- Phase 1b/2 trial in lead KRAS-mutated metastatic colorectal cancer program continues to show an objective response rate and median progression-free survival that substantially exceed those seen in historical control trials

- 12 of 35 (34%) patients treated per protocol at the recommended Phase 2 dose (RP2D) in combination with FOLFIRI and bevacizumab achieved a complete response or partial response (CR: 1 patient; PR: 11 patients)

- Dr. Smeal has over 20 years of industry experience developing targeted therapies and previously served as CSO of Cancer Biology at Eli Lilly and Company, and director of Pfizer Oncology Research Unit

- Conference call and webcast to take place on Tuesday, January 18, 2022, at 5:00 PM ET

- Pfizer invests $15 million in Cardiff Oncology common shares

- Announced updated clinical data from lead KRAS-mutated metastatic colorectal cancer program showing an objective response rate and median progression free survival that substantially exceed those seen in historical control trials

- Lead clinical program of onvansertib in KRAS-mutated metastatic colorectal cancer continues to generate data showing robust response to treatment and progression-free survival

- Dr. Ruffner is a US-trained hematologist/oncologist with over 25 years of clinical care, oncology biotechnology and pharmaceutical drug development experience

- Mani Mohindru, Ph.D., Chief Executive Officer of Novasenta, an early-stage biopharmaceutical company, has deep expertise in all phases of drug development, finance, strategy and investor relations

- Trial represents a key component of onvansertib's KRAS-targeted clinical programs and is designed to leverage the synergy of onvansertib when combined with irinotecan/5-FU

- 7 of 18 (39%) evaluable patients in the Phase 1b/2 trial have achieved a partial response to-date

- Evaluable participants (n=20) are heavily pretreated (median of 3 prior lines of treatment); an increase in progression-free survival is a desired outcome

- 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

-- Highly aggressive KRAS-mutated tumors account for ~50% of metastatic colorectal cancer (mCRC); no targeted treatments available and response to standard-of-care is only 5%