Cardiff Oncology, Inc.
CRDF evidence brief
What we can confirm
- BioSniper Score:
- 7.2 / 10
- Market Cap:
- $94.1M
- Lead Asset:
- Onvansertib (Onv) (Phase 2)
What it means
What to watch
Prepared research question
What matters most for CRDF—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · CRDF
Cardiff Oncology is a clinical-stage biotechnology company developing onvansertib, an oral PLK1 inhibitor, for RAS-mutated metastatic colorectal cancer and other solid tumors, with a planned registrational trial in first-line RAS-mutated mCRC expected to begin in Q1 2027 subject to additional financing.
Key risk: Capital insufficiency
BioSniper Score
Based on 4 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 3 clinical trials for Cardiff Oncology, Inc..
Cardiff Oncology is a clinical-stage biotechnology company developing onvansertib, an oral PLK1 inhibitor, for RAS-mutated metastatic colorectal cancer and other solid tumors, with a planned registrational trial in first-line RAS-mutated mCRC expected to begin in Q1 2027 subject to additional financing.
- Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition to develop onvansertib, an oral and highly selective PLK1 inhibitor, for cancers with unmet medical need [sec_mda · as of 2026-02-24].
- Positive Phase 2 CRDF-004 data presented at ASCO support advancement of 30 mg onvansertib plus FOLFIRI/bevacizumab into a planned registrational program for first-line RAS-mutated mCRC [news · published 2026-08-11].
- Following a successful End-of-Phase 2 meeting with the FDA, the company aligned on key elements of a registrational trial and plans to initiate the study in Q1 2027, subject to securing additional financing [news · published 2026-08-11].
- As of June 30, 2026, the company reported cash & equivalents of $9.2M, total revenue of $0.1M, net income of -$9.2M, and shareholders' equity of $26.5M [sec].
- The company completed a $10 million Registered Direct offering in August 2026 to extend cash runway [news · published 2026-08-11].
What works
- Onvansertib has a well-validated oncology drug target (PLK1) and has shown positive Phase 2 data in first-line RAS-mutated mCRC, with results presented in an oral session at ASCO [news · published 2026-08-11].
- The company has secured FDA alignment on key elements of a registrational trial design for onvansertib in first-line RAS-mutated mCRC, de-risking the path to a pivotal study [news · published 2026-08-11].
- A U.S. patent (No. 12,144,813) covering the method of using onvansertib in combination with bevacizumab for KRAS-mutated mCRC has an expected expiration date no earlier than 2043, providing long-term intellectual property protection [sec · filed 2025-04-29].
What to weigh
- The company has incurred net losses since inception and has negative operating cash flows; as of March 31, 2026, it had $46.1 million in cash, cash equivalents and short-term investments, which is only sufficient to fund operations into the first quarter of 2027 [sec_mda · as of 2026-05-14].
- The planned registrational trial initiation in Q1 2027 is subject to securing additional financing, and the company's current capital resources are not sufficient to meet funding requirements for at least the next 12 months [news · published 2026-08-11] [sec_mda · as of 2026-05-14].
- Drug development efforts are in early stages with high risk of completion due to uncertainties in clinical testing, regulatory approval cycles, and the need for additional capital [sec_mda · as of 2026-08-11].
From the filings
Quoted directly from source documents.
Positive Phase 2 CRDF-004 data support advancement into registrational program
“Positive Phase 2 CRDF-004 data presented in an oral session at ASCO support advancement of 30 mg onvansertib plus FOLFIRI/bevacizumab into planned registrational program for first-line RAS-mutated mCRC”
News · August 11, 2026
FDA alignment on registrational trial design
“Following successful End-of-Phase 2 meeting with FDA, Company aligned on key elements of registrational trial; plans to initiate study in Q1 2027, subject to securing additional financing”
News · August 11, 2026
Cash runway extends into Q1 2027
“Completed $10 million Registered Direct offering, extending cash runway”
News · August 11, 2026
Patent protection until at least 2043 for key combination
“the United States Patent and Trademark Office (USPTO) issued patient No. 12,144,813 which has an expected expiration date of no earlier than 2043”
SEC filings · April 29, 2025
Catalyst timeline
- 2023-04-04 · Phase 1 start for onvansertib in CMML and MDS/MPN overlap neoplasms — Phase 1 study to determine safety and efficacy in patients with proliferative CMML and MDS/MPN overlap neoplasms.
