- Onvansertib and the androgen receptor (AR) signaling inhibitor abiraterone synergize in an AR-independent manner in in-vitro and in-vivo metastatic castrate-resistant prostate cancer (mCRPC) models

-- Virtual event will take place on Monday, April 12, 2021 at 11 a.m. ET and will include a Q&A session

- Two-fold increase (29% to 63%) in disease control rate at 12 weeks (the trial's primary efficacy endpoint) seen in patients receiving onvansertib for 14 days vs. 5 days in a 21-day cycle

- Trial will evaluate the safety and efficacy of onvansertib in combination with standard-of-care for second-line treatment of patients with metastatic PDAC who have failed first line treatment with a gemcitabine-based chemotherapy regimen

- Of the 12 Phase 1b patients evaluable for efficacy as of the ASCO-GI data cut-off date (November 1, 2020), 5 (42%) achieved a partial response (PR) and 8 (67%) have shown a durable response ranging from 6.1 to 13.7 months

-- Trial on track to meet prespecified criteria for success on its primary endpoint, with 31% (8/26) disease control rate in evaluable patients in cohorts A and B. Patients eligible for the trial have two consecutive rises in PSA levels indicating initial resistance to abiraterone (Zytiga®)

-10 of 11 (91%) patients achieved disease control (SD - stable disease plus PR - partial response) with only 1 patient progressing in <6 months while on treatment

- Virtual event will take place on Wednesday, Sept. 23, 2020 at 11 a.m. EDT and will include a Q&A session

- Fireside chat will address KRAS inhibition and the promise of onvansertib as a new therapeutic option in colorectal cancer

- 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