Cardiff Oncology, Inc. · NASDAQ:CRDF

Cardiff Oncology — Technical Presentation (December 2024)

32 slides from Cardiff Oncology's technical presentation, Dec 10, 2024

  1. Slide 1: CRDF-004 Trial 1st Line RAS-mutated mCRC Initial Data Release

    DECEMBER 10, 2024 CRDF-004 Trial 1st Line RAS-mutated mCRC Initial Data Release

  2. 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

  3. Slide 3: Mark Erlander, PhD, Chief Executive Officer

    Mark Erlander, PhD Chief Executive Officer

  4. Slide 4: Agenda

    1st line RAS-mut mCRC trial data (CRDF-004) Commercial opportunity in 1st line mCRC The broader onvansertib opportunity AGENDA

  5. Slide 5: Onvansertib specifically targets PLK1, a well-established cancer target

    Onvansertib specifically targets PLK1, a well-established cancer target Onvansertib First oral, well-tolerated PLK1-selective inhibitor 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 sp

  6. Slide 6: 1st line RAS-mut mCRC trial data (CRDF-004)

    1st line RAS-mut mCRC trial data (CRDF-004) AGENDA Fairooz Kabbinavar, MD, FACP Chief Medical Officer

  7. Slide 7: Trial design of CRDF-004: first-line RAS-mutated mCRC Phase 2 trial

    Trial design of CRDF-004: first-line RAS-mutated mCRC Phase 2 trial First-line SoC: Chemo + bevacizumab First-line SoC: Chemo + bevacizumab 28 DAY CYCLE 6 7 8 9 10 11 12 13 14 20 21 22 23 24 25 26 27 28 ONVANSERTIB ONVANSERTIB ENROLLMENT CRITERIA ENDPOINTS * Primary: Secondary: ORR DoR and PFS KRAS+

  8. Slide 8: Trial design of CRDF-004: enrollment criteria, endpoints and objectives

    Trial design of CRDF-004: first-line RAS-mutated mCRC Phase 2 trial ENROLLMENT CRITERIA ENDPOINTS * Primary: Secondary: ORR DoR and PFS KRAS+/NRAS+ Unresectable First-line mCRC N=90 R No prior bev mCRC Onv 30mg + Onv 20mg + SoC alone 6 RANDOMIZATION ARMS Demonstrate onvansertib’s efficacy in first-l

  9. Slide 9: Patient maturity across arms are balanced in the current data set

    Patient maturity across arms are balanced in the current data set mCRC Onv 30mg + Onv 20mg + SoC alone 6 RANDOMIZATION ARMS NUMBER OF EVALUABLE* PATIENTS TIME ON TRIAL 2 mos 4 mos 6+mos Total patients 3 2 4 9 4 4 2 10 3 5 3 11 10 11 9 30 R * Evaluable patients defined as those with at least their fi

  10. Slide 10: ORR for the experimental arms is higher than for the control arms

    ORR for the experimental arms is higher than for the control arms * Date Labels: estimated date of 8-week scan * Radiographic response determined per RECIST 1.1 by blinded independent central review. Waterfall plot reflects interim data as of November 26, 2024 from an ongoing trial and unlocked data

  11. Slide 11: ORR for control and experimental arms is similar for FOLFIRI and FOLFOX

    Patient Number FOLFIRI / bev ORR for control and experimental arms is similar for FOLFIRI and FOLFOX * Radiographic response determined per RECIST 1.1 by blinded independent central review. Waterfall plot reflects interim data as of November 26, 2024 from an ongoing trial and unlocked database. 25%

  12. Slide 12: Dose response: Higher onvansertib dose shows increased ORR

    Dose response: Higher onvansertib dose shows increased ORR with deeper responses Best Radiographic Response BY ONVANSERTIB DOSE* – as of November 26, 2024 * Radiographic response determined per RECIST 1.1 by blinded independent central review. Waterfall plot reflects interim data as of November 26,

