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1. Company Snapshot

1.a. Company Description

Cardiff Oncology, Inc., a clinical-stage oncology company, develops medicine treatment for cancer patients in California.Its lead drug candidate is onvansertib, an oral selective Polo-like Kinase 1 Inhibitor for anti-cancer therapeutics; CY140, an inhibitor of PLK1, PLK2, and PLK3 that is in phase 1/2 studies in solid tumors and leukemias; metastatic colorectal cancer that is in clinical trials; and TROV-054 is a Phase 1b/2 for FOLFIRI and bevacizumab.The company's TROV-053 is also in Phase II clinical trial in combination with Zytiga for metastatic castration-resistant prostate cancer.


The company primarily serves pharmaceutical manufacturers.The company was formerly known as Trovagene, Inc.and changed its name to Cardiff Oncology, Inc.


in May 2012.Cardiff Oncology, Inc.was incorporated in 1999 and is headquartered in San Diego, California.

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1.b. Last Insights on CRDF

The recent 3-month performance of Cardiff Oncology, Inc. was negatively driven by a quarterly loss of $0.20 per share, exceeding the Zacks Consensus Estimate of a loss of $0.19. This underperformance was partly due to escalating clinical trial costs and potential regulatory hurdles for its lead program, onvansertib. Additionally, the company's cash and investments of $79.9 million as of March 31, 2025, while sufficient to operate until Q1 2027, may pose funding challenges by 2026, potentially impacting the company's growth prospects.

1.c. Company Highlights

2. Cardiff Oncology's Q4 2024 Earnings Highlight Strong Cash Position and Clinical Progress Amidst Challenging Valuation

Cardiff Oncology reported a strong financial position in its Q4 2024 earnings, with $91.7 million in cash and short-term investments as of December 31, 2024. This includes net proceeds from a $40 million capital raise, which was supported by encouraging initial data from its CRDF-004 trial. The company's cash runway is now expected to extend into the first quarter of 2027, providing ample liquidity to advance its clinical programs. However, the company remains pre-revenue, and analysts estimate a significant decline in next year's revenues, with a projected growth rate of -64.0%. This reflects the ongoing developmental stage of the company as it focuses on advancing its pipeline rather than generating immediate sales. As CEO Mark Vignhetto noted during the earnings call, "Our focus remains on executing our clinical strategy and unlocking the full potential of onvansertib."

Publication Date: Mar -09

📋 Highlights
  • Positive CRDF-004 Trial Data:: Cardiff Oncology reported a 64% overall response rate (ORR) in the 30 mg onvansertib arm of its CRDF-004 trial for first-line RAS-mutated mCRC, significantly outperforming the 33% ORR in the control arm. This data supports the potential of onvansertib in combination with standard-of-care regimens.
  • Successful Capital Raise and Enrollment Progress:: The company completed a $40 million capital raise following the positive trial data. Enrollment for the CRDF-004 trial is nearing completion, with expectations to finalize enrollment in the next few weeks and present additional clinical data in H1 2025.
  • Strengthened Intellectual Property:: A new patent was issued covering the use of onvansertib with bevacizumab for KRAS-mutated mCRC patients, expiring no earlier than 2043. This enhances the drug's market exclusivity and underscores its unique combination potential.
  • Promising Preclinical Data in Breast Cancer:: Cardiff Oncology presented preclinical data demonstrating onvansertib's potential in combination with paclitaxel and ENHERTU for HR-positive breast cancer, expanding its therapeutic potential beyond colorectal cancer.
  • Strong Financial Position:: The company reported $91.7 million in cash and short-term investments, with a cash runway extending into Q1 2027. A shelf registration statement was filed to replace the expiring S-3, with no shares issued, maintaining financial flexibility.

Clinical Progress and Pipeline Momentum

Cardiff Oncology's Q4 update was headlined by the promising results from its CRDF-004 trial, a randomized Phase 2 study evaluating onvansertib in combination with standard-of-care regimens for first-line RAS-mutated metastatic colorectal cancer (mCRC). The data showed a 64% overall response rate (ORR) in the 30 mg onvansertib arm compared to 33% in the control arm, with deeper tumor responses observed in the higher-dose group. Enrollment for the trial is nearing completion, with expectations to finalize enrollment in the next few weeks. The company plans to present additional clinical data in the first half of 2025, which could serve as a key catalyst for the stock.

Intellectual Property and Preclinical Data

Beyond the clinical updates, Cardiff Oncology highlighted its intellectual property strategy, with a new patent issued in Q4 2024 covering the use of onvansertib in combination with bevacizumab for KRAS-mutated mCRC patients. The patent, which expires no earlier than 2043, underscores the drug's unique synergy with bevacizumab and strengthens the company's competitive position. Additionally, Cardiff presented promising preclinical data at the San Antonio Breast Cancer Symposium, demonstrating onvansertib's potential in combination with paclitaxel and ENHERTU for HR-positive breast cancer. This diversification of the pipeline highlights the company's efforts to explore additional indications and broaden the drug's market potential.

