Cardiff Oncology, Inc. (CRDF): History, Ownership, Mission, How It Works & Makes Money

When you look at the biotech landscape, how does a clinical-stage company like Cardiff Oncology, Inc. (CRDF) with a market capitalization of $148 million (as of October 2025) manage to stand out in the multi-billion-dollar oncology market? The answer lies in their focused mission on PLK1 inhibition to develop novel therapies, especially for the high-unmet-need population of RAS-mutated metastatic colorectal cancer (mCRC). You need to understand the financial reality-a Q3 2025 revenue of only $0.12 million-against the clinical promise of their lead asset, onvansertib, which showed a 19% improvement in confirmed Objective Response Rate (ORR) in a key Phase 2 trial this year. This is a classic biotech trade-off: cash burn, with a runway into Q1 2027, for the defintely high-risk, high-reward potential of a breakthrough cancer treatment.

Cardiff Oncology, Inc. (CRDF) History

You're looking for the foundational story of Cardiff Oncology, Inc., and honestly, it's a classic biotech pivot. The company you see today, focused on its lead drug onvansertib, is a complete transformation of its original self. It started as a diagnostics company called Trovagene, Inc., and only fully committed to its oncology therapeutics mission-specifically, its Polo-like Kinase 1 (PLK1) inhibitor-with a major rebrand in 2020.

This history is critical because it explains why their lead asset, onvansertib, is a third-generation inhibitor: it has been through years of development and strategic re-focusing. The shift from diagnostics to a pure-play clinical-stage oncology company is the single most important event in its history.

Given Company's Founding Timeline

Year established

The company was established in 1999, initially operating under the name Trovagene, Inc..

Original location

The original and current corporate headquarters are in San Diego, California.

Founding team members

While the original 1999 founders are not explicitly detailed in public records, the company's evolution was shaped by key leaders who transitioned the company to its current form. Dr. Thomas Adams was a critical figure, serving as Chairman of the Board since 2009 and CEO until 2020. The current trajectory is led by Dr. Mark Erlander, who served as Chief Scientific Officer since 2013 and took over as Chief Executive Officer in May 2020.

Initial capital/funding

Specific initial seed funding from 1999 is not public, but the company's total funding to date is approximately $80.5 million, accumulated through various placements and offerings over its history. More recently, the company secured a key $40 million in an oversubscribed underwritten registered direct offering in February 2025 to fuel its clinical programs.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's history is defined by two major, deliberate transformations: the shift from a diagnostics technology platform to a drug development pipeline, and the subsequent strategic focus on a first-line therapy for a difficult-to-treat cancer population.

The 2020 name change from Trovagene to Cardiff Oncology, Inc. was more than a rebrand; it was a clear signal to the market that the company was now exclusively an oncology drug developer. This move streamlined their mission, cutting away the complexity of the older diagnostics business to focus solely on onvansertib, their PLK1 inhibitor. That's a tough, but necessary, move in biotech.

The second major shift happened in 2023, following a Type C meeting with the FDA, where the company decided to pivot its lead program, onvansertib, from second-line to first-line RAS-mutated metastatic colorectal cancer (mCRC). This is a huge commercial bet, but it makes sense because the first-line setting offers a significantly larger market opportunity and the data suggested better efficacy in patients who had not yet received bevacizumab (bev-naïve).

• Strategic Pivot: Moving onvansertib to the first-line setting targets an estimated $10.95 billion market for RAS-mutated mCRC in 2025, offering a much higher potential for peak sales, which analysts project could reach $2 billion to $3 billion annually.
• Financial Health: As of September 30, 2025, the company reported approximately $60.6 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into the first quarter of 2027. Net cash used in operating activities for Q3 2025 was $10.8 million.
• Leadership Strength: The June 2025 appointment of Dr. Roger Sidhu as Chief Medical Officer, a seasoned oncology executive with over 20 years of experience, was a defintely key move to strengthen the leadership as the company prepares for a potential Phase 3 trial and commercialization.

