Cardiff Oncology, Inc. (CRDF)·Q4 2024 Earnings Summary

Executive Summary

• Robust interim efficacy signal in first‑line RAS‑mutated mCRC: 64% ORR at the 30mg onvansertib dose vs 33% control; clear dose‑response and deeper tumor regressions supported the December financing and registrational plans .
• Strengthened balance sheet and runway: $91.7M cash + short‑term investments at 12/31/24 and runway projected into Q1 2027; oversubscribed $40M offering priced at $2.60 per share in December .
• Q4 operating cash burn ~$10.3M, consistent with typical quarterly burn; full‑year net cash used in operations rose to $37.7M from $30.9M YoY .
• Near‑term catalyst: additional CRDF‑004 clinical data (more mature ORR dataset) planned in 1H 2025; PFS readout expected later (too early in 1H) .
• Regulatory pathway confidence: Management cites Pfizer’s BREAKWATER as validation for an ORR‑based accelerated approval followed by PFS for full approval; CRDF’s observed ORR delta aligns with that precedent .

What Went Well and What Went Wrong

What Went Well

• Efficacy signal and dose‑response: “Patients on the 30mg onvansertib dose arm demonstrated a 64% response rate, compared to a 33% response rate in the control arm… deeper tumor regression compared to the 20mg dose” .
• Operational progress: Trial closed to new screening with enrollment completion expected within weeks; ~60 patients had been dosed by December, setting up a more mature update in 1H 2025 .
• Capital and IP: $40M oversubscribed financing and issuance of a new patent (expected expiry ≥2043) covering bev‑naïve KRAS‑mut mCRC treated with onvansertib + bevacizumab .

What Went Wrong

• Elevated cash usage: FY24 net cash used in operating activities increased to ~$37.7M from ~$30.9M in FY23, reflecting higher clinical spend and staffing .
• Net loss widened: FY24 net loss of $45.4M vs $41.4M in FY23; quarterly royalty revenue remains de minimis (Q4 ~$0.151M) .
• PFS timing pushed: Management indicated PFS curves will be too immature for 1H 2025; investors must wait for durability endpoints beyond the near‑term ORR update .

Financial Results

Note: Q4 figures derived from FY24 minus 9M24 where quarterly disclosures were not provided; all inputs from company filings/press releases .

Segment breakdown: Not applicable (no operating segments disclosed) .

KPIs (Clinical/Operational)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Patients on the 30mg onvansertib dose arm demonstrated a 64% response rate, compared to a 33% response rate in the control arm… increased ORR and deeper tumor regression compared to the 20mg dose… similar safety profiles for both doses.” — CEO Mark Erlander .
• “Cash and short‑term investments as of December 31, 2024, totaled $91.7 million… cash used in operating activities was $10.3 million in Q4 2024… runway into the first quarter of 2027.” — CFO James Levine .
• “Pfizer’s BREAKWATER… accelerated approval using ORR… same as our registrational plans agreed with FDA… reinforces the validity of our strategy.” — CEO Mark Erlander .
• “We closed the trial to new patients entering screening… anticipate complete enrollment in the next few weeks.” — CEO Mark Erlander .

Q&A Highlights

• Timing and maturity of next data: Company targets a more mature ORR update in 1H 2025; PFS likely too early in 1H, expected later .
• Dose selection and registrational cadence: Intends to meet FDA expeditiously to decide 30mg vs 20mg and finalize the 005 registrational design; may proceed without all 90 if signal is clear .
• Benchmarking ORR delta: BREAKWATER’s ORR 61% vs 40% seen as consistent with CRDF‑004 interim 64% vs 33% .
• Enrollment scope for update: Enrollment near completion; goal is a substantive, more mature dataset (not necessarily all 90 evaluable) in 1H 2025 .

Estimates Context

• Wall Street consensus (EPS and revenue) for Q4 2024 was unavailable due to S&P Global access limits during retrieval. As a result, we cannot assess beat/miss vs consensus at this time; we will update once SPGI data is accessible [GetEstimates error].

Key Takeaways for Investors

• The interim ORR and dose‑response at 30mg, coupled with favorable tolerability, are supportive of an ORR‑based accelerated approval pathway and constitute the primary near‑term stock catalyst; watch for 1H 2025 update timing .
• Runway extended into Q1 2027 following the $40M raise; supports execution through registrational planning and additional readouts without immediate financing overhang .
• Expect dose selection and registrational trial design clarity after upcoming FDA interactions; a 30mg selection would align with deeper regressions and higher ORR signal .
• PFS/OS durability remains the key medium‑term question; management flags PFS immaturity in H1—set expectations for ORR‑led narrative near term and durability later .
• Clinical/news flow breadth (breast cancer posters, IP expansion) increases optionality but the stock is likely to trade primarily on mCRC first‑line outcomes and regulatory path .
• Quarterly financials remain R&D‑heavy with minimal royalty revenue and recurring net losses; monitor cash burn (~$10.3M in Q4) vs runway and trial milestones .
• Absence of consensus estimates limits immediate beat/miss framing; focus on qualitative strength of efficacy signal and FDA alignment to gauge sentiment into the 1H readout .

Appendix: Prior Quarter References

• Q3 2024 press release (financials, runway into Q1 2026; initial CRDF‑004 readout by year‑end) .
• Q2 2024 8‑K press release (financials; runway through Q3 2025; 33 sites active; initial readout expected 2H 2024) .
• Dec 10, 2024 interim data press release (first 30 evaluable: ORR 64% at 30mg vs 33% control) .
• Dec 10, 2024 financing press release ($40M offering; pricing details) .
• Feb 27, 2025 8‑K and earnings press release with FY financials and runway .
• Q4 2024 earnings call transcript (registrational path; enrollment close; cash burn; 1H data timing; BREAKWATER precedent) .