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Oncternal Therapeutics, Inc. (ONCT)·Q3 2023 Earnings Summary

Executive Summary

  • ONCT reported Q3 2023 grant revenue of $0.2M, net loss of $9.9M, and EPS of $-0.17; cash and investments were $40.3M with no debt, and cash runway reiterated into 2025 .
  • The company advanced both clinical programs: ONCT-534 dosed first mCRPC patient and received FDA Fast Track in October; ONCT-808 treated additional R/R aggressive B-cell lymphoma patients with initial data expected in December 2023 and further readouts in 2024 .
  • Operating expenses rose sequentially to $10.6M vs $9.7M in Q2, reflecting the active clinical ramp; YoY net loss improved from $11.1M (Q3’22) to $9.9M (Q3’23) .
  • Near-term stock catalysts: ONCT-808 December data and ONCT-534 initial clinical data in 1H 2024; FDA Fast Track for ONCT-534 strengthens regulatory momentum .

What Went Well and What Went Wrong

What Went Well

  • Dosed first ONCT-534 mCRPC patient; FDA granted Fast Track designation in October 2023, validating unmet need and potential pathway acceleration .
  • ONCT-808 treated additional patients; management highlighted encouraging expansion and persistence of CAR-expressing T cells and expects initial clinical data in December 2023 .
  • Balance sheet resilience with $40.3M cash/investments, no debt, and runway into 2025 maintained, supporting upcoming clinical inflection points .

What Went Wrong

  • Sequential increase in total operating expenses to $10.6M from $9.7M in Q2, implying higher cash burn as trials ramp (though still below Q1’s $12.3M) .
  • Minimal revenue base continues (NIH grant-derived), leaving financials highly dependent on R&D execution rather than commercial revenue .
  • Consensus estimates were unavailable via S&P Global, limiting standard “beat/miss” framing for revenue and EPS this quarter [GetEstimates error].

Financial Results

MetricQ1 2023Q2 2023Q3 2023
Grant Revenue ($USD Millions)$0.2 $0.1 $0.2
Total Operating Expenses ($USD Millions)$12.3 $9.7 $10.6
R&D Expense ($USD Millions)$9.0 $6.6 $7.5
G&A Expense ($USD Millions)$3.3 $3.1 $3.1
Interest Income ($USD Millions)$0.656 $0.579 $0.528
Net Loss ($USD Millions)$(11.487) $(8.966) $(9.862)
EPS ($USD)$(0.20) $(0.15) $(0.17)
Cash & Short-term Investments ($USD Millions)$54.3 $45.5 $40.3
Shares Outstanding (Millions)58.7 ~58.7 ~59.0
MetricQ3 2022Q2 2023Q3 2023
Net Loss ($USD Millions)$(11.125) $(8.966) $(9.862)
EPS ($USD)$(0.21) $(0.15) $(0.17)
Total Operating Expenses ($USD Millions)$11.7 $9.7 $10.6
Grant Revenue ($USD Millions)Not clearly specified in text table $0.1 $0.2

Notes:

  • Revenue is derived from NIH R&D grants rather than product sales .
  • Margins are not meaningful given de minimis grant revenue; focus remains on OpEx discipline and clinical progress .

Segment breakdown: Not applicable (no commercial segments) .

KPIs:

  • Clinical progress: first ONCT-534 patient dosed; additional ONCT-808 patients treated; initial ONCT-808 data in December 2023; initial ONCT-534 data 1H 2024 .
  • Regulatory: FDA Fast Track granted for ONCT-534 in October 2023 .
  • Manufacturing/process: CAR-T manufacturing delivering large numbers of high-quality CAR-expressing T cells; potential to reduce vein-to-vein times .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThroughInto 2025 (Q1/Q2) Into 2025 (Q3) Maintained
ONCT-808 Initial Data2023By end of 2023 (Q1/Q2) December 2023 (Q3 call) Clarified timing
ONCT-808 Additional Data20242024 (Q1/Q2) 2024 (Q3) Maintained
ONCT-534 Study InitiationQ3 2023Initiate in Q3 2023 (Q2) First patient dosed Oct 2023 (Q3) Achieved
ONCT-534 Initial Data1H 20241H 2024 (Q1/Q2) 1H 2024 (Q3) Maintained
Regulatory Designation (ONCT-534)2023—FDA Fast Track (Oct 2023) New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2023, Q2 2023)Current Period (Q3 2023)Trend
R&D execution (534, 808)Q1: 808 study initiated; 534 IND-enabling completed . Q2: 534 IND cleared; first 808 patients dosed 534 first patient dosed; additional 808 patients treated; December data planned Accelerating
Regulatory/legalLimited prior mentions (no designations) FDA Fast Track for 534 (Oct 2023) Positive momentum
Manufacturing/processQ1: 8-day CAR-T manufacturing; bridging may be minimized . Q2: robust, reproducible, shorter than several approved CAR Ts High-quality CAR T output; potential reduced vein-to-vein times Strengthening
Prostate cancer landscape/positioningQ2: Targeting ARSI-resistant, oral option post-ARSI failure Addresses unmet need; commentary on PSMA4/SPLASH; preference for oral option post-ARPI resistance Confidence maintained
Dose strategy/Project OptimusQ1/Q2: Starting at 1M CAR cells/kg; quick escalation Explicit Project Optimus alignment; randomization across two dose levels Clarity improved
Cash runwayQ1/Q2: Into 2025 Into 2025 reiterated Maintained