The company is now positioned as a clinical-stage firm with a single, high-potential asset, which makes its future entirely dependent on the success of its Phase 2 and upcoming Phase 3 trials. For a deeper dive into who is betting on this strategy, you should be Exploring Cardiff Oncology, Inc. (CRDF) Investor Profile: Who's Buying and Why?

Cardiff Oncology, Inc. (CRDF) Ownership Structure

Cardiff Oncology, Inc. is a clinical-stage biotechnology company, publicly traded on the Nasdaq Stock Market under the ticker symbol CRDF, with its ownership distributed among institutional, insider, and retail investors.

This structure, where institutions hold a significant but not controlling stake, means the company is primarily governed by its Board of Directors, but major decisions are defintely influenced by the interests of large institutional shareholders like BlackRock, Inc. and Vanguard Group Inc..

Cardiff Oncology's Current Status

As of November 2025, Cardiff Oncology, Inc. is a public, clinical-stage biotechnology company focused on developing novel cancer therapies using PLK1 inhibition (an approach that targets a specific enzyme, Polo-like Kinase 1, crucial for cell division in cancer).. The company is listed on the Nasdaq Capital Market (NasdaqCM: CRDF)..

Its financial health is supported by a cash position of approximately $60.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, which is projected to provide a cash runway into the first quarter of 2027.. A notable strategic investment is the $15 million equity stake held by Pfizer Inc., which also manages the CARDIF-004 trial..

Cardiff Oncology's Ownership Breakdown

The company's control is a balance between large institutional funds, company insiders (officers and directors), and the general public (retail investors). This breakdown shows that no single entity holds a majority stake, requiring management to navigate diverse stakeholder interests.

Here's the quick math: Institutional and Insider ownership combined is 68.49%, meaning a majority of shares are held by sophisticated or affiliated parties. The largest individual insider, Robert Merrill Hunter, holds about 5.07 million shares, valued at approximately $11.09 million as of November 2025..

Cardiff Oncology's Leadership

The company is steered by a management team with deep experience in oncology and drug development, which is crucial for a clinical-stage biotech. The leadership is focused on advancing its lead drug candidate, onvansertib, through clinical trials..

• Mark Erlander, PhD: Chief Executive Officer (CEO) since May 2020. He leads the overall strategy, bringing a strong background as a former Chief Scientific Officer at bioTheranostics..
• James Levine: Chief Financial Officer (CFO). He manages the company's financials and investor relations, having previously served as CFO of Cidara Therapeutics, where he led collaborations valued over $1.3 billion..
• Tod Smeal, PhD: Chief Scientific Officer (CSO) since January 2022. He oversees the scientific direction, with past leadership roles in oncology research at Eli Lilly and Company and Pfizer..
• Roger Sidhu, MD: Chief Medical Officer (CMO). He guides the clinical development programs, drawing on over 20 years of oncology leadership experience, including advancing therapeutics from Phase 1 to commercial launch..

This team's collective experience, especially the extensive drug development history at major pharmaceutical companies like Pfizer, helps to outline a clear path for onvansertib's registrational trial. If you want to dive deeper into the company's core principles, you can review their Mission Statement, Vision, & Core Values of Cardiff Oncology, Inc. (CRDF).

Cardiff Oncology, Inc. (CRDF) Mission and Values

Cardiff Oncology, Inc. is a clinical-stage biotechnology company with a singular focus: developing novel therapies to significantly improve outcomes for cancer patients, especially those with historically difficult-to-treat mutations. Their core purpose transcends typical financial metrics, centering on scientific advancement to solve a critical unmet medical need.

You're looking at a company where the science drives the strategy, not the other way around. This is defintely a long-term play on a specific biological pathway.

