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Here are 1-3 brief analogies to describe Cardiff Oncology (CRDF):

• A clinical-stage Genentech, focused on developing new cancer therapies.
• An early-stage Amgen, entirely dedicated to finding and developing novel oncology drugs.

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• Onvansertib: A PLK1 inhibitor currently in clinical development for various cancers, including KRAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), and small cell lung cancer (SCLC).

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Cardiff Oncology (CRDF) is a clinical-stage biopharmaceutical company focused on developing novel precision therapies for cancer. As a company in the research and development phase, its product candidates are still undergoing clinical trials and have not yet received regulatory approval. Consequently, the company does not have any approved products on the market generating commercial revenue.

Therefore, Cardiff Oncology does not have major customers in the traditional sense of selling products or services to other companies or individuals. Its operations are primarily funded through equity financing, strategic collaborations, and other capital-raising activities, rather than through product sales.

Should any of its drug candidates receive regulatory approval in the future, its revenue streams would typically come from:

• Licensing and Collaboration Agreements: With larger pharmaceutical companies (potential future partners, not current customers) who would commercialize the drug in exchange for upfront payments, milestone payments, and royalties.
• Direct Sales (Post-Approval): To pharmacies, hospitals, and healthcare systems (potential future customers) for prescription to individual patients.

However, these are future potential revenue sources and not current customers for Cardiff Oncology.

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• Catalent, Inc. (CTLT)
• Thermo Fisher Scientific Inc. (TMO)

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Mark Erlander, Ph.D. Chief Executive Officer

Dr. Erlander has served as Chief Executive Officer of Cardiff Oncology since May 2020, and previously as Chief Scientific Officer from March 2013 to May 2020. Prior to joining Cardiff Oncology, he was Chief Scientific Officer at bioTheranostics, a molecular diagnostic testing company and subsidiary of bioMérieux, from 2008 to 2013. From 2000 to 2008, Dr. Erlander was Chief Scientific Officer at Arcturus, Inc. (later AviaraDx), which was acquired by bioMérieux in 2008. He also served as a Group Leader and Research Fellow in drug discovery at Johnson & Johnson from 1994 to 2000. Dr. Erlander holds 44 issued patents and has co-authored over 90 scientific publications.

James Levine Chief Financial Officer

Mr. Levine has served as Chief Financial Officer since 2021. He possesses extensive corporate and investment banking experience with both private and public biotechnology and pharmaceutical companies. Prior to joining Cardiff Oncology, Mr. Levine served as CFO of Cidara Therapeutics, where he was responsible for the financial aspects of collaborations with Janssen Pharmaceuticals and Mundipharma, totaling over $1.3 billion. Earlier in his career, he was President and Chief Executive Officer of Sapphire Energy Inc., a private industrial biotechnology company that was subsequently sold to two private investor groups. Mr. Levine also held positions at Verenium Corp and served as a Managing Director in the investment banking division of Goldman Sachs & Co.

Roger Sidhu, MD Chief Medical Officer

Dr. Sidhu was appointed Chief Medical Officer in June 2025. He is an accomplished drug developer with over 20 years of oncology leadership and clinical experience, having advanced therapeutics from Phase 1 to Phase 3 clinical development and through commercial launch. Dr. Sidhu was most recently Acting CEO and Chief Medical Officer at Treadwell Therapeutics, a privately held biotechnology company. His previous roles include Executive Vice President and Chief Medical Officer at Roivant Sciences, Chief Medical Officer at Eterna Therapeutics, Inc., and Chief Medical Officer at Cell Design Labs, which was acquired by Gilead subsidiary Kite, where he then served as VP, Clinical Development. He also spent nearly a decade at Amgen, where he led multiple phase 3 clinical trials for panitumumab (Vectibix®), leading to its approvals.