  13. Slide 13: Spider plots show deepening responses for onvansertib 30mg dose

    Spider plots show deepening responses for onvansertib 30mg dose * Radiographic response determined per RECIST 1.1 by blinded independent central review. Spider plot reflects interim data as of November 26, 2024 from an ongoing trial and unlocked database. Radiographic Response over Time* – as of Nov

  14. Slide 14: Swimmer plot shows most patients remain on trial

    Swimmer plot shows most patients remain on trial Radiographic Response over Time* – as of November 26, 2024 Best Response # Confirmed Partial Response # Partial Response # Stable Disease Reason For Discontinuation # indicates % change from baseline # Progressive Disease > On Treatment To Pursue Surg

  15. Slide 15: ORR is consistently higher for patients receiving onvansertib + SoC

    ORR is consistently higher for patients receiving onvansertib + SoC FOLFOX + bev FOLFIRI + bev 25% (1 of 4) Control Arms Onvansertib Arms Total 40% (2 of 5) 33% (3 of 9) All 30mgs onv 20mgs onv 50% (6 of 12) 66% (6 of 9) 57% (12 of 21) CRDF-004 Evaluable Population (N = 30) * Radiographic response d

  16. Slide 16: Demographics and baseline characteristics

    Demographics and baseline characteristics* * Demographics and baseline characteristics are as of November 26, 2024 from an ongoing trial and unlocked database. Side of tumor data for one patient is currently not available. Control Arms (SoC) N=9 SoC + Onvansertib 20mg N=10 SoC + Onvansertib 30mg N=1

  17. Slide 17: Treatment emergent adverse events (TEAE) data

    Treatment emergent adverse events (TEAE) data* * Data consists of all adverse events entered into the EDC as of Nov 26, 2024, from an ongoing trial and unlocked EDC database. N: number of patients; events shown occurred in ≥10% of total patients; numbers indicate number of patients experiencing the

  18. Slide 18: mCRC program positions onvansertib for accelerated and full approval

    mCRC program positions onvansertib for accelerated and full-approval mCRC clinical development program agreed with FDA at June 2023 Type C meeting CRDF-004 1st line RAS-mutated mCRC trial 90 patients, randomized, 2 doses of onvansertib CRDF-005 1st line RAS-mutated mCRC registrational trial 320 pati

  19. Slide 19: Agenda

    1st line RAS-mut mCRC trial data (CRDF-004) Commercial opportunity in 1st line mCRC The broader onvansertib opportunity AGENDA

  20. Slide 20: Factors driving the large TAM: 1. Large Patient Population

    (TROV-054) Factors driving the large TAM for onvansertib in 1st line RAS-mut mCRC 1. Large Patient Population: 48,000 new US cases per year (1st line RAS-mut mCRC) Onvansertib targets all RAS-mutated mCRC1 52% RAS-mutated * Company estimates of first-line and second-line mCRC population with KRAS- a

  21. Slide 21: Factors driving the large TAM: 2. Significant Unmet Need

    Factors driving the large TAM for onvansertib in 1st line RAS-mut mCRC 2. Significant Unmet Need: No new drugs approved in 20 years FOLFOX (approved 1996) FOLFIRI (approved 2002) Chemotherapy None Targeted therapy Bevacizumab (Avastin® ) Antiangiogenic (approved 2004) / Standard of Care for 1st / 2n

  22. Slide 22: Factors driving the large TAM: 3. Straightforward adoption

    Factors driving the large TAM for onvansertib in 1st line RAS-mut mCRC 3. Straightforward adoption: No impediments to adding onvansertib to SoC Oral onvansertib is added to SoC Onvansertib + SoC is well-tolerated First-line SoC: Chemo + bevacizumab First-line SoC: Chemo + bevacizumab 28 DAY CYCLE 6

  23. Slide 23: Agenda

    1st line RAS-mut mCRC trial data (CRDF-004) Commercial opportunity in 1st line mCRC The broader onvansertib opportunity AGENDA