Cardiff Oncology's Core Purpose

The company's existence is fundamentally tied to its lead asset, Onvansertib, a polo-like kinase 1 (PLK1) inhibitor, which is designed to target tumor vulnerabilities and overcome treatment resistance in several cancers. This focus is their cultural DNA.

For the 2025 fiscal year, this commitment meant significant operational burn, with net cash used in operating activities for the third quarter alone being approximately $10.8 million, reflecting substantial investment in clinical trials. For a deeper dive into their financial position, you should check out Breaking Down Cardiff Oncology, Inc. (CRDF) Financial Health: Key Insights for Investors.

Official Mission Statement

The company is driven by a commitment to patients who have few options, aiming for a fundamental shift in cancer treatment. They remain focused on their mission to deliver a transformative therapy that could redefine the standard of care for RAS-mutated metastatic colorectal cancer (mCRC) and for other cancers.

• Develop new oncology therapeutic options for cancer patients.
• Redefine the standard of care for RAS-mutated mCRC.
• Serve a patient population that has seen no therapeutic advancements in decades.

This mission is the reason they are a clinical-stage company with trailing 12-month revenue of only $501K as of September 30, 2025, because their value is in the science, not current sales.

Vision Statement

Cardiff Oncology's vision is built on a foundation of scientific rigor and sustainable growth to ensure their therapeutic developments reach patients. It's about creating a successful biotech firm that can consistently deliver on its promise to stakeholders-patients, investors, and the scientific community.

• Foster scientific knowledge of cancer biology.
• Develop targeted therapies addressing specific cancer pathways.
• Build a sustainable and successful biotechnology company.

Honestly, the vision shows they are planning to be around long enough to see their drug, Onvansertib, through the registrational phase of development.

Cardiff Oncology Slogan/Tagline

The company uses a powerful, concise tagline that encapsulates their ambitious goal in the oncology space. It's a direct statement about their intent to change the trajectory of the disease for patients with high unmet need.

• Turning the Tide on Cancer.

As of September 30, 2025, the company had approximately $60.6 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into Q1 2027, giving them the financial runway to pursue this vision.

Cardiff Oncology, Inc. (CRDF) How It Works

Cardiff Oncology operates as a clinical-stage biotechnology company, meaning its core business is developing a single, novel drug candidate, onvansertib, through clinical trials to gain regulatory approval and eventual commercialization. The company's value creation is currently driven by advancing this drug, a Polo-like Kinase 1 (PLK1) inhibitor, as a combination therapy to overcome tumor resistance in difficult-to-treat cancers.

Cardiff Oncology's Product/Service Portfolio

Cardiff Oncology's Operational Framework

The company's operations are laser-focused on clinical development, which is typical for a biotech at this stage. You're not selling product; you're selling progress toward a regulatory milestone. The entire framework is built around managing the risk and cost of the CRDF-004 Phase 2 trial and planning the pivotal Phase 3 study.

• Clinical Trial Execution: Manage the ongoing Phase 2 CRDF-004 trial for mCRC, which completed enrollment earlier this year. The next major clinical data update is expected in Q1 2026.
• Financial Management: Maintain a cash runway that extends into Q1 2027, based on the approximately $60.6 million in cash and investments as of September 30, 2025. Here's the quick math: Q3 2025 net cash used in operating activities was about $10.8 million, so expense management is defintely crucial.
• Regulatory Strategy: Engage with the FDA to finalize the design of the registrational Phase 3 trial (CARDIF-005), aiming for both accelerated approval (based on response rate) and full approval (based on progression-free survival).
• Value Creation: Advance onvansertib through the clinical pipeline, which converts research and development (R&D) spend-Q3 2025 R&D costs were $8.2 million-into potential future market exclusivity and blockbuster sales.

You can see how this all connects by Exploring Cardiff Oncology, Inc. (CRDF) Investor Profile: Who's Buying and Why?

Cardiff Oncology's Strategic Advantages

In the high-stakes world of oncology, a clinical-stage company needs more than just promising early data; it needs a clear path and a unique mechanism. Cardiff Oncology has a few strong cards to play right now.