Tod Smeal, Ph.D. Chief Scientific Officer

Dr. Smeal has served as Chief Scientific Officer of Cardiff Oncology since January 2022. Prior to this, he was CSO at Hexagon Bio from 2020 to 2021, and Chief Scientific Officer of Cancer Biology at Eli Lilly and Company from 2015 to 2020. He also served as a Director at the Oncology Research Unit of Pfizer from 2003 to 2015, and as a Senior Group Leader at the SUGEN site of Pharmacia and Upjohn and SUGEN from 1998 to 2003.

Brigitte Lindsay Senior Vice President of Finance and Corporate Secretary

Ms. Lindsay has served as Senior Vice President of Finance since 2023 and Corporate Secretary since 2019, having previously been Vice President of Finance from 2019 to 2023 and Controller from 2012 to 2019. She brings extensive biotech experience, including serving as Controller for AviaraDx both before and after its acquisition by bioMérieux. Before AviaraDx, she was Manager of Financial Reporting and Analysis at Carl Zeiss Meditec.

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The key risks to Cardiff Oncology's business are primarily associated with its status as a clinical-stage biotechnology company, its financial sustainability, and the competitive landscape of oncology drug development.

1. Clinical and Regulatory Uncertainty: As a clinical-stage company, Cardiff Oncology's primary drug candidate, onvansertib, faces significant uncertainty regarding its efficacy and safety in future trials, which could prevent FDA approval. Approval processes for new drugs are lengthy, expensive, and challenging to predict. There are no guarantees that ongoing or future clinical trials will be completed successfully, that the product will receive regulatory approval for any indication, or that it will prove commercially successful. Unexpected side effects or safety concerns could lead to trial suspension or discontinuation. This risk is particularly significant as the company's pipeline heavily relies on onvansertib.
2. Need for Additional Financing: Cardiff Oncology currently has no approved products and thus relies heavily on investor funding to support its operations and advance its clinical programs. While the company projects its current cash reserves to fund operations into Q1 2027, advancing into later-stage clinical trials, particularly Phase 3, will significantly increase costs and will likely necessitate additional capital beyond its present resources. The company's consistently negative operating and net margins highlight ongoing operational inefficiencies and profitability challenges, indicating a potential need for future dilutive funding.
3. Market Competition: Cardiff Oncology operates in a highly competitive biotechnology sector, facing significant competition from other companies developing therapies for similar cancer targets. Furthermore, market risks include potential delays in the adoption of its drug, challenges in securing reimbursement, and competitive pressure from other drug classes, such as KRAS inhibitors, which could target a broader range of RAS-mutated cancers.

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The rapid advancement and increasing clinical success of direct KRAS inhibitors, particularly the development of next-generation pan-KRAS inhibitors or highly effective mutation-specific inhibitors beyond G12C (e.g., G12D, G12V), poses a clear emerging threat. While Cardiff Oncology's onvansertib is a PLK1 inhibitor being developed in combination therapies for KRAS-mutated cancers (such as metastatic colorectal cancer), the emergence of highly potent and effective direct KRAS inhibitors, potentially as monotherapies or in simpler combination regimens, could significantly reshape the treatment landscape for these cancers. This could diminish the market opportunity and perceived value of complementary or indirect approaches like PLK1 inhibition if direct KRAS targeting proves to be a more fundamental and effective solution for a broader range of KRAS mutations.

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Cardiff Oncology's primary product is onvansertib, a highly selective Polo-like Kinase 1 (PLK1) inhibitor, currently in clinical development for various cancers, with a significant focus on RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC).

