Name: Cardiff Oncology, Inc. Q1 2019 Earnings Call
Start: 2019-05-08T00:00:00.000Z

Executive Summary

Trovagene (now Cardiff Oncology) reported Q1 2019 total revenues of $0.162M and net loss per share of $1.02; operating expenses fell YoY on lower SG&A, offset by higher R&D .
No earnings call was held; the company issued its Q1 release “in lieu of conducting a conference call,” limiting real-time guidance commentary and Q&A .
Clinical execution was the quarter’s clear positive: updated AML data showed 50% complete responses at higher dose levels and early activity in mCRPC patients resistant to Zytiga®; mCRC trial funding and FDA “study may proceed” were secured .
Corporate actions and liquidity improved optics: a 1-for-6 reverse split restored Nasdaq compliance and ~$3.0M was raised via warrant exercises; quarter-end cash was ~$11.3M .

What Went Well and What Went Wrong

“We achieved a critical milestone in our ongoing Phase 1b/2 trial in AML, with a complete response (2 CR’s and 1 CRi) in 3 of 6 (50%) evaluable patients at the highest doses…” — Dr. Thomas Adams, CEO .
Early mCRPC signal: PSA responses observed in 2 of 6 patients with AR‑V7 resistance; a patient achieved the primary efficacy endpoint of disease stabilization .
Trial funding and regulatory progress: FDA “study may proceed” for mCRC and agreement with PoC Capital to fund the trial .

No earnings call, limiting color on outlook and investor Q&A .
Cash burn from operations increased YoY to $(3.36)M (vs $(2.86)M), reflecting clinical ramp despite SG&A reductions .
Continued net losses: Q1 net loss was $(3.905)M and net loss per share $(1.02), with R&D rising to support trials .

Metric	Q3 2018	Q4 2018	Q1 2019
Total Revenues ($USD Thousands)	88	78	162
Loss from Operations ($USD Thousands)	(3,855)	(4,104)	(3,962)
Total Operating Expenses ($USD Thousands)	3,943	4,182	4,124
Net Loss ($USD Thousands)	(3,769)	(4,159)	(3,905)
Net Loss per Share ($USD)	(0.18)	(1.09)	(1.02)
Weighted Avg Diluted Shares (Thousands)	20,623	3,832	4,087

Segment revenue breakdown:

Revenue Component ($USD Thousands)	Q3 2018	Q4 2018	Q1 2019
Royalties	73	76	62
Services and Other	15 (diagnostic + clinical research)	2 (services)	100 (services and other)
Total	88	78	162

Margins (calculated):

Metric	Q3 2018	Q4 2018	Q1 2019
Gross Profit ($USD Thousands)	61 (88–27; calc from )	78 (78–0; calc from )	162 (162–0; calc from )
Gross Profit Margin (%)	69.3% (61/88; calc from )	100.0% (78/78; calc from )	100.0% (162/162; calc from )

Key operating KPIs:

KPI	Q3 2018	Q4 2018	Q1 2019
R&D Expense ($USD Thousands)	1,830	2,497	2,649
SG&A Expense ($USD Thousands)	1,665	1,685	1,475
Net Cash Used in Operating Activities ($USD Thousands)	(3,500)	(3,600)	(3,360)
Cash & Cash Equivalents ($USD Thousands)	15,066	11,453	11,330

Metric	Period	Previous Guidance	Current Guidance	Change
R&D Spend / OpEx	FY 2019	None provided	“We expect increases in research and development costs as we advance the onvansertib clinical development programs in AML, mCRPC and mCRC.”	Qualitative increase (no formal range)

No formal quantitative guidance on revenue, margins, tax, or segment metrics was provided in Q1 2019 .

Topic	Previous Mentions (Q3 2018)	Previous Mentions (Q4 2018)	Current Period (Q1 2019)	Trend
R&D execution (AML/mCRPC/mCRC)	Dose escalation progress; preparing mCRC IND	AML activity in >88% evaluable patients; mCRC IND “study may proceed” planned enrollment mid-year	AML 50% CR/CRi at higher doses; early mCRPC PSA responses; mCRC trial funded and cleared to proceed	Strengthening clinical signals; accelerated execution
Regulatory/legal	EU Orphan Drug Designation for AML	EC granted Orphan Drug Designation	FDA “study may proceed” for mCRC	Continued progress
Financing/Nasdaq compliance	Cash $15.1M; planning financing strategies	Cash $11.5M	Reverse split 1:6; Nasdaq compliance regained; ~$3.0M warrants exercised	Improved listing status; incremental cash
IP/patents	MIT license; NPM1 claims allowed	New patent claim allowances; MIT license reiterated	New patent 10,155,006 for onvansertib + anti‑androgens combinations	Portfolio broadened
Product performance (mCRPC)	Safety lead-in completed; opening full enrollment	Poster overview; second dosing arm planned	Early PSA responses including AR‑V7 patients	Emerging efficacy signal
Corporate actions	—	—	Reverse split; regained compliance	Stabilization actions successful

“We achieved a number of key milestones in the first quarter of 2019…complete response…in 3 of 6 (50%) evaluable patients at the highest doses of onvansertib…in combination with decitabine.” — Dr. Thomas Adams, CEO .
“Early prostate specific antigen (PSA) response was observed…when onvansertib is added to abiraterone (Zytiga®) in 2 of 6 patients to-date; the first patient achieved the primary efficacy endpoint of disease stabilization.” .
“Received a ‘Study May Proceed’ notification from the FDA for our Phase 1b/2 trial in metastatic Colorectal Cancer (mCRC)…and subsequent agreement with PoC Capital to fund this trial.” .

No conference call was held for Q1 2019; the press release was issued in lieu of a call, so no analyst Q&A or live guidance commentary is available .

S&P Global consensus EPS and revenue estimates for Q1 2019 were not available via our data source at time of analysis; as such, we cannot provide a beat/miss framework for this quarter. We searched for Q1 2019 “Primary EPS Consensus Mean” and “Revenue Consensus Mean” but did not retrieve usable values due to access limitations.

Clinical momentum is building: AML complete responses at higher doses and early mCRPC activity in a resistant population are meaningful de‑risking signals for onvansertib across indications .
Funding and regulatory path in mCRC is in place (PoC Capital agreement; FDA “study may proceed”), setting up near-term enrollment and data catalysts at USC Norris and Mayo Clinic .
Operating discipline remains evident: SG&A down ~$1.0M YoY in Q1, though R&D increased ~$0.8M to support trials; cash burn modestly higher YoY .
Corporate actions stabilized listing status and added cash: 1-for-6 reverse split, Nasdaq compliance regained, ~$3.0M from warrant exercises; quarter-end cash ~$11.3M provides near-term runway .
Short-term trading implications: watch for ongoing AACR/ASCO‑GU readouts, AML dose escalation updates, and initial mCRC enrollment progress—each can drive sentiment in a catalyst‑driven micro‑cap .
Medium-term thesis: value creation hinges on translating early signals in AML/mCRPC/mCRC into robust, reproducible efficacy with manageable safety; continued IP strengthening and biomarker strategy may enhance differentiation .
Risk factors remain: ongoing need for financing, clinical uncertainty, and execution risk across multiple trials as highlighted in forward‑looking statements .