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Cardiff Oncology, Inc. (CRDF): Business Model Canvas [Dec-2025 Updated] |
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Cardiff Oncology, Inc. (CRDF) Bundle
You're looking at Cardiff Oncology, Inc. as they pivot from a clinical-stage biotech to a potential commercial player, and honestly, understanding their engine is key right now. Their whole model hinges on onvansertib, a novel PLK1 inhibitor, especially with that promising Phase 2 data showing a 19% improvement in ORR for RAS-mutated mCRC-a huge unmet need. With operating expenses forecasted between $90 million and $92 million for 2025, the focus is clearly on pushing that registrational Phase 3 trial forward while managing their cash runway. Dive into the full Business Model Canvas below to see exactly how their key activities, resources, and revenue streams are set up for this critical transition.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Key Partnerships
You're looking at the structure of Cardiff Oncology, Inc.'s alliances, which are critical for advancing onvansertib through late-stage development. These relationships directly impact the burn rate and timeline for their lead asset.
Pfizer Ignite for Strategic Support and Clinical Trial Operations
Cardiff Oncology, Inc. has an expanded relationship with Pfizer, leveraging its Pfizer Ignite service for clinical execution support on the CRDF-004 trial. This relationship stems from an earlier equity investment made by Pfizer in November 2021.
Financially, this partnership is supported by a recent capital infusion; as of November 2025, Pfizer holds a $15 million equity stake in Cardiff Oncology, Inc., which bolsters the company's financial stability. The CRDF-004 trial, evaluating onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC), is being conducted with this support. Data from this trial must be shared with Pfizer two days before any public disclosure.
Contract Research Organizations (CROs) and Clinical Trial Management
While specific CRO names aren't detailed, the cost of managing global clinical trials is evident in the operating expenses. The CRDF-004 Phase 2 trial enrolled patients across 41 U.S. clinical sites. The financial commitment to these external services is significant.
Here's a look at the quarterly spending tied to these clinical activities:
| Reporting Period End Date | Total Operating Expenses | Increase from Prior Year Period | Primary Driver |
| June 30, 2025 (Q2 2025) | $14.9 million | Up by $2.2 million | Costs associated with CRDF-004 clinical trial and outside service costs. |
| March 31, 2025 (Q1 2025) | $14.5 million | Up by $3.4 million | Costs associated with CRDF-004 clinical trial and development of onvansertib. |
| September 30, 2025 (Q3 2025) | $12.1 million | Decrease of $0.7 million | Reduction in clinical trial expenses and preclinical activities. |
The cash position as of September 30, 2025, was $60.6 million, with management projecting this is sufficient to fund operations into Q1 2027. That's a runway of about 18 months from the end of Q3 2025.
Academic and Network Collaborations
Cardiff Oncology, Inc. relies on data generated through various studies to support its development strategy. The company announced positive data from an investigator-initiated trial of onvansertib in combination with paclitaxel in metastatic triple negative breast cancer (mTNBC) presented at ASCO 2025. This shows reliance on external research groups to generate supporting data.
The company's focus is on leveraging PLK1 inhibition to overcome treatment resistance, which requires alignment with established clinical standards. The CRDF-004 trial protocol was developed with agreement from the FDA, outlining endpoints for accelerated approval based on objective response rate (ORR).
- Data from the CRDF-004 trial as of the July 8, 2025 cut-off showed a 19% improvement in confirmed ORR in the 30mg onvansertib arm versus control.
- The company secured a second patent protecting onvansertib for bevacizumab-naïve mCRC patients, extending protection until 2043.
Potential Future Pharmaceutical Licensing or Co-development Partners
The near-term focus is on executing the Phase 2 CRDF-004 trial to generate data for the next step. The company is planning for a Phase 3, randomized trial (CARDIF-005) with registrational intent. The FDA has agreed that this trial design, using ORR at an interim point for accelerated approval and PFS/OS trends for full approval, provides a clear path forward. Securing a larger partner for this Phase 3 execution and subsequent commercialization is a likely strategic goal, given the capital intensity of late-stage trials.
