Cash of $46 Million; CRDF-004 Data @ASCO, Phase III mCRC Trial Start by YE:26

研报英文原文证据摘录

Cash of $46 Million; CRDF-004 Data @ASCO, Phase III mCRC Trial Start by YE:26

US$4.55 / US$1.48

and leukopenia, largely attributed to the chemotherapy backbone. 30mg onvansertib Shares Out (mil) 68.4

+ Avastin + FOLFIRI achieved a confirmed ORR of 72.2% (13/18) vs. 43.2% Form 10Q as of May 7th

(16/37) on SoC (p=0.052), whereas 20mg onvansertib achieved a lower 44.4% (8/18) Market Cap. (mil) US$115.6

confirmed ORR. The SoC arms performed similarly, with a 42.1% (8/19) ORR with Total Assets ($mil) 49

FOLFIRI and 44.4% (8/18) ORR with FOLFOX. Onvansertib has already shown a Avg Daily Vol (000) 690

Book Value/Share US$0.51 significant improvement in mPFS over control at 10.97 months (HR=0.37, p=0.048)

Price/Book 331%

with approximately 10 months of follow-up. 6-month PFS rates were 94.1% with 30mg Net Cash Per Share US$0.67

onvansertib and 88.8% on SoC. Cardiff will present Phase II CRDF-004 data including Div Yield 0.00%

more mature PFS in a Rapid Oral session at ASCO on Tuesday June 2nd. (#3510) Fiscal Year End Dec

• Registrational Trial Start in 2026. Cardiff held an End-of-Phase II meeting with FDA Price Performance - 1 Year

and aligned on the Phase III trial design of 30mg onvansertib + Avastin and FOLFIRI USD

in 1st-line RAS-mutant mCRC patients. The primary endpoint will likely be ORR for 5

accelerated approval with secondary endpoints of PFS and OS for full approval. Cardiff 4.5

will share more details on trial design in mid'26 and hopes to initiate the Phase III trial this 4

year dependent upon financing. Cardiff anticipates few barriers to uptake of onvansertib 3.5

in mCRC due to the clean safety and simple addition of daily oral dosing for 5 days on 3

2.5

top of SoC therapy. 2

1.5

RISKS TO ACHIEVEMENT OF PT & RECOMMENDATION 1