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Cardiff Oncology, Inc. (CRDF)·Q2 2019 Earnings Summary

Executive Summary

  • Q2 2019 total revenues were $0.138M, up year-over-year from $0.112M, and down sequentially from $0.162M; diluted EPS improved to $(0.79) vs $(1.02) in Q1 2019 and $(5.27) in Q2 2018 .
  • Operating expenses were $4.4M (R&D $2.8M; SG&A $1.5M); loss from operations was $(4.22)M; period-end cash and cash equivalents were $10.8M, providing near-term liquidity for clinical programs .
  • Pipeline milestones included initiation of a Phase 1b/2 mCRC trial (KRAS-mutant) at USC/Mayo, acceptance of three ESMO abstracts (including an oral presentation for AML), and preclinical synergy with venetoclax in AML; management did not host an earnings call and instead issued a press release .
  • Near-term catalysts: ESMO oral AML presentation (Sep 27–Oct 1, 2019) and preliminary safety/efficacy readouts later in 2019 from ongoing trials (AML, mCRPC, mCRC) .

What Went Well and What Went Wrong

What Went Well

  • Strong clinical momentum: “We continue to make great progress with our clinical development of onvansertib with three clinical trials actively enrolling patients and advancing as planned,” including mCRC enrollment initiation and upcoming ESMO presentations .
  • AML progress: Updated Phase 1b/2 AML data show complete responses (CR and CRi) at higher doses with decitabine and no dose-limiting toxicities; ~90% clinical benefit to-date, supporting continued dose escalation .
  • Emerging combinations: Preclinical data demonstrated significant synergy of onvansertib with venetoclax in AML models; collaboration initiated with Nektar to evaluate onvansertib + ONZEALD in CRC models .

What Went Wrong

  • Continued operating losses: Loss from operations $(4.22)M and net loss $(4.13)M persist as R&D scales across programs; SG&A declined, but absolute OpEx remains elevated for a development-stage oncology company .
  • Sequential revenue dip: Revenues decreased to $0.138M from $0.162M in Q1 2019 (royalties and services/other), reflecting limited commercial activity during clinical focus .
  • Financing needs flagged: Risk factors reiterated include need for additional financing and ability to continue as a going concern, underscoring capital dependence to fund trials .

Financial Results

Metric (USD)Q4 2018Q1 2019Q2 2019
Total Revenues ($000s)$78 $162 $138
Royalties ($000s)$76 $62 $37
Services & Other ($000s)$2 $100 $101
Cost of Revenues ($000s)$0 $0 $0
Research & Development ($000s)$2,497 $2,649 $2,830
SG&A ($000s)$1,685 $1,475 $1,528
Total Operating Expenses ($000s)$4,182 $4,124 $4,358
Loss from Operations ($000s)$(4,104) $(3,962) $(4,220)
Net Loss ($000s)$(4,159) $(3,905) $(4,125)
EPS – Basic/Diluted ($)$(1.09) $(1.02) $(0.79)
Weighted Avg Diluted Shares (000s)3,832 4,087 5,242
Cash & Cash Equivalents ($000s, period-end)$11,453 $11,330 $10,791

Year-over-Year comparison (Q2 2019 vs Q2 2018):

Metric (USD)Q2 2018Q2 2019
Total Revenues ($000s)$112 $138
EPS – Basic/Diluted ($)$(5.27) $(0.79)
Total Operating Expenses ($000s)$4,551 $4,358

Segment breakdown: Not applicable; no reportable segments disclosed .

KPIs:

  • Net cash used in operating activities: Q2 2019 $3.4M vs $3.3M in Q2 2018 (press release narrative) .
  • Weighted-average diluted shares: 5.242M in Q2 2019 (reflecting capital raises/exercises) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Formal Revenue/EPS GuidanceFY/Q2 2019None disclosed None disclosed (press release only; no call) Maintained (none)
R&D Spending DirectionFY 2019Not previously quantified“We expect increases in research and development costs as we advance the onvansertib clinical development programs in AML, mCRPC and mCRC.” Raised (directional)
Cash Runway/Capital PlanFY 2019Not quantifiedEquity investments of $3.0M at premium in April/May 2019; exercises of warrants YTD; cash $10.8M at 6/30 Update (liquidity actions)

No tax, margin, OI&E, or dividend guidance was provided .

