- First patient dosed in Phase 2 first-line trial in patients with RAS-mutated mCRC for new lead program with the support of FDA and clinical execution from Pfizer Ignite -
- Interim topline data from first-line RAS-mutated mCRC trial is expected in mid-2024 -
- New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients -
- Cash and equivalents of
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
“2024 is a pivotal year for
Upcoming expected milestones
- First-line RAS-mutated mCRC randomized data readout expected in mid-2024
Company highlights for the quarter ended
- Provided a clinical update on Phase 2 randomized second-line ONSEMBLE trial in mCRC. New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients. In the trial, patients who were bev naïve demonstrated an objective response rate (ORR) of 50% on onvansertib. No clinical responses were observed in patients who received standard of care with FOLFIRI/bev or patients who were previously exposed to bev. For additional information, please refer to the press release issued by the Company today which provided an update on the ONSEMBLE trial.
- Announced first patient dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer. The trial, whose clinical execution is being conducted by Pfizer Ignite, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard of care (SoC) vs. SoC alone. Interim topline results from CRDF-004 are expected in mid-2024. Contingent upon the results,
Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent. - Announced the publication of data from Phase 1b study in second line KRAS-mutated mCRC in
Clinical Cancer Research . The findings of the Phase 1b portion of the Phase 1b/2 study for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer disclosed byCardiff Oncology in August 2023 have been published in the peer-reviewed journalClinical Cancer Research , a journal of theAmerican Association for Cancer Research .
Full Year 2023 Financial Results:
Liquidity, cash burn, and cash runway
As of
Net cash used in operating activities for the full year 2023 was approximately
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q3 2025.
Operating results
Total operating expenses were approximately
Conference Call and Webcast
About
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern
Cardiff Oncology Contact:
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
332-895-3225
Kiki@gilmartinir.com
Media Contact:
551-344-5592
richa@taftcommunications.com
Condensed Statements of Operations (in thousands, except for per share amounts) | |||||||
Year Ended December 31, | |||||||
2023 | 2022 | ||||||
Royalty revenues | $ | 488 | $ | 386 | |||
Costs and expenses: | |||||||
Research and development | 32,857 | 27,107 | |||||
Selling, general and administrative | 13,043 | 13,181 | |||||
Total operating expenses | 45,900 | 40,288 | |||||
Loss from operations | (45,412 | ) | (39,902 | ) | |||
Interest income, net | 4,069 | 1,581 | |||||
Other expense, net | (98 | ) | (383 | ) | |||
Net loss | (41,441 | ) | (38,704 | ) | |||
Preferred stock dividend | (24 | ) | (24 | ) | |||
Net loss attributable to common stockholders | $ | (41,465 | ) | $ | (38,728 | ) | |
Net loss per common share — basic and diluted | $ | (0.93 | ) | $ | (0.89 | ) | |
Weighted-average shares outstanding — basic and diluted | 44,677 | 43,600 | |||||
Condensed Balance Sheets (in thousands) | |||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 21,655 | $ | 16,347 | |
Short-term investments | 53,168 | 88,920 | |||
Accounts receivable and unbilled receivable | 288 | 771 | |||
Prepaid expenses and other current assets | 2,301 | 5,246 | |||
Total current assets | 77,412 | 111,284 | |||
Property and equipment, net | 1,238 | 1,269 | |||
Operating lease right-of-use assets | 1,708 | 2,251 | |||
Other assets | 1,279 | 1,387 | |||
Total Assets | $ | 81,637 | $ | 116,191 | |
Liabilities and Stockholders’ Equity | |||||
Current liabilities: | |||||
Accounts payable | $ | 1,966 | $ | 1,956 | |
Accrued liabilities | 7,783 | 5,177 | |||
Operating lease liabilities | 691 | 675 | |||
Total current liabilities | 10,440 | 7,808 | |||
Operating lease liabilities, net of current portion | 1,458 | 2,040 | |||
Total Liabilities | 11,898 | 9,848 | |||
Stockholders’ equity | 69,739 | 106,343 | |||
Total liabilities and stockholders’ equity | $ | 81,637 | $ | 116,191 | |
Condensed Statements of Cash Flows (in thousands) | |||||||
Year ended | |||||||
2023 | 2022 | ||||||
Operating activities | |||||||
Net loss | $ | (41,441 | ) | $ | (38,704 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Loss on disposal of fixed assets | — | 1 | |||||
Depreciation | 398 | 236 | |||||
Stock-based compensation expense | 4,509 | 4,256 | |||||
(Accretion) amortization of (discounts) and premiums on short-term investments, net | (921 | ) | 632 | ||||
Release of clinical trial funding commitment | — | 139 | |||||
Changes in operating assets and liabilities | 6,568 | (380 | ) | ||||
Net cash used in operating activities | (30,887 | ) | (33,820 | ) | |||
Investing activities: | |||||||
Net capital expenditures | (582 | ) | (892 | ) | |||
Net purchases, maturities and sales of short-term investments | 36,777 | 39,041 | |||||
Net cash provided by investing activities | 36,195 | 38,149 | |||||
Financing activities: | |||||||
Proceeds from exercise of options | — | 75 | |||||
Net cash provided by financing activities | — | 75 | |||||
Net change in cash and cash equivalents | 5,308 | 4,404 | |||||
Cash and cash equivalents—Beginning of period | 16,347 | 11,943 | |||||
Cash and cash equivalents—End of period | $ | 21,655 | $ | 16,347 |
Source:
2024 GlobeNewswire, Inc., source