EX-99.1 2 a991excardiffoncologycor.htm EX-99.1 a991excardiffoncologycor
Company Overview The Onvansertib Opportunity

 

 
S G2 G1 M Irinotecan Taxanes

 

 
S G2 G1 M

 
G2 G1 M S PLK1 plays multiple roles during cell cycle S-Phase G2/M Checkpoint M-Phase

 
G1 M S G2 PLK1 plays multiple roles during cell cycle S-Phase G2/M Checkpoint M-Phase

 
G2 G1 S M PLK1 plays multiple roles during cell cycle S-Phase G2/M Checkpoint M-Phase

 
ONVANSERTIB INHIBITS PLK1

 
• • • SPECIFICITYPROPERTIES

 
WHAT WHY WHERE

 
WHAT WHY WHERE

 
1st LINE 2nd LINENormal Mutated

 
2nd LINE HISTORICAL ORR 5% 11.4% 13% *1st LINENormal Mutated

 
2nd LINE1st LINENormal Mutated

 
KRAS/NRAS Mutations in mCRC1

 
93% KRAS/NRAS Mutations in mCRC1

 
MOA 2 1 KRAS/NRAS Mutations in mCRC1

 
28 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL

 
28 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL 1 2 3

 
All Doses RP2D Durability

 

 
KRAS Variant CR+PR SD PD Total

 
20222021

 
20222021 2008 2013 2017

 
WHAT WHY WHERE

 
Onvansertib’s safety profile

 
S G2 G1 M KRAS HYPERSENSITIVITY1 SYNERGY WITH CHEMO MOA 1 MOA 2

 
KRAS HYPERSENSITIVITY1 MOA 1

 
SYNERGY WITH CHEMOKRAS HYPERSENSITIVITY1 S G2 G1 M MOA 1 MOA 2

 
S G2 G1 M TUMOR CELL CYCLE DNA REPLICATION PHASE

 
S G2 G1 M TUMOR CELL CYCLE DNA REPLICATION PHASE CELL GROWTH PHASE

 
S G2 G1 M TUMOR CELL CYCLE CELL GROWTH PHASE

 
S G2 G1 M TUMOR CELL CYCLE CELL GROWTH PHASE

 
WHAT WHY WHERE

 
1 2 GOALS 2025 Q1 Q2 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

 
DEMONSTRATE CONFIRM POSITION OPERATE

 
28 DAY CYCLE ENROLLMENT CRITERIA

 
ENDPOINTS Primary Key Secondary Other Secondary ENROLLMENT CRITERIA

 
Preclinical Ph1/2 Ph2/3 Investigator-initiated trials Combination with: Status Investigator

 
BREAKTHROUGH GROWTH INITIATIVE • • • Pfizer • • SUMMARY TERMS

 
Targets with oncogenic alterations Targets without oncogenic alterations

 
2023 2024

 
20252023 2024

 
KRAS-Mutated Metastatic Colorectal Cancer (mCRC)

 

 
No major/unexpected toxicities GRADE TEAEs* 1 2 3 4 All • • • GRADE TEAEs* 1 2 3 4 All

 
28 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL PHASE 1b PHASE 2

 
2008 2013 2017

 
Predictive response biomarker • • • % KRAS Mutant Allelic Frequency (MAF)*

 
ORR (%) mPFS (mo)

 
HISTORICAL REFERENCE 5.7 4.5 5.6 11.2 11.5 — PFS OS

 
ENROLLMENT CRITERIA • • • • DESIGN STATS • • •

 
KRAS-Mutated Metastatic Colorectal Cancer Bevacizumab Subgroup Data

 
Enrollment*

 
Normal RAS Mutated 1st LINE 2nd LINE mCRC Ph1b/2 trial

 
Normal RAS Mutated EFFICACY DATA FROM HISTORICAL TRIALS IN mCRC 2nd Line mOS (mo)1-22nd Line mPFS (mo)1-2 2nd LINE 2nd Line ORR3-6

 
Normal HISTORICAL CONTROLS VS ONVANSERTIB* Ph 1b/2 DATA 2nd Line mPFS (mo)1-2 2nd LINE 2nd Line ORR3-6 RAS Mutated

 
N= No (naïve) Yes (exposed) No single patient characteristic explains observed ORR difference

 
No (naïve) Yes (exposed) How should we respond to this observation? ACTIONS OPPORTUNITY

 
All Doses RP2D Durability Bev naïve patients

 
Bev exposure in 1st lineNo prior bev exposure (naïve) Best response of: CR/PR SD PD

 

 
Metastatic Pancreatic Adenocarcinoma (mPDAC)

 
14 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL

 
14 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL 1 2 3

 
14 DAY CYCLE ENROLLMENT CRITERIA SINGLE ARM TRIAL HISTORICAL mPFS* 3.1 mo HISTORICAL RESPONSE RATE* 7.7% ORR 20% ≥6 mo

 

 
Investigator-Initiated Trial Triple Negative Breast Cancer (TNBC)

 
TRIAL RATIONALE

 
− ENROLLMENT CRITERIA PRIMARY ENDPOINTS 28 DAY CYCLE

 
ENROLLMENT CRITERIA 28 DAY CYCLE PRIMARY ENDPOINTS SECONDARY ENDPOINT −

 
Investigator-Initiated Trial Small Cell Lung Cancer (SCLC)

 
TRIAL RATIONALE

 
ENROLLMENT CRITERIA 21 DAY CYCLE PRIMARY ENDPOINT SECONDARY ENDPOINTS

 
PARPi Pre-Clinical Data

 
Onvansertib + PARP inhibitors

 
Onvansertib + PARP inhibitors* P ro b ab ili ty o f S ur vi va l