- Phase 1b: 7 (33%) of evaluable patients achieved an objective response, with a complete response (CR/CRi) in 5 (31%) patients treated at the four highest onvansertib dose levels

-- Initiation of Expanded Access Program follows FDA granting Fast Track Designation of onvansertib for second-line treatment of patients with KRAS-mutation mCRC

- Positive data presented at ASCO follows announcement of Fast Track Designation granted by the FDA for onvansertib in second-line treatment of patients with KRAS-mutated mCRC

- The U.S. Food and Drug Administration reviewed the Company's request for Fast Track designation and concluded that investigation of onvansertib, in combination with FOLFIRI/bevacizumab, for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer meets the criteria for a Fast Track development program

- Funding will also enable the addition of new trial sites to accelerate completion of the Phase 2 clinical trial

- New corporate name, Cardiff Oncology, reflects the Company's mission and commitment to turning the tide on cancer by developing new treatment options for cancer patients

- Ongoing Phase 1b/2 trial has enrolled 12 patients with 88% response in 7 of 8 evaluable patients; to-date 3 patients with a partial response (PR); 4 patients with stable disease (SD)

Nominees bring extensive expertise in the fields of oncology drug development and commercialization, biopharmaceutical company financing and strategic operations

- Onvansertib demonstrates efficacy in Zytiga®-resistant metastatic castration-resistant prostate cancer (mCRPC) across known androgen receptor resistance mechanisms

- All patients showed tumor regression by radiographic scan at 8 weeks and confirmation by further tumor shrinkage at 16 weeks; clinical benefit achieved in 100% (n=5) of patients

- Efficacy observed at onvansertib doses ranging from 27 to 90 mg/m2 with a complete response (CR) and CR with incomplete count recovery (CRi) rate of 31% (5/16)

- Patients develop resistance to venetoclax in about 11 months with no viable therapeutic options; median survival of only 1.7 to 2.3 months and poor prognosis

- 72% of patients had decreases in PSA levels with the addition of onvansertib to Zytiga® following 1 cycle of treatment; 60% of patients completing 3 months of treatment and evaluable for efficacy achieved primary endpoint of disease control

- Results from completed Phase 1b and ongoing Phase 2 trial of onvansertib in relapsed/refractory AML to be presented in oral session