Management Commentary

  • “We continue to execute on our plan to advance both ONCT-534… and ONCT-808… towards potential significant clinical inflection points by mid-2024… We believe ONCT-534 can address a significant unmet medical need… We have seen encouraging expansion and persistence of CAR expressing T cells… We look forward to presenting an initial data update by the end of 2023.” — James Breitmeyer, CEO (press release) .
  • “ONCT-534… received Fast Track Designation from FDA… We expect our initial clinical data readout in the first half of 2024… [ONCT-808] plan to announce initial clinical data in December… manufacturing process is delivering large numbers of high-quality CAR-expressing-T cells and may offer reduced vein-to-vein times.” — CEO remarks (call) .
  • “Grant revenue was $0.2M… total operating expenses $10.6M… Net loss $9.9M or $0.17 per share… $40.3M in cash and investments and no debt… sufficient to fund operations into 2025.” — Richard Vincent, CFO (call) ; (press release) .
  • “We have seen encouraging expansion and persistence of CAR-expressing T cells… positively correlated with clinical response in previous CD19 CAR-T studies.” — Salim Yazji, CMO (call) .

Q&A Highlights

  • Enrollment velocity for ONCT-534 and ONCT-808: Investigators enthusiastic; ample patient pools; early dose cohorts structured for rapid progression under Bayesian design (ONCT-534) .
  • Early efficacy expectations: Management optimistic for ONCT-808 efficacy to discuss in December; potential for quick complete responses analogous to other CAR-Ts .
  • Dose expansion criteria/durability: For post-CD19 CAR-T relapse patients, objective response and durability are key given short median PFS (~3 months) and OS (~6 months) in this setting .
  • Project Optimus: Intention to randomize between two dose levels to balance efficacy and safety before registration-directed studies .
  • Competitive context in mCRPC: Despite PSMA4/SPLASH developments, management sees strong demand for oral options post-ARPI resistance and remains confident in ONCT-534 opportunity .

Estimates Context

  • Wall Street consensus via S&P Global was unavailable for ONCT Q3 2023 due to missing mapping; therefore, standard beat/miss comparisons cannot be provided this quarter [GetEstimates error].
  • Near-term sell-side revisions are more likely to track clinical timelines (December 2023 ONCT-808 update; 1H 2024 ONCT-534 data) and regulatory progress (Fast Track), rather than revenue/EPS given grant-based revenue .
MetricQ3 2023 ActualQ3 2023 Consensus
Grant Revenue ($USD Millions)$0.2 N/A (consensus unavailable via S&P Global)
EPS ($USD)$(0.17) N/A (consensus unavailable via S&P Global)

Key Takeaways for Investors

  • Regulatory tailwind: FDA Fast Track for ONCT-534 enhances optionality for expedited interactions and potential future filings; strengthens mCRPC thesis post-ARPI resistance .
  • Near-term catalysts: Initial ONCT-808 data in December 2023 and further readouts in 2024; ONCT-534 initial data in 1H 2024 — these events are likely to be central to stock narrative .
  • Clinical execution: 534 first patient dosed and 808 additional patients treated; CAR-T manufacturing highlights (quality and vein-to-vein time) are constructive for scalability .
  • Balance sheet: $40.3M cash/investments, no debt, and runway into 2025 provide funding for planned data catalysts without near-term financing dependency .
  • Prostate cancer positioning: Management sees significant unmet need for an oral therapy post-ARPI resistance; commentary suggests confidence despite PSMA4/SPLASH developments .
  • Risk factors: Sequential OpEx increase (Q3 vs Q2) as programs ramp; outcomes in high-risk R/R aggressive B-NHL post-CD19 CAR-T population are inherently challenging .
  • Estimates unavailable: With S&P Global consensus missing, trading focus likely centers on clinical and regulatory milestones rather than quarterly P&L metrics [GetEstimates error] .