Cardiff Oncology reports positive efficacy signals for onvansertib in mCRC, a $40M funding round, and new patent issuance.
Quiver AI Summary
Cardiff Oncology, Inc. announced positive results from its ongoing first-line clinical trial of onvansertib in RAS-mutated metastatic colorectal cancer (mCRC), showcasing a 64% response rate in patients receiving the 30mg dose, compared to 33% in the control group. The company also secured $40 million in an oversubscribed direct offering and was granted a new U.S. patent for onvansertib's use in treating KRAS-mutated mCRC. With cash reserves of $91.7 million, Cardiff expects its funding to last into Q1 2027. The CEO emphasized the promising data's validation for onvansertib as an effective treatment, and further trial updates are anticipated in the first half of 2025.
Potential Positives
- Robust initial efficacy signal demonstrated in the ongoing CRDF-004 clinical trial, with a 64% objective response rate for patients receiving the 30mg dose of onvansertib, compared to 33% in the control arm.
- $40 million raised in an oversubscribed underwritten registered direct offering, enhancing the company’s financial position and supporting further clinical development.
- Issuance of a new patent for the use of onvansertib in treating KRAS-mutated mCRC, extending exclusivity and potential market differentiation.
- Projected cash runway extending into Q1 2027, providing confidence in resources to continue operations and clinical programs.
Potential Negatives
- Increase in net loss from $41.4 million in 2023 to $45.4 million in 2024, indicating worsening financial performance.
- Operating expenses rose to $49.3 million in 2024, an increase of $3.4 million from the prior year, highlighting escalating costs that could concern investors.
- Net cash used in operating activities increased significantly from $30.9 million in 2023 to $37.7 million in 2024, suggesting higher cash burn rates that could impact future sustainability.
FAQ
What are the key results from the CRDF-004 trial?
The CRDF-004 trial showed a 64% objective response rate for 30mg onvansertib compared to 33% in the control group.
How much funding did Cardiff Oncology raise recently?
Cardiff Oncology raised $40 million in an oversubscribed underwritten registered direct offering from investors.
What does the new patent cover for onvansertib?
The new patent claims the method of using onvansertib for treating KRAS-mutated metastatic colorectal cancer.
What is the cash runway for Cardiff Oncology?
As of December 31, 2024, Cardiff Oncology has a projected cash runway into Q1 2027 with $91.7 million available.
When will Cardiff Oncology provide more clinical updates?
The company expects to share additional clinical updates from the CRDF-004 trial in H1 2025.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CRDF Insider Trading Activity
$CRDF insiders have traded $CRDF stock on the open market 6 times in the past 6 months. Of those trades, 6 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $CRDF stock by insiders over the last 6 months:
- GARY W PACE has made 2 purchases buying 361,615 shares for an estimated $940,199 and 0 sales.
- JAMES E. LEVINE (Chief Financial Officer) has made 3 purchases buying 7,716 shares for an estimated $36,725 and 0 sales.
- RENEE P TANNENBAUM purchased 10,000 shares for an estimated $34,224
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$CRDF Hedge Fund Activity
We have seen 66 institutional investors add shares of $CRDF stock to their portfolio, and 32 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- COMMODORE CAPITAL LP added 5,384,616 shares (+inf%) to their portfolio in Q4 2024, for an estimated $23,369,233
- ORBIMED ADVISORS LLC added 1,538,462 shares (+inf%) to their portfolio in Q4 2024, for an estimated $6,676,925
- ADAGE CAPITAL PARTNERS GP, L.L.C. added 1,292,308 shares (+inf%) to their portfolio in Q4 2024, for an estimated $5,608,616
- LAURION CAPITAL MANAGEMENT LP added 576,924 shares (+inf%) to their portfolio in Q4 2024, for an estimated $2,503,850
- POINT72 ASSET MANAGEMENT, L.P. added 508,438 shares (+inf%) to their portfolio in Q4 2024, for an estimated $2,206,620
- IKARIAN CAPITAL, LLC added 450,000 shares (+inf%) to their portfolio in Q4 2024, for an estimated $1,953,000
- TWO SIGMA ADVISERS, LP removed 316,400 shares (-95.5%) from their portfolio in Q4 2024, for an estimated $1,373,176
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
- Robust initial efficacy signal with onvansertib + chemo/bev in ongoing first-line RAS-mut metastatic colorectal cancer (“mCRC”) clinical trial (CRDF-004) -
- Priced oversubscribed $40 million underwritten registered direct offering with participation from new and existing healthcare dedicated investors -
- Issuance of new patent with claims for the use of onvansertib for treating KRAS-mut mCRC -
- Cash and equivalents of $91.7 million as of December 31, 2024, projected runway into Q1 2027 -
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, Feb. 27, 2025 (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, 2024, and provided a business update.