Finance: draft 13-week cash view by Friday.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Key Activities
You're looking at the core engine driving Cardiff Oncology, Inc. right now: the clinical and intellectual property work centered on onvansertib. This is where the capital is being spent to try and turn a promising molecule into an approved therapy.
Conducting the Phase 2 CRDF-004 trial for RAS-mutated mCRC
The Phase 2 CRDF-004 trial, which evaluates onvansertib combined with standard of care (SoC) for first-line RAS-mutated metastatic colorectal cancer (mCRC), reached a major milestone with the completion of patient enrollment in April 2025. The trial randomizes patients across three arms: 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint Cardiff Oncology is focused on is the objective response rate (ORR).
Data reported as of the July 8, 2025 data cutoff showed encouraging efficacy signals for the higher dose. Specifically, the 30mg onvansertib cohort demonstrated a 19% improvement in confirmed ORR compared to the control arm in the intent-to-treat population. Early progression-free survival (PFS) data also showed a trend favoring the 30mg arm. The next clinical update from this ongoing trial is expected in the first quarter of 2026.
Planning and initiating the registrational Phase 3 trial (CRDF-005)
With Phase 2 enrollment complete, the key activity shifts to planning the registrational Phase 3 trial, designated CRDF-005. This planned study is designed to be a 320-patient trial. The goal is to secure both accelerated approval based on response rates and full approval based on PFS and lack of detriment to overall survival. Updates regarding the final design of the CRDF-005 trial are anticipated in the first quarter of 2026, pending ongoing FDA interactions.
Research and development of the PLK1 inhibitor, onvansertib
The entire R&D effort is focused on onvansertib, a PLK1 inhibitor. This activity is supported by the company's current financial position, though the Phase 3 trial will likely require further capital. As of September 30, 2025, Cardiff Oncology reported approximately $60.6 million in cash and investments, projecting a runway into the first quarter of 2027. The net cash used in operating activities for the third quarter of 2025 was approximately $10.8 million. Analysts project that onvansertib could achieve peak sales between $2 billion and $3 billion annually upon potential approval.
Here's a look at the recent operating expense trend supporting these R&D activities:
| Reporting Period End Date | Total Operating Expenses | Net Cash Used in Operating Activities |
| March 31, 2025 (Q1 2025) | $14.5 million | $12.8 million |
| June 30, 2025 (Q2 2025) | $14.9 million | $8.3 million |
| September 30, 2025 (Q3 2025) | $12.1 million | $10.8 million |
Securing regulatory approvals from the FDA for onvansertib
A critical activity is navigating the regulatory pathway with the FDA. The company has engaged with the FDA, and previous interactions, such as a June 2023 Type C meeting, outlined a development path for the registrational trial (CRDF-005) for potential accelerated and full approval. The company is actively preparing to consult with the FDA based on the CRDF-004 response rates.
Protecting intellectual property with new patents, like the one extending to 2043
Cardiff Oncology has been successful in securing its market position through patent grants. The company has secured two new U.S. patents that extend its intellectual property protection for onvansertib in colorectal cancer treatment through at least 2043.
- U.S. patent No. 12,144,813 covers the use of onvansertib in combination with bevacizumab for treating KRAS mutated mCRC patients who have not previously received bevacizumab.
- U.S. patent No. 12,263,173 covers the use of onvansertib in combination with bevacizumab for treating all bev-naïve mCRC patients, including both RAS-mutated and RAS wild-type across all therapy lines.
The company also benefits from a strategic relationship with Pfizer, which holds a 3% stake and provided a $15 million equity investment to support trial operations.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Key Resources
You're looking at the core assets Cardiff Oncology, Inc. (CRDF) is relying on right now to push its pipeline forward. These aren't just line items; they are the tangible and intangible things that make the business run, especially as you map out their near-term strategy.
