EX-99.1 2 tm2322922d1_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1

| AU GU ST 7 , 2 0 2 3 mCRC Program Update and Clinical Development Plan

| PFIZER We expect clinical data from our 1st line RAS-mutated mCRC trial in mid-2024

| mCRC clinical development program agreed with FDA • • • • • •

| 5 3 Annual eligible U.S. patients (’000s)* 15 12 40 0 50 23 48

| Line of Therapy Ph2 Ph3 Investigator-initiated trials Trial Combination with:

| CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD Onvansertib clinical development plan in mCRC

| CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD Onvansertib clinical development plan in mCRC

| Onvansertib PROPERTIES SPECIFICITY • • •

| 1st LINE 2nd Normal LINE RAS Mutated

| 2nd Normal 1st LINE LINE RAS Mutated

| MOA 21 RAS-mutations in mCRC1

| 28 DAY CYCLE ENROLLMENT CRITERIA EFFICACY ENDPOINTS 1 2 3

| PHASE 1b PHASE 2 ITT population (N) 50 68 Evaluable population* (N) 48 66 We enrolled 50 initial patients, and then an additional 18 patients, in our trial TOTAL

| 1st LINE 2nd Bev exposed vs bev naïve patients LINE

| KRAS Variant CR+PR SD PD Total G12C G12D G12V G13D G12S G12A Q61H G13C

| • • • • • • • 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% Lymphocytopenia 2 7 0 0 9 13% Anemia 22 5 2 0 29 43% Dyspepsia 9 0 0 0 9 13% Alopecia 20 5 0 0 25 37% ALT Increase 8 0 1 0 9 13% Abdominal Pain 14 8 3 0 25 37% Hypocalcemia 9 0 0 0 9 13% Stomatitis 15 6 3 0 24 35% Insomnia 9 0 0 0 9 13% Hypertension 4 10 9 0 23 34% Dehydration 1 5 2 0 8 12% Thrombocytopenia 17 5 1 0 23 34% Hypokalemia 6 2 0 0 8 12% Constipation 17 2 1 0 20 29% Arthralgia 6 2 0 0 8 12% Vomiting 11 6 3 0 20 29% Hand / Foot Syndrome 5 2 0 0 7 10% Epistaxis 15 0 0 0 15 22% Hemorrhoids 5 2 0 0 7 10% Headache 13 0 0 0 13 19% Non-Cardiac Chest Pain 6 1 0 0 7 10% Decreased Appetite 4 6 2 0 12 18% ALP Increase 5 1 1 0 7 10% Back Pain 10 2 0 0 12 18%

| CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD Onvansertib clinical development plan in mCRC

| Our findings establish the scientific basis of our bev naïve clinical finding

| Tumor volume (mm 3 ) 0 10 20 30 0 500 1000 1500 2000 2500 SW620 (KRAS G12V) The combination had significant superior anti-tumor activity compared to the single agents

| KRAS-mut tumors from mice treated with onv + bev appear smaller and pale (less vascularized)

| ••••••

| PLK1 inhibition using siRNA against PLK1 (siPLK1) prevented hypoxia-induced HIF1a expression In 4 RAS-mutant CRC cell lines*, onvansertib inhibited hypoxia-induced HIF1a expression

| This new MOA, which inhibits a “survival switch” of tumorigenesis, may underlie the increased efficacy observed clinically

| • • • – – • •

| RAS-mutations in mCRC1 MOA 2 1 3

| CLINICAL FINDINGS FROM 2L Ph 1b/2 TRIAL SCIENTIFIC BASIS FOR CLINICAL FINDINGS CLINICAL DEVELOPMENT PATH FORWARD Onvansertib clinical development plan in mCRC

| • • 2nd line mCRC 1st line mCRC • …and FDA agreed with Cardiff Oncology’s proposed 1st line clinical program FDA suggested we consider moving to a 1st line clinical development path…

| • • • Clinical Commercial • • Transition from 2L to 1L Regulatory • • • •

| ENROLLMENT CRITERIA ENDPOINTS Primary Secondary Benchmark of success

| 2 nd Line mCRC 1 st line mCRC 2 nd Line mCRC 1 st line mCRC

| BREAKTHROUGH GROWTH INITIATIVE • • • PFIZER PFIZER Ignite • •

| 2023 2024 2025

| PFIZER We expect clinical data from our 1st line RAS-mutated mCRC trial in mid-2024

| Appendix: Additional Ph 1b/2 Clinical Data

| As an independent cohort in the Ph 1b/2 trial, the expansion cohort replicated the finding of improved responses from the bev naïve patients

| No single patient characteristic explains the difference in response rates by prior bev status

| Appendix: Additional Preclinical Data

| 0 5 10 15 20 -50 0 50 100 150 200 200 400 600 Treatment time (days) C1143 (KRAS G12D) ** *** 0 5 10 15 20 0 50 100 150 200 250 Treatment time (days) C1144 (KRAS G12C) ** **** Vehicle Onv+Irino Onvansertib Irinotecan

| 0 5 10 15 20 0 100 200 300 Treatment time (days) C1138 (KRAS G13D) ** *** 0 5 10 15 20 0 200 400 600 800 Treatment time (days) B8239 (KRAS G12C) *** *** 5 10 15 20 0 100 200 300 Treatment time (days) C1143 (KRAS G12D) * ****