“2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “We were excited to report that patients on the 30mg onvansertib dose arm demonstrated a 64% response rate, compared to a 33% response rate in the control arm. In the experimental arm, we observed a dose response relationship with the 30mg dose of onvansertib demonstrating increased ORR and deeper tumor regression compared to the 20mg dose of onvansertib with similar safety profiles for both doses. We believe this correlation between the dose of onvansertib and the magnitude of therapeutic effect serves as validation that onvansertib is a biologically active drug for the treatment of cancer, which we believe may translate to additional oncology indications in our pipeline. In addition to the robust efficacy signal in the CRDF-004 trial, these data suggest that onvansertib could safely be combined with both standard of care first-line chemotherapy options for mCRC in the U.S. With our balance sheet strengthened by a $40M investment from biotech specialist investors, we now look forward to sharing additional clinical updates from CRDF-004 in H1 2025.”
Upcoming expected milestones
Additional clinical data from CRDF-004 trial expected in 1H 2025
Company highlights for the quarter ended December 31, 2024, and subsequent weeks include:
Announced positive initial data from ongoing first-line RAS-mutated mCRC clinical trial (CRDF-004)
Phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to standard-of-care (SoC) consisting of FOLFIRI plus bevacizumab (“bev”) or FOLFOX plus bev. Patients will be randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.
Patients on the 30mg onvansertib dose arm demonstrated 64% objective response rate (ORR) versus 33% ORR in the control arm.
The 30mg dose of onvansertib demonstrated a higher ORR and deeper tumor regression compared to the 20mg dose of onvansertib (64% vs. 50%).
Onvansertib was well tolerated at both doses.
Raised $40 million in an oversubscribed underwritten registered direct offering
The financing included participation from new and existing healthcare dedicated investors.
Patent issuance from the United States Patent and Trademark Office (USPTO)
U.S. patent No. 12,144,813 has an expected expiration date of no earlier than 2043. The patent claims cover the method of using onvansertib in combination with bev for the treatment of KRAS mutated mCRC patients who have not previously been treated with bev (“bev naïve”). This patent is supported by the unexpected benefits of the treatment in such bev naïve patients.
Presented two posters at the San Antonio Breast Cancer Symposium
Onvansertib demonstrated synergy in combination with paclitaxel in hormone receptor positive (HR+) breast cancer cell lines and robust antitumor activity in patient-derived xenograft (PDX) models resistant to first-line therapies. These data support that onvansertib in combination with paclitaxel represents a promising therapeutic strategy for HR+ breast cancer patients after progression on endocrine therapy and CDK4/6 inhibitors. A phase 1b/2 clinical trial is ongoing to evaluate the safety and efficacy of onvansertib in combination with paclitaxel in advanced triple negative breast cancer (NCT05383196).
Onvansertib in combination with trastuzumab deruxtecan (T-DXd) was well tolerated, overcame T-DXd resistance, and displayed enhanced anti-tumor activity compared to monotherapies in drug resistant HR+ breast cancer patient derived xenograft (PDX) models. The combination of T-DXd with onvansertib represents a promising therapeutic strategy for HR+ breast cancer patients resistant to first-line therapies.
Published clinical data of the combination of onvansertib with FOLFIRI and bev in second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO)
Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated and exhibited clinical activity in the second-line setting.
A post hoc analysis revealed a greater clinical benefit in bev naïve patients, who demonstrated an ORR of 77% and mPFS of 14.9 months compared to an ORR of 10% and mPFS of 6.6 months in those previously exposed to bev.
Full Year 2024 Financial Results:
Liquidity, cash burn, and cash runway
As of December 31, 2024, Cardiff Oncology had approximately $91.7 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the full year 2024 was approximately $37.7 million, an increase of approximately $6.8 million from $30.9 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 into Q1 2027.