The lead asset is onvansertib, which is a proprietary PLK1 inhibitor. This molecule is central to their value proposition, currently being evaluated in the ongoing CRDF-004 Phase 2 randomized trial for first-line RAS-mutated metastatic colorectal cancer (mCRC).
Here's a quick look at some of the most critical, hard numbers defining their current resource base and clinical progress as of late 2025:
| Metric Category | Specific Data Point | Value/Amount | As of Date/Context |
| Financial Health | Cash and Investments | $60.6 million | September 30, 2025 |
| Financial Health | Projected Cash Runway | Into Q1 2027 | Based on Q3 2025 projections |
| Clinical Efficacy (CRDF-004) | Improvement in Confirmed ORR (30mg cohort vs. control) | 19% improvement | July 8, 2025 data cut-off |
| Clinical Efficacy (CRDF-004) | Confirmed Objective Response Rate (ORR) for 30mg cohort | 49% | July 8, 2025 data cut-off |
| Intellectual Property | Patent Expiration for Key mCRC Treatment Combination | No earlier than 2043 | U.S. patent No. 12,263,173 |
| Operational Spending | Net Cash Used in Operating Activities (Q3 2025) | Approximately $10.8 million | Q3 2025 |
The intellectual property portfolio is a major, defintely non-tangible resource. Cardiff Oncology secured U.S. patent No. 12,263,173, which extends protection for the use of onvansertib in combination with bevacizumab for treating all bevacizumab-naïve mCRC patients, regardless of RAS mutation status, across all therapy lines, with an expected expiration date no earlier than 2043. This builds upon an earlier patent covering first-line KRAS-mutated mCRC.
You need to factor in the human capital, too. The company has key scientific and clinical personnel driving the development. A notable addition is the new Chief Medical Officer, Dr. Roger Sidhu, who was appointed in the second quarter of 2025 to guide onvansertib through the registrational phase of development.
The clinical data itself acts as a resource, validating the science. The positive Phase 2 CRDF-004 data, based on the July 8, 2025 cut-off, showed a 19% improvement in confirmed Objective Response Rate (ORR) for the 30mg onvansertib cohort over the control arm. Furthermore, the 30mg arm achieved a 49% confirmed ORR in the intent-to-treat population.
You can also look at the operational efficiency as a resource, as it extends the runway. Total operating expenses for the three months ended September 30, 2025, were approximately $12.1 million, which was a decrease from the same period in 2024. This improved cost control helps support the cash position of $60.6 million as of September 30, 2025, funding operations into Q1 2027.
To summarize the key non-financial, scientific resources:
- Onvansertib, a PLK1 inhibitor targeting a well-validated oncology drug target.
- Positive data showing a 19% ORR improvement in first-line RAS-mutated mCRC.
- IP protection extending through 2043 for broad mCRC treatment combinations.
- Key personnel, including the recently appointed Chief Medical Officer, Dr. Roger Sidhu.
Finance: draft 13-week cash view by Friday.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Value Propositions
Cardiff Oncology, Inc.'s value proposition centers on delivering superior clinical benefit by targeting tumor vulnerabilities to overcome treatment resistance, primarily through its lead asset, onvansertib, a PLK1 inhibitor.
Novel oral therapy for first-line RAS-mutated mCRC, an area of high unmet need.
The CRDF-004 Phase 2 trial data, cut off July 8, 2025, supports this proposition with clear efficacy signals over standard of care (SoC) alone in this difficult-to-treat population.
Improved objective response rate (ORR) over standard of care alone.
The data from the CRDF-004 trial shows a dose-dependent response, with the higher dose cohort demonstrating a significant lift in response rates:
| Treatment Arm | Confirmed Objective Response Rate (ORR) | Improvement Over Control |
| 30mg Onvansertib + SoC | 49% | 19% improvement over control |
| Control (SoC Alone) | 30% | N/A |
This confirmed ORR of 49% in the 30mg arm compares favorably to the control arm's 30% in the intent-to-treat population (N=110). In a separate analysis of the same trial, the 30mg dose cohort achieved an ORR of 64% compared to 33% in the control arm.
