Hook & thesis
Cardiff Oncology is a classic small-cap clinical-stage gamble: almost no commercial revenue, recurring quarterly losses, but a clinical program that—if it produces convincing Phase 2/registration-enabling data—could justify a meaningful re-rating. At today's price (~$2.79 on 01/13/2026) the market is valuing the equity at roughly $187 million. That implies an enterprise value materially below a typical biotech valuation for mid-stage oncology assets once you account for the cash on the balance sheet.
My baseline thesis is measured enthusiasm: this is a high-risk, event-driven long where position size should reflect the binary nature of clinical readouts. The company has cash (see below) to fund near-term work and investor visibility through presentations, but readouts in 2026 are the primary value drivers. Buy selectively into weakness; respect a tight stop and plan exits around data dates.
What the company does and why the market should care
Cardiff Oncology is a clinical-stage biotechnology company developing PLK1 inhibitors, led by onvansertib, targeting indications with high unmet need such as RAS-mutated metastatic colorectal cancer (mCRC) and investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). PLK1 inhibition is a well-validated mechanism in oncology and the company is positioning onvansertib where KRAS-driven disease biology suggests potential leverage.
The market cares for two straightforward reasons: (1) the RAS/KRAS landscape is expanding rapidly and KRAS-directed strategies are in vogue—growth projections for the KRAS inhibitors category are robust—and (2) onvansertib sits in combination/regimen niches where positive clinical data can trigger partner interest or accelerated development paths. For a small company, a single binary clinical outcome can change valuation multiples dramatically.
Hard numbers that matter
- Price: $2.79 per share (last trade snapshot 01/13/2026).
- Shares (diluted average, most recent quarter): 66,879,000 shares reported in the quarter ended 09/30/2025.
- Implied market cap: approximately $187 million (price times diluted shares).
- Cash on balance sheet (09/30/2025): $60.6 million.
- Quarterly operating cash burn (net cash from operating activities for Q3 2025): -$10.834 million; recent quarters show similar negative operating cash flow (-$12.794m in earlier quarter; -$8.328m in another), so a reasonable working average burn is roughly $10.5m per quarter.
- Runway: cash of $60.6m / ~ $10.8m/qtr burn implies approximately 5.6 quarters of runway as of 09/30/2025 - roughly 14 months. That places a liquidity cliff into late 2026 unless the company reduces spend, raises additional capital, or receives partner funding.
- Recent quarterly performance: Q3 FY2025 showed revenues of $120,000 (nominal) and net loss of ~$11.258 million. Operating expenses were $12.094 million in the same quarter.
These numbers paint the typical clinical-stage picture: minimal revenue, predictable cash burn and reliance on capital markets or partnerships to extend runway beyond the next 12-18 months.
Valuation framing - why today's price has room to move
The market cap (~$187m) minus cash ($60.6m) gives an enterprise value near $126m. For a pre-commercial oncology company with a differentiated mechanistic hypothesis and some positive early signals, that EV is modest compared with deals or market values we see when programs show convincing efficacy or when larger partners step in. The stock historically has reached multi-dollar levels; recent price history shows prior intraday highs near $4.99 in late 2024 and spikes above $4 in 2025. A successful Ph2 readout could rapidly re-rate the shares toward prior highs and beyond; a failed readout, conversely, could halve the market cap or worse.
Because there are no meaningful commercial revenues to justify discounted cash flow models, valuation is event-driven. Compare qualitatively to other small oncology names that traded at EVs of many hundreds of millions after positive mid-stage data: the optionality is asymmetric but the probability of success is low—hence the 'measured' part of the thesis.
Catalysts to watch (most relevant for 2026)
- Clinical readouts from the RAS-mutated mCRC program - primary value driver if timing occurs in 2026.
- Investigator-initiated trial updates in mPDAC, SCLC or TNBC that could broaden the clinical utility.
- Investor conferences and company presentations (recently at Piper Sandler on 11/24/2025) that improve investor visibility and shape expectations.
- Business development activity or partnership announcements - a licensing deal would likely be a material positive.
- Financing moves - registered offerings or direct placements (company priced a $40m RDO in 12/10/2024) that affect dilution and runway.
Concrete trade idea - entry, stops, targets
Trade direction: Long (event-driven swing).
Entry: $2.40 - $3.00. Prefer to scale in: initiate 50% of intended position near the lower half of this band and add into the remainder on confirmation of constructive clinical updates or volume-backed price strength.
Stop-loss: $1.80. A break below $1.80 (roughly ~35% below current) signals either accelerating selling, clinical disappointment priced in, or a broader risk-off move that I want stopped out of. Keep position sizing small enough that a stop at $1.80 represents an acceptable portfolio loss.
Targets:
- Target 1 (near-term/swing): $5.00 - corresponds to a move back toward multi-dollar levels and prior intraday highs; reasonable if interim data or positive presentations improve sentiment.
- Target 2 (event-driven stretch): $8.00 - achievable only with clear positive mid-stage efficacy, a partnering announcement or accelerated pathway; treat this as a high-upside but lower-probability outcome.
Position sizing note: This is a high-risk biotech. Consider limiting exposure to a small percentage of speculative capital (e.g., 1-3% of total portfolio) unless you can tolerate full loss of capital.
Risks (at least four + a counterargument)
- Binary clinical risk - if onvansertib fails to demonstrate meaningful response rates or safety in target indications, the stock will likely decline sharply.
- Cash runway / dilution - $60.6m cash as of 09/30/2025 and an operating burn of ~ $10.8m per quarter implies ~14 months of runway. The company may need to raise capital in 2026, which could dilute shareholders or depress the stock on announcement.
- Competition and shifting standards - the KRAS/oncology landscape is evolving quickly. Newer modalities or combinations could reduce the attractiveness of PLK1 pathways or limit commercial potential.
- Regulatory and execution risk - clinical trial execution, enrollment delays, or regulatory setbacks can push timelines and increase cash needs.
- Market volatility - small-cap biotechs trade with high volatility and can experience severe moves unrelated to fundamentals (e.g., broader risk-off, sector rotations).
Counterargument to the thesis: One could reasonably argue that the company is adequately priced for success already—some of the optimism around KRAS and RAS-directed strategies is priced into small biotech valuations, and any meaningful funding dilution in 2026 could offset good clinical data by expanding the share base. In other words, upside may be limited unless data are unequivocally strong or a partner offers a robust, non-dilutive deal.
What would change my mind
I would increase conviction if the company (a) reports clear, statistically robust efficacy signals from the RAS-mutated mCRC program in 2026; (b) announces a strategic partnership or non-dilutive funding that materially extends runway beyond 18 months; or (c) demonstrates a clear path toward registration with compelling safety/efficacy and supportive regulatory feedback. Conversely, a missed primary endpoint, a material acceleration of cash burn without commensurate progress, or a dilutive financing that appears necessary to survive the next 6-9 months would cause me to exit and reassess.
Final thoughts
Cardiff Oncology is a textbook speculative biotech play: modest EV after considering cash, meaningful optionality if clinical readouts are positive, and material downside if they are not. For traders who can stomach binary outcomes, the stock offers an asymmetric bet if entered at the right price with tight risk controls. For patient investors, stay oriented to data milestones and M&A/partnering news—those are the events that will determine whether measured enthusiasm converts into outsized returns or an expensive lesson.
Disclosure: This is an actionable trade idea, not personalized investment advice. Size positions to your risk tolerance and consider consulting a licensed financial professional before acting.