Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update
Cardiff Oncology, Inc. (CRDF) announces positive clinical data for RAS-mutated mCRC trials, with cash reserves of $75 million till Q3 2025. The company's lead program, onvansertib, shows promising results in treating mCRC, with upcoming data readouts expected in mid-2024.
Positive
First patient dosed in Phase 2 first-line trial for RAS-mutated mCRC with FDA support and clinical execution by Pfizer Ignite.
Interim topline data for first-line RAS-mutated mCRC trial expected in mid-2024.
New clinical data from second-line ONSEMBLE trial demonstrates onvansertib's efficacy in combination therapy for RAS-mutated mCRC patients.
Cash and equivalents of $75 million as of December 31, 2023, projected to fund operations into Q3 2025.
Company highlights include positive clinical updates and milestones for lead program in mCRC treatment.
Operating expenses increased to $45.9 million for the full year 2023 due to clinical program costs and staff-related expenses.
Cardiff Oncology to host a conference call and webcast on February 29, 2024, to discuss financial results and business updates.
The commencement of a Phase 2 trial for a new treatment targeting RAS-mutated metastatic colorectal cancer (mCRC) represents a significant advancement in oncology therapeutics. The RAS gene family is known to be involved in many cancers and mutations in these genes can drive tumor growth and resistance to therapy. The use of onvansertib, a Polo-like kinase 1 (PLK1) inhibitor, could potentially disrupt cancer cell division and lead to improved patient outcomes. The objective response rate (ORR) of 50% in bev naïve patients observed in the ONSEMBLE trial is particularly noteworthy, as it suggests a substantial improvement over standard care for this patient subset.
The anticipation of interim topline data from the trial in mid-2024 will keep the medical community and investors closely watching Cardiff Oncology's progress. If the data prove positive, it may not only revolutionize the standard of care for mCRC but also position onvansertib as a frontrunner in a market that has seen little innovation in the past two decades. The potential impact on patient care and the company's valuation could be considerable, especially given the projected cash runway into Q3 2025, which indicates a stable financial position to support ongoing trials.
Cardiff Oncology's financial results and cash position as of December 31, 2023, are of high importance to investors. With $75 million in cash and equivalents and a reduced net cash burn from operations year-over-year, the company appears to be managing its resources efficiently while advancing its clinical programs. This financial prudence is critical as the company navigates the costly and uncertain terrain of drug development.
The decreased cash burn and extended cash runway into Q3 2025 provide the company with a buffer to reach significant clinical milestones without immediate dilutive financing. However, the increase in total operating expenses reflects the company's investment in clinical trials and staff, which is a necessary step to drive the development of onvansertib forward. Investors should monitor the balance between expenses and the progress of clinical trials, as any delays or setbacks could impact the financial stability of the company.
The therapeutic landscape for mCRC, particularly in the context of RAS mutations, has been stagnant for the last 20 years. Cardiff Oncology's advancement into a Phase 2 trial with the support of Pfizer Ignite is a strategic move that could capture a significant market share if onvansertib is successful. The focus on RAS-mutated mCRC, a large cancer indication with a substantial unmet need, could position Cardiff Oncology as a key player in the oncology market.
Given the high incidence of colorectal cancer and the prevalence of RAS mutations, the potential market for onvansertib is sizable. The partnership with Pfizer Ignite for clinical execution also lends credibility to the program and may facilitate future collaborations or licensing agreements. The market will be attuned to the release of the interim topline data in mid-2024, as it will be a significant indicator of the drug's efficacy and safety, which are critical factors in the drug's commercial potential and the company's growth trajectory.
02/29/2024 - 04:07 PM
- 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 $75 million as of December 31, 2023, projected runway into Q3 2025 -
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
“2024 is a pivotal year for Cardiff Oncology and we are excited for our upcoming randomized data readout from our lead program in first-line mCRC later this year,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “The mCRC data we shared in August 2023, and the ONSEMBLE data we are disclosing today, demonstrates onvansertib’s contribution to the standard of care of bevacizumab (bev) and chemotherapy in treating RAS-mutated mCRC. Given there have been no new therapies approved in this large cancer indication in the last 20 years, 2024 marks a critical step in realizing onvansertib’s potential to provide clinical benefit to the large number of newly-diagnosed RAS-mutated mCRC patients, and create value for the stakeholders in our company.”
Upcoming expected milestones
First-line RAS-mutated mCRC randomized data readout expected in mid-2024 Company highlights for the quarter ended December 31, 2023, and subsequent weeks include:
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 by Cardiff Oncology in August 2023 have been published in the peer-reviewed journal Clinical Cancer Research , a journal of the American Association for Cancer Research.Full Year 2023 Financial Results:
Liquidity, cash burn, and cash runway
As of December 31, 2023, Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the full year 2023 was approximately $30.9 million , a decrease of approximately $2.9 million from $33.8 million for the same period in 2022.
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 $45.9 million for the full year ended December 31, 2023, an increase of $5.6 million from $40.3 million for the same period in 2022. The increase in operating expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, and higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.
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 February 29, 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
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.
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's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Investor Contact:
Kiki Patel, PharmD
Media Contact:
Richa Kumari
Cardiff Oncology, Inc. 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
Cardiff Oncology, Inc. December 31, 2023 December 31, 2022 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
Cardiff Oncology, Inc. Year ended December 31, 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
What is the ticker symbol for Cardiff Oncology, Inc.?
The ticker symbol for Cardiff Oncology, Inc. is CRDF.
What is the expected timeline for the first-line RAS-mutated mCRC randomized data readout?
The first-line RAS-mutated mCRC randomized data readout is expected in mid-2024.
How much cash and equivalents did Cardiff Oncology have as of December 31, 2023?
Cardiff Oncology had approximately $75 million in cash and equivalents as of December 31, 2023.
What is the objective response rate (ORR) observed in bev naïve patients in the second-line ONSEMBLE trial?
Bev naïve patients in the second-line ONSEMBLE trial demonstrated an objective response rate (ORR) of 50% on onvansertib.
What is the projected cash runway for Cardiff Oncology based on current expectations?
Cardiff Oncology believes its current cash resources are sufficient to fund its operations into Q3 2025.