- 2024-02-27 · Phase 2 start for onvansertib in first-line RAS-mutated mCRC — Randomized, open-label study of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab.
- 2025-12-22 · Phase 3 start for zipalertinib (not onvansertib) — This is a Phase 3 study for a different drug (zipalertinib), not onvansertib; relevance to Cardiff Oncology is indirect.
Risks & what to watch (4)›
Key risks
- Capital insufficiency — Cash runway only into Q1 2027; registrational trial initiation subject to additional financing [sec_mda · as of 2026-05-14] [news · published 2026-08-11]
- Clinical development risk — Drug development is early-stage with high uncertainty in trial completion, regulatory approval, and commercialization [sec_mda · as of 2026-08-11]
- Reliance on single drug candidate — Pipeline is heavily dependent on onvansertib; failure in registrational trial would significantly impact the company [pipeline]
- Competitive landscape — Multiple competitors in RAS-mutated mCRC and CMML, including larger institutions with greater resources [pipeline]
What to watch
- Initiation of the registrational trial for onvansertib in first-line RAS-mutated mCRC, expected in Q1 2027 subject to financing [news · published 2026-08-11]
- Ability to secure additional capital to fund the registrational program and extend cash runway beyond Q1 2027 [news · published 2026-08-11]
- Updates from the Phase 2 investigator-initiated trials in mPDAC, SCLC, mTNBC, and CMML [sec_mda · as of 2026-02-24]
- FDA feedback and regulatory milestones related to the planned Phase 3 registrational trial [news · published 2026-08-11]
Sources: Catalysts · News · Pipeline · SEC filings · SEC MD&A · Generated September 24, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.41 · 0% dilution
Lead: Phase 2
1 candidate
No upcoming catalysts tracked
4 buys · 0 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
115
Total value held
$39.4M
| Holder | Shares | Value |
|---|---|---|
| blackrock, inc. | 3,981,387 | $6.4M |
| vanguard capital management llc | 2,855,966 | $4.6M |
| laurion capital management lp | 2,646,738 | $4.3M |
| pfizer inc | 2,411,575 | $3.7M |
| acorn capital advisors, llc | 1,762,084 | $2.9M |
| geode capital management, llc | 1,599,663 | $2.6M |
| franklin resources inc | 1,205,803 | $2.0M |
| state street corp | 1,186,947 | $1.9M |
| blair william & co/il | 922,407 | $1.5M |
| flputnam investment management co | 595,127 | $964K |
Showing top 10 of 115 institutional holders of Cardiff Oncology, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 27.5%
- Days to cover
- 25.5
- Shares short
- 18,374,168
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CRDF short interestGovernance
Frequently asked questions
What is the AI investment thesis for Cardiff Oncology, Inc.?
Cardiff Oncology is a clinical-stage biotechnology company developing onvansertib, an oral PLK1 inhibitor, for RAS-mutated metastatic colorectal cancer and other solid tumors, with a planned registrational trial in first-line RAS-mutated mCRC expected to begin in Q1 2027 subject to additional financing.
What is Cardiff Oncology, Inc.'s lead drug candidate?
Cardiff Oncology, Inc.'s most advanced tracked candidate is Onvansertib (Onv) (Phase 2) for Metastatic Colorectal Cancer; Recurrent Chronic Myelomonocytic Leukemia.
Who is the CEO of Cardiff Oncology, Inc.?
Dr. Mani Mohindru Ph.D. is the chief executive officer of Cardiff Oncology, Inc. (CRDF).
Where is Cardiff Oncology, Inc. headquartered?
Cardiff Oncology, Inc. (CRDF) is headquartered in San Diego, CA, United States.
What therapeutic areas does Cardiff Oncology, Inc. focus on?
Cardiff Oncology, Inc. develops therapies across Oncology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.