On August 8, 2024 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Cardiff Oncology, AUG 8, 2024, View Source [SID1234645588]).

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"The first half of 2024 has been productive for Cardiff Oncology as we have been focused on the enrollment of our CRDF-004 trial for first-line treatment of RAS-mutated mCRC evaluating onvansertib + chemo/bev," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "We are working closely with our clinical operations partner, Pfizer Ignite, and are encouraged by ongoing enrollment trends at the 33 sites currently open to enrollment. We believe the robust body of evidence generated to date from our Phase 1b/2 and ONSEMBLE trials lays a strong foundation for our upcoming data readout for CRDF-004 later this year. Furthermore, we are optimistic about the potential of onvansertib to change the treatment paradigm for the entire first-line RAS-mutated mCRC patient population who has not had access to any new therapies in over 20 years."

Upcoming expected milestones

•First-line RAS-mutated mCRC randomized data readout expected in 2H 2024
Company highlights for the quarter ended June 30, 2024 and subsequent weeks include:
•Updated clinical development plan for metastatic pancreatic ductal adenocarcinoma (mPDAC) with a planned new investigator-initiated trial
◦The new mPDAC trial will evaluate onvansertib in combination with the recently approved first-line standard of care, NALIRIFOX, details of which we will announce when available. The trial replaces a previously planned Phase 2 trial of onvansertib in combination with first-line standard of care, Gemzar and Abraxane.
•Published preclinical data of the combination of onvansertib and olaparib in olaparib-resistant ovarian cancer models in a peer-reviewed journal
◦The combination of onvansertib and olaparib, a PARP inhibitor approved in ovarian cancer, demonstrated inhibition of tumor growth and prolonged survival in olaparib-resistant high-grade serous ovarian carcinomas. The combination was well tolerated in vivo, and these findings underscore onvansertib’s ability to slow the progressions of ovarian carcinomas. Resistance to olaparib has been shown in clinical settings and these data support the ability of onvansertib to resensitize ovarian cancers to PARP inhibitors.
•Presented five abstracts at AACR (Free AACR Whitepaper) providing a strong scientific rationale for the clinical development of onvansertib across multiple tumor types and various combinations

◦The posters are located in the "Scientific Presentations" section of the Cardiff Oncology website and a press release summarizing the data can be found here.

Second Quarter 2024 Financial Results

Liquidity, cash burn, and cash runway
As of June 30, 2024, Cardiff Oncology had approximately $60.3 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the second quarter of 2024 was approximately $9.2 million, an increase of approximately $2.1 million from $7.1 million for the same period in 2023.
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations through the end of Q3 2025.
Operating results
Total operating expenses were approximately $12.7 million for the three months ended June 30, 2024, an increase of $0.4 million from $12.3 million for the same period in 2023. The increase in operating expenses was primarily due to clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, offset by an employee severance agreement which occurred during the previous period.

Conference Call and Webcast

Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on August 8, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company’s website following the completion of the call.