Onvansertib shows synergy with standard chemotherapy without significant added toxicity.
The combination of onvansertib with chemotherapy and bevacizumab was reported as well-tolerated, with no major or unexpected toxicities observed. Neutropenia was the most common Grade 3 or higher adverse event associated with onvansertib. Early Progression-Free Survival (PFS) data showed a trend favoring the 30mg dose arm versus control.
Treatment for other difficult cancers: mPDAC, SCLC, and TNBC.
Cardiff Oncology, Inc. is also evaluating onvansertib in investigator-initiated trials across other indications where treatment resistance is a major issue:
- Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
- Small Cell Lung Cancer (SCLC)
- Metastatic Triple Negative Breast Cancer (mTNBC)
For mTNBC, an investigator-initiated trial combining onvansertib with paclitaxel demonstrated a 40% objective response rate (ORR) by RECIST 1.1 at the recommended Phase 2 dose (RP2D) of 18mg/m² (n=10).
The potential financial scale of this value proposition is suggested by analyst estimates placing peak sales for onvansertib between $2 billion and $3 billion per year. Furthermore, the company secured new U.S. patents extending its colorectal cancer treatment runway to 2043.
The company's financial position as of September 30, 2025, was approximately $60.6 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into Q1 2027. For the full year 2025, projected revenue is between $76.0 million and $78.0 million, with revised operating expenses forecasted in the range of $90 million to $92 million.
Potential to redefine care for a patient population with few therapeutic advancements.
The company is preparing to consult with the FDA for potential accelerated approval based on the response rates observed in the CRDF-004 trial.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Customer Relationships
You're looking at how Cardiff Oncology, Inc. engages its key stakeholders-the people who make the science move and the money flow. For a clinical-stage biotech, these relationships are the lifeblood, especially when advancing a lead asset like onvansertib.
High-touch engagement with clinical investigators and trial sites
The company relies heavily on the commitment of investigators to drive its clinical programs forward. This high-touch approach is evident in the execution of the CRDF-004 trial.
- The Phase 2 CRDF-004 trial enrolled its targeted number of patients across 41 clinical sites in the U.S..
- Enrollment completion for this trial was announced in April 2025.
- The trial evaluates onvansertib in combination with standard-of-care (SoC) for first-line RAS-mutated metastatic colorectal cancer (mCRC).
Direct communication with the FDA for regulatory pathway discussions
Navigating the U.S. Food and Drug Administration (FDA) is a continuous, direct dialogue, shaping the path to potential approval for onvansertib.
- Ongoing FDA interactions outline a clear development path for onvansertib in first-line mCRC.
- A June 2023 Type C meeting established the development path and agreed upon the design for the registrational trial, CRDF-005.
- The company plans to advance toward regulatory discussions following the CRDF-004 data release.
- The design for the planned 320-patient Phase 3 study, CRDF-005, will be finalized pending FDA feedback.
Investor relations and presentations to secure ongoing funding
Securing capital is a critical relationship managed through frequent, high-profile interactions with the financial community to support operations extending into the future.
Here's the quick math on the financial runway and recent backing:
| Financial Metric | Amount / Date |
|---|---|
| Cash Position (as of last quarter, Q3 2025) | $60-61 million |
| Cash Position (as of June 30, 2025) | $71.0 million |
| Projected Cash Runway | Until Q1 2027 |
| Pfizer Equity Investment | $15 million |
Cardiff Oncology management actively engages investors through scheduled events to communicate progress and address funding needs for the Phase 3 trial.
- Management participated in the Stifel 2025 Healthcare Conference on November 12, 2025.
- The company is scheduled to present at the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025.
- Presentations in September 2025 included the Wells Fargo 20th Annual Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference.
Scientific and medical conferences to disseminate clinical data
Sharing clinical findings at major medical meetings validates the science and builds credibility with the broader medical community, which influences investigator recruitment and future prescribing habits.