Operating results
Total operating expenses were approximately $49.3 million for the full year ended December 31, 2024, an increase of $3.4 million from $45.9 million for the same period in 2023. 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 today at 4:30 p.m. ET/1:30 p.m. PT. 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.
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), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), 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, 2024, 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
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
kiki@gilmartinir.com
Media Contact:
Michael Laurer
Taft Communications
732-233-4881
Cardiff Oncology, Inc. Condensed Statements of Operations (in thousands, except for per share amounts) | ||||||||
Year Ended December 31, | ||||||||
2024 | 2023 | |||||||
Royalty revenues | $ | 683 | $ | 488 | ||||
Costs and expenses: | ||||||||
Research and development | 36,852 | 32,857 | ||||||
Selling, general and administrative | 12,482 | 13,043 | ||||||
Total operating expenses | 49,334 | 45,900 | ||||||
Loss from operations | (48,651 | ) | (45,412 | ) | ||||
Other income (expense), net: | ||||||||
Interest income, net | 3,259 | 4,069 | ||||||
Other expense, net | (39 | ) | (98 | ) | ||||
Total other income, net | 3,220 | 3,971 | ||||||
Net loss | (45,431 | ) | (41,441 | ) | ||||
Preferred stock dividend | (24 | ) | (24 | ) | ||||
Net loss attributable to common stockholders | $ | (45,455 | ) | $ | (41,465 | ) | ||
Net loss per common share — basic and diluted | $ | (0.95 | ) | $ | (0.93 | ) | ||
Weighted-average shares outstanding — basic and diluted | 47,650 | 44,677 | ||||||
Cardiff Oncology, Inc. Condensed Balance Sheets (in thousands) | ||||||||
December 31, 2024 | December 31, 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 51,470 | $ | 21,655 | ||||
Short-term investments | 40,276 | 53,168 | ||||||
Accounts receivable and unbilled receivable | 773 | 288 | ||||||
Prepaid expenses and other current assets | 2,535 | 2,301 | ||||||
Total current assets | 95,054 | 77,412 | ||||||
Property and equipment, net | 898 | 1,238 | ||||||
Operating lease right-of-use assets | 1,169 | 1,708 | ||||||
Other assets | 69 | 1,279 | ||||||
Total Assets | $ | 97,190 | $ | 81,637 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 4,821 | $ | 1,966 | ||||
Accrued liabilities | 7,897 | 7,783 | ||||||
Operating lease liabilities | 710 | 691 | ||||||
Total current liabilities | 13,428 | 10,440 | ||||||
Operating lease liabilities, net of current portion | 813 | 1,458 | ||||||
Total Liabilities | 14,241 | 11,898 | ||||||
Stockholders’ equity | 82,949 | 69,739 | ||||||
Total liabilities and stockholders’ equity | $ | 97,190 | $ | 81,637 | ||||
Cardiff Oncology, Inc. Condensed Statements of Cash Flows (in thousands) | ||||||||
Year Ended December 31, | ||||||||
2024 | 2023 | |||||||
Operating activities | ||||||||
Net loss | $ | (45,431 | ) | $ | (41,441 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 404 | 398 | ||||||
Stock-based compensation expense | 4,760 | 4,509 | ||||||
Accretion of discounts on short-term investments, net | (598 | ) | (921 | ) | ||||
Changes in operating assets and liabilities | 3,172 | 6,568 | ||||||
Net cash used in operating activities | (37,693 | ) | (30,887 | ) | ||||
Investing activities | ||||||||
Capital expenditures | (80 | ) | (582 | ) | ||||
Net purchases, maturities and sales of short-term investments | 13,808 | 36,777 | ||||||
Net cash provided by investing activities | 13,728 | 36,195 | ||||||
Financing activities | ||||||||
Proceeds from sales of common stock, net of expenses | 53,407 | — | ||||||
Proceeds from exercise of options | 373 | — | ||||||
Net cash provided by financing activities | 53,780 | — | ||||||
Net change in cash and cash equivalents | 29,815 | 5,308 | ||||||
Cash and cash equivalents—Beginning of period | 21,655 | 16,347 | ||||||
Cash and cash equivalents—End of period | $ | 51,470 | $ | 21,655 | ||||
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