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Context Therapeutics Inc. (CNTX)·Q4 2022 Earnings Summary

Executive Summary

  • Q4 2022 capped a strategic pivot: Context discontinued ONA-XR and refocused on CTIM-76 (CLDN6 x CD3 bispecific), extending cash runway into late 2024 .
  • Preclinical CTIM-76 data and IND-enabling work progressed; IND filing targeted for Q1 2024, setting the near-term catalyst path .
  • Financials remain pre-revenue; FY net loss was $14.8M and Q4 EPS was approximately $(0.22) (calculated from FY and 9M results) .
  • Consensus estimates (EPS, revenue) were unavailable in S&P Global for CNTX at the time of review; investors should anchor on the cash runway and development milestones (S&P Global estimates unavailable).
  • Stock reaction catalysts: program discontinuation and CLDN6 nomination; upcoming IND for CTIM-76 and AACR data presentations were highlighted as external visibility drivers .

What Went Well and What Went Wrong

What Went Well

  • CTIM-76 nominated as lead CLDN6 x CD3 bispecific candidate; IND-enabling underway and IND targeted for Q1 2024: “We selected this bispecific based on the specificity... With the selection of CTIM-76... we are well-positioned to rapidly advance our clinical development plan... IND... in Q1 2024.” — CEO Martin Lehr .
  • Strong preclinical selectivity and potency for CTIM-76 with wide therapeutic window; minimal off-target binding (CLDN3/4/9) and cytokine activation reported in multiple assays .
  • Cash runway extended into late 2024 via portfolio prioritization: “Cash runway extended into late 2024” and focus on CTIM-76 .

What Went Wrong

  • ONA-XR discontinued: elevated LFTs observed in OATH (three patients; one discontinuation) and increased costs/delays to mitigate abnormalities led to program cessation .
  • Competitive pressure in breast cancer (e.g., Enhertu, capivasertib) reduced perceived ONA-XR commercial viability, contributing to the pivot .
  • Pre-revenue status persists, driving continued operating losses and reliance on external financing; FY net loss increased vs prior year ($14.8M vs $10.5M) on higher R&D/G&A .

Financial Results

Quarterly P&L and Cash

MetricQ1 2022Q2 2022Q3 2022Q4 2022
Revenues ($USD)$0 $0 $0 $0
Net Loss ($USD)$(3.438M) $(3.987M) $(3.854M) $(3.557M) (calculated from FY $14.836M and 9M $11.279M )
Diluted EPS ($)$(0.22) $(0.25) $(0.24) $(0.22) (calculated from FY $(0.93) and 9M $(0.71) )
Cash & Equivalents ($USD)$45.728M $42.921M $39.427M $35.497M

Notes: Company has not recognized revenue since inception .

Operating Expenses by Quarter

MetricQ1 2022Q2 2022Q3 2022Q4 2022
R&D Expense ($USD)$1.351M $1.517M $2.078M $2.144M (calculated from FY $7.091M )
G&A Expense ($USD)$2.091M $1.991M $1.971M $1.737M (calculated from FY $7.790M )
Acquired IPR&D ($USD)$0 $0.500M $0 $0

Margins (not meaningful in pre-revenue)

MetricQ1 2022Q2 2022Q3 2022Q4 2022
Net Income Margin %NM (pre-revenue) NM (pre-revenue) NM (pre-revenue) NM (pre-revenue)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany-levelInto Q1 2024 (Sept 2022) Into late 2024 (Mar 2023) Raised/Extended
CTIM-76 IND FilingProgramCandidate selected Q4 2022; IND-enabling underway IND submission expected Q1 2024 Maintained timeline
ONA-XR DevelopmentProgramMultiple Phase 2/1b trials ongoing Discontinued; strategic options to be explored Lowered/Stopped

Earnings Call Themes & Trends

(Company did not furnish an earnings call transcript for Q4 2022; themes synthesized from filings and press releases.)

TopicPrevious Mentions (Q-2 and Q-1 2022)Current Period (Q4 2022)Trend
R&D execution (CLDN6)CLDN6 collaboration; milestone paid; candidate selection anticipated CTIM-76 nominated; preclinical specificity/potency; IND-enabling; IND Q1 2024 Strengthening
ONA-XR clinical statusMultiple Phase 2/1b trials underway (SMILE, OATH, ELONA) Preliminary SMILE data (4-month PFS 44%); OATH LFT elevations; discontinuation decision Mixed → Discontinued
Manufacturing partnershipsLonza development & license agreements signed Nov 2022 Lonza cited as GMP partner for CTIM-76 Executing
Cash runwayTo Q4 2023/Q1 2024 (Q2/Q3 guidance) Extended to late 2024 via portfolio prioritization Improving
Competitive landscapeBreast cancer competition acknowledged Enhanced emphasis on CLDN6 vs CAR-T/ADC competitors; Astellas/Ganymed and BioNTech landscape Refocus to immuno-oncology

Management Commentary

  • “Given the challenging market conditions... increasingly competitive landscape for breast cancer treatments, and recent study findings, we have decided to discontinue the development of ONA-XR... shifting our development focus to our compelling preclinical asset CTIM-76.” — CEO Martin Lehr .
  • “We’re pleased that preclinical data regarding CTIM-76 will be presented at AACR... and look forward to hosting an investor R&D webinar...” — CEO Martin Lehr .
  • “We selected this bispecific based on the specificity... well-positioned to rapidly advance our clinical development plan... IND... Q1 2024.” — CEO Martin Lehr .

Q&A Highlights

No Q4 2022 earnings call transcript was found; therefore, no management Q&A was available to assess guidance clarifications or tone changes (no transcript available) [ListDocuments returned none].

Estimates Context

  • Wall Street consensus EPS and revenue estimates from S&P Global were unavailable for CNTX for Q4 2022 at the time of review (S&P Global estimates unavailable).
  • Without consensus, investors should focus on cash runway, operating burn and milestone timing (CTIM-76 IND Q1 2024) .

Key Takeaways for Investors

  • The pivot away from ONA-XR reduces clinical risk/costs and extends runway into late 2024; near-term value inflection shifts to CTIM-76 IND submission and initial clinical entry .
  • CTIM-76 shows compelling preclinical selectivity/potency with a wide therapeutic window—positioned competitively against CLDN6 CAR-T/ADC approaches; manufacturing aligned via Lonza .
  • Financial profile remains pre-revenue; Q4 net loss ($3.6M) and steady quarterly burn ($3.5–$4.0M) highlight cash discipline post-prioritization .
  • Discontinuation of ONA-XR removes potential liver safety overhang from the portfolio; competitive breast cancer landscape acknowledged as headwind .
  • Upcoming catalysts: AACR preclinical updates (as referenced) and the IND submission for CTIM-76 in Q1 2024 .
  • Absence of Street estimates reduces traditional “beat/miss” framing; monitor operating expense trendlines and cash balances each quarter .

Appendix: Prior Quarter Press Releases and Program Updates

  • Dec 8, 2022: SMILE Phase 2 preliminary data (4-month PFS 44%) and ELONA trial design; safety/tolerability noted .
  • Dec 1, 2022: CTIM-76 nominated as lead CLDN6 x CD3 bispecific; IND Q1 2024; R&D webinar .
  • Q3 2022 10-Q: Lonza agreements (development and license) for CTIM-76 manufacturing; cash $39.4M at 9/30/22 .