- Positive data from an investigator-initiated trial in metastatic triple-negative breast cancer (mTNBC) was presented at the ASCO Annual Meeting in Chicago from May 30 to June 3, 2025.
- The company held a conference call on July 29, 2025, to share updated clinical data from the CRDF-004 trial.
- The 30mg onvansertib arm in CRDF-004 showed a 49% confirmed objective response rate (ORR) versus 30% in the control arm.
Patient advocacy groups for clinical trial awareness and support
While specific partnership metrics aren't public, the relationship is centered on the patient population Cardiff Oncology aims to serve, particularly those with limited options.
- The CRDF-004 trial specifically targets patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
- The company notes the patient population has not seen meaningful treatment advancements for decades.
- The goal is to bring a transformative therapy to patients, which requires awareness and support from advocacy networks.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Channels
You're looking at how Cardiff Oncology, Inc. gets its message and its potential product to the right people right now. Since they are pre-commercial, the channels are heavily weighted toward clinical validation and investor awareness.
Clinical Trial Sites
The primary channel for generating clinical data and engaging with the treating physician community is through active clinical trial sites. The Phase 2 CRDF-004 trial, evaluating onvansertib for first-line RAS-mutated metastatic colorectal cancer (mCRC), was a major focus for this channel.
- The CRDF-004 trial reached its targeted enrollment across 41 clinical sites in the U.S..
- Enrollment for the CRDF-004 trial completed in April 2025.
- The trial randomized patients to either 20mg of onvansertib plus Standard of Care (SoC), 30mg of onvansertib plus SoC, or SoC alone.
Direct Engagement with Key Opinion Leaders (KOLs) in Oncology
Engagement with KOLs happens directly through clinical trial participation and advisory roles, which is critical for shaping future treatment paradigms. The Chief Medical Officer, Roger Sidhu, MD, was involved in presenting data, indicating direct KOL-level interaction.
Scientific Publications and Medical Conference Presentations
Presenting data at major medical meetings is the core channel for scientific validation. The company has a history of presenting at key oncology and investment conferences.
Cardiff Oncology, Inc. has presented data from its ongoing clinical trials, including CRDF-004, at the following events in 2025:
| Conference Name | Date(s) 2025 | Format/Key Presenters |
| ASCO Annual Meeting | Prior to Q3 2025 | Announced positive data from investigator-initiated trial in mTNBC |
| H.C. Wainwright 27th Annual Global Investment Conference | September 9, 2025 | Fireside Chat; Mark Erlander, CEO |
| Wells Fargo 20th Annual Healthcare Conference | September 5, 2025 | 1x1 Meetings |
| Morgan Stanley 23rd Annual Global Healthcare Conference | September 8, 2025 | 1x1 Meetings |
| Piper Sandler Virtual Oncology Symposium | October 9, 2025 | Fireside Chat; CEO, CFO (James Levine), and CMO (Roger Sidhu, MD) |
| Noble Capital Markets Emerging Growth Virtual Equity Conference | October 9, 2025 | Fireside Chat; Mark Erlander, CEO |
| Guggenheim Securities 2nd Annual Healthcare Innovation Conference | November 11, 2025 | Fireside Chat and 1x1 Meetings; Mark Erlander, PhD (CEO) |
| Stifel 2025 Healthcare Conference | November 12, 2025 | Corporate Presentation and 1x1 Meetings; Mark Erlander, PhD (CEO) |
The company also lists scientific publications in journals such as International Journal of Molecular Sciences and Cancer Research Communications.
Investor Presentations and Press Releases for Corporate Communication
Corporate communication channels are managed through Investor Relations and Media Relations teams, utilizing press releases and webcasts.
- Investor Contact is Kiki Patel, PharmD, at Gilmartin Group.
- Media Contact is Meghan Bianco at Taft Communications, a division of RF|Binder.
- The company issued a press release for Third Quarter 2025 Results on November 6, 2025.