Onvansertib for RAS-mutated Metastatic Colorectal Cancer (mCRC)

• The addressable market for onvansertib in first-line RAS-mutated metastatic colorectal cancer in the U.S. alone is estimated to encompass approximately 63,000 patients annually.
• Analysts project potential annual U.S. sales for onvansertib in this indication to range from $567 million to $3.78 billion.
• The metastatic colorectal cancer market size in the 7 Major Markets (7MM) was approximately $15 billion in 2022. The global market for mCRC was estimated to be around $5.9 billion in 2024 and is projected to grow at a 5.1% Compound Annual Growth Rate (CAGR) until 2034.
• RAS-mutated cancers represent about half of the entire mCRC market. Approximately 150,000 new colorectal cancer patients are diagnosed annually in the U.S.
• Broader estimates for the KRAS inhibitors market, which includes mCRC, in the 7MM were approximately $500 million in 2023, with significant growth expected by 2034. In 2023, the United States had approximately 151,000 cases of KRAS mutant colorectal cancer.
• Some analysts project peak sales for onvansertib across its indications (likely significant portion from mCRC) to be between $2 billion and $3 billion annually.

Onvansertib for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

• The global pancreatic cancer market size is projected to grow at an approximately 18% CAGR between 2024 and 2036, reaching an estimated revenue of $36 billion by the end of 2036, up from approximately $6 billion in 2023.
• North America is expected to account for the largest revenue in the pancreatic cancer market.
• KRAS mutations are found in about 60-90% of pancreatic cancer patients, highlighting a significant target population for onvansertib.

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Expected Drivers of Future Revenue Growth for Cardiff Oncology (CRDF) over the Next 2-3 Years

Cardiff Oncology (CRDF) is a clinical-stage biotechnology company primarily focused on developing novel therapies for various cancers, with its lead drug candidate being onvansertib. Over the next 2-3 years, the company's revenue growth is anticipated to be driven by the following factors:

1. Regulatory Approval and Commercialization of Onvansertib for First-Line RAS-mutated Metastatic Colorectal Cancer (mCRC): The most significant driver of future revenue growth is the successful clinical development, regulatory approval, and subsequent commercial launch of onvansertib for the first-line treatment of RAS-mutated metastatic colorectal cancer. The Phase 2 CRDF-004 trial has shown encouraging results, with the 30mg dosage demonstrating a 19% improvement in confirmed objective response rate (ORR) compared to standard of care alone. Upcoming clinical updates in early 2026 are expected to provide further insights into onvansertib's efficacy and tolerability. Analysts have indicated that if approved, onvansertib could achieve blockbuster status with annual sales potentially ranging from $1.2 billion to $2.5 billion in the RAS-mutant mCRC market.
2. Expansion of Onvansertib into Additional Cancer Indications: Beyond mCRC, Cardiff Oncology is also pursuing the development of onvansertib in other indications through investigator-initiated trials. These include metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC). Positive data and progression in these additional cancer types could significantly broaden the market opportunity for onvansertib and contribute to new revenue streams.
3. Strategic Partnerships and Licensing Agreements: As a clinical-stage biotechnology company, Cardiff Oncology may generate revenue through strategic partnerships and licensing agreements for onvansertib. Such collaborations could involve upfront payments, milestone payments tied to clinical and regulatory achievements, and royalties on future sales, particularly as the drug progresses through later stages of development and toward potential commercialization. Speculation around future partnerships has been mentioned as a potential positive catalyst for the company.

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Share Issuance

• In 2024, Cardiff Oncology successfully raised $40 million through an oversubscribed underwritten registered direct offering.
• The company's outstanding shares increased from approximately 44.7 million as of February 22, 2024 to 66.5 million shares currently, reflecting capital raises to fund operations.

Inbound Investments

• Cardiff Oncology expanded its relationship with Pfizer, focusing on shifting its lead RAS-mutated metastatic colorectal cancer (mCRC) program to a first-line setting.

Capital Expenditures

• Capital expenditures were approximately $0.04 million in 2024, $0.08 million in 2023, $0.58 million in 2022, $1.01 million in 2021, and $0.21 million in 2020.
• As a clinical-stage biotechnology company, these expenditures are primarily focused on supporting its research and development activities and advancing its clinical trial programs for its lead asset, onvansertib.