By John Vandermosten, CFA
NASDAQ:CRDF
READ THE FULL CRDF REPORT HERE
1Q:26 Financial Results
Cardiff Oncology, Inc. (NASDAQ:CRDF) reported first quarter 2026 financial and operational results in a press release and Form 10-Q filing with the SEC on May 14th, 2026. For the three-month period ending March 31st, 2026 Cardiff reported revenues of $41,000 and operational expense of $12.9 million. Loss per share was $0.18. Operational expenses fell 11% as lower Research and Development (R&D) expenses were partially offset by higher General and Administrative (G&A) expenses. For the quarter ending March 31st, 2026 and versus the same prior quarterly period:
- Revenues of $41,000 compared to $109,000 and represent Cardiff’s sales-based and usage-based royalties on assets unrelated to onvansertib;
- Research and development expenses totaled $6.8 million, down 35% from $10.5 million attributable to a reduction in clinical trial expenses and a decrease in preclinical activities for the CRDF-004 clinical trial;
- Selling, General & Administrative expenses were $6.1 million, up 53% from $4.0 million. Increases relate to employee severance agreements and an increase in stock-based compensation attributable to the modification of stock options. These increases were offset by a decline in Outside Services and Professional Fees and Facilities and Other costs;
- Net interest income of $0.5 million was down compared with prior period amounts due to reduced interest income on lower cash levels and other expense of $1,000 compared to other income of $7,000;
- Net loss was $12.4 million vs. a net loss of $13.4 million or $0.18 and $0.20 per share, respectively.
As of March 31st, 2026, cash, equivalents and short-term investments totaled $46.1 million. This amount compares to the $58.3 million balance in cash held at the end of 2025. Cash burn for 1Q:26 was $12.3 million versus $12.8 million for 1Q:25. Cardiff’s cash is expected to support operating activities until 1Q:27. The company will need to raise additional capital to fund the CRDF-005 Phase III registrational study.
Nerviano Dispute
Earlier this year, Nerviano Medical Sciences sent written notice to Cardiff alleging that it was in a material breach of the onvansertib license agreement between the two. Brief details of the interaction were included in the 2025 Form 10-K. Nerviano attributed the breach to the failure of Cardiff to name a Nerviano employee as joint inventor for US patents 12,144,813 and 12,263,173. Cardiff maintains that there is no breach and that the agreement does not require Cardiff to name Nerviano employees on patents that have been developed exclusively by Cardiff. It seeks injunctive relief requiring Nerviano to continue performing under the agreement and for the court to declare that it did not breach the agreement. Details of the event are in a Form 8-K filed on May 19th, 2026.
The patent licensed by Nerviano has an expiry of May 2030 and it is likely that a full five years of patent term extension (PTE) will be allowed. With the PTE, the effective end of protection is 2035. We believe that the wording in the original license arrangement will be key to the outcome. While we do not provide legal opinions and lack complete visibility into the patents' development, we can point investors to the language in the agreement dated March 13th, 2017 with Cardiff’s predecessor Trovagene. The language states that Trovagene/Cardiff has entire rights to intellectual property it solely develops:
10.2 Ownership of Inventions. Subject to the terms hereof, including the licenses and other rights granted hereunder, all Inventions shall be owned as follows:
- Nerviano shall own the entire right, title and interest in and to all Inventions (including all patents and other intellectual property rights thereto) made solely by its employees or others acting on behalf of Nerviano (or solely by such persons and Third Parties performing work for Nerviano) in the performance of the Development Plan or other activities undertaken under this Agreement (“After-Developed Nerviano Inventions”). All After-Developed Nerviano Inventions will be included in the license and right granted under Article 3 above;
- Trovagene shall own the entire right, title and interest in and to all Inventions (including all patents and other intellectual property rights thereto) made solely by its employees or others acting on behalf of Trovagene (or solely by such persons and Third Parties performing work for Trovagene) in the performance of the Development Plan or other activities undertaken under this Agreement;
(c) The Parties shall jointly own all Joint Inventions (as defined below). Nerviano’s rights in and to each Joint Invention (including all patent rights and other intellectual property rights to it) will be included in the license and rights granted under Article 2 above, and, subject to such license and rights, each Party may make, use, sell, keep, license or assign its interest in Joint Inventions and otherwise undertake all activities a sole owner might undertake with respect to such Joint Inventions, without the consent of and without accounting to the other Party. “Joint Inventions” means Inventions for which it is determined, in accordance with United States patent law, that both: (i) one or more employees, consultants or agents of Nerviano or any other persons obligated to assign such Invention to Nerviano; and (ii) one or more employees, consultants or agents of Trovagene or any other persons obligated to assign such Invention to Trovagene, are joint inventors.
Starting a New Chapter
On January 27th, 2026, the Cardiff board of directors announced that it had appointed a new chief executive officer in an interim role and would seek a new executive team to lead the company. Dr. Mani Mohindru took the reins of the company and was later confirmed as permanent President and CEO as disclosed in an April 9thpress release. Two other executive appointments were concurrently announced in that same release including Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, as Chief Operating Officer.
AACR Poster
Cardiff presented a poster at the 2026 American Association for Cancer Research (AACR) Annual Meeting held in San Diego, California from April 17 to 22. The title of the poster is PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models. It summarized preclinical work that examined the combination of trastuzumab deruxtecan (T-DXd) (Enhertu) with onvansertib and its effect on patient-derived xenograft models. Tumor volumes were measured using monotherapy of T-DXd and onvansertib and the combination of the two compared with a control. The xenograft models consistently showed that the combination therapy limited and even reversed tumor growth.
The poster concluded that onvansertib enhances T-DXd efficacy and overcomes its resistance across triple negative breast cancer (TNBC) and hormone receptor positive (HR+) breast cancer models. The combination induces synergistic DNA damage and apoptosis. The authors claim that PLK1 inhibition offers a strategy to deepen and prolong T-DXd response in advanced HER2-low breast cancer resistant to first-line therapies.
Next Steps for Onvansertib
Following meetings with the FDA, Cardiff has essentially finalized its design of the anticipated Phase III registrational trial for onvansertib in 1H:26. The trial will be designated CRDF-005 and will evaluate 30 mg of onvansertib with FOLFIRI and bevacizumab (bev) vs. the standard of care of FOLFOX/bev and FOLFIRI/bev. In its latest investor presentation, management provided a preliminary trial design that seeks to enroll first line mCRC patients that are KRAS and NRAS positive presenting unresectable tumors. Dual primary endpoints are anticipated to be ORR and PFS with secondary endpoints of DoR and OS. We expect more detail after funding arrangements are clear.
Source: Cardiff May 2026 Corporate Presentation
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