- The company reported Q3 2025 net cash used in operating activities of approximately $10.8 million.
- Cash, cash equivalents, and short-term investments as of September 30, 2025, were approximately $60.6 million.
Future Pharmaceutical Sales Force for Commercialization Post-Approval
As of late 2025, Cardiff Oncology, Inc. is a clinical-stage company, not a commercial one, meaning a dedicated, large-scale sales force is not yet an active channel. The current financial structure supports operations into Q1 2027 based on Q3 2025 cash reserves and burn rate, which precedes the expected Phase 3 trial completion and potential regulatory approval. The need for additional financing for the upcoming Phase 3 trial (CRDF-005) is acknowledged, which would precede the build-out of a commercial sales infrastructure.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Customer Segments
You're looking at the specific groups Cardiff Oncology, Inc. (CRDF) targets with its onvansertib development programs as of late 2025. These segments drive clinical trial enrollment, physician adoption, and potential partnership value.
Patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
This is the lead indication, where the CRDF-004 Phase 2 trial completed enrollment. The patient population size is substantial, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. The trial enrolled patients across 41 clinical sites in the U.S. The intent-to-treat population for the July 8, 2025, data cut-off was N=110 patients.
Oncologists and hematologists treating mCRC and other solid tumors.
These are the prescribers and investigators. The data presented to them from the CRDF-004 trial showed compelling efficacy signals that influence adoption. For instance, the 30mg onvansertib dose arm demonstrated a confirmed Objective Response Rate (ORR) of 49% compared to 30% in the control arm, representing a 19% improvement. Also, data from an early-stage metastatic triple-negative breast cancer (mTNBC) trial showed a 40% ORR for the onvansertib plus paclitaxel combination in a small group of 10 patients.
Patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
This segment is being addressed through ongoing investigator-initiated trials, though specific enrollment numbers for this indication aren't detailed in the latest public reports. The company is leveraging its PLK1 inhibition technology here to target tumor vulnerabilities.
Patients with small cell lung cancer (SCLC) and triple-negative breast cancer (TNBC).
Cardiff Oncology, Inc. is exploring onvansertib in these indications via investigator-initiated trials as well. The mTNBC data point, showing a 40% ORR in the early trial, is a key data point for engaging oncologists treating this difficult-to-treat population.
Pharmaceutical companies seeking late-stage oncology assets for licensing.
These entities are potential partners for late-stage development or commercialization. The company's financial stability, with cash and investments of $60.6 million as of September 30, 2025, projects a runway into Q1 2027, which is relevant for partnership timelines. Furthermore, the intellectual property portfolio offers significant protection, with a new USPTO patent covering mCRC treatment extending protection until at least 2043. Pfizer holds an equity investment of $15 million, and a research agreement is in place with Merck & Co. to explore combination studies with pembrolizumab. The Q3 2025 net cash used in operating activities was approximately $10.8 million.
Here's a quick look at the key financial and IP data points relevant to potential partners:
- Cash Runway Projection: Into Q1 2027.
- Cash Position (as of 9/30/2025): $60.6 million.
- Q3 2025 Operating Cash Use: $10.8 million.
- mCRC Patent Expiration (Extended): At least 2043.
- Pfizer Equity Stake: $15 million.
The company definitely needs to secure additional funding for the planned Phase 3 trial, which is a key dependency for this segment.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Cost Structure
Cardiff Oncology, Inc.'s cost structure is heavily weighted toward the clinical development of its lead asset, onvansertib. Significant Research and Development (R&D) costs for clinical trials are the primary expenditure driver, as evidenced by the Q1 2025 operating expenses of approximately $14.5 million, which was primarily due to costs associated with the CRDF-004 clinical trial and other clinical programs related to onvansertib development.
The full-year 2025 Operating Expenses forecast has been revised to a range between $90 million and $92 million. This projection follows a period of increased spending, with total operating expenses for the three months ended June 30, 2025, reaching approximately $14.9 million.