Earnings Call Themes & Trends

No earnings call was held for Q2 2019; the company issued a press release in lieu of conducting a conference call . The table below tracks narrative themes across prior quarters and the current press release.

TopicPrevious Mentions (Q4 2018)Previous Mentions (Q1 2019)Current Period (Q2 2019)Trend
R&D execution (AML, mCRPC, mCRC)AML showing activity in >88% evaluable patients; mCRPC opened to full enrollment; mCRC IND cleared, mid-year start expected AML dose escalation with CR/CRi at higher doses; mCRC study may proceed; mCRPC responses emerging Three trials actively enrolling; AML CR/CRi at highest doses; mCRC enrollment initiated; mCRPC first patient achieved disease stabilization Strengthening
Regulatory/Scientific presentationsASH AML poster; ASCO-GU mCRPC poster AACR AML update; ASCO-GU mCRPC poster ESMO acceptance (3 abstracts; AML oral presentation) Positive visibility
Partnerships/CombinationsMIT license for PLK inhibitor + anti-androgen; biomarker approach initiatives PoC Capital funding for mCRC study Nektar collaboration (ONZEALD) in CRC models; venetoclax synergy in AML Expanding
Financing/LiquidityCash $11.5M at 12/31; noted OpEx trends Cash $11.3M at 3/31; operating cash usage $3.0M equity investments at premium; cash $10.8M at 6/30; warrant exercises Active capital management
Risk/DisclosuresNeed for financing; going concern; trial risks reiterated Same language reiterated Same language reiterated Ongoing

Management Commentary

  • “We continue to make great progress with our clinical development of onvansertib with three clinical trials actively enrolling patients and advancing as planned.” — Dr. Thomas Adams, CEO .
  • “We initiated enrollment in our third study, a Phase 1b/2 clinical trial in metastatic Colorectal Cancer (mCRC)… and look forward to providing preliminary safety and efficacy readouts later this year.” .
  • “Preclinical data demonstrating significant synergy of onvansertib in combination with venetoclax… [and] updates to our Phase1b/2 AML trial showing patients achieving a complete response (CR and CRi)… early data from our Phase 2 study… demonstrating response to treatment and the first patient to achieve the primary efficacy endpoint…” .

Q&A Highlights

  • No earnings call was conducted; the company issued the press release in lieu of an earnings call. Therefore, no Q&A session or additional guidance clarifications were provided .

Estimates Context

  • Wall Street consensus (S&P Global) for Q2 2019 could not be retrieved during this session; therefore, comparisons to consensus for revenue and EPS are unavailable at this time. Values retrieved from S&P Global were unavailable due to system limits.*

Key Takeaways for Investors

  • Clinical traction is building: mCRC enrollment initiation and AML/mCRPC signals, plus ESMO oral AML presentation, should drive data flow and potential sentiment improvement in 2H19 .
  • Operating losses are consistent with development-stage oncology; R&D spend is increasing as trials advance, while SG&A is trending lower YoY, reflecting focus on clinical execution .
  • Liquidity actions (premium equity investments; warrant exercises) and ~$10.8M cash at quarter-end support near-term operations, but management reiterates financing risks typical of clinical-stage companies .
  • Revenue remains immaterial and variable (royalties and services), underscoring that value creation hinges on clinical data, regulatory progress, and partnership optionality rather than near-term sales .
  • Absent an earnings call, the press release was the sole source for Q2 disclosures; investors should monitor upcoming conference presentations and trial updates for catalysts and risk management cues .
  • Partnerships and combination strategies (venetoclax in AML, ONZEALD in CRC) broaden the therapeutic rationale and could support differentiated positioning if clinical efficacy translates .

Notes:

  • CRDF operated as Trovagene, Inc. during the period; all figures are from company filings/press releases .
  • No non-GAAP adjustments were disclosed; tables reflect GAAP condensed statements from exhibits .