Investment Considerations and Valuation Analysis

From a valuation perspective, Cardiff Oncology's stock continues to reflect the high-risk, high-reward nature of its clinical-stage pipeline. The company's price-to-sales ratio of 374.93 and enterprise value over EBITDA of -4.28 highlight the significant premium investors are placing on its potential future revenues. The negative return on invested capital (ROIC) of -57.67% and return on equity (ROE) of -73.98% further underscore the challenges of investing in a pre-revenue biotech company. However, the company's strong cash position and promising clinical data may justify the valuation for investors willing to take on the risk. As the company approaches key milestones, including the completion of enrollment in the CRDF-004 trial and the presentation of additional data in 2025, the stock could experience significant volatility based on the outcome of these events.

3. NewsRoom

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Cardiff Oncology, Inc. (NASDAQ:CRDF) Receives $10.63 Average Price Target from Analysts

Nov -25

Source: defenseworld.net

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Cardiff Oncology to Present at the Piper Sandler 37th Annual Healthcare Conference

Nov -24

Source: globenewswire.com

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Cardiff Oncology Reports Third Quarter 2025 Results and Provides Business Update

Nov -06

Source: globenewswire.com

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Cardiff Oncology to Participate in Two Upcoming Investor Conferences

Nov -04

Source: globenewswire.com

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Cardiff Oncology: Preparing For A Defining 2026

Oct -25

Source: seekingalpha.com

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Cardiff Oncology's Promising Cancer Breakthrough Ahead - Why I Choose To Buy

Oct -22

Source: seekingalpha.com

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Cardiff Oncology to Participate in Two Upcoming Investor Conferences

Oct -02

Source: globenewswire.com

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Cardiff Oncology to Participate in Three Upcoming Investor Conferences

Aug -28

Source: globenewswire.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (0.00%)

6. Segments

Novel Therapies for Cancers

Expected Growth: 15.4%

Growing demand for innovative cancer treatments, increasing adoption of CAR-T cell therapy and gene editing, and rising prevalence of cancer cases drive the growth of novel therapies market.

7. Detailed Products

Onvansertib

Onvansertib is a small molecule inhibitor of the Polo-like kinase 1 (PLK1) enzyme, which is involved in the regulation of cell division and is often overexpressed in cancer cells.

Onvansertib + Low-Dose Cytarabine

Combination therapy of Onvansertib with low-dose cytarabine, a chemotherapy medication, for the treatment of AML.

Onvansertib + Nab-Paclitaxel

Combination therapy of Onvansertib with nab-paclitaxel, a chemotherapy medication, for the treatment of metastatic breast cancer.

Onvansertib + Gemcitabine

Combination therapy of Onvansertib with gemcitabine, a chemotherapy medication, for the treatment of metastatic pancreatic cancer.

8. Cardiff Oncology, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Cardiff Oncology, Inc. has a moderate threat of substitutes due to the availability of alternative cancer treatments.

Bargaining Power Of Customers

Cardiff Oncology, Inc. has a low bargaining power of customers due to the lack of negotiating power of individual patients.

Bargaining Power Of Suppliers

Cardiff Oncology, Inc. has a moderate bargaining power of suppliers due to the presence of multiple suppliers of raw materials.

Threat Of New Entrants

Cardiff Oncology, Inc. has a high threat of new entrants due to the growing demand for cancer treatments and the presence of new biotech companies.

Intensity Of Rivalry

Cardiff Oncology, Inc. operates in a highly competitive industry with many established players, leading to a high intensity of rivalry.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 2.99%
Debt Cost 3.95%
Equity Weight 97.01%
Equity Cost 14.02%
WACC 13.72%
Leverage 3.08%

11. Quality Control: Cardiff Oncology, Inc. passed 5 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

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Xeris Biopharma

A-Score: 5.2/10

Value: 6.2

Growth: 7.1

Quality: 5.4

Yield: 0.0

Momentum: 10.0

Volatility: 2.7

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Assembly Biosciences

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Value: 6.2

Growth: 3.8

Quality: 4.6

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Actinium Pharmaceuticals

A-Score: 3.7/10

Value: 6.8

Growth: 5.9

Quality: 3.1

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Clearside Biomedical

A-Score: 3.3/10

Value: 8.4

Growth: 3.6

Quality: 6.1

Yield: 0.0

Momentum: 0.5

Volatility: 1.0

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Cardiff Oncology

A-Score: 3.1/10

Value: 6.6

Growth: 4.1

Quality: 4.6

Yield: 0.0

Momentum: 2.5

Volatility: 0.7

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OmniAb

A-Score: 2.7/10

Value: 7.7

Growth: 1.6

Quality: 4.6

Yield: 0.0

Momentum: 0.0

Volatility: 2.3

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

2.11$

Current Price

2.11$

Potential

-0.00%

Expected Cash-Flows