• Unique Mechanism of Action: Onvansertib is a PLK1 inhibitor, a well-validated but under-leveraged oncology target. This mechanism is designed to overcome treatment resistance, which is the biggest hurdle in cancers like mCRC.
• Targeted Patient Population: The company is specifically targeting the RAS-mutated first-line mCRC population, a significant market opportunity estimated to be valued at $10.95 billion in 2025. They are currently the only company focused on this specific first-line segment.
• Strategic Partnerships and Financial Backing: A key partner, Pfizer, manages the CRDF-004 trial and holds a $15 million equity stake. This partnership provides operational expertise and a strong vote of confidence from a major pharmaceutical player.
• Favorable Clinical Data: The positive Phase 2 data, particularly the 19% ORR improvement in mCRC, gives them a strong negotiating position with regulators and potential commercial partners. That's a meaningful clinical signal.
• Intellectual Property (IP) Protection: They have issued patents protecting their intellectual property in colorectal cancer, extending protection until 2043, which secures the long-term commercial opportunity if the drug is approved.

Cardiff Oncology, Inc. (CRDF) How It Makes Money

Cardiff Oncology, Inc. is a clinical-stage biotechnology company, so it does not generate revenue from the sale of any approved therapeutic products. Instead, the company's limited revenue comes from royalties on older, pre-onvansertib intellectual property licenses and interest earned on its substantial cash reserves, which are primarily funded by equity financing.

Cardiff Oncology's Revenue Breakdown

To be clear, the company's entire revenue base for the third quarter of 2025 was a mere $0.12 million. This is a crucial number because it tells you the business model is almost entirely dependent on successfully advancing its lead drug candidate, onvansertib, through clinical trials. The small revenue stream is not a driver of operations, but a minor offset to massive R&D costs.

The 100% figure for Royalty Revenue in Q3 2025 is based on the reported $120,000 in royalty revenues, which constituted the entire quarterly revenue. This stream is generated from third parties licensing older cancer research technologies developed before the focus shifted to onvansertib. The trend is actually decreasing, with Q3 2025 Royalty Revenue of $120,000 being lower than the $165,000 reported in the same period a year prior. The other potential stream, Interest Income, is variable and often accounts for a portion of the 9-month total revenue of $0.4 million, but was negligible in the most recent quarter.

Business Economics

The economics of a clinical-stage biotech like Cardiff Oncology are simple: spend heavily on research and development (R&D) to create a product that can be sold at a premium later. This is a high-risk, high-reward model. Right now, the company has no product pricing strategy because it has no product approved for sale; its entire economic value is tied to the clinical success of onvansertib in trials like CRDF-004 for RAS-mutated metastatic colorectal cancer (mCRC). If the drug works, the valuation explodes; if it fails, the value is near zero. It's a binary bet.

• Primary Cost Driver: R&D expenses are the lifeblood. For Q3 2025, R&D expenses were $8.2 million, which is over 68 times the total revenue of $0.12 million.
• Cash Burn Rate: The company's net cash used in operating activities for Q3 2025 was approximately $10.8 million. This is the real number you need to watch.
• Future Revenue Model: The long-term plan is to secure regulatory approval for onvansertib, then either commercialize it directly or, more likely, enter into a lucrative licensing or collaboration agreement with a large pharmaceutical partner. That future revenue would be measured in hundreds of millions or billions, making the current royalty revenue negligible.

The core economic fundamental here is the cash runway-how long they can keep the lights on and the trials running without needing more capital. You can find more on the company's strategic goals here: Mission Statement, Vision, & Core Values of Cardiff Oncology, Inc. (CRDF).

Cardiff Oncology's Financial Performance

The financial performance of Cardiff Oncology is best understood through its liquidity and cash burn, not its top-line revenue. The goal is capital preservation while hitting clinical milestones, and they've done a defintely good job managing their runway.