Here's a look at the recent quarterly operating expense trend:
| Period Ending | Total Operating Expenses |
| March 31, 2025 (Q1 2025) | $14.5 million |
| June 30, 2025 (Q2 2025) | $14.9 million |
| September 30, 2025 (Q3 2025) | $12.1 million |
| Full Year 2024 | $49.3 million |
The cost base also includes salaries and wages for key hires and general administrative expenses. For the full year 2024, the increase in operating expenses was attributed, in part, to higher salaries and staff costs from increased headcount and stock-based compensation.
The cash burn rate reflects these ongoing costs. Net cash used in operating activities was approximately $10.8 million in Q3 2025. This cash usage is what drives the need to manage the current cash position of approximately $60.6 million as of September 30, 2025, which the Company projects is sufficient to fund operations into Q1 2027.
Manufacturing and supply chain costs for onvansertib, while not detailed in isolation, are part of the overall cost structure, which is currently being impacted by external factors. Specifically, Cardiff Oncology is facing cost pressures due to U.S. tariffs on goods produced in China, which are expected to increase the Surgical Glaucoma segment's cost of goods sold by $1.0 million to $1.5 million over the full year 2025.
Key cost components influencing the structure include:
- Costs associated with the CRDF-004 clinical trial.
- Outside service costs for onvansertib development.
- Salaries and staff costs, including stock-based compensation.
- Tariff-related increases impacting the Surgical Glaucoma segment COGS.
Finance: draft 13-week cash view by Friday.
Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Revenue Streams
You're looking at the revenue side for Cardiff Oncology, Inc. (CRDF) as of late 2025, and honestly, it's what you'd expect for a clinical-stage biotech deep into trials. The current revenue picture is quite thin, reflecting the pre-commercial stage.
Minimal current revenue, primarily from royalties on prior licensed technologies. Right now, the money coming in is almost entirely from those prior deals. This isn't a sales-driven business yet; it's about earning from past intellectual property work. For the third quarter ending September 30, 2025, the reported royalty revenues were exactly $0.12 million.
To give you a clearer picture of this core, small revenue stream, here's how the royalty income has looked recently:
| Period Ending | Royalty Revenue (in millions USD) | Total Revenue (in millions USD) |
|---|---|---|
| September 30, 2025 (Q3 2025) | $0.12 | $0.12 |
| June 30, 2025 (Q2 2025) | $0.121 | $0.121 |
| March 31, 2025 (Q1 2025) | $0.109 | N/A |
Interest income from cash, cash equivalents, and investments. While not broken out separately as a major stream, Cardiff Oncology, Inc. maintains a cash balance that generates interest. As of September 30, 2025, the company held approximately $60.6 million in cash, cash equivalents, and short-term investments. That's a decent pile of capital that will be earning something, though it's secondary to the R&D burn.
Q3 2025 Total Revenue was only $0.12 million, typical for a pre-commercial biotech. This figure is the bottom line for revenue in the quarter. For context, the cumulative revenue for the first three quarters of 2025 was reported as $0.35 million. This low number is standard when a company is focused on expensive clinical development rather than product sales.
Future revenue from product sales of onvansertib post-FDA approval. The real financial upside hinges on onvansertib. The company is tracking positive data from the ongoing Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). If this progresses and gains approval, sales of onvansertib will become the primary revenue driver. The CEO noted that approximately 150,000 new CRC patients are diagnosed annually in the U.S. alone, representing the commercial opportunity.
Potential milestone payments and royalties from future licensing deals. Beyond direct product sales, Cardiff Oncology, Inc. has the potential for non-sales revenue tied to its pipeline progress. This includes:
- Potential milestone payments from existing or future partners based on clinical or regulatory achievements.
- Royalties on net sales of any licensed products, including onvansertib, should they be commercialized by a partner.
The company's focus on advancing onvansertib is designed to hit value-creating milestones that could trigger these payments, helping to extend the current cash runway, which was projected into Q1 2027 based on the $60.6 million cash position.
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