINGLE ARM TR
Slide 49: Early data from our mPDAC trial data is encouraging
49 Early data from our mPDAC trial data is encouraging * Swimmer and spider plots reflect interim data as of August 30, 2022 from an ongoing trial and unlocked database Swimmer plot* – as of August 30, 2022 0 2.5 5.0 7.5 Months Change in tumor size from baseline* 04-008 05-009 02-011 05-014 04-012 2
Slide 50: Additional onvansertib programs
50 Pancreatic cancer (mPDAC) Prostate cancer (mCRPC) Triple negative breast cancer (TNBC) Small cell lung cancer (SCLC) Accelerating our mCRC program Additional onvansertib programs
Slide 51: AACR data showed disease control increased with dose density
51 APRIL 2022 AACR data showed disease control increased with dose density Evaluated onvansertib + abiraterone / prednisone in mCRPC patients showing initial abiraterone resistance by rising PSA Disease control increased with onvansertib dose density • From 29% to 45% of patients achieving PSA stabi
Slide 52: We are not planning to fund any future mCRPC development activity
52 We are not planning to fund any future mCRPC development activity The trial completed enrollment (n=72) and generated important clinical data: • Negligible toxicities attributed to onvansertib • Disease control increased with dose density Cardiff Oncology is not planning for any company- sponsore
Slide 53: Additional onvansertib programs
53 Pancreatic cancer (mPDAC) Prostate cancer (mCRPC) Triple negative breast cancer (TNBC) Small cell lung cancer (SCLC) Accelerating our mCRC program Additional onvansertib programs
Slide 54: Onvansertib + paclitaxel is superior to single agent therapy
54 Onvansertib + paclitaxel is superior to single agent therapy * SUM159 cells were implanted in the mammary fat pad of NOD-scid-IL2 receptor gamma null female mice, and treatments began as follows when tumor volume reached 40 mm3: vehicle, onvansertib oral (PO) twice per week (days 1-2), paclitaxel
Slide 55: Single arm trial Ph 1b/Ph 2 with onvansertib + paclitaxel
55 Single arm trial Ph 1b: N=14−16 Ph 2: N=34 This is the first trial to explore onvansertib + paclitaxel combination Metastatic TNBC relapsed or progressed ENROLLMENT CRITERIA PRIMARY ENDPOINTS Phase 1b Safety, characterization of DLTs Determination of RP2D Paclitaxel 80 mg/m2 28 DAY CYCLE 22 23 24
Slide 56: This is the first trial to explore onvansertib + paclitaxel combination
56 This is the first trial to explore onvansertib + paclitaxel combination ENROLLMENT CRITERIA Paclitaxel 80 mg/m2 28 DAY CYCLE 22 23 24 25 26 27 28 O N V A N S E R T I B RP2D PRIMARY ENDPOINTS Phase 1b Safety, characterization of DLTs Determination of RP2D Phase 2 ORR (RECIST 1.1) SECONDARY ENDPOIN
Slide 57: Additional onvansertib programs
57 Pancreatic cancer (mPDAC) Prostate cancer (mCRPC) Triple negative breast cancer (TNBC) Small cell lung cancer (SCLC) Accelerating our mCRC program Additional onvansertib programs
Slide 58: Onvansertib demonstrates single-agent activity in SCLC
58 Onvansertib demonstrates single-agent activity in SCLC * Mice were implanted with SCLC PDX and treated with vehicle, cisplatin 3mg/kg IP weekly, or onvansertib oral 60mg/kg 10 ON / 4 OFF onvansertib cisplatin control 2000 1500 1000 500 0 Tu m or v ol um e (m m 3 ) 10 20 300 2000 1500 1000 500 0 0
Slide 59: This is the first trial to explore onvansertib monotherapy
59 Single-arm trial Stage 1: N=15 Stage 2: N=20 This is the first trial to explore onvansertib monotherapy Relapsed who have received ≤ 2 prior therapies ENROLLMENT CRITERIA 15 16 17 18 19 20 21 O N V A N S E R T I B 21 DAY CYCLE onvansertib monotherapy 15 mg/m2 Phase 2 ORR (RECIST 1.1) PRIMARY ENDP
Slide 60: Our pipeline opens many attractive opportunities for onvansertib
60 Our pipeline opens many attractive opportunities for onvansertib Preclinical Ph1/2 Ph2/3 mPDAC TNBC SCLC Ovarian mCRC Onivyde/5-FU Paclitaxel None (monotherapy) PARP inhibitors FOLFIRI/bev Investigator-initiated trials Combination with: Enrolling Enrolling Status Enrolling Evaluating Activation m
Slide 61: Targeting PLK1 opens doors to large patient populations
61 Targeting PLK1 opens doors to large patient populations 53 RETROS1 Annual eligible US patients (’000s)* ONVANSERTIB 15 SCLCTNBC 12 mPDAC 39 23 mCRC Targets with oncogenic alterations ROS1 RET KRAS G12C EGFR TRK Targets without oncogenic alterations PLK1 PARP CDK4/6 PD1/PDL1 VEGF *ROS1 estimated e
Slide 62: We have multiple important catalysts over the next two years
62 We have multiple important catalysts over the next two years 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 mPDAC data readout SCLC data readout TNBC data readout 15 SCLCTNBC 12 mPDAC 39 23 mCRC mCRC randomized data readout 2L K/N-mut 2L 2L invasive Salvage
Slide 63: At June 30, 2022, our financial position is robust
63 2025 Q1 Q2 At June 30, 2022, our financial position is robust * Financial information above is derived from our unaudited financials in Form 10Q filed on 8/4/22. June 30, 2022 cash and investments* $122.0M Net cash used in Operating Activities* (Rolling two-quarter period ending June 30, 2022) $1
Slide 64: Our clinical development program supports our key goals
64 Our clinical development program supports our key goals 1 Validate prior mCRC data with a randomized trial 2 Demonstrate clinical POC in additional indications GOALS 2025 Q1 Q2 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Slide 65: Our clinical development program supports our key goals
65 Our clinical development program supports our key goals Phase 1b/2 single arm Phase 2 randomized Strong ORR + DoR + PFS MAF biomarker opportunity Efficient design Confirm dose; stratify bev1 Validate prior mCRC data with a randomized trial 2 Demonstrate clinical POC in additional indications GOAL
Slide 66: Appendix
66 APPENDIX
Slide 67: Summary of onvansertib mCRC Ph1b/2 trial data over time
67 Summary of onvansertib mCRC Ph1b/2 trial data over time * Data releases include certain follow up data and reflect interim data from an ongoing trial and unlocked database. ASCO GI Jan 2021 KOL Event Sept 2021 Investor Webcast Jan 2022 Investor Webcast Sept 2022 Data Cutoff Date Nov 1, 2020* July