• Cash Position: As of September 30, 2025, the company held approximately $60.6 million in cash, cash equivalents, and short-term investments.
• Cash Runway: Based on their current operating expenses, management projects this cash position provides a financial runway into the first quarter of 2027.
• Net Loss: The company reported a net loss of approximately $11.3 million for the third quarter of 2025. This loss is expected and reflects the cost of running clinical trials, not a failure of the business model.
• Operating Expenses: Total operating expenses for Q3 2025 were about $12.1 million, a slight decrease from the $12.8 million in the same period last year, showing some cost control.
• Liquidity: The balance sheet shows a strong liquidity position, with a current ratio of 4.42, indicating they have ample current assets to cover short-term liabilities. However, the Altman Z-Score of -3.7 signals financial distress, which is common for pre-revenue biotechs but still a risk factor to monitor.

The next concrete action for you is to monitor the Q1 2026 clinical update on the CRDF-004 trial, as that data will be the single largest factor in the company's valuation and long-term financial viability.

Cardiff Oncology, Inc. (CRDF) Market Position & Future Outlook

Cardiff Oncology, Inc. is a clinical-stage biotech company that is currently a high-risk, high-reward proposition, with its future trajectory tied almost entirely to the success of its lead drug candidate, onvansertib, in the first-line RAS-mutated metastatic colorectal cancer (mCRC) market. The company operates with a micro-cap valuation of approximately $143.48 million as of November 14, 2025, positioning it as a niche player aiming for a multi-billion dollar opportunity in an area of high unmet medical need.

Positive Phase 2 data from the CRDF-004 trial, showing a 19% improvement in confirmed objective response rate (ORR) for the 30mg onvansertib arm, suggests a potential breakthrough, but the market awaits the more mature progression-free survival (PFS) data expected in Q1 2026. The company projects full-year 2025 revenue between $76.0 million and $78.0 million, mostly from non-core activities, against operating expenses forecast to be between $90 million and $92 million. That's a tight cash position, so the next clinical update is defintely critical.

Competitive Landscape

In the oncology space, Cardiff Oncology faces competition from both large pharmaceutical companies and other clinical-stage biotechs, but its specific focus on the entire RAS-mutated population with a Polo-like Kinase 1 (PLK1) inhibitor gives it a unique angle. The following table illustrates its relative size against two comparable clinical-stage peers, using market capitalization as a proxy for market standing.

Here's the quick math: Cardiff Oncology is the smallest of this peer group by a significant margin, holding roughly one-tenth of the combined market capitalization of these three clinical-stage firms. This highlights its concentrated risk profile, but also the outsized return potential if onvansertib succeeds. Exploring Cardiff Oncology, Inc. (CRDF) Investor Profile: Who's Buying and Why?

Opportunities & Challenges

The company's strategy is clear: advance onvansertib to a pivotal Phase 3 trial as quickly as possible, leveraging the positive Phase 2 data and the massive market need in mCRC.

Industry Position

Cardiff Oncology's industry standing is defined by its technology and its clinical-stage status. It is a niche, single-asset biotech company focused on PLK1 inhibition, a mechanism designed to overcome treatment resistance in tumors. The company is not a market share leader in the broader oncology field, but it holds a unique and currently uncontested position in the first-line RAS-mutated mCRC segment.

• Micro-Cap Status: With a market cap around $143 million, it's highly sensitive to clinical trial news.
• Cash Runway: Cash and investments of approximately $60.6 million as of September 30, 2025, provide an operational runway into Q1 2027, which is reasonable for its current trial phase.
• Strategic Uniqueness: Its onvansertib is the only drug specifically targeting the entire RAS-mutated mCRC population in the first-line setting.

The company is currently in a waiting pattern; the next action is to prepare for the Q1 2026 data release, which will dictate the path to the pivotal Phase 3 trial and any potential partnership discussions.