Oncternal Therapeutics, Inc. (ONCT)·Q4 2023 Earnings Summary

Executive Summary

• Q4 2023 was an operationally focused quarter: Oncternal advanced ONCT-534 (mCRPC) with the third dosing cohort fully enrolled and reiterated an initial data readout in Q2 2024; ONCT-808 (ROR1 CAR-T) showed an encouraging early response signal, though a Grade 5 SAE at a higher dose prompted protocol changes and a lower-dose re-escalation path .
• Financials: Grant revenue was $0.30M; total operating expenses fell to $9.9M, driving a net loss of $9.2M and a basic/diluted EPS of $(3.11); cash/short-term investments were $34.3M with no debt, and management guided cash runway into Q1 2025 .
• Cash burn moderated vs prior quarters as ZILO-301 wind-down reduced R&D outlays; management noted Q4 R&D was ~$1M below expectations, with non-cash SBC of ~$2.2M included in OpEx .
• Upcoming catalysts: initial ONCT-534 data in Q2 2024 and ONCT-808 mid-2024; reverse split (1-for-20) executed in January 2024, restoring Nasdaq compliance and aligning reported share/EPS metrics going forward .

What Went Well and What Went Wrong

What Went Well

• ONCT-534 enrollment and dose escalation are on plan; third cohort (160 mg) fully enrolled with initial clinical readout expected in Q2 2024. Management reiterated belief in the novel mechanism and multi-billion dollar potential if moved earlier in the treatment paradigm .
• ONCT-808 showed an encouraging signal at the initial dose (1×10^6 CAR T cells/kg): 2/3 complete metabolic responses and 1/3 partial response at the December 4, 2023 cutoff .
• Cost control: OpEx trended down; R&D undershot expectations due to efficient ZILO-301 program wrap-up and in-house work, supporting cash runway into Q1 2025 .

What Went Wrong

• Safety event at higher ONCT-808 dose (3×10^6 CAR T cells/kg): one fatal SAE consistent with CRS/ICANS in an elderly patient with bulky disease, prompting protocol amendments to ensure safety and to test lower doses .
• Revenue remains limited to NIH grants ($0.30M), making traditional margin analysis non-informative; net losses persist as programs advance without product revenue .
• Estimate comparisons unavailable: S&P Global consensus mapping not provided for ONCT, limiting “beat/miss” quantification versus Street expectations (S&P Global data unavailable).

Financial Results

Notes:

• Q4 2023 EPS/share counts reflect post–reverse split reporting; Q2–Q3 2023 figures reflect pre-split reporting, limiting direct EPS comparability across quarters .

Actual vs Estimates (S&P Global):

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We are encouraged by the progress in our clinical programs… ONCT-534… initial clinical readout in the second quarter… ONCT-808… encouraging initial response results… protocol amendments will further ensure patient safety...” — James Breitmeyer, CEO .
• “Our grant revenue was $0.3 million… total operating expenses… $9.9 million… Net loss… $9.2 million… $34.3 million in cash… no debt… sufficient to fund operations into the first quarter of 2025.” — Richard Vincent, CFO .
• “We have been able to dose escalate as planned without unexpected dose-limiting toxicities… third dosing cohort of 160 mg… fully enrolled.” — James Breitmeyer (ONCT-534) .
• “Encouraging response signal at the initial dose… two of the three patients achieving CMR and the third achieving PR… [but] fatal SAE at 3×10^6… we decided to implement… protocol changes…” — Press release highlights .

Q&A Highlights

• ONCT-534 dosing/data timing: Management expects to discuss both 160 mg and 300 mg cohorts by end of Q2 2024, subject to trial progress .
• ONCT-808 revised dose schedule: New cohorts at 0.3×10^6, 0.6×10^6, then 1×10^6, with SRC potentially deciding intermediate doses between 1 and 3×10^6 based on observed safety/efficacy .
• IRB/FDA process: FDA agreed to protocol changes; IRBs processing logistics; investigators eager with identified patients, suggesting recruitment may restart swiftly .
• OpEx/cash burn: Q4 R&D lower due to ZILO-301 efficient wind-down; cash burn excluding ~$2M SBC is ~$7.5–$9M as enrollment ticks up .
• Market sizing: ONCT-534 TAM “near $1B” in post-ARPI mCRPC; multibillion potential if moved earlier (native AR activity) .

Estimates Context

• S&P Global consensus estimates for Q4 2023 revenue and EPS were unavailable for ONCT due to missing CIQ mapping; therefore, formal beat/miss analysis versus Street consensus cannot be determined (S&P Global data unavailable).
• Given program milestones in 2024 and refined cash runway to Q1 2025, Street models may revisit OpEx cadence (R&D/G&A) and timing of clinical readouts; management commentary suggests cost controls from program wind-downs, but enrollment could push cash burn toward the upper end of the stated range .

Key Takeaways for Investors

• Clinical catalysts are near term: ONCT-534 initial data in Q2 2024 and ONCT-808 mid-2024; stock likely sensitive to efficacy/safety signals and dose optimization outcomes .
• ONCT-534 narrative strengthening: activity against native AR supports earlier-line potential and a larger TAM; any PSA/response signals at 160–300 mg could be pivotal .
• ONCT-808 risk-reward recalibration: early efficacy at 1×10^6 is encouraging; the safety event at 3×10^6 reorients the program to a lower-dose strategy—watch for CRS/ICANS profile and durability of responses .
• Cash runway into Q1 2025 with no debt provides operational flexibility through multiple data readouts; monitor quarterly burn and SBC impact to gauge any financing needs .
• Reverse split completed in January 2024; EPS/share comparability across 2023 quarters is limited—focus on absolute OpEx trends and cash balance trajectory .
• Absence of available Street consensus reduces near-term “beat/miss” catalysts; trading likely driven by clinical updates and safety/regulatory clarity (S&P Global data unavailable).
• Medium-term thesis: If ONCT-534 demonstrates compelling efficacy and tolerability post-ARPI and ONCT-808 shows durable responses with manageable safety, the company could unlock substantial value in high-unmet-need oncology segments .