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Oncternal Therapeutics, Inc. (ONCT)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 results were in line with expectations for a development-stage biotech: grant revenue rose to $0.80M, OpEx held near $9.7M, and net loss was $8.6M ($2.89/share). Cash and short-term investments were $21.4M with runway into Q1 2025 .
  • Clinical execution advanced: ONCT-534 (DAARI) escalated through the 1,200 mg cohort with no dose-limiting toxicities (DLTs); initial clinical/biomarker data guided for Q3 2024 and additional readouts in Q4 2024 .
  • ONCT-808 (ROR1 CAR-T) is open and enrolling under revised protocol; management expects a clinical data update in Q4 2024; no DLTs observed in the current cohort .
  • Guidance timing shifted later vs prior quarter: ONCT-534 initial readout moved from late Q2 to Q3 2024; ONCT-808 update moved from “mid-2024” to Q4 2024—near-term stock catalysts hinge on those data readouts .
  • S&P Global Wall Street consensus for Q2 was unavailable for ONCT; therefore, no beat/miss determination versus estimates can be provided at this time.

What Went Well and What Went Wrong

  • What Went Well

    • Dose escalation and safety for ONCT-534: “We have not observed any dose-limiting toxicities or other concerning side effects… sixth dosing cohort…1,200 mg… now fully enrolled.”
    • Program momentum and timelines reaffirmed: “We plan to share an initial clinical data update for ONCT-534 later in the third quarter.”
    • Cash runway reiterated: “$21.4 million in cash… and no debt… sufficient to support our operations into the first quarter of 2025.”

  • What Went Wrong

    • Timing delays vs prior guidance: ONCT-534 initial data moved from late Q2 to Q3 2024; ONCT-808 update moved from “mid-2024” to Q4 2024 .
    • Continued high OpEx for a pre-revenue company: total operating expenses were $9.7M in Q2, with R&D at $6.6M and G&A at $3.1M .
    • Limited disclosure on 808 enrollment magnitude; management declined to provide counts in Q2 Q&A, which can frustrate visibility into program breadth .

Financial Results

MetricQ4 2023Q1 2024Q2 2024
Grant Revenue ($USD Millions)$0.30 $0.57 $0.80
Total Operating Expenses ($USD Millions)$9.9 $9.3 $9.7
R&D Expense ($USD Millions)$6.7 $6.0 $6.6
G&A Expense ($USD Millions)$3.3 $3.3 $3.1
Net Loss ($USD Millions)$(9.2) $(8.4) $(8.6)
Diluted EPS ($)$(3.11) $(2.83) $(2.89)
Weighted Avg. Shares (MM)2.95 ~2.96 2.96
Cash & Short-term Investments ($USD Millions)$34.3 $27.0 $21.4
Product Revenue / Gross Marginn/a (no commercial revenue)n/an/a

Notes:

  • Year-over-year compares are available within Q2 tables: Q2 2024 grant revenue $0.801M vs $0.106M in Q2 2023; net loss $8.559M vs $8.966M (improved YoY) .
  • Margins are not meaningful due to lack of product revenue.

KPIs and Liquidity

KPIQ4 2023Q1 2024Q2 2024
Cash RunwayInto 2025 Into Q1 2025 Into Q1 2025
Shares Outstanding (Approx.)2.9M ~3.0M ~3.0M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ONCT-534 initial clinical data2024Late Q2 2024 Q3 2024 Delayed
ONCT-534 additional data readouts2024Q4 2024 Q4 2024 Maintained
ONCT-808 clinical data update2024Mid-2024 Q4 2024 Delayed
Cash runwayThroughInto Q1 2025 Into Q1 2025 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’23, Q1’24)Current Period (Q2’24)Trend
ONCT-534 dose escalation and safetyQ4’23: 160 mg cohort fully enrolled; progressing per plan . Q1’24: 300 mg cohort fully enrolled; escalation to 600 mg anticipated; no unexpected DLTs .Sixth cohort at 1,200 mg fully enrolled; “no dose-limiting toxicities or other concerning side effects”; initial data in Q3 Improving execution; safety maintained
ONCT-808 protocol/safetyQ4’23: Grade 5 SAE at 3×10^6; protocol amendments to improve safety (eligibility, infection screening, lower doses) . Q1’24: Sites re-opened, investigators eager; dosing schedule defined (0.3 → 0.6 → 1.0×10^6; SRC to decide further) .Open and enrolling under amended protocol; “no dose-limiting toxicity” in current cohort; data update in Q4 Stabilizing; cautious optimism
Cash runway & OpEx disciplineQ4’23: runway into 2025; OpEx benefited from winding down zilo programs . Q1’24: runway into Q1’25 reaffirmed .Runway into Q1’25 reaffirmed; cash $21.4M at Q2 end Stable but shorter runway as cash declines
Disclosure/visibilityQ4’23/Q1’24: active communication on cohort progress and dosing schema .Enrollment counts for 808 not disclosed; timing pushed later in 2024 Slightly more conservative disclosures
Program catalystsQ4’23/Q1’24: 534 initial readout by late Q2; 808 mid-2024 .534 Q3 initial + Q4 further; 808 Q4 update Catalysts consolidated into H2’24

Management Commentary

  • CEO on 534 and 808 progress: “We have not observed any dose-limiting toxicities or other concerning side effects… sixth dosing cohort…1,200 milligrams…fully enrolled… We plan to share an initial clinical data update… later in the third quarter.”
  • CEO on 808 safety status: “There have been no dose-limiting toxicities observed in the current dosing cohort. We expect to report updated clinical results…in the fourth quarter of 2024.”
  • CFO on liquidity: “As of June 30, 2024, we had… $21.4 million in cash… and no debt. We believe these funds will be sufficient to support our operations into the first quarter of 2025.”

Q&A Highlights

  • Expected scope of 534 Q3 data: Early safety plus initial PSA parameters likely from earlier cohorts given limited follow-up; deeper efficacy and longer follow-up targeted for Q4 .
  • Potential 534 dose exploration above 1,200 mg: Management will decide with SRC based on PK, biomarkers, efficacy, and safety; higher daily tablet count is feasible (200 mg tablet) if warranted .
  • 808 enrollment disclosure: Company did not disclose counts; reiterated revised dosing regimen and absence of DLTs under current schema .

Estimates Context

  • S&P Global consensus for Q2 2024 (EPS and Revenue) was unavailable for ONCT at time of analysis (S&P Global mapping error returned by tool). As a result, no beat/miss assessment versus Street consensus can be provided.
  • Actuals for Q2 2024 are presented above; investors should focus on H2’24 clinical catalysts (534 Q3/Q4, 808 Q4) as primary stock drivers .

Key Takeaways for Investors

  • H2’24 is catalyst-heavy: 534 initial clinical/biomarker data in Q3 and additional in Q4; 808 update in Q4—these readouts are the likely stock movers .
  • 534 safety profile remains clean through 1,200 mg with no DLTs; early signals (e.g., PSA) expected to start emerging in Q3 with more mature data in Q4 .
  • 808 program is back enrolling under tighter eligibility and lower-dose schema; no DLTs in current cohort; update pushed to Q4—watch for durability and safety balance after prior Grade 5 event at higher dose in 2023 .
  • Cash runway into Q1 2025 provides a limited but adequate window to deliver the H2 readouts; absent partnership/financing, runway will be a key overhang to monitor as data approach .
  • Operating discipline is respectable for stage: OpEx ~ $9.7M, R&D $6.6M, G&A $3.1M in Q2; continued control will help extend runway into clinical catalysts .
  • Near-term positioning: Shares are likely to trade on 534’s initial Q3 safety/biomarker readout and the Q4 depth update; any early efficacy or compelling biomarker shifts could drive a re-rating given high unmet need in post-ARPI mCRPC .
  • Medium-term thesis: If 534 demonstrates activity against AR mutations and splice variants with acceptable tolerability, label expansion potential (earlier lines) could be meaningful; 808’s ability to treat CD19 CAR-T failures remains a differentiated angle pending safety/efficacy confirmation .

Supporting Sources:

  • Q2 2024 8-K and press release, including financials and milestones .
  • Q2 2024 earnings call transcript .
  • Prior quarters’ press releases and calls for trend and prior guidance .