  24. Slide 24: Our pipeline opens many attractive opportunities for onvansertib

    Our pipeline opens many attractive opportunities for onvansertib * For investigator-initiated trials (IITs) only, the investigator’s institution is provided. The planned first-line mPDAC trial will be conducted by an investigator to be named. mPDAC = metastatic pancreatic ductal adenocarcinoma; SCLC

  25. Slide 25: Cardiff Oncology: Positioned to improve 1st line RAS-mut mCRC treatment

    Cardiff Oncology: Positioned to improve 1st line RAS-mut mCRC treatment First-in-Class PLK1 inhibitor Onvansertib: first well-tolerated PLK1-selective inhibitor PLK1 inhibition disrupts tumor growth several ways FDA / Pfizer FDA-agreed path to 1st line RAS-mut mCRC accelerated approval Pfizer is equ

  26. Slide 26: Appendix

    APPENDIX

  27. Slide 27: FOLFIRI/Bev Treatment Emergent Adverse Effects (TEAEs)

    FOLFIRI/Bev Treatment Emergent Adverse Effects (TEAEs) Patients received FOLFIRI+Bev Control arm FOLFIRI/Bev (N=4) N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total Any Adverse Events 4 (100.0) 2 ( 50.0) 2 ( 50.0) 0 ( 0.0) 4 (100.0) Fatigue 1 ( 25.0) 1 ( 25.0) 0 ( 0.0) 0 ( 0.0) 2 ( 50.0) Nausea 2

  28. Slide 28: FOLFIRI/Bev/Onvansertib 20mg Treatment Emergent Adverse Effects

    FOLFIRI/Bev/Onvansertib 20mg Treatment Emergent Adverse Effects (TEAEs) Patients received FOLFIRI + Bev +20 mg dose of onvansertib Experimental arm FOLFIRI/Bev/Onv 20mg (N=6) N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total Any Adverse Events 6 (100.0) 6 (100.0) 4 ( 66.7) 0 ( 0.0) 6 (100.0) Fati

  29. Slide 29: FOLFIRI/Bev/Onvansertib 30mg Treatment Emergent Adverse Effects

    FOLFIRI/Bev/Onvansertib 30mg Treatment Emergent Adverse Effects (TEAEs) Patients received FOLFIRI + Bev + 30 mg dose of onvansertib Grade 4 neutropenia in both patients resolved in 9 and 16 days. Treatment was delayed by 7 and 15 days, respectively until the AE resolved. Both patients are still on s

  30. Slide 30: FOLFOX/Bev Treatment Emergent Adverse Effects

    FOLFOX/Bev Treatment Emergent Adverse Effects (TEAEs) Patients received FOLFOX+ Bev Grade 4 neutropenia resolved in 8 days. Treatment was delayed for 8 days until the AE resolved. Patient is still on study treatment. Control arm FOLFOX/Bev (N=5) N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total A

  31. Slide 31: FOLFOX/Bev/Onvansertib 20mg Treatment Emergent Adverse Effects

    FOLFOX/Bev/Onvansertib 20mg Treatment Emergent Adverse Effects (TEAEs) Patients received FOLFOX+ Bev +20 mg dose of onvansertib Experimental arm FOLFOX/Bev/Onv 20mg (N=4) N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total Any Adverse Events 4 (100.0) 4 (100.0) 3 ( 75.0) 0 ( 0.0) 4 (100.0) Fatigue

  32. Slide 32: FOLFOX/Bev/Onvansertib 30mg Treatment Emergent Adverse Effects

    FOLFOX/Bev/Onvansertib 30mg Treatment Emergent Adverse Effects (TEAEs) Patients received FOLFOX+ Bev + 30 mg dose of onvansertib Experimental arm FOLFOX/Bev/Onv 30mg (N=5) N (% of total) Grade 1 Grade 2 Grade 3 Grade 4 Total Any Adverse Events 5 (100.0) 4 ( 80.0) 3 ( 60.0) 0 ( 0.0) 5 (100.